The United Republic of Tanzania

MINISTRY OF HEALTH AND SOCIAL WELFARE

TEACHING GUIDES FOR NATIONAL TECHNICAL AWARDS (NTA) LEVEL 6 CURRICULUM

FOR MEDICAL LABORATORY SCIENCES SCHOOLS IN TANZANIA

VETA, MOROGORO

APRIL 16 – 27, 2012

 GROUP PHOTOGRAPH OF THE PARTICIPANTS

PREPARATION OF TEACHING GUIDES FOR NTA LEVEL 6 CURRICULUM FOR MEDICAL

LABORATORY SCIENCES SCHOOLS, VETA, MOROGORO, APRIL 26, 2012
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List of Abbreviations and Acronyms
ABS - Absorbance
AIDS - Acquired human immunodeficiency syndrome
AMREF - African Medical Research Foundation
ASCP - American Society for Clinical Pathology
ATCC - American Type Culture Collection
CD4 - Cluster of differentiation
CDC - Centres for Disease Control and Prevention
CLSI - Clinical and Laboratory Standards Institute
Conc - Concentration
CSF - Cerebral spinal fluid
CV - Coefficient of variation
DBS - Dried Blood Sample
EDTA - Ethylene-diamine-tetraacetic acid
EIA - Enzyme immunoassay
EQA - External Quality Assurance
FBC - Full Blood Count
FN - False negative
FP - False positive
g - gram
GP - Good Practice
HCL - Hydrochloric acid
HIV - Human immunodeficiency virus
ID - Identity
IP - Implementation Plan
IQA - Internal Quality Assurance
IQC - Internal Quality Control
ISO - International Standards Organisation
IU/L - International Unit per litre
IUPAC - International Union of Pure and Applied Chemistry
MAC - MacConkey
ml - millilitre
MLT - Medical Laboratory Technology
MOHSW - Ministry of Health Social Welfare
MSDS - Material Safety Data Sheets
NCCLS - National Committee for Clinical Laboratory Standards
NIH - National Institutes of Health
NTA - National Technical Awards
o
C - Degrees Centigrade
OPD - Out-patient Department
PDCA - Plan, Do Check and Act
pH - potential of hydrogen
PT - Proficiency Testing
QA - Quality Assurance
QC - Quality Control
SD - Standard Deviation
SGOT/AST Serum glutamic oxaloacetic transaminase/Aspartate
transaminase

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SGPT/ALT Serum glutamic pyruvic transaminase/Alanine
Aminotransferase
SLMTA - Strengthening Laboratory Management Towards Accreditation
SOPs - Standard Operating Procedures
STAT - immediate, urgent, rush used in medical laboratory
STD - Standard
TAT - Turnaround Time
TN - True negative
TP - True positive
TPHA - Treponema pallidum haemagglutination
TPPA - Treponema pallidum particle agglutination
VDRL - Veneral Disease Research Laboratories
WHO - World Health Organization
µl - microliter

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Acknowledgement
The development of these Teaching Guides for National Technical Awards Level 6 for the
Competence-Based curriculum for Medical Laboratory Sciences has been accomplished through
involvement of different partners and stakeholders.

Special thanks go to the American Society for Clinical Pathology (ASCP) for funding the
activity and participants’ employers for allowing the team members to participate in the review.

I wish also to take this opportunity to acknowledge the Diagnostic Services Section in the
Hospital Services Department of Ministry of Health and Social Services (MOHSW) for their
tireless efforts in looking for the funds and their participation in this exercise.

Likewise, I do recognise great ideas and contributions by consultants from ASCP, Centre for
Disease Control and Prevention (CDC), AMREF, CEDHA, , Muhimbili University of Health
and Allied Sciences (MUHAS), Muhimbili National Hospital, Mwalimu Nyerere Memorial
Academy (MNMA), School of Medical Laboratory Sciences from: Muhimbili, Singida, Nkinga,
Kolandoto College of Health Sciences (KCHS), Ruaha University College (RUCO), Mvumi,
College of Health Sciences Zanzibar; and Mt. Meru Regional Hospital, Arusha and MOHSW
staff from the Diagnostic Services, NHLQATC, HES and National Blood Transfusion Services
(NBTS)

The list of those who contributed to this great job is too long to be registered here. The Human
Resources Development Directorate, MOHSW as a whole therefore wishes to take this
opportunity to thank all those who actively took part in these teaching guides for the betterment
of health services development in Tanzania.

The Government of United Republic of Tanzania through its Partnership Framework with the
US Government recognises the PEPFAR funding support through CDC to the MOHSW

Type Name of the Official

Type Title

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Foreword
The MOHSW is committed to provide comprehensive access to quality health services for all
Tanzanians in line with the Tanzania Development Vision 2025 (TDV2025) and Millennium
Development goals (MDGs)

In order to attain these goals, the MOHSW established PHC Development Programme.
Among the strategies laid down in this programme is the human development to meet the
human resource demand for health and a balanced skill mix.

In order to achieve the goal, the MOHSW with support from ASCP organised a laboratory
experts workshop to the prepare the Teaching Guide for NTA Level 6 Curriculum for
Medical Laboratory Schools in Tanzania. Members of the workshop were:

1 Dr. C.G. Massambu, Assistant Director–Diagnostic Services, MOHSW

2 Majige Dickson, Ag. HLS, Laboratory Technologist, MOHSW
3 Sufi Jaffar, Laboratory Manager, NHLQATC, MOHSW
4 Nsunza Manase, Principal HLTS, Singida
5 Mjilima Jackson, Principal HLTS, Mvumi, Dodoma
6 Bukuru Nestory, Head S/RUCO, Iringa
7 Makelemo Joram S., Laboratory Scientist, National Health Laboratory Quality Assurance
and Training Centre, MOHSW
8 Kuwoko Lucas, Laboratory Tutor, RUCO, Iringa
9 Kusuhibwa Peter S., Principal Nkinga Health Laboratory School, Tabora
10 Isaliga Malimi S., Principal, Kolandoto College of Health Services, Kolandoto,
Shinyanga
11 Ellinger Pat, Consultant, ASCP, USA
12 Arneson Wendy, Trainer, ASCP, USA
13 Ramadhan Jaku I., Laboratory Technologist, Zanzibar
14 Shayo Jackson, Computer Analysis, CEDHA, Arusha
15 Msami Fildonin, Laboratory Technologist, Mount Meru Hospital, Arusha.
16 Maliki Shaban, Laboratory Scientist, Singida HTC
17 Shija Esther, Laboratory Technologist, MNH
18 Hongoli Godfrey, Histo-Technologist, MUHAS
19 Mlingi Grace, Laboratory Technologist, NBTS
20 Dr. Edda Vuhahula, Senior Lecturer, MUHAS
21 Mgaya Vincent Y., Retired HLS, DSM
22 Binto M. Binto , Assistant Lecturer , Mwalimu Nyerere Memorial Academy
23 Towo Ndeonasia A., Quality Safety Officer, NBTS
24 Ntambuto O. Sostenes, Laboratory Scientist, SMLS MUHAS
25 Dr. Theodore Tigahwa, Health Education Expert, HES, MOHSW
26 Ocheng David, Project Manager, AMREF Tanzania
27 Marogo Jackson K., Senior Laboratory Scientist, NHL QATC
28 Siriwa Martha, Support Staff (Secretary), Diagnostic, MOHSW
29 Mandari Nathan, Support Staff (Driver), MOHSW

The MOHSW hopes that these Teaching Guides for NTA Level 6 Curriculum will enable
tutors in our health laboratory sciences training schools to effectively and efficiently deliver
the competence-based curriculum developed by the MOHSW for this level.

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Type Name of the Official
Type Title

8
Executive Summary

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Chapter One

Module Code MLT06101: Laboratory Management Leadership

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Session 1: Name: Organization

NTA Level 6, Semester 1, Module Code: MLT 06101 – Name; Laboratory Management
and Leadership

Total Session Time: 120 minutes

Prerequisites Modules;
 MLT 05214 - Planned Preventive Maintenance of Laboratory Equipment and Instrument.
 MLT 05212 -Maintenance of Laboratory Supplies

Learning Objectives

Upon completion of this module, the students are expected to be able to:
1. Define the term organisation
2. Describe key components of organisation
3. List organizational functions and describe the situation in which each is required
4. Understand the functions of organogram and prepare organogram for laboratory services

Step 2: Definition of Term (10 minutes)

 Organization is a collection of people working together under a defined structure for the
purpose of achieving pre-determined outcomes through the use of financial, human and
material resources.
 Organizations serve the following functions;
 Provide society with products and services
 Offer employment and economic exchange for members
 Give a framework for a social system (Organization are social habitats for people)
 Success of any organization is a function of the capabilities of the individuals rather than
they way in, which they are organized. It performs best where information flows is rapid
both internally and externally to permit accurate decision to be made. The clinical
laboratory is typically an organization within health system that provides specific
services, which are vital to the overall mission of providing patient care.
 Understanding basic concepts of organization structure and function can give insight into
how we act and react in our own systems as talented personnel performs much better in
well-structured and good organization. Clinical laboratory personnel need to understand
the structure and politics of the organization. Such appreciation can foster better
understanding of system decision and help in career advancement opportunities. The
laboratory needs to have a working structure that;
 Defines the role of all staff in quality system
 Allocates sufficient resources to implement and monitor a quality operation (Ex.
Quality Coordinator)
 Builds in quality systems at all points in the laboratory workflow
 The role of the management is to facilitate the achievement of organization goals in an
effective and efficient manner by working through people within defined boundaries. It
concerns with the direction and control of various activities to attain organization
objectives. In other words laboratory managements’ Job helps:

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  To accomplish goals
 With people
 Using resources effectively
 In a quality organization

Step 3: Key Components of organisation (10 minutes)

 The operating organizations are the major components that transform the inputs to the
outputs through the implementation of organizational strategy.
 The following elements are represented in the organization;
 Work- The tasks performed to provide the products or services
 People-Including skills, knowledge, and workforce expectations
 Formal Organization- Formal structures, policies, and procedures for performing the
work
 Informal Organization-Culture and informal rules and understanding about how the
system works

Source: Laboratory Management: Principles and Processes by Harmening

Drawn by Wendy Arneson

• The lack of fit between any of the components of the operating organization being
informal and formal structures, people and work requirements-will compromise the
system and can produce a huge problems including operational inefficiencies, tension
among personnel, morale problems, miscommunication and overall dysfunction of the
organization.

Step 4: Organizational functions (50 minutes)

• Management is needed at every level in the organization. Effective management is a
process that begins with establishment of goals and ends with assessment of the
achievement of those goals. Within this process are functions that enable these goals to be
realized. These basic functions include;
 Organizing
 Planning
 Directing/coordinates
 Controlling

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  Decision Making

ORGANIZING:
 Is the process of determining the steps needed to implement successful plan. It includes
allocating or reallocating resources including equipments, funds, time and or staffing.
Organizing brings structure to your plan by detailing what has to be done, who has to do
it and how it is going to be done.
 As a management function, organizing is a skill that contains a number of activities and
responsibilities. Effectively organizing and leading a workforce requires prioritizing,
coordinating, communicating, collaborating, team building and directing.
 Priority may be established based on urgency or availability of resources. Prioritizing will
allow you to more appropriately allocate the resources identified. Clearly setting priorities
for the laboratory is a primary responsibility of the laboratory manager.
 Delegation of responsibility as an organization process for coordination of activities
 Once the duties and responsibility of every individual have been fixed, one must be given
authority necessary to carry out the duties assigned to him. A chain of command is
created from top to bottom through successive delegation of authority.
 Delegation is the assignment of authority and responsibility to another person (normally
from Manger to subordinates. It empowers subordinates to make decision.
• Key aspect is ability to delegate and track/manage all projects
 Authority delegated to an individual manager should be adequate to enable him to
accomplish results expected of him. Authority should be delegated to the lowest possible
level, consistent with necessary control so that coordination and decision-making can take
place as close as possible to the point of action

Delegation Process
• What to delegate
• Routine tasks that are not management sensitive
• Who to choose
• A willing candidate with the talent and experience needed for success
• How to delegate
• Define goals, expectations, timelines, and report back intervals

At the end of the day the one who delegates will be responsible for tasks delegated to
delegatee.

• Authority - in context of a business organization can be defined as the power and right of
a person to use and allocate the resources efficiently, to take decisions and to give orders
so as to achieve the organizational objectives. Authority must be well defined. All people
who have the authority should know what is the scope of their authority is and they
shouldn’t misutilize it. Authority is the right to give commands, orders and get the things
done. The top-level management has greatest authority. Authority always flows from top
to bottom. It explains how a superior gets work done from his subordinate by clearly
explaining what is expected of him and how he should go about it. Authority should be
accompanied with an equal amount of responsibility. Delegating the authority to someone
else doesn’t imply escaping from accountability. Accountability still rests with the person
having the utmost authority.
• Responsibility - is the duty of the person to complete the task assigned to him. A person
who is given the responsibility should ensure that he accomplishes the tasks assigned to
him. If the tasks for which he was held responsible are not completed, then he should not

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 give explanations or excuses. Responsibility without adequate authority leads to
discontent and dissatisfaction among the person.
• Exercise:
 Are tasks delegated appropriately within your laboratory?
o Are there tasks that your manager or supervisor could delegate to you?
o Are there tasks you could delegate to others?

Organizing Your Time

 Organize available time each day (planner or calendar); set aside time for staff
interactions, planning, and administrative functions
 Create and manage a to do list; accomplish the number one priority first and work down
the list; check off completed items
 Determine best use of time available each day – the 20 % that will yield most results
 Schedule routine daily functions at the same time each day if possible – email, voicemail,
reading mail
 Do not allow time wasters to get in the way; manage interruptions
 Organize the office with a place for everything- keep desk and files clean and organized
 Date stamp everything that enters the office; enter due date on all items with a deadline
 Touch paper only once- move to the outbox or completed area, to files, or to trash
 Manage mail daily- in one day, out the next
 Identify the fastest, most efficient way to work
 Meet only if necessary and keep short
 Say no to things that drag on productive time

Exercise; Discussion: Organizing Your Time

• How can you better manage your time on a daily basis?

*To conclude, the process of organizing is a series of steps, which must be undertaken to
create a logical structure of authority-responsibility relationship. This process involves
division of work, placement of individual on jobs, delegation of authority, and coordination
of individual efforts and execution of responsibility for results.

PLANNING:
 Is the management function that clarifies the process of attaining the desired goals of an
organization. It includes activities such as data gathering, assessment, and calculation of
risks and determination of strategy. Planning requires an emphasis of creativity,
innovation, vision, flexibility and thinking beyond as well as understanding the
organization’s purpose. Planning is concerned with the future impact of today’s decisions.
 Planning is a process that is essential to:
 Make advanced rational decisions about the future
 Accomplish goals and objectives in a timely and efficient manner
 Anticipate and react positively to changes
 Forecasting and choice of a course of action
 Analyze information and make improvement
 Reduce ambiguity and anxiety among staff
 Remain competitive and cost effective
 Be pro active rather than reactive
 For laboratories planning may mean;

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  Development of short term (operational) and long term (strategic) plans for where the
laboratory will go in the future
 Determining the best use of resources to accomplish the goals and objectives of the
laboratory/hospital
 Short-term plans developed to guide operations
 Annual operating plan based on the strategic priorities of the organization
 Planning on implementation of specific projects, for example, new equipment
introductions

Planning Tools: Gant Chart

• List all tasks for implementation of the project
• List the task with earliest start date, length of time to complete the step, and whether it is
sequential (dependent on previous step) or can be done in parallel; list all resources
needed to complete each task
• Use graph paper and put days/weeks across the top and task list on the left

Planning Tools: Action Planning Grid

• List all actions/steps on the left of the grid
• Across top create columns - who will complete the task, when it will begin, and the
deadline for completion and status comments

Task Assigned To Start Due Status

Exercise: Gap Analysis

• Work in pairs
• Develop a project plan for the implementation of a new analyzer/method in your
laboratory using tools described.

DIRECTING:
 Is a managerial function of supervising, guiding, motivating and leading people towards
attainment of planned targets of performance. In the process of directing subordinates, a
manager takes active steps to ensure that employees accomplish their tasks according to
the established plans and policies.
 Directing function of management embraces the following activities;
 Issuing orders and instructions
 Supervising (overseeing) people at work
 Motivation i.e. creating the willingness to work for certain objectives
 Communication i.e, establishing understanding with employees regarding plans and
their implementation
 Influencing the behavior of employees and gain the commitment of the employees to
achieve organizational/departmental goals

CONTROLLING:

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 Is the process of ensuring that the organization is moving in the desired direction and that
progress is being made towards the achievement of goals. It tries to answer the question-
“Are we doing things right?” The process of controlling involves the following steps:
 Establish laboratory standards and measure performance against the standards
 Measure of actual performance and comparing it with he standard
 Finding variances between the two and reasons thereof, and
 Take corrective action when activities fail to meet the standards or are “out of
control”
*A databased approach avoids over-controlling (Hands on Eyes on)

Example of Operations Best Practices

 Personnel – % of employees not meeting certain critical competencies is higher than other
laboratories
 Action: in-service on identified problematic competency areas and redo competency
assessment
 Quality – QC out of control
 Action: follow SOP for out-of-control situations; troubleshoot the problem; rerun
patient samples
Best Practices
• Specimen acceptability rate – more than 95%
• Phlebotomy waits time – less than 30 min.
• Test turnaround time – rapid HIV results in a day
• Quality control assessments – performed daily

EXERCISE; Individual
• What would be the best practices you would track in your laboratory?
• What would represent acceptable performance?
• You have been hired as the laboratory manager. How do you introduce yourself? What is
your plan of action for being in charge? What are first steps you intend to take in the
running of your laboratory?

DECISION MAKING:
 Is the thought process of selecting a logical choice from the available options.
 When trying to make a good decision, a person must weigh the positive and negative of
each option and consider the alternatives. In other words decision-making can be
regarded as the mental processes (cognitive process) resulting in the selection of a course
of action among several alternative scenarios. Every decision-making process produces a
final choice. The output can be an action or an opinion of choice.

*For effective decision making a person must be able to forecast the outcome of each option
as well as based on all these items determine which option is the best for that particular
situation.

 When making decision it involves the following process;

 Establish a structured decision-making process such as decision tool
 Involve those directly affected by the decision and those with direct knowledge of the
problem
 Consider degree of acceptance
 Consider impact on other departments or customers
Factors in Good Decision Making

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• Getting all of the facts – a systematic approach
• Involving people closest to the action
• Good implementation strategy
• Good communication of the decision
• Knowledge of the job
Factors in Poor Decision Making
• Not enough information
• Emotion-based decisions
• Not enough input from others
• Lack of experience with the problem
• Fear of consequences of making the wrong decision
• Poor implementation/communications

Step 5: Organogram for laboratory services (35 minutes)

 Organogram is the chart that helps you to understand the levels of authority and lines of
communication in an organization. It shows a chain of command consisting of authority
nd responsibility relationships. The managers at each level of the organization derive their
authority from the managers at the higher levels
• Organizes jobs along lines of authority
• Defines reporting structure and span of control
• Defines authority to make decisions and accountability for results
• Works together with job descriptions to define the working structure of the
organization.
• The purpose of drawing the organisation chart (Organogram) is to show all concerned as
to what is the organization structure, how the organization has been divided into
departments and departments into sections and most important as to what responsibility
and duties are assigned to each officer. It also shows the chain of command and
delegation of authority.
Advantages of Oganogram
 Shows the lines of command
 Responsibility for work at different levels is clear
 The lines of communication both upwards and downwards are indicated
 The coordination among the various departments improves the efficiency of the
organisation
Disadvantage of Organogram
 The charts indicate the responsibilities of different levels have been divided on
departments basis therefore it becomes difficult to incorporate new changes.
 Some authorised persons make the decisions only. It becomes difficult to make decision
in some cases and causes delay which can give loss to an organization
 The rivalry among different departments may be harmful to the organization

Forms of Organization Charts-Organogram

 Vertical Organization Charts- This charts gives lines of command in vertical forms
 Horizontal Organization Charts-This charts gives the lines of command from left to right
in horizontal form.

E.g. Organogram

Laboratory
Manager
Laboratory
Information17
Systems Mgr.
Chemistry Haematolog Microbiolog Blood Bank Phlebotomy
Supervisor y y Supervisor Supervisor
Exercise Activity;
Prepare organogram for your laboratory

Step 7: Key Points (5 Minutes)

 Management is needed at every level in the organization. Effective management is a
process that begins with establishment of goals and ends with assessment of the
achievement of those goals. Within this process are functions that enable these goals to be
realized. These basic functions include:
 Organizing
 Planning
 Directing/coordinates
 Controlling
 Decision Making

Step 7: Evaluation (5 Minutes)

 Define the term organization
 What are the key functions of organization

References:
1. N.A Saleemi; (1997) Management Principles and Practices, Publishers Nairobi, Kenya,
June
2. Denise M. Harmening; (2007) Laboratory Management ‘Principles and Processes’,
Second Edition, D.H Publishing and Consulting.INC. St Petersburg Florida33711, 2007
3. Jane Hudson; (2004) Principles of Clinical Laboratory Management ‘A study Guide and
WorkBook’ Pearson Education, Inc, Upper Saddle River, New Jersey, 07458, 2004
4. Walter J. Wadsworth; (2005) ‘The Agile Manager’s Guide to Leadership’, Velocity
Business Publishing, INC. Bristol, VT 05443,USA, 2005
5. Senior Leadership and Management Course; ‘Tanzania Institutional Capacity Building
Project’ Participants Manual, MOHSW, November 2011

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Session 2: Name; Leadership and Management Practices

NTA Level 6, Semester 1, Module Code: MLT 06101 – Name; Laboratory Management
and Leadership

Total Session Time: 120 minutes

 s

Learning Objectives

Upon completion of this module, the students are expected to be able to:
1. Define a leader and a manager
2. Explain qualities of a leader and a manager
3. Describe the importance of leadership
4. Explain attributes of effective leadership
5. Explain leadership styles

 .

Step 2: Definition of Terms

 Leadership is defined in many different ways; however many definitions of leadership

contains common elements. For example,
 Chester Barnard; ‘defined leadership as the ‘ability of a superior to influence the
behaviours of his subordinates and persuade them to follow a particular course of
action’
 Koontz and O’Dannell; ‘Leadership is the ability of a manager to induce
subordinates to work with confidence’
 Allen; ‘Leader is the one who guides and directs other people’
 Suzan Komives and her colleagues; In health care services leadership is ‘a process
of one individual influencing another individual or group to achieve particular
objectives.
 In other words leadership is ‘enabling others to face challenges and achieve positive
results’
 A Manager Versus A leader
 A Manager is the person responsible for planning and directing the work of a group of
individuals, monitoring their work, and taking corrective action when necessary.
Managers may direct workers directly or they may direct several supervisors who
direct the workers. The manager must be familiar with the work of all the groups
he/she supervises, but does not need to be the best in any or all of the areas. It is more
important for the manager to know how to manage the workers than to know how to
do their work well.

 A leader is someone who leads strongly, but isn't bossy. Someone who is admirable but
not superior. Someone who gets the job done, but doesn't rush.

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 The manager coordinates the cutting of a path through the jungle by the workers while the
leader makes certain we are in the right jungle”
 A manager directs people through the use of formal authority while a leader may not have
formal power but he always has power (i.e. ability to influence)
 Maccoby Michael suggests that ‘managers are primarily administrators who are able to
influence decision and actions whereas leaders influence the opinions and attitudes of
others to accomplish a mutually agreed on task while the group’s integrity and morale
purpose.

* A good leader needs not necessarily to be a manager but an effective manager must have
many of the qualities of a good leader. Thus, managers should be leaders if they are to secure
maximum contributions from the subordinates

Step 3: Qualities of a leader and a manager (35 minutes)

Leadership and management are often thought of as the same thing. However, there is an
important distinction between the two. The main points of difference between the two are as
follows;
The manager:
 Maintains control of operations by meeting operational standards
 Assures high testing quality and customer service
 Assures staff compliance with policies and procedures
 Accomplishes goals; makes good decisions
 Manages resources effectively including time
 Administers and maintains
 Focuses on the present realistic situation
 Focuses on systems and structures
 Day to day operations
 Managers are people who do things right

The leader:
• Establishes and communicates goals
• Creates shared vision and commitment
 Competent, confident and caring
 Visible, positive, optimistic
 Honors all commitments
 Risk-taker and problem solver
 Seeks mutually beneficial solutions
 Admits Errors/Failures
 Innovates and develops
 Investigates reality
 Foc
 /uses on people
 Inspires trust
 Has a long-range perspective
 Good listener
 Creates environment for success
 Effective coach and mentor
 Provides effective feedback

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 Involves others and values their viewpoints
 Shares Information
 Trusts others and is
 Leaders are people who do the right thing

In most case the managers become ineffective if they portray ‘the boss’ qualities in a working
environment. The example below explains;
 The boss drives group members, the leader coaches
 The boss depends upon authority, the leader on good will.
 The boss inspires fear, the leader inspires enthusiasm
 The boss says ‘I’, the leader says ‘WE’
 The boss assign the task, the leader set the pace
 The boss says” Get there on time”, the leader gets there ahead of time
 The boss fixes the blame for the breakdown, the leader fixes the breakdown
 The boss knows how it is done, the leader shows how.
 The boss says, “GO”, the leader says, “Lets go”
*Therefore effective managers should use both formal authority and personal power

Exercise; Group
 Describe the most effective manager you have had. Was that person also a leader?
 Describe the best leader you have ever wok with. Was that person your manager?

Step 4: Importance of leadership (20 minutes)

 Good leadership is essential to effective management. Leader is the fulcrum on which
needs of the organization and demands of the individuals are balanced. More failures of
organizations are attributable to poor leadership than to any other cause. Poor leadership
can nullify the soundest organisation. It is the quality of leadership that usually
determines the fate of an organization.
 The significance of leadership is reflected in the following functions;
 Motivating Employees; A good leader improves the loyalty and commitment of
employees towards the organization. The leader creates and maintains an environment
conducive to high performance. Good leadership itself is a motivating force for
individuals, which inspire people to work hard.

Morale Building;
 A good leader shapes the thinking and attitudes of the group and maintains discipline. He
develops good human relations and facilitates interactions between members of the group.
 Creating Confidence;
 A good leader provides advice and guidance by which subordinates can recognise
their qualities and capacity. He serves as a father figure and members gain strength
and security by identifying emotionally with him.
 Coordination;
 Leadership help to unify individual efforts. A good leader creates a community of
interests by harmonising organisational goals and individual interests of the
subordinates. He resolves internal conflicts by serving as arbitrator and mediator
between the opposing factions
 Facilitate Change;

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  A good leader has ability to convince people about the need for change. In a World of
change and uncertainty, the organization leader become a vial element in the very
process of change
 Goal Setting;
 A leader provides guidance to the group by setting and interpreting the objectives. He
moulds the internal relationship within the group.
 Representation;
 A leader is the representative of his followers. He serves as the true guardian of its
interests
*Thus leadership leads to higher performance and determines the effectiveness of an
organisation.

Step 5: Attributes of effective leadership (20 minutes)

 Whereas we recognize the fact that people of different personalities all have the potentials
to become effective leaders, we also suggest that there are certain attributes commonly
shared by effective leaders.
 Take a moment to visualize the leaders who you admire and trust. What are the reasons
you would work harder for them rather than someone else?
 It is the essence of being a leader that opens up opportunities. Here are some attributes of
effective leader;
 Character
 Qualities of character include purpose, creating value, trust, congruence and
compassion
 Integrity
 The value we place on ourselves and on others is a key attribute for effective
leadership. Integrity, sincerity and honest engender trust and respect. In other words
we admire leaders who “talk the talk” and “walk the walk”

 Vision
 These are leaders who are able to see the “big picture” and able to effectively
communicate the strategic direction of their vision to the organization.
 Passion
 Passion enables great leaders to get through the painstaking tasks of creating change
an inevitable outcome of the leadership process. Passion inspires and creates
followership
 Credibility
 It’s based on excellent credentials, substantive knowledge, and sound practical
experience. Leaders must be willing to assume greater responsibility for changing
group outcomes
 Courage
 It is essential for creating a new vision, taking risks and challenging the status quo.
 Insight
 Perceptions into realities that exist in and out side of the organization are important
attributes for effective leadership.
 Humility
 Good listener and a perpetual learner who is willing to admit that others also have
good ideas and accept that one can be wrong.
 Sense of Humour

22
  If you are going to be a leader, a good sense of humor will help you and others. When
appropriately used humour is a valuable tool especially for minimising stress
 Emotional Intelligence
 These are emotional competencies that describe the abilities needed to manage our
relationships and ourselves effectively. These include self-awareness, self-
management, social awareness and social skills.
 Positive self- esteem
 A leader works selflessly to support people working towards the common good of the
organization. A successful leader has positive self-esteem and self-respect evidenced
by the leader’s positive behaviours such as taking risks confidently and
communicating with clarity.

Step 6: Styles of leadership (20 Minutes)

 A leadership style reflects the behavioural pattern o the leader. Various styles of
leadership may be described as follows:-
 Autocratic or Authoritarian Leadership
 An autocratic leader is the one who takes all the decisions himself without consulting
his subordinates. It is characterized by maximum possible centralisation of authority,
close supervision, unilateral decision-making and one- way communication. It is boss
–centred leadership. An autocratic leader is generally disliked, as there is no scope for
initiative and self-development. Behaviour of subordinates becomes hostile and
attention is focused upon pleasing the leader. An autocratic leader may be of two
types. If he uses negative sanction and expects unquestioned obedience from the
subordinates he is called ‘strict autocrat’. In case he uses his power and positive
rewards to influence the group members he is known as benevolent autocrat.
 Democratic or Participative Leadership
 A democratic leader permits his subordinates to participate in the process of decision-
making. Decentralization of authority, participative planning, and two ways
communication are the main features of democratic leadership. It is group –centred as
group makes decisions. A democratic leader is a team manager and operates
according to majority opinion.
 Laissez Faire or Free-rein Leadership
 Under this type of leadership, the leader leaves it to the subordinates to decide and
control them believing that they are competent and motivated. He believes that people
will perform better if they are left free to make and enforce their own decision. This
style of leadership may be successful where the subordinates are highly competent
and fully dedicated to the organization. Free-rein ignores the manager’s contribution
just as autocratic ignores the contribution of the group.
 Bureaucratic Leadership
 A bureaucratic leader depends upon rules and regulations developed by him. The
rules specify the function and duties of every member of the organization. Such a
rule-centered leadership often results in red-tape and inefficiency.

Step 7: Key Points (5 minutes)

 The importance of good leadership
 Key functions of a leader and a manager

Step 8: Evaluation (5 minutes)

 What is the difference between leadership and management?

23
 List and discuss different leadership skills and where it applies

References:
1. Denise M. Harmening; (2007) Laboratory Management ‘Principles and Processes’,
Second Edition, D.H Publishing and Consulting.INC. St Petersburg Florida33711, 2007
2. N.A Saleemi; (1997) Management Principles and Practices, Publishers Nairobi, Kenya,
June 1997

24
Session 3: Human Resource Management (HRM)

NTA Level 6, Semester 1, Module Code: MLT 06101 – Name; Laboratory Management and
Leadership

Learning Objectives

Upon completion of this module, the students are expected to be able to:
1. Define the term Human Resource Management and Human Resource Planning
2. Describe the HRM function in the laboratory
3. Develop orientation and training checklists
4. Define key Competence for Laboratory Staff
5. Discuss the approaches to handling conflict
 they have any questions before continuing.

Step 2: Define the following terms; Human Resource Management and Human
Resource Planning (10 minutes)

 Human Resource Management (HRM) is the function within an organization that

focuses on recruitment of, management of, and providing direction for the people who
work in the organization. It is the organizational function that deals with issues related to
people such as compensation, hiring, performance management, organization
development, safety, wellness, benefits, employee motivation, communication,
administration, and training.
 HRM can also be defined as the management of most valuable asset ‘the people who
collectively contributes to achievement of organization goals. While the human resources
available to management in an organization are only part of resources, which must be
coordinated, it is through the combined efforts of people that monetary, material and
other resources are utilised for organizational objectives.

 Human Resources Planning (HRP) refer to classic HR administrative functions, and the
evaluation and identification of human resources requirements for meeting organizational
goals. It also requires an assessment of the availability of the qualified resources that will
be needed. To ensure their competitive advantage in the marketplace and anticipate
staffing needs, organizations must implement innovative strategies that are designed to
enhance their employee retention rate and recruit fresh talent into their companies.
Human resources planning is one way to help a company develop strategies and predict
company needs in order to keep their competitive edge.
 HRP seeks to concern the following circumstances from which HR can be used:
 Determining the numbers to be employed at a new location
 Retaining your highly skilled staff
 Managing an effective downsizing programme
 Where will the next generation of managers come from?
 To address these questions you need to understand:

25
  The present career system (including patterns of promotion and movement, of
recruitment and wastage), the characteristics of those who currently occupy senior
positions and the organisation’s future supply of talent.

 Within a quality system, management must assess the total job to be done to achieve the
goals of the organization and determine:
 What knowledge and skills are needed?
 How many people with each skill set?
 When are they needed?
 How will they be scheduled?
 How will they be supervised?

Step 3: HRM functions in the laboratory (30 minutes)

 The business is no better than the people it keeps as human resource are the most
important asset of an organization. The success of an organization (e.g. laboratory)
depends on the calibre and motivation of its employees. Securing, developing and
maintaining an efficient and dedicated work force is therefore a vital function of
management. The duties or functions of HR manager can as:-
 Personnel Recruitment and Selection
 Position/Job Descriptions
 Orientation and Training
 Competency Assessment
 Performance Management (Performance Standards, Coaching and Counseling,
Discipline, Performance Review
 Continuing Education
 Staffing and Scheduling

RECRUITMENT AND SELECTION

 Recruitment refers to the discovery and development of the sources required personnel so
that sufficient number of staffing will always be available.
 Sources of recruitment can broadly classified as:-
 Internal sources;
 Transfers, promotions, and present employees
 External Sources;
 Schools, On-the-job training (certain skills), Advertisements, Family and friends,
Vendors (employment agencies), professional bodies, other laboratories, unsolicited
applicants,
 Staffing Needs Assessment
 Identify job to be done-gap in service delivery
 Identify skill set needed
 Determine hours needed to fulfill needs (part vs. full time/days or evening)
 Employee Selection refers to Process to determine employee fit and qualifications for the
position.
 Determine what they can do
 Determine how willing are they to do it
 Tools to guide selection – application, CV, job description, assessment tools, and
interviews
 The selection process includes;
 Obtain CV or application
 Review for posted qualifications

26
  Level of education
 Training required by the MOH
 Interview to verify what they can do and their motivation to do the job
 Obtain references from previous employers, co-workers or instructors
 Assess technical skills
o Problem-solving
o Manipulation skills (e.g.. pipetting)
o Mathematical
 Assess non-technical skills such as:
o Communications (written and oral)
o Customer Service
o Commitment
o Color-blindness
 Example of interview question;
 Describe a QC problem that you solved independently.
 Describe the last time you did more than was required by your job.
 Describe a time when you were presented with a problem you could not solve.
 Intelligence and personality tests can be administered to measure the mental capability of
an individual and temperaments, maturity, emotional balance and other personality traits
of an individual.

POSITIONING/JOB DESCRIPTION
 Every new employee is given a particular job to perform on the basis of hi/her abilities. It
is therefore, necessary to match the worker and the job. Correct placement of employees
improves job satisfaction and productivity and reduces labor turnover and absenteeism.
Recruitment process begins with the writing of the job description. Job description lists
the essential functions of the job defined as those that are important. It should also include
a listing of the requirements with regard to education and experience. The amount of
authority and reporting structure is also defined in the job description

 Uses of Job Descriptions

 Selection - Used to evaluate if applicants meet basic requirement
 Compensation - Used in defining compensation level for each position
 Performance management - Sets expectations and helps employee understand their
duties
 Laboratory Organization - Used to define roles and responsibilities in the organization

 PERFORMANCE MANAGEMENT (PM)

 Is a terminology for managing both behavior and results in an organization. It
includes activities that ensure that goals are consistently being met in an effective and
efficient manner. Performance management can focus on the performance of an
organization, a department, employee, or even the processes to build a product or
service, as well as many other areas. PM set and communicate achievable, realistic
performance expectations/standards
 Define expected performance in the areas of technical tasks, communications, work
habits, teamwork
 Causes of Performance Failure
 Inadequate initial orientation
 Inadequate training
 Equipment or method problem

27
  Sample problem
 Poor documented procedures or failure to follow procedures
 Difficulty changing behavior
 Performance Management Process;
 Assess performance by observation and work sample
 Provide effective feedback on areas that need improvement
 Assure that poor performance is corrected
 Reinforce and recognize good performance
 Document all aspects of performance – positive and negative
*After assessing performance you need to provide feedback to the staff

 Types of Feedback
 Coaching – Feedback given to help an employee reach his/her maximum performance
level (positive approach)
 Counselling – Feedback given and often documented when employee must improve
his/her performance (negative)

 How to Give Feedback

 Pick appropriate time and place
 Be specific and direct
 Be descriptive, not judgmental
 Point out positive aspects first
 Direct feedback towards improving behavior and stress impact of work on patient
care, not toward person

 Performance Appraisal
 A system to assess overall performance on the standards (usually annually)
 Evaluation is based on:
 Technical performance standards
 Customer service expectations
 Work habits
 Communication skills
 Organizational skills – safety

 Exercise; Role Play on Feedback

 Supervisor discusses with a technologist a problem with his documentation of QC

CONTINUING EDUCATION
 Is an educational program that brings staff up-to-date in a particular knowledge area.
 May be used to improve competency in certain problem areas
 Important in maintaining laboratory quality and state of the art systems
 Journal club, vendor support, or computer / online access
 Make learning an expectation for everyone
 Focus continuing education on staff needs based on competency assessment.

STAFFING & SCHEDULING

 Defines the number and skill mix of staff needed for the workload
 Skill mix defines the proper mix of assistants, technician, and technologist needed for
efficient operation

28
  Staffing model defines the minimum number of each type of personnel needed for
each operating shift
 Scheduling of each shift of operation is based on the staffing model

Factors to consider when scheduling:

 Factors to consider:
 Daily workload
 Complexity
 Working hours of lab
 Space
 Urgent vs routine
 Manual vs automated
 Skill level
 Training: new employees, students

Step 4: Orientation and training (15 minutes)

 When a newly appointed employee reports for work, he should be made familiar with the
work environment and the fellow employees. Also be oriented to the organization
policies, rules and regulations. Orientation is the process of introducing a new staff
member to the new work environment and tasks / duties.
 Orientation tries to achieve the following;
 Builds the confidence of new employee in the organization
 Develop among new comers a feeling of belongingness to the organization
 To foster a close and cordial relationship between the new and old employees
 To ensure the newcomer do not form false impression and negative attitude towards
the organization or the job
 To give the new employee the necessary information such as location of locker
rooms, cafeteria, rest period, leave rules etc.

 An Orientation Checklist is used to ensure every new staff member receives the same
information. At the end of orientation, complete initial competency assessment to assess
capability, which can be a base for conducting training or re-training.

 Example of Orientation Checklist

 Explain the lab’s role in support of organizational goals
 Review the job description
 Review performance expectations such as customer service and others
 Tour the work area and introduce to all management and staff
 Show where all manuals and resources are kept
 Review and sign for all procedures and policies including safety
 Explain performance evaluation process
 Review quality system essentials and QA responsibilities
 Assign a trainer
 Train on all methods and equipment including safety equipment
 Employee Training;
 Training is an important element in a quality system
 Quality training follows a systematic and prescribed process
 Training guides, checklists, and just-in-time training modules ensure training is
consistent

29
 When to do training?
 During orientation
 Based on defined needs
 Example: new instrument or method introduced
 Based on competency issues
 Example: identified by competency assessment
 Ongoing – continuing education

 Performance management is part of this process as well.

Exercise:
 How do you train employees for a new procedure?

Step 5: Key Competence for Laboratory Staff:

Competency
 What is competency?
 Is having the essential ability to perform specific tasks that are part of the total testing
process. Important competencies are those competencies that are important to job
performance and have an important impact on quality of care.
 Accessioning competencies when processing specimen;
 Logs in all specimens and assign unique identifying number (accessioning number)
 Follow specimen rejection policy rejects specimens appropriately
 Spins specimens appropriately at correct time and speed of centrifugation
 Example of Phlebotomy Competencies
 Properly identify the patient: use two identifiers like comparing the name of the
patient from the request form and asking the patient name.
 Label all specimens with complete patient information immediately after the
specimen is drawn
 Example of Technologist Competencies
 Notify clinician of critical results/panic values
 Keeps current on all new and revised policies and adheres to defined procedures at all
times
 Ensures all quality control and maintenance are performed on schedule. Assures QC
data are within acceptable limits
 Identifies unsuitable specimens and notifies the clinician for recollection. Documents
appropriately on laboratory reports
 How is it measured?
 Competency Assessment – a process for determining and documenting the ability of
personnel to perform specific key job duties
 Competency Assessment Process
 Develop a written policy on competency assessment that identifies when, what, and
how competency will be assessed
 Identify important competencies for each process in the laboratory
 Develop competency assessment checklists
 Review policy at least annually
 Communicate the policy to all staff

As an organization you need to have a competence policy as to;

• Example of when the assessment will occur?

30
  Initially after orientation on new staff and at least annually on current staff or with
introduction of new methods
• Example of what will be assessed?
 Every important job task and procedure performed (pre-analytical, analytical, and
post-analytical
• Example of how the assessment is done?
 Based on skill assessment of important competencies (those competencies important
to the job and that have a direct impact on quality patient care)
 SOPs reviewed and knowledge assessed
 Direct observation of performance including trouble-shooting or problem solving
capability

Establishing a Competency Program

• Prepare a schedule for assessing each employee
• Prepare a checklist of the important competencies
• Determine assessment method
• Document and evaluate results
• Take remedial/corrective action
• Have a plan for addressing competency problems

Exercise: Group Work;

• Work in pairs to identify at least 3 important competencies for phlebotomy

Step 6: Approaches to handling conflict We define conflict as a disagreement through

which the parties involved perceive a threat to their needs, interests or concerns. Within this
simple definition there are several important understandings that emerge:
• Disagreement - Generally, we are aware there is some level of difference in the positions
of the two (or more) parties involved in the conflict. But the true disagreement versus the
perceived disagreement may be quite different from one another. In fact, conflict tends to
be accompanied by significant levels of misunderstanding that exaggerate the perceived
disagreement considerably. If we can understand the true areas of disagreement, this will
help us solve the right problems and manage the true needs of the parties.
• Parties involved - There are often disparities in our sense of who is involved in the
conflict. Sometimes, people are surprised to learn they are a party to the conflict, while
other times we are shocked to learn we are not included in the disagreement. On many
occasions, people who are seen as parts of the social system (e.g., work team, family,
company) are influenced to participate in the dispute, whether they would personally
define the situation in that way or not.
• Perceived threat - People respond to the perceived threat, rather than the true threat,
facing them. Thus, while perception doesn't become reality per se, people's behaviors,
feelings and ongoing responses become modified by that evolving sense of the threat they
confront. If we can work to understand the true threat (issues) and develop strategies
(solutions) that manage it (agreement), we are acting constructively to manage the
conflict.
• Needs, interests or concerns - There is a tendency to narrowly define "the problem" as
one of substance, task, and near-term viability. However, workplace conflicts tend to be
far more complex than that, for they involve ongoing relationships with complex,
emotional components. Simply stated, there are always procedural needs and
psychological needs to be addressed within the conflict, in addition to the substantive
needs that are generally presented.

31
• So, is it still a simple definition of conflict? We think so, but we must respect that within
its elegant simplicity lies a complex set of issues to address. Therefore, it is not surprising
that satisfactory resolution of most conflicts can prove so challenging and time
consuming to address.

Conflict Management
• Common barriers to collaboration
• The need to be right
• Poor listening
• Placing blame
• Not sharing information

Class Exercise;
• True or False? Conflict is…
• Natural and inevitable
• Conflict is just a difference
• Conflict can be constructive
• Conflict can promote better solutions
• Conflict is a necessary part of team building

Types of Conflict
• Role/Status
• Values
• Perception
• Divergent goals
• Expectations

Considerations in Conflicts
• Decide whether or not to address the conflict
• If important, confront the problem
• Don’t spend too much or too little time to resolve conflict
• Be patient as well persistent
• Define the manager’s role in mediation of conflicts between staff

Mediation – A Model for Problem Solving

• Separates the people from the problem
• Focuses on interests not positions
• Creates options for mutual gain
• Inserts objectivity into the process
• Set ground rules for the session
• Each party expresses their issue to third party
• Identify the interests behind the different positions
• Each party listens until they understand the other person’s issues
• Generate a compromise that may serve both interests
• Write up the agreement

Step 7: Key Points (5 minutes)

• List HRM functions
• Key competencies in the laboratory
• Performance management

32
Step 8: Evaluation (10 minutes)
 Work in pairs to identify at least 3 important competencies for phlebotomy
 Work in pairs and discuss a staffing challenge at your laboratory. Discuss how you have
tried to address it?

References:
1. Denise M. Harmening; (2007) Laboratory Management ‘Principles and Processes’,
Second Edition, D.H Publishing and Consulting.INC. St Petersburg Florida 33711, 2007
2. N.A Saleemi; (1997) Management Principles and Practices, Publishers Nairobi, Kenya,
June 1997

33
Session 4: Equipment Management

NTA Level 6, Semester 1, Module Code: MLT 06101 – Name; Laboratory Management and
Leadership

Learning Objectives

Upon completion of this module, the students are expected to be able to:
1. Define the term equipment
2. Describe importance of equipment maintenance program in the laboratory
3. Explain key components of Equipment Management Process
4. Describe an effective preventive maintenance program in the laboratory
5. Mention function Checks to be followed when performing PPM

 .

Step 2: Definition of terms

 Laboratory equipment refers to the various tools and equipment used by scientists
working in a laboratory. These include tools such as Bunsen burners, and microscopes as
well as speciality equipment such as, microscopes, spectrophotometers and calorimeters,
blood analysers, centrifuges, autoclaves, micro-plate washers, laboratory glassware such
as beakers or reagent bottles etc.
 Laboratory equipment is generally used to either perform an experiment or for diagnosis
purposes. Larger or more sophisticated equipment is generally called a scientific
instrument.

Step 3: Importance of equipment maintenance in the laboratory The importance of an

effective maintenance program cannot be overlooked because it plays such an important role
in the effectiveness of laboratory operations. Maintenance may be considered as the heath
care of our laboratory equipments. It is required to effectively reduce waste and run an
efficient, continuous testing and service operation.
 The cost of regular maintenance is very small when it is compared to the cost of a major
breakdown at which time there is no production.

Purpose of Maintenance
 The main purpose of regular maintenance is to ensure that all equipment required for
laboratory diagnosis and production are operating at 100% efficiency at all times.
Through short daily inspections, cleaning, lubricating, and making minor adjustments,
minor problems can be detected and corrected before they become a major problem that
can shut down a production line. A good maintenance program requires company-wide
participation and support by everyone ranging from the top executive to the shop floor
personnel.
 Some surveys conducted by different people shows that the actual cost for a breakdown is
between four to fifteen times the maintenance costs. When the breakdown causes
production to stop, the costs are very high because no parts are being produced.
 For years, maintenance has been treated as a dirty, boring and often overlooked job
therefore it is very important to get the best productivity from an equipment. The simple

34
 question is often, "Why do we need to maintain things regularly to keep things as reliable
as possible?"

Step 4: Key components of Equipment Management Process (35 minutes)

 Equipment Management Process is a process for selecting and maintaining laboratory
equipment necessary to meet patient care needs. It involves the following functions:
 Equipment Selection, selection costs and Purchase
 Equipment Installation and Calibration
 Preventative Maintenance, Service and Repair
 Troubleshooting

 Equipment / Instrument Selection

 Define needs to be filled – including customer input on testing needs
 For example, the introduction of Ant Retro Treatment (ART) reveals a need for an
automated Hematology analyzer to improve accuracy of cell counts
 The selection process requires the following steps;
o Gather information on all potential vendors for instrument or method needed (can
use internet, vendor presentations, colleagues, journals) to search for information.
o Decide what you want and then measure each vendor against your needs/wants
o Set criteria for purchase and selection of equipment

Selection Criteria Checklist

35
* You need to be careful when establishing the costs as the costs may be incorporated into
contracts in the following ways:
 Cost per test contract
 Cost per result reported contract
 Cost per reportable patient contract

Exercise; Work in pairs

 Define the criteria for selection you will use when you want to procure a new equipment
for laboratory services?

Equipment Installation and Calibration

 Before installing equipment you need to do the following preparation;
 Site Leadership’s role- Pre Installation

36
  Obtain all critical requirements for instrument installation from vendor (back-up
power, vacuum/pressure)
 Get instrument specifications including physical requirements
 Arrange schedule and timeframe with vendor for the installation
 Negotiate with vendor on what they will do on-site ahead of time

Installation
 Vendor’s Role
 Have vendor perform instrument validation and method comparison studies
 Have vendor help establish reference range
 Vendor calibrates instrument and runs quality control
 Vendor trains personnel on all aspects of instrument performance (calibration, QC,
data entry) and troubleshooting
 Vendor leaves records of all studies and instrument manuals

Post-Installation
 Site leadership assesses competency of staff on critical elements of training
 Site leadership establishes instrument maintenance program
 Vendor or internal resources provides ongoing support through service contract

Calibration of Equipment;
 After installation the vendor must perform the initial calibration based on manufactures
instruction and train the rest of the staff on calibration procedure.
 Vendor performs initial calibration using calibrators and manufacturer’s instructions
(QC may not be used)
 Vendor trains all staff on calibration procedures
 Management defines frequency and triggers for calibration and writes SOP for
calibration
 Management assess staff competency on calibration procedures
 Staff performs calibration using calibrator or standard as defined (QC may not be
used)
 Calibrators added to supply inventory to assure continuous supply

Step 5: Effective Preventive Maintenance Program in the laboratory (20 minutes)

 A good preventative maintenance program assures continuous operation of lab
instruments with limited downtime. It;
 Assures a high level of performance and quality laboratory results
 Lengthens the life of the equipment
 Decreases expenses of instrument operation
 Improves staff efficiency in producing results and customer satisfaction
 Preventative maintenance procedures and schedule are defined in vendor manual.
Procedures for maintenance and schedule are refined by each facility based on laboratory
needs.
 Planned Preventative Maintenance (PPM) Procedure
 Defined at intervals – daily, weekly, monthly
 Performed and documented on maintenance records including problem log for
instrument issues
 Maintenance records must be reviewed weekly by site leadership to assure completion
and adequate function

37
 Example 1. PPM Schedule
SN Equipment Name of Frequency
Name the Daily Weekl Mont Quart Biann Annu
Procedure y hly erly ual al
1. Centrifuge Routine √
Maintenan
ce
Validation √
Service √
(Calibratio
n)
2. Spring hand Routine √
Balance Maintenan
ce
Validation √
Service √
(Calibratio
n)
3. Sphygmoman Routine √
ometer Maintenan
Machine ce
Validation NA
Service
(Calibratio
n)

Example 2. PPM Procedure

ELISA READER
Equipment Operation Daily Maintenance Calibration Frequen
Procedures cy
ELISA  Switch ON the  Keep the  To be done  Six
READER main power machine clean by mont
supply. and cover it if it Engineer. hly.
 Switch ON reader is not in use.  Quart
machine and wait  Check integrity erly.
for initialization. or front panel
 Ensure that there is switches if it is
communication intact.
among the reader,  Exchange bulb if
computer and it is blown out by
printer open the back
 Select the program cover by using
(Gen.5) Alan key.
 Select the required Remove the
protocol from the blown bulb, fix
computer screen new bulb and
 Ensure important replace the
data are entered, cover.
e.g. date, lot

38
 number, user
name, expiry date
etc.
 Command READ
(a dialog box will
ask you to place
the plate on the
carrier)
 Place the plate on
the carrier
 Click OK (reading
process starts)
 Check validities
(e.g. a message
error may appear).
 Command Print if
readings are
satisfactory.
 Remove the plate.

HOT AIR OVEN (MEMMERT)

Equipment Operation Daily Maintenance Calibration Frequen
Procedures cy
Hot air oven Connect the main, Keep machine clean
(Memmert) switch on by Pushing by cleaning weekly
the push turn key. with disinfectant.
o Hold down the set o Ensure
Key to select the availability of To be done by Quarterly
operating mode. power supply. Engineer.
o Select the o Check indicators
parameter by if they are
rotating the functioning.
push/turn control. o Check the
o Select the fan temperature if it
speed by pushing is in the require
or turning control range
clockwise until the o Check door
fan symbol is gasket if it is
flashing, hold intact.
down the set key
to push or turn
control to set 50%
fan speed.
o Push the push or
turn control
clockwise until the
air valve symbol is
flashing to set the

39
 air valve to 20%.

o Turn the push /

turn control
clockwise until the
over temperature
display MAX to
set the
temperature.

REFREGERATOR
Equipment Operation Daily Maintenance Calibration Frequen
Procedures cy
Refrigerator  Put on the power  Cleaning of  No  Six
and the fried guard exterior parts. Month
 Switch ON the  Temperature ly
refrigerator monitoring
 Set required  Check
temperature temperature chart
 Ready for use recorder if
properly function
Weekly
o Clean of interior
surface and
shelves
o Change
temperature chart
recorder and write
date on it
Monthly
o Brushing dirty or
dust of condenser
and compressor
o Change
temperature chart
Quarterly
o Verify operation
of the alarms (if
are there) – see
detailed
procedures

FREEZERS
Equipment Operation Daily Maintenance Calibration Frequen
Procedures cy
Freezers  Put on the power Daily
and fridge guard o Temperature
 Switch ON the monitoring
Freezer.
Weekly

40
  Set required o Change
temperature temperature
 Ready for use charts and date
them (if there
available).

Biannually
o Thaw and wash
interior surface
free twice a year

Manual Multichannel Pipette

Equipme Operation Procedures Daily Maintenance Calibration Frequen
nt cy
1. o Adjust the equipment Daily:
Manual according to the o Clean the pipette Yes By User
Multicha required volume to using 10%
nnel be pipette hypochlorite
Pipette o Fix appropriate solution
pipette tips
o Ready to use Periodically
o Discard the used o Check the
pipette tips equipment for
o Keep the equipment accuracy and
on always precision when
using for the first
time.

Quarterly
o Perform greasing
and change
rubber rings
2. o Adjust the equipment Daily:
Manual according to the o Clean the pipette Yes By User
Single required volume to using 10%
Channel be pipette. hypochlorite
Pipette o Fix appropriate solution
pipette tips
o Ready to use Periodically
o Discard the used o Check the
pipette tips equipment for
o Keep the equipment accuracy and
on it’s stand always precision when
using for the first
time.

Quarterly
o Perform greasing
and change
rubber rings

41
Service and Repair
 When doing PPM may results into the need to doing service. Here are some steps;
 Evaluate QC and maintenance records regularly to detect instrument problems early
 Define procedures for obtaining service
 Equipment management procedures should include procedures for obtaining
service/repair
 Maintain service and repair logs of all service performed for life of the instrument

Step 6: Function Checks to be followed when performing PPM (30 minutes)

Function Checks
 As a laboratory manager you need to set up a schedule for maintenance of laboratory
equipment by referring to manufacturer recommendation and installation guide. The
following function checks may assist in planning for PPM;
 Performance checks defined by manufacturer to verify that the instrument is working
properly
 Performed daily, weekly, or monthly
 Document on function check log
 Examples: background checks, daily temperature checks, change of reagents for
analysers and blank washing.
 Function check failure must result in troubleshooting

Troubleshooting Equipment Problems

 Troubleshooting occurs when:
 Function checks are not within tolerance limits
 QC results are not within tolerance limits
 System does not seem to be operating properly
 Laboratory results appear unusual

*Define step-wise troubleshooting procedures for each instrument (Troubleshooting guide is

often in vendor manual).

 Exercise
 Group Work – Maintenance Schedule
 Work in pairs
 You have received a new BD Facscount analyzer. Determine how you will set up a
schedule for maintenance and function checks.

Step 7: Key Points (10 minutes)

 Importance of a good instrument management program
 Important steps to follow when instrument is installed in the laboratory
 Manage the calibration, troubleshooting and maintenance of laboratory instruments

Step 8: Evaluation (5 minutes)

 Define the term PPM
 List the criteria for selection and procurement of new equipment

References:
1. Laboratory Management Training (TOT) Modules
2. National Blood Transfusion Services Manual on PPM for User ‘1st Edition 2011’

42
3. National Operational Guidelines for Care and Treatment
4. Health care Technical Service Policy guidelines

43
Session 5: Supply Chain Management

NTA Level 6, Semester 1, Module Code: MLT 06101 – Name; Laboratory Management and
Leadership

Total Session Time: 120 minutes

Prerequisites Modules;
 MLT 05214 - Planned Preventive Maintenance of Laboratory Equipment and Instrument.
 MLT 05212 -Maintenance of Laboratory Supplies

Learning Objectives

Upon completion of this module, the students are expected to be able to:
1. Define the term Supply Chain Management
2. Describe Inventory Management Process for laboratory supplies
3. Determine reorder level for Laboratory supplies

Step 2: Define the Term; Supply Chain Management

 Supply Chain Management (SCM) is the oversight of materials, information, and finances
as they move in a process from supplier to consumer. Supply chain management involves
coordinating and integrating these flows both within and among companies. It is said that
the ultimate goal of any effective supply chain management system is to reduce inventory
(with the assumption that products are available when needed). As a solution for
successful supply chain management, sophisticated software systems with Web interfaces
are competing with Web-based application service providers (ASP) who promise to
provide part or all of the SCM service for companies who rent their service.
 Supply chain management flows can be divided into three main flows:
 The product flow
 The information flow
 The finances flow
 The product flow includes the movement of goods from a supplier to a customer, as well
as any customer returns or service needs. The information flow involves transmitting
orders and updating the status of delivery. The financial flow consists of credit terms,
payment schedules, and consignment and title ownership arrangements.

Step 3: Inventory Management Process for laboratory supplies (50 minutes)

 Inventory Management Process is the process for maintaining an adequate supply chain
(central to local) to maintain uninterrupted service and meet patient care needs. Inventory
Management leads to High Quality Testing by;
 Ensuring consistent availability of supplies and materials, when needed
 Avoids the use of expired reagents and supplies
 Minimizes wastage of expensive supplies
 Inventory Management Process comprises of the following steps:
 Organize inventory at site laboratory
o Count and maintain records of inventory

44
 o Requisition/order from central supply/store
o Define reorder quantities/minimum stock level
o Receive and store of supplies
o Define return process (wrong orders)
 Inventory process need to have a good storage facility to secure your materials and
supplies.

Facility Storage
 Is a system to organize, secure, and properly store reagents and supplies for laboratory
use. Requirements for proper organization of storage facility are;
 Assess storage requirements of reagents and supplies
 Identify a secure and adequate storage site
 Locked
 Free from extreme temperature, direct sunlight, and humidity
 Free of pests
 Use of shelves and bins to organize supplies
 Organize the supplies carefully
 Keep refrigerated supplies in designated well maintained and monitored refrigerators
(record temperature daily)
 Store according to temperature requirements
 Store similar items together (controls with controls, calibrators with calibrators)
 Within each group of similar items, arrange them in alphabetical order
 Group identical items in smaller groups that is easy to count.
 Label the shelves with the name of each item in that area of the shelf
 Store all items on shelves with shorter expiry dates at the front
 Check weekly for any expired reagents/supplies and organization of storage

Exercise: Work in Pairs;

 Discuss how your supplies are currently stored and share ideas for improvement

Record Keeping
 Record-keeping is essential to know what you have
 Records will tell you what you have in stock, how much is on the shelf, and when you
need to reorder supplies
 Create stock and bin cards for each supply
 Create an inventory list (stock book) for all ordered supplies

Stock Card
 Simple, heavy weight cards
 Kept for each item in stock

Example of stock card information;

 Item name (concentration etc.)
 Order/catalog number
 Units
 Price per unit
 Reorder level
 Expiration date
 Special storage requirements

45
Stock Card example
Item Name: __________ Unit: ___________
Manufacturer: ________________________
Minimum Stock (Re-Order Level): ___________

Date Received Issued Quantity Quantity Balance Lot # Signature

From to received Issued

Stock Book
• Contains listing of all items in the store
• Update monthly after physical count
• Use information from stock cards
• Also called stock register

Example of Stock Book information;

• Item name
• Quantity requested
• Date requested
• Quantity received
• Date received
• Lot number
• Expiry Date

Stock Book example

Item Quantity Date Quantity Date Lot # Expiry
Name (Units) requested Received received Date
Requested

Bin Cards
• Make bin card for each item from stock card
• Keep the bin card in front of the item
• Record each supply receipt and removal on the bin card
• Supply receipt should include the date of receipt and quantity received
• When supplies are received or issued, record on the card actual stock on hand
• Make a weekly count of all items in stock

Requesting Supplies
• Complete requisition form according to defined process
• Accurately complete all required fields
• Maintain documentation on all supplies received from central stores

46
 MINISTRY OF HEALTH AND SOCIAL
WELFARE

REPORT & REQUEST FORM FOR LABORATORY SUPPLIES

Facility Code: Facility Name: Type (GOV/NGO/FBO/OTHER):
Name of District / Region: Date Submitted:
Reporting Period: Beginning Month: Ending Month: Year:
LABORATORY SUPPLIES FOR HEALTH FACILITIES

Lost/ Closing Estimated Quantity

Unit Received Balanc Consumed Needed Price Cost
Opening Adjuste Quantity Approved Approved
MSD Code Supply Item of e
Balance This Period d [A+B C-D] [(E 3)x7-D] Requested FY 04 [GxH] Quantity Cost
Issue
(A) (B) (C) (D) (E) (F) (G) (H) (I) (J) (K)

HIV Diagnosis

Bioline HIV1/2
20277006 30 tests Kit

Determine HIV
20271514 1&2 100 tests Kit

Unigold HIV1
/HIV2 25Tests kit

Vironostika Uniform
20291345 Ag/Ab 192 tests kit

Vironostika Uniform
Ag/Ab 576 tests kit

Enzygnost Anti-HIV 1/2

Plus Plus 192 tests kit

Enzygnost Anti-HIV 1/2

Plus Plus 960 tests kit

LABORATORY SUPPLIES FOR HEALTH FACILITIES

Quantity
Received Lost/ Closing Estimated
Unit Opening Needed Quantity Price Cost Approved Approved
Balanc Consumed
Balance T his Adjuste Requested Quantity Cost
MSD Code Supply Item of e [(E 3)x7- FY 04 [GxH]
Period d [A+B C-D]
Issue (A) D] (G) (H) (I) (J) (K)
(B) (C) (D) (E)
(F)

Cost Summary
Cost Approved Additional Funding Source :
Page T otal Cost
Indicate CHF, NHIF, UF etc

Sub-total

T otal cost of additional supplies from Form Blank

R&R (if any)

T otal cost of order

T otal available allocation

T otal Supplemental funding Used

Completed by: Signature:

Approved by: Signature:

Step 4: Re-Order Level for Laboratory Supplies; (35 minutes)

 Reorder Levels is the minimum stock level at which you should reorder the item and the
amount you should reorder. It is done to avoid expiration and waste. Reorder amount
should be the amount likely to be consumed during a period of time.
 As a laboratory manager you need to identify how frequently your laboratory received
shipments/deliveries (often monthly) in order to factor in lead-time.

Determine When to Re-order

 Re-order when stock reaches minimum level

Terminology:
 Minimum stock - Amount of stock required to support testing operations until additional
supplies are received
 Lead time – Time between placing an order and receiving it
 Average usage – number of test kits used in a given time period
 Calculate the average monthly consumption
 Example: 200 packs of controls used in last 12 months /12 = average monthly
consumption
 Use a reorder factor for the frequency of delivery based on lead time to receive
supplies
 Multiply the average monthly consumption by the lead-time. The result is reorder
level.
 Calculating accurate reorder levels based on consumption and lead-time for delivery
assures that you will not run out of supplies even if a regular delivery is missed.

47
  Calculate and note on bin card the minimum reorder level and number of kits/units to
reorder for each reagent/supply
 Review annually and adjust reorder levels as needed based on usage

Calculating Reorder Levels

 Minimum Stock Level = Maximum lead time in weeks x Average Usage
 Example;
o Maximum lead time = 12 weeks
o Average usage/wk = 3 kits
o Minimum stock level = 12 x 3 = 36 kits
*When only 36 kits are left, place an order

Receipt /delivery and Storage

 When supplies and materials are delivered to your laboratory you should do the
following:-
 Verify the contents of order received with requisition form
 Check that items are in good condition and within expiry dates
 Record the quantity received and date each item was received on stock cards and in
stock book
 Add quantity received to current stock in inventory
 Label items with receipt date, receiving person’s initials and expiration dates
 Store each item behind the existing items in correct bin
 Examine Lot Number & Expiry Date
Return Process
 If the items delivered to your laboratory do not meet the standards, specification and
requirements for your order, the best way is not to accept the delivery and return to
supplier. This accompanied by not signing the deliver note. The return process involves;
 Return items that do not pass inspection on receipt for example:
 Refrigerated items that are not in a cold pack or maintained at proper temperature
 Items with any physical damage or deterioration
 Items with short expiry dates
 Incorrect orders (short or over-issued, wrong)
 Document all order discrepancies on a report form

Step 5: Key Points (10 minutes)

 Importance of good Inventory Management System
 Record keeping as a tool for good inventory system
 Facility and storage

Step 6: Evaluation (10 minutes)

 Define the task you will perform to organise the laboratory store room

References
1. Denise M. Harmening; (2007) Laboratory Management ‘Principles and Processes’,
Second Edition, D.H Publishing and Consulting.INC. St Petersburg Florida 33711, 2007
2. N.A Saleemi; (1997) Management Principles and Practices, Publishers Nairobi, Kenya,
June 1997

48
Session 6:

NTA Level 6, Semester 1, Module Code: MLT 06101 – Name; Laboratory Management and
Leadership

Total Session Time: 120 minutes

Prerequisites Modules;
 MLT 05214 - Planned Preventive Maintenance of Laboratory Equipment and Instrument.
 MLT 05212 -Maintenance of Laboratory Supplies

Learning Objectives

Upon completion of this module, the students are expected to be able to:
1. Define the term budget.
2. Explain types of operating budget
3. Describe the components of laboratory budget
4. Explain ways of monitoring and decreasing expenses in a laboratory

Step 2: Definition of Term (10 minutes)

 Before we define the term budget it is good to understand the term financial management,
as budget is one of the component of financial management.
 The term financial management can be defined as the planning, directing, monitoring,
organizing, and controlling of the monetary resources of an organization. It is the
management of the finances of a business / organisation in order to achieve financial
objectives
 A budget is a financial document used to project future income and expenses. A budget is
a plan that outlines an organization's financial and operational goals. So a budget may be
thought of as an action plan expressed into monetary terms. Planning a budget helps a
business to allocate resources, evaluate performance, and formulate future plans.
 The budgeting process may be carried out by individuals or by companies to estimate
whether the person/company can continue to operate with its projected income and
expenses. The budget is prepared simply using paper and pencil, or on computer using a
spread sheet program like Excel.
 While planning a budget can occur at any time, for many organization or businesses,
planning a budget is an annual task, where the past year's budget is reviewed and budget
projections are made for the next three or even five years based on estimates.
 In the health care, the demand for services exceeds the availability of resources therefore
it is necessary to optimize the use of resources available and make decision among
competing demands. In doing so the need for operating our laboratory in a cost effective
manner is paramount. The laboratory manager/supervisor should be able to respond to the
following question:
 How much did the laboratory spend on various testing
 Did expenditure for the tests to the laboratory result in more cost-effective patient
care?

49
Step 3: Types of operating budget (20 minutes)
 The type and format of the operating budget selected depend on the organization
requirements. Among budget types are the following: Fixed, Flexible, Rolling and Zero-
based budget.
 Fixed Budget
 This assumes a single level of activity. If a laboratory is confident that its expenditure
won’t change during the budget cycle, there will be no new tests brought in and no
new equipment purchased, then this type can be used
 Flexible Budget
 Reflects expected laboratory revenue and expenses and it anticipate changes. In this
budget some expenses are fixed and some are variable. The flexible budget provides
information on specific objectives such as appropriate resource usage and adjusts
budgeted expenses to the actual activity on the basis of specific activity indicators
 Rolling Budget
 This is a continuous budget that is updated periodically in preparation for the next
budget cycle. A rolling budget for 12 months period is reviewed and revised every
quarter. The past quarter becomes history and the new quarter is added to the
projection to move ahead. This type of budget is used for cash projections and
therefore frequently up dated. Rolling or incremental budget assumes that all current
operations are essential to the process and working. It addresses only changes like
new equipment, new position and new programs. The advantage of this type of budget
is that; it has minimal time commitment for incremental budget preparation and
disadvantage is assumption that all existing operations are essential for business.

 Zero-Based Budget
 Management annually re evaluate all activities to decide whether they should be
eliminated or funded. Projects are approved based on funds availability and funding
level is determined by priorities. E zero-based budget helps to determine levels of
resource requirements within a service or program. Each department manager is
required to justify the entire unit budget annually as if all of its activities were totally
new.

Step 4: Components of laboratory budget (45 minutes)

 The Laboratory Budget is a planning tool that reflects projected revenues, expenses, and
operating margin
 Margin (net contribution) = revenue – expenses
 There are two components to the budget
 Capital
 Operating

Operating Budget
 The operating budget is for ongoing expenses of operations, for example:
 Personnel Expense
 Laboratory Supplies
 Blood Expense
 Reference Laboratory Testing
 Leases
 Depreciation
 Courier Costs

50
  Service Contracts

The Capital Budget

 Large one-time expense items greater than $1000
 Example – equipment, renovations
 Hospitals/Health Centers have fixed capital budget that includes instrument purchases,
furniture, renovations, LIS, refrigerators, and most other laboratory equipment
 Must justify carefully by identifying the goals for new programs and projections for
future workload.
 Capital Budget Items can be categorized;
 Capital expenditures necessary for continuance of present service or new equipment
required for volume growth
 Capital items that represent a cost savings for profit with the present service volume
and mix.
 Capital items that represent an improvement in the quality of effectiveness for present
services
 Capital items related to new programs or improvement fo existing programs
 The Capital Budget involves
 Write the business plan including:
o Initial outlay
o Estimate of future revenues and expenses
o Return on investment (ROI)
 Link capital to expense budget

Example of the clinical laboratory budget;

SN Description/Salary Budget Budget
Proposed Target
1 S-level Mgt Registr 228,384 218,384
2 Laboratory Techn staff 1,910,629 1,900,629
3 Laboratory Techn Staff 98,000 88,0000
4 Clerical employees 113,335 103,355
5 Clerical employees 1,620 1,620
6 Casual/Office/Clerical 1,620 1,620
Employees
Salary Total
Non Salary
1 Medical Supplies 84,400 80,400
2 Reagents 1,588,699 1584,699
3 Repair and Maintanance 1000 1000
4 Stationaries 2500 2500
5 Telephone Usage 3000 3100
6 Travel 2000 2000
Non Salary Total

Capital Equipment Justification

A laboratory manager needs to have support documentation for High-Cost Budget Items
 A statement of the general purpose of the item
 A statement of the importance of the item

51
 Some measure of expected use of the item
 A description of availability of the same or similar items or services available elsewhere
 An estimate of patient care benefits, the number who will benefit, and the basic
characteristics of the population served by the item.
 An estimate of the expected life of the item
 An estimate of all costs associated with the acquisition of the item
 An estimate of yearly cash outflows associated with the item
 An estimate of yearly cash inflows or savings associated with the item

Capital Equipment Justification Method

• Net present value (NPV) analysis, payback period, or critical to laboratory operations
• NPV analysis
 Analyze cash outlay
 Analyze cash recovery (revenue, labor savings)
 Depreciation
 Must be positive

Exercise;
• On which budget would you find each item?
 Salary for new laboratory technician
 Cost for repairs to Hematology analyzer
 Monthly phone / fax expenses
 Cost for new BD Facscount analyzer
 Invoice for 1,000 test tubes and 5,000 gloves
 Renovations and expansion of laboratory size
 Laundry expenses / replacement laboratory coats

Laboratory Costs
• Budgets help anticipate and contain costs
• Cost information can be used to make better financial management decisions for the
laboratory
• Costs are divided into cost categories
 Direct Cost
 Indirect Costs
 Overhead Costs
 Fixed Cost
 Variable Cost
Direct Costs
• Cost associated with a particular service or production cost
 Reagents/Supplies
 Technician/
 Technologist Salaries
 Supervisory and clerical personnel
Indirect Costs
• Cost associated with many services and products. They are the Cost not directly traceable
to the test
 Building and equipment maintenance
 Utilities
 Housekeeping
 Purchasing

52
Overhead Costs
• Costs that do not contribute to revenue
 Utilities
 Administration of hospital
Fixed cost
• Cost that does not change with volume
 Manager’s salary
 Custodial wages
 Depreciation of plant and equipment
Variable cost
• Costs that change proportionately with a change in volume
• Increases/decreases with volume
 Testing reagents
 Phlebotomy
 Supplies
 Step variable cost – varies with volume, but not in direct proportion to volume

The table below shows example of variable cost for Reagents and Supplies
Number of Tests Costs of Reagents and Supplies Total Variable Costs
1 $. 25 $. 25
10 $.25 $ 2.50
100 $.25 $ 25.00

Cost Accounting
• Two Models
 Job order costing – accumulate all costs for a single test; more accurate but
demanding
 Process costing – accumulate all costs and then divide by units produced; less
accurate but easier

Cost Per Test Evaluation

• Include all direct and indirect costs of producing the test including calibrators, controls,
and repeat tests. Example;
 Total fixed cost for the test system is $300 and total variable expense is $1 per test.
 Your monthly volume is 100.
 Total cost is $300 plus $1x100 = $400.
 Cost per test - $400 divided by 100 = $4.00

Full Test Cost

The calculation for full cost includes;

Direct:
• Labor (variable and fixed)
• Materials (supplies, reagents, disposables)
• Equipment (lease, rental, or purchase depreciation)
• Equipment service and maintenance
Indirect:
• Laboratory overhead
• Hospital expense allocation

53
Calculation of costs enables a manager to make important decision about operation in cost
effective way. Example a manager may decide;
• Produce test (Make) or send-out (Buy) to reference laboratory
 Send out should be considered if send out costs less; if TAT is better; if valuable
testing personnel time is used; if expertise does not exist
• Perform instrument maintenance internally (Make) or buy vendor service contract
• Grow your own staff (Make) or buy from other institution/agency

Step 5: Monitoring and decreasing expenses in a laboratory (20 minutes)

• The budget is a tool to reassure, to clarify,, to lower the risk, to keep track and to help
obtain goals. If properly prepared budgets can increase revenues, decrease spending and
identify new ways to make improvements. Out of control situations (variance) should be
avoided and actions should be taken immediately by planning and monitoring trends for
effective correction and recommendation to management. It is important to understand
various causes of variances during operation by doing analysis of factors affecting
performance.

Variance Analysis
• Variance analysis is the comparison of the deviation of actual costs to budget or expected
standard costs.
• Materials and labor variances can be computed for each materials (reagents, supplies,
consumables) item and for each labor operation.
• Monitor revenue and expenses monthly
• Identify any significant dollar and % variances from the budget (plus or minus 5%)
• Verify budget numbers – verify expenses carefully
• Gather data and identify cause of variances
• Take corrective actions if possible

Causes of Budget Variances

• Posting errors
• Billing errors by vendors
• Staffing problems/overtime
• Volume increases or decreases
• Bulk purchase
• Unanticipated purchase
• Supply Losses/Expiration
• Large expense realized in one month

Expense Reduction Strategies

• High quality testing with reduced repeats, errors (higher quality costs less)
• Automation of testing
• Computerization of tasks
• Workstation consolidation
• Staff cross-training
• Good scheduling with high productivity
• Control of overtime and extra hours
• Turnaround time management
• Reduce use of controls where possible (no over-control on highly accurate, precise
instruments)
• Streamlining processes

54
• Reduce/eliminate waste
• Volume discount on reagents
• Careful inventory control

Financial/Productivity Monitors
• Total tests per full-time employee (FTE)
• Total tests per worked hour
• Total supply expense
• Supply expense/test
• Staffing expense/test
• Total expense/test

Step 6: Key Points (5 minutes)

• Types of budget
• Laboratory costs
• Strategies to reduction of laboratory expenses

Step 7: Evaluation (15 minutes)

• Mention two types of budget
• How can costs be reduced in the laboratory

References:
1. Denise M. Harmening; Laboratory Management ‘Principles and Processes’, Second
Edition, D.H Publishing and Consulting. INC. St Petersburg Florida 33711, 2007
2. Laboratory Management Training Module ‘TOT Guide’

55
Session 7: Customer Service and Satisfaction

NTA Level 6, Semester 1, Module Code: MLT 06101 – Name; Laboratory Management and
Leadership

Total Session Time: 120 minutes

Prerequisite Modules:
• MLT 05214 - Planned Preventive Maintenance of Laboratory Equipment and Instrument.
• MLT 05212 -Maintenance of Laboratory Supplies

Learning Objectives

Upon completion of this module, the students are expected to be able to:
1. Define the term customer
2. Identify internal and external customer of the laboratory
3. Describe various customer service expectation strategies
4. Describe the importance of treating your employees as customers
5. Describe effective communications skills that are used with customers
6. Explain ways to measure good customer service in your laboratory

 .

Step 2: Define a customer

 A customer can be defined as;
 General: A party that receives or consumes products (goods or services) and has the
ability to choose between different products and suppliers.
 A person who purchases goods or services from another
 Anyone who receives products or services from a supplier of the products or services
 Customer care involves putting systems in place to maximise your customers'
satisfaction with your business. It should be a prime consideration for every business -
your daily functioning and performance at the laboratory depends on keeping your
customers happy. So don't neglect the importance of customer care in all areas of your
laboratory business.
 On the other hand good customer service is the lifeblood of any business. You can offer
promotions and slash prices to bring in as many new customers as you want, but unless
you can get some of those customers to come back, your business won't succeed. Good
customer service is all about bringing customers back. And about sending them away
happy - happy enough to pass positive feedback about your business along to others, who
may then try the product or service you offer for them and in their turn become repeat
customers. In most cases you will find profitable organization caring to the customer
however non-profit, service organization needs to institute good customer service as a
way of improving and maintaining work performance and standards.
 Today the health-care industry has become more competitive presenting a need to treat
customers with the utmost respect as well as to continue to provide quality care and
reduce costs. Anyone who is a recipient of an output of service should be considered a
customer. In the health care a customer includes patient, visitors, physicians, staff and
other health care providers within facility.

56
 There are three Rs of customer satisfaction;
 RESULTS: Customer expects superior results from our product or service. They
expect the product or service to be the best value for their money.
 RELATIONSHIP: Customers expect a relationship that is consistent with their value
system.
 RESOURCE: Customers expect you to be a resource to help them solve a problem

Step 3: Internal and external customer of the laboratory (5 minutes)

 From laboratory perspective a laboratory customer may imply;
 A laboratory employee receives work from the laboratory in-charge so the employee
is the laboratory in-charge’s customer
 The ward receives laboratory results from the laboratory so the ward is the
laboratory’s customer
 The patient receives phlebotomy service from the phlebotomist so the patient is the
phlebotomist’s customer
 The 2 primary laboratory customers are the patient and the clinician because the patient is
the focus of everything we do! However the internal and external laboratory customers
are:
 Internal – clinician, nurses, laboratory staff, other hospital departments.
 External – patients, families, suppliers

Step 4: Customer Service Expectation strategies (25 minutes)

 Laboratory customers require high quality test result provided in a courteous and timely
manner on a report that is readable and easy to interpret.
 There are several strategies that can be used by the manager to be sure the customer is
satisfied with the services provided.
 It is critical to set customer service expectations for all staff and to hold staff
accountable for the expectations
 Define customer service expectations; incorporate into job descriptions
 Supervisors and leaders must role model the behaviors they expect, or staff will not
display them
 Train all staff members on customer service and expectations
 Coach and counsel staff to improve skill; assess customer service on performance
appraisal

What Do Laboratory Customers Want?

 Patients want;
 Laboratory staff to be professional:
 Be informed and competent
 Be well groomed and clean
 Adhere to safety precautions
 Be courteous, friendly, and caring
 Ask good questions and listen to their concerns/feelings
 Follow-up on promises made
 Clinicians want laboratory to provide;
 An adequate test menu
 Information about tests performed
 Information about patient preparation and appropriate specimens
 Reports that are easy to read and interpret
 Accurate results and fast turnaround time

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 Examples of External Customer Service Expectations;
 Puts patient and customer needs first in all daily activities by responding to customer
needs before continuing with other routine work
 Listens with empathy and concern to a customer and identifies clearly the customer’s
needs
 Takes personal responsibility for correcting customer service problems

 Examples of Internal Customer Service Expectations;

 Uses common courtesies such as please, thank you, and excuse me
 Volunteers to assist co-workers without being asked
 Displays a helpful and caring attitude in each interaction with co-workers
 Treats all individuals with respect and kindness
 The fact to consider is that:
o Dissatisfied customer tell eight to ten people about their bad experience in you
service while
o Satisfied customer normally will tell five people of the good service provided to
them.
 Map to success Customer Service
 Define who your internal and external customers are
o Talk with customers to determine their needs, expectations, and desires
o Set customer service expectations
o Observe staff behaviour for good customer care skills; coach and counsel staff
o Train staff and management on customer service and customer expectations
o Use process improvement to address service issues related to process
o Measure customer satisfaction (physician and patient satisfaction surveys)
o Reward good customer service and celebrate successes

Exercise; Role Play

Mr. Nsunza comes in for his monthly laboratory tests. Rachel the phlebotomist will be
drawing his blood. Demonstrate good customer service for this client.

Step 5: Importance of treating your employees as customers (15 minutes)

 Employees are important assets of an organization and if they are not satisfied they
cannot execute good customer’s service to other customers.
 Happy employees make patients and other customers happy!
 Be sensitive and address employee concerns and needs
 Provide a positive work environment for employees – the job of management

 As an employer you need to design reward and recognition system for your employee;
 Promote behaviours that you recognize
 Develop strategies for recognition of good customer service behaviors
 Recognition is not expensive – often a simple thank you is enough
 Formal customer service recognition

Exercise; Group Work

Work in pairs and discuss ways you could recognize good service behaviors in your
laboratory.

58
Step 6: Effective communications skills that are used with customers
Customer Communication raise the level of customer service excellence through the use of
excellent customer communication.
 Make your customers feel important and appreciated
 Remain calm in the most demanding situations
 Transform complaints into valuable customer feedback
 Become a master in the art of listening
 Be successful with the most difficult people

Good oral communications skills:

 Speak clearly; provide to-the-point instructions
 Maintain eye contact
 Explain procedures clearly
 Exhibit confidence
 Answer questions completely but if you do not know, say so and state you will find out
and get back to them

Empathic listening:
 Listen for facts
 Let them complete sentences without interruption
 Restate what you think they said
 Listen for feelings
 Listen with non-verbals like nodding, leaning forward
 Listen for non-verbals – what is not said

Ways to Make Customers Angry

 When you are communicating with a customer you need to be careful otherwise you may
make the customer angry and that will have a negative impact resulting into loosing
customer. Don’t do or say anything that would cause the customer to become angry in the
first place. The customer may be angry if;
 Tell them “It is just our policy”
 Make them wait while you chat or complete routine work
 Never have laboratory reports ready on time
 Losing specimens
 Don’t deliver on what you promise
 Tell them something that is not true/correct
 Violate their privacy
 Tell them “I am too busy” or “We are short-staffed”
*Your role as a staff is to turn an unhappy customer into happy customer.

Managing the Angry Customer

 Take them into private area
 Remain calm and do not take it personally
 Do not interrupt while he/she vents
 Listen carefully for the real complaint
 Provide a blameless apology “I am sorry you had that experience”
 State “What can I do to help you?”
 Show empathy and concern

59
 Propose solutions; resolve the problem if you can or refer to a supervisor
 Perceive all complaints as positive – as opportunities to improve service
 Remember to document the occurrence (occurrence report form in Module 7)

Exercise- Role Play

Doctor Charles comes to the laboratory very upset that the results of the HIV test performed
on his patient were incorrect. How will you communicate with him? What steps will you
take to resolve the problem?

Step 7: Ways to measure good customer service in your laboratory (30 minutes)
 We all know customer satisfaction is essential to the survival of our businesses. How do
we find out whether our customers are satisfied? The best way to find out whether your
customers are satisfied is to ask them.
 When you conduct a customer satisfaction survey, what you ask the customers is
important. How, when, and how often you ask these questions are also important.
However, the most important thing about conducting a customer satisfaction survey is
what you do with their answers.

How You Ask Whether Customers Are Satisfied?

 There are many ways to ask your customers whether or not they are satisfied with your
company, your products, and the service they received.
 You can ask them:
o Face-to-face

As just before they are about to walk out of your store or office, ask them.

 Call them on the phone

 If you have their phone number, and their permission, you can call them after their visit
and ask how satisfied they are.
 Mail them a questionnaire
 This technique has been used for a long time. The results are predictable.
 Email them a customer satisfaction survey
 Be careful to not violate Spam laws
 Email them an invitation to take a customer satisfaction survey

 That’s a good time to make sure your customer is satisfied, her problem was resolved and
to get her input on how your support team might improve.
 We have an example survey below that help you understand exactly how well you met
your customer’s support needs.

When To Conduct A Customer Satisfaction Survey

 Ask your customers how you are doing
 Invite customer comments and complaints (complaint, suggestion box)
 Survey key clinician customers
 Assess patient satisfaction with phlebotomy service
 Assess employee satisfaction

Example of Customer Survey questionnaire

 How easy or difficult was it to contact our laboratory staff at the reception section?

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  Extremely easy
 Somewhat easy
 Somewhat difficult
 Very difficult

 How knowledgeable was the laboratory staff when you visited for blood drawing?
 Very knowledgeable
 Somewhat knowledgeable
 Slightly knowledgeable
 Not at all knowledgeable

 How polite was the laboratory staff you met at the phlebotomy room?
 Very polite
 Somewhat polite
 Slightly polite
 Not at all polite
 You need to analyse this findings and use the feedback as an inputs for improvement of
laboratory services.

Step 8: Key Points (5 minutes)

 Identify laboratory customers
 Customer satisfaction strategies

Step 9: Evaluation (5 Minutes)

 Identify three internal and external customers of the laboratory
 Describe laboratory customer service expectation
 List the tools that can be used to solicit customer feedback

References:
1. Laboratory Management Training Module ‘TOT Guide’
2. N.A Saleemi; (1997) Management Principles and Practices, Publishers Nairobi, Kenya,
June
3. Denise M. Harmening; (2007) Laboratory Management ‘Principles and Processes’,
Second Edition, D.H Publishing and Consulting.INC. St Petersburg Florida33711, 2007
4. Jane Hudson; (2004) Principles of Clinical Laboratory Management ‘A study Guide and
WorkBook’ Pearson Education, Inc, Upper Saddle River, New Jersey, 07458, 2004
5. Walter J. Wadsworth; (2005) ‘The Agile Manager’s Guide to Leadership’, Velocity
Business Publishing, INC. Bristol, VT 05443,USA, 2005
6. Senior Leadership and Management Course; ‘Tanzania Institutional Capacity Building
Project’ Participants Manual, MOHSW, November 2011

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Chapter Two

Module Code MLT06102: Laboratory Biosafety and Biosecurity

62
Session 1: Assessment criteria for laboratory Biosafety and Biosecurity

NTA Level 6, Semester 1: Module Code: MLT06102: Laboratory Biosafety and

Biosecurity

Learning Objectives

By the end of this session, students are expected to be able to:

1. Define laboratory Biosafety and Biosecurity
2. Distinguish between Biosafety and Biosecurity
3. List criteria for assessment Biosafety and Biosecurity containment level (Type of
organism, risk level, laboratory procedure
4. Explain levels of the laboratory Biosafety and Biosecurity (i, ii, iii, and iv)
5. Describe requirements of each Biosafety and Biosecurity level

Definition of:
 Laboratory Biosafety is the term used to describe containment principles, technologies
and practices that are implemented to prevent unintentional exposure to pathogens or
potentially hazardous biological agents and toxins, or their accidental release into the
environment.
 Biosecurity refers to institutional and personal security measures designed to prevent the
loss, theft, misuse, diversion or intentional release of pathogens and toxins.
 Biosafety Level is an assignment of hazardous agent based on risk assessment, depending
on agent and conditions of use which require professional judgment

Step 3: Distinction between Biosafety and Biosecurity (10 minutes)

Laboratory Biosafety:
 Limit access to laboratory areas while work is in progress
 Protect people from dangerous pathogens

Biosecurity:
 Limit access to areas that contain certain biological agents or assets
 Protect people from microbial agents from loss, theft, diversion or intentional misuse

Step 4: Criteria for assessment of Biosafety and Biosecurity containment level (10
minutes)
(Type of organism, risk level, laboratory procedures)
The primary risk criteria used to define and assess the four ascending levels of containment
referred to as Biosafety levels I through IV are:
 Infectivity
 Severity of disease
 Transmissibility of the agent that cause moderate to severe disease
 The nature of work being conducted, and
 Origin of the agent, whether indigenous or exotic
Each level of containment describes the microbiological practices, safety equipment and
facility safeguards for the corresponding level of risk associated with handling a particular
agent.

63
The facilities safeguards help protect non-laboratory occupants of the building and the public
health environment.
Below is a list of Biosafety containment levels
 Biosafety level I
 Biosafety level II
 Biosafety level III
 Biosafety level IV

Note: No one should conclude that the absence of an agent in the existing documented
cases is safe to handle at Biosafety level I, or without a risk assessment to determine the
appropriate level of containment.

Risk Group 1 Agents

 No or low individual and community risk
 A microorganism unlikely to cause human or animal disease

Risk Group 2 Agents

 Moderate individual risk, low community risk
 Pathogen causes human or animal disease but is unlikely to be a serious hazard to
laboratory workers, the community, livestock or the environment
 May cause serious infection but effective treatments and preventive measures are
available
 Risk of spread is limited

Risk Group 3 Agents

 High individual risk, low community risk
 Pathogen usually causes serious human or animal disease but does not ordinarily spread
to others
 Effective treatment and preventive measures are available
Risk Group 4 Agents
 High individual and community risk
 A pathogen causes serious human or animal disease; readily transmitted from one
individual to another
 Effective treatment and preventive measures are usually not available

Risk Groups and Biosafety Levels summary

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 Risk Groups and Biosafety Levels
Risk Biosafety Laboratory Type Laboratory Safety
Group Level Practices Equipment

Basic – Basic teaching, GMT None; open

Biosafety research bench work
1 Level 1

Basic – Primary health GMT plus Open bench

Biosafety services; protective plus BSC for
Level 2 diagnostic clothing, aerosols
2 services, biohazards
research sign

World Health National Institutes

Organization of Health

Risk Groups and Biosafety Levels

Risk Biosafety Level Laboratory Type Laboratory Safety
Group Practices Equipment

Containment- Special Level 2 + BSC and/or

Biosafety diagnostic special clothing, other primary
3 Level 3 services, access control, devices for all
research directed airflow activities

Maximum Dangerous Level 3 + airlock Class III BSC,

Containment – pathogen units entry, shower or positive
Biosafety exit, special pressure suites
4 Level 4 waste disposal with class II
BSCs, double
ended
autoclave

World Health National Institutes

Organization of Health

Step 5: Levels of laboratory Biosafety and Biosecurity Each level of containment

describes the microbiological practices, safety equipment and facility safeguards for the
corresponding level of risk associated with handling a particular agent.
 The facilities safeguards help protect non-laboratory occupants of the building and the
public health environment.
 Biosafety level I –is the basic level of protection and is appropriate for agents that are not
known to cause disease in normal, healthy humans.
 Biosafety level II – is appropriate for handling moderate-risk agents that cause human
disease of varying severity by ingestion or through percuteneous or mucus membrane
exposure.
 Biosafety level III- is appropriate for agents with a known potential for aerosol
transmission, for agents that may cause serious and potentially lethal infections and that
are indigenous or exotic in origin.
 Biosafety level IV –is appropriate for handling indigenous or exotic agents that pose a
high individual risk of life threatening disease by infectious aerosols and for which no
treatment is available.

65
Step 6: Requirements for each laboratory Biosafety and Biosecurity containment level
(I, II, III, and IV)

Biosafety containment levels

 Biosafety containment levels requirements are basically placed into three areas:
 Microbiological practices
 special practices
 safety equipment
 laboratory facilities

Biosafety Containment Level I

Standard Microbiological Practices

 Laboratory supervisor must enforce the institutional policies that control access to the
laboratory
 Persons must wash their hands after working with potentially hazardous materials and
before leaving the laboratory
 Eating, drinking, smoking, handling contact lenses, applying cosmetics and storing food
for human consumption must not be permitted in laboratory areas. Food must be stored
outside the laboratory area in cabinets or refrigerators designated and used for this
purpose.
 Mouth pipetting is prohibited; mechanical pipetting devices must be used
 Policies for safe handling of sharps, such as needles, scalpels, pipettes, and broken
glassware must be developed and implemented
 Decontaminate work surfaces after completion of work and after any spill or splash of
potentially infectious material with appropriate disinfectant
 A sign incorporating the universal biohazard symbol must be posted at the entrance to the
laboratory when infectious agents are present. This sign may include the name of the
agent(s) in use, and the name and phone number of the laboratory supervisor or other
responsible personnel.
 An effective integrated pest management program is required.

Special practices
 Special containment equipment or facility design is not required,
 Suitable for work involving well-characterized agents not known to consistently cause
disease in immunocompetent adult humans
 Minimal potential hazard to laboratory personnel and the environment.
 Laboratories are not necessarily separated from the general traffic patterns in the
building.
 Work is typically conducted on open bench tops using standard microbiological
practices.
 Laboratory personnel must have specific training in the procedures conducted in the
laboratory.
 An effective integrated pest management program is required.

66
 Biosafety Level 1

Biosafety Level 1

Safety equipment (Primary barriers and Personal Protective Equipment)

 Special containment devices or equipment, such as BSCs, are generally required.
 Protective laboratory coats, gowns, or uniforms are recommended to prevent
contamination of personal clothing.
 Protective eyewear must be used when conducting procedures that have the potential to
create splashes of microorganisms or other hazardous materials. Persons who wear
contact lenses in the laboratory should also wear eye protection

67
 Gloves must be worn to protect hands from exposure to hazardous materials. Gloves
selection must be based on an appropriate risk assessment. Alternative to latex gloves
should be available.

Laboratory Facilities (Secondary Barriers)

 Laboratories should have doors for access control
 Laboratories must have a sink for hand washing
 The laboratory should be designed so that it can be easily cleaned
 Carpets and rugs are not appropriate.
 Laboratories windows that open to the exterior should be fitted with screens
*-
Biosafety containment level I is the basic level of containment. It relies on;
 Standard microbiological practices
 No special primary or secondary barriers

Biosafety containment level II

 Biosafety containment level II is the second biosafety level of containment;
 Builds upon BSL-1
 BSL-2 is suitable for work involving agents that pose moderate hazards to personnel
and the environment.
 Laboratory personnel have specific training in handling pathogenic agents
 Personnel are supervised by scientists competent in handling infectious agents and
associated procedures
 Access to the laboratory is restricted when work is being conducted
 All procedures in which infectious aerosols or splashes may be created are conducted
in biological safety cabinets (BSCs) or other physical containment equipment.

 Standard Microbiological Practices

 Laboratory supervisor must enforce the institutional policies that control access to the
laboratory
 Persons must wash their hands after working with potentially hazardous materials and
before leaving the laboratory
 Eating, drinking, smoking, handling contact lenses, applying cosmetics and storing
food for human consumption must not be permitted in laboratory areas. Food must be
stored outside the laboratory area in cabinets or refrigerators designated and used for
this purpose.
 Mouth pipetting is prohibited; mechanical pipetting devices must be used
 Policies for safe handling of sharps, such as needles, scalpels, pipettes, and broken
glassware must be developed and implemented. Whenever practical, laboratory
supervisors should adopt improved engineering and work practice controls that reduce
the risk of injuries. Precaution should always be taken with sharps.
 Decontaminate work surfaces after completion of work and after any spill or splash of
potentially infectious material with appropriate disinfectant
 A sign incorporating the universal biohazard symbol must be posted at the entrance to
the laboratory when infectious agents are present. This sign may include the name of
the agent(s) in use, and the name and phone number of the laboratory supervisor or
other responsible personnel
 Laboratory supervisor must ensure that laboratory personnel receive appropriate
training regarding their duties, the necessary precautions to prevent exposures and

68
 exposure evaluation procedures. Personnel must receive annual updates or additional
training when procedural or policy changes occur. All laboratory personnel and
particularly women of child-bearing age should be provided with information
regarding immune competence and conditions that may predispose them to infection;
they should therefore be encouraged to self-identify to the institution’s healthcare
provider for appropriate counselling and guidance
 An effective integrated pest management program is required

Special practices
 All persons entering the laboratory must be advised of the potential hazards and meet
specific entry/exit requirements.
 Laboratory staff must be provided with medical surveillance, as appropriate, and offered
available immunizations for agents handled or potentially present in the laboratory
 A laboratory specific Biosafety manual must be developed and adopted for use as policy.
The Biosafety manual must be available and accessible.
 Potentially infectious materials must be placed in durable, leak proof container during
collection, handling, processing, storage, or transport within a facility.
 Laboratory equipment should be routinely decontaminated, as well as after spills,
splashes, or other potential contamination.
 Incidents that may result in exposure to infectious materials must be immediately
evaluated and treated according to procedures described the laboratory Biosafety
manual. All such incidents must be reported to the laboratory safety officer/laboratory
supervisor. Medical evaluation, surveillance, and treatment should be provided and
appropriate records be maintained.
 Animal and plants not associated with work being performed must not be permitted in
the laboratory.
 All procedures involving the manipulation of infectious materials that may generate an
aerosol should be conducted within a BSC or other physical containment device

Mandatory
Warning Sign
Designate
Biosafety Level
Special Entry
Procedures
– Immunizations
– PPE
Contact
Information

69
 Safety equipment (Primary Barriers and Personal Protective Equipment)
 Properly maintained BSCs, other appropriate PPEs, or other physical containment
devices must be used whenever procedures with a potential for creating infectious
aerosols or splashes are conducted; or whenever high concentrations or large volumes
of infectious agents are used
 Gloves must be worn to protect hands from exposure to hazardous materials. Gloves
selection must be based on an appropriate risk assessment. Alternative to latex gloves
should be available. Gloves must not be used outside the laboratory. Disposable
gloves should not be re-used
 Eye, face and respiratory protection should be used in rooms containing infected
animals as determined by the risk assessment.
 Eye, face protection (goggles, mask, face shield or other splatter guard) is used for
anticipated splashes or sprays of infectious or other hazardous materials when the
microorganisms must be handled outside the BSC or containment device. Eye and
face protection must be disposed of with other contaminated laboratory waste or
decontaminated before reuse.

 Laboratory Facilities (Secondary Barriers)

 Laboratory doors should be self-closing and should have locks in accordance with the
institutional policies.
 Laboratory must have a sink for hand washing. The sink may be manually, hands-
free, or automatically operated. It should be located near the exit door.
 Laboratory should be designed so that it can be easily cleaned and decontaminated.
Carpets and rugs in laboratories are not permitted.
 Laboratory furniture must be capable of supporting anticipated loads and uses. Spaces
between benches, cabinets, and equipment should be accessible for cleaning.
 Bench tops must be impervious to water and resistant to heat, organic solvents, acids,
alkalis, and other chemicals.
 Laboratories windows that open to the exterior are not recommended. However if a
laboratory does not have windows that open to the exterior, they must be fitted with
screens
 An eye wash station must be readily available.
 A method for decontaminating all laboratory waste should be available in the facility
(e.g., autoclave, chemical disinfection, incineration, or other validated
decontamination method)

 Biosafety containment level III

 Is applicable to clinical, diagnostic, teaching, research, or production facilities where
work is performed with indigenous or exotic agents that may cause serious or
potentially lethal disease through inhalation route exposure. Laboratory personnel
must receive specific training in handling pathogenic and potentially lethal agents,
and must be supervised by scientists competent in handling infectious agents and
associated procedures. All procedures involving the manipulation of infectious
materials must be conducted within BSCs or other physical containment devices.

 Standard Microbiological Practices

 Laboratory supervisor must enforce the institutional policies that control access to the
laboratory
 Persons must wash their hands after working with potentially hazardous materials and
before leaving the laboratory

70
 Eating, drinking, smoking, handling contact lenses, applying cosmetics and storing food
for human consumption must not be permitted in laboratory areas. Food must be stored
outside the laboratory area in cabinets or refrigerators designated and used for this
purpose.
 Mouth pipetting is prohibited; mechanical pipetting devices must be used
 Policies for safe handling of sharps, such as needles, scalpels, pipettes, and broken
glassware must be developed and implemented. Whenever practical, laboratory
supervisors should adopt improved engineering and work practice controls that reduce the
risk of sharps injuries.
 Decontaminate work surfaces after completion of work and after any spill or splash of
potentially infectious material with appropriate disinfectant.
 Perform all procedures to minimize the creation of splashes and/or aerosols.
 A sign incorporating the universal biohazard symbol must be posted at the entrance to the
laboratory when infectious agents are present. This sign may include the name of the
agent(s) in use, and the name and phone number of the laboratory supervisor or other
responsible personnel
 An effective integrated pest management program is required.

Special practices
 All persons entering the laboratory must be advised of the potential hazards and meet
specific entry/exit requirements.
 Laboratory staff must be provided with medical surveillance, as appropriate, and offered
available immunizations for agents handled or potentially present in the laboratory
 A laboratory specific Biosafety manual must be developed and adopted for use as policy.
The Biosafety manual must be available and accessible.
 Potentially infectious materials must be placed in durable, leak proof container during
collection, handling, processing, storage, or transport within a facility.
 Laboratory equipment should be routinely decontaminated, as well as after spills,
splashes, or other potential contamination.
 Incidents that may result in exposure to infectious materials must be immediately
evaluated and treated according to procedures described the laboratory Biosafety manual.
All such incidents must be reported to the laboratory safety officer/laboratory supervisor.
Medical evaluation, surveillance, and treatment should be provided and appropriate
records be maintained.
 Animal and plants not associated with work being performed must not be permitted in the
laboratory.
 All procedures involving the manipulation of infectious materials that may generate an
aerosol should be conducted within a BSC or other physical containment device
 The laboratory supervisor must ensure that laboratory personnel demonstrate efficiency in
standard and special microbiological practices before working with BSL-3 agents
 Laboratory personnel must receive specific training in handling pathogenic and
potentially lethal agents
 Must be supervised by scientists competent in handling infectious agents and associated
procedures.
 Biosafety Level 2 plus all procedures involving the manipulation of infectious
materials must be conducted within BSCs, or other physical containment devices
 Personnel wear additional appropriate personal protective equipment including
respiratory protection as determined by risk assessment

71
 Safety equipment (Primary Barriers and Personal Protective Equipment)
 Properly maintained BSCs (preferably Class II and Class III), other appropriate PPEs,
or other physical containment devices must be used whenever procedures with a
potential for creating infectious aerosols or splashes are conducted; or whenever high
concentrations or large volumes of infectious agents are used
 Gloves must be worn to protect hands from exposure to hazardous materials. Gloves
selection must be based on an appropriate risk assessment. Alternative to latex gloves
should be available. Gloves must not be used outside the laboratory. Disposable
gloves should not be re-used
 Eye, face and respiratory protection should be used in rooms containing infected
animals as determined by the risk assessment.
 Eye, face protection (goggles, mask, face shield or other splatter guard) is used for
anticipated splashes or sprays of infectious or other hazardous materials when the
microorganisms must be handled outside the BSC or containment device. Eye and
face protection must be disposed of with other contaminated laboratory waste or
decontaminated before reuse.

Laboratory Facilities (Secondary Barriers)

 Laboratory doors should be self-closing and should have locks in accordance with the
institutional policies. The laboratory must be separated from areas that are open to
unrestricted traffic flow within the building. Laboratory access is restricted. Access to the
laboratory is through two self-closing doors. A clothing change room (anteroom) may be
included in the passage way between the self-closing doors.
 Laboratory must have a sink for hand washing. The sink may be manually, hands-free, or
automatically operated. It should be located near the exit door. If the laboratory is
segregated into different laboratories, a sink must also be available for hand washing in
each zone. Additional sinks may be required as determined by the risk assessment.
 Laboratory should be designed so that it can be easily cleaned and decontaminated.
Carpets and rugs in laboratories are not permitted. Seams, floors, walls, and ceiling
surfaces should be sealed. Spaces around doors and ventilation openings should be
capable of being sealed to facilitate space decontamination.
 Laboratory furniture must be capable of supporting anticipated loads and uses. Spaces
between benches, cabinets, and equipment should be accessible for cleaning. Bench tops
must be impervious to water and resistant to heat, organic solvents, acids, alkalis, and
other chemicals.
 All windows in the laboratory must be sealed.
 BSCs must be installed so that fluctuations of the room air supply and exhaust do not
interfere with proper operations. BSC should be located away form doors, heavily
travelled laboratory areas, and other possible airflow.
 Vacuum lines must be protected with HEPA filters or their equivalent. Filters must be
replaced as needed. Liquid disinfectant traps may be required.
 An eye wash station must be readily available in the laboratory.
 A ducted air ventilation system is required. This system must provide sustained
directional airflow by drawing into the laboratory from ‘clean’ areas towards ‘potentially
contaminated’ areas. The laboratory shall be designed such that under failure conditions
of the airflow will not be reversed.
 The BSL-3 facility design, operational parameters, and procedures must be verified and
documented prior to operation. Facilities must be re-verified and documented at least
annually.

72
 Laboratories windows that open to the exterior are not recommended. However if a
laboratory does not have windows that open to the exterior, they must be fitted with
screens
 An eye wash station must be readily available.
 A method for decontaminating all laboratory waste should be available in the facility
(e.g., autoclave, chemical disinfection, incineration, or other validated decontamination
method)

o Directional air flow

Biosafety containment level IV:

Is required for work with dangerous and exotic agents that pose a high individual risk of
aerosol transmitted laboratory infections and life-threatening disease that is frequently fatal,
for which there are no vaccines or treatments, or a related agent with unknown risk of
transmission. Agents with a close or identical antigenic relationship to agents requiring BSL-
4 containment must be handled at this level until sufficient data are obtained either to confirm
continued work at this level, or re-designate the level. Laboratory staff must have specific and
thorough training in handling extremely hazardous infectious agents. They must understand
the primary and secondary containment functions of standard and special practices,
containment equipment, and laboratory design characteristics. All laboratory staff and
supervisors must be competent in handling agents and procedures requiringBSL-4
containment.

73
There are two models for BSL-4 laboratories:
1. A cabinet laboratory – Manipulation of agents must be performed in a Class III BSC; and
2. A suit laboratory – Personnel must wear a positive pressure supplied air protective suit.
All these two types have special engineering and design features to prevent microorganisms
from being disseminated into the environment.

Standard Microbiological Practices

 Laboratory supervisor must enforce the institutional policies that control access to the
laboratory
 Eating, drinking, smoking, handling contact lenses, applying cosmetics and storing food
for human consumption must not be permitted in laboratory areas
 Mechanical pipetting devices must be used
 Policies for safe handling of sharps, such as needles, scalpels, pipettes, and broken
glassware must be developed and implemented
 Decontaminate all wastes before removal from the laboratory by an effective and
validated method.
 A sign incorporating the universal biohazard symbol must be posted at the entrance to the
laboratory when infectious agents are present. This sign may include the name of the
agent(s) in use, and the name and phone number of the laboratory supervisor or other
responsible personnel.
 All laboratory staff and supervisors must be competent in handling agents and procedures
requiring BSL-4 containment.
 Access to the laboratory is controlled by the laboratory supervisor in accordance with
institutional policies
 An effective integrated pest management program is required.
 Perform all procedures to minimize the creation of splashes and/or aerosols.

Special Practices
 All persons entering the laboratory must be advised of the potential hazards and meet
specific entry requirements in accordance with institutional policies. Only persons whose
presence in the facility or individual laboratory a room is required for specific or support
purposes are authorized to enter. Entry into the facility must be limited by means of
secure, locked doors. A logbook or other means of documenting the date and time of all
persons entering and leaving the laboratory must be maintained. While the laboratory is
operational, personnel must enter and exit the laboratory through the clothing change and
shower rooms except during emergences. All personal clothing must be removed in the
outer clothing change room. All persons entering the laboratory must use laboratory
clothing including undergarments, pants, shirts, jumpsuits, shoes, and gloves (as
appropriate). All persons leaving the laboratory must take a personal body shower. Used
laboratory clothing must not be removed from the inner change room through the
personal shower. These must be treated as contaminated materials and decontaminated
before laundering.
 Laboratory personnel and support staff must be provided appropriate occupational
medical services including medical surveillance and available immunizations for agents
handled or potentially present in the laboratory. A system must be established for
reporting and documenting laboratory accidents, exposures, employee absenteeism and
for the medical surveillance of potential laboratory-associated illnesses.
 Laboratory equipment must be routinely decontaminated, as well as after spills, splashes,
or other potential contamination.

74
 Incidents that may result in exposure to infectious materials must be immediately
evaluated and treated according to procedures described the laboratory Biosafety manual.
All such incidents must be reported to the laboratory safety officer/laboratory supervisor.
Medical evaluation, surveillance, and treatment should be provided and appropriate
records be maintained.

Safety Equipment (Primary Barriers and Personal Protective Equipment)

Cabinet Laboratory
 All manipulations of infectious materials within the laboratory must be conducted in the
Class III biological safety cabinet. Double door, pass through autoclave must be provided
for decontaminating materials passing out of the Class III BSC(s).
 Workers in the laboratory must wear protective laboratory clothing with a solid front such
as tie-back or wrap-around gowns, scrub suits or coveralls. No personal clothing,
jewellery, or other items except eyeglasses should be taken passed the personal shower
area.
 Eye, face, and respiratory protection should be used in rooms containing infected animals
as determined by the risk assessment. Prescription eyeglasses must be decontaminated
before removal through the personal body shower.
 Disposable gloves must be worn underneath cabinet gloves to protect the worker from
exposure should a break or tear occur in a cabinet glove.

Suite laboratory.
 Personnel wearing a one-piece positive pressure supplied air suit must conduct all
procedures.
 All manipulations of infectious agents must be performed within a BSC or other primary
barrier system.
 Equipment that may produce aerosols must be contained in primary barrier devices that
exhaust air through HEPA filtration before being discharged into the laboratory. These
HEPA filters should be tested annually and replaced as needed.
 HEPA filtered exhaust air from a Class II BSC can be safely re-circulated into the
laboratory environment if the cabinet is tested and certified at least annually and operated
according to manufacturer’s specifications.
 Workers must wear laboratory clothing, such as scrub suits, before entering the room
used for donning positive pressure suits. All laboratory clothing must be removed in the
dirty side change room before entering the personal shower.
 Inner disposable gloves must be worn to protect against break or tears in the outer suit
gloves. Disposable gloves must not be worn outside the change area. Alternatives to latex
gloves should be available. Do not wash or reuse disposable gloves. Inner gloves must be
removed and discarded in the inner change room prior to entering the personal shower.
Dispose of used gloves with other contaminated waste.
 Decontamination of outer suit gloves is performed during laboratory operations to remove
gross contamination and minimize further contamination of the laboratory.

Laboratory Facilities (Secondary Barriers)

Cabinet Laboratory
 The BSL-4 cabinet laboratory consists of either a separate building or a clearly
demarcated and isolated zone within a building. Laboratory doors must have locks in
accordance with the institutional policies.52 Biosafety in Microbiological and Biomedical
Laboratories

75
 Rooms in the facility must be arranged to ensure sequential passage through an inner
(dirty) changing area, a personal shower and an outer (clean) change room upon exiting
the room(s) containing the Class III BSC(s).
 An automatically activated emergency power source must be provided at a minimum for
the laboratory exhaust system, life support systems, alarms, lighting, entry and exit
controls, BSCs, and door gaskets. Monitoring and control systems for air supply, exhaust,
life support, alarms, entry and exit controls, and security systems should be on an
uninterrupted power supply (UPS).
 A double-door autoclave, dunk tank, fumigation chamber, or ventilated airlock must be
provided at the containment barrier for the passage of materials, supplies, or equipment.
 A hands-free sink must be provided near the door of the cabinet room(s) and the inner
change room. A sink must be provided in the outer change room. All sinks in the room(s)
containing the Class III BSC must be connected to the wastewater decontamination
system.
 Walls, floors, and ceilings of the laboratory must be constructed to form a sealed internal
shell to facilitate fumigation and prohibit animal and insect intrusion. The internal
surfaces of this shell must be resistant to chemicals used for cleaning and
decontamination of the area. Floors must be monolithic, sealed and coved.
 All penetrations in the internal shell of the laboratory and inner change room must be
sealed.
 Openings around doors into the cabinet room and inner change room must be minimized
and capable of being sealed to facilitate decontamination.
 Drains in the laboratory floor (if present) must be connected directly to the liquid waste
decontamination system.
 Services and plumbing that penetrate the laboratory walls, floors, or ceiling must be
installed to ensure that no backflow from the laboratory occurs. These penetrations must
be fitted with two (in series) backflow prevention devices. Consideration should be given
to locating these devices outside of containment. Atmospheric venting systems must be
provided with two HEPA filters in series and be sealed up to the second filter.
 Decontamination of the entire cabinet must be performed using a validated gaseous or
vapor method when there have been significant changes in cabinet usage, before major
renovations or maintenance shut downs, and in other situations, as determined by risk
assessment. Laboratory Biosafety Level Criteria: BSL-4 53
 Selection of the appropriate materials and methods used for decontamination must be
based on the risk assessment.
 Laboratory furniture must be of simple construction, capable of supporting anticipated
loading and uses. Spaces between benches, cabinets, and equipment must be accessible
for cleaning and decontamination. Chairs and other furniture must be covered with a non-
porous material that can be easily decontaminated.
 Windows must be break-resistant and sealed.
 If Class II BSCs are needed in the cabinet laboratory, they must be installed so that
fluctuations of the room air supply and exhaust do not interfere with proper operations.
Class II cabinets should be located away from doors, heavily traveled laboratory areas,
and other possible airflow disruptions.
 Central vacuum systems are not recommended. If, however, there is a central vacuum
system, it must not serve areas outside the cabinet room. Two in-line HEPA filters must
be placed near each use point. Filters must be installed to permit in-place decontamination
and replacement.
 An eyewash station must be readily available in the laboratory.

76
 A dedicated non-recirculating ventilation system is provided. Only laboratories with the
same HVAC requirements (i.e., other BSL-4 labs, ABSL-4, BSL-3-Ag labs) may share
ventilation systems if gas-tight dampers and HEPA filters isolate each individual
laboratory system.
 The supply and exhaust components of the ventilation system must be designed to
maintain the laboratory at negative pressure to surrounding areas and provide differential
pressure or directional airflow, as appropriate, between adjacent areas within the
laboratory.
 Redundant supply fans are recommended. Redundant exhaust fans are required. Supply
and exhaust fans must be interlocked to prevent positive pressurization of the laboratory.
 The ventilation system must be monitored and alarmed to indicate malfunction or
deviation from design parameters. A visual monitoring device must be installed near the
clean change room so proper differential pressures within the laboratory may be verified
prior to entry.
 Supply air to and exhaust air from the cabinet room, inner change room, and
fumigation/decontamination chambers must pass through HEPA filter(s). The air exhaust
discharge must be located away from occupied spaces and building air intakes.54
Biosafety in Microbiological and Biomedical Laboratories
 All HEPA filters should be located as near as practicable to the cabinet and laboratory in
order to minimize the length of potentially contaminated ductwork. All HEPA filters must
be tested and certified annually.
 The HEPA filter housings should be designed to allow for in situ decontamination and
validation of the filter prior to removal. The design of the HEPA filter housing must have
gas-tight isolation dampers, decontamination ports, and ability to scan each filter
assembly for leaks.
 HEPA filtered exhaust air from a Class II BSC can be safely re-circulated into the
laboratory environment if the cabinet is tested and certified at least annually and operated
according to the manufacturer’s recommendations. If BSC exhaust is to be recirculated to
the outside, BSCs can also be connected to the laboratory exhaust system by either a
thimble (canopy) connection or a hard ducted, direct connection ensuring that cabinet
exhaust air passes through two (2) HEPA filters—including the HEPA in the BSC—prior
to release outside. Provisions to assure proper safety cabinet performance and air system
operation must be verified.
 Class III BSCs must be directly and independently exhausted through two HEPA filters in
series. Supply air must be provided in such a manner that prevents positive pressurization
of the cabinet.
 Pass through dunk tanks, fumigation chambers, or equivalent decontamination methods
must be provided so that materials and equipment that cannot be decontaminated in the
autoclave can be safely removed from the cabinet room(s). Access to the exit side of the
pass-through shall be limited to those individuals authorized to be in the BSL-4
laboratory.
 Liquid effluents from cabinet room sinks, floor drains, autoclave chambers, and other
sources within the cabinet room must be decontaminated by a proven method, preferably
heat treatment, before being discharged to the sanitary sewer.
 Decontamination of all liquid wastes must be documented. The decontamination process
for liquid wastes must be validated physically and biologically. Biological validation
must be performed annually or more often if required by institutional policy.
 Effluents from showers and toilets may be discharged to the sanitary sewer without
treatment.

77
 13 A double-door, pass through autoclave(s) must be provided for decontaminating
materials passing out of the cabinet laboratory. Autoclaves that open outside of the
laboratory must be sealed to the interior wall. This bioseal must be durable and airtight
and capable of Laboratory Biosafety Level Criteria: BSL-4

Biosafety Level Summary Table

78
 CDC/NIH Guidelines
Biosafety Levels
(www.cdc.gov)

BSL-1
BSL-3

Lower Risk
BSL-2

Higher
Risk

Factors to consider in classification of biosafety levels

 Pathogenicity of the agent
 Modes of transmission and host range of organism
 Local availability of preventive measures
 Local availability of effective treatment

Step 7: Key Points (5 minutes)

 Definitions of Biosafety and Biosecurity
 Assessment criteria
 Biosafety levels
 Risk groups

Step 8: Evaluation (5 minutes)

 Describe requirements of each Biosafety and Biosecurity level

References:
1. Pearson C.A. (1995): Medical Administration for Frontline Doctors 2nd Ed. FSG
Communication Ltd;
2. MOH (1994): Proposals for Health Sector Reforms;
3. MOH (2000): District Health Management Training Modules -1, 3 and 4 2nd Version;
4. Kanani S. Maneno J. & Schluter P. (1984): Health Service Management for Health
Workers; and
5. C.H. Wood Et. All (1981): Community Health.
6. CDC – Atlanta (2009) Biosafety in microbiological & biomedical laboratories, HHS
Publication, 5th edition

79
Session 2: Biosafety and Biosecurity evaluation measures

Learning Objectives

By the end of this session, students are expected to be able to:

1. List bio-safety measures (PPE, engineering devices, good laboratory practice, chemical
disinfection, PEP, Immunization, self awareness, good laboratory design, training)
2. Explain elements of effective safety managements (designation of a safety officer,
assessments of risk in the work place, development of exposure control plan,
development of safety guidelines and procedure, employee training / hazard
communication occurrence documentation and record keeping)
3. Prepare evaluation tool for bio-safety measures
4. Evaluate the bio-safety status of a particular laboratory

Step 2: Bio-safety measures (25 minutes)

 Biosafety measures
 The establishment of the National Environmental Management Committee (NEMC)
and Occupational Safety and Health Authority (OSHA) has necessitated an employer
to be able to demonstrate that hazards have been identified at work place; that the
risks they pose have been formally assessed; that specific risk control measures are
fully effective. Workers are the first line of defense for protecting themselves, others
in the laboratory, and the public from exposure to hazardous agents. Protection
depends on the conscientious and proficient use of good microbiological practices and
the correct use of safety equipment.
 PPE (such as gloves, goggles, gowns, coats, shoe covers, boots, respirators, splash
shields, face shields, safety glasses and goggles) is often used in combination with
BSCs and other devices that contain the agents, animal s, or materials being handled.
 Engineering devices: Engineering devices or controls are designed to remove or
minimize exposures to hazardous biological materials.
 Biosafety Cabinet (BSC) is the principal device used to provide containment of
infectious droplets or aerosols generated by many microbiological procedures. Open-
fronted Class I and Class II BSCs are primary barriers that offer significant protection
to laboratory personnel and to the environment when used with good microbiological
techniques. The gas-tight Class III biological safety cabinet provides the highest
attainable level of protection to the personnel and the environment. Safety centrifuge
cup is another example of primary barrier designed to prevent aerosols from being
released during centrifugation. Other examples of engineering facilities include
specialized ventilation systems to ensure directional airflow, air treatment systems to
decontaminate or agents from exhaust air, and controlled access zones
 Good laboratory practices: Procedures that are designed to assure that laboratory
workers are observing the minimal necessary requirements for Biosafety in the
laboratory. They include the standard microbiological practices, special practices and
safety equipment (primary or secondary barrier depending on the safety level
considered). BSL I has no need of using any special procedures to reinforce or
implement Biosafety.

80
 Chemical disinfection: Manufacturers of chemicals have a duty to carry out a risk
assessment of a chemical before it is sold and will normally provide copies of Material
Safety Data Sheet (MSDS) on all substances. They also have a statutory duty to provide
information on a defined group of hazardous substances.
 MSDS define the criteria for safe packaging, transport and use of hazardous
chemicals, the hazardous nature of a large number of chemicals in a standardized
manner; standardize the labelling of hazardous chemicals using a defined set of
symbols. All chemical suppliers are therefore responsible for supplying MSDS for
hazardous chemicals, which show most of the information required to make an
assessment of the risks associated with using that substance.
 Disinfectants are substances that are applied to non-living objects to destroy
microorganisms that are living on the objects.
http://en.wikipedia.org/wiki/Disinfectant - cite_note-cdc-0. Disinfection does not
necessarily kill all microorganisms, especially non resistant bacterial spores; it is less
effective than sterilisation, which is an extreme physical and/or chemical process that
kills all types of life
 Disinfection is a procedure that reduces the level of microbial contamination.
 Disinfection is generally a less lethal process than sterilization. It eliminates nearly all
recognized pathogenic microorganisms but not necessarily all microbial forms (e.g.
microbial spores) on inanimate objects. It is controlled significantly by a number of
factors:
o The nature and number of contaminating microorganisms (especially the
presence of bacterial spores)
o The amounts of organic matter present (e.g. soil, faeces and blood)
o The type and condition of instruments, devices, and materials to be disinfected
o The temperature

 Chemical disinfection can be performed using the following:-

 Chlorine dioxide
o In the prevention and control of legionnaires disease causing microbes,
o The bactericidal efficiency is relatively unaffected by pH values between 4 and
10;
o The required contact time for ClO2 is lower
o Chlorine dioxide has better solubility
o Chlorine dioxide does not react with NH3 or NH4+
o ClO2 destroys phenols and has no distinct smell

 Alcohols
o Alcohols, usually ethanol or isopropanol, are sometimes used as a disinfectant, but
more often as an antiseptic (the distinction being that alcohol tends to be used on
living tissue rather than nonliving surfaces).
o Other advantages are:
o They are non-corrosive, but can be a fire hazard.
o They also have limited residual activity due to evaporation, which results in brief
contact times unless the surface is submerged, and have a limited activity in the
presence of organic material.
o Alcohols are most effective when combined with purified water to facilitate
diffusion through the cell membrane; 100% alcohol typically denatures only
external membrane proteins.http://en.wikipedia.org/wiki/Disinfectant - cite_note-
foodsafety-8

81
 o A mixture of 70% ethanol or isopropanol diluted in water is effective against a
wide spectrum of bacteria, though higher concentrations are often needed to
disinfect wet surfaces.http://en.wikipedia.org/wiki/Disinfectant - cite_note-
alcoholreview-9 Additionally, high-concentration mixtures (such as 80% ethanol
+ 5% isopropanol) are required to effectively inactivate lipid-enveloped viruses
(such as HIV, hepatitis B, and hepatitis C). Alcohol is, at best, only partly
effective against most non-enveloped viruses (such as hepatitis A), and is not
effective against fungal and bacterial spores.
 Aldehydes
o Aldehydes, such as formaldehyde and glutaraldehyde, have a wide microbiocidal
activity and are sporocidal and fungicidal.
o They are partly inactivated by organic matter and have slight residual activity.
o Some bacteria have developed resistance to glutaraldehyde, and it has been found
that glutaraldehyde can cause asthma and other health hazards; hence ortho-
phthalaldehyde is replacing glutaraldehyde.
 Oxidizing agents
o Oxidizing agents act by oxidizing the cell membrane of microorganisms, which
results in a loss of structure and leads to cell lysis and death. A large number of
disinfectants operate in this way. Chlorine and oxygen are strong oxidizers, so
their compounds figure heavily here.
 Sodium hypochlorite
o Common household bleach is a sodium hypochlorite solution and is used in the
home to disinfect drains, toilets, and other surfaces. In more dilute form, it is used
in swimming pools, and in still more dilute form, it is used in drinking water.
When pools and drinking water are said to be chlorinated, it is actually sodium
hypochlorite or a related compound—not pure chlorine—that is being used.
Chlorine partly reacts with proteinaceous liquids such as blood to form non-
oxidizing N-chloro compounds, and thus higher concentrations must be used if
disinfecting surfaces after blood spills. http://en.wikipedia.org/wiki/Disinfectant -
cite_note-14 Commercial solutions with higher concentrations contain substantial
amounts of sodium hydroxide for stabilization of the concentrated hypochlorite,
which would otherwise decompose to chlorine, but the solutions are strongly basic
as a result. Sodium hypochlorite is effective against Tb, hepatitis, fungi,
staphylococcus and enterococus.
 PEP – (Post-exposure prophylaxis)
 Is any prophylactic treatment started immediately after exposure (for occupational and
non-occupational individuals) to a pathogen (such as a disease-causing virus), in order
to prevent infection by the pathogen and the development of disease.

GUIDELINES FOR POST EXPOSURE PROPHYLAXIS (PEP) [Hepatitis B, C, HIV]

 Information about primary HIV infection indicates that systemic infection does not occur
immediately after exposure, leaving a brief window of opportunity during which
administration of PEP might prevent viral transmission and replication. Commencement
of PEP within 2 hrs after exposure might inhibit or prevent systemic infection. After an
exposure the following steps should be pursued:

 First Aid
 Following any occupational exposure, the following are recommended before
reporting:

82
 o Wash percutaneous injuries with soap under running water (tap or stored water)
and allow the wound to bleed freely; do not compress to stop bleeding.
o Use water to flush out nose, mouth or areas of the skin (broken) that have been
splashed with blood.
o Irrigate eyes when exposed with saline or clean water
o Report and document incident immediately through supervising officer.
o Index worker and supervisor should consult an expert or the designated persons
listed immediately.
 Evaluate exposure risk Assessment
 Low risk
o Solid needle injury
o Superficial sharps injuries
o Exposure to blood / fluid from asymptomatic HIV patient with low viral load or
suppressed viral load on therapy
o Exposure to a small amount of infected blood / fluid
o Splash of blood on intact skin
 High risk
o Deep injury with hollow especially large bore needle
o Exposure to blood / fluids of patient with AIDS or advanced HIV infection or
acute sero-conversion illness
o Extensive and deep sharp injury
o Exposure to large volume of infected blood / fluid
o Splash of blood on broken skin.
 Evaluation of exposure source
o Known Source - Enquire whether patient is known to be infected with HIV, HBV
or HCV
o Evaluate HIV infected patients’ stage, performance status, CD4 cell count (or
lymphocyte counts) and clinical condition
o If status unknown, test for HBsAg, HCV and HIV antibodies using rapid HIV
testing technique with informed consent. [Screening for HIV should not be
delayed or deferred to await HBV and HCV screening]
o If source is not infected with any of the above viruses, baseline testing or further
follow-up is not necessary (unless strong suspicion or possibility that he / she is in
the window period –should especially suspect sexually active individuals).
o If source person refuses testing, consider clinical presentation, diagnoses and
history of risk behaviours; consider source infected if sexually active.
o Unknown Source - Evaluate the likelihood of exposure to a source at high risk for
infection
o Consider the likelihood of infection among patients in the exposure setting

 Immunization - All staff should be offered protective immunization.

o Rubella antibody tests must be offered to all female staff of childbearing age and
immunization offered if results are negative. Immunization should also be offered
to all staff that has tested unreactive for Hepatitis B, Rabies, Polio and
Toxoplasmosis. A chest X-ray may be taken, or evidence produced of having had
one taken in the previous 12 months. It is essential that the total number of X-rays
is kept to a minimum, because of the cumulative risks of this procedure. Staff
handling tuberculous material must have an annual X-ray and must have a skin
test for tuberculosis or produce evidence of having a positive reaction.

83
  Self-awareness: All staff must be oriented on all the hazards posed in the work place.
Oriented staff should be listed and sign in appreciation that they have been oriented.

 Good laboratory design: Aerosol and droplet routes are important considerations in
specification of safety equipment and facility design that result in a given BSL level.
 Basic certain considerations must be taken into account in the design of medical
laboratories:
 All laboratory surfaces should be impervious to water and easy to clean
 Laboratory benches should be resistant to attack by chemicals such acids, alkalis,
solvents and disinfectants
 Access to the laboratory must be restricted to authorized personnel
 Safety cabinets and rooms where the possibility of exposure to hazardous biological
agent must be built and controlled in compliance with local and international
directives
 Doors giving access to rooms dealing with infective organisms must carry a
BIOHAZARD label
 If the laboratory is mechanically ventilated, an inward airflow must be maintained by
extracting air to the external atmosphere
 Autoclaves for the sterilization of waste material must be readily accessible
 Hand basins with wrist lever taps or foot pedals for hand washing must be fitted in
each laboratory where patient specimen are handled to minimize cross-contamination

Step 3: (15 minutes) Elements of effective safety management

 Designation of a safety officer- Any institution must have a permanent safety officer who
will form a safety committee. He/she will serve as a safety committee secretary. Safety
officer will be responsible for all safety issues of the institution/facility. He/she will be
responsible for the implementation of any recommended safety issues after consultation
with the institution top management.
 Assessments of risk in the work place- Assessment of the risk at the work place,
management, mitigation and communication of the risk determines principles, practices
and technology needed to work safely and securely. It involves identifying a particular
biological hazardous agent, the risk it poses, the type of practice under which it can be
contacted (mode of contact), the vulnerable group of health provider likely to be infected,
and type of mitigation measures.
 Development of safety guidelines and procedure- safety guidelines and procedures must
be devised for:
 The safe collection, storage and transportation of patient samples, biological agents
 The safe disposal of infected material the safe handling and processing of patient
samples within the work place the safe collection and disposal of contaminated waste
including the use of secure and identifiable containers.
 Regulation for such collection and disposal must be in compliance with local and
international regulations. Every employee must be provided with the written
instructions at the work place which detail the procedures or guidelines to be followed
in the event of an accident which may have resulted in the release of a hazardous
biological agent
 Employee training / hazard communication -
 Inform and educate individuals about their responsibilities in the laboratory and
institution
 Practice drills: loss or theft of materials, emergency response to accidents and injuries,
incident reporting and identification of/response to security breaches

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  Support the creation and implementation of a trained program within the facility
 Authority of the facility or institution must approve the planned training program and
hence provide resources for reinforcing the implementation
 All staff should be trained on the chain of command, roles, and responsibilities in the
work place
 The training program must be integrated in institutional policies for training and re-
training
 The information on who is supposed to be trained on what should be communicated to
staff and documented in their respective information documents
 Occurrence documentation: All incidences regarding safety in the laboratory must be
reported as an occurrence
 Record keeping: All incidences reported as occurrences must be recorded in both soft and
hard copies.

Step 4: Evaluation tool for Biosafety measures (60 minutes)

 Biosafety assessment tool: Biosafety assessment tool is intended to assist in assessments
of microbiological laboratory safety and security status of biomedical laboratories.
 Laboratory premises
NOT
S/N ASSESSMENT CRITERIAL YES NO
APPLICABLE
1. Have guidelines for commissioning and
certification been considered for facility
construction or post-construction
evaluations?
2. Do the premises meet national and local
building requirements, including those
relating to natural disaster precautions if
necessary?
3. Are the premises generally uncluttered
and free from obstructions?
4. Are the premises clean?
5. Are there any structural defects in
floors?
6. Are floors and stairs; uniform and slip-
resistant?
7. Is the working space adequate for safe
operation?
8. Are the circulation spaces and corridors
adequate for the movement of people
and large equipment?
9. Are the benches, furniture and fittings in
good condition?
10. Are bench surfaces resistant to solvents
and corrosive chemicals?
11. Is there a hand washing sink in each
laboratory room?
12. Are the premises constructed and
maintained to prevent entry and
harbourage of rodents and arthropods?

85
 13. Are all exposed steam and hot water
pipes insulated or guarded to protect
personnel?
14. Is an independent power support unit
provided in case of power breakdown?
15. Can access to laboratory areas be
restricted to authorized personnel?
16. Has a risk assessment been performed
to ensure that appropriate equipment
and facilities are available to support the
work being considered?

Storage facilities
S/N ASSESSMENT CRITERIAL YES NO NOT
APPLICABLE
1. Are storage facilities, shelves, etc.
arranged so that stores are secure
against sliding, collapse or falls?
2. Are storage facilities kept free from
accumulations of rubbish, unwanted
materials and objects that present
hazards from tripping, fire, explosion
and harbourage of pests?
3. Are freezers and storage areas lockable?

Sanitation and staff facilities

S/N ASSESSMENT CRITERIAL YES NO NOT APPLICABLE
1. Are the premises maintained in a clean,
orderly and sanitary condition?
2. Is drinking water available?
3. Are clean and adequate toilet (WC) and
washing facilities provided separately
for male and female staff?
4. Are hot and cold water, soap and towels
provided?
5. Are separate changing rooms provided
for male and female staff?
6. Is there accommodation (e.g. lockers)
for street clothing for individual
members of the staff?
7. Is there a staff room for lunch, etc.?
8. Are noise levels acceptable?
9. Is there an adequate organization for the
collection and disposal of general
household rubbish?
Heating and ventilation
S/N ASSESSMENT CRITERIAL YES NO NOT
APPLICABLE
1. Is there a comfortable working

86
 temperature?
2. Are blinds fitted to windows that are
exposed to full sunlight?
3. Is the ventilation adequate, e.g. at least
six changes of air per hour, especially
in rooms that have mechanical
ventilation?
4. Are there HEPA filters in the
ventilation system?
5. Does mechanical ventilation
compromise airflows in and around
biological safety cabinets and fume
cupboards?

Lighting
S/N ASSESSMENT CRITERIAL YES NO NOT APPLICABLE
1. Is the general illumination adequate
(e.g. 300-400 lx)?
2. Is task (local) lighting provided at
workbenches?
3. Are all areas well lit, with no dark
or ill-lit corners in rooms and
corridors?
4. Are fluorescent lights parallel to the
benches?
5. Are fluorescent lights colour-
balanced?

Services
S/N ASSESSMENT CRITERIAL YES NO NOT
APPLICABLE
1. Is each laboratory room provided with
enough sinks, water, and electricity and
gas outlets for safe working?
2. Is there an adequate inspection and
maintenance programme for fuses,
lights, cables, pipes, etc?
3. Are faults corrected within a reasonable
time?
4. Are internal engineering and
maintenance services available, with
skilled engineers and craftsmen who
also have some knowledge of the nature
of the work of the laboratory?
5. Is the access of engineering and
maintenance personnel to various
laboratory areas controlled and
documented.
6. If no internal engineering and

87
 maintenance services are available,
have local engineers and builders been
contacted and familiarized with the
equipment and work of the laboratory?
7. Are cleaning services available?
8. Is the access of cleaning personnel to
various laboratory areas controlled and
documented?
9. Are information technology services
available and secured?

Laboratory Biosecurity
S/N ASSESSMENT CRITERIAL YES NO NOT
APPLICABLE
1. Has a qualitative risk assessment been
performed to define risks that a security
system should protect against?
2. Have acceptable risks and incidence
response planning parameters been
defined?
3. Is the whole building securely locked
when unoccupied?
4. Are doors and windows break-proof?
5. Are rooms containing hazardous
materials and expensive equipment
locked when unoccupied?
6. Is access to such rooms, equipment and
materials appropriately controlled and
documented?

Fire prevention and fire protection

S/N ASSESSMENT CRITERIAL YES NO NOT
APPLICABLE
1. Is there a fire alarm system?
2. Are the fire doors in good order?
3. Is the fire detection system in good
working order and regularly tested?
4. Are fire alarm stations accessible?
5. Are all exists marked by proper,
illuminated signs?
6. Is access to exist market where the
routes to them are not immediately
visible?
7. Are all exits unobstructed by
decorations, furniture and equipment,
and unlocked when the building is
occupied?
8. Is access to exits arranged so that it is
not necessary to pass through high-

88
 hazard areas to escape?
9. Do all exits lead to an open space?
10. Are corridors, aisles and circulation
areas clear and unobstructed for
movement of staff and fire-fighting
equipment?
11. Is all fire-fighting equipment and
apparatus easily identified by an
appropriate colour code?
12. Are portable fire extinguishers
maintained fully charged and in
working order, and kept in designated
places at all times?
13. Are laboratory rooms with potential
fire hazards equipped with appropriate
extinguishers and/or fire blankets for
emergency use?
14. If flammable liquids and gases are used
in any room, is the mechanical
ventilation sufficient to remove vapours
before they reach a hazardous
concentration?
15. Are personnel trained to respond to fire
emergencies?

Flammable liquid storage

S/N ASSESSMENT CRITERIAL YES NO NOT
APPLICABLE
1. Is the storage facility for bulk
flammable liquids separated from the
main building?
2. Is it clearly labelled as a fire-risk area?
3. Does it have a gravity or mechanical
exhaust ventilation system that is
separate from the main building
system?
4. Are the switches for lighting sealed or
placed outside the building?
5. Are the light fittings inside sealed to
protect against ignition of vapours by
sparking?
6. Are flammable liquids stored in proper,
ventilated containers that are made of
non-combustible materials?
7. Are the contents of all containers
correctly described on the labels?
8. Are appropriate fire extinguishers
and/or fire blankets placed outside but
near to the flammable liquid store?

89
9. Is “No smoking” signs clearly
displayed inside and outside the
flammable liquid store?
10. Are only minimum amounts of
flammable substances stored in
laboratory rooms?
11. Are they stored in properly contracted
flammable storage cabinets?
12. Are these cabinets adequately labeled
with “Flammable liquid-Fire hazard”
signs?
13. Are personnel trained to properly use
and transport flammable liquids?

Compressed and liquefied gases

S/N ASSESSMENT CRITERIAL YES NO NOT
APPLICABLE
1. Is each portable gas container legibly
marked with its contents and correctly
colour-coded?
2. Are compressed-gas cylinders and their
high-pressure and reduction valves
regularly inspected?
3. Are reduction valves regularly
maintained?
4. Is a pressure-relief device connected
when a cylinder is in use?
5. Are protection caps in place when
cylinders are not in use or are being
transported?
6. Are all compressed gas cylinders
secured so that they cannot fall,
especially in the event of natural
disaster?
7. Are cylinders and liquid petroleum gas
tanks kept away from sources of heat?
8. Are personnel trained to properly used
and transport compressed and liquefied
gases?

Electrical hazards
S/N ASSESSMENT CRITERIAL YES NO NOT
APPLICABLE
1. Are all new electrical installations and
all replacements, medications or repairs
made and maintained in accordance
with a national electrical safety code?
2. Does the interior wiring have an
earthed/ grounded conductor (i.e. a

90
 three wire system)?
3. Are circuit breakers and earth-fault
interrupters fitted to all laboratory
circuits?
4. Do all electrical appliances have testing
laboratory approval?
5. Are the flexible connecting cables of all
equipment as short as practicable, in
good condition, and not frayed,
damaged or spliced?
6. Is each electric socked outlet used for
only one appliance (no adapters to be
used)?

Personal protection
S/N ASSESSMENT CRITERIAL YES NO NOT
APPLICABLE
1. Is protective clothing of approved
design and fabric provided for all staff
for normal work, e.g. gowns, coveralls,
aprons, gloves?
2. Is additional protective clothing
provided for work with hazardous
chemicals and radioactive and
carcinogenic substances, e.g. rubber
aprons and gloves for chemicals and for
dealing with spillages; heat-resistant
gloves for unloading autoclaves and
ovens?
3. Are safety glasses, goggles and shields
(visors) provided?
4. Are there eyewash stations?
5. Are there emergency showers (drench
facilities)?
6. Is radiation protection in accordance
with national and international
standards, including provision of
dosimeters?
7. Are respirators available, regularly
cleaned, disinfected, inspected and
stored in a clean and sanitary
condition?
8. Are appropriate filters provided for the
correct types of respirators, e.g. HEPA
filters for microorganisms, appropriate
filters for gases or particulates?
9. Are respirators fit-tested?

Health and safety of staff

91
S/N ASSESSMENT CRITERIAL YES NO NOT
APPLICABLE
1. Is there an occupational health service?
2. Are first-aid boxes provided at strategic
locations?
3. Are qualified first-aiders available?
4. Are such first-aiders trained to deal with
emergencies peculiar to the laboratory,
e.g. contact with corrosive chemicals,
accidental ingestion of poisons and
infectious materials?
5. Are non-laboratory workers, e.g.
domestic and clerical staff, instructed on
the potential hazards of the laboratory
and the material it handles?
6. Are notices prominently posted giving
clear information about the location of
first-aiders, telephone numbers of
emergency services, etc?
7. Are women of childbearing age warned
of the consequences of work with
certain microorganisms, carcinogens,
mutagens and teratogens?
8. Are women of childbearing age told that
if they are, or suspect that they are,
pregnant they should inform the
appropriate member of the
medical/scientific staff so that
alternative working arrangements may
be made for them if necessary?
9. Is there an immunization programme
relevant to the work of the laboratory?
10. Are skin tests and/or radiological
facilities available for staff who work
with tuberculous materials or other
materials requiring such measures?
11. Are proper records maintained of
illnesses and accidents?
12. Are warning and accident prevention
signs used to minimize work hazards?
13. Are personnel trained to follow
appropriate Biosafety practices?
14. Is laboratory staff encouraged to report
potential exposures?

Laboratory equipment
S/N ASSESSMENT CRITERIAL YES NO NOT
APPLICABLE
1. Is all equipment certified safe for use?

92
2. Are procedures available for
decontaminating equipment prior to
maintenance?
3. Are biological safety cabinets and fume
cupboards regularly tested and
serviced?
4. Are autoclaves and other pressure
vessels regularly tested and serviced?
5. Are centrifuge buckets and rotors
regularly inspected?
6. Are HEPA filters regularly changed?
7. Are pipettes used instead of hypodermic
needles?
8. Is cracked and chipped glassware
always discarded and not reused?
9. Are there safe receptacles for broken
glass?
10. Are plastic used instead of glass where
feasible?
11. Are sharps disposal containers available
and being used?

Infectious Materials
S/N ASSESSMENT CRITERIAL YES NO NOT
APPLICABLE
1. Are specimens received in a safe
condition?
2. Are records kept of incoming materials?
3. Are specimens unpacked in biological
safety cabinets with care and attention
to possible breakage and leakage?
4. Are gloves and other protective clothing
worn for unpacking specimens?
5. Are personnel trained to ship infectious
substances according to current national
and/or international regulations?
6. Are workbenches kept clean and tidy?
7. Are discarded infectious materials
removed daily or more often and
disposed of safely?
8. Are all members of the staff aware of
procedures for dealing with breakage
and spillage of cultures and infectious
materials?
9. Is the performance of sterilizers checked
by the appropriate chemical, physical
and biological indicators?
10. Is there a procedure for decontaminating
centrifuges regularly?

93
 11. Are sealed buckets provided for
centrifuges?
12. Are appropriate disinfectants being
used? Are they used correctly?
13. Is there special training for staff who
work in containment laboratories –
Biosafety Level 3 and maximum
containment laboratories – Biosafety
Level 4?

Chemicals and radioactive substances

S/N ASSESSMENT CRITERIAL YES NO NOT
APPLICABLE
1. Are incompatible chemicals effectively
separated when stored or handled?
2. Are all chemicals correctly labelled with
names and warnings?
3. Are chemical hazard warning charts
prominently displayed?
4. Are spill kits provided?
5. Is staff trained to deal with spills?
6. Are flammable substances correctly and
safely stored in minimal amounts in
approved cabinets?
7. Are bottle carriers provided?
8. Is a radiation protection officer or
appropriate reference manual available
for consultation?
9. Is staff appropriately trained to safely
work with radioactive materials?
10. Are proper records of stocks and use of
radioactive substances maintained?
11. Are personal radiation exposures
monitored

Step 5 Biosafety status of a particular laboratory (5 minutes)

 A checklist of Biosafety issues corresponding to a level of that particular laboratory must
be prepared.
 The management/safety officer of the laboratory is informed two weeks before
conducting an audit.
 The audit is conducted accompanied with the laboratory’s safety officer using the
prepared checklist, the gaps observed are noted and communicated to the safety officer as
non-conformances and ask him/her to sign before the non-conformance (s).
 The evaluation report is prepared and submitted to the laboratory management, a copy of
which should be retained with the evaluator.

Step 6 key points (5minutes)

Define the following terms
 PPE

94
 Engineering devices
 Good laboratory practices
 Chemical disinfection

Step 7 Evaluation (5 minutes)

 List bio-safety measures
Answer: (PPE, engineering devices, good laboratory practice, chemical disinfection,
PEP, Immunization, self awareness, good laboratory design, training)

References:
1. Pearson C.A. (1995): Medical Administration for Frontline Doctors 2nd Ed. FSG
Communication Ltd;
2. MOH (1994): Proposals for Health Sector Reforms;
3. MOH (2000): District Health Management Training Modules -1, 3 and 4 2nd Version;
4. Kanani S. Maneno J. & Schluter P. (1984): Health Service Management for Health
Workers; and C.H. Wood Et. All (1981): Community Health.
5. CDC – Atlanta (2009) Biosafety in microbiological & biomedical laboratories, HHS
Publication, 5th edition

95
Session 3: Biosafety and Biosecurity Evaluation Report

Learning Objectives

By the end of this session, students are expected to be able to:

1. Develop Biosafety and Biosecurity checklist
2. Analyse evaluation Data
3. Write evaluation Report
4. Communicate evaluation Report
5. Keep Records of evaluation report

 .

Step 2: Biosafety and Biosecurity checklist

 A checklist for Biosafety and Biosecurity should involve the following sections:
 Laboratory premises
 Storage facilities
 Sanitation and staff facilities
 Fire prevention and Fire protection
 Flammable liquid storage
 Compressed liquefied gas
 Electrical Hazards
 Personal Protection
 Health and Safety of staff
 Laboratory Equipment
 Infectious materials
 Chemical and Radioactive Elements

 The present checklist that is referred to in this session (3rd) and the 2nd session has been
adopted from WHO-World Health Organization, Biosafety in Microbiological and
Biomedical Laboratories, 3rd edition (2004) – refer to Session 2 step 4 above.

Step 3: Evaluation Data Analysis The method for analysing data during this evaluation is
that of comparing the checklist against the actual performance of the facility stepwise in
accordance with the details in the checklist.
 The performance trend of the facility is tracked to see whether the facility is on the right
track in safety issues or not.
 Prediction on whether the performance is good or not; just by an observation on the
number and percentage of conformances against non- conformances.

Step 4: Evaluation Report Writing The following approach is followed for evaluation
report writing:
 The first stage is the introduction/preamble part-what was the evaluation being done for
 Outline the objectives of the evaluation
 Use those objectives to develop a checklist
 Highlight the actual observed incidences versus the checklist requirements- observations
versus the checklist requirements leads to the actual findings.

96
 Use the findings to make a conclusion.
 Conclusion -if the findings are below the checklist requirements the Biosafety and
Biosecurity implementation in a particular facility is poor; if the findings are in line with
the checklist requirements the implementation is very good and it should be maintained.
 Recommendation- write a recommendation using the findings obtained in order to
improve and sustain the performance of the facility’s safety.

Step 5: Evaluation Report Communication This is the final phase of the evaluation
process, which involves putting the information generated into the hands of relevant
Biosafety and Biosecurity stakeholders.
 Biosafety and Biosecurity stakeholders are interested in information about how the work
can be improved and its sustainability.
 Once a safety evaluation report has been prepared the management and the safety
committee are liable to officially receive it and disseminate it in a cascading manner to
the safety stakeholders within the facility for implementation according to the facility
organogram.
 The time frame to monitor whatever is supposed to be corrected as a non-conformance
should be set after which another evaluation is to be conducted.
 Report communication in any laboratory facility is subject to the policy of each
laboratory as stated in their quality or safety manuals.

Step 6: Evaluation Records

 All evaluation records are kept in the laboratory as is directed in the facility quality
manual and safety manual.
 A responsible person for keeping the records of all documents in the laboratory is the
laboratory quality officer, manager or director/laboratory supervisor, though every facility
must have its own quality as well as safety manuals in which record-keeping protocol is
clearly addressed.
 Records should be kept in lockable cupboards and only accessed by authorized personnel.
 Should any visitor need access to any facility document the facility supervisor, Manager
or Director, should give the approval.
 Smooth record keeping in any facility depends on among other things, the size of the
facility and the available capital.
 The small the size of the facility, the small the capital that is needed for record
management and vice versa.

Step 7: Key Points

 Analyse evaluation Data
 Write evaluation Report

Step 8: Evaluation List key items needed for developing a Biosafety and Biosecurity
checklist in a particular laboratory.

References:
1. Pearson C.A. (1995): Medical Administration for Frontline Doctors 2nd Ed. FSG
Communication Ltd;
2. MOH (1994): Proposals for Health Sector Reforms;
3. MOH (2000): District Health Management Training Modules -1, 3 and 4 2nd Version;

97
4. Kanani S. Maneno J. & Schluter P. (1984): Health Service Management for Health
Workers; andC.H. Wood Et. All (1981): Community Health.
5. CDC – Atlanta (2009) Biosafety in microbiological & biomedical laboratories, HHS
Publication,
6. WHO, Geneva (2004) Biosafety in microbiological & biomedical laboratories

98
Chapter Three

Module Code MLT06103: Laboratory Public Health Education

99
Session 1: Introduction to Health Education and Health Promotion.

NTA Level 6, Semester 1, Module Code: 3 MLT06103 Laboratory Public Health

Education and Health Promotion

Total Session Time: 120 minutes

Prerequisites - None

Learning Objectives

By the end of this session students are expected to:

1. Define the following terms (health promotion, health education, mentor, trainer, teacher,
trainee, facilitator, communication, target audience, behaviour, culture, values and norms)
2. Explain the importance of health education and promotion in promoting health and
disease prevention
3. List requirements for conducting effective health education program (human resources,
teaching materials, venue, time)

 ASK students if they have any questions before continuing; If there is a question respond
accordingly.

Step 2 Definition of the Following Terms (25 minutes)

Ac


Information, education and communication provide the informed contexts for making
choices. They are important and key components of health promotion, which aims at
improving knowledge and sharing information related to health. This include: the society’s
opinions and experiences of health and how it can be sought; knowledge from epidemiology
experts, social and other sciences on the aspects of health, disease and factors affecting them;
and descriptions of the total contexts through which health and health choices are adjusted.

Definition of the following terms:

 Health – is the state of complete physical, mental and social wellbeing, not merely the
absence of disease or infirmity; WHO (1946)
 Health promotion – is the process of enabling people to increase control over, and to
improve their health
 Health education: - Any combination of learning opportunities designed to facilitate
voluntary adaptation of behaviour, which will improve or maintain health.
 Mentor
 Trainer
 Teacher -
 Trainee – A person involved or participating in a process of acquiring new knowledge,
ideas and skills that may lead in modification of behaviour and attitude.

100
 Facilitator - A person with skills in a process of assisting and enabling trainee,
participants or intended audience to acquire new knowledge, ideas and skills
 Target audience- According to the context of this guide this is an individual or groups of
people which health information is directed to influence behaviour change conducive to
health
 Life style – refers to collection of behaviours that make up a person’s way of life
(including diet, clothing, family life, housing and work)
 Customs – Behaviours that are shared by many people
 Values – Characteristics held to be important and prized by an individual or community.
In most communities values are qualities at an abstract level such as having many cows,
having many children, highly educated, intelligent.
 Norms – Any attributes in the community or society considered un acceptable

Step 3: The importance of health education and promotion in promoting health and
disease prevention (30 minutes)

Activity: In class exercise (15 minutes)

 Ask students to form small groups of three or five participants to buzz on importance
health education and health promotion in promotion of health and disease prevention
and write responses on flip chart
 SUMMARIZE their responses and confirm correct answers using notes below

The importance of health education and health promotion in promoting health and
disease prevention

Most health problems cannot be intervened by drugs and treatment alone. The promotion of
health and prevention of diseases involve some changes in life styles or human behaviour.

Health education and health promotion are among of the essential factors for involving other
partners (such as community members, policy makers and donors) in planning and strategies
of promoting health and disease prevention. Drugs and treatment alone cannot make people
healthy; hence it is important to consider other influences on health that may contribute in
health improvement. Some of these influences include;-
a. Life style and behaviour; -knowledge, beliefs, culture and social influence
b. Environment; - housing, water and sanitation, hazardous wastes, pollution, food
production and climates
c. Health care delivery system – preventive services, traditional medicine, healthy policy
and primary health care
Well designed health education programme shall facilitate motivation among people to adopt
health promoting behaviours, facilitate people to make decisions about their health and
acquire the necessary confidence and skills to apply their decisions into practice.

Step 4: Requirements for conducting effective health education program (35 minutes)

Activity: 4 In class exercise (25 minutes)

ASK the students to list requirements for conducting effective health education program

SUMMARIZE their responses and confirm correct answers using notes below

101
Requirements for conducting health education program or session
 Information on cultural, social, economic and political factors that influence people’s
(patients) behaviour
 Human resources – skilled health educator/health worker, lay health worker and volunteer
 Accessibility of facilitating and enabling factors (time, venue/site, materials, money,
personal abilities, environment, significant others, drugs and supplies)

Step 5. Key Points: Summary of the session (15 minutes)

Activity: 5 In class exercise

SUMMARIZE the session using notes below:-
We defined Health promotion as the process of enabling people to increase control over,
and to improve their health
Health education is any combination of learning opportunities designed to facilitate
voluntary adaptation of behaviour, which will improve or maintain health.

Health education is important in promoting health and disease prevention because it

provides an opportunity for informed base for making choices conducive to health among
clients and policy makers.

Evaluation of the session

Activity: In class exercise (10 minutes)

ASK the students

 To mention at least 3 requirements for conducting effective health education program
Answers:
 Skilled health educator/health worker
 Information on cultural, social, economic and political factors
 Accessibility of facilitating and enabling factors
2.Mention the influences on health
Answers:
 Life style and behaviour
 Environment
 Health care delivery system

References
1. Behaviour Change Communication Training Toolkit (2006), International Training &
Education Center on HIV;
2. Hubley, J. (1995): An action guide to health education and health promotion

102
Session 2: Preparation of Health Education Program or Session Plan

NTA Level 6, Semester 1, Module Code: 3 MLT06103 Laboratory Public Health

Education and health promotion

Total Session Time: 120 minutes

Prerequisites- None

Learning Objectives

By the end of this session students are expected to:

1. Mention the essential requirements for conducting health education training needs
assessment
2. Describe health education training plan
3. Communicate health education training plan
4. Describe health education teaching materials
5. Design health education session presentation
6. Demonstrate correct approach of creating rapport
7. Facilitate health education training session

Step 2. Essential requirements for conducting health education training needs

assessment (5 minutes)

Essential requirements for conducting health education training needs assessment

 Policy support
 Skilled personnel in health education training and needs assessment (research)
 Needs assessment plan
 Needs assessment proposal
 Funding agent
 Study area and study subjects
 Data collectors
 Authority to utilize and implement needs assessment results

Step 3: Health education training plan (15 minutes)

Activity in class exercise 15 minutes

 Ask students to form groups of three to five participants and list down the contents of
the health education plan.
 Allow one student from each group to present responses on flip chart

SUMMARIZE their responses and confirm correct answers using notes below

Health education training plan should contain the following contents:

 Topic/problem (preferably felt problem or need)

103
 Objective and scope of training, time, venue, appropriate teaching materials
 Training/facilitation methodology
 Characteristics of the target audience or participants and their tasks/activities

Step 4. Communicating training plan for health education (15 minutes)

Activity in class exercise 10 minutes

 Ask each student to mention effective communication channels/methods for the health
education-training plan.
 Allow each student to present his/her responses on flip chart
SUMMARIZE their responses on a flipchart or board and confirm correct answers using
notes below
Communicating training plan for health education
 Communication involves the transfer of information, ideas, emotions, knowledge and
skills between people. Components of communication includes:- Source, message
channel, and receiver
 Communication may involve ordinary conversation, such as explaining a point, asking
questions or just talking to pass the time. However in health education and health
promotion we communicate for special purposes such as:- to promote improvements in
health through modification on human, social political factors that influence behaviours.

The effective communication for health education training plan depends on the following
factors:
 Credibility of the facilitator/teacher -
 Characteristics of students/audience
 Relevance of the problem/topic
 Medium of communication
 Channel
 Conducive environments
 Pre-test and refining

Therefore a health education-training plan may be communicated through:

a. Face to face - spoken words, visual (real objects and models, pictures/written words
when visual aid is used
b. Mass media – radio, TVs, internet, phones, LCD
c. Prints - leaflet, books, newspaper, posters, designed papers

Step 5: Health education teaching materials (25 minutes)

Activity in class exercise 10 minutes

 Ask participants form groups of three to five participants and brainstorm on the
appropriate health education teaching materials, their advantages and disadvantages.
 Allow each group to nominate one student to present responses on flip chart

SUMMARIZE their responses and confirm correct answers using notes below

104
Teaching health education does not differ from other teachings, it needs teaching aids or
materials to facilitate transfer of knowledge and skills. When well planned and properly used
teaching materials can greatly improve the health education teaching process. A teaching
material is only a material for teaching, just showing an LCD picture or a diagram by itself
shall only have minimal effect. It is better to use them just for formal one-way teaching they
should be used to stimulate understanding, discussion and participatory learning. So far there
is no best health education training materials; it just depends the circumstances.

The health education materials include:

1. Prints
 Flip charts
 Posters
 Leaflets
 Fliers
 Fact sheets
 Calendars
 Banners
 Newspapers and magazines
 Newsletters
 Billboards
 Wheel covers
 Clothes/flannelgraphs
 Cartoons
 Stickers
 Wall chart

2. Electronic
 Radio adverts, spots and programmes
 Television spots and programmes
 Liquid crystallized density (LCD)
 Phones
 Video-cassette recorders (VCR)
 Cartoons
 Slides
 Films
 Flash cards
 Pictures

3. Popular
 Traditional drawings and symbols
 Drums
 Fortune telling cards or signs

Types of health education materials

There are three types of health education materials:

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1. Temporary – Radio and Television adverts, spots and programmes, electronic billboards
and banners, stickers
2. Semi permanent – Posters, leaflets, fliers, clothes, paints
3. Permanent - Billboards, signboards, Traditional drawings and symbols
Carvings (wooden, stone, metal, ray, plastics), books, booklets, puppets

Step 6: Presentation of health education session (20 minutes)

Activity in class exercise 10 minutes

 Ask participants form groups of three to five participants and buzz essential
requirements for presentation of health education session
 Allow each group to nominate one student to present responses on flip chart
SUMMARIZE their responses and confirm correct answers using notes below
When designing presentation for health education session it is important for a facilitator to
ask himself/herself the following questions:-

1. Is the session relevant and appropriate to the intended audience?

2. Do I have the skills to design and present the session?
3. Has the analysis and segmentation of the intended audience been done?
4. Is the session culturally acceptable by the intended audience?
5. Is the health content accurate?
6. Can it be used to stimulate discussion?
7. Are teaching materials available?
8. Do the intended audience have the necessary facilitating and enabling factors to action
sought for?

Step 7: Creating rapport (5 minutes)

Prior facilitating health education session it important to introduce yourself and the session,
speak loud and clear, use appropriate language to the intended audience. Avoid mannerisms
that may destruct the audience attention,

Activity in class exercise 3 minutes

 Ask each participant to mention requirements necessary for creating rapport prior
conducting health education session
 Allow each student to present responses on flip chart

SUMMARIZE their responses and confirm correct answers using notes below

Step 8: Facilitating health education training session (15 minutes)

Activity in class exercise 10 minutes

 Ask participants form groups of three to five participants and brain storm on the
facilitation of health education session
 Allow each group to nominate one student to present responses on flip chart

SUMMARIZE their responses and confirm correct answers using notes below

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Organizing and presenting health education session is an art; it needs skilled personnel in
health communication and related health problem or felt need. It is important to know the
intended audience and their experience on the topic or problem. It should be a relevant health
need (felt need) to make the session more meaningful. It is important to introduce yourself
and the session, speak loud and clear, and use appropriate language to the intended audience.
Avoid mannerisms that may destruct the audience attention, monitor and evaluate the session.

There are three methods of presenting of health education session:-

1. Interpersonal health education- spoken words, visual objects and models, pictures or
writings provided to patients in clinics and hospitals as part of the treatment and
rehabilitation process.
2. Group health education - provided to patients in clinics and hospitals as part of the
treatment and rehabilitation process – through radio, TVs, LCD
3. This may happen during patient health education
4. Mass (public) health education –through radio, TVs, internet, phones, LCD,
Newspaper, magazine

Step 9: Summary of Key Points (10 minutes)

Summarize the session: In this session we have discussed the following:

Some of essential requirements for conducting health education training needs assessment
include

Policy support and skilled personnel in health education training and needs assessment
(research)

The effective communication for health education training plan depends on several factors,
some these include
 Credibility of the facilitator/teacher
 Characteristics of students/audience

There are three types of health education materials:-

1. Temporary – Radio and Television adverts
2. Semi permanent – Posters, leaflets, fliers,
3. Permanent - Billboards, signboards, Traditional drawings and symbols

There are three methods of presenting of health education session:

1. Interpersonal health education- spoken words, visual objects and models
2. Group health education - provided to patients in clinics and hospitals as part of the
treatment and rehabilitation process
3. Mass (public) health education –through radio, TVs, internet, Newspaper, magazine

Step 10: Evaluation (15 minutes)

Activity in class exercise

Ask participants the following questions:

1. What type of health education materials is the best?
Answer. There is no best material it just depends on the circumstance

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 2. Why it is important to conduct health education training needs assessment prior
conducting health education programme?
Answer: To establish evidence based gaps/needs on health education that shall facilitate to
develop realistic health education session/programme

References
1. Behaviour Change Communication Training Toolkit (2006), International Training &
Education Center on HIV;
2. Hubley, J. (1995) An action guide to health education and health promotion

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Session 3: Implementing Health Education Programmes and Sessions

NTA 6, Semester 2, Module: Laboratory Public Health Education and Promotion

Total Session Time: 120 minutes

Prerequisites- None

Learning Objectives

By the end of this session students are expected to be able to:

1. Identify the target groups for health education training session
2. Describe steps of preparing health education training sessions
3. Communicate with trainees about participating in health education session
4. Develop health education training objectives
5. Describe performing mentorship
6. Document procedures of health education training
7. Keep records of health education training programme

Step 2: Identification of the target groups for health education training session (5
minutes)

You will have to think carefully how to make sure that you get the session participants you
need. The aim is to get the group which is of the right educational level and experience to
benefit from the session or programme, who are enthusiastic and motivated and can put into
practice their newly learnt ideas and skills.

If it is a community health education programme, community leadership shall select the

target audience. Target group should preferably be mixed male and female, background
disciplines and experiences
In addition above target group or the intended audience to be involved in health education
session can be identified by considering the following factors.
 Ability to learn
 Weakness to the health problem
 Eager to learn

Step 3. Information to the target group (15 minutes)

Activity in class exercise 10 minutes

 Ask each students to mention methods of informing trainees to participate in health

education training session
 Allow one student to record responses on flip chart

SUMMARIZE their responses and confirm correct answers using notes below

Trainees to participate in health education training session should be informed in advance.

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The organizing authority should make formal invitation. This may be inform of official letter,
E-mail, telephone or recognized verbal information depending on the circumstances.
After the information (invitation) has been sent to intended trainees, follow up should be
made to confirm each trainee participation

Step 4. Preparation of health education training session (15 minutes)

Activity in class exercise 10 minutes

 Ask each students to form small groups of three to five members to brainstorm steps
for preparing health education training session
 Allow one student from each group to record responses on flip chart

SUMMARIZE their responses and confirm correct answers using notes below

1. Identify category of trainees and the number to participate in the session

2. Prepare the session relevant to the needs of the target group
3. Determine the size of the group
4. Specify dates, time, and venue and time table
5. Formulate the objectives of the session you want to address
6. Send invitation letters to trainees
7. Indicate the sequence the information should be presented to make it as logical as
possible
 Questions to be asked to verify understanding of the target group
 Demonstration of skills to the group
 Provide opportunity to demonstrate and practice the skills in class, health facility and
communities

8. Make practice on using the teaching materials you think shall facilitate understanding
 Prepare all required teaching materials such as: - Flip charts, marker pens, masking tape,
LCD, extension cords, and the room should be conducive.
 Social facilities should be available i.e. food, accommodation, lights, comfortable seats,
toilet facilities, refreshments, communication facilities and accessible health services.

Step 5. Development of health education training objectives (25 minutes)

Step 5: Activity in class exercise 15 minutes

 Ask each students to formulate two training objectives for health education training
session (Note objectives should be smart)
 Allow each of them to read before others
 Record responses on flip chart

SUMMARIZE their responses and confirm correct answers using notes below

Training objectives are statements of training to be achieved by the end of the teaching
session or programme. They form the basis for planning the content of the learning activities
and for the evaluation of the outcome. Training objectives should state:-
1. The exact learning required; what is to change and by how much

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2. How the change shall be measured, i.e. test conditions
3. The time over which the training should take place.

The activities in a job description can form the overall objectives for training programme.
However it is better to formulate objectives for each type of training programme needed to
perform an activity.

An objective should be measurable and SMART. Setting measurable and SMART objectives
shall enable you to:-
1. Let others know exactly what you are planning
2. Make decision about implementation
3. Evaluate the health education-training programme.
4. Specify the intended change being sought
5. Determine the amount of change needed
6. Specify the target group (intended audience)
7. Specify the time scale required for desired change to take place
8. Achieve changes that are relevant and realistic

Psycho-motor skills such as handling objects or communication skills are not difficult to
measure as they can be directly observed.
Changes in knowledge, thinking and attitudes are more difficult to measure due to the fact
that they take place within a person’s mind and are not directly observable. They can only be
measured by expressing them as actions such as to give opinions, describe situations, answer
questions and undertake tests. Some examples of behavioural objectives are as follow:-

By the end of the session the participants:

1. On being asked we will be able to list correctly the different stages of the life-cycle of
hookworm (knowledge objective).
2. Being taken to a house we shall be able to choose the proper location for a pit latrine
(decision making objective)
3. In a test context we shall be able to use VIPP cards to encourage learner participation in a
small group teaching session (communication skill objective)
4. On being provided a pencil, ruler, rubber and paper we shall be able draw a good diagram
of mosquito (psycho – motor objective)
5. On being given histogram data we shall inteprate correctly the message and take action
for making an intervention plan (attitude or decision making objective)

Step 6. Describe mentorship (25 minutes)

Activity in class exercise 15 minutes

 Ask each students define the term “mentor” and how it may be conducted
 Allow each student to write responses on a flipchart paper
 SUMMARIZE their responses and confirm correct answers using notes below

 Mentorship refers to a personal development relationship in which a more experienced

or more knowledgeable person helps to guide a less experienced or less knowledgeable
person. However, true mentoring is more than just answering occasional questions or
providing ad hoc help. It is about an ongoing relationship of learning, dialog, and
challenge.

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 The person in receipt of mentorship may be referred to as a protégé (male), a protégée
(female), an apprentice or, in recent years, a mentee.
 Mentoring is a process that always involves communication and is relationship based, but
its precise definition is elusive. One definition of the many that have been proposed, is
 Mentoring is a process for the informal transmission of knowledge, social capital, and the
psychosocial support perceived by the recipient as relevant to work, career, or
professional development; mentoring entails informal communication, usually face-to-
face and during a sustained period of time, between a person who is perceived to have
greater relevant knowledge, wisdom, or experience (the mentor) and a person who is
perceived to have less (the protégé)".
 A mentor might use a variety of approaches, for example coaching, training and
counseling

Step 7. Documentation procedures of health education training session (5 minutes)

Activity in class exercise 3 minutes

 Ask each students form groups of three to five members and buzz on procedures for
documenting health education training sessions
 Allow one student from each group to come forward and write responses on a flipchart
paper

SUMMARIZE their responses and confirm correct answers using notes below

Documenting health education training session is part of the technical and managerial tasks
of the health promotion programme. When planning health education training session we
usually set objectives and related tasks that facilitate the achievement of the objectives.
Therefore it is crucial to monitor and document all activities aimed at achieving those
objectives. Monitoring requires continuous recording using various and appropriate methods
such as:- registers, forms, video camera, still camera, tape recorders and ledgers. This is best
done on daily basis. All daily training activities should be documented and evaluated at every
end of the day.

Step 8: Record keeping for health education training programme (15 minutes)

Activity in class exercise 10 minutes

 Ask each students form groups of three to five members to brainstorm on procedures
for recording and keeping health education training programme
 Allow one student from each group to come forward and write responses on a flipchart
paper

SUMMARIZE their responses and confirm correct answers using notes below

Recording and reporting of Health education training session is among of the most
challenging activities within the health sector. Therefore it is recommended that every health
service provider facilitating health education training session should keep records of all the
activities performed on each day at his/her work place. (Insert recording and reporting form
for health education session)

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Key components to be reported are:-
 The topic, problem or health need
 The causes of the problem
 Associated human behaviour
 The role of health education
 The role of health communication
 Target group which health education and promotion was directed
 What approach, methodology was used to communicate the message or topic i.e.
persuasion, coercion or informed decision-making, single issue or broad based health,
intensive campaign or ongoing programme.
 The level to which communication or the message or topic was delivered i.e. individual,
family, community, national and international
 Communication channel used
 Communication or facilitation methods used.

Step 9. Summary of Key Points (10 minutes)

Summarize the session: In this session we have discussed the Implement health education
program/session. In this session we have gone through eight steps and discussed about:-
 Introduction of the session and learning objectives
 Identification of the target groups for health education training session
 Information to the intended target group
 Preparation of health education training session
 Development of health education training objectives
 Perform mentorship
 Documentation procedures of health education training session
 Record keeping for health education training programme

Step 10: Evaluation (15 minutes)

Activity in class exercise 10 minutes

 Ask participants the following questions:-

Mention at least six steps of preparing health education training session.
Answers:
1. Prepare the session relevant to the needs of the target group
2. Determine the size of the group
3. Specify dates, time, and venue and time table
4. Formulate the objectives of the session you want to address
5. Send invitation letters to trainees

 What are the advantages for setting measurable and SMART objective/s?
Answers:
Measurable and SMART objectives shall enable you to:-
i. Let others know exactly what you are planning
ii. Make decision about implementation
iii. Evaluate the health education-training programme.
iv. Specify the intended change being sought
v. Determine the amount of change needed
vi. Specify the target group (intended audience)

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 vii. Specify the time scale required for desired change to take place
viii. Achieve changes that are relevant and realistic

References
1. Behaviour Change Communication Training Toolkit (2006) , International Training &
Education Center on HIV;
2. Hubley, J. (1995) An action guide to health education and health promotion

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Session: 4 Assess health education training program/session

Total Session Time: 120 minutes

Prerequisites- None

Learning Objectives

By the end of this session students are expected to be able to:

1. Prepare assessment tool for health education training session
2. Assess the impact of health education training session
3. Write assessment report of health education training session
4. Disseminate report on assessment of health education training programme.
5. Keep records of the report on assessment of health education training program/session

Step 2: Assessment tool for health education training session (20 minutes)

Health education training programmes are assessed for various reasons. In the short term you
will need to be sure that the target group or students have mastered the task and learning
components in the course; in the long term you will need to find out whether they are actually
putting into practice the new ideas they have learnt and if they are having an impact on the
health of the community.

To gather this information it is important to have a formalized tool, in this case may be a
questionnaire or a checklist.

A checklist that has been pretested and shared among different partners may be very useful to
collect assessment information for health education training programme.
Information that may be gathered include;-

Short-term assessment
1. Were the participants satisfied with the content of the programme?
2. Were there topics that they could have liked to have seen included?
3. Was it facilitated in a user friendly method?
4. Was the channel of communication used appropriate?
5. Was the level at which the programme conducted appropriate?
6. Was the timing for programme best?
7. Were the food, accommodation and social arrangements entertaining?
8. At the end of the training programme were they able to perform to a satisfactory the skills
identified in the task analysis and course objective?
9. Do the participants feel confident that they can put into practice their new skills?
10. Is there a need to follow up training?
11. Are there any general recommendations on policy from the participants?

Long-term assessment
1. Are the participants satisfied with their training?
2. Do they have any further suggestions on training contents?

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3. Are the participants putting into practice what they have learnt?
4. What barriers if any are preventing them from undertaking their tasks?
5. Are their employees or significant others satisfied with the results of the training?
6. Is the community satisfied with the results of training?
7. What impact have their activities had upon the health of the community?
8. Is there a need for follow-up training?

Step 3. Assessment of the impact of health education training session (15 minutes)

Activity in class exercise 5 minutes

 Ask each students to mention methods for assessing the impact health education
training session
 Write responses on a flip chart
 SUMMARIZE their responses and confirm correct answers using notes below

Assessment of the impact of health education training programme aims at looking for long
term achievements. You need to find out whether participants are actually putting into
practice the new ideas they have learnt and if they are having observable changes on the
health of the family and community. Assessment of the impact of health education training
programme may be conducted by an appraisal or rapid assessment. Assessment protocol
should be developed to collect necessary information; direct interviews, focus group
discussion, observation, exit interview, may be some of the methods used for gathering
information regarding the impact of the health education training programme.

Step 4: Writing assessment report of health education training programme/session (15

minutes)
Step 4: Activity in class exercise 5 minutes
 Ask students to form groups of three to five participants and list headings of health
education training assessment report
 Write responses on a flip chart
 SUMMARIZE their responses and confirm correct answers using notes below

After conducting assessment of health education training programme, report should be

submitted to the relevant authority.
Report should contain the following headings:-
 Title for the programme or topic
 Table of contents
 Definition of terms
 Abbreviation and acronyms
 Abstract (summary)
 Acknowledgement
 Introduction/background information
 Statement for the need for assessment
 Rationale for the assessment(benefit)
 Broad Objective
 Specific objectives
 Methodology( ways)
 Findings/results

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 Discussion
 Conclusion
 Recommendation(what to be done to improve)
 References
 Appendices

Step 5. Disseminating report on health education training program/session (25 minutes)

Activity in class exercise 10 minutes

 Ask each students to mention methods for disseminating report health education
training session
 Write responses on a flip chart
 SUMMARIZE their responses and confirm correct answers using notes below

After the report on health education training programme has been written, it is important to
share with different partners who play part in health and development. There are several
methods or channels, which can be used to disseminate the report. These can be through:-
1. Meetings, seminars, conferences
2. Circulating report in hardcopies
3. Teleconference
4. Electronic, internets, audio visual teleconference

Step 6. Summary of Key Points (5 minutes)

In this session we have discussed about assessing health education training programmes for
various reasons. Some of the reasons are :- (a) To find out whether training objectives have
been achieved or not. (b) To know if the training programme has been efficient in relation to
the allocated resources. (c) To find out whether participants can actually put into practice the
new ideas they have learnt and if they are having an impact on the health of the community

Step 7. Evaluation (5 minutes)

Step7: Activity in class exercise 5 minutes

1. Ask participants to mention two types for assessment of the health education training
programme
Answer: (a) Short term
(b) Long term
2. Ask students to list headings of report on assessment of health education training
session
Answer. Answers:
 Title for the programme or topic
 Table of contents
 Definition of terms
 Abbreviation and acronyms
 Abstract
 Acknowledgement
 Introduction/background information
 Statement for the need for assessment
 Rationale for the assessment
 Broad Objective

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  Specific objectives
 Methodology
 Findings/results
 Discussion
 Conclusion
 Recommendation
 References
 Appendices

References
1. Behaviour Change Communication Training Toolkit (2006) , International Training &
Education Center on HIV;
2. Hubley, J. (1995) An action guide to health education and health promotion

118
\Session 5: Methods for conducting health education session

NTA Level 6: Semester 1: Module Code MLT06103: Laboratory Public Health Education

Total Session Time: 120 minutes

Prerequisites- None

Learning Objectives

By the end of this session students are expected to be able to:

1. List methods of conducting health education session (Group discussion, Lecturing,
Lecture discussion, role play, Group work, brain storming, demonstration, assignment)
2. Explain the importance of each method
3. Explain the criteria for selecting a particular method

Step 2: Methods for conducting health education session (20 minutes)

There are several methods for conducting health education session; however there has been a
serious challenge on health education programmes that put too much on traditional formal
teaching methods where the participants are passive and simply listens. Currently more
emphasis is put on participatory learning methods and dialogue such as;

1. Group discussion- Group is a collection of more than one person in a face to face
situation working together on a task that require collaboration and co-operation in order
to attain a certain goal
2. Lecture discussion- Is an approach which involves the teacher, talking to the students
about the subject content where there is two way communication and examination of
ideas, issues in depth through debate or any conversation for a certain purpose /solution.
3. Role play- This is the use of drama in which Participants act out situations for themselves
in order to acquire communication and problem solving skills and understand situations.
Role play is a direct way of learning where by a participant is given a role and has to
think, internalize and speak immediately without detailed planning. Learning takes place
through experience, it is not passive.
4. Simulations- Is a teaching method where teachers or students use something in a place
of a real thing or an activity to be carried out by someone.
5. Case study- A case study is a scenario or problem written in the form of a story. It
presents an issue relating to an event, activity, or problem, which students are asked to
research, debate, and/or solve. Or is a puzzle that needs to be solved.
6. Group work- This can be a small group consisting of 2 to 50 participants or students. For
large groups lecture is mostly used as a teaching method. However this method makes
participants passive just keeping on listening and writing what the facilitator says. For
groups of 2 to 20 there are opportunities participants to participate in learning process.
7. Buzz group- It is a relatively small group of participants divided into smaller group of
about 3 to 5, usually to discuss a problem or situation for a short time say 5 minutes
8. Brain storming – Is a problem solving technique used to generate a number of ideas
from learners /trainee in a short time approximately 5-10 minutes while suspending
judgments/answer

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9. Demonstration- Demonstration is a teaching method where teacher performs an
instructional activity systematically and scientifically in the presence of his/her students
in order to show them how to do a task. It includes showing intellectual, psychomotor
skills as well as attitudes.
10. Assignment-is a task or activity assigned to learners.
11. Lecture – Is an approach, which involves the teacher talking to the students or
participants about the subject content where there is little or no chance of participant to
participate into the learning process?
12. Drama or popular theatre- This is one of the methods used in providing health
education to various target audiences. A drama group may visit a community and
develops the drama in discussing local health issues and suggesting solutions.

Step 3. The importance of each method

Activity in class exercise 40 minutes

 Ask each student to mention the importance each teaching method listed in previous
step
 Write responses on a flip chart

SUMMARIZE their responses and confirm correct answers using notes below

1. 1. Group discussion- It is very useful for changing attitudes of students /participants

and can be used following video or lecture in order to reinforce learning. Students may
criticize each other’s views and not the person. Besides it provides an interesting
feedback on student’s knowledge of the topic that encourages deep learning through
which do not feel like a hard work. It broadens views to participations
2. Lecture discussion- This is a participant centered method where participants control
learning; it also provides participants interaction by either among themselves or with a
facilitator. It is highly effective for attitude change, mastery of subject content which
enhances long term retention.
3. Role play-Provides good opportunity to address attitudinal issues through which each
participant has a high degree of participation. It brings learning to realistic life through
which emotions can be felt. Participants can reach their peers about their feelings and
aspirations in their role rather than the facilitator telling them. Role play facilitates
participants to acquire social skills such as cooperation, communication and counselling.
4. Simulations-Gives good chance for participants to feel how various procedures are
performed, participants can test their skills, judgment and bring them to the realty.
5. It also provides an opportunity for participants to give feedback on their performance
before they can care real patients. Participants can repeat the complicated skills until they
master to Control the destruction of resources in the real teaching
6. Case studies –In this method is possible to represent an issue relating to an event,
activity, or problem, which participants are asked to research, debate, and/or solve. Or is a
puzzle that allows solution to be formulated.
7. Group work- Small group work facilitates active participation in which participants may
assume the ability of an effective leader as well as an effective follower, and may learn to
cope with other peoples idiosyncrasies. Participants may be able to present a logical
argument and analyze others arguments, cooperate with others and adopt a variety of
roles when working co-operatively.
8. Brainstorming is important because it enables participants be involved in learning
process. It also requires few resources in terms of time and facilitator; It uses student’s

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 experiences. More important is that brain storming encourages teamwork in learning
process and effective in solving problems of client’s diagnosis through generating
opinions in orders to come up with solution e.g. treatment
9. Demonstration-When performed well demonstration can be highly motivating better
than a lecturing. Demonstration is important in for linking theory to practice in variable
paces. In this method key points may be stressed and repeated, participants enjoy actively
performing things and watch the sequence and build-up. Expert can demonstrations may
be available through video, internets
10. 9. Assignment- This method enables participants to practice setting direction for self
learning, develops critical thinking to students and enables them to create problem
solving skills.

Generally participatory learning methods have many advantages. Participants are actively
participating in the learning process; hence they are more likely to remember what was
discussed during the session. They draw from their own experience; they are permitted to
discover issues for themselves and can develop problem-solving skills.

Other advantages of participatory learning methods include:-

 It provides participants greater pride in what they can do for themselves
 Possible to discover the beliefs and practices of people in the community.
 It makes participants think for themselves and less dependent on a facilitator
 It creates close feeling between the facilitator and participants
 It makes health education more fun
 It shows facilitator’s interest and respect for the opinions of the participants.

Step 4. Criteria for selecting a particular method

Step 4: Activity in class exercise 25 minutes
 Ask student to form groups consisting two to five members and brainstorm on
selection criteria for teaching methods
 Write responses on a flip chart
SUMMARIZE their responses and confirm correct answers using notes below

Selection of methods for conducting health education session will depend on what the
facilitator is trying to achieve, the nature of the audience and what resources are at your
disposal. Generally the following criteria should be considered when selecting methods for
conducting health education session;-
 Characteristics of participants or students
 Topic or session
 Teaching environments
 Objectives of the training programme
 Capacity and capability of the facilitator
 Economical capacity of the training institution
 Other programme considerations

Step 5. Summary of Key Points

Activity in class exercise 25 minutes
Summarize the session as follows:
In this session we have discussed methods and importance of conducting health
education session such as:- Group discussion, Lecturing, Lecture discussion ,role play,

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 Group work, brain storming, buzzing, demonstration, assignment

Step 6. Evaluation
Activity in class exercise 5 minutes
Ask participants
1. To mention the methods for conducting health education session
Answers: Group discussion, Lecturing, Lecture discussion, role play, Group work, brain
storming, buzzing, demonstration, assignment
2. List six advantages of participatory health education training methods
Answers:
 Provide participants greater pride in what they can do for themselves
 Possible to discover the beliefs and practices of people in the community.
 Makes participants think for themselves and less dependent on a facilitator
 Creates close feeling between the facilitator and participants
 Makes health education more fun
 Shows facilitator’s interest and respect for the opinions of the participants.

References
1. International Training & Education Center on HIV (2006) Behaviour Change
Communication Training Toolkit
2. John Hubley (1995) An action guide to health education and health promotion
3. Keith Tones and Sylvia Tilford (1995) Health Education; Effectiveness, efficiency and
equity second edition
4. Ian Ree and Stephen Walker (2007) Teaching, Training and Learning: a practical guide

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Session 6: Selection of target group for conducting specific health
education session and venue

NTA Level 6: Semester 1: Module Code MLT06103: Laboratory Public Health Education

Total Session Time: 120 minutes

Prerequisites- None

Learning Objectives

By the end of this session students are expected to be able to:

 Identify the target group to participate in health education session
 Give reasons for selecting the target group
 Identify methods for conducting health education session to the target group
 Communicate each method effectively

Step 2: Identification of the target group to participate in health education session

It is important to consider carefully how you will make sure that you get the health education-
training participants you want. The ideal situation is to have participants who are of the right
educational level and experience to benefit from the training programme, who are
enthusiastic and motivated and can put into practice their newly-learnt ideas and skills. If it is
a community health education programme, the participants shall probably have been selected
by the community leadership.

It is wise to get a good mix of participants especially male and female with various
background disciplines and experiences. It is unfortunate that sometimes people may be sent
to a training session for a variety of reasons; because of personal connections with the boss,
because of seniority, economic gain and so like. The following steps are recommended is
selecting the target audience to participate in health education training programme:-
 Formation of an organizing committee to plan the training programme with clearly and
well defined responsibility for each member.
 Setting of objectives for the training programme, specify dates and length of the training
programme.
 Decision on the number and category participants to participate in the training
 Send official invitation letters, E-mails
 Make follow up to confirm their participation and have a reserve list in case some drop
out.
 Identify internal and external facilitators
 Conduct meeting with facilitators to brief them about the training programme and identify
training materials and other resources.
 Choose the place where the training shall take place, venue including accommodation,
food, recreational facilities
 Buy the required teaching materials
 Plan the timetable

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 Arrange for stationary facilities

Step 3. Reasons for selecting target group

Human behaviour plays an important role in prevention, control, treatment and rehabilitation
processes of most health problems. However it is obvious that the influences on person’s
behaviour may be outside their control at the family, community, and district, regional,
national and international level

Health education is one of the most important components of health promotion and it
involves motivation to adopt health promoting behaviours and assisting people to make
decisions about their health and acquire the necessary confidence and skills to put their
decisions into practice.

Therefore the target group to participate in health education training session are selected
because they should
1. Have a dialogue with communities including minorities and disadvantaged groups
2. Influence policy makers, policy advisors, policy influencers and decision makers to adopt
health promoting policies and laws.
3. Raise awareness among decision makers of issues of poverty, human rights, equity,
environmental issues
4. Ensure that the government provides support to government health-promoting policies
5. Communicate new laws and policies to the community
6. Facilitate development of community action on health and development issues.

Step 4. Methods for conducting health education session for each group
Activity in class exercise 30 minutes
Ask each student to mention methods for conducting health session according to specific
group
(Responses: See session 5; step 2&4)

SUMMARIZE their responses and confirm correct answers using notes below

Step 5. Communicate the methods

Activity in class exercise 30 minutes

1.Ask students to form groups of three to five members to describe the correct approaches
for communicating each of the methods they have mentioned in step 4 above
2.Allow one participant from each group to come forward and present the group work

SUMMARIZE their responses and confirm correct answers using notes below

Step 6. Summary of Key Points

Activity in class exercise 15 minutes

Summarize the session as follows:

In this session we have discussed about identification of the target group to participate in
health education session, and state reasons for the target group to be involved in training
programme. Some of the reasons are:-
 They should have a dialogue with communities including minorities and disadvantaged

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 groups
 To influence policy makers, policy advisors, policy influencers and decision makers to
adopt health promoting policies and laws and
 Raise awareness among decision makers of issues of poverty, human rights, equity,
environmental issues

Step 7: Evaluation
Activity in class exercise 10 minutes

Ask participants state the role of human behaviour in disease prevention and control and its
determinants
Response: Human behaviour plays an important role in prevention, control, treatment and
rehabilitation processes of most health problems. However it depends on the influences on
person’s behaviour may be outside their control at the family, community, and district,
regional, national and international level

References
1. International Training & Education Center on HIV (2006) Behaviour Change
Communication Training Toolkit
2. John Hubley (1995) An action guide to health education and health promotion
3. Keith Tones and Sylvia Tilford (1995) Health Education; Effectiveness, efficiency and
equity second edition
4. Ian Ree and Stephen Walker (2007) Teaching, Training and Learning: a practical guide

125
Session 7: Conduct health education sessions

Total Session Time: 120 minutes

Prerequisites- None

Learning Objectives

By the end of this session students are expected to be able to:

1. Identify and arrange the venue for health education training session
2. Choose the appropriate training methods
3. Conduct health education training session
4. Manage groups
5. Monitor learning process

Step 2. Identification and arrangement of the venue for health education training
session
Identifying the training venue is determined by the training programme objectives,
economical position and characteristics of participants. It is advisable to select a venue where
participants can get chances of leaving pressures of their work to reflect and concentrate only
on training programme. In case of community outreach the facilitator should collaborate with
the community authority to determine the appropriate venue.

Conducive training places, food, accommodation and recreational facilities are important
when considering the venue so much so that training programme shall be more likely to be
put into practice if it is conducted in a user friendly environments where relevant application
of the knowledge and skills gained can be possible.

Step 3. Choosing the appropriate training methods (20 minutes)

Activity in class exercise 5 minutes

 Ask students to form small groups of three to five members to describe the selection of
training methods for health education session
 Write responses on a flip chart

SUMMARIZE their responses and confirm correct answers using notes below

There are several methods for conducting health education session such as; Group discussion,
lecturing, lecture discussion, role play, drama or popular theatre, group work, brain storming,
buzzing, demonstration, assignment, games, counselling, popular media, mass media, songs,
storytelling, pictures, drama and popular theatre, puppets and traditional symbols.

Choosing the appropriate methods depends on characteristics of the target audience or

participants and channels. For example if you choose to work with communities the
appropriate methods may be drama and popular theatre, demonstration and traditional
symbols. If you choose to work through schools to reach young people the appropriate
methods probably may involve classrooms activities or schools games

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Step 4. Conducting health education training session (20 minutes)
 Ask each student describe the process of events in conducting health education training
session
 Write responses on a flip chart

SUMMARIZE their responses and confirm correct answers using notes below

Running health education training session, the facilitator or teacher should follow the
following process:-
1. Introduce yourself and the topic – gain every participant’s attention
2. Provide a summary of the main points to be covered
3. Present the facts and other information showing relevant visual aids when appropriate
4. Speak loud and clear so that every participant can hear well.
5. Try not to be distracting by too much moving around, hands in pockets or mannerisms
such clipping fingers, jangling keys, Yes; Yes and IK, IK syndromes.
6. Keep constant watch on the reactions of the group to your facilitation. Look around for
signs of misunderstanding or boredom in the class. Actively encourage questions and
opinions.
7. Provide practical assignments or reading to follow on from the training method. Handouts
listing the main points are often useful.
8. Summarize the session by highlighting and emphasizing the must to know matters.
9. Evaluate the training session by asking questions or setting a task.

Step 5. Management of groups during health education session (25 minutes)

 Ask students to form groups of three to five members to buzz on management of
groups during health education training session.
 Write responses on a flip chart

SUMMARIZE their responses and confirm correct answers using notes below

A group is a dynamic whole based on interdependence rather than similarity (Lewin). A

group is not just a collection of people; they should share some characteristics and interact. A
group may have as few as four people and as many as 24.The modalities of interaction,
opportunities for exchange of ideas and successes in achieving objectives are affected by the
group size. With too many members it will be difficult for everyone to contribute effectively,
while with too few members most members will have good chance to contribute. An ideal
size of a group should consist of 8 to 12 members.

There are many reasons why we work in groups for health and health promotion activities.
Some of circumstances that demands group are; problem solving, teaching and learning, self
help group and community based groups.

Working in groups can be highly motivating and achieve good results, meanwhile may be
frustrating, difficult and lead to failures. Difficulties in working with groups may arise from;-
 Lack of common purpose, every group member needs something different
 Some group members dominate the discussion, others are quite and do not voice out their
ideas
 Disagreements, personal clashes and conflicts among group members
 Every group members wants to talk but nobody is willing to make decisions

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 Members may fail to attempt the assigned tasks
 Poor and irregular attendance

Group dynamics.
Functioning of a group is called group dynamic and the characteristics of the group include;
size and membership, nature of the tasks undertaken, the decision making process, the roles
of group members, group processes, the roles of each member, group processes, and patens of
group leadership.

The following are characteristics of groups:

 The positive type – they can be of great help to the chairperson particularly when
discussion bogged down
 The quarrelsome type: Keep cool. Don’t allow yourself to become involved in an
argument. Ask them question and they will probably make some foolish or far-fetched
statements that can be dealt with by other group members. Don’t allow anyone to
become personal.
 The know-all type: They may be bluffing and not really know the answers. When they
give an opinion ask them to give reasons. If the reasons seem faulty ask other members
of the group o comment. This helps to build up confidence in the group so they will not
be imposed on.
 The talkative type: don’t discourage them. If they are well-informed their opinion can
be of help to the group. If they talk for too long they can bore others. Be prepared to
interrupt them tactfully and ask a direct question of someone else.
 The shy type: they may know a great deal but they shy to speak out. Often the talkative
and know-all types are the men; the woman may be more shy but have much of
importance to contribute to the group. When suitable opportunity arises, call upon them
by name to give an opinion but be sure that the question is an easy one to build up
confidence to contribute more to the group.
 The uncooperative rejecting type: be patient and try to win their friendship.
Acknowledge their experience and let them feel that you depend upon their help for the
success of the meeting.
 The highbrow intellectual type: Be patient, but keep to the point; if necessary rephrase
their statements for the benefit of other members. Ask them to help the group with
difficult technical points. Take care that they do not over-awe the rest of the group and
make them feel inadequate.
 The persistent questioner: They are often out to trap the chairperson. Pass their
questions back to the group and then get the questioner’s views.
 Some other kinds of difficult group behaviours were identified in that same workshop and
given the personalities of animals.
 The donkey - who is very stubborn and will not change his point of view ‘I will not be
moved’.
 The Lion – who fights whenever others disagree with is plans or interferes with his
desire.
 The rabbit – who runs away when he senses tension or conflict or switches quickly to
another topic.
 The Ostrich - who buries his head in the sand and refuses to admit any problem at all.
 The Monkey – who fools around and prevents the group from concentrating on serious
business.

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 Hyena –who laughs’ and makes jokes to avoid dealing with difficulties or puts rivals
down.
 The Elephant – who blocks the way and stubbornly prevents the group from continuing
along the road to their desired goals.
 The giraffe – who looks down on others and on the Programme in general, feeling that ‘I
am above it all’
 The Tortoise – who withdraws from the group, refusing to give ideas, or opinions.
 The Cat – who is always looking for sympathy, ‘It is so difficult for me’.
 The Peacock - who is always competing for attention, ‘See what a fine fellow I am.

Step 6. Monitor learning the process of conducting health education session (25
minutes)
Activity in class exercise 25 minutes

 Ask students to form groups of three to five members to brainstorm on monitoring

process of health education training session.
 Write responses on a flip chart

SUMMARIZE their responses and confirm correct answers using notes below

Monitoring is the ongoing routine collection and analysis of information that you record as
your activities are progressing. Using monitoring, you should be able to check whether
activities are being carried out as planned and whether they are effective or not. Monitoring
will help you keep your work on track, and can let you know when things are going wrong. If
things are going wrong, you will be able to take action to correct any problems. Monitoring
should enable you to determine whether the resources you have are sufficient and are being
well used and whether the capacity you have is sufficient and appropriate. Monitoring can
take place at any time during the implementation process, on a regular or periodic basis. For
instance, you will be able to monitor health education training activities daily, fortnightly or
monthly, or as the need arises. So as you can see, monitoring is absolutely crucial.

While you are undertaking health education training activities, make sure that the planned
activities are actually delivered in the way that they have been planned. It is easy to begin
with plans and then to go off the beaten track. The method which enables you to know
whether the activities are being implemented as planned is called monitoring.

The data which shows the progress of health education activities can be collected by several
methods, from various sources. During all your health education work, you will be able to
observe how health education training activities are being perceived, and the reaction of the
community or participants. Of course, you will make periodic review of students or visits to
households, during which time you can check whether their health-related practice has
actually changed. It is important to make a periodic review of your recorded activities. For
example, you can review your achievements and check whether you have completed what
you have planned to do. Feedback from clients and community, particularly those who
participated in the activities, will always be the most important sort of monitoring.

Step7. Summary of Key Points

Activity in class exercise 5 minutes

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 1. Summarize the session as follows:
 In this session we have discussed about Identification of the training venue and
learnt that this is determined by the training programme objectives, economical
position and characteristics of participants.
 Conducting health education training session, we discussed that the facilitator or
teacher should follow the following process:-
 Introduce yourself and the topic – gain every participant’s attention
 Provide a summary of the main points to be covered
 Present the facts and other information showing relevant visual aids when
appropriate
 Speak loud and clear so that every participant can hear well.
 Try not to be distracting by too much moving around, hands in pockets or
mannerisms such clipping fingers, jangling keys, Yes; Yes and IK, IK
syndromes.
 Keep constant watch on the reactions of the group to your facilitation. Look
around for signs of misunderstanding or boredom in the class. Actively
encourage questions and opinions.
 Provide practical assignments or reading to follow on from the training method.
Handouts listing the main points are often useful.
 Summarize the session by highlighting and emphasizing the must to know
matters.
 Evaluate the training session by asking questions or setting a task.

Step 8. Evaluation
Activity in class exercise 15 minutes
Ask participants
1. What are determinants for identifying a venue for health education training session
Response
Identification of the training venue is determined by the training programme objectives,
economical position and characteristics of participants. It is advisable to select a venue
where participants can get chances of leaving pressures of their work to reflect and
concentrate only on training programme. In case of community outreach the facilitator
should collaborate with the community authority to determine the appropriate venue
2. Mention five characteristics of group

References
1. International Training & Education Center on HIV (2006) Behaviour Change
Communication Training Toolkit
2. John Hubley (1995) An action guide to health education and health promotion
3. Keith Tones and Sylvia Tilford (1995) Health Education; Effectiveness, efficiency and
equity second edition
4. Ian Ree and Stephen Walker (2007) Teaching, Training and Learning: a practical guide

130
Chapter Four

Module Code MLT06104: Health Economics and Entrepreneurship

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Session 1: Introduction to Entrepreneurship

Learning Objectives:

By the end of this session, students are expected to be able to:

1. Define the following terms as used in entrepreneurship: (Entrepreneurship,
2. Entrepreneur, Intrapreneurship and Intrapreneurs, Opportunity).
3. List ten qualities of a successful entrepreneur
4. Explain five benefits of entrepreneurship skills for the health professionals
5. List four steps of entrepreneurial processes
6. List five factors that may hinder the adoption of entrepreneurial skill
7. Demonstrate the application of entrepreneurial qualities in health profession

Step 2: Definitions of key terms Entrepreneurship

 Entrepreneurship is defined differently by different scholars, but looking at their
contribution, they all focus on the rational and optimum ways of application of resources
in operations with the view of fulfilling individual and / organizational needs. Therefore,
it is interesting to know what entrepreneurship is,
 Basically entrepreneurship is one of the four factors of production, others being land,
labour and capital
 “But, how does land, capital and labour produce without entrepreneurship?”
We need entrepreneurship to be combined with other factors of production in order to
complete the process of production.
Currently, key actors (scholars, policy makers, managers) take entrepreneurship in a wide
range of meanings.
These include:
 The process of business start-up or new venture development (Gavron et al., 1998 in
Gibb, 1999),
 The development of entrepreneurial traits, skills and behaviors in individuals (Gibb, 1993,
1999)
 The development of a wider understanding of “business” culture in a society (OECD,
1989 in Gibb, 1999).
 The process of creating something new and assuming the risks and rewards (Hisrich et al,
2004)
 The fostering of business management skills among the population for the development
of capacities for individuals and teams to develop and grow companies (Churchill, 1991,
in Gibb, 1999),
 The abilities associated with innovation in technology and management aimed at doing
new things or old things in new ways with new combinations of resources (Gibb, 1999).
 Economists, for example, focus on the entrepreneurs’ ability to act as change-agents i.e.
mobilizing resources, adopting technologies, opening markets, and exploiting
opportunities.
 Sociologists and anthropologists concentrate on the ways entrepreneurial activity is
influenced by group pressure, ethnic characteristics or commercial values.
 Psychologists focus on the motivational and behavioral attributes of potential
entrepreneurs

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 Management scientists highlight functional attributes, core competencies and the ability
to deal successfully with routine managerial activities.

Therefore, in almost all of the definitions of entrepreneurship, there is agreement that we are
talking about a kind of behavior that include:
 Initiative taking
 The organizing and recognizing of social and economic mechanisms to turn resources and
situation to practical account and
 The acceptance of risks or failure

1. Entrepreneur
A term entrepreneur is defined by different scholars in different perspectives.
 Cantillon (1734) defines the entrepreneur in an economic context as “someone who has
the courage to operate under conditions of uncertainty and risk.”
 He regards entrepreneurial income or profit as rising out of decision-making and risk-
taking
 He further regards the entrepreneur as one who has judgment, perseverance and
knowledge of the world as well as of business
 Schumpeter (1934) views the entrepreneur as one who is defined by what he does and not
what he owns; and to him, innovation is the central issue.
 He argues that an entrepreneur must:
o Introduce a new good or quality of a good
o Introduce a new method of production,
o Open a new market,
o Utilize a new source of raw materials or intermediate goods and carry out a new
organizational form of the industry.
 Hisrich et al (2004) defines an entrepreneur as an innovator
 An individual who can develop something unique
 Kirzner (1992) argues that the entrepreneurial process is always competitive and that an
entrepreneur has nothing but his alertness.
 An entrepreneur is one who alerts to economic opportunities, using information
advantages for his own profit. Learning and experience are crucial elements for
successful entrepreneurs.
 An entrepreneur is a person who organizes and mange a business undertaking assuming
the risk for the sake of profit (http//www.sba.gov/content)
 He /she see an opportunity
 Make a plan
 Start the business
 Manage the business and receive profit
 Kilby (1961) refers to entrepreneurship by specifying the “functions of the entrepreneur”
and notes that they normally include:
 Perceiving the opportunity for a profitable investment,
 Committing the necessary risk capital,
 Assembling all the needed administrative and material inputs to erect an enterprise,
and, once production is underway,
 Providing on-going management and responding to competition.
 It is therefore summarized that an entrepreneur is someone who:
 Produces something new or
 Improves over the previously existing one, or

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  Produces and / introduces the same product or service in new markets through
innovation, dynamism, risk taking, and alertness.
 A person who sees an opportunity in the market, gather resources, creates and grows a
business venture to satisfy these needs. He / she takes the risk of the venture and is
rewarded with profits if it succeeds

2. Intrapreneurship
Is the process of practicing entrepreneurship within an existing organization (Hisrich et al,
2004)
 Thus, its orientation remains under entrepreneurship context.
 The entrepreneurial business occurs within the organization. The staff member sees the
opportunities and utilize them for adding value or growth -personally or in the entire
organization
 There three types of cooperate entrepreneurship,
 One is the creation of new business in the existing organization,
 second is the transformation or renewal of existing organization
o This can also be an innovation including the adoption of new solution to old
problems, and
 Third is a frame-breaking or discontinuous change where there is changing of the
rules of competition of industry/business
o Cooperate entrepreneurship is the extent to which new products or services and /or
markets are developed e.g. if there are more than an average number of new
services / products and markets it in the organization
3. Intrapreneur
 Is a person who acts in an entrepreneurial ways within an existing organization (Hisrich et
al, 2004)
 The operation attributes must reflects an entrepreneur orientation

4. Opportunity
 Is a favorable set of circumstances that creates a need for a new product and / service. Is
the chance to do something in way which is different from and better than the way it is
done at the moment (Barringer et al, 2010)
 “How do we identify / recognize an opportunity”
 Various sources of opportunity are available. What is needed is just acting in
entrepreneurial ways throughout the process.
 Sources of opportunities include:
 New product based on existing or new technology or existing product
 New service
 New means of production
 New ways of distribution- less time, easy access, or more convenient
 Improved service- offering additional service element to customer
 Relationship building- develop close & trust relation
 Given the above sources of opportunities, the following methods are suggested as useful
in spotting opportunity
 From creative groups
 Problem analysis
 Customer proposals
 Features stretching-changing the product feature
 Product blending-creating new product by merge ring together features from different
products or services

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  Combine approach- using all of the above

Step 3: The qualities of a successful entrepreneur (10 Minutes)

Activity: In class exercise: organize the class in small group of 3 to 5students to brainstorm
on the qualities of a successful entrepreneur (10 minutes)
ASK the students to summarize their responses on a flipchart or board and confirm correct
answers using notes below

 Based on the agreement reached from the definitions of entrepreneurship, the

entrepreneurial attitude is focused at:
 Initiative taking
 The organizing and recognizing of social and economic mechanisms to turn resources
and situation to practical account and
 The acceptance of risks or failure
 Thus, entrepreneurship can be practiced in every area of the social economic field of
specialization especially if the following qualities / characteristics of an entrepreneur can
be presented:

Table 3.1: Qualities of a Successful entrepreneur

 Innovative  Achievement motivated / result oriented
 Hard worker  Resources assembler
 Team player  Passionate
 Persuasive  Committed
 Creative  Determined
 Energetic  Perseverance
 Self confident  Opportunity oriented
 Self starter  Problem solver
 Tolerant of ambiguity  Calculated risk taker
 Visionary  Internal locus of control
 Independent  Optimistic
 Proactive  Hard worker
Source: Barringer et al (2010) and Kuratko et al (2001)

Step 4: The benefits of entrepreneurship to the health professionals (10 minutes)

Activity: In class exercise: organize the class in small group of 3 to 5 students to
brainstorm on the benefits of entrepreneurship to the health professionals (10 minutes)
ASK the students to summarize their responses and confirm correct answers using notes
below

Entrepreneurship is very significant to the general social economic perspective and in

particular the health professionals because the as economic stakeholder develop new product
and services, the impact side effects results into creative destruction that leads to product /
services obsolescence.
The concept of creative destruction results in opportunity creation and elimination, an aspect
that can be managed using the application of entrepreneurship and Intrapreneurship.
Therefore, in health profession point of view, entrepreneurship is linked with the following
benefits:
 Health promotion

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 Wealth creation
 Job creation
 Poverty alleviation
 Equity
 Participation
 Social stability

Therefore, entrepreneurship in health care industry can be viewed in the following

phenomenon:
 Provides sense of personal growth and self-achievement aspiration e.g. when a health
specialist knows how to use available opportunities he/she can start a business.
 Enhance habit of hard working, creativity, & innovativeness thus, performance can be
enhanced
 Help in discovery of gaps in the previous operations at any level within and outside the
industry.
 Contributes in poverty reduction

Step 5: The entrepreneurial Process (15 Minutes)

Activity: In class exercise: organize the class in small group of 3 to 5 students to
brainstorm on the entrepreneurial process (10 minutes)
ASK the students to summarize their responses and confirm correct answers using notes
below
The entrepreneurial processes consist of four steps namely:
 Deciding to become an entrepreneur
 Developing a successful business idea
 Moving from an idea to the entrepreneurial firm
 Managing and growing the entrepreneurial firm

Step 6: List five factors that may hinder the adoption of entrepreneurial skill (10
Minutes)
Activity: In class exercise: organize the class in small group of 3 to 5 students to
brainstorm on the factors hindering the adoption of entrepreneurial skill (10 minutes)
ASK the students to summarize their responses and confirm correct answers using notes
below
 Based on the literature and experience, we believe that entrepreneurship have valuable
significance to the stakeholders at large (individuals, organizations, countries and
multinational organizations). On the other hand, its implementation calls for various core
and noncore / support services while the actors are have varied endowment of such
services. This creates a potential for hindering of some actors to apply the entrepreneurial
skills successfully.
 Generally, the hindering factors include:
 Poor financing
 Lack of operational experience
 Poor infrastructure
 Poor technology
 Social cultural factors
 Gender imbalance in entrepreneurial participation
 Lack of accountability
 Poor governance at various levels (organizational, national level)

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  Overdependence attitude

Step 7: Demonstrate the application of entrepreneurial attitude in health profession (20

minutes)
Activity: In class exercise: organize the class in small group of 3 to 5 students to
brainstorm on the factors hindering the adoption of entrepreneurial skill (10 minutes)
ASK the students to demonstrate their understanding on entrepreneurial qualities and
confirm their attitude in the role play using notes above

ROLE PLAY: Facilitator should guide students on how they should demonstrate the use of
entrepreneurial skills in tackling health related challenging situation in a way that can allow
them to display their entrepreneurial qualities. While demonstrating, a facilitator should
observe the trend and note the displayed entrepreneurial qualities (if any). Also, a facilitator
should ASK students to observe the demonstrating group and record their observation
findings for presentation during the evaluation session after demonstration. Lastly, a
facilitator should give reports of their demonstration. Appropriate conducts (verbal and / non
verbal) that reflect the student’s entrepreneurial qualities must be commented.
The facilitator should allocate each group member to a particular position, for example, to
attend a medical emergency; there may be the following positions to be assumed with
different demonstration roles:
1 Receptionist
2 Counsellor
3 Doctor
4 Laboratory technologist
5 Nurse
6 Pharmacist

Step 8: Key Points (10 minutes)

 Entrepreneur
 Opportunity
 Entrepreneurship
 Entrepreneurial
 Entrepreneurial process
 Entrepreneurial venture
 Entrepreneurial orientation

Step 9: Evaluation (10 Minutes)

 ASK students to answer some questions focusing on the general coverage and key points
 While responding, compare their responses and confirm correct answers using notes

References:
1. Barringer, B.R. (2010), Entrepreneurship; Successfully Launching New Ventures, third
edition, Pearson Education, Boston
2. Deakins, D and Freel, M. (2003), Entrepreneurship and Small Firm, Fourth Edition,
McGraw Hill Education
3. Hisrich, R.D. (2004), Entrepreneurship, Fifth Edition, Tata McGraw - Hill Education,
New Delhi
4. Hisrich, R. D; Peters, M. P. and Shepherd, D. A. (2008), Entrepreneurship, Seventh
Edition, McGrawHill, Singapore

137
5. Scarborough, N. M. (2011), Essentials of Entrepreneurship and Small Business
Management, Sixth edition, Prentice Hall, New Jersey
6. Burns, P. (2007), Entrepreneurship and Small Business, Second Edition, Palgrave
Macmillan, London
7. Lovelock, C; Wirtz, J. And Chatterjee, J. (2006), Services Marketing; People,
Technology, Strategy, Fifth Edition, Pearson Education, India
8. Kottler, P and Armstrong, G. (2002), Principles of Marketing, Ninth Edition, Pearson
Education, New Delhi
9. Wickham, P.A. (2006), Strategic Entrepreneurship, Fourth Edition, Prentice Hall,
England
10. Abrahams, R and Vallone, J. (2005), Business Plan in a Day; Get it Done Right – Get it
Done Fast, Prentice Hall, New delhi
11. Scarborough, N. M; Wilson, D. L and Zimmerer, T. W. (2009), Effective Small Business
Management; An Entrepreneurial Approach, Ninth Edition, Pearson Education, New
Jersey
12. Abraham, R. (2007), The owner’s Manual for Small Business, Prentice Hall, New Delhi
13. Piercy, N. F. (2007), Market Lead Strategic Change; A Guide to Transforming the
Process of Going to Markets, Ninth Edition, Butterworth Heinemann, Great Britain

138
Session 2: Attributes of Professional and Non Professional Behaviour in
health services

NTA Level 6, Semester 1, Module Code: MLT 06104 - Health Economics and
Entrepreneurship

Total Session Time: 120 minutes

Pre-requisites: None

Learning Objectives:

By the end of this session, students are expected to be able to:

1. List seven common attributes of professional and non professional behaviour as applied
in health businesses
2. Describe effects of professional and non professional behaviour
3. Demonstrate professional behaviour in operating health businesses

Step 2: Common attributes of professional behaviour as applied in Health businesses

(15 Minutes)

 Common attributes of professional behaviour as applied in health businesses are such as:
 Respect each other
 Avoid conflict of interest
 Preserve confidentiality
 Protect organization’s assets
 Ensure financial integrity and responsibility
 Obey the law
 Ensure client privacy
 Common attributes of unprofessional behaviour as applied in health businesses are such
as:
 Putting own interests ahead of organization
 Use of abusive behaviour
 Safety violation
 Lying to clients
 Discrimination
 Sexual harassment
 Stealing

Step 3: Describe effects of professional and non-professional behaviour (15 minutes)

In class exercise: Students should continue being in their formed group of 5 or more
students to demonstrate professional behaviour in operating health businesses (10
minutes)
ASK students to list potential effects for the professional and non professional behaviour
in health businesses
ASK the students to summarize their responses and confirm correct answers using
notes below

139
The most common effects of strong professional behaviour are as indicated in table 4.1
below. A Facilitator should describe the context likely to cause the potential payoff as
indicated in the table.

Figure 3.1: Potential payoff for establishing a strong professional behaviour

Decreased Vulnerability Improve Institution’s
Reputation

Improve Customers’ Strong Better Access to Capital

Royalty Professional
Behaviour
Improve Employees’ Ethical Potential avoidance of
Commitments Culture fines and Penalty

Source: Barringer et al (2010)

Similarly, the facilitator should explain the most common effects of strong non professional
behaviour are as indicated in table 4.2 below. A Facilitator should describe the context likely
to cause the potential payoff as indicated in the table.

140
Figure 3.2: Potential payoff for establishing a strong non professional behaviour
Increased Vulnerability Decreased Institution’s
Reputation

Decreased Customers’ Strong Non Limited Access to Capital

Royalty Professional
Behaviour
Decreased Employees’ Increased Potential for
Commitments Fines and Penalty

Source: Barringer et al (2010)

Step 4: Demonstrate professional behaviour in operating health businesses (60 Minutes)

Activity: In class exercise: organize the class in group of 5 or more students to demonstrate
professional behaviour in operating health businesses (10 minutes)
ROLE PLAY: Facilitator should guide students on how they should demonstrate the use of
professional behaviour in operating health businesses. While demonstrating, a facilitator
should observe the trend and note the events by classifying them in term of professional or
non-professional behaviours. Also, a facilitator should ASK students to observe the
demonstrating group and record their observation findings for presentation during the
evaluation session after demonstration. Lastly, a facilitator gives reports of their
demonstration. Appropriate conducts (verbal and / non verbal) must be commented.
The facilitator should allocate each group member to a particular position, for example, to
provide a medical care to the outpatient; there may be the following positions to be assumed
with different demonstration roles:
1 Receptionist
2 Doctor
3 Laboratory technologist
4 Nurse
5 Pharmacist

Step 5: Key Points (10 minutes)

 Entrepreneur
 Opportunity
 Entrepreneurship
 Entrepreneurial
 Entrepreneurial process
 Entrepreneurial venture
 Entrepreneurial orientation
 Professionalism
 Professional behavior

Step 6: Evaluation (10 Minutes)

 ASK students to answer some questions focusing on the general coverage and key points
 While responding, compare their responses and confirm correct answers using notes

References:

141
1 Barringer, B.R. (2010), Entrepreneurship; Successfully Launching New Ventures, third
edition, Pearson Education, Boston
2 Deakins, D and Freel, M. (2003), Entrepreneurship and Small Firm, Fourth Edition,
McGraw Hill Education
3 Hisrich, R.D. (2004), Entrepreneurship, Fifth Edition, Tata McGraw - Hill Education,
New Delhi
4 Hisrich, R. D; Peters, M. P. and Shepherd, D. A. (2008), Entrepreneurship, Seventh
Edition, McGrawHill, Singapore
5 Scarborough, N. M. (2011), Essentials of Entrepreneurship and Small Business
Management, Sixth edition, Prentice Hall, New Jersey
6 Burns, P. (2007), Entrepreneurship and Small Business, Second Edition, Palgrave
Macmillan, London
7 Lovelock, C; Wirtz, J. And Chatterjee, J. (2006), Services Marketing; People,
Technology, Strategy, Fifth Edition, Pearson Education, India
8 Kottler, P and Armstrong, G. (2002), Principles of Marketing, Ninth Edition, Pearson
Education, New Delhi
9 Wickham, P.A. (2006), Strategic Entrepreneurship, Fourth Edition, Prentice Hall,
England
10 Abrahams, R and Vallone, J. (2005), Business Plan in a Day; Get it Done Right – Get it
Done Fast, Prentice Hall, New delhi
11 Scarborough, N. M; Wilson, D. L and Zimmerer, T. W. (2009), Effective Small Business
Management; An Entrepreneurial Approach, Ninth Edition, Pearson Education, New
Jersey
12 Abraham, R. (2007), The owner’s Manual for Small Business, Prentice Hall, New Delhi
13 Piercy, N. F. (2007), Market Lead Strategic Change; A Guide to Transforming the
Process of Going to Markets, Ninth Edition, Butterworth Heinemann, Great Britain

142
Session 3: Explain the requirements for establishing health businesses
Enterprise

NTA Level 6, Semester 1, Module Code: MLT 06104 - Health Economics and
Entrepreneurship

Total Session Time: 120 minutes

Pre-requisites: None

Learning Objectives:

By the end of this session, students are expected to be able to:

1. Identify types of health business
2. List the requirement for establishing laboratory health business
3. Explain the importance of each requirement
4. Describe health laboratory services as business enterprise

Step 2: Types of laboratory health business (20 Minutes)

There are generally four types of laboratory related type of health business namely:
 Establishing laboratory services
 Establishing laboratory equipment and supplies enterprises
 Licensing a certificate of registration to other parties with proven abilities to establish the
lab-oratory enterprises competitively at a predetermined fee rate.
 Career counselor (academic, medical, management, family, crisis,
 Lecturers / tutor
 Establishment of laboratory institution / school
 Establish hospitals (partnering with other health professionals)

Step 3: Requirements for establishing health business (20 Minutes)

Activity: In class exercise: organize the class in small group of 3 to 5 students to
brainstorm on the requirements for establishing health business (10 minutes)
ASK the students to summarize their responses and confirm correct answers using
notes step 2 and those given below

Types of laboratory health business

The facilitator should clarify the session by focusing on the types of laboratory health
business as indicated in step 2 above. The actor should be facilitated to select a preferred but
feasible business from the list.

Health business environments

The analysis of the health business environments should be classified into internal and
external environments. While the internal environments looks at the organization’s own
ability in relation to actual and potential competitors, the external environment aims at

143
analyzing the uncontrollable factors (factors that their effect cuts across all stakeholders in a
non discriminatory manner. The analysis should generally be as indicated in figure 3.1 below:

Figure 3.1: Business Environment Analysis

Source: Piercy (2007); Kotler et al (2002) and Lovelock et al (2006)

The business registration processes

The process of business registration is as presented as follows (assuming that the promoter
will be identified)
 Determine the organization’s mission
 Determine the organization’s name
 Determine the office location
 The promoter should identify other directors who could be invited to the Board of
Director’s team (NOTE: A minimum of 2 Directors are accepted for company registration
and a maximum of 50 Directors for a company limited by shares)
 Organize a meeting to negotiate on the distribution of shares by all Directors (NOTE: A
director with majority share carries more weight in influencing the decisions based on the
ground that capital contribution is subjected to the percentage of share per Director, for
example, a Director with 52% of shares is liable to contribute 52% of the total capital and
the same is assumed in case of profit / loss distribution).
 Prepare a firm’s MEMORANDUM and ARTICLE OF ASSOCIATION (MEMART)
 Submit the MEMART to BRELA for registration process (NOTE: preliminary
consultation has to be done before submitting the final draft of the MEMART for
registration process.
 After attaining a registered position, the organization has to continue with the following
additional steps:
 Apply for certificate of TIN number from TRA
 Apply for business licence from the relevant Municipal council / District council

144
  Apply for specialized registration by specialized Governing Board (PHLPC, PHLB)
as appropriate.
 NB: if the option is to operate as a sole proprietor, the registration process can start at
item number 8 to 10

Step 3: The importance of each requirement (25 minutes)

In class exercise: Students should continue being in their formed group of 5 or more
students to brainstorm on the importance of (10 minutes)
ASK students to list the importance of each requirement for establishing health businesses
ASK the students to summarize their responses and confirm correct answers using notes
below
It is important to understand the requirement for establishing health businesses, each
requirement carries distinctive importance as explained below:

Types of laboratory health business

Developing an outstanding knowledge of the type of business is important because it helps
the actor to carry out the analysis of the type of business against various criteria in facilitating
the adoption of rational and optimum decision making.
Some criteria that may be referred to are such as capital requirement, social cultural attitude,
political interests, technological factor, economic factor and legal factor. The business idea
has to be ranked to each factor to verify its fit before making decision to optimize on it, the
great the fit, the better and vice versa.

Health business environments

These can be assessed from the internal perspectives looking at Strength, Weakness,
Opportunities and Challenges / Threats in relation to the competitors. The better the
competitive position of the implementing organization in comparative terms with the
competitors, the more unlike for that organization to be challenged.
On the other hand, external environments are to be considered because their bear an
uncontrollable effects. Factors such as Political, economic, social cultural, technological and
legal factors fall under this category.
The business registration processes
It is important to understand the health business registration process in order to ensure the
legality of the organization’s existence. In health business the aspect is more critical because
it involve more than one regulatory board in its operations. Actually, the health business are
regulated by the following regulatory board; Ministry of industry and trade, Private Health
Laboratory Board (PHLB), Health Laboratory Practitioners Council (HLPC).
Generally, the requirements are important because they help to validate the existence of the
organization make it possible for the organization to enjoy the relevant support services and
privileges where applicable

Step 4: health laboratory services as business enterprise (25 Minutes)

Activity: In class exercise: organize the class in group of 5 or more students to list
characteristics of a business enterprises (10 minutes)
 Any business enterprise is expected to present with the following characteristic:
 Must have management
 Must have mission and vision
 Must have an office
 Must have employees
 Must have a predetermined segment of customer to serve

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  Must be registered by appropriate regulatory board (LHLB, HLPC)
 Must have a business licence
 Must have certificate of incorporation (if registered as legal entity / company)
 Must have certificate of TIN number
 Must have something of value to offer to the target customers
The facilitator should describe the laboratory services as business enterprise by explaining
each of the characteristics 1 to 10.

Step 5: Key Points (5 minutes)

 Entrepreneur
 Opportunity
 Entrepreneurship
 Entrepreneurial
 Entrepreneurial process
 Entrepreneurial venture
 Entrepreneurial orientation
 Professionalism
 Professional behavior
 Business enterprise
 Laboratory services

Step 6: Evaluation (10 Minutes)

 ASK students to answer some questions focusing on the general coverage and key points
 While responding, compare their responses and confirm correct answers using notes

References:
1 Barringer, B.R. (2010), Entrepreneurship; Successfully Launching New Ventures, third
edition, Pearson Education, Boston
2 Deakins, D and Freel, M. (2003), Entrepreneurship and Small Firm, Fourth Edition,
McGraw Hill Education
3 Hisrich, R.D. (2004), Entrepreneurship, Fifth Edition, Tata McGraw - Hill Education,
New Delhi
4 Hisrich, R. D; Peters, M. P. and Shepherd, D. A. (2008), Entrepreneurship, Seventh
Edition, McGrawHill, Singapore
5 Scarborough, N. M. (2011), Essentials of Entrepreneurship and Small Business
Management, Sixth edition, Prentice Hall, New Jersey
6 Burns, P. (2007), Entrepreneurship and Small Business, Second Edition, Palgrave
Macmillan, London
7 Lovelock, C; Wirtz, J. And Chatterjee, J. (2006), Services Marketing; People,
Technology, Strategy, Fifth Edition, Pearson Education, India
8 Kottler, P and Armstrong, G. (2002), Principles of Marketing, Ninth Edition, Pearson
Education, New Delhi
9 Wickham, P.A. (2006), Strategic Entrepreneurship, Fourth Edition, Prentice Hall,
England
10 Abrahams, R and Vallone, J. (2005), Business Plan in a Day; Get it Done Right – Get it
Done Fast, Prentice Hall, New delhi
11 Scarborough, N. M; Wilson, D. L and Zimmerer, T. W. (2009), Effective Small Business
Management; An Entrepreneurial Approach, Ninth Edition, Pearson Education, New
Jersey

146
12 Abraham, R. (2007), The owner’s Manual for Small Business, Prentice Hall, New Delhi
13 Piercy, N. F. (2007), Market Lead Strategic Change; A Guide to Transforming the
Process of Going to Markets, Ninth Edition, Butterworth Heinemann, Great Britain

147
Session 4: Steps in establishing business Enterprises

NTA Level 6, Semester 1, Module Code: MLT 06104 - Health Economics and
Entrepreneurship

Total Session Time: 120 minutes

Pre-requisites: None

Learning Objectives:

By the end of this session, students are expected to be able to:

1. Identify and evaluate the opportunity
2. Develop the business plan
3. Determine the resources required
4. Start and Manage the business

Step 2: Identifying and evaluate the opportunity (20 Minutes)

iii) Opportunity
 Is a favorable set of circumstances that creates a need for a new product and / service. Is
the chance to do something in way which is different from and better than the way it is
done at the moment (Barringer et al, 2010), examples of health business opportunities in
laboratory services sub-industry are such as:
 Establishing a laboratory services equipments and supplies enterprises
 Developing career as researcher
 Consultant
 Trainer
 etc

Step 3: Develop the business plan (25 minutes)

In class exercise: Students should continue being in their formed group of 5 or more
students to brainstorm on the business plan in operating health businesses (10 minutes)
ASK the students to summarize their responses and confirm correct answers using notes
below
A business plan is a written document describing all relevant internal and external elements
and strategies for starting a new business or expanding the existing business. It presents a
description of the future direction of the business. More details will be presented in the next
session.

Step 4: Determine the resources required (25 Minutes)

In class exercise: Students should continue being in their formed group of 5 or more
students to demonstrate professional behaviour in operating health businesses (10 minutes)
ASK the students to summarize their responses and confirm correct answers using notes
below
Resources are valuable assets that can be allocated at different positions in the organization to
facilitate the organization’s operations. Resources can be classified in human resources and
non human resources (finance, time, buildings, motor vehicles, information and others).

148
Step 5: Start and manage the business (25 minutes)
In class exercise: Students should continue being in their formed group of 5 or more
students to demonstrate on how to start and manage a health businesses (10 minutes)
ASK the students to summarize their responses and confirm correct answers using notes
below
Starting and managing a business is a process that reflects the life of the organization in
implementing the mission and vision at hand. The complete process has to go through five
stages as presented in table 4.5.1 below. The facilitator should explain each stage by
presenting the stages and the associated characteristic and proposed managerial approaches as
appropriate.

Table 4.5.1 Organizational Lifecycle, Characteristics, Objectives and Strategies

Characteristics Stages
Introduction Growth Maturity Decline
Sales Low sales Rapidly Peak sales Declining
rising sales sales
Costs High cost per Average cost Low cost per Low cost per
customer per customer customer customer
Profit Negative Rising profit High profit Declining
profit
Customers Innovators Early Middle majority Laggards
adopters
Competitors Few Growing Stable number Declining
number but beginning to number
decline
Marketing Objectives
Create service Maximizing Maximizing Reducing
awareness and trial market share profit while expenditure
defending while milking
market share the brand
Operational Strategies (7Ps)
1. Product (Services)
2. Price
3. Place
4. Promotion (Advertisement and personal Selling)
5. Processes
6. People
7. Physical Evidences
Source: Kotler et al (2002)

Step 5: Key Points (10 minutes)

 Entrepreneur
 Opportunity
 Entrepreneurship
 Entrepreneurial
 Entrepreneurial process
 Entrepreneurial venture
 Entrepreneurial orientation
 Professionalism

149
 Professional behavior
 Organization Life Cycle (OLC)
 Operations’ strategies
 Market and marketing

Step 6: Evaluation (10 Minutes)

 ASK students to answer some questions focusing on the general coverage and key points
 While responding, compare their responses and confirm correct answers using notes

References:
1. Barringer, B.R. (2010), Entrepreneurship; Successfully Launching New Ventures, third
edition, Pearson Education, Boston
2. Deakins, D and Freel, M. (2003), Entrepreneurship and Small Firm, Fourth Edition,
McGraw Hill Education
3. Hisrich, R.D. (2004), Entrepreneurship, Fifth Edition, Tata McGraw - Hill Education,
New Delhi
4. Hisrich, R. D; Peters, M. P. and Shepherd, D. A. (2008), Entrepreneurship, Seventh
Edition, McGrawHill, Singapore
5. Scarborough, N. M. (2011), Essentials of Entrepreneurship and Small Business
Management, Sixth edition, Prentice Hall, New Jersey
6. Burns, P. (2007), Entrepreneurship and Small Business, Second Edition, Palgrave
Macmillan, London
7. Lovelock, C; Wirtz, J. And Chatterjee, J. (2006), Services Marketing; People,
Technology, Strategy, Fifth Edition, Pearson Education, India
8. Kottler, P and Armstrong, G. (2002), Principles of Marketing, Ninth Edition, Pearson
Education, New Delhi
9. Wickham, P.A. (2006), Strategic Entrepreneurship, Fourth Edition, Prentice Hall,
England
10. Abrahams, R and Vallone, J. (2005), Business Plan in a Day; Get it Done Right – Get it
Done Fast, Prentice Hall, New delhi
11. Scarborough, N. M; Wilson, D. L and Zimmerer, T. W. (2009), Effective Small Business
Management; An Entrepreneurial Approach, Ninth Edition, Pearson Education, New
Jersey
12. Abraham, R. (2007), The owner’s Manual for Small Business, Prentice Hall, New Delhi
13. Piercy, N. F. (2007), Market Lead Strategic Change; A Guide to Transforming the
Process of Going to Markets, Ninth Edition, Butterworth Heinemann, Great Britain

150
Session 5: Health Business Plan Development

NTA Level 6, Semester 1, Module Code: MLT 06104 - Health Economics and
Entrepreneurship

Total Session Time: 120 minutes

Pre-requisites: None

Learning Objectives:

By the end of this session, students are expected to be able to:

1. Define a business plan
2. Explain the importance of a business plan to an entrepreneur
3. List the contents of a business plan

Step 2: Business plane defined (10 Minutes)

A business plan is a written document describing all relevant internal and external elements
and strategies for starting a new business or expanding the existing business. It presents a
description of the future direction of the business.

Step 3: Explain the importance of a business plan to an entrepreneur (25 minutes)

In class exercise: Students should continue being in their formed group of 5 or more
students to brainstorm on the importance of a business plan (10 minutes)
ASK students to summarize their responses and confirm correct answers using notes below
The use of a business plan is associated with the following importance:

Importance to the entrepreneurs

 It helps to proactively avoid doing mistakes in the play ground, thus, minimizes the risk
of failure
 It is the base for determining the potential capital requirement
 It serves time as all activities are stipulated in the business plan document before going to
the play ground
 It helps to predict the strategic approaches likely to facilitate the organization’s
competitive move in term of marketing, human resources, and financial resources.
 Helps to predict the business performance based on the financial projection
 Helps to indicate the capital structure, asset structure and ownership structure.
 He / she is given an opportunity to know the target customers’ needs
 Type of service
 Expected level of service performance
 Pricing expectation
 Pre and post purchase services
 Social values and their relative needs

 Importance to the lenders

 They made able to judge the feasibility of the organization’s performance

151
  They can analyse the potential for recovering the landed amount of money based on
the marketing strategic approach, operation strategies and the financial strength of the
firm and the industry analysis details
 It gives the potential for verifying the owner’s ability to manage the proposed
business operations

 Importance to the target customers

 They are given an opportunity to tell their need attributes
o Type of service
o Expected level of service performance
o Pricing expectation
o Pre and post purchase services
o Social needs

Step 4: List the contents of a business plan (60 Minutes)

Activity: In class exercise: organize the class in group of 5 or more students to
brainstorm on the contents of a business plan (10 minutes)
ASK students to summarize their responses and confirm correct answers using notes
below
 The contents of a business is as follows
 Cover Page
 Table of contents
 Executive summary
 Company Description
 The project concept
 Industry analysis
 Market analysis
 Marketing plan
 Management team and company structure
 Operation and implementation plan
 Financial projections

Step 5: Key Points (10 minutes)

 Entrepreneur
 Opportunity
 Entrepreneurship
 Entrepreneurial
 Entrepreneurial process
 Entrepreneurial venture
 Entrepreneurial orientation
 Professionalism
 Professional behavior
 Business plan

Step 6: Evaluation (10 Minutes)

 ASK students to answer some questions focusing on the general coverage and key points
 While responding, compare their responses and confirm correct answers using notes

References:

152
1. Barringer, B.R. (2010), Entrepreneurship; Successfully Launching New Ventures, third
edition, Pearson Education, Boston
2. Deakins, D and Freel, M. (2003), Entrepreneurship and Small Firm, Fourth Edition,
McGraw Hill Education
3. Hisrich, R.D. (2004), Entrepreneurship, Fifth Edition, Tata McGraw - Hill Education,
New Delhi
4. Hisrich, R. D; Peters, M. P. and Shepherd, D. A. (2008), Entrepreneurship, Seventh
Edition, McGrawHill, Singapore
5. Scarborough, N. M. (2011), Essentials of Entrepreneurship and Small Business
Management, Sixth edition, Prentice Hall, New Jersey
6. Burns, P. (2007), Entrepreneurship and Small Business, Second Edition, Palgrave
Macmillan, London
7. Lovelock, C; Wirtz, J. And Chatterjee, J. (2006), Services Marketing; People,
Technology, Strategy, Fifth Edition, Pearson Education, India
8. Kottler, P and Armstrong, G. (2002), Principles of Marketing, Ninth Edition, Pearson
Education, New Delhi
9. Wickham, P.A. (2006), Strategic Entrepreneurship, Fourth Edition, Prentice Hall,
England
10. Abrahams, R and Vallone, J. (2005), Business Plan in a Day; Get it Done Right – Get it
Done Fast, Prentice Hall, New delhi
11. Scarborough, N. M; Wilson, D. L and Zimmerer, T. W. (2009), Effective Small Business
Management; An Entrepreneurial Approach, Ninth Edition, Pearson Education, New
Jersey
12. Abraham, R. (2007), The owner’s Manual for Small Business, Prentice Hall, New Delhi
13. Piercy, N. F. (2007), Market Lead Strategic Change; A Guide to Transforming the
Process of Going to Markets, Ninth Edition, Butterworth Heinemann, Great Britain

153
Session 6: Prepare a Business Plan: Part 1

NTA Level 6, Semester 1, Module Code: MLT 06104 - Health Economics and
Entrepreneurship

Total Session Time: 120 minutes

Pre-requisites: None

Learning Objectives:

By the end of this session, the students are expected to be able to:
1. Describe the Cover page in a business plan
2. Describe how to create a Table of contents in a business plan
3. Describe the Executive summary in a business plan
4. Describe the Company Description in a business plan
5. Describe Industry analysis portion in a business plan
6. Describe Market analysis portion in a business plan

Step 2: Cover Page (5 Minutes)

A cover page is the outer cover of the business plan document. It contains the following
items:
 Name of the owner (organization)
 Contact address (Box number, telephone number, email, website
 Title of the business plan
 Principal consultant particulars

Step 3: Table of Contents (5 minutes)

 This section contains a list of all headings described in the business plan. Therefore it is
logical to do it terminally.

Step 4: Executive Summary (5 Minutes)

 This section summarizes the business plan; it is advisable to be a maximum of a page and
be done terminally as well.

Step 5: Company Description (25 Minutes)

Activity: Organize the class in-group of 5 or more students to brainstorm on the contents of
a company description. Example, “How would you describe a health laboratory
business?” (10 minutes)
ASK students to summarize their responses and confirm correct answers using notes
below
A company description should include the following details:
 Company history
 Mission statement

154
 Vision statement
 Products / services available (Breadth of service line)
 Current status in the market and industry
 Legal status and ownership
 Key partners (if any)

Step 6: Industry analysis (30 Minutes)

 Generally analyzing the industry is very critical before deciding on whether to capitalize
on the business opportunity. An outstanding industry analysis is expected to cover the
following exhaustively:
 Industry:
o Size
o Growth rate
o Sales projections
 Industry structure
 Nature of participants
 Key success factors
 Industry trends
 Long term prospects

Step 7: Market analysis (25 minutes)

Activity: Organize the class in group of 5 or more students to brainstorm on the contents of
the market analysis as presented in a business plan (10 minutes)
ASK students to summarize their responses and confirm correct answers using notes below
The market analysis done focusing at the following items:
 Selection of target market
 Target market segmentation
 Prediction of buyers’ behaviour
 Competitor analysis (size, quality of human resources, technology, breadth of services,
pricing mechanisms, after sale services)

Step 8: Key Points (10 minutes)

 Entrepreneur
 Opportunity
 Entrepreneurship
 Entrepreneurial
 Entrepreneurial process
 Entrepreneurial venture
 Entrepreneurial orientation
 Professionalism
 Professional behavior
 Business plan
 Industry analysis
 Company

Step 9: Evaluation (10 Minutes)

 ASK students to answer some questions focusing on the general coverage and key points
 While responding, compare their responses and confirm correct answers using notes

155
References:
1. Barringer, B.R. (2010), Entrepreneurship; Successfully Launching New Ventures, third
edition, Pearson Education, Boston
2. Deakins, D and Freel, M. (2003), Entrepreneurship and Small Firm, Fourth Edition,
McGraw Hill Education
3. Hisrich, R.D. (2004), Entrepreneurship, Fifth Edition, Tata McGraw - Hill Education,
New Delhi
4. Hisrich, R. D; Peters, M. P. and Shepherd, D. A. (2008), Entrepreneurship, Seventh
Edition, McGrawHill, Singapore
5. Scarborough, N. M. (2011), Essentials of Entrepreneurship and Small Business
Management, Sixth edition, Prentice Hall, New Jersey
6. Burns, P. (2007), Entrepreneurship and Small Business, Second Edition, Palgrave
Macmillan, London
7. Lovelock, C; Wirtz, J. And Chatterjee, J. (2006), Services Marketing; People,
Technology, Strategy, Fifth Edition, Pearson Education, India
8. Kottler, P and Armstrong, G. (2002), Principles of Marketing, Ninth Edition, Pearson
Education, New Delhi
9. Wickham, P.A. (2006), Strategic Entrepreneurship, Fourth Edition, Prentice Hall,
England
10. Abrahams, R and Vallone, J. (2005), Business Plan in a Day; Get it Done Right – Get it
Done Fast, Prentice Hall, New delhi
11. Scarborough, N. M; Wilson, D. L and Zimmerer, T. W. (2009), Effective Small Business
Management; An Entrepreneurial Approach, Ninth Edition, Pearson Education, New
Jersey
12. Abraham, R. (2007), The owner’s Manual for Small Business, Prentice Hall, New Delhi
13. Piercy, N. F. (2007), Market Lead Strategic Change; A Guide to Transforming the
Process of Going to Markets, Ninth Edition, Butterworth Heinemann, Great Britain

156
Session 7: Prepare a Business Plan: Part 2

NTA Level 6, Semester 1, Module Code: MLT 06104 - Health Economics and
Entrepreneurship

Total Session Time: 120 minutes

Pre-requisites: None

Learning Objectives:

By the end of this session, students are expected to be able to:

1. Describe preparation of a Marketing plan
2. Describe the Management team and company structure
3. Describe the Operation and implementation plan
4. Describe the Product / Service Design and Development plan

 .

Step 2: Marketing plan (25 Minutes)

The marketing plan should be presented under the following headings:
 Overall marketing strategies
 7Ps for services (Product, Price, place, promotion, Processes, People and physical
evidences)

 4Ps for physical products (Product, Price, place, promotion)

Step 3: Management team and organogram

The management team of the organization should be presented in a manner that reflects the
reporting relationships as follows. It should indicate title of the position, duties and
responsibilities of the position, previous industry and related experiences, previous success
and education background.
 Board of Directors and / advisers
 Operations’ management team
 Chief Executive Officer / Managing Director
 Departmental directors
 Departmental managers
 Supervisors
 Operational staffs

Step 4: Operations and implementation plan

The operations’ implementation plan should reflect how the tasks can be carried out by
different sections. Thus it should cover the following items:
 Behind the stage operations
 Staff selection
 Relationship with suppliers
 Relationship with regulatory board / ies
 Succession plan and / emergency plan
 Human resources development approach

157
 Front stage operations
 Member tours
 Operation hours
 Staff assistance
 Fitness machines
 Workshops
 Reporting system / approach

Step 5: Product / Service Design and Development plan (25 minutes)

The tasks are highly linked with research findings. Thus, there must be concerns to refer to
the R & D department for reliable and valid tasks. The focus should be on the following items
 Development status and tasks
 Challenges and risks
 Intellectual property

Step 5: Financial plan The financial plan should be presented focusing at addressing the
following items:
 Sources and uses of funds statement
 Assumption sheet
 Pro-forma income statement
 Pro-forma balance sheets
 Pro-forma cash flows
 Ratio analysis
 Appendices

Step 6: Key Points (10 minutes)

 Entrepreneur
 Opportunity
 Entrepreneurship
 Entrepreneurial
 Entrepreneurial process
 Entrepreneurial venture
 Entrepreneurial orientation
 Professionalism
 Professional behavior
 Business plan
 Financial statement

Step 7: Evaluation (10 Minutes)

 ASK students to answer some questions focusing on the general coverage and key points
 While responding, compare their responses and confirm correct answers using notes

References:
1. Barringer, B.R. (2010), Entrepreneurship; Successfully Launching New Ventures, third
edition, Pearson Education, Boston
2. Deakins, D and Freel, M. (2003), Entrepreneurship and Small Firm, Fourth Edition,
McGraw Hill Education

158
3. Hisrich, R.D. (2004), Entrepreneurship, Fifth Edition, Tata McGraw - Hill Education,
New Delhi
4. Hisrich, R. D; Peters, M. P. and Shepherd, D. A. (2008), Entrepreneurship, Seventh
Edition, McGrawHill, Singapore
5. Scarborough, N. M. (2011), Essentials of Entrepreneurship and Small Business
Management, Sixth edition, Prentice Hall, New Jersey
6. Burns, P. (2007), Entrepreneurship and Small Business, Second Edition, Palgrave
Macmillan, London
7. Lovelock, C; Wirtz, J. And Chatterjee, J. (2006), Services Marketing; People,
Technology, Strategy, Fifth Edition, Pearson Education, India
8. Kottler, P and Armstrong, G. (2002), Principles of Marketing, Ninth Edition, Pearson
Education, New Delhi
9. Wickham, P.A. (2006), Strategic Entrepreneurship, Fourth Edition, Prentice Hall,
England
10. Abrahams, R and Vallone, J. (2005), Business Plan in a Day; Get it Done Right – Get it
Done Fast, Prentice Hall, New delhi
11. Scarborough, N. M; Wilson, D. L and Zimmerer, T. W. (2009), Effective Small Business
Management; An Entrepreneurial Approach, Ninth Edition, Pearson Education, New
Jersey
12. Abraham, R. (2007), The owner’s Manual for Small Business, Prentice Hall, New Delhi
13. Piercy, N. F. (2007), Market Lead Strategic Change; A Guide to Transforming the
Process of Going to Markets, Ninth Edition, Butterworth Heinemann, Great Britain

159
Session 8: Prepare a Business Plan: Part 3

NTA Level 6, Semester 1, Module Code: MLT 06104 - Health Economics and
Entrepreneurship

Total Session Time: 120 minutes

Pre-requisites: None

Learning Objectives:

By the end of this session, students are expected to be able to:

1. List sources and uses of funds statement
2. List assumptions that should be considered
3. Prepare pro-forma income statement of a business plan
4. Prepare pro-forma balance sheets of a business plan
5. Prepare pro-forma cash flows of a business plan
6. Describe how to apply ratio analysis
7. Prepare Financial projections

Step 2: Sources and uses of fund statement (10 Minutes)

 A facilitator should explain the possible sources of fund for health business, identify
potential cost elements (uses of fund) during the operations.

Step 3: List assumptions (5 minutes)

 The facilitator should list assumptions underpinning the financial projection so that the
evaluation by the funders should also be guided within the entrepreneur’s scope of plan /
thinking.

Step 4: Prepare pro-forma income statement

 Focus should be directed on the following items:
1. Sales projection (projected demand trend based on particular assumptions, pricing)
2. Estimating cost of sales:
a. Purchase
b. Transport
3. Operation expenses
4. Tax projection

Step 5: Pro-forma balance sheet

 The focus should be on the following classifications:

1. Assets
a. Fixed assets (Accumulated depreciation should be considered)
b. Current assets
2. Liabilities

Step 5: Pro-forma cash flow (20 Minutes)

160
 Activity: Organize the class in group of 5 or more students to brainstorm on the contents of
the pro-forma cash flow (10 minutes)
ASK students to summarize their responses and confirm correct answers using notes
below
 The case flow should be classified as follows:
1. Cash in flow
2. Cash out flow

Step 6: Ratio analysis (25 Minutes)

 This aims at testing the feasibility of the project. The facilitator should focus on ratios as
classified below:
 Profitability ratios
a. Return on asset
b. Return on capital / Equity
c. Profit margin
 Liquidity ratio
d. Current ratio
e. Quick ratio
 Overall financial stability ratio
f. Debt to equity ratio
 Current Ratio
 Return on asset
 Return on capital
 Return on investment

Step 7: Key Points (5 minutes)

 Entrepreneur
 Opportunity
 Entrepreneurship
 Entrepreneurial
 Entrepreneurial process
 Entrepreneurial venture
 Entrepreneurial orientation
 Professionalism
 Professional behavior
 Business plan
 Financial statement
 Ratio analysis

Step 8: Evaluation (5 Minutes)

 ASK students to answer some questions focusing on the general coverage and key points
 While responding, compare their responses and confirm correct answers using notes

References:
1. Barringer, B.R. (2010), Entrepreneurship; Successfully Launching New Ventures, third
edition, Pearson Education, Boston
2. Deakins, D and Freel, M. (2003), Entrepreneurship and Small Firm, Fourth Edition,
McGraw Hill Education

161
3. Hisrich, R.D. (2004), Entrepreneurship, Fifth Edition, Tata McGraw - Hill Education,
New Delhi
4. Hisrich, R. D; Peters, M. P. and Shepherd, D. A. (2008), Entrepreneurship, Seventh
Edition, McGrawHill, Singapore
5. Scarborough, N. M. (2011), Essentials of Entrepreneurship and Small Business
Management, Sixth edition, Prentice Hall, New Jersey
6. Burns, P. (2007), Entrepreneurship and Small Business, Second Edition, Palgrave
Macmillan, London
7. Lovelock, C; Wirtz, J. And Chatterjee, J. (2006), Services Marketing; People,
Technology, Strategy, Fifth Edition, Pearson Education, India
8. Kottler, P and Armstrong, G. (2002), Principles of Marketing, Ninth Edition, Pearson
Education, New Delhi
9. Wickham, P.A. (2006), Strategic Entrepreneurship, Fourth Edition, Prentice Hall,
England
10. Abrahams, R and Vallone, J. (2005), Business Plan in a Day; Get it Done Right – Get it
Done Fast, Prentice Hall, New delhi
11. Scarborough, N. M; Wilson, D. L and Zimmerer, T. W. (2009), Effective Small Business
Management; An Entrepreneurial Approach, Ninth Edition, Pearson Education, New
Jersey
12. Abraham, R. (2007), The owner’s Manual for Small Business, Prentice Hall, New Delhi
13. Piercy, N. F. (2007), Market Lead Strategic Change; A Guide to Transforming the
Process of Going to Markets, Ninth Edition, Butterworth Heinemann, Great Britain

162
Session 9: Introduction to health Economics

NTA Level: 6, Semester: I, Module: 4 Module Code: MLT 06104 Name: Health
Economics and Entrepreneurship

Total Session Time: 120 minutes

Pre-requisites: None

Learning Objectives:

By the end of this session, students are expected to be able to:

1. Understand the meaning of the following terms, economics, health economics, cost
effectiveness, cost efficiency and resources as used in health economics
2. Explain the branches of economics
3. Explain the relevance / importance of health economics to the health professionals
4. Explain the factors influencing health and health care services
5. Explain the economy, its working mechanisms and basic problems

 .

Step 2: The meaning of the terms; economics, cost effectiveness, cost efficiency and
resources as used in health economics (20 Minutes)
Activity: In class exercise: organize the class in group of 3 or 5 students to brainstorm on
the key terms in health economics and define them (10 minutes)
ASK the students to summarize their responses and confirm correct answers using notes
below
 Key terms
 Economics is a social being concerned with efficient use of the scarce resources to
achieve the maximum satisfaction of economic wants (Brue, 2002).
 According to Dwivedi (2006), economics is the study of how people allocate their
limited resources to their alternative uses to produce and consume goods and services
to satisfy their endless want or to maximize their gain.
 Cost effectiveness is the efficient use of the scarce resources.
 Cost effectiveness analysis is a type of economic evaluation that measures
therapeutic effects in physical or natural units and computes a cost / effectiveness
ratio for comparison purposes.
 Cost benefit analysis is the type of economic evaluation that measures costs and
benefits in monetary units and compute a net pecuniary gain / loss.
 Efficiency is the extent to which the program has converted / is expected to convert its
resources / inputs (such as funds, expertise, time, assets) economically into results to
achieve the maximum possible outputs, outcomes and impacts with the minimum
possible inputs
 Cost efficiency is the extent to which the program has converted / is expected to
achieve its results at lower costs compared with alternative.
 Resources are a source or supply from which the organizations gain profit. Typically,
resources are materials or other assets that are transformed to produce benefits and in
the process may be consumed or made unavailable. Resources have three main

163
 characteristics; first they should yield utility, limited availability and potential for
depletion or consumption.

Step 3: branches of economics (15 minutes)

 A major distinction is made between macroeconomics, which studies the functioning of
the economy as a whole, and microeconomics, which analyses the behavior of individual
components like industries, firms and households.
 Macroeconomics: The study of the behavior of the entire economy and concerned
with the behavior of the economy as a whole or with the broad aggregate of economic
life such as:
o National output,
o National income,
o The overall price level,
o Unemployment,
o Foreign trade.
 Economics plays two distinct roles in promoting the understanding of national
economic issues. First it helps to describe, explain and predict economic behavior-as
for example when it helps us understand the causes of poverty. But for many people
the pay-off from such economic knowledge comes when it is applied to a second task,
that of improving economic performances. This distinction between description and
prescription is central to modern economics.

 Microeconomics: Deals with the behavior of individual prices and quantities (Issues
at individual level). Our knowledge of economics helps us to manage our personal
lives, to understand society and to design better economic policies. The role of better
economic understanding in guiding our individual lives will be as varied as are our
personalities or physiognomies:
o Learning about the stock market or about interest rates may help people manage
their own finances better;
o Knowledge about price theory and antitrust policy may improve the skills of
lawyer;
o Better awareness of the determinants of cost and revenue will produce better
business decisions.
o The doctor, the investor and the farmer all need to understand about accounting
and regulation to make the highest profits from their businesses.

Step 4: The factors influencing health status (25 minutes)

In class exercise: Students should continue being in their formed group of 3 or 5 students
to brainstorm on the factors influencing health status (10 minutes).
ASK the students to summarize their responses and confirm correct answers using notes
below
The factors influencing health status are as follows:
 Health care availability
 Quality of health care
 Access to (quality) health care
 Expenditure on health care
 Technology
 Consumption pattern
 Life style (smoking, drugs, drinking and reckless driving)

164
 Preventive efforts
 Water and sanitation

Step 5: Five relevance / importance of health economics health professionals (20

minutes)
The relevance of health economics includes but not limited to the following:
 Helps in health and social welfare policy management
 Formulation
 Implementation
 Monitoring and evaluation
 Helps in managerial decision making with regards to resources allocation for enhanced
health and social welfare
 Rational decision
 Optimum decision
 Helps in project management for health and social welfare
 Design
 Implementation
 Monitoring and evaluation
 Helps in influencing problem solving at operational level
 Helps in strategic/PLANNED pricing mechanisms for health services
 Synergistic/DONOR partnering in public private context

Step 6: Economic tools to aid the analysis of health issues (25 minutes)

The microeconomic tools used in the analysis of health related issues are such as:

 The Production Possibilities Frontier / Production Possibilities Curve

 Demand and supply
 Marginal analysis
 Market structure

The Production Possibilities Frontier / Production Possibilities Curve

The PPF defines the current limit on production capabilities and possibilities in a given
economic situation of:
 Resources restraint including technology
Is a helpful theoretical tool that illustrate the idea of scarcity, opportunity cost and trade - offs
It represents the maximum output combinations that are achievable under the given resources
envelop.

Demand and supply

These forms the market forces, that is demand and supply are the main mechanisms for the
market to remain in equilibrium.
Demand shows the amount of goods / services that the customer is willing and able to
purchase at alternative prices. The law of demand is states that the higher the price of a goods
/ services, the low the quantity of goods / services demanded and vice versa.
 Demand entails:
 Demand function
 Demand schedule

165
  Demand curve
 Determinants of demand
 Consumer surplus / deficit
 Supply involves
 The supply function
 Supply schedule
 Supply curve
 Supply shifters
 Producer surplus / deficit
 Market equilibrium
 Price restrictions
 Comparative statics
Marginal Utility analysis – MU
 MU is the additional utility gained from one more unit of good / service consumed eg
health. TU usually rises with more consumption of goods / services, but it rises at
decreasing rate. While TU rises, MU decreases / declines. MU is the slop of TU. MU
analysis concept is an optimization tool / allocative tool. It answer the question that,
 “is it useful to add another unit in our consumption? In our production?
 What will an additional Doctor contribute in the production of service?
 It insists on resources being resources being allocated optimally, a state, which is reached
by equating the marginal value they contribute. Basically, where their marginal values are
positive, more resources can continue being employed / used on those goods. On the other
hand, where their marginal values are less / negative, resources are moved away

Market structure
 Market structure is the organizational features of an industry that influence the firm’s
behaviour in its choice of price and output. It is classified on the basis of the degree of
competition among the firms within the industry. The features of interest include number
of firms, distinctiveness of their product / services, the degree of control over the price of
their products / services and elasticity of demand.
 The type of market structure includes:
 Perfect competitive markets
 Monopoly markets
 Imperfect competitive markets
o Oligopolistic competition
o Monopolistic competition

Step 7: Key Points (5 minutes)

 Health economics
 Production efficiency
 Economy
 Economic growth
 Employment
 Productive resources
 Resources

Step 8: Evaluation (5 Minutes)

 ASK students to answer some questions focusing on the general coverage and key points
 While responding, compare their responses and confirm correct answers using notes

166
References:
1. Dwivedi, D.N (2006), Microeconomics Theory and Applications, Pearson Education,
New Delhi – India
2. Daniel, N. (1985), Just Health care, Cambridge University press, New York
3. Feldsetein, S. (2002), Health Care Economics Delmer Publisher, New York
4. William Jack (1999): Principle of Health Economics for Developing Countries,1st Ed.
WBI Development Studies the World Bank;
5. McConnel, C.R and Brue, S. (2002), Macroeconomics, McGraw – Hill Irwin, Fifteenth
edition, USA
6. McConnel, C.R and Brue, S L. (2002), Microeconomics, McGraw – Hill Irwin, Fifteenth
edition, USA
7. URT, (1999), The Health Sector Reform Program
8. www.tutor2u.net/business/gcse/finance
9. www.cartercenter.org/resources/pdf/health
10. www.eis.sfv.cuni.cz/en/syllab/JEM101

167
Session 10: Principles / theories of health economics

NTA Level: 6, Semester: I, Module: 4 Module Code: MLT 06104 Name: Health Economics
and Entrepreneurship

Total Session Time: 120 minutes

Pre-requisites: None

Learning Objectives:

By the end of this session, students are expected to be able to:

1. Describe the theory of demand
2. Explain the concept of market demand
1.1. Market demand schedule
1.2. Market demand curve
1.3. Factors influencing market demand

 .

Step 2: The theory of demand (50 Minutes)

The theory of demand

The theory of demand states that the higher the price of goods / services, the low the demand
and vice versa, other factors remaining constant. This indicates negative relationships
between price of goods / services and their relative demand.

Demand function
The theory of demand is presented in term of function. The term demand function refers to
the numerical presentation of the relationships between price of goods / services and their
relative demand.
ie. Qd = a - bx
Where Qd = Dependent variable ie. Quantity demanded
a = Vertical intercept ie. Constant term = 100
b = Slope of line ie. Coefficient of Price = 2
x = Independent variable ie. Price =P
Example of a demand function is: QD = 100 - 2P

Demand schedule
Demand schedule is a tabular representation of the relationships between the price of goods /
services and its relative demand. It represents the data in the demand function
Example of a demand schedule using the demand function Qd = 100 – 2P is as follows:
 Demand schedule is prepared using imaginary numbers that are inserted in
the corresponding cells in the table.
If Qd = 100 – 2P, then assuming the following variable imaginary number for P: 5, 10, 15
and 20
Table 1: Demand Schedule for the function: Qd = 100 – 2P
P 5 10 15 20
Dd 90 80 70 60

168
Demand curve
Demand curve is a graphical representation of the relationships between price of goods /
services and its relative demand. It reflects the function and the demand schedule data. For
example, the demand curve for the function Qd = 100 – 2P as presented in the demand
schedule above would look as presented below.

It
depicts the concept that the higher the price the low the demand and vice versa
Factors influencing demand; health management perspective
Factors influencing demand are wide but generally the following applies. The facilitator
should explain the factors influencing demand focusing at the following:
 Consumer preferences / tastes
 Number of buyers
 Own price
 Price of complementary goods
 Price of substitute goods
 Income of consumers
 Consumer expectations
 Weather and / season of the year
 Social cultural values
 Consumers’ literacy level
 Nature of goods / service
 Necessary / essential
 Luxury/ prestigious
 Inferior
 Normal goods
 Population in the target market

Why demand curve slop down to the right?

169
 Various factors are likely to cause the trend whereby demand curve slop down to the
right. Basically, it is because of the existing negative relationships between the price of
the services / goods and the relative demand for it.
 Some of the key aspects to be considered are:
 Income effect
 Substitution effects
 Expectation effect
 Diminishing marginal utility effect
 Exceptions to the law of demand

Why increasing demand for health care?

 Rising incomes; the role of elasticity
 Increasing aging population
 The role of health professionals
 The role of insurance
 Government tax subsidy effect
 Moral hazard problem
 Less prevention - Insured people are less careful / sensitive to their health taking
limited steps to prevent accidents / illness
 Over consumption - Insured people have greater incentive to use health care more
intensively than they would if they did not have insurance

Step 3: Market demand (40 Minutes)

 The concept of market demand refers to the summation of all individual demands in a
given time frame..
 For example of market demand for a firm with three buyers would be as follows:

Market demand for XYZ Company Limited with three buyers in Manzese Market –
20TH – 30th, 2012
Price per unit Quantity demanded Total demand at each
(Tshs) A B C price “∑(A+B+C)”
100 0 600 100 700
80 200 500 80 780
60 400 400 60 860
40 600 300 40 940
20 800 200 20 1020
0 1000 150 0 1150
Market Demand 5450

Step 4: Key Points (5 minutes)

 Health economics
 Individual demand
 Market demand
 Demand function
 Demand schedule
 Demand curve

Step 5: Evaluation (15 Minutes)

 ASK students to answer some questions focusing on the general coverage and key points

170
 While responding, compare their responses and confirm correct answers using notes

Reference
1. Dwivedi , D.N (2006), Microeconomics Theory and Applications, Pearson Education,
New Delhi – India
2. Daniel, N. (1985), Just Health care, Cambridge University press, New York
3. Feldsetein, S. (2002), Health Care Economics Delmer Publisher, New York
4. William Jack (1999): Principle of Health Economics for Developing Countries,1st Ed.
WBI Development Studies the World Bank;
5. McConnel, C.R and Brue, S. (2002), Macroeconomics, McGraw – Hill Irwin, Fifteenth
edition, USA
6. McConnel, C.R and Brue, S L. (2002), Microeconomics, McGraw – Hill Irwin, Fifteenth
edition, USA
7. URT, (1999), The Health Sector Reform Program
8. www.tutor2u.net/business/gcse/finance
9. www.cartercenter.org/resources/pdf/health
10. www.eis.sfv.cuni.cz/en/syllab/JEM101

171
Session 11: Principles / theories of health economics

NTA Level: 6: Semester: I, Module: 4 Module Code: MLT 06104 Name: Health Economics
and Entrepreneurship

Total Session Time: 120 minutes

Pre-requisites: None

Learning Objectives:

By the end of this session, students are expected to be able to:

1. Describe the theory of supply
2. Explain the concept of market supply
1.1. Market supply function
1.2. Market supply schedule
1.3. Market supply curve
1.4. Factors influencing market supply

Step 2: The theory of supply (50 Minutes)

The theory of supply
The theory of supply states that the higher the price of goods / services, the higher the supply
and vice versa, other factors remaining constant. This indicates positive relationships between
price of goods / services and their relative supply.

Supply function
The theory of supply is presented in term of function. The term supply function refers to the
numerical presentation of the relationships between price of goods / services and their
relative supply.
ie. Qs = a + bx
Where Qs = Dependent variable ie. Quantity supplied
a = Vertical intercept ie. Constant term = 100
b = Slope of line ie. Coefficient of Price = 2
x = Independent variable ie. Price =P
Example of a supply function is: Qs = 100 + 2P

Supply schedule
Supply schedule is a tabular representation of the relationships between the price of goods /
services and its relative supply. It represents the data in the supply function
Example of a supply schedule using the supply function Qs = 100 + 2P is as follows:
 Supply schedule is prepared using imaginary numbers that are inserted in
the corresponding cells in the table.
If Qs = 100 + 2P, then assuming the following variable imaginary number for P: 5, 10, 15
and 20
Table 1: Supply Schedule for the function: Qs = 100 + 2P
P 5 10 15 20
Dd 110 120 130 140

172
Supply curve
Supply curve is a graphical representation of the relationships between price of goods /
services and its relative supply. It reflects the supply function and the supply schedule data.
For example, the supply curves for the function Qs = 100 + 2P as presented in the supply
schedule above would look as presented below.

It depicts the concept that the higher the price the higher the supply and vice versa
Factors influencing supply; health management perspective
Factors influencing supply are wide but generally the following applies. Change in one or
more of these factors can result in change in the supply trend. The facilitator should explain
the factors influencing demand focusing at the following:
 Resources’ prices (Raw materials / inputs)
 Type of technology used (traditional technology Vs Modern technology)
 Number of buyers and their relative preferences
 Number of sellers
 Sellers’ expectation (future price)
 Tax rate and subsidy effect
 Price of complementary goods
 Price of substitute goods
 Income of consumers
 Consumer expectations
 Weather and / season of the year
 Social cultural values
 Consumers’ literacy level
 Nature of goods / service
 Necessary / essential
 Luxury/ prestigious
 Inferior
 Normal goods

Step 3: Market supply (40 Minutes)

173
 The concept of market supply refers to the summation of all individual supply in a given
time frame.
 For example of market supply for a firm with three buyers would be as follows:

Market supply for XYZ Company Limited with three buyers in Manzese Market – 20TH
– 30th, 2012
Price per unit Quantity supplied Total supply at each
(Tshs) A B C price “∑(A+B+C)”
100 0 600 100 700
80 200 500 80 780
60 400 400 60 860
40 600 300 40 940
20 800 200 20 1020
0 1000 150 0 1150
Market Supply 5450
Note that: For single company, the market supply at a give time frame should be equal to the
market demand other factors remaining constant.

Step 5: Key Points (10 minutes)

 Health economics
 Individual supply
 Market supply
 Supply function
 Supply schedule
 Supply curve

Step 6: Evaluation (10 Minutes)

 ASK students to answer some questions focusing on the general coverage and key points
 While responding, compare their responses and confirm correct answers using notes

References:
1. Dwivedi, D.N (2006), Microeconomics Theory and Applications, Pearson Education,
New Delhi – India
2. Daniel, N. (1985), Just Health care, Cambridge University press, New York
3. Feldsetein, S. (2002), Health Care Economics Delmer Publisher, New York
4. William Jack (1999): Principle of Health Economics for Developing Countries, 1st Ed.
WBI Development Studies the World Bank;
5. McConnel, C.R and Brue, S. (2002), Macroeconomics, McGraw – Hill Irwin, Fifteenth
edition, USA
6. McConnel, C.R and Brue, S L. (2002), Microeconomics, McGraw – Hill Irwin, Fifteenth
edition, USA
7. URT, (1999), The Health Sector Reform Program
8. www.tutor2u.net/business/gcse/finance
9. www.cartercenter.org/resources/pdf/health
10. www.eis.sfv.cuni.cz/en/syllab/JEM101

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Session 12: Principles / theories of health economics

NTA Level: 6, Semester: I, Module: 4: Module Code: MLT 06104 Name: Health
Economics and Entrepreneurship

Total Session Time: 120 minutes

Pre-requisites: None

Learning Objectives:

By the end of this session, students are expected to be able to:

1. Describe the concept of market Equilibrium

Step 2: Market equilibrium (5 Minutes)

Market equilibrium refers to a state at which the quantity of products / services supplied
attains an equal to the quantity of products / services demanded. Therefore: Market
equilibrium is
“Qs = Qd”
For example using if Qs = 40 + 2P and Qd = 100 – 4P
The supply and demand for the function: Qs = 40 + 2P and Qd = 100 – 4P
Assuming that the price “P” varied from 5, 10, 15 and 20, the supply and demand Schedule
would be as follows.
P 5 10 15 20
Qs = 40 + 2P 50 60 70 80
Qd=100 - 4P 80 60 40 20

Therefore, as depicted in the demand and supply curve above, the equilibrium is 60units
while the equilibrium price is 10. This is because at a price of 10, the quantity supplied and
the quantity supplied is equal (ie 60 units).
To determine market equilibrium using mathematical computation:

175
Market equilibrium curve
Market equilibrium curve is a graphical representation of the relationships between market
price of goods / services and its relative quantity supplied and demanded. Using the supply
function and demand function Qs = 40 +2P and Qd = 100 - 4P, the following supply and
demand schedule is produced and consequently its relative equilibrium curve.
P 5 10 15 20
Qs = 40 + 2P 50 60 70 80
Qd=100 - 4P 80 60 40 20

As a result of the above supply and demand schedule, the following equilibrium curve can be
produced

176
Step 3: Demonstration of the application of health economics in managing practical
challenges in health services (55 Minutes)
 ROLE PLAY: Facilitator should guide students on how they should demonstrate the use
of health economic skills in tackling health related practical challenging situation in a
way that can allow them to apply the skills gained in the session. While demonstrating, a
facilitator should observe the trend and note the displayed managerial skills reflecting the
application of health economics skills (if any). Also, a facilitator should ASK students to
observe the demonstrating group and record their observation findings for presentation
during the evaluation session after demonstration. Lastly, a facilitator should give reports
of their demonstration. Appropriate conducts (verbal and / non verbal) that reflect the
student’s entrepreneurial qualities must be commented.
 The facilitator should allocate each group member to a particular position, for example, to
attend a medical emergency, there may be the following positions to be assumed with
different demonstration roles:
 The students should present cases that can call for application of health economics skills
aiming at managing challenges associated with the following situations.
 Supply increase while demand decreasing
 Supply decrease while demand increasing
 Simultaneous increase in supply and demand
 Simultaneous decrease in supply and demand
In order to attain the best result, the following positions can be assumed.
 Customer group
 Employees (nurses, doctors, pharmacists, laboratory specialists)
 Management team

Step 5: Key Points (5 minutes)

 Health economics
 Market supply

177
 Market demand
 Market equilibrium

Step 6: Evaluation (15 Minutes)

 ASK students to answer some questions focusing on the general coverage and key points
 While responding, compare their responses and confirm correct answers using notes

References:
1. Dwivedi, D.N (2006), Microeconomics Theory and Applications, Pearson Education,
New Delhi – India
2. Daniel, N. (1985), Just Health care, Cambridge University press, New York
3. Feldsetein, S. (2002), Health Care Economics Delmer Publisher, New York
4. William Jack (1999): Principle of Health Economics for Developing Countries,1st Ed.
WBI Development Studies the World Bank;
5. McConnel, C.R and Brue, S. (2002), Macroeconomics, McGraw – Hill Irwin, Fifteenth
edition, USA
6. McConnel, C.R and Brue, S L. (2002), Microeconomics, McGraw – Hill Irwin, Fifteenth
edition, USA
7. URT, (1999), The Health Sector Reform Program
8. www.tutor2u.net/business/gcse/finance
9. www.cartercenter.org/resources/pdf/health
10. www.eis.sfv.cuni.cz/en/syllab/JEM101

178
Session 13: Elasticities of Demand and Supply

NTA Level: 6, Semester: I, Module: 4: Module Code: MLT 06104: Name: Health
Economics and Entrepreneurship

Total Session Time: 120 minutes

Pre-requisites: None

Learning Objectives:

By the end of this session, students are expected to be able to:

1. Explain the concept of price elasticity of demand
2. Explain the concept of price elasticity of supply
1.1. Define
1.2. Determinant of price elasticity of supply
3. Demonstrate the application of the concept of elasticity in health economics

Step 2: The concept of price elasticity of demand (30 Minutes)

The term elasticity of demand measures the degree of responsiveness of demand for a
commodity to the change in any of the factors influencing demand. Thus, price elasticity of
demand refers to the measurement of the degree of of responsiveness of demand of a
commodity to the change in price. It is also defined as the percentage change in the quantity
demanded of a commodity as a result of a percentage change in its price. Note that, Negative
sign is ignored

For example, the demand for a given product is 200 units at a price of 600 per unit. When the
price changed to 900 per unit, the demand went as low as 120 units. You are required to
calculate the price elasticity of demand.

179
Interpretation criteria:
ep > 1 = Elastic
ep = 1 = Unitary elastic
ep < 1 = Inelastic
Therefore, given that the ep is 0.8, the demand for the product is inelastic because its
calculated ep is less than 1. This could be a necessary good whereby its consumption can not
be postponed, example health services, food etc.
******It is important that the facilitator discuss further by predicting the types of products
that are likely to respond in this manner and give examples.****************

Determinants of price elasticity of demand

The price elasticity of demand can be influenced by various factors. The facilitator should
explain the influences of price elasticity of demand focusing on the following factors.
1. Availability of substitutes
2. Nature of the commodity
3. Proportion of income to be spend by the customer
4. Time factor
5. Range of alternative uses of a commodity
6. The proportion of market supplied
7. Direction of change in price

Uses of elasticity concept

The concept of price elasticity is useful in health economic in the following ways:
1. Helps in guiding the pricing strategies with the view of maximizing / making large
profit
2. It is useful in health economic analysis, at least for specifying the relationships
between the dependent and independent variables in applied research.
3. It is useful for policy management, especially with regard to taxation policies
a. Raising revenue,
b. Controlling price
c. Granting subsidy to the industries
d. Determining price for the public utilities etc

Step 3: The concept of price elasticity of supply (20 Minutes)

Activity: In class exercise: organize the class in group of 3 or 5 students to brainstorm on
the concept of price elasticity of supply (10 minutes)

180
 ASK the students to summarize their responses and confirm correct answers using notes
below

Price elasticity of supply refers to the measurement of the degree of responsiveness of

quantity supplied of a commodity to the change in it market price. It is also defined as the
percentage change in the quantity supplied of a commodity as a result of a percentage change
in its price

For example, the supply for a given product is 200 units at a price of 600 per unit. When the
price changed to 900 per unit, the supply went as high as 400 units. You are required to
calculate the price elasticity of supply.

Therefore, given that the ep is 2, the supply for the product is elastic because its calculated ep
is great than 1. This could be a luxury good whereby its consumption can be postponed,
example alcohol, gold etc.

181
******It is important that the facilitator discuss further by predicting the types of products
that are likely to respond in this manner and give examples. ****************

Step4: Demonstrate the application of the concept of elasticity in health economics

Activity: In class exercise: organize the class in group of 3 or 5 students to demonstrate on
the application of the concept of elasticity in health services (10 minutes)
ASK the students to summarize their responses and confirm correct answers using notes
below
ROLE PLAY: Facilitator should guide students on how they should demonstrate the use of
health economic skills in tackling health related practical challenging situation in a way that
can allow them to apply the skills gained in the session. While demonstrating, a facilitator
should observe the trend and note the displayed managerial skills reflecting the application of
health economics skills (if any). Also, a facilitator should ASK students to observe the
demonstrating group and record their observation findings for presentation during the
evaluation session after demonstration. Lastly, a facilitator should give reports of their
demonstration. Appropriate acts that reflect the student’s application of health economic
concepts must be commented.
The students should present cases that can call for application of health economics skills
aiming at managing challenges associated with the following situations.
1. Supply increase while demand decreasing
2. Supply decrease while demand increasing
3. Simultaneous increase in supply and demand
4. Simultaneous decrease in supply and demand
In order to attain the best result, the following positions can be assumed.
1. Customer group seeking health services
2. Employees (nurses, doctors, pharmacists, laboratory specialists) – health
services provider
3. Management team for decision making / approving suggestions

Step 5: Key Points (5 minutes)

 Health economics
 Market supply
 Market demand
 Elasticity

Step 6: Evaluation (15 Minutes)

 ASK students to answer some questions focusing on the general coverage and key points
 While responding, compare their responses and confirm correct answers using notes

References:
1. Dwivedi, D.N (2006), Microeconomics Theory and Applications, Pearson Education,
New Delhi – India
2. Daniel, N. (1985), Just Health care, Cambridge University press, New York
3. Feldsetein, S. (2002), Health Care Economics Delmer Publisher, New York
4. William Jack (1999): Principle of Health Economics for Developing Countries,1st Ed.
WBI Development Studies the World Bank;
5. McConnel, C.R and Brue, S. (2002), Macroeconomics, McGraw – Hill Irwin, Fifteenth
edition, USA
6. McConnel, C.R and Brue, S L. (2002), Microeconomics, McGraw – Hill Irwin, Fifteenth
edition, USA

182
7. URT, (1999), The Health Sector Reform Program
8. www.tutor2u.net/business/gcse/finance
9. www.cartercenter.org/resources/pdf/health
10. www.eis.sfv.cuni.cz/en/syllab/JEM101

183
Session 14: Health financing

NTA Level: 6, Semester: I, Module: 4: Module Code: MLT 06104: Name: Health
Economics and Entrepreneurship

Total Session Time: 120 minutes

Pre-requisites: None

Learning Objectives:

By the end of this session, students are expected to be able to:

1. Define the term health financing
2. Understand different sources of financing health services secto
3. Identify factors that influence the choice of health financing system
4. Determine the strength and weakness of different financing mechanisms

Step 2: Financing and health systems financing (25 Minutes)

Financing is the process of raising revenue to pay for goods / services.
Health system financing is the whole process of mobilizing, accumulating and allocating
money to cover the health needs of the people, individually and collectively, in the health
system.
From the above definition, the whole process of health care financing involves the following
key points:
1. Where the money came from?
2. How was it collected?
3. How was it pooled?
4. How was it distributed to the third party payer?
5. How was it used to pay the providers for their services?

Step 3: Sources of financing health services sector (25 Minutes)

Health care and financing is a broader term used to define alternative arrangements for
paying, allocating, organizing and managing health resources. It include therefore:
 Defining a level / quality of care preferably a minimum basic health services package to
be provided in an accessible and equitable manner.
 Identify different modalities of financing to establish a financially sustainable system.
 Institute different mechanisms to mobilize fund and rationalizing the use of available
resources including cost and risk sharing mechanisms / insurance plans.
The main sources of health financing are grouped into two main sources:
 Public sources
 Direct government budgeting
 National health services
 Public health services and public health services
 Social health insurance
 Community financing
 Private sources
 Direct payment by households
 Private voluntary health insurance eg AAR, strategies, Medex
 Employers based health insurance

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  Payments by community and other local organizations

Step 4: Factors that influence the choice of health financing system (25 minutes)
There is an increasing interest on how health services are funded both in industrialized and
developing countries. The following factors among others influence a health services sector
and should be given attention in health care financing.
1. Demographic changes
These have major effects on health care provision due to the following reasons;
 Demographic change may lead to variations in the health coverage of the population.
Rapid population growth rates can cause tremendous strains on the provision of social
services including health care.
 The age structure of the population has an important significance to the provision of
health care. There are higher health service unit costs associated with the young and the
old. The antenatal, obstetric and under five age groups are all relatively heavy users of
health care, as are the elderly with their higher incidence rate of chronic illness.
 Demographic factor relates to the relationship between economic producers and
dependants of a country. High dependent ratio means an increased burden on the
productive population for providing health care.
2. Economic recession
 This can be expressed by low or even negative growth rates, increasing debt burdens and
high inflation rates. This has severe implications for the ability of governments to
maintain, let alone expand, expenditure on health care. Such effects on the supply of
health care are exacerbated by the increased need for health care brought about by the
recession itself through the links between poverty and ill health.
3. Rising expectation
 Expectation of health care consumers specially, the middle classes, to receive high
technology medical care similar to that available in the industrialized world.
4. Equity
 Equity is frequently defined asan expression of social justice. It has to do fundamentally
with a fair distribution of benefits from health and social development; it goes beyond
equality of access to health care. It calls for responses that are in accord with the needs of
the individuals in relation to the needs for all. From these explanations, equity can be
defined in the following ways:
 Equal resources expended for each individual
 Equal resources expended for each case of a particular condition
 Equal access to health services
 Equal quality of health care
 Equal status of health for all
 Equal healthy life gained per shilling / dollar expended
 Care according to needs
 The concerns for equity may influence the choice and system of financing health care. To
extend and improve basic health care at a time when there is such strong middle class
pressure may only be available by providing substantial additional resources to the health
sector.
5. Diseases pattern changes
 Disease-pattern change may result due to changes in average income levels or due to
changes in social development. Thus, In addition to shifts in disease patterns, the
advances of medical technology have led to the possibility of treatment for health
problems previously accepted as untreatable. This again places further pressures on
health-care providers.

185
6. Efficiency
 Given the limited resources available for health in developing countries, it is essential to
taste and use resources as efficiently as possible.
7. Displacement effects
 Rather than generating additional resources for the health sector, new or expanded
financing mechanisms may merely displace funding from other sources. Examples of
displacement effects include:
 Foreign assistance government support for health care;
 Counter-funding often a precondition for foreign assistance, which may divert funds
away from existing priority projects;
 Health insurance schemes, which may in some instances displace earth than additional
to the total of resources being allocated to health care (e.g. displacing direct
payments);
 Charitable contributions which may be withdrawn when other sources are developed
and
 Government allocations, which may be reduced when other sources of finance (such
as user fees) are developed.

Step 5: Criteria for choosing source of health financing system (25 minutes)
 In selecting a system of financing health care some criteria should be used. Below are
some of the criteria that can be used.
 Viability and ease of using the system
o This implies bureaucratic and cost simplicity, social acceptability ad technical
feasibility
 Revenue generating ability
o Net revenue minus earning ability = Revenue minus operating costs. The
administration of user-changes for example, may include the costs of billing,
accounting and the safe storage and collection of funds. Even where additional
staff is not employed and existing staff are used, it implies an opportunity cost to
the health service in terms of alternative activities which the staff could have been
engaged in had they not been involved in the revenue generating scheme.
 Effects on service – provision
o Systems of financing, for example, which involve three parties – the patient the
provider and an insurance company – may lead to over-provision of certain
services.
 Effects on equity
o That is equal access to care for these in equal needs

Step 6: Key Points (5 minutes)

 Health economics
 Financing
 Health financing
 Health systems

Step 7: Evaluation (15 Minutes)

 ASK students to answer some questions focusing on the general coverage and key points
 While responding, compare their responses and confirm correct answers using notes

References:

186
1. Dwivedi , D.N (2006), Microeconomics Theory and Applications, Pearson Education,
New Delhi – India
2. Daniel, N. (1985), Just Health care, Cambridge University press, New York
3. Feldsetein, S. (2002), Health Care Economics Delmer Publisher, New York
4. William Jack (1999): Principle of Health Economics for Developing Countries,1st Ed.
WBI Development Studies the World Bank;
5. McConnel, C.R and Brue, S. (2002), Macroeconomics, McGraw – Hill Irwin, Fifteenth
edition, USA
6. McConnel, C.R and Brue, S L. (2002), Microeconomics, McGraw – Hill Irwin, Fifteenth
edition, USA
7. URT, (1999), The Health Sector Reform Program
8. www.tutor2u.net/business/gcse/finance
9. www.cartercenter.org/resources/pdf/health
10. www.eis.sfv.cuni.cz/en/syllab/JEM101

187
Session 15: Introduction to Business Finance

NTA Level: 6, Semester: I, Module: 4 Module Code: MLT 06104Name: Health Economics
and Entrepreneurship

Total Session Time: 120 minutes

Pre-requisites: None

Learning Objectives:

By the end of this session, students are expected to be able to:

1. Define the terms finance, profit, loss, gross profit and double entry.
2. Understand the classification of business cost
3. Calculate expenses according to their variability
4. Calculate gross profit from business
5. Compute Net profit (loss) before income taxes
6. Compute Net profit (loss) after income tax
7. Keep records and analyze the profit trend

Step 2: Definition of terms (finance, profit, loss, gross profit and double entry) (15
Minutes)
Finance is defined the science of the management of money and other assets. It is the supply
of money or capital, the management of money, banking, investments, and credit.
Profit - in accounting perspectives, profit means the amount by which revenue is great than
expenses for a set of transaction. That is
“Profit (P) = Total Revenues (TR - Total Costs (TC)” should result in positive
figures.
P = TR – TC = +VE
For example; if the sales (revenue) is Tshs 1000/= and the costs related to the selling process
are Tshs. 600/=;
Then Profit = 1000 – 600 = 400/=
This means that Tshs 400/= was the amount raised in excess of the costs allocated to finance
the selling process.

Loss – Similarly, in accounting terms, loss means the amount by which revenue are less than
expenses for a set of transaction. That is
“Profit (P) = Total Revenues (TR - Total Costs (TC)” result in negative figures
P = TR – TC = - VE
For example; if the sales (revenue) is Tshs 2000/= and the costs related to the selling process
are Tshs.2 600/=;
Then Profit /Loss = 2000 – 2600 = - 400/=
This means that Tshs - 400/= was the amount lost in deficit of recouping at least the actual
costs allocated to finance the selling process.

Gross profit is the excess of sales over the costs of goods / services sold in a given period.
The term costs of sales include; purchase costs, transport costs and all other costs incurred in
the process of making the goods / service available for sale the point of sale.Thus,
“Sales – Costs of Goods Sold = Gross Profit”

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Double entry A double-entry bookkeeping system is a set of rules for recording financial
information in a financial accounting system in which every transaction or event changes at
least two different nominal ledger accounts. In the double-entry accounting system, each
accounting entry records related pairs of financial transactions for asset, liability, income,
expense, or capital accounts. The process of recording of a debit amount to one account and
an equal credit amount to another account, results in total debits being equal to total credits
for all accounts in the general ledger. If the accounting entries are recorded without error, the
aggregate balance of all accounts having positive balances will be equal to the aggregate
balance of all accounts having negative balances. Accounting entries that debit and credit
related accounts typically include the same date and identifying code in both accounts, so that
in case of error, each debit and credit can be traced back to a journal and transaction source
document, thus preserving an audit trail.

Step 3: classification of business cost (15 Minutes)

Activity: In class exercise: organize the class in group of 3 or 5 students to brainstorm on
the classification of business costs (10 minutes)
ASK the students to summarize their responses and confirm correct answers using notes
below
Classification of cost means, the grouping of cost according to their common characteristics.
The important ways of classifying costs are:
1. By nature or element (material, labour, expenses)
2. By functions (production, selling, distribution, administration, R & D and
development)
3. By traceability (direct or indirect)
4. By variability (fixed, variable or semi - variable)
5. By controllability (controllable, uncontrollable)
6. By normality(normal, abnormal cost)
For the interest of classifying cost with the view of facilitating the students to understand the
cost classification for health management, the focus is put on the classification on the bases
of their variability namely variable costs and fixed costs.
Variable costs are cost that varies in relation to change in volume of production of goods /
services. They includes cost of labour, material or overhead that changes according to the
change in the volume of production units services. The combination of fixed costs and
variable costs make up the total cost of production / services delivery, examples of variable
costs are such as cost of reagents, supply and other raw materials.

Fixed costs are costs that do not vary in relation to change in volume of production of goods /
services. The total fixed costs, stays the same, examples of fixed costs are such as building
cost, machinery costs.

Step 4: Calculate expenses according to their variability (15 minutes)

In any operations, some expenses will remain constant whether activities increases or falls at
least within a given range of change of activities. These expenses are called fixed expenses.
An example of this would be the rent of shop which would remain at the same figure whether
sales increases or decreases at least in a short run. Of course, such fixed expenses can only be
viewed as fixed in short run. If sales double, then the operation might well need large or more
assistants. A large shop also would mean higher rate, higher fire insurance and so on, and
with more assistants, the total wage bill would be large.

189
Fixed Costs
No. of Bs test Total Fixed costs (Tshs)
50 50000
100 50000
150 50000
200 50000
250 50000
300 50000

Variable expenses on the other hand, will change with swing in activity, suppose that,
wrapping materials are used in the shop, then it could well be that, an increase of the sales by
10% may see 10% of more wrapping material being used. Some expenses could be partly
fixed partly variable

Variable Costs
No. of Bs test Cost per test (Tshs) Total Variable costs (Tshs)
50 1000 50000
100 1000 100000
150 1000 150000
200 1000 200000
250 1000 250000
300 1000 300000

Total Costs
Total cost is the sum of Total variable costs plus total fixed cost as indicated in the table
below:
No. of Bs test Total Variable costs (Tshs) Total Fixed Costs Total Costs
50 50000 50000 100000
100 100000 50000 150000
150 150000 50000 200000
200 200000 50000 250000
250 250000 50000 300000

Step 5: Calculation of gross profit from business (15 minutes)

Activity: In class exercise: organize the class in group of 3 or 5 students to brainstorm on
the demonstration of the calculation of gross profit from the business (10 minutes)
ASK the students to summarize their responses and confirm correct answers using notes
below
In order to calculate the gross profit, reference need to be made in the trading account that
shows the income from the sales and the direct costs of making those sales. It includes the
balance of stock at the start and end of the period of those particular sales. An example of the
trading account of the business would look as follows.
i.e.: Gross Profit = Revenue – Cost of sales

Note: Cost of sales = opening stock plus purchases less closing stock

Trading Profit and loss Account for XYZ for the year ended 3oth April, 2012.
Descriptions DR (Tshs) CR (Tshs)
Sales 1,200,000

190
 Less: Opening stock “Plus” 150,000
Purchase 400,000
Stock available for sale 550,000
Less: Closing stock (220,000)
Cost of sales (deduct them from the sales figure) –add (330,000)
other costs
Other Costs (transportation costs and other direct costs) (70,000)
Gross Profit 800,000

Step 6: Compute net income before tax from business (15 minutes)
Activity: In class exercise: organize the class in group of 3 or 5 students to brainstorm on
the demonstration of the calculation of net profit from the business (10 minutes)
ASK the students to summarize their responses and confirm correct answers using notes
below
The net profit is obtained by deducting operation expenses from the gross profit as
demonstrated below, based on the details in the Trading Profit and loss Account for XYZ for
the year ended 30th April 2012 above. In order to obtain net profit we are required to less
operation expenses from the gross profit.
i.e. “Net Profit = Gross Profit – Operation Expenses”
Trading Profit and loss Account for XYZ for the year ended 30th April 2012.
Descriptions DR (Tshs) CR (Tshs)
Sales 1,200,000
Less: Opening stock of reagents and supplies 150,000
Purchase of reagents and supplies 400,000
Stock available for sale 550000
Less: Closing stock 220,000
Cost of sales 330000
Gross Profit C / f 800000
1200000 1200000
Gross profit b / f 800000
Less: Operation Expenses;
Wages 100000
Electricity and water 20000
Rent 50000
Administration expenses 80000
Transport 85000
Bank charges 15000
Net profit before tax c / f 4500,000
800000 800000
Net profit before tax b / f 450000
Less: Corporate tax (30%) 135000
Net profit after tax 315000
450000 450000

Step 7: Compute Net profit (loss) after income tax (10 Minutes)
Net profit is determined as a result of profit before tax less corporate income tax at 30%.
More details are indicated instep 5 above.
Net profit before tax b / f 450000
Less: Corporate tax (30%) 135000

191
 Net profit after tax 315000
450000 450000

Step 8: Keep records and analyze the profit trend (20 minutes)
In order to be able to determine a business profitability / performance, a business firm must
maintain proper books of accounts. It’s from these records where financial transactions can
be extracted in form of source documents, ledger accounts, trial balance, trading, profit and
loss, cash flow and the balance sheet. In such context, where the firm maintains positive
figure as net profit we assume that its performance is good and vice versa.

Step 10: Key Points (5 minutes)

 Finance
 Profitability
 Profit
 Variable cost
 Fixed costs
 Loss
 Total costs

Step 11: Evaluation (10 Minutes)

 ASK students to answer some questions focusing on the general coverage and key points
 While responding, compare their responses and confirm correct answers using notes

References:
1. Stephen A.R, Rondolph. W.W and Bradford D.J (2001), Essentials of Corporate Finance,
3rd edition, McGraw-Hill Irwin, New York, USA
2. Buckley, A., Ross, S. A., Westerfield, R. W. and Jaffe, J. F. (1998), Corporate Finance
Europe,
3. European edition, London: McGraw-Hill Publishing Company.
4. Crowther, D. (2004), Managing Finance – A socially Responsible Approach, 1st edition,
Boston:
5. Elsevier Butterworth-Heinmann.
6. Young, J. F. (1982), Decision-making for Small Business Management, 2nd edition,
Florida,
7. Robert E. Krieger Publishing Company.
8. www.tutor2u.net/business/gcse/finance
9. www.cartercenter.org/resources/pdf/health
10. http://www.answers.com/topic/finance#ixzz1tfrwr9ux
11. www.eis.sfv.cuni.cz/en/syllab/JEM101
13. http://www.investorwords.com/5221/variable_cost.html#ixzz1tEJTK4Fm

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Chapter Five

Module Code MLT06105: Laboratory Ethics and Professional Code of

Conduct

193
Session 1: Describe legal regulations governing the provision of health
services (non-laboratory)

NTA LEVEL 6, SEMESTER 1, MODULE CODE: MLT 06105 - LABORATORY

ETHICS AND PROFESSIONAL CODE OF CONDUCT

Total Session Time: 120 minutes

Pre-requisites: Module Codes:

 MLT04104: Health Ethics and Professional Code of Conduct
 MLT05101: Laboratory Ethics and Professionalism

Learning Objectives:

By the end of this session, students are expected to be able to:

1. Define Legal Act and Regulatory body.
2. List at least five non-laboratory legal regulatory Acts and their related bodies that govern
the provision of health services in Tanzania.
3. Describe major functions of at least four non-laboratory regulatory bodies that govern the
provision of health services in Tanzania.

Step 2: Definition of terms (15 minutes)

 Legal Act: A bill, which has passed through, the various legislative steps required for it
and which has become a law.
 Regulatory body: Government body formed or mandated under the terms of a legislative
Act to ensure a compliance with the provisions of the Act and in carrying out its purpose.
Also known as regulatory authority body

NB: Regulatory bodies exercise regulatory functions that are imposing requirements,
restrictions and conditions, setting standards in relation to any activity, and securing
compliance, or enforcement. They cover a wide variety of professionals, for example Medical
Council of Tanganyika (Registers Doctors to Dentists in Tanzania)

Step 3: Non-laboratory legal regulatory Acts and/or their related bodies that govern the
provision of health services in Tanzania (30 minutes).
 The tutor should list various regulatory bodies that govern provision of health services in
Tanzania as follows;
 The Medical Practitioner and Dentists Act CAP 152
 Medical Council of Tanganyika
 The Nurses and Midwives Registration Act, 1997
 The Nurses and midwives Council
 The Pharmacy Act of 2011
 The Pharmacy Council
 Traditional and Alternative Medicines Act Cap 244
 Traditional and Alternative Health Practice Council (TAHPC)
 The Medical Radiology and Imaging Professions Act (TMRIPA)

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  Medical Radiology and Imaging Professions Council
 The Environmental Health Practitioners Regulation Act CAP 428
 The Environmental Health Practitioners Regulation
 Private Hospitals Regulations Act
 Private Hospitals Advisory Board (PHAB)

Step 4: Major functions of regulatory bodies that govern the provision of health services
in Tanzania ( 45 minutes)
 The Medical Council of Tanganyika (ref. The Medical Practitioners and Dentists Act,
1959 or the most current edition)
 To cause to be kept and maintained registers of medical practitioners and dentists
 To cause to be published in the Gazette next following the date of registration, or as soon
as conveniently may be thereafter, the name, address and registered qualifications of each
medical practitioner and dentist duly registered.
 To direct, should it think fit, the restoration to the register, with or without payment of
further fees, of the name of any person previously erased from the register by direction of
the Council.
 To administer a caution to, or censure, or order the suspension from practice or direct the
erasure from the register of the name of any medical practitioner or dentist convicted of
any felony or misdemeanor or who after due inquiry by the Council is deemed by it to
have been guilty or infamous conduct in any professional respect.
 To decide which medical diplomas and which diplomas in dentistry may be recognized
for the time being by the Council as furnishing a sufficient guarantee that the holder
possesses the requisite knowledge and skill for the efficient practice in medicine, surgery
and midwifery or for the practice in dentistry.
 To approve hospitals or other institutions and posts therein for the purpose of enabling
persons provisionally registered under this Act to obtain the experience necessary to
enable them to be registered.

 The Nurses and Midwives Council (ref. The Nurses and Midwives Registration Act
1997)
 Advices the Minister on matters concerning nursing and midwifery and make
recommendations on policy matters and gives directions and approves performance
procedures.
 Scrutinize, regulate, approve, monitor and evaluate the implementation of curricular
of the nursing education.
 Grant approval of examiners for final examinations, and fix the place where and the
times at which such examinations shall be held.
 Moderate, approve and publish results of the final nursing/midwifery examinations;
 Publish annually in the official Gazette as soon as practicable in the year and on such
other occasions as it may deem fit, the names and particulars of nurses and midwives
contained in the register and roll, issue and cancel licenses.
 Make entry of and amend any particulars thereon and to replace my license proved to
have been lost or destroyed.
 Prescribe standards and conditions for establishing new schools of nursing or
midwifery, which does not maintain the prescribed standards and conditions.
 Keep and maintain a register of schools of nursing/midwives.
 Caution, censure and order the suspension or closure of schools of nursing or
midwifery which does not maintain the prescribed standards and conditions;

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  Prescribe the form of professional oath/pledge to be used or administered upon all
nurses on successful to completion of their training.
 Caution, censure, order the suspension from practice or order the removal from the
register or roll of the name of any registered or enrolled nurse or midwife for
malpractice, negligence or infamous conduct in any obeying any professional
respective or for disobeying any regulation or directive made under the Act and to
decide upon the determination of any period of suspension and restoration to the
register of any name so removed.
 The Pharmacy Council (ref The Pharmacy Act, 2011);
 The sole authority for registering, enrolling and listing of Pharmacists, Pharmaceutical
technicians and Pharmaceutical assistants, respectively.
 Advise the Minister on the matter relating to Pharmacy practice.
 Safeguard and promote the provision of pharmaceutical services in compliance to the
norms and values in both private and public sectors, with goals of achieving definite
therapeutic outcomes for the health and quality of life of a client.
 Uphold and safeguard the acceptable standards of Pharmacy practice in both public
and private sectors
 Establish, develop, maintain and control acceptable standards.
 Regulate standards and practices of Pharmacy professions.
 Enquire into any query relating to a pharmacy practice raised by the public.
 Traditional and Alternative Health Practice Council (TAHPC)
 The main functions of the Council shall be;
o To monitor, regulate, promote, support the development of traditional medicine
and to implement the provision of the Act and in particular;
o To supervise and control the practice of traditional and alternative health
practitioners
o To publish newly registered practitioners and other necessary issues
o To promote the practice of traditional and alternative health practitioners
o To register and enroll persons who fulfill the requirements
o To register and regulate the traditional and alternative health delivery facilities
o To protect the society from abuse of traditional and alternative health practitioner
and research on human beings
o To control the dissemination of information and all advertisement pertaining
traditional and alternative medicine
o To regulate and set standards, where possible, for traditional and alternative health
material remedies and practices
o To provide for protection of Tanzanian medicinal plants, and other natural
resources of medicinal value, such as animals, minerals, aquatic and marine
products including their parts thereof.
o The Council shall maintain a system of consultation and co-operation with other
institutions or bodies and the Authority responsible for food, drugs and medical
devices on matters relating to herbal medicine.
o The bodies or institutions concerned in no. 2 above, may enter into agreement for
the purpose of implementing functions or objectives, and that the signed
memorandum shall have the force of Law.
o The Council when performing its duties under this Act, particularly when issuing
instructions or directions in connections to the matters pertaining quality, efficacy
and safety in herbal medicine and herbal drugs, shall consult first with other
institutions or bodies and whose functions are related or similar to those
specified under the Act

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 Medical Radiology and Imaging Professions Council
 Sole Authority for Registering, enrolling and enlisting of Medical Radiology and
Imaging Professionals
 Regulate and set standards of conduct and activities of Medical Radiology and
Imaging Professionals.
 Evaluate academic and practical qualifications of Medical Radiology and Imaging
Professionals for the purpose of registering under the Act.
 Remove any name from the Register Roll or List subject to such conditions as the
Council may impose.
 Approve Institutions and Curricula for training Medical Radiology and Imaging
Professionals.
 The Environmental Health Practitioners Regulation Act
 Advice the Minister on issues pertaining to Environmental Health.
 Issue and cancel Registration Certificates.
 Make, issue, promote and oversee adherence to a code of conduct and where
necessary to exercise disciplinary measures.
 Publish annually as soon as practicable in the year and on such other occasions as it
may deem fit, the names and particulars of Environmental Practitioners contained in
the register.

Step 5: Key Points (10 minutes)

 Regulatory bodies exercise regulatory functions that are imposing requirements,
restrictions and conditions, setting standards in relation to any activity, and securing
compliance, or enforcement.
 Regulatory bodies advise the Minister on issues pertaining to the Act to ensure a
compliance with the provisions of and in carrying out its purpose.
 Oversee adherence to Ethics and Code of Professional Conduct; and where necessary to
exercise disciplinary measures.

Step 6: Evaluation (10 minutes)

 ASK the students to:
 Define the terms Legal Act and Regulatory body.
 List at least five non-laboratory legal regulatory Acts and their related bodies that
govern the provision of health services in Tanzania
 ASK students if they have any comments or need clarification on any points.

References:
1. Medical and Dentistry Practitioners Act Cap 152
2. Nurses and Midwifery Act, 1997
3. The Pharmacy Act, 2011
4. Traditional and Alternative Medicines Act Cap 244
5. The Medical Radiology and Imaging Professions Act (TMRIPA) No. 21 of 2007
6. The Environmental Health Practitioners Regulation Act Cap 428

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Session 2: Describe legal regulations governing the provision of health
laboratory services

NTA LEVEL 6, SEMESTER 1, MODULE CODE: MLT 06105 - LABORATORY ETHICS AND
PROFESSIONAL CODE OF CONDUCT

Total Session Time: 120 minutes

Pre-requisites: Module Code:

 MLT04104: Professional Ethics
 MLT0510: Laboratory Ethics and Professionalism.

Learning Objectives

By the end of this session, students are expected to be able to:

1. Define the following terms: Health Laboratory Practitioner, Health laboratory Scientists,
Health Laboratory Technologist, Health Laboratory Assistant, Pathologist, Approved
person, Private Laboratory service.
2. List legislature Acts governing health laboratory services governing health laboratory
services.
3. List regulatory authorities governing health laboratory services.
4. Explain responsibility of each regulatory authority.
5. Explain the legal requirement in regard to laboratory ethics and professional code of
conduct.

Step 2: Definition of terms (15 minutes)

 Health Laboratory practitioner

 Includes a health laboratory scientist, Health laboratory technologist and Health
laboratory assistant.
 Health laboratory Scientist
 Means a person who holds a degree or an advanced diploma in health laboratory
sciences issued by a University or Institution of higher learning recognized by the
Council.
 Health laboratory technologist
 Means a holder of a diploma in health laboratory sciences from a University or
training Institution recognized by the Council.
 Health laboratory assistant
 Means a person who has undergone health laboratory training at Certificate level in a
training Institution recognized by the Council.
 Pathologist
 Means a medical practitioner who holds a postgraduate qualification in one of the
major laboratory disciplines such as clinical chemistry, haematology and blood
transfusion, anatomical pathology, microbiology/immunology,
parasitology/entomology, and registered with the Medical Practitioners and Dentists
Ordinance.
 Approved person

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  Means a registered health laboratory practitioner or a pathologist approved by the
Private Health Laboratories Board (PHLB) to manage private health laboratory in
accordance with the provisions of the Private Health Laboratories Regulation Act.
 Private health laboratory
 Means any health laboratory registered by the Private Health Laboratories Board to
provide health laboratories registered by the PHLB to provide health laboratory
services in accordance with the Private Health Laboratory Regulation Act.

Step 3: List legislature Act governing health laboratory services and their related
applications (10 minutes)
 Health Laboratory Practitioners’ Act Cap 48
 The Act applies to:
o Health Laboratory Scientists
o Health Laboratory Technologists
o Health Laboratory Assistants and
o Licensed persons

 Private Health Laboratories Regulation Act No. 10 of (PHLRA) 1997

 The Act applies to all private health laboratories, approved persons and any other
person engaged in the management of private health laboratory.

Step 4: List regulatory authorities governing health laboratory services and their
composition (20 minutes)
 The Health Laboratory Practitioners Council (HLPC)
 The Council shall consist of the following who shall be appointed by the Minister
responsible for Health;
 A Chairman- appointed from amongst senior health laboratory practitioners
 A representatives from the Diagnostic Services of the Ministry
 A representative from the Private Health Laboratories in Tanzania
 A representative from the Regional Health Laboratory technologists
 A member representing health laboratory practitioner from referral hospitals
 A representative from the Medical Laboratory Scientists Association of Tanzania
 A representative from association of Pathologists of Tanzania
 A representative from the Association of Private Hospitals in Tanzania
 A member representing Health Laboratory Assistants
 A head of Heath Laboratory Services unit of the Ministry
 A representative from the Training section of the Ministry
 A State attorney from the Attorney General Office
 Appointment of the Registrar and Deputy Registrar
 The Minister shall appoint Health Laboratory Practitioners from the public service to be
the registrar and deputy registrar of the Council, respectively.

 The Private Health Laboratories Board (PHLB)

 Composition of members includes;
o The Director of Hospital Services (MOHSW) – Chairman
o A pathologist
o The Principal Health Laboratory Technologist (Head, Laboratory Services)
MOHSW
o A Senior Health Laboratory Technologist from any Private Health Laboratory

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 o A Senior Health Laboratory Technologists representing voluntary agency
organizations
o A legally qualified person representing and appointed by the Attorney General
o Not more than two other members appointed by the Minister responsible for
Health
o Appointment of the Registrar and assistant Registrar of PHLB
 The Minister appoints public officers to be the Registrar of PHLB and Assistant Registrar
of PHLB, respectively.

Step 5: Explain responsibility of each regulatory authority (20 minutes)

 Functions of HPLC;
 To prescribe the ethics and code of conduct for Health laboratory Practitioners
 To regulate the standards and practice of the Health Laboratory Professionals.
 To evaluate and approve applications from qualifies health laboratory practitioners
and persons intending to be licensed
 To keep and maintain the register, the role and record of licensed persons
 To issue certificates of registration and enrollment of health laboratory practitioners
 To issue licenses to licensed persons
 To advise the government on matters relating to delivery of the health laboratory
services
 Advise and regulate the implementation of the curricular for the training of health
laboratory practitioners
 Conduct examinations for health laboratory practitioners prior to registration or
enrollment, if necessary.
 Prescribe standards and conditions for establishing a training Institution for health
laboratory practitioners.

 Functions of PHLB;
 To receive, scrutinize, approve and register all applications for establishing private
health laboratories within Tanzania.
 To monitor or regulate all private health laboratories with Tanzania
 To keep and maintain register for private health laboratories
 To hold regular meetings to deliberate on matters relating to private health
laboratories
 The Board shall set fees payable by owners of private health laboratories which fees
shall include;
o Application fees
o Registration fees
o Any other fees as may be prescribed by the Board

Step 6: Explain the legal requirement in regard to laboratory ethics and professional
code of conduct (25 minutes)
 Legal duties/requirement (Refer PART IV of the Act)
 It is the duty of every health laboratory practitioner and licensed person to attend their
clients according to ethics and code of conduct
 Every health laboratory practitioner or licensed person shall comply with the internal
quality control requirements and participate in external quality assessment practice
 Every health laboratory practitioner or a licensed person is required to report to the
supervisor or the Council any misconduct of a fellow health laboratory practitioner
and licensed person

200
 Offences for illegal practicing and penalties (Refer PART VII of the Act)
 Any person who practices as a health laboratory practitioner or a licensed person
without being registered, enrolled or licensed commits an offence and shall be liable
on conviction to a prescribed fine and/or imprisonment as stated by the Act
 Any employer who knowingly and willfully employs unregistered or un-enrolled
health laboratory practitioner or unlicensed person, commits an offence and shall be
liable on conviction to a fine and/or imprisonment as stated in the Act
 In addition to the penalty imposed, the Court may order diagnostic instruments or
appliances used by or belonging to, or found in possession to a person convicted be
forfeited, destroyed or otherwise disposed of.
 Any person who procures illegal registration, enrollment or licensing commits an
offence and shall be liable on conviction to a fine and/or imprisonment as prescribe in
the Act.
 Any person who gives false information or utters forged documents commits an
offense and is liable on conviction to a fine and/or imprisonment as prescribe in the
Act.

Step 7: Key Points (10 minutes)

 Tanzania Health laboratory Services Legislature Acts
 Health Laboratory services regulatory authorities and their functions
 Ethical requirements and penalties

Step 8: Evaluation (5 minutes)

 Ask the student to
 Define a health laboratory practitioner
 List five functions of the laboratory services regulatory bodies
 Mention three examples of offences that a laboratory practitioner or his/her employer
may commit and their respective Court penalties

ASK students if they have any comments or need clarification on any points. SUMMARIZE
their responses and confirm correct answers.

References:
1. The Health Laboratory Practitioner Act, 2007 (Enacted by the Parliament of the United
Republic of Tanzania
2. Private Health Laboratory Regulation Act, 1997 (Enacted by the Parliament of the United
Republic of Tanzania) Ethics and code of Professional conduct Regulations
3. Supplement No. 28 of 23rd July 2010 Subsidiary Government Legislation 259/23 July
2010: The Health Laboratory Practitioner Act CAP 48 (Code of Ethics and Professional
Conduct) Regulation

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Session 3: Explain policy guidelines governing provision of health
laboratory services

NTA LEVEL 6, SEMESTER 1, MODULE 5 - CODE: MLT O6105 HEALTH ETHICS AND
PROFESSIONAL CODE OF CONDUCT.

Total Session Time: 120 minutes

Prerequisites
 MLT04104: Health Ethics and Professional Code of Conduct
 MLT05101: Laboratory Ethics and Professionalism
 MLT06105: Session 2

Learning Objectives

By the end of this session, students are expected to be able to:

1. Define policy and policy guidelines
2. List policy guidelines involved in the provision of health laboratory services
3. List the main components of the policy guidelines governing provision of health
laboratory services

Step 2: Definition of Terms (10 minutes)

 Policy:
 A plan or cause of action guiding principles or procedures considered advantageous
regarding organizational goal and a plan for achieving that goal.
 A set of principles, rules and guidelines formulated or adapted by an organization to
reach its long term goal
 Guideline
 Systematically developed statements or indications to assist practitioners and client’s
decision about appropriate health care intervention for specific diseases or
circumstances (such AIDS, disease outbreak or disaster, etc.).
 Is a statement by which to determine a course of action. It aims to streamline
particular processes according to a set of routine or sound practice.

Step 3: List of Policy guidelines involved in the provision of health laboratory services.

 Blood Transfusion guidelines include;

 National Blood Transfusion Policy Guidelines (refer the guidelines)
 Guidelines on the clinical use of blood and blood products (refer the guidelines)
 Blood donor recruitment and retention guidelines
 Specific Blood Transfusion practice guidelines

 National Health Care Technology Guideline

 National Standard Guidelines for Health Laboratory Services (refer guidelines)

202
 Operational Plan for the National Laboratory System to support HIV/AIDS Care and
Treatment (Refer the guidelines)
 National Laboratory Quality Assurance Framework to Support Healthcare interventions
(Refer the guidelines)

Step 4: Main components of the policy guidelines governing provision of health

laboratory services.
 Make presentation as follows:
 Blood Transfusion guidelines include;
o National Blood Transfusion Policy Guidelines (refer the guidelines)
 Introduction
 Objectives
o Guidelines on the clinical use of blood and blood products (refer the guidelines)
 Introduction
 Ethical and legal aspects of blood transfusion
 Ordering and administration of blood
 Identification and verification
 The blood unit
 The patient
 Aseptic techniques
 Temperature of blood
 Indications of blood transfusion
 Specific coagulation factors
 Transfusion reactions
o Blood donor recruitment and retention guidelines
 Introduction
 Objectives
 Strategies for blood donor recruitment and retention.
o Specific Blood Transfusion practice guidelines
 Introduction
 Specific blood transfusion articled
 Quality systems
o National Health Care Technology Guideline components include;
 Introduction
 Objectives
 Organization management and planning,
 Financing
 Infrastructure
 Selection of technology
 Procurement
 Continued operation
 Personnel, Training and Registration
o National Standard Guidelines for Health Laboratory Services (refer guidelines)
include;
 Objectives
- Broad Objective
 To maintain good quality, accessible, effective and efficient health
laboratory services in supporting the provision of Essential Health
Package at all Health Care Levels.
- Specific objectives:

203
  To set minimum standard of physical infrastructure for health
laboratories.
 To provide a guide to equipping and setting range of essential tests at
each level of laboratory services.
 To set minimum personnel requirements at all health laboratory levels.
 To set ethical code of conduct
 To set methodology standardization.
 To develop performance assessment systems.
 To set management organizational structure for laboratory services.
o Human resource (Minimum manning levels at different levels)
 Specimen Collection Point (SCP)
 Health professional with knowledge on collection of laboratory
specimens - 1
 Dispensary and Health Centre Laboratory
 Laboratory Assistant - 1
 Laboratory attendant - 1
 Level I Laboratory
 Laboratory Technologists - 2
 Laboratory Assistant - 2
 Laboratory Attendant - 2
 Level II Laboratory
 Haematology & Blood Transfusion Technologist - 1
 Clinical Chemistry Technologist - 1
 Microbiology & Immunology - 1
 General Registered Laboratory Technologists - 5
 Laboratory Attendants - 3
 Level III Laboratory
Specialised Laboratory Laboratory
Pathologists Total
Technologist Technologist Attendant
Haematology/Transf
1 2 4 2 9
usion
Clinical Chemistry 2 2 2 2 8
Microbiology 1 2 4 2 9
Parasitology - 1 3 2 6
Histopathology 1 3 2 2 8
TOTAL 5 10 15 10 40

 Operational Plan for the National Laboratory System to support

 HIV/AIDS Care and Treatment (Refer the guidelines) components;
o Introduction
o Required Tests for HIV/AIDS Care and Treatment (ART Patients)
o Distribution of Testing Capacity
o General laboratory supplies
o Equipment maintenance
o Quality Management
o Procurement
o Data Management
o Sample Transportation

204
 National Laboratory Quality Assurance Framework to Support Healthcare interventions
components;(Refer the guidelines)
o Introduction
o Justifications for instituting laboratory quality systems
o Components (elements) of Laboratory Quality Systems
 Organization
 Personnel
 Equipment
 Purchasing and Inventory
 Process control
 Documents and records
 Information and Management
 Occurrence management assessment
 Process improvement
 Customer service
 Facility and safety
o Laboratory Quality Assurance Management
 Laboratory Network Information Sharing
 Monitoring and Evaluation

Step 5: Key Points (10 minutes)

 Present key Points as follows:
 Definition of policy and policy guidelines
 Objectives of National Standard Guidelines for Health Laboratory Services
 Essential elements of laboratory quality system

Step 6: Evaluation (10 minutes)

 Ask the students to:
 Define Policy and Policy Guidelines
 State the broad objective of the standard guidelines of Health Laboratory Services
 Summarise their responses and them if they have any question.
 Mention at least seven essential elements/components of health laboratory quality
system
 ASK students if they have any comments or need clarification on any points.

References: (MOHSW Guidelines)

1. National Laboratory Quality Assurance Framework to support Health Care Interventions
2. National Standard Guidelines for Health Laboratory Services - 2003
3. Operational Plan For The National Laboratory System to Support HIV/AIDS Care and
Treatment - 2005
4. National Blood Transfusion Policy Guidelines –2006
5. Guidelines on the clinical use of blood and blood products - 2006
6. Blood donor recruitment and retention guidelines - 2006
7. Specific Blood Transfusion practice guidelines – 2006
8. National Health Technology Policy Guideline -2002

205
Session 4: Apply regulations in providing health laboratory services

NTA LEVEL 6, SEMESTER 1, MODULE 5 - CODE: MLTO6105 HEALTH ETHICS AND

PROFESSIONAL CODE OF CONDUCT.

Total Session Time: 120 minutes

Pre-requisites
 MLT04104: Health Ethics and Professional Code of Conduct
 MLT05101: Laboratory Ethics and Professionalism
 MLT06105: Session 1-3

Learning Objectives

By the end of this session, students are expected to be able to:

1. Identify sections in the regulations governing provisions of laboratory services
2. Interpret regulations governing provisions of laboratory services.
3. List actions that breach regulations

Step 2: Class Group work on identification and interpretation of sections in the

regulations governing provisions of laboratory services (50 minutes)

Activity: Group work (50 minutes)

DIVIDE the class into small groups that do not exceeding 10 students
PROVIDE to each group a copy of ‘The Health Laboratory Practitioner’s Act, 2007 (CAP
48) and a copy ‘The Private Health Laboratories Regulations Act, No 10 of 1997 as a
resource to work on;
 Identification of sections in the regulations governing provisions of laboratory services
 Interpretation of regulations governing provisions of laboratory services
 Preparation of their presentations

Step 3: Group work presentation on identification and interpretation of sections in the

regulations governing provisions of laboratory services (30 minutes)

Activity: Group work presentation (30 minutes)

PRESENTATION and DISCUSSION on:
 Sections identified in the regulations governing provisions of laboratory services
 The interpretation of regulations governing provisions of laboratory services
SUMMARISE the presentations as shown below.

 Sections in the regulations governing provisions of laboratory services
 ‘The Health Laboratory Practitioner’s Act, 2007 (CAP 48)
o PART III – Sections 14-25
 Registration
- Eligibility

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 - Procedure for Registration
- Types of Registration
 Provisional Registration
 Full registration
 Temporary Registration
- Certificate of Registration
 Enrolling
- Qualifications for Enrolment
- Procedure for Enrolment
- Certificate of Enrolment
 Licensing
- Eligibility for Licensing
- Procedure for Licensing
- License

o PART IV on Duties of Health Laboratory Practitioners

 Every health laboratory practitioner and licensed person has a duty to attend
their clients according to ethics and code of professional conduct.
 Every health laboratory practitioner or licensed person must comply with the
internal quality control requirements and participate in external assessment
practice
 Every health laboratory practitioner or licensed person is required to report to
the supervisor or the Council any misconduct of a fellow health laboratory
practitioner and licensed person.

 The Private Health Laboratories Regulations Act, No 10 of 1997

o PART III (Section 10-13)
 Duties of Registrar in relation to registered private health laboratories
 Registration and publications of particulars of approved persons
 Restrictions on management by private health laboratories
 Identification of private health laboratories
o PART IV (Sections 14-15)
 Registration of Private health Laboratories
 Cancellation Registration of Private health Laboratories
o PART V (Section 16, 19 and 21)
 Inspection and Search
 Entitlement to practice for fees
 Appeal

 The interpretation of regulations governing provisions of laboratory services

A. ‘The Health Laboratory Practitioner’s Act, 2007 (CAP 48) PART III – Sections
14-25
o Who is eligible for registration?
 Provisional Registration- Is given to any recently qualified Health Laboratory
Practitioner (Lab Scientist or Lab technologist) who has to acquire health
laboratory experience (for not less than one year) to enable him/her carry out
laboratory tests and procedures under supervision.
 Full Registration- Is given to any Health laboratory practitioner who has
satisfied the Council that he/she has acquired not less than one year practical
experience under supervision in a health laboratory facility.

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  Temporary Registration - Is given to any foreigner health laboratory
practitioner (not ordinarily a resident of Mainland Tanzania) who has satisfied
the Council that he/she has been registered in his/her country and practiced for
more than a year, and intends to carry out any health laboratory work or a
specific assignment in research or teaching in mainland Tanzania.
o Procedure for registration;
 Submission of application form in the prescribed form to the Registrar
 An application shall be accompanied by;
- A certified copy or copies of certificates for academic qualifications
- An application fee as prescribed in the Regulations
- Other documents as may be required by the Council
 If the Council is not satisfied with the evidence provided, the person seeking
registration shall be required to pass such examinations as the Council may
direct.
o Who will be issued with a certificate of registration?
 The Registrar will issue a certificate of Registration to any registered
Health laboratory scientist or health laboratory technologist upon payment of
a prescribed fee in a prescribed form.
o Enrolment;
 A person shall be entitled to be enrolled if;
- Has attained a certificate in health laboratory sciences from a recognized
training institution
- Has produced evidence to the satisfaction of the Council of his entitlement
for enrolment as a health laboratory assistant.
o Procedure for enrolment
 Submission of an application in the prescribed form to the Registrar
accompanied by;
- A certified copy or copies of certificate of academic qualifications
- An application fee as prescribed
- Other documents as may be required by the Council
o What happens after submission of the applications?
 The Council may approve OR reject the application
o Certificate of Enrolment of a health laboratory assistant will be issued upon;
 Payment of the prescribed fee
o Licensing
 Eligibility
- Any non-laboratory health professional who has attained a specialized
training to perform a specified rapid health laboratory test

B. The Private Health Laboratories Regulations Act, No 10 of 1997

o Eligibility to own and/or manage a private health laboratory;
 Any approved person fully registered Health Laboratory Practitioner under the
Health Laboratory Practitioner Act can be eligible to own and or manage a
private health laboratory facility.
 Must possess a certificate of registration of the facility.

o Restriction on management of private health laboratories

 No person shall manage or cause to be managed a private health laboratory
unless that person is an approved person.
 Registration of private laboratory

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  No person or approved person shall manage any private health laboratories
unless that health laboratory is registered by the PHLB
 The approved person or the owner shall make an application for the
registration of a private health laboratory to the Board.
o Inspection and Search
 The approved person who manage and/or owns a private health laboratory
shall allow the officer authorized by the Board in writing free entry to
premises for purpose to ascertain whether the facility renders services in
accordance with provision of The Private Health Laboratories Regulations
Act.

Step 4: Group work and presentation on identification of actions that breach

regulations

Activity: Group work presentation (20 minutes)

PRESENTATION on:
i) Identification of actions that breach regulations
SUMMARISE the presentations as shown below
 Actions that breach Health Laboratory Practitioner’s Act (PART VII)
 Person who practices as health laboratory practitioner or licensed person without
being registered enrolled or licensed.
 Any employer who knowingly and wilfully employs unregistered or unrolled health
laboratory practitioner or unlicensed person
 Any person who illegally procures or attempts to procure registration, enrolment or
licensing
 Person who produces any false or fraudulent statement or documents for the purpose
of obtaining registration, enrolment or licensing
 Any person who deliberately makes or causes to be made any false information in any
matter relating to the Register, the Roll or the Record of licensed persons.

 Actions that breach The Private Health Laboratories Regulations Act

 PART III and PART IV
o Operation of unregistered private health laboratory
o Practicing as health laboratory practitioner or licensed person without being
registered, enrolled or licensed

Step 5: Key Points (5 minutes)

 The interpretation of regulations governing provisions of laboratory services
 Actions that breach regulations governing provisions of laboratory services

Step 6: Evaluation (5 minutes)

 Mention health laboratory practitioners who are eligible for registration
 List actions that breach the regulations governing provision of health laboratory services

References:
1. The Health Laboratory Practitioner’s Act, 2007 (CAP 48)
2. The Private Health Laboratories Regulations Act, No 10 of 1997

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Session 5: Apply policy guidelines in providing health laboratory services

NTA LEVEL 6, SEMESTER 1, MODULE 5 - CODE: MLTO6105 HEALTH ETHICS AND

PROFESSIONAL CODE OF CONDUCT.

Total Session Time: 120 minutes

Pre-requisites
 MLT04104: Health Ethics and Professional Code of Conduct
 MLT05101: Laboratory Ethics and Professionalism
 MLT06105: Session 1- 4

Learning Objectives
By the end of this session, students are expected to be able to:
1. Identify sections in the ‘National Standard Guidelines for Health laboratory Services’ and
in ‘National Laboratory Quality Assurance Framework’, governing provision of
laboratory health services.
2. List actions that breach the two policy guidelines.

 .

Step 2: Class Group work on identification and interpretation of sections in the policy
guidelines governing provisions of laboratory services (50 minutes)

Activity: Group work (50 minutes)

DIVIDE the class into small groups that do not exceeding 10 students
PROVIDE the following guidelines as a resource materials;
 National Standard Guidelines for Health Laboratory Services
 National Laboratory Quality Assurance Framework (to support Health Care
Interventions) to work on;
 Identification of sections in the policy guidelines governing provisions of health
laboratory services
 Preparation of their presentations

Step 3: Group work presentation on identification and interpretation of sections in the

two policy guidelines governing provisions of laboratory services (30 minutes)

Activity: Group work presentation (30 minutes)

PRESENTATION and DISCUSSION on:
 Sections identified in the policy guidelines governing provisions of laboratory services
SUMMARISE the presentations as shown below.

A. National Standard Guidelines for Health Laboratory Services

 Section 1.2 What are the laboratory roles as described in this guideline?
 To provide relevant reports and epidemiological data that should allow for a better
surveillance, recognition of epidemic or unusual infections, control of prevalent

210
 communicable and non-communicable diseases as well as in the follow up care of
patients.
 To provide other health workers with laboratory information that will help in reaching
an early and correct diagnosis and prompt treatment or management.
 To produce and test the efficacy of laboratory supplies, drugs and vaccines.
 To conduct and participate in research and training
 Section 3.6 What does the Standard Guideline instruct on Laboratory safety
 Laboratory safety guidelines for all health laboratories shall be developed and
reviewed from time to time by the National Diagnostic Services Advisory Committee
(NDSAC). The National and Zonal laboratories shall appoint safety officers while at
lower levels the laboratory in charge shall be the one responsible for safety.
 Section 3.8 What is the responsibility of Health Laboratory Practitioner in regard of
Code of Ethics?
 Be dedicated to the use of clinical laboratory science to benefit mankind.
 Actively seek to establish co-operative and specific working relationships with other
health professionals.
 Provide expertise to advice and counsel other health professionals.
 Maintain strict confidentiality of patient information and test results.
 Safeguard and privacy of patients.
 Be responsible for the logical process from the acquisition of the specimens to the
production of data and the final report of test results.
 Be accountable for the quality and integrity of clinical laboratory services.
 Exercise professional judgment, skills and care while meeting established standard.
 Uphold and maintain the dignity and respect of the profession and strive to maintain a
reputation of honesty, integrity and reliability.
 Strive to improve professional skills and knowledge, and adopt scientific advance that
benefit the patient and improve the delivery of reliable test results.

 Section 3.9 What are the job description of the health laboratory practitioner?
 3.9.1 Health Laboratory Assistant
o Preparation of Reagents
o To perform basic Laboratory investigations in Parasitology, Haematology, Blood
Transfusion, Bacteriology and Clinical Chemistry and emergency call duties.
o To maintain Cleanness of the Laboratory, glassware and equipment.
o Collection of blood from patients and proper preservation of specimens.
o Monitor quality of laboratory investigations and procedures.
o To keep record of laboratory investigations, procedures and utilise received
information or guidelines.
o To prepare quarterly report/data, utilise and send the reports to the required
authority.
o Any other relevant assigned task.

 3.9.2 Health Laboratory Technologist:

o Acquisition of supplies and preparation of reagents.
o To perform laboratory investigations in Parasitology, Haematology, Blood
Transfusion, Bacteriology, Serology, Clinical Chemistry, Histopathology and
emergency call duties.
o To teach and supervise junior staff
o To ensure that the laboratory is well kept, the equipment and reagents are in good
working order.

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 o Collection of blood from patients and proper preservation of specimens.
o Monitor quality of laboratory investigations and results.
o Keep the record of laboratory investigations and procedures.
o To prepare quarterly report /data, utilise and send the report to the required
authority,
o To receive and apply information and guidelines
o Any other relevant assigned task.

 Health laboratory Scientist

o To perform molecular biology tests and other specialized tests in the department
o To implement laboratory quality management systems.
o To observe good laboratory practice at all times when executing laboratory duties.
o To provide necessary technical assistance and guidance to junior laboratory staff.
o Assist in the training of laboratory technologists and technicians on molecular
biology tests.
o Participate in EQA schemes especially molecular biology tests and review the
results thereof.
o To prepare, distribute analyze and provide feedback on EQA panels.
o To apply molecular biology knowledge and skills in disease surveillance and
quality assurance
o Identification and addressing of complaints, non-conformances and corrective
actions
o Comply with established quality management system and safety procedures.
o To participate in operational research for both clinical and public health services.
o To prepare and submit, quarterly, semi-annual and annual reports.
o To maintain statistics of molecular laboratory tests and keep records and
documents thereof.
o Recognize and respond to emergencies
o To perform any other duties as assigned by the section head.

 3.9.4 Pathologists
o Co-ordinate Health Laboratory activities
o Supervise the supplies system
o Advise on Training and development needs of laboratory personnel.
o Advise and recommend on procurement of proper equipment technology in
collaboration with the Health Care Technical Services unit and the NDSAC.
o Promote standardisation of techniques, method and equipment
o Enforce laboratory safety code.
o Co-ordinate health laboratory Information system
o Perform duties pertaining to own specialty and attend emergency call duties.
o Prepare annual reports, utilise and send them to the required authorities.
o Any other relevant assigned task.

Section 4: What are the standards for each health laboratory level?
 Standards for each health laboratory levels are set in terms of;
 Premises
 Furniture
 Essential supplies
 Test menu

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Section 5: On Management of Health Laboratories
National organogram Refer National Standard Guidelines Section 5.10 page 38
B. National Laboratory Quality Assurance Framework (to support Health Care
Interventions
 What is the purpose and objectives of instituting health laboratory quality system?
o Section 2.2 Purpose
 This framework is intended for use by laboratory directors, supervisors,
quality managers and all laboratory practitioners as a means to ensure that
laboratories have in place policies, processes, procedures, activities, and
records that support the activities described herein. Also it is intended to be
used by Health Administrators in planning and monitoring health care
interventions in disease intervention programs such as the National
Tuberculosis and Leprosy Control Programme (NTLP), Expanded Programme
on Immunization (EPI), National AIDS Control Programme (NACP), National
Blood Transfusion Services (NBTS) and National Malaria Control Programme
(NMCP) among others to assure quality laboratory service in the health care.
 Furthermore, the schools of medical laboratory technology and other health
sciences may use this document to identify training requirements to suit
prevailing health care needs.
o 2.3 Main Objective
 This document is intended to provide guidelines and methods to assess the
quality and reliability of laboratory services in Tanzania by instituting a
comprehensive quality assurance program thus, improving healthcare delivery.

o Section 6.1 Laboratory Indicators (Monitoring and Evaluation)

 Two levels of indicators will be monitored;
i. Laboratory (facility) indicators-
o Will include assessment of key laboratory indicators such as Staff
disposition, available test menu, workload, equipment and their
operational status, reagent stocks, supplies management and
implementation of lab QA schemes done monthly, quarterly and
annually.
ii. Laboratory network indicators
o Will include the proportion of laboratories reporting timely, late or
non-reporting; comprehensiveness of reporting; national laboratory test
menu and workload according to levels of laboratories; equipment and
their operational status, reagent stocks, supplies management and
implementation of lab QA schemes.

o Section 7.0 National Laboratory Quality Assurance (NLQA) activities

7.1 Strengthen Internal Quality Control (IQC)
7.2 Strengthen External Quality Assessment (EQA)
7.2.1 Proficiency testing; this involves periodic distribution of panels of
samples with known reactivity to different testing
sites/laboratories.
7.2.2 On-site evaluation; which involves visiting the laboratory and
observing various activities including testing.
7.2.3 Retesting or rechecking samples; which involves retesting a subset
of samples in a referral laboratory. This is implemented in medium
to high throughput laboratories

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Step 4: Group work and presentation on examples of actions that breach the two policy
guidelines governing provision of health laboratory services
Activity: Group work presentation (20 minutes)
PRESENTATION on:
 Identification of actions that breach the two policy guidelines
SUMMARISE the presentations as shown below;

 Examples of actions that breach the;

 The National Standard Guidelines for Health Laboratory Services
o Non-compliance to Laboratory safety guidelines (Section 3.6)
o Non-compliance to Code of Ethics (Section 3.8)
o Non-compliance to prescribed technical practice of health laboratory practitioners
(Section 5.11)
 The Quality assurance framework
o Incompliance to quality assurance framework (section 7.1 and 7.2)

Step 5: Key Points (5 minutes)

 Laboratory roles as described in the ‘National Standard Guidelines for Health Laboratory
Services
 Actions that breach the two guidelines that govern provisions of laboratory services

 Purpose and objectives of ‘The Quality assurance framework’.

Step 6: Evaluation (5 minutes)

 List three actions that breach the provision of health laboratory services in reference to
the ‘National Standard Guidelines for Health Laboratory Services’ and ‘The Quality
assurance framework’.
 Explain the purpose and the objectives of ‘The quality assurance Framework’.

References:
1. National standard guidelines for health laboratory services
2. National laboratory quality assurance framework to support healthcare interventions
3. Other Policy Guidelines relevant in provision of health laboratory services such as Blood
Policy guideline, Operational Plan for the National Laboratory System to support
HIV/AIDS care and treatment.

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Session 6: Assess compliance to legal and policy guidelines (PREPARATION
OF ASSESSMENT TOOLS)

NTA LEVEL 6, SEMESTER 1, MODULE 5 - CODE: MLTO6105HEALTH ETHICS AND

PROFESSIONAL CODE OF CONDUCT.

Total Session Time: 120 minutes

Prerequisites
 MLT04104: Health Ethics and Professional Code of Conduct
 MLT05101: Laboratory Ethics and Professionalism
 MLT06105: Session 4 &5

Learning Objectives

By the end of this session, students are expected to be able to:

1. Define the terms ‘Assessment and Assessment tool’
2. Prepare assessment tool to assess compliance with legal and policy guidelines

Step 2: Definition of terms (15 minutes)

 ‘Assessment’ is the systematic collection, review , and use of information about

educational programs or activities of an organization, undertaken for the purpose of
improving student learning and development or improving performance of an
organization.

NB: Assessment involves making our expectations explicit and public; setting appropriate
criteria and high standards for learning quality; systematically gathering, analyzing, and
interpreting evidence to determine how well performance matches those expectations and
standards; and using the resulting information to document, explain, and improve
performance.

 ‘Assessment tool’ is a device such as a chart that helps a team or assessors determine the
state of the process either before or after the event or implementation.

Step 3: Class Group work on preparation of assessment tool (75 minutes)

Activity: Group work (75 minutes)

DIVIDE the class into small groups that do not exceed 10 students
PROVIDE to each group a copy of ‘Code of Ethics and Professional Conduct for Health
Laboratory Practitioner’s Regulation and/or any policy guideline to assist in the preparation
of assessment tool.
SUPERVISE the preparation of the assessment tool group-wise.

Step 4: Key Points (10 minutes)

 Definition of the terms “Assessment and Assessment tool’.

215
Step 5: Evaluation (10 minutes)
 ASK the students to:
 Define the terms “Assessment and Assessment tool’

SUMMARIZE their responses and confirm correct answers’

ASK THE STUDENTS: If there is any question.

References:
1. HLPC Code of Ethics and Professional Conduct for Health laboratory Practitioners
2. National Standard guidelines for Health Laboratory Services
3. National Laboratory Quality Assurance Framework
4. Any other Laboratory Health policy guidelines
5. Any other laboratory regulatory Acts or documents

216
Session 7: Assess compliance to legal and policy guidelines (Presentation
and Discussion of the Assessment tools)

NTA LEVEL 6, SEMESTER 1, MODULE 5 - CODE: MLTO6105HEALTH ETHICS AND

PROFESSIONAL CODE OF CONDUCT.

Total Session Time: 120 minutes

Prerequisites
 MLT04104: Health Ethics and Professional Code of Conduct
 MLT05101: Laboratory Ethics and Professionalism
 MLT06105: Session 4 to 6

Learning Objectives

By the end of this session, students are expected to be able to:

1. Prepare assessment tool to assess compliance with legal and policy guidelines
2. Fill in assessment findings

Step2: Group work presentation on assessment tool on compliance to legal and policy
guidelines (75 minutes)

Activity: Group work presentation (60 minutes)

PRESENTATION by groups and DISCUSSION on: Prepared assessment tool in
compliance to legal and policy guidelines (ethics and code of conduct) 40 minutes
SUMMARISE the presentations as shown below (15 minutes).
An example of an assessment tool is shown below;

ASSESSMENT TOOL ON COMPLIANCE TO LEGAL AND POLICY GUIDELINES

Facility……………Level……Ownership…………..District….…………Region….…………
.
Date of Assessment ……………………………
Assessed Standards Operational Yes Partial Not at Rem
attribute assessed Definition all arks
Respect  Does the lab  Decently dressed,
to Client staff appear Proper uniform,
and smart, in identification tags,
colleagues proper personal not in alcohol/drug
presentation influence etc
and proper
attire?
 Is the client
greeted by the
Laboratory
Staff?

217
Assessed Standards Operational Yes Partial Not at Rem
attribute assessed Definition all arks
 Does the
laboratory staff
provide
information to
the client on
respective
laboratory
procedure?
 Does the
Laboratory
staff respond
adequately to
questions
asked by the
client?
 Does the lab
staff treat all
clients
equitably based
on their needs
regardless of
factors such as
economic
status, race,
age, sex and
physical
attributes?
 Does the staff
respect
customs, value,
spiritual beliefs
and human
dignity of
patients and
colleagues?
Accounta  Are the health
-bility lab
practitioners
registered or
enrolled by the
HLPC?
 If the facility is
private, is it
registered by
PHLB?

218
Assessed Standards Operational Yes Partial Not at Rem
attribute assessed Definition all arks
 Are the health
lab
practitioners
givenwriten
job
description?
 Is the
attendance
register
available and
in use?
 Are the staff in
their working
stations and
performing
their duties?
Confident  Is there  Rooms with closed
iality and adequate doors to prevent
privacy privacy? client from being
seen or heard
while meeting with
health provider OR
Areas are
sectioned off by
curtains /screens.
 Are the  Results are safely
patient’s and confidentially
results or kept in locked
information cabinets, lockers,
kept and or computer and
released in the accessed by
strictest authorized staff
confidentiality? only.
 Results are
confidentially sent
to the clinician
who requested the
test (and not the
patient or relative
or another staff)
Safety  Is the
and laboratory and
protectio its
n surroundings
clean and tidy?

219
 Assessed Standards Operational Yes Partial Not at Rem
attribute assessed Definition all arks
 Does lab staff
use gloves
appropriately?
 Are there waste
bins according
to IPC
guidelines?
 Does the
laboratory have
First Aid Kit?
 Does the lab
have fire
extinguisher
facilities?
 Are laboratory
safety rules and
regulations
displayed
(SOP)?
 Is the safety
cabinet/safety
hood
available?
 Is safety
cabinet/safety
hood
functioning?
 Is the safety
cabinet/safety
hood used?
Emergenc  Is the
y occurrence log
situations available?
/occurren  Is the
ces occurrence log
in use?
 Are there
measures taken
after an
occurrence had
been reported?

Key:
Yes - The attribute is fully observed/available
Partial - The attribute is partially observed
Not at All - The attribute is not observed at all

220
Remarks - Any observation note in respect to Code of Ethics and Professional
Conduct

Step 3: GROUP TASK- Each group to fill in the developed assessment tool (15 Minutes)
Activity: Group work presentation (15 minutes)
WITH THE TUTORS ASSISSTANCE, EACH GROUP: Is given a copy of the prepared
Assessment tool and fill in the tool.

Step 4: Key Points (10 Minutes)

 Preparation of Assessment Tool on compliance to legal and guideline policy
 Main components addressed in the developed assessment tool

Step 5: Evaluation (10 Minutes)

 List at least five components addressed in the develop Assessment tool for assessing
compliance with legal and policy guidelines

References:
1. HLPC Code of Ethics and Professional Conduct for Health laboratory Practitioners
2. National Standard guidelines for Health Laboratory Services
3. National Laboratory Quality Assurance Framework
4. Any other Laboratory Health policy guidelines
5. Any other laboratory regulatory Acts or documents

221
Session 8: Assess compliance to legal and policy guidelines (PRACTICAL
ASSESSMENT OF A HEALTH LAB FACILITY)

NTA LEVEL 6, SEMESTER 1, MODULE 5 - CODE: MLTO6105HEALTH ETHICS AND

PROFESSIONAL CODE OF CONDUCT.

Total Session Time: 120 minutes

Prerequisites
 MLT04104: Health Ethics and Professional Code of Conduct
 MLT05101: Laboratory Ethics and Professionalism
 MLT06105: Session 4 to 7

Learning Objectives

By the end of this session, students are expected to be able to:

1. Conduct assessment of compliance with legal and policy guidelines

Step2: Transportation and introduction of students, to the laboratories selected to be

assessed (15 minutes)
Activity: Transportation and introduction of students, to the laboratories selected to
be assessed
TUTOR TO VISIT nearest health laboratory facilities prior to the planned student’s visit.
TUTOR TO INTRODUCE the students to lab staff on the day of assessment exercise.

Step 3: Conduct assessment in the Health lab facility by group work (90 minutes)
Activity: Students to visit the health laboratory facility and assess the compliance to legal
and guidelines policy (Code of Ethics and Professional Conduct), using the prepared
assessment tool.

Step4: Transport students, to the training School (10 minutes)

Activity: Transport and introduction of students, to the training School

TUTOR acknowledges and thanks the visited Laboratories Administration.

References:
1. HLPC Code of Ethics and Professional Conduct for Health laboratory Practitioners
2. National Standard guidelines for Health Laboratory Services
3. National Laboratory Quality Assurance Framework
4. Any other Laboratory Health policy guidelines
5. Any other laboratory regulatory Acts or documents

222
Session 9: Assess compliance to legal and policy guidelines

NTA LEVEL 6, SEMESTER 1, MODULE 5 - CODE: MLTO6105 - HEALTH ETHICS AND

PROFESSIONAL CODE OF CONDUCT.

Total Session Time: 120 minutes

Prerequisites
 MLT04104: Health Ethics and Professional Code of Conduct
 MLT05101: Laboratory Ethics and Professionalism
 MLT06105: Session 4 to 8

Learning Objectives

By the end of this session, students are expected to be able to:

1. Describe assessment report writing format
2. Write assessment report of compliance with legal and policy guidelines
3. Present assessment report of compliance with legal and policy guidelines

Step 2: GROUP WORK: Assessment Report writing format (25 minutes)

 Title page
 Table of contents
 Acknowledgement
 Acronyms
 Executive summary
 Introduction
 Objectives
 Main report: Findings and analysis/observation based on what was supervised
 Conclusions and recommendations
 Appendices
 References

Step 3:Report writing on compliance with legal and policy guidelines (80 minutes)
Group Activity: Each group of students to write the report on findings observed in the
health laboratory facility on compliance to legal and guideline policy.
The report should be prepared for class presentation and later feedback to the respective
visited laboratory facility.

Step 4: Key Points (10 Minutes)

 Assessment Report writing format y

Step 5: Evaluation (10 Minutes)

ASK STUDENTS TO: Describe: The Assessment Report writing format

223
References:
1. HLPC Code of Ethics and Professional Conduct for Health laboratory Practitioners
2. National Standard guidelines for Health Laboratory Services
3. National Laboratory Quality Assurance Framework
4. Any other Laboratory Health policy guidelines
5. Any other laboratory regulatory Acts or documents

224
Session10: Assess compliance to legal and policy guidelines (ASSESSMENT
REPORT GROUP WORK PRESENTATION AND DISCUSSION)

NTA LEVEL 6, SEMESTER 1, MODULE 5 - CODE: MLTO6105HEALTH ETHICS AND

PROFESSIONAL CODE OF CONDUCT.

Total Session Time: 120 minutes

Prerequisites
 MLT04104: Health Ethics and Professional Code of Conduct
 MLT05101: Laboratory Ethics and Professionalism
 MLT06105: Session 4 to 9

Learning Objectives

By the end of this session, students are expected to be able to:

1. Write assessment report on compliance with legal and policy guidelines in a proper
format
2. Identify legal and policy guidelines in compliances based on the report findings.

Step 2: Group Activity (20 minutes)

Group Activity: Group work on: Identification of legal and policy guidelines in
compliances based on the assessment report findings.
GROUP WORK: Presentation on the identified legal and policy guidelines in compliances
based on the assessment report findings.
TUTOR TO: Summarise the presentations by giving examples of in compliances at the
assessed Laboratories as follows::

EXAMPLES OF IN COMPLIANCES
 Presence of Unregistered Health Laboratory Practitioners.
 Presence of Unregistered Health Laboratory Facility
 Lack of Occurrence Log (book) Lack of
 Lack of privacy at the phlebotomy room
 Lack of Personal Protective Gears
 Lack of Staff Job Description
 Lack of Attendance Registers
 Lack of Confidentiality in records

Step 3: Report writing on compliance with legal and policy guidelines (75 minutes)
Group Activity: to make presentation of their assessment report for the visited report.
TUTOR TO: Rectify the report during discussions to ensure proper format and inclusion
of all important findings

Step 4: Key Points (10 Minutes)

 Identification of legal and policy guidelines in compliances based in the report findings

225
Step 5: Evaluation (10 Minutes)
 List the common incompliance observed in majority of laboratory health facilities visited

References:
1. HLPC Code of Ethics and Professional Conduct for Health laboratory Practitioners
2. National Standard guidelines for Health Laboratory Services
3. National Laboratory Quality Assurance Framework
4. Any other Laboratory Health policy guidelines
5. Any other laboratory regulatory Acts or documents

226
Chapter Six

Module Code MLT06106: Laboratory Information Management

227
Session 1: Laboratory Information System

NTA Level 6, Semester 1: Module Code: MLT 06106 – Laboratory Information Management

Total Session Time: 120 minutes

Prerequisites; MLT 05110 Application of Computer in Health Laboratory

Learning Objectives

By the end of this session student will be able to:

1. Define laboratory information system (LIS)
2. Explain laboratory information system (LIS)
3. Explain Function of LIS
4. Explain benefit of LIS
5. Mention types of LIS

Step 2: Define LIS Laboratory Information System is a group of software for analyzing data,
it can be paper based or electronically

Step 3: Explain LIS Laboratory information systems are often part of an integrated system
informatics solution, which involves many disparate applications.
 Use of an LIS is a critical piece of the clinical IT spectrum of systems and contributes
significantly to the overall care given to patients.
 The LIS is used in inpatients and outpatients settings and is in many cases designed to
support both.
 Physicians and lab technicians use laboratory information systems to supervise many
varieties of inpatient and outpatient medical testing, including Phlebotomy (as
phlebotomy is an area where clients starts for outpatients). Haematology and Blood
Transfusion, Clinical Chemistry, Histopathology. Immunology and Microbiology.
Parasitology.

 Basic laboratory information systems commonly have features that:

 Manage patient check in
 Patient demographics
 Order entry,
 Specimen receiving
 Specimen processing
 Result entry
 Dispatch/Releasing (of results)
 Achieving (retrieve/saving).

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LIS-All Areas of Testing Cycle
NB: LIS tracks and stores every detail about a patient from the minute they arrive until they
leave and keeps the information stored in its database for future reference.

Step 4: Function of Laboratory Information System (LIS) It supports the operation of

laboratories to:
 Collection of data
o This collects necessary information’s which are needed from clients/ (patients and
Clinicians) for Laboratory uses
 Store information
o There are some information’s which are required for research, teaching must be
stored
 Analyze information
o Data may be analyzed in the way that can be clear understood and applicable
 Report data to the requestor and clinical activities, associated with the provision, and
utilization of clinical laboratory services.
 Report data to Administration that is organizing, directing and controlling
administrative
 Archive information especially retrieve information for planning

Step 5: Benefits of Laboratory Information System (20 LIS)

 Improve data management for entire Laboratory use and planning
 Enable centralization of information, confidentiality and security
 Support and enhance lab processes
 Generate routine reports rapidly and accurately
 Increase confidence in data by reducing data entry errors
 Helps with WHO certification process

Step 6: Types of Laboratory Information System (LIS) These are 2 types of Laboratory
Information System
 Paper based
 Electronic Laboratory Information System

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Step 7: Key Points
 L IS is a group of system for analyzing of data (includes paper based and eLIS)
 The LIS is used in inpatients and outpatients settings
 Report data to the requestor and clinical activities, and utilization of clinical laboratory
services.
 Achieve data for administration usage especially during planning and budgeting
 LIS divided in to two types, Paper base and Electronic

Step 8: Evaluation (5 minutes)

 What is LIS?
 Write the functions of LIS?
 What are the benefits of LIS?
 Mention types of LIS

References:
1. President’s Emergency Plan for AIDS Relief, APHL. Guidebook for Implementation of
Laboratory Information Systems in Resource Poor Settings, January 2006
2. MOHSW, APHL, CDC. Laboratory Information System, Paper Based Laboratory
Information Tools. JUNE 2007
3. MOHSW, WWW.moh.tz, Document version 1.0, Custom Software,
WWW.CustomSoftware.ie Software version 8.2, Laboratory Information System, User
Manual, Net Acquire May, 10 2008
4. MOHSW Diagnostic Service Section. Laboratory Information System, Paper Based
Laboratory Information Tools. January 2012
5. Bott, E. and Siechert, C. (2001). Microsoft Windows XP Inside Out.
6. Cook, L.R. (2001). 1st Edition, Computer Fundamentals –Understanding How they
Work. Ventage Press.
7. Herniter, M.E. (2000). Personal Computer Fundamentals for Students, Hardware
Windows 2000 Application (2nd Ed). Prentice Hall.
http://www.gcflearnfree.org/computer/
8. Joos, I. W., N. Smith, M., Nelson, R. et al. (2006). Introduction to Computers for
Healthcare Professionals (4th Ed). Barb Mews: London.
9. Morris M & Charles, M. (2003). Logol Computer Designer Fundamentals. Prentice Hall.
10. O’leary, T. J & O’leary, L. I. (2006). Computing Essentials, Introductory Edition.
Arizona State University: Boston Burr Ridge.

230
Session 2: Manual Laboratory Information System

NTA Level 6, Semester 1: Module Code: MLT 06106 – Laboratory Information Management

Total Session Time: 120 minutes

Prerequisites; MLT 05110 Application of Computer in Health Laboratory

Learning Objectives
By the end of this session student will be able to:
1. Define manual laboratory information system
2. Explain the three major groups of Paper Based Tools used in Laboratory
3. Explain the four major categories of General Laboratory Management Tools
4. Explain the Disease Reporting Forms

Step 2: Define Manual LIS (5 minutes)

Activity: Brainstorm (5 minutes)

ASK students to define the meaning of the term ‘Manual LIS’

WAIT for some student response; encourage all definitions of the term.
SUMMARIZE the responses using the information below.

Manual LIS is a non-computerized laboratory information system which use paper based
tools from Clinical activities, to Laboratory including Administration and finally higher
Authorities.

Step 3: Explain three major groups of Paper Based Tool used in the Laboratory
(60minutes)
 Paper Based Tools used in the Laboratory are in three major groups
 These are;
o Standardized Paper Based LIS Tools
o Laboratory Management Tools
o Disease Reporting Forms

 Standardized Paper Based includes:

 Diagnostic Investigation Form
o Registers
 Reception Register
 Results Register

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 Investigation form composed of
 Hospital Details – The area where Requestor fills out
o Important when specimen needs to be referred to another laboratory
 Client Details – Requestor fills out
 Hospital registration number, File number – the number the client has been registered
at that particular hospital or clinic
 Postal address – this information may be useful in mapping an area of interest
(outbreak)
 Also valuable if more than one person has same name and same type of investigation
 Date of birth is very important
 Requestors Details
 Filled out by person who requests the investigation
 Assists different persons involved in health care to ascertain to verify the validity of
request
 “Head of Firm” may also be called the “Head of Department” or “Head of Clinic”
 Specimen collection date and time – important to fill out for time sensitive tests and
helps to monitor the viability of the specimen
 Clinical notes - Helps with the investigation
 Diagnosis

232
 o Any information is important
o Clinician can document what has been discussed or seen on physical exam
 Information needed for investigation
o Good for chronic patients and for follow-up patients
o Nature of specimen – important to fill out to ensure correct specimen is collected
for a particular test - Example is test for CD4 but specimen is serum

Notes of investigating department

 This area documents the receipt of the specimen with the date and time received and by
whom. Additional comments can also be noted

Report – Result portion of form

 Important to make sure all of the other parts of the form are filled out prior to receiving it
into the lab
 The laboratory writes the specimen (investigation) number, name and signature - Ensure
the information on the container is the same as on the form
 Results are entered here

NB: Make sure that investigation forms are filled properly

Registers:
 Reception Register
 Result Registers
 Bacteriology
 Cluster of Differentiation
 Clinical Chemistry
 Haematology
 Histopathology & Cytology (4)
 HIV Testing
 Parasitology – Stool & Urine
 Parasitology – Blood parasites
 Serology
 Hormones and Tumors Markers

Reception Register
Reception registers for both inpatient and out-patient

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It is very important that all column are completely filled out so the patient medical
information’s are complete
• Reception register is used for both in-patients and out-patients
• No other registers are used in reception
• All specimens are registered in this register before processing begins
• The numbering is continuous
 On January 1 of the year the numbering starts at 1
 On December 31st the numbering stops
• One number per specimen – if one patient and three specimens
 Three Investigation Forms
 Three entries in the registers
• Record all specimens in the reception register even if they do not fit criteria for testing –
record those that do not fit the criteria in the specimen rejection register (provides
tracking and the clinician should be immediately notified)

• Result Registers
 Fourteen Result Registers
o Bacteriology
o Cluster of Differentiation
o Clinical Chemistry
o Haematology
o Histopathology & Cytology (4)
o HIV Testing
o Parasitology – Stool & Urine
o Parasitology – Blood parasites
o Serology
o Hormones and Tumors Markers
o Blood Bank

It is very important that all column are completely filled out so the patient medical
information’s are complete
Laboratory Management Tools
 Equipment Monitoring

234
 Specimen Management & QA/QC
 Job Cards
 Personnel Monitoring

Disease Reporting Forms

 These forms usually collect number of tests performed. Data reports almost depends
organization planning, it can be Monthly, Quarterly, Semi-annually and annually

Step 4: Explain four major categories of General Laboratory Management Form

(25minutes)
These are:
 Equipment Monitoring
 Specimen Management & QA/QC
 Job Cards
 Personnel Monitoring

Equipment Monitoring
 Temperature Charts
 For all equipment needing temperature monitoring, rooms, etc.
 Calibration Log
 Service Log

Specimen Management & QA/QC

 Specimen Rejection Form
 Specimen Transfer Form
 Deficiency/Corrective Action Log Sheet
 Occurrence Management Log
 Levey-Jennings Chart

Job Cards
 ELISA Worksheet
 HIV Rapid Test – Result Template
 Clinical Chemistry
 Culture bench books
 Hematology
 Parasitology
 Other worksheets depends sections activities

Personnel Monitoring
 Job descriptions
 Training Log
 Annual Leave Chart
 Promotions

Step 5: Explain Disease Report Forms (15minutes)

 These forms are usually for administrative purposes up to higher authority
 The following are the forms for reporting diseases
 Concerned in collection of information for data analysis

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 Data reports almost depends organization planning can be Monthly, Quarterly, Semi-
annually and annually. These are:
 Microbiology – bacteriology
 Microbiology – serology
 Microbiology – culture
 Chemistry– Blood & Serum
 Chemistry – Urine, CSF & Other Body Fluids
 Haematology
 Blood Transfusion
 Histopathology & Cytology
 Parasitology
 Hormones & Tumors Markers

Step 6: Key points (5 minutes)

 Manual LIS is a non-computerized laboratory information system, which use paper based
tools from Clinical activities, to Laboratory including Administration and finally higher
Authorities.
 Major groups of Laboratory paper based tools; standardized paper based, management,
and disease forms
 Categories of Laboratory management tools: Equipment Monitoring, Specimen
Management & QA/QC, Job Cards, Personnel Monitoring
 Disease Report Forms are usually for laboratory administrative purposes up to higher
authority

Step 7: Evaluation (5 minutes)

 What is manual LIS?
 Mention 3 groups of paper based tools.
 Mention 4 categories of Laboratory management tools.

References:
1. President’s Emergency Plan for AIDS Relief, APHL. Guidebook for Implementation of
Laboratory Information Systems in Resource Poor Settings
2. MOHSW, APHL, CDC. Laboratory Information System, Paper Based Laboratory
Information Tools. JUNE 2007
3. MOHSW, WWW.moh.tz, Document version 1.0, Custom Software,
WWW.CustomSoftware.ie Software version 8.2, Laboratory Information System, User
Manual, Net Acquire May, 10 2008
4. MOHSW Diagnostic Service Section. Laboratory Information System, Paper Based
Laboratory Information Tools. January 2012
5. Bott, E. and Siechert, C. (2001). Microsoft Windows XP Inside Out.
6. Cook, L.R. (2001). 1st Edition, Computer Fundamentals –Understanding How they
Work. Ventage Press.
7. Herniter, M.E. (2000). Personal Computer Fundamentals for Students, Hardware
Windows 2000 Application (2nd Ed). Prentice Hall.
http://www.gcflearnfree.org/computer/
8. Joos, I. W., N. Smith, M., Nelson, R. et al. (2006). Introduction to Computers for
Healthcare Professionals (4th Ed). Barb Mews: London.
9. Morris M & Charles, M. (2003). Logol Computer Designer Fundamentals. Prentice Hall.
10. O’leary, T. J & O’leary, L. I. (2006). Computing Essentials, Introductory Edition.
Arizona State University: Boston Burr Ridge.

236
Session 3: Electronic Laboratory Information System

NTA Level 6, Semester 1: Module Code: MLT 06106 – Laboratory Information Management

Total Session Time: 120 minutes

Prerequisites; MLT 05110 Application of Computer in Health Laboratory

Learning Objectives
By the end of this session student will be able to:
1. Define eLIS
2. Name major components of eLIS
3. Explain functions of each major component of eLIS
4. Explain advantages and disadvantages of eLIS
continuing.

Step 2: Define eLIS (15 minutes)

Activity: Brainstorm (15 minutes)

ASK students to define the meaning of the term ‘eLIS’

WAIT for some student response; encourage all definitions of the term.
SUMMARIZE the responses using the information below.

Electronic Laboratory Information System is the process of recording all activities relate
to laboratory using computer system.

 The system which used to manage those activities is called Laboratory Information
System
 eLIS is a class of software that receive, process and stores information generated by
medical laboratory process.
 This system often must interface with instruments and other information system such as
hospital information system (HIS). A LIS is high configurable application, which is
customized to facilitate a wide variety of laboratory workflow models.
 Deciding on the LIS vendor is a major undertaking for all laboratories.
 Vendor selection typically takes months of research to few years depending on the
complexity of organization.
 There are many laboratory discipline require the support of computerized information.

Step 3: Name Major Components of eLIS (10 minutes)

 Software
 Hardware

Step 4: Explain function of each major component (35 minutes)

 These are physical device, which supports LIS.
 The eLIS hardware categorized by their functions
 These are:
 Input devices

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  Output devices
 Processor
 Input devices allow user to enter data to the system, and these are keyboard, mouse,
scanner, barcode reader and laboratory automated machines
 Output devices are those which give out results.
 These are:
 Monitors
 Speakers
 Printers

Processor is the device which process data to information

 This is Central Processing Unity (CPU)
 The eLIS Software are all programs or application with specific purpose
 These software are the one which tells the system what to do.

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Step 5: Explain Advantages and Disadvantages of eLIS (45minutes)
Advantages
 Error reduction—A well planned computer system, with check systems for errors, will
help to alert the user of inconsistencies, and reduce the number of errors. It will also
provide information that is legible.
 Quality control management—It becomes easy to keep good quality control records
perform analysis on QC data, and generate statistics automatically.
 Provision of options for data searching—A variety of parameters can be used for data
retrieval, e.g. it is usually possible to access data by name, by laboratory or patient
number, and sometimes by test result or analysis performed. This kind of data searching
is almost impossible with paper-based systems.
 Access to patient information—Most computer systems allow access to all recent
laboratory data for a patient. This is very useful in the process of checking the most recent
results against previous data to look for changes, which is a good practice, and helps to
detect errors. Some computer systems give enough information to determine the
admitting diagnosis or access other useful information related to the illness.
 Generate reports—It is easy to generate detailed, legible reports quickly. A LIMS will
provide standardized (or customized) reports.
 Ability to track reports—A computer system makes it much easier to track reports; to
know when work was finished, who performed the work, when the data was reviewed,
and when the report was sent.
 Ability to track and analyze trends—The computer and its databases provide very
strong search capabilities, and with careful design it will be possible to retrieve and use
large amounts of data effectively to track and analyze trends of various kinds.
 Improved capability for maintaining patient confidentiality—It is often easier to
maintain confidentiality of laboratory data when using a computer than when dealing with
a hand-written report form by establishing computer user codes that control access to the
data.
 Financial management—Some systems will allow for financial management, for
example, patient billing.

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 Integration with sites outside the laboratory—A LIMS can be set up so that data
comes into the laboratory system directly from a patient or client registration point. Data
can be transmitted to many sites or interfaces as needed. Results can be provided directly
to computers accessible to the health care provider or public health official. Computers
can handle data entry into a national laboratory database, and almost any other data
application that is needed.
 Manufacturer-provided training—Purchased laboratory information systems often
include on-site training for staff. To make the full use of the system, it is essential that
either on-site training of all staff or training at the manufacturer’s headquarters is
provided.

Disadvantages
 It is important to remember that in spite of all of the advantages, computers do have
disadvantages.
 Some of these are as follows.
 Training—Personnel training is required, and because of the complexity of LIMS,
this training can be time consuming and expensive.
 Time to adapt to a new system—When starting up a computer system it may seem
inconvenient and unwieldy to laboratory staff. Personnel accustomed to manual
systems may be challenged by such tasks as correcting errors and uncertain of how to
proceed when encountering situations where a field must be filled in.
 Cost—Purchase and maintenance are the most expensive parts of a computerized
system, and the costs can be prohibitive in some settings. Additionally, some settings
will not have good maintenance that is locally available. Surprisingly, computers use
lots of paper, and the cost of materials must be planned for, as this can add up. Also
remember that technology changes rapidly, and the life of a computer may not be
more than a few years. This might require repurchase of computer equipment
periodically in order to remain current and compatible with other systems.
 Physical restrictions—Adequate space and dedicated electrical requirements are
necessary, as well as placement of the computer away from heat, humidity, and dust.
 Need for back-up system—All computer information must be carefully backed up.
Loss of data due to a damaged disk or system crash cannot be tolerated, and backup
systems will be critical.

Step 6: Key points (5minutes)

 Electronic Laboratory Information System is the process of recording all activities relate
to laboratory using computer system.
 Major components of Elis are software and hardcopy
 eLIS categorized according to their functions are input devices, output devices and
processor

Step 7: Evaluation (5minutes)

 What is eLIS?
 What are the components of eLIS?
 What is output device?

References:
1. President’s Emergency Plan for AIDS Relief, APHL. Guidebook for Implementation of
Laboratory Information Systems in Resource Poor Settings

240
2. MOHSW, APHL, CDC. Laboratory Information System, Paper Based Laboratory
Information Tools. JUNE 2007
3. MOHSW, WWW.moh.tz, Document version 1.0, Custom Software,
WWW.CustomSoftware.ie Software version 8.2, Laboratory Information System, User
Manual, Net Acquire May, 10 2008
4. MOHSW Diagnostic Service Section. Laboratory Information System, Paper Based
Laboratory Information Tools. January 2012
5. "2011 LIMS Buyers Guide: Introduction". Laboratory Informatics Institute,
Inc.http://files.limstitute.com/share/lbgonline/introduction.htm. Retrieved 2011-04-25.
6. "2011 Laboratory Information Management: So what is a LIMS?” Sapio Sciences.
http://sapiosciences.blogspot.com/2010/07/so-what-is-lims.html Retrieved 2011-04-25.
7. Vaughan, Alan. "LIMS: The Laboratory ERP". LIMSfinder.com.
http://www.limsfinder.com/BlogDetail.aspx?id=30648_0_29_0_C Retrieved 2011-04-25.
8. McLelland, Alan (1998). "What is a LIMS - a laboratory toy, or a critical IT component?”
pp. 1.

241
Session 4: Receive, Store and Retrieve Laboratory Information

NTA Level 6, Semester 1: Module Code: MLT 06106 – Laboratory Information Management

Total Session Time: 120 minutes

Prerequisites; MLT 05110 Application of Computer in Health Laboratory

Learning Objectives

By the end of this session student will be able to:

1. Prepare material for receiving, storing and retrieving, laboratory information system
2. Receive laboratory information using available materials
3. Store received information appropriately using eLIS

Step 2: Define terms (10 minutes)

Activity: Brainstorm (5 minutes)

ASK students to define the meaning of the term ‘Manual LIS’

WAIT for some student response, encourage all definitions of the term.
SUMMARIZE the responses using the information below.
 Receive To get or to acquire something. Someone can receive an item (such as a letter or
a present) or can receive something non-tangible (such as a word of encouragement).
 Store a place where materials are kept.
 This is a place where anything which is supposed to be reserved
 An operational data store (ODS) is a type of database often used as an interim area for a
data warehouse, a data warehouse, contains mostly statistic data
 Retrieve is the area of study concerned with searching for documents, for information
within documents, and for metadata about documents, as well as that of searching
structured storage, relational databases, and the World Wide Web.
 When evidence is to be removed from the laboratory for return to the submitter, for
presentation in court, or for disposal, make appropriate entries in laboratory records.

Step 3: Prepare material for receiving, storing and retrieving, laboratory information
system (15minutes)
Laboratory information management system (LIMS) is the accepted standard for data storage
and retrieval throughout the analytical laboratory
Materials needed:
 General investigation form
 General information from client/patient
 Registers book/log –manually
 Reception registers
 Results register
 Computer-electronically
 Storage devices

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  Printers
 Communication devices
 General laboratory management tools
 Equipment monitoring
 Specimen management & QA/QC
 Job cards
 Personnel monitoring
 Disease reporting forms

Step 4: Receive laboratory information using available materials (15 minutes)

The person receiving the evidence from the laboratory shall be properly identified and shall
sign and date a receipt for the evidence. Maintain the signed receipt in the case file either
manually or electronically.
 General investigation form
 Manage patient check in
 Patient demographics
 Order entry,
 Specimen receiving
 Result entry
 Reception registers
 Manage patient check in
 Patient demographics
 Order entry
 Specimen receiving
 Results register
 Result entry
 Dispatch/Releasing (of results)
 Computer- electronically

All information from General investigation form and results to be logged in Computer

Step 5: Store received information appropriately using eLIS (55 minutes)

Generally storage receiving in laboratory information system have seven information
processes.
 The Processes are:
 Collecting
 Organising
 Storing & Retrieving
 Processing
 Analysing
 Transmitting & Receiving
 Displaying.
 Each process has elements of:
 The types of information or data being dealt with and the form in which it is
represented
 Specific hardware and software; procedures; people and groups; and issues.
Ergonomic considerations and the relationships among information technologies and
the environments in which they are used must also be addressed.

243
The flow of information can be represented across all of these processes, including data-flow
diagrams, systems and block diagrams, systems flowcharts and other emerging techniques.
Decisions should be made about the most appropriate form that information should take, the
most appropriate tools for the task and the issues affecting and affected by the decisions
taken.

This is a summary of t for each process in the Information Life-Cycle

Describing the information processes

Collecting Identifying sources of data and deciding how and in what form it
might be collected. The process of gathering data, includes manual
recording, surveys, forms, data-logging, audio and video, and
various hardware and software for transforming data into digital
form (scanners, a/d convertors, video capture, remote sensing,
keyboards, graphics tablets, OCR etc.).
Organising Data can be organised in various ways. The processes of organising
data should include non-electronic means such as paper-based
forms, as well as electronic forms.
Storing and Data can be stored or retrieved both on-line and off-line in various
Retrieving formats. Primary and secondary storage. Consideration should be
given to alternatives for such storage, including paper-based
storage, data archiving and backup, storage media. This will
include consideration of alternatives, speed and frequency of
retrieval, storage capacity, estimating storage requirements.
Processing In this section both manual and automated processing should be
considered and the advantages/disadvantages of each.
 Processing as manipulating digital data.
 The role of hardware and software.
 Programs as instructions for manipulating data.
 Elementary operation of the CPU and processor speeds.
Examination of the kinds of processing is necessary for example:
Image processing; word-processing; data processing; text-

244
 processing; video-processing; audio-processing; and the hardware
and software requirements of each.
Source: http://hsc.csu.edu.au/ipt/info_systems/2-1/what_information_processes.htm

Storage information supposed to be

 Protect and store evidence in an orderly, traceable, and retrievable fashion and in a
manner, which preserves the integrity of the evidence.
 Secure the evidence storage area from unauthorized entry.
 Maintain adequate records for all evidence placed in the evidence storage area.
 Establish procedures for routine maintenance of the contents of the evidence storage area.
 When evidence is first placed in the evidence storage area, specify procedures for
eventual removal. These procedures shall ensure that after a reasonable period of time,
the submitting agency is contacted requesting instructions for disposition of the evidence.

Step 6: Key points (5minutes)

 Retrieve is the area of study concerned with searching for documents, for information
within documents, and for metadata about documents, as well as that of searching
structured storage, relational databases, and the World Wide Web.
 Laboratory information management system (LIMS) is the accepted standard for data
storage and retrieval throughout the analytical laboratory
 There are seven information processes: Collecting, Organising, Storing & retrieving,
Processing, Analysing Transmitting & Receiving Displaying.

Step 7: Evaluation (15minutes)

 Define the term: Retrieve in laboratory information system
 What do you understand the word store in laboratory information system
 Mention information processes

References:
1. WWW.grcoatley.mcc.education.nsw.gov.au
2. President’s Emergency Plan for AIDS Relief, APHL. Guidebook for Implementation of
Laboratory Information Systems in Resource Poor Settings
3. MOHSW, APHL, CDC. Laboratory Information System, Paper Based Laboratory
Information Tools. JUNE 2007
4. MOHSW, WWW.moh.tz, Document version 1.0, Custom Software,
WWW.CustomSoftware.ie Software version 8.2, Laboratory Information System, User
Manual, Net Acquire May, 10 2008
5. MOHSW Diagnostic Service Section. Laboratory Information System, Paper Based
Laboratory Information Tools. January 2012
6. Bott, E. and Siechert, C. (2001). Microsoft Windows XP Inside Out.
7. Cook, L.R. (2001). 1st Edition, Computer Fundamentals –Understanding How they
Work. Ventage Press.
8. Herniter, M.E. (2000). Personal Computer Fundamentals for Students, Hardware
Windows 2000 Application (2nd Ed). Prentice Hall.
http://www.gcflearnfree.org/computer/
9. Joos, I. W., N. Smith, M., Nelson, R. et al. (2006). Introduction to Computers for
Healthcare Professionals (4th Ed). Barb Mews: London.
10. Morris M & Charles, M. (2003). Logol Computer Designer Fundamentals. Prentice Hall.

245
11. O’leary, T. J & O’leary, L. I. (2006). Computing Essentials, Introductory Edition.
Arizona State University: Boston Burr Ridge.

246
Session 5: Maintain the security of laboratory information

NTA Level 6, Semester 1, Module Code: MLT 06106 - Laboratory Information

Management

Total Session Time: 120 minutes

Prerequisites; GST 04202 - BASIC COMPUTER SKILLS AND INFORMATION MANAGEMENT

Learning Objectives

By the end of this session student will be able to:

1. Identify laboratory information security
2. Identify different laboratory information security requirements
3. Create computer / file password
4. Maintain professional ethics in handling laboratory information

Step 2: Define the terms

 Information can be defined as processed data.
 Security is the prevention of that information from being lost or accessed with an
authorized person.
 So in order to prevent Laboratory information you need to secure it.

Step 3: Different laboratory information security

 Access control
 This refers to exerting control over who can interact with a resource. Often but not
always, this involves an authority, who does the controlling. The resource can be a
given building, group of buildings, or computer-based information system. But it can
also refer to a restroom stall where access is controlled by using a coin to open the
door.
 Preventive maintenance
 Is a regular, repetitive work done to keep equipment in good working order and to
optimize its efficiency and accuracy. This activity involves regular, routine cleaning,
lubricating, testing, calibrating and adjusting, checking for wear and tear and
eventually replacing components to avoid breakdown. This will help the system from
o Minimizes running cost
o Prolongs life of the equipment
o Reduce equipment breakdown and down-time
o Ensure quality of laboratory services
 Confidentiality
 All employees have a responsibility to maintain the confidentiality of medical
information. Medical information should never be discussed outside of the laboratory.
It should only be discussed with the ordering doctor or an authorized representative of
the doctor. Employees should verify the identity of the individual requesting such
information
 Employees who communicate with patients, physicians or their office staff, insurance
company representatives or government employees about any laboratory activity
should only give information they know to be true and accurate. Employees should

247
 never give false information and should never guess the answer to any question. In
case of doubt, refer the person to a supervisor.
 Confidentiality can be applied by
o Keep locked is a security policy, which will give permission only authorised
person to enter in a certain room. Weakness of this approach is when the
authorised person is not there nothing will be done
o Disclose with permission, here you won’t be allowed to view some information
unless you have permission from supervisor. The weakness of this is easy to forge
the permit.
o Use password, this type of security is good because numbers are used in order to
access the system. Weakness of password is if you forget the numbers you can’t
access anything.
o Putting into confidential file here secured document is kept into file which
cannot be viewed by anyone. Confidential file has weakness because it can be
stolen or misplaced

Step 4: Identify laboratory information security requirements (25 minutes)

 Functional Requirements
 Laboratory staff
 Information Technology staff
 Patient management
 Maintenance management
 Specimen management
 Inventory Management
 System Requirements
 Software architecture
 Operating system
 Connectivity
 Database
 Support
 Operational requirements
 Training
 Backup and disaster recovery plan
 Security

Step 5: Create computer / file password (10 minutes)

 This process will depend on which operating system is in your computer but most of
Windows Operating the procedure in the same.
 Select the folder you wish to encrypt.
 Right-click the folder and click Properties.
 Click the Sharing tab.
 Check the box Make this folder private
 Click Apply and then Ok.

Step 6: Activity (15 minutes)

Activity: Create computer and file password (15 minutes)
ASK the students:. To sit in groups and create file password

Step 7: Ethics in handling laboratory information (20 minutes)

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 Ethics in handling Laboratory information introduces moral principles and values
applicable to the laboratory information system workplace. Sound ethics policies ensure
good conduct and safety within the lab. Many laboratories develop their own ethics model
for their LIS.

 Function
 In a laboratory , LIS ethics is essential for workplace performance. Employees must
consciously safeguard data from falsification and prevent dangerous situations from
happening through carelessness. Ethics policies help stop discrimination, racism and
harassment from happening in the laboratory.
 Features
 Ethics prevents negligence in the work area by holding employees accountable for
their actions. For example, it is unethical for an employee to knowingly handle a
chemical in a way that is dangerous to himself and others. It is ethical for someone to
stop that employee from handling the chemical dangerously.
 Considerations
 Poor ethics within a laboratory can have severe consequences. Civil lawsuits, criminal
charges and large fines can be filed against a business for misrepresentation of data,
client favoritism or violating environmental and state laws. Poor ethics can also
damage the laboratory's reputation, leading to government or business loss

Step 8: Key Points (5 minutes)

 Laboratory information security requirements are Operational, functional and system
requirement
 Laboratory information security can be access control, confidentiality and preventive
maintenance
 Ethics in handling Laboratory information introduces moral principles and values
applicable to the laboratory information system workplace.

Step 9: Evaluation (5)

 Ethics in handling laboratory information
 What do Confidentiality means?

References
1. "2011 LIMS Buyers Guide: Introduction". Laboratory Informatics Institute,
Inc.http://files.limstitute.com/share/lbgonline/introduction.htm. Retrieved 2011-04-25.
2. "2011 Laboratory Information Management: So what is a LIMS?". Sapio Sciences.
http://sapiosciences.blogspot.com/2010/07/so-what-is-lims.html. Retrieved 2011-04-25.
3. Vaughan, Alan. "LIMS: The Laboratory ERP". LIMSfinder.com.
http://www.limsfinder.com/BlogDetail.aspx?id=30648_0_29_0_C. Retrieved 2011-04-25
.
4. McLelland, Alan (1998). "What is a LIMS - a laboratory toy, or a critical IT
component?", pp. 1.

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Session 6: Methods of analyzing laboratory information

NTA Level 6, Semester 1, Module Code: MLT 06106 - Laboratory Information Management

Total Session Time: 120 minutes

Prerequisites

Learning Objectives

By the end of this session, students will be able to:

1. List different methods of analyzing laboratory information’s (computer, manual)
2. Explain advantages and disadvantages of different methods of analyzing information
3. Explain advantage of analyzing the laboratory information

Step 2: Different methods of analyzing laboratory information’s (30 minutes)

 Analysis is the process of breaking a complex topic or substance into smaller parts to
gain a better understanding of it. The technique has been applied in the study of
mathematics and logic, though analysis as a formal concept is a relatively recent
development.
 Analyzing Laboratory information can be analyzed manual or electronically.
 Analyze Manually
 Analyse information manual is called qualitative method.
 Analysis of qualitative (descriptive) information is a creative and critical process. The
way the information has been gathered will probably determine how it can best be
analyzed.
 For example, if drawings of a community have been done at the beginning, middle and
end of the project, can be analyzed by presenting a series of drawings to a number of
individuals and asking them to:
 Validate the drawings (are they truly representative, and if not, why not).
 Rate the difference (very good, good, not very good).

Analyszing using computer

 This is to analyze information electronically. This process need component such as
hardware,software and storage devices
 Hardware are computer itself, printers for printing results
 Storage devices like flash drive and hard disk drive
 Software for analysis.

Analysis softwares
 This are specialized computer programs for statistical analysis. There are lots of statistical
software bt the common are Statistical Package for social Science (SPSS) and Epi-Info.

Epi-Info
 public domain statistical software for epidemiology developed by Centers for Disease
Control and Prevention (CDC)
 From a user's perspective, one of the most important functions of Epi Info is the ability to
rapidly develop a questionnaire, customize the data entry process, quickly enter data into

250
 that questionnaire, and then analyze the data. For epidemiological uses, such as outbreak
investigations, being able to rapidly create an electronic data entry screen and then do
immediate analysis on the collected data can save considerable amounts of time versus
using paper surveys.
 Epi Info uses three distinct modules to accomplish these tasks: MakeView, Enter, and
Analysis. Other modules include the Report module, a mapping module, a menu module,
and various utilities such as the NutStat program.
 Statistical Package for social Science (SPSS)
 SPSS is among the most widely used programs for statistical analysis in social science. It
is used by market researchers, health researchers, survey companies, government,
education researchers, marketing organizations and others. The original SPSS manual
(Nie, Bent & Hull, 1970) has been described as one of "sociology's most influential
books" In addition to statistical analysis, data management (case selection, file reshaping,
creating derived data) and data documentation (a metadata dictionary is stored in the data
file) are features of the base software.
 SPSS places constraints on internal file structure, data types, data processing and
matching files, which together considerably simplify programming. SPSS datasets have a
2-dimensional table structure where the rows typically represent cases (such as
individuals or households) and the columns represent measurements (such as age, sex or
household income). Only 2 data types are defined: numeric and text (or "string").
 The graphical user interface has two views which can be toggled by clicking on one of the
two tabs in the bottom left of the SPSS window. The 'Data View' shows a spreadsheet
view of the cases (rows) and variables (columns).
Step 3: Advantages and disadvantages of different methods of analyzing information
(25 minutes)

Advantages of Statistical Software

 Rapidly development of questionnaire
 Quick searching information
 Customize the data entry process
 Quickly entering of data
 Accuracy
 Quick results
 Eliminate usage of papers
 Find unusual data.
 Purpose and transform data.
 Analysis everywhere.
 Sustainable innovation.

Disadvantages of Statistical software

 Suitable hardware and software start-up costs.
 Training is required
 If you delete any of your variables you cannot restore it.
 System Configuration
 Security Risks Involved

Step 4: Advantage of analyzing the laboratory information (25 minutes)

 Can enable easier and faster interpretation of information
 Correlate processing data with established data

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 Provide more detail information than descriptive statistic
 Yield insight into relationship between variables
 Generate convincing support for a given hypothesis
 Be generally accepted due to wide spread use in business and academics

Step 5: Key Points (5 minutes)

 Analysis is the process of breaking a complex topic or substance into smaller parts to
gain a better understanding of it.
 Analysis software is a specialized computer program for statistical analysis.

Step 6: Evaluation (5 minutes)

 Mention advantages of statistical software
 Mention advantages of analyzing laboratory information

Reference
1. Levesque, R. SPSS Programming and Data Management: A Guide for SPSS and SAS
Users, Fourth Edition (2007), SPSS Inc.,
2. www.peciousheat.net/chaplaincy/auditor

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Session 7: Collect and Analyse Laboratory Data

NTA Level 6, Semester 1: Module Code: MLT 06106 – Laboratory Information Management

Total Session Time: 120 minutes

Prerequisites; MLT 05110 Application of Computer in Health Laboratory

Learning Objectives

By the end of this session student will be able to:

1. Prepare tools for Laboratory information collection
2. Collect information using prepared information tools
3. Conduct gap analysis
4. Prepare assessment report
5. Maintain assessment reports

Step 2: Define ( 5 minutes)

Activity: Brainstorm (5minutes)

ASK students to define the meaning of the term ‘’

WAIT for some student response, encourage all definitions of the term.
Collect =gather/bring together information’s or data
Analyse data = evaluation of data

Step 3: Prepare tools for Laboratory information collection The various methods of data
gathering involve the use of appropriate recording forms. These are called tools or
instruments of data collection. They consist of
 Observation
 Interview
 Questionnaire
 Rating scale
 Checklist
 Document schedule/data sheet
 Schedule for institutions

 Each of the above tools is used for a specific method of data gathering:
 Observation schedule for observation method, interview schedule and interview guide
for interviewing, questionnaire for mail survey, and so on

Functions
 The tools of data collection translate the research objectives into specific questions/ items,
the responses to which will provide the data required to achieve the research objectives.
 In order to achieve this purpose, each question/item must convey to the respondent the
idea or group of ideas required by the research objectives, and each item must obtain a
response which can be analysed for fulfilling the research objectives.

253
 Information gathered through the tools provides descriptions of characteristics of
individuals, institutions or other phenomena under study.
 It is useful for measuring the various variables pertaining to the study.
 The variables and their interrelationships are analysed for testing the hypothesis or for
exploring the content areas set by the research objectives.

A brief description of the various tools of data collection is given below:

 Observation schedule
 This is a form on which observations of an object or a phenomenon are recorded. The
items to be observed are determined with reference to the nature and objectives of the
study.
 They are grouped into appropriate categories and listed in the schedule in the order in
which the observer would observe them.
 The schedule must be so devised as to provide the required verifiable and quantifiable
data and to avoid selective bias and misinterpretation of observed items.
 The units of observation must be simple, and meticulously worded so as to facilitate
precise and uniform recording.

 Interview guide
 This is used for non-directive and depth interviews.
 It does not contain a complete list of items on which information has to be elicited
from a respondent: it just contains only the broad topics or areas to be covered in the
interview.
 Interview guide serves as a suggestive reference or prompter during interview.
 It aids in focussing attention on salient points relating to the study and in securing
comparable data in different interviews by the same or different interviewers.
 Interview schedule and mailed Questionnaire both these tools are widely used in
surveys.
 Both are complete lists of questions on which information is elicited from the
respondents.
 The basic difference between them lies in recording responses.
 While the interviewer fills out a schedule, the respondent completes a questionnaire.

 Rating Scale
 This is a recording form used for measuring individual's attitudes, aspirations and
other psychological and behavioural aspects, and group behaviour.
 Checklist
 This is the simplest of all the devices.
 It consists of a prepared list of items pertinent to an object or a particular task.
 The presence or absence of each item may be indicated by checking 'yes' or 'no' or
multipoint scale.
 The use of a checklist ensures a more complete consideration of all aspects of the
object, act or task.
 Checklists contain terms, which the respondent understands, and which more briefly
and succinctly express his views than answers to open-ended question.
 It is a crude device, but careful pre-test can make it less so. It is at best when used to
test specific hypothesis.
 It may be used as an independent tool or as a part of a schedule/questionnaire.
 Document Schedule/Data Sheet.

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  This is a list of items of information to be obtained from documents, records and other
materials. In order to secure measurable data, the items included in the schedule are
limited to those that can be uniformly secured from a large number of case histories or
other records.
 Schedule for Institutions
 This is used for survey of organisations like business enterprises, educational
institutions, social or cultural organisations and the like.
 It will include various categories of data relating to their profile, functions and
performance. These data are gathered from their records, annual reports and financial
statements.

Step 4: Collect information using prepared information tools

 During collection of information, the tools are used as following:
 Observation is either an activity of a living being, such as a human, consisting of
receiving knowledge of the outside world through the senses, or the recording of data
using scientific instruments. The term may also refer to any data collected during this
activity. An observation can also be the way you look at things or when you look at
something.
o Asking a question about a natural phenomenon
o Making observations of the phenomenon
o Hypothesizing an explanation for the phenomenon
o Predicting a logical consequence of the hypothesis
o Testing the hypothesis by an experiment, an observational study, or a field study
o Creating a conclusion with data gathered in the experiment
 Interview is a conversation between two people (the interviewer and the interviewee)
where questions are asked by the interviewer to obtain information from the
interviewee.
o Informal, conversational interview - no predetermined questions are asked, in
order to remain as open and adaptable as possible to the interviewee’s nature and
priorities; during the interview the interviewer “goes with the flow”.
o General interview guide approach - intended to ensure that the same general areas
of information are collected from each interviewee; this provides more focus than
the conversational approach, but still allows a degree of freedom and adaptability
in getting the information from the interviewee.
o Standardized, open-ended interview - the same open-ended questions are asked to
all interviewees; this approach facilitates faster interviews that can be more easily
analyzed and compared.
o Closed, fixed-response interview - all interviewees are asked the same questions
and asked to choose answers from among the same set of alternatives. This format
is useful for those not practiced in interviewing.
 Questionnaire
o A questionnaire is a research instrument consisting of a series of questions and
other prompts for the purpose of gathering information from respondents.
Although they are often designed for statistical analysis of the responses, this is
not always the case. The questionnaire was invented by Sir Francis Galton.
o Usually, a questionnaire consists of a number of questions that the respondent has
to answer in a set format. A distinction is made between open-ended and closed-
ended questions. An open-ended question asks the respondent to formulate his
own answer, whereas a closed-ended question has the respondent pick an answer
from a given number of options. The response options for a closed-ended question

255
 should be exhaustive and mutually exclusive. Four types of response scales for
closed-ended questions are distinguished
 Rating Scale
o Rating scale is a set of categories designed to elicit information about a
quantitative or a qualitative attribute. In the social sciences, common examples are
the Likert scale and 1-10 rating scales in which a person selects the number which
is considered to reflect the perceived quality of a product.
o A rating scale is a method that requires the rater to assign a value, sometimes
numeric, to the rated object, as a measure of some rated attribute.

 Types of Rating Scales

o All rating scales can be classified into one of three classifications:-
 Some data are measured at the ordinal level. Numbers indicate the relative
position of items, but not the magnitude of difference. One example is a Likert
scale:
- Statement: e.g. "I could not live without my computer".
- Response options:
o Strongly disagree
o Disagree
o Agree
o Strongly agree
 Some data are measured at the interval level. Numbers indicate the magnitude
of difference between items, but there is no absolute zero point. Examples are
attitude scales and opinion scales.
 Some data are measured at the ratio level. Numbers indicate magnitude of
difference and there is a fixed zero point. Ratios can be calculated. Examples
include age, income, price, costs, sales revenue, sales volume and market
share.
 Checklist
o A checklist is a type of informational job aid used to reduce failure by
compensating for potential limits of human memory and attention.
 It helps to ensure consistency and completeness in carrying out a task.
 A basic example is the "to do list." A more advanced checklist would be a schedule,
which lays out tasks to be done according to time of day or other factors.

 Example checklist
 Checklists are often presented as lists with small checkboxes down the left hand side
of the page. A small tick or checkmark is drawn in the box after the item has been
completed.
 Other formats are also sometime used. Aviation checklists generally consist of a
system and an action divided by a dashed line, and lack a checkbox as they are often
read aloud and are usually intended to be reused.
 Document schedule/data sheet
 The concept of document has been defined as “any concrete or symbolic indication,
preserved or recorded, for reconstructing or for proving a phenomenon, whether
physical or mental" (Briet, 1951, 7; here quoted from Buckland, 1991).
 Documents are sometimes classified as secret, private or public. They may also be
described as a draft or proof. When a document is copied, the source is referred to as
the original.
 Spread sheet

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  A spreadsheet is a computer application with tools that increase the user's
productivity in capturing, analyzing, and sharing tabular data sets. It displays multiple
cells usually in a two-dimensional matrix or grid consisting of rows and columns.

Step 5: Conduct gap analysis Gap analysis is a quality-measurement tool used to identify
the gulf between actual performance and desired performance, and to recommend strategies
for bringing the ideal state into actual practice.
 Gap analysis highlights services and/or functions that have been accidentally left out,
deliberately eliminated, or is yet to be developed or procured.
 Identify Expectations
 A gap analysis begins with a thorough identification of expectations from an internal
and external perspective. Internally, determine target performance levels through
studying benchmarks and business goals. Externally, determine what customers
expect in terms of the quality and timeliness of process delivery.
 If standards do not exist, set best-of-breed performance targets and use these as the
baseline expectation of performance.
 Gather Data
 Collect relevant data about the process being improved to determine the current-state
metrics.
 There are many statistical techniques (including statistical process capability and
regression analyses) that can help provide context if direct measurements are not
possible.
 Close the Gap
 Review the expectations and the current-state data to determine where the gaps exist.
 Explore the causes of deviation from the ideal using tools like cause-effect diagrams,
and identify specific improvement efforts that can bring greater efficiency to different
parts of the process.
 Learn the Lessons
 When the improvement effort concludes, have a wrap-up meeting to discuss whether
the specific process improvements can be sustained over time, and whether
inefficiencies identified in the gap analysis affect other areas of the business and
therefore might provide a ready target for a rapid-cycle process-improvement effort

Step 6: Prepare assessment report

 Assessment report means / look like appraisal, evaluation, judgement report.
 Assessment focuses on applied clinical assessment, with an emphasis on information
relevant to the use of assessment measures, including test development, validation, and
interpretation practices.
 Articles cover the assessment of cognitive and neuropsychological functioning,
personality, and psychopathology, as well as empirical assessment of clinically relevant
phenomena, such as behaviors, personality characteristics, and diagnoses.
 Generally there are four parts of laboratory assessment report, so during preparation make
sure that, the part 1 up to 4 includes all basic requirements for laboratory assessment
report.
 Part I Includes worksheets to determine and record laboratory performance for the
immediately preceding 12 months where data is complete. Selection of the most recent
12-month period, rather than the most recent calendar year as a basis for calculation,
provides an assessment of current performance and permits inspection of laboratories at
any time during the calendar year.

257
 Part II Provides a profile of the laboratory and serves to identify resource needs.
 Part III Contains the assessment checklist for evaluation of laboratory operating
procedures and practices
 Part IV Summarizes the findings of the accreditation assessment and action planning
worksheet.

Step 7: Maintain assessment report Maintain assessment report/any report means

preserve/retain,/sustain/ keep.
 Assessment reports or any document reports for Clinical activities and Laboratory are
maintained for future references
 Make sure assessment report/document & records properly maintained, easily accessible
and indicated on an up-to-date Master List.
 Example Quality Assurance assessment are documented and reported for future
references.
 Confidentiality, including access by authorized users, is maintained.
 File copies, and reference copies as required, are easily located and available and
maintained in good condition
 Maintenance system ensures distributed documents are complete and current.
 Range communications, distribution networks, training programmers for document users
in maintaining documents, quality assurance checks, access and retention of documents,
handling referenced and non-referenced documents.

Step: Key points (5minutes)

 The various methods of data gathering involve the use of appropriate recording forms.
These are called tools or instruments of data collection. They consist of: Observation,
Interview, questionnaire, Rating scale Checklist, , Document schedule/data sheet,
Schedule for institutions
 Gap analysis highlights services and/or functions that have been accidentally left out,
deliberately eliminated, or is yet to be developed or procured.

Step 7: Evaluation (5minutes)

 What are the tools or instruments of data collection?
 What is a checklist?
 What is a questionnaire?

References:
1. President’s Emergency Plan for AIDS Relief, APHL. Guidebook for Implementation of
Laboratory Information Systems in Resource Poor Settings
2. MOHSW, APHL,CDC. Laboratory Information System, Paper Based Laboratory
Information Tools. JUNE 2007
3. MOHSW, WWW.moh.tz, Document version 1.0, Custom Software,
WWW.CustomSoftware.ie Software version 8.2, Laboratory Information System, User
Manual, Net Acquire May, 10 2008
4. MOHSW Diagnostic Service Section. Laboratory Information System, Paper Based
Laboratory Information Tools. January 2012
5. Bott, E. and Siechert, C. (2001). Microsoft Windows XP Inside Out.
6. Cook, L.R. (2001). 1st Edition, Computer Fundamentals –Understanding How they
Work. Ventage Press.

258
7. Herniter, M.E. (2000). Personal Computer Fundamentals for Students, Hardware
Windows 2000 Application (2nd Ed). Prentice Hall.
http://www.gcflearnfree.org/computer/
8. Joos, I. W., N. Smith, M., Nelson, R. et al. (2006). Introduction to Computers for
Healthcare Professionals (4th Ed). Barb Mews: London.
9. Morris M & Charles, M. (2003). Logol Computer Designer Fundamentals. Prentice Hall.
10. O’leary, T. J & O’leary, L. I. (2006). Computing Essentials, Introductory Edition.
Arizona State University: Boston Burr Ridge.

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Session 8: Prepare laboratory information report

NTA Level 6, Semester 1, Module Code: MLT 06106 - Laboratory Information

Management

Total Session Time: 120 minutes

Prerequisites: MLT 05110 Application of Computer in Health Laboratory

Learning Objectives

By the end of this session, students will be able to:

1. Define the terms
2. Assemble different reports
3. Discuss methods of report presentation
4. Compile the assessment report including the introductions, background results,
conclusions recommendations and summary
5. Keep Records

Step 2: Definition of Terms (5 minutes)

Activity: Brainstorm (5 minutes)

ASK students to define the meaning of the term ‘Report’

WAIT for some student response; encourage all definitions of the term.
SUMMARIZE the responses using the information below.

 Report is a textual work (usually of writing, speech, television, or film) made with the
specific intention of relaying information or recounting certain events in a widely
presentable form.
 A report is a presentation of facts and findings, usually as a basis for
 Recommendations; written for a specific readership, and probably intended to be kept as a
record.
 Some examples of reports are: scientific reports, recommendation reports, white papers,
annual reports, auditor's reports, workplace reports, census reports, trip reports, progress
reports, investigative reports, and budget reports

Step 3: Assemble different reports (20 minutes)

 Headings to indicate topics
 Content to a specific audience
 Mode of Presentation
 Where to store?

Step 4: Methods of report presentation (50 minutes)

 This is the way of how to present your report. In order to present a good report, it should
be presented in tabular, graphical and graphical.

260
 Tabular presentation
 Presentation of data in tables so as to organization them into a compact, concise and
readily comprehensible form.
 They can display the characteristics of data more efficiently than the raw data.
 Types of Tabular
 Simple Table
o One variable (quantitative or qualitative)
o Corresponding frequency

 Cross tabulation:
 Two–dimensional tables: two variables are cross classified
 Three-dimensional tables: three variables are cross-classified (outcome of treatment
by age and sex)

 Contingency table
 This type demonstrating the relationship between two or more variables

 Criteria of a proper table

 Simple
 Understandable and self explanatory
 All symbols, codes, or abbreviations should be explained in details in a foot note
 Each row or column should be labeled concisely and clearly
 Units of the data should be clearly mentioned
 The title should be clear, precise, and should answer the questions, what? Where and
when?
 Totals should be shown

 Criteria of a proper table

 The title should be separated from the body of the table by lines or spaces
 Avoid too much ruling
 If the data are not original, their source should be mentioned as a foot note or in the
title

Figure 1. Example of Table

261
Figure 2. Example of Table

 Graphical Presentation
 The use of diagrams to display distribution or characteristics of one or more sets of
data in a compact and readily comprehensible form. They can provide a better visual
appreciation of characteristics of data than tabular presentation
 Graphs can be drawn by hand or on a computer. Program such as Microsoft Excel,
produce graphs and perform some statistical calculations. Statistics program such as
SPSS is higher-powered program that perform many statistical tests as well as
producing graphs.

 Graphs
 It is a pictorial display of quantitative data using a coordinate system, where the X is
the horizontal axis and the Y is the vertical axis.
 X-axis usually includes the independent variable (method of classification)
 Y-axis includes the dependent variable

 General Principles
 Simple, no more lines or symbols should be used in a single graph than the eye can
follow.
 Self-explanatory
 The title can be placed at the top, or at the bottom of the graph.
 When more than one variable or relation is shown on a graph, each should be
differentiated clearly by a “key”
 Scale divisions and the units into which the scales is divided should be indicated
clearly

 Different types of graphs are as follows

 Arithmetic scale line graph
o This is particularly beneficial to present the trend of one or more sets of data.
o In general the Y-axis is 2/3 the X-axis
o An equal distance represents an equal quantity anywhere on an axis.
o The slop of the line indicates the rate of increase or decrease

262
 o Two or more lines following a parallel path indicate identical rates of increase or
decrease

 Arithmetic scale line graph

o Trends in Cardiovascular Operations and Procedures
Procedures in Thousands

2000

1500

1000

500

0
79 80 85 90 95 00 01 02
Years

Catheterizations Open-Heart Bypass

PTCA Endarterectomy Pacemakers

Source: CDC/NCHS

 Histogram
 Graphical display of frequency distribution of quantitative variable.
 The values of the quantitative variable (as class interval) will be placed on the X-axis
(representing the width of the rectangles), and the corresponding frequency (or
relative frequency) will be placed on the Y-axis (representing the height of the
rectangles)

 The area is proportional to the height, and examining the relative height of the
respective bar can directly compare the frequencies in different categories.
 It is important that the class interval should be equal; otherwise the area should be
compared.
 Only one set of data can be shown in one histogram

 Frequency Polygon
 Another form of graphical presentation of frequency distribution of quantitative
variables.
 It is similar to the histogram, but instead of using rectangles to present data, the
midpoint of the top of each rectangle are plotted, and connected together by straight
lines.
 More than one set of data can be demonstrated on the same graph, to facilitate direct
comparison.
 It provides information about underlying characteristics of data.
 The area under the frequency polygon is equal to the area under the equivalent
histogram

 Cumulative frequency polygon, and cumulative frequency charts

263
  The cumulative frequency are plotted against the upper tabulated value for each class .
 It is used to estimate by interpolation the frequency of occurrence of a value of the
variable less than or equal to a specified value. Stem-and Leaf Plot

 Scatter diagram
 A pair of measurements is plotted as a single point on a graph.
 The value of one variable of each pair is plotted on the X axis and the value of the
other variable is plotted on the Y axis
 The pattern made by the plotted points is indicative of the relationship between these
two variables, which might be linear (if they follow straight line) or curvilinear (if the
pattern doesn't follow straight line) A scatter diagram could suggest:

 No relationship: when one variable changes with no change in the other variable, or
when the pattern is buzzard
 Linear relationship: an increase in the 1st variable is associated with an increase
(positive) or decrease (negative) in the 2nd variable, and the pattern follows a straight
line.
 Curvilinear (positive or negative) relationship: the pattern of increase or decrease will
not follow a straight line.

 Pictorial Presentation
 Is visual representation as by photography or painting
 Pictograms
 Uses series of small identifying symbols to present the data. Each symbol represents a
fixed number of units

 Charts
 These are pictorial methods of presenting statistical information . They can convey
many different types of information as lengths, proportion, geographical distribution,
and special relationships.
 Bar chart
 Used to present discrete or qualitative data
 It includes separated bars of equal width

264
  The method of classification of the variable is usually placed on the X-axis, and the
Y-axis usually represents the corresponding frequency or relative frequency.

 It can be used to present more than one set of data simultaneously using different colors,
shades, etc. In this case a key should be used.
 Comparison will be made on the basis of the height of the bar (frequency). i.e.: the width
of the bar has no value.
 It is important that the vertical axis should start at the zero, otherwise the heights of the
bars are not proportional to the frequencies.

 Distribution of coronary risk factors among patients with chronic metabolic syndrome

 Component bar chart

 It is a type of charts based on proportion.
 It uses bars that are either shaded or colored to show the relative contribution of each
of its components

265
Estimated Direct and Indirect Costs of Cardiovascular Diseases and Stroke

450
400 393.5
Billions of Dollars 350
300 254.8
250
200
142.1
150
100 56.8 59.7
50 27.9
0

Total CVD*
Heart Failure
Stroke
Disease

Hypertensive
Coronary

Disease

Congestive
Heart

Heart

Disease
Source: Heart Disease and Stroke Statistics – 2005 Update.

 Pie chart
 It is a type of charts based on proportion
 It uses wedge-shaped portions of a circle to illustrate the relative contribution of each
part to the total (division of the whole into segments)
 To demonstrate the angel of each wedge, we multiply the relative frequency of each
division by 360 degrees.
 Start at 12 o’clock,
 It is preferable to arrange segments in order of their magnitude (starting with the
largest), and proceed clockwise around the chart.

Percentage Breakdown of Deaths From Cardiovascular Diseases

Coronary Heart Disease
13%
Stroke
0%
4%
Congestive Heart Failure
5%
High Blood Pressure
6% 53%
Diseases of the Arteries

Rheumatic Fever/Rheumatic
Heart Disease
18%
Congenital Cardiovascular
Defects
Other

Source: CDC/NCHS.

 Map charts

266
  These are used to present the geographical distribution of one or more sets of data
 Flow chart
 It is used to illustrate the sequence of a series of events.
 It is characterized by multiple arrows
 Development of Atherosclerotic Plaques

Reach Pleque Lipid Fatty Stricky Normal

Thromobus

Ross R. Nature. 1993;362:801-809.

Lipid Core

 Suggestions for the design and use of tables, graphs, and charts
 Choose the method most effective for data and purpose
 Point out one idea at a time
 Limit the amount of data and include one kind of data in each presentation
 Black and white are better for exhibits that are to be reproduced
 Use adequate , properly located titles and labels
 Mention the source , if it is not yours
 Care and caution in proposing conclusions

Step 5: Compile the assessment report (10 minutes)

 To compile report the following steps should be followed
 Introduction
 Background
 Results
 Conclusion
 Recommendation
 Summary

Step 6: Keep Records (20 minutes)

 Keeping a record of your activities, plans and tasks is essential to ensuring you can recall
key facts, numbers, contacts, dates etc.

267
 The question becomes, what kind of record, and what system should you use to record
 A record should be no more than a tool to achieve other ends, not an end in itself. The
goal is to keep a brief record of the important information you may need later so that your
energies can be channelled into doing project work.
 You should keep a different record book for each project or campaign, and the record
books you use should be different from a daily calendar that you use to keep day-to-day
appointments.
 This will help you keep your records and separate tasks for separate projects organized,
and your day-to-day life organized also.
 The record book should be large, but not too large. Large enough so that you are not
running out of pages often, but it should not be so large that it is a burden to carry around.
Of course, you can also use one of computerized record books now available as they are
small enough to carry with you.
 Record only essential information. Record what you will likely need to recall later, but
not so much that you are spending unnecessary amounts of time in your record keeping.
In most projects, the vital information includes:
 Day, date, time, person, number, summary of conversation of all phone calls. Special care
should be made to get the correct spelling of the person's name (it is often easy to do this
at the beginning of a conversation; in some cases, just asking about the spelling shows
that you are serious and that you consider the person an important contact).
 Summaries of contacts with experts, public officials' administrators, etc. Usually you can
make notes during such meetings. Occasionally, you can't (e.g. at a meeting with a
politician giving you inside information who might feel more constrained and apt to
censor or leave out information if s/tre is talking in the presence of someone who is
recording virtually everything being said). In such cases, you will want to pay close
attention during the meeting, to the point of repeating important names in your mind or
using memory tricks so you don't forget, and then making a summary of the conversation
afterwards. Many people find that just making the summary later helps over a period of
months to increase your ability to pick out and remember important items.
 Summaries of project meetings can also be recorded in your log, making it a one-stop
summary of what is happening in your project. The key to note-taking is to stick to key
new information, summaries of important information from project members working on
other parts of the issue than you are, specific dates, events coming up, contacts,
assignments, etc. It is a valuable skill to develop to be able to record the key information
of a meeting as it progresses without hindering your ability to participate.
 Go through your log regularly (e.g. once each week) to make sure you did everything you
wanted to or agreed to do. Also, reviewing meeting, phone and contact summaries might
suggest new ideas to you.
 Review your record book for key information occasionally. As your record book fills up,
it's a good idea to go through and underline key names and./or circle key topics with a red
pencil for quick reference in the future.

Step 7: Key Points (5 minutes)

 Methods of report presentation are tabular, graphical and pictorial
 A record should be no more than a tool to achieve other ends, not an end in itself. The
goal is to keep a brief record of the important information you may need later so that your
energies can be channelled into doing project work.

Step 8: Evaluation (5 minutes)

268
 Mention components of bar charts
 List different types of graphs

References
1. How to write reports John Mitchell. (Fontana/Collins)
2. Report writing A. E. Derbyshire. (Edward Arnold)
3. Writing technical reports Bruce M. Cooper. (Pelican)
4. The technique of clear writing Robert Gunning. (McGraw-Hill)

269
Session 9: Electronic methods for disseminating / communicating
laboratory information

NTA Level 6, Semester 1, Module Code: MLT 06106 - Laboratory Information

Management

Total Session Time: 120 minutes

Prerequisites

Learning Objectives

By the end of this session student will be able to:

1. Explain electronic methods of disseminating / communicating laboratory information
2. Explain advantages and disadvantages of using electronic method for disseminating /
communicating laboratory information
3. Differentiate programs used in disseminating / communicating laboratory information

Step 2: Definition of Terms (10 minutes)

Activity: Brainstorm (10 minutes)

ASK students to define the meaning of the term ‘dissemination and communication’
WAIT for some student response, encourage all definitions of the term.
SUMMARIZE the responses using the information below.

 Dissemination
 In simple terms, the term dissemination of information is defined as the process of
making information available to the public.

 Communication
 Is the activity of conveying information. Communication has been derived from the
Latin word "communis", meaning to share. Communication requires a sender, a
message, and an intended recipient, although the receiver need not be present or
aware of the sender's intent to communicate at the time of communication; thus
communication can occur across vast distances in time and space. Communication
requires that the communicating parties share an area of communicative commonality.
The communication process is complete once the receiver has understood the message
of the sender. Feedback is critical to effective communication between parties.

Step 3: Methods of disseminating/communicating laboratory information (20 minutes)

 Print
 Brochures
 Publications (Reports, Newsletters, Briefs)
 Newspapers
 Magazines
 Meetings/Conferences

270
 Radio
 Television
 Internet

 Computer methods of Disseminating Information electronically are

 Listservs
This is an automatic mailing list server developed by Eric Thomas for BITNET in
1986. When e-mail is addressed to a LISTSERV mailing list, it is automatically
broadcast to everyone on the list. The result is similar to a newsgroup or forum,
except that the messages are transmitted as e-mail and are therefore available only to
individuals on the list.

o Effective way to reach target audience

o Require e-mail access only (except in some cases for registration)
o Cost-efficient
o Accessible

Examples of Listservs
o COMMUNITY-HEALTH-L (Management Sciences for Health)
o DemoNetAsia
o Development Forum (World Bank)
o H-DEMOG (Michigan State University and National Endowment for the
Humanities, US)
o Interagency Gender Working Group (Population Reference Bureau)
o Population (Audubon Population and Habitat Program)
o PROCAARE: Program for the Collaboration Against AIDS and Related
Epidemics (Harvard AIDS Institute)
o Repronet-L (JHPIEGO Corporation)

 Development Forum (World Bank) www.worldbank.org/devforum

o Electronic forum for dialogue and knowledge sharing within development
community
o Emphasis is on learning from stakeholders in developing countries
o Ongoing series of development dialogues that vary in content, format, and
duration
o Each usually focused on a particular subject and limited in duration
o Accessible via web and e-mail
o Open to public

Development Forum (World Bank)

271
  Dissemination Website
o Reach a wider audience
o More permanent
 Examples
o id21
o InfoShare

 Population and Health InfoShare www.phishare.org

o Electronic library of material from partner organizations
o Platform for sharing information on reproductive and child health, HIV/AIDS,
and population
o Partner organizations present study results, reports, presentations, and other
materials

InfoShare Homepage

 InfoShare Features
o Web pages about the organization

272
 o Email document distribution
o Data on use of the material
o Material listed in InfoShare E-mail updates

 Email Distribution & Updates Data on Use of the Material

 Membership
o Free
o Complete registration form
o Organizations with science-based research, policy, or program findings relevant to
less developed countries

 Registration

 Contributing Material
o Add new documents
o Manage documents

273
 o View usage statistics
o Edit account information and website profile

Step 4: Advantages and disadvantages of using electronic method for disseminating /

communicating laboratory information (15 minutes)
 Advantages of using electronic disseminating laboratory information system are
 Inexpensive
 Fast, efficient
 Easy to update
 Readily available
 Wide audience
 Target audience
 Easily accessible for users
 Disadvantages of using electronic disseminating laboratory information system
 Loss of data
 Require training personnel
 Require internet connection

Step 5: Different programs used in disseminating / communicating laboratory

information (15 minutes)
 Electronic mail (E-mail) program
 E-mail is a program, which will allow computer user to read and send electronic mail.
s a method of exchanging digital messages from an author to one or more recipients.
Modern email operates across the Internet or other computer networks. Some early
email systems required that the author and the recipient both be online at the same
time, in common with instant messaging.

 Website
 Is a set of related web pages containing content (media) such as text, image, video,
audio, etc. A website is hosted on at least one web server, accessible via a network
such as the Internet or a private local area network through an Internet address known
as a Uniform Resource Locator. All publicly accessible websites collectively
constitute the World Wide Web.

Step 6: How to use listserv and dissemination website (45 minutes)

Activity: View dissemination sites (45 minutes)

ASK the students:. To sit in groups and open dissemination website

Step 7: Key points (5 minutes)

 Dissemination of information is defined as the process of making information available to
the public.
 Computerized methods of Disseminating Information electronically are
 Listservs
 Dissemination Website
 Programs used in disseminating / communicating laboratory information
 Electronic mail (E-mail) program
 Website

Step 8: Evaluation (5 minutes)

274
 What are the advantages of electronic dissemination of laboratory information?
 What are the disadvantages of electronic dissemination of laboratory information?

References
1. "2011 LIMS Buyers Guide: Introduction". Laboratory Informatics Institute,
Inc.http://files.limstitute.com/share/lbgonline/introduction.htm. Retrieved 2011-04-25.
2. "2011 Laboratory Information Management: So what is a LIMS?". Sapio Sciences.
http://sapiosciences.blogspot.com/2010/07/so-what-is-lims.html. Retrieved 2011-04-25.
3. Vaughan, Alan. "LIMS: The Laboratory ERP". LIMSfinder.com.
http://www.limsfinder.com/BlogDetail.aspx?id=30648_0_29_0_C Retrieved 2011-04-25.
4. McLelland, Alan (1998). "What is a LIMS - a laboratory toy, or a critical IT
component?", pp. 1.

275
Session 10: Transmit electronic information to appropriate receiver

NTA Level 6, Semester 1, Module Code: MLT 06106 - Laboratory Information Management

Total Session Time: 120 minutes

Prerequisites

Learning Objectives

By the end of this session, students will be able to:

1. Define electronic information
2. Identify appropriate receiver
3. Describe how to send electronic information to the receiver
4. Describe how to track information for feedback
5. Describe how to keep records of electronic information transmitted

Step 2: Define electronic information (10 minutes)

Activity: Brainstorm (10 minutes)

TASK students to define the meaning of the term ‘Electronic information’

WAIT for some student response, encourage all definitions of the term.
SUMMARIZE the responses using the information below.

 Information is data that has been verified to be accurate and timely, is specific and
organized for a purpose, is presented within a context that gives it meaning and relevance,
and that can lead to an increase in understanding and decrease in uncertainty.
 Electronic information can be defined as the management of information that is
recorded on printed or electronic media using electronic hardware, software and
networks. It includes the description of strategies, processes, infrastructure, information
technology and access management.

Step 3: Identify appropriate receiver (20 minutes)

 You should know who is the receiver? What do we really know about them? Often, they
are just a dim and shadowy figure in the mind, but we can usually get a clearer picture by
asking three questions:
 What does the receiver know?
When you want to send electronic information two common mistakes are to
overestimate a receiver knowledge-and blind them with science, or to underestimate it
- and bore them to tears. We must always try to discover how much the reader knows
already, so that we can communicate at their level of knowledge.
 What are the receiver attitudes?
However good our ideas, they may get thrown out if we don't take account of these,
the receiver special interests, likes, and dislikes. The truth has many faces, and it is
only sensible to feature the one most likely to appeal to them.
 What does the receiver really want?

276
 The receiver is rarely a passive recipient of our report, to be swayed this way and that
by our arguments. We'll need to find out just what their hopes and expectations are.
Then we shall know what we're up against, and can prepare our case accordingly

Step 4: Sending electronic information to the receiver (20 minutes)

 Identify information receiver
 Identify channels of transfer information (Bluetooth, telephone, internet)
 Identify where the information is stored
 Identify type of information (text or pictorial)
 Identify size of information to be sent

Step 5: Tracking information for feedback (20 minutes)

 Clarify
 Ask questions for clarification to check if you have understood the idea / the behavior
well. Avoid questions that imply criticism.
o Value
 State explicitly what you appreciate in the behaviour or idea. Avoid going
straight through to negative points.
o Concerns and suggestions
Concerns
 Make clear what you don’t like or what is worrying you. Avoid speaking en
absolute and accusing terms. Make clear that what you say is subjective.
 Suggestions/Expectations
 Offer concrete suggestions or make expectations clear. Be clear and
constructive.

Step 6: Keeping records of electronic information transmitted (10 minutes)

 Provide file name
 Identify the size of information
 Identify means of storing information
 Create copy of the information for backup

Step 7: Key Points (5 minutes)

 Information is data that has been verified to be accurate and timely, is specific and
organized for a purpose, is presented within a context that gives it meaning and relevance,
and that can lead to an increase in understanding and decrease in uncertainty
 In order to identify information receiver you should know who is the receiver? What do
we really know about them, and what do receiver want.

Step 8: Evaluation (5 minutes)

 What is electronic information?
 How to keep records of electronic information transmitted
 How to track information for feedback

Reference
1. David Bearman, "Guidelines for the Management of Electronic Records: A Manual for
Policy Development and Implementation, Electronic Records Management Guidelines:
A Manual for Policy Development and Implementation (New York, 1990)

277
2. Walch, "The Role of Standards in the Archival Management of Electronic Records," pp.
41-42

278
Session 11: Tele-medicine for pathological interpretation

NTA Level 6, Semester 1, Module Code: MLT 06106 - Laboratory Information Management

Total Session Time: 120 minutes

Prerequisites

Learning Objectives

By the end of this session, students will be able to:

1. Describe Tele-medicine
2. Identify requirements for tele-medicine (computer, digital camera, network connections,
telephone)
3. Use of each requirement for tele-medicine
4. Explain importance of tele-medicine
5. Take picture / photograph for tele-medicine
6. Communicate picture/photograph through tele-medicine for pathological interpretation
7. Document the results of pathological interpretation

Step 2: Tele-medicine (20 minutes)

 Basically tele-medicine is the combination of medicine & information technology.
 It is used to transfer information from one place to other,by using audio or video methods.
Telemedicine is the examination of patients from distance via electronic connection is the
use of telecommunication and information technologies in order to provide clinical health
care at a distance.
 It helps eliminate distance barriers and can improve access to medical services that would
often not be consistently available in distant rural communities. It is also used to save
lives in critical care and emergency situations.
 These technologies permit communications between patient and medical staff with both
convenience and fidelity, as well as the transmission of medical, imaging and health
informatics data from one site to another.

 Telemedicine can be broken into three main categories:

 Store-and-forward,
 Remote monitoring and
 Real-time interactive services.

Step 3: Requirements for tele-medicine (10 minutes)

 For tele medicine to take place it require the following
 Computer
 Digital camera
 Network connections
 Telephone
 Computer peripherals

Step 4: Use of each requirement for tele-medicine (10 minutes)

279
 Computer is is for storing, editing and presenting your pictures
 Digital camera is for taking pictures
 Network connections is the channel of communication. When sending pictures in your
computer they will be transfered through network channels
 Telephone allow voice communication between people

Step 5: Explain importance of tele-medicine (15 minutes)

 Increase of customers
 Higher income/Sales
 Improvement of social fame
 Economies of scale
 Experience and possibility of undertaking complicated incidents
 Higher reliability of diagnoses
 Reduction of required time for customer service

Step 6: Take picture / photograph for tele-medicine (10 minutes)

 When take picture for telemedicine you have to create quality picture and which will be
understood by the customer or audience.

Step 7: Communicate picture/photograph through tele-medicine for pathological

Interpretation (minutes)
 Identify what is needed at that time
 Identify means of communication
 Identify who is the receiver
 Summarize picture instruction
 Identify receiver location

Step 8: Document the results of pathological interpretation (20 minutes)

 All relevant documentation is to be obtained and reviewed prior to the session.
 A full explanation is to be given to the patient and where applicable their family
 Patient consent is to be obtained and documented before the session.
 At the start of the session, all participants are to introduce themselves
 If necessary the camera(s) is to be readjusted to reassure participants that there is no one
observing without permission
 If necessary the staff member in charge of the session is to give an explanation of the
technical aspects of the Telemedicine equipment including sound quality and time delays,
as well as camera placement.
 The session is then to be conducted.
 If the session has involved a patient then the session is to be documented in the patient’s
clinical record

Step 9: Key Points (5 minutes)

 Telemedicine It is used to transfer information from one place to other, by using audio or
video methods
 Telemedicine helps eliminate distance barriers and can improve access to medical
services that would often not be consistently available in distant rural communities

280
Step 10: Evaluation (5 minutes)
 Importance of telemedicine
 Mention telemedicine categories

Reference
1. Mendelson Daniel N. and Salinsky Eillen Miller, (1997), “Health Information Systems
and the Role of State Government”, Health Affairs,
2. Olumide O. S., Adewale S., (2004), “An internet – based telemedicine system in
Nigeria”,
3. TELEMEDICINE JOURNAL AND e-HEALTH Volume 8, Number 1, 2002 © Mary
Ann Liebert, Inc
4. Bedi B. S., (2003), “Telemedicine in India Initiatives and Perspective”, eHealth:
5. Jennett P, Jackson A, Ho K, Healy T, Kazanjian A, Woollard R, et al . The essence of
telehealth readiness in rural communities: an organizational perspective. Telemed J E
Health 2005

281
Chapter 7

Module Code: MLT 06107: Laboratory Quality Management System

282
Session 1: Pre-Analytical Phase Of The Quality Assurance Cycle

NTA Level 6: Semester 1, Module Code: MLT 06107: Laboratory Quality

Management System

Total Session Time: 120 minutes

Pre-requisites
MLT05104 Quality Assessment of Laboratory Services
MLT05106 Calibration of Laboratory Equipment and Instrument
MLT04208 Occurrence Management and Record Keeping
MLT04103 Laboratory Safety and Waste Management

Learning Objectives
By the end of this session, students are expected to be able to:
1. Define pre-analytical phase of the quality assurance cycle
2. List processes required for pre-analytical phase
3. Explain pre-analytical phase of the quality assurance cycle
4. List essential supplies needed to support Pre-analytical phase processes
5. Describe, using of organogram, laboratory services at a regional level
6. Explain personnel competence assessment
7. Describe procedures for laboratory bio-safety and containment
8. Describe proper packaging, storage and transportation of laboratory specimens
9. Explain the importance of recording and drawing temperature chart
10. Organize the laboratory workplace to allow for smooth, efficient service

Step 2: Activity: List processes required for pre-analytical phase (10 minutes)

List of processes in the pre-analytical phase:

 Patient/Client Preparations
 Sample Collection
 Personnel Competency
 Test Evaluations
 Sample Receipt and Accessioning
 Sample
 Transport

Step 3: Explain pre-analytical phase of the quality assurance cycle

 The processes in the Quality Assurance Cycle:
 Pre-analytic:
o Specimen collection and transport guidelines; criteria for acceptability of
specimens
 Standardized patient identification procedures
 Standardized specimen labeling procedure

283
  Written specimen collection procedures with correct containers and handling
procedures
 Defined quality indicators for specimen collection and transport process
 Written and enforced specimen rejection policies
 Written procedures for situations requiring redraws

Figure 1: The laboratory Quality Assurance Cycle

Source: Module 5: Laboratory Process Management, Training Modules for Managers of
HIV/AIDS Care and Treatment Centres in Tanzania, Laboratory Management, MOHSW,
July 2008

Figure 2: The Laboratory Quality System Essentials

284
Source: Module 5: Laboratory Process Management, Training Modules for Managers of
HIV/AIDS Care and Treatment Centres in Tanzania, Laboratory Management, MOHSW,
July 2008

Step 4: List essential supplies needed to support pre-analytical phase processes (5

minutes)

Activity: In class exercise

ASK the students to list essential supplies needed to support pre-analytical phase processes

SUMMARIZE their responses and confirm correct answers using notes below
 List essential supplies needed to support pre-analytical phase processes:
 Specimen collection containers (urine, blood, stool, swabs, CSF, transport media,
glass slides)
 Labels
 Markers
 Forms
 SOPs for specimen collection (refer to Specimen Collection Manual)
 Disinfectants, antiseptic
 Material Safety Data Sheets (MSDS)
 First aid kit
 Tourniquet
 Plaster
 Time (wall clock or wrist watch – needed to note time of collection)
 Occurrence logbook
 Register book
 Specimen transportation guidelines
 Environmental monitoring tools and devices
 Protective gears

Step 5: Describe, using of organogram, laboratory services at a regional level (20

minutes)
 Organizes jobs along lines of authority
 Defines reporting structure and span of control
 Defines authority to make decisions and accountability for results
 Works together with job descriptions to define the working structure of the organization

285
Figure 3: An example of laboratory organisational structure at a regional hospital level
Source: Mount Meru Regional Hospital, Arusha

Step 6: Personnel competence assessment

 Define competence assessment
 Competence assessment is defined as: having the essential ability to perform specific
tasks that are part of the total testing process
 Finding the right person to do the job at the time needed should be considered based on
the level of competence and type of pre-analytical activities required
 Designed to help employees develop skills to perform specific job tasks
 Uses SOPs and job-related documents
 Measures training outcomes using competency assessment
 Important competencies – those competencies that are important to job performance and
have an important impact on quality of care

Figure 4: Blood draw procedure

Source: Module 5: Laboratory Process Management, Training Modules for Managers of
HIV/AIDS Care and Treatment Centres in Tanzania, Laboratory Management, MOHSW,
July 2008

286
Step 7: Procedures for laboratory bio-safety and containment (15 minutes)
 Define biosafety
 Biosafety is: the application of a combination of laboratory practices and procedures,
laboratory facilities and safety equipment when working with potentially infectious
microorganisms
 Good Biosafety Practice
 Awareness of hazards
 Knowledge of how laboratory infections occur
 Knowledge of procedures and techniques to reduce hazards
 Good laboratory practices
 Biosafety Process
 Awareness
o Advise workers of possible exposures, safeguards and responsibilities
 Training
o Inform workers of hazards of their work, and use of appropriate practices,
techniques and procedures
 Vigilance
o Maintain vigilance to guard against safety procedure compromises or errors
 Biosafety Requirements
 A supervisor is required for oversight
 Standard Operating Procedures must be written (SOPs)
 Training of personnel must occur
o Awareness of potential hazards
o Work practices and techniques
 Biosafety manual specific for each laboratory area
 Blood-borne Pathogens Exposure Control Plan
 Who could be exposed?
o Classify all staff with possible exposure to blood and/or body fluids
 How will we prevent exposure?
o Employee training, safety devices, gloves, disinfection, no eating/drinking, SOP
for each work practice with risk, Hepatitis B vaccine
 What happens if exposure occurs?
o Post-exposure medical follow-up and treatment
 Using Biosafety Equipment
 Use appropriate biosafety equipment correctly because each and every biological
sample is potentially infectious
 Staff are at risk:
o During sampling
o During transport of sample
o At the opening of the sample
o During handling of the sample in the laboratory
 Precautions During Sample Collection
 Clean the outer tube with 10% diluted household bleach (hypochlorite)
 Wear gloves
 Wear laboratory coat, mask, and protective glasses appropriately
 Use evacuated tubes (vacutainers) for blood sampling
 Organize and disinfect bench space with 10% hypochlorite
 Clean spills with chlorine 10%
 Decontaminate equipment and materials by soaking in chlorine 10%

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  Wear gloves, lab coat, (mask, glasses)
 Dispose of needles in sharps containers without re-capping,
 Disinfection (sodium hypochlorite %),
 Do not recap, bend, or manipulate needles in any way
 Precautions During Testing
 Use gauze to cover tubes when removing stoppers
 Centrifuge tubes with stoppers on
 Wear gloves and lab coats
 Wear goggles when changing instrument tubing or probes
 Disinfect work areas and equipment surfaces carefully per guidelines
 Perform high risk procedures under a biologic safety cabinet

Figure 5: Safety Cabinet Class II

Source: Module 10 - Safety and facility management. Training Modules for Managers of
HIV/AIDS Care and Treatment Centres in Tanzania, Laboratory Management, MOHSW,
July 2008

 Decontamination
 Process or treatment that renders a medical device, instrument, or environmental
surface safest to handle
 A decontamination procedure can range for sterilization to simple cleaning with soap
and water
 Sterilization, disinfection and anti-sepsis are all forms of decontamination
 Biosafety Resources
 Biosafety in Microbiological and Biomedical Laboratories
o BMBL 4th Edition
o CDC/NIH
o In country safety guidelines
o WHO Biosafety Guidelines
o ISO 15 190
o Documentation on disinfectants

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Figure 6: Biosafety Reference Materials
Source: Module 10 - Safety and facility management. Training Modules for Managers of
HIV/AIDS Care and Treatment Centres in Tanzania, Laboratory Management, MOHSW,
July 2008

Step 8: Proper packaging, storage and transportation of laboratory specimens (5

minutes)
 All three categories of samples have specific packaging instructions and labeling
requirements depending on their classification. All potentially hazardous material requires
triple packaging.
 The primary container is a tube or vial containing the sample; it is made of glass, metal or
plastic. It must have a leak-proof seal; if necessary it can be wrapped with waterproof
tape. The tube or vial must be labeled with a permanent marker.
 The secondary container is a watertight polyethylene box intended to protect the primary
container. It is supplied with cardboard or bubble-wrap, or a vial holder in which several
primary containers can be placed in order to protect them. Absorbent material (gauze,
absorbent paper) must be added in a sufficient quantity to absorb the fluid completely in
case of breakage.
 The outer container is a strengthened cardboard box used to protect the secondary
container. Both the secondary and outer containers are reusable as long as they are intact,
but old labels must be removed.

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Figure 7: Triple packing of infectious materials
Source: Guidelines on Specimen Collection, Storage and Transportation, AMREF
Publication

Step 9: Importance of recording and drawing temperature chart (5 minutes)

 It is important to monitor the environment and equipment temperature by recording and
plotting them accordingly
 It is good laboratory practice
 It serves as an early warning system for equipment and environment being monitored

Step 10: Organization of the laboratory workplace to allow for smooth, efficient service
(Demonstration) (20 minutes)
 Design good processes to meet customer needs
 Eliminate steps that do not add value to the customer
 Arrange equipment and supplies close to staff to eliminate time in motion
 Plan workflow and physical space to enhance efficiency
 Minimize number of workstations
 Mistake-proof processes to minimize human error
 Automate tasks where possible
 Make errors difficult to commit
 Make errors visible if committed
 Absorb errors that are committed

Activity: In class exercise (20 minutes)

DEMONSTRATE TO STUDENTS: How to organize laboratory workspace to allow for

smooth, efficient services? Simple, daily tasks can easily become laborious when the needed
supplies and materials are not readily available. This activity demonstrates that organization
is the key to performing any daily activity

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Required items:
 Specimen collection containers (urine, blood, stool, swabs, CSF, transport media, glass
slides)
 Labels
 Markers
 Forms
 SOPs for specimen collection (refer to Specimen Collection Manual)
 Disinfectants, antiseptic
 Material Safety Data Sheets (MSDS)
 First aid kit
 Tourniquet
 Plaster
 Time (wall clock or wrist watch – needed to note time of collection)
 Occurrence logbook
 Register book
 Specimen transportation guidelines
 Environmental monitoring tools and devices
 Protective gears

SUMMARIZE and clarify

Step 11: Key Points (5 minutes)

 Successful laboratory testing depends on the following:
 Advance planning
 Collection of appropriate and adequate specimen
 Correct preservation packaging and rapid transportation to an appropriate laboratory
 The ability of the laboratory to accurately perform the diagnostic test
 Proper biosafety and decontamination procedures to reduce the reduce the risk of the
disease spread
 Sufficient appropriate equipment and supplies

Step 12 Evaluation (10 minutes)

ASK STUDENTS TO:
 Explain the key components of quality system essentials applied to pre-analytical phase

ANSWER:
List of processes in the pre-analytical phase:
 Patient/Client Preparations
 Sample Collection
 Personnel Competency
 Test Evaluations
 Sample Receipt and Accessioning
 Sample
 Transport

ASK STUDENTS FOR ANY COMMENTS OR NEED FOR CLARIFICATION

References:

291
1. Laboratory Quality Management System: Handbook, WHO 2011, ISBN 978 92 4 154827
4
2. Training Modules for Managers of HIV/AIDS Care and Treatment Centres in Tanzania,
Laboratory Management, MOHSW, July 2008
3. Sadiki F. Materu; Guidelines on Specimen Collection, Storage and Transportation,
AMREF Publication

292
Session 2: The Quality Systems Essentials At Analytical Phase

NTA Level 6: Semester 1, Module Code: MLT 06107 – Name: Laboratory Quality
Management System

Total Session Time: 120 minutes

Pre-requisites Modules
 MLT04208: Occurrence Management and Record Keeping
 MLT04103: Laboratory Safety and Waste Management

Learning Objectives
By the end of this session, students are expected to be able to:
1. Explain analytical phase of the quality assurance cycle
2. List quality system essentials of the analytical phase (Refer analytic phase of quality
assurance cycle)
3. Describe SOP
4. Distinguish between QA and QC
5. Describe how to perform QC of any test
6. Define accuracy, precision, mean, median, mode, standard deviation and coefficient of
variation)
7. Explain how to interpret QC results
8. Explain how to document laboratory procedures and results

Step 2: Explain analytical phase of the quality assurance cycle (10 minutes)

Source: Module 5: Laboratory Process Management, Training Modules for Managers of

HIV/AIDS Care and Treatment Centres in Tanzania, Laboratory Management, MOHSW,
July 2008

 The analytical phases of the quality assurance cycle include:

 Quality control:

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 o Quality control is used to test the analytical phase of patient testing.
o It is a process or system for monitoring the quality of laboratory testing, and the
accuracy and precision of results
o Quality control samples are tested along with patient samples to monitor the
validity of the analysis.
o If quality control samples which have a known concentration do not give expected
results, it can often mean an error occurred that affected patient results as well.
 Testing evaluation: In general testing evaluation depends on the following outcomes:
o Qualitative evaluation:
 Running one known positive and one known negative patient before using the
lot to assure there is not a problem with the new lot must check new lots.
 New lots of reagents must give the same results as obtained with the old lot.
 QC material may be used as an alternative.
o Quantitative evaluation:
 Changes in lot numbers of reagents may cause the need to recalibrate the
system and then rerun the controls to verify proper calibration.
 The assayed control mean and standard deviation often takes into
consideration changes in reagent lot numbers since the values are calculated as
lot-to-date

Step 3: List quality system essentials of the analytical phase (10 minutes)
 Quality control
 Testing evaluation

Step 4: Describe SOP (30 minutes)

 SOPs are approved documents or manuals that describe how to perform various
operations in the laboratory
 SOPs are tools to efficiently implement preset quality objectives in all functions and
activities of a laboratory
 SOPs contain step-by-step instructions that laboratory staff should carefully follow to
produce the right result at the right time on the right specimen from the right patient
with result interpretation based on correct reference data in a consistent manner, and with
safe laboratory practice
 Give management and customers an assurance of quality
 Provide laboratory staff with written instructions on how to perform testing
 Identify all reagents and supplies needed for inventory
 Serve as a guide for new staff training
 Help to assess employee competence and identify retraining needs
 Prevent unauthorized modifications to procedures

Purpose of SOPs
• The “HOW TO DO IT”
• Present procedures / work instructions for practical implementation
• SOPs, sometimes referred to as the Local Laboratory Manual, are required to
 Improve and maintain the quality of laboratory services to patients
 Identify problems with poor work performance
• Provide Laboratory staff with written instructions on how to perform tests consistently to
an acceptable standard in their laboratory

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• Serve as a guide for new staff training
• Prevent unwarranted short-cuts being taken when performing tests
• Make clinical and epidemiological interpretation of test results easier by standardising
specimen collection techniques, test methods and test reporting
• Help to assess employee competence and identify retraining needs
• Facilitate the preparation of a list and inventory of essential reagents, chemicals and
equipment
• Give management assurance of quality service and correct scientific practices
• Promote safe laboratory practice

Common Elements of SOPs

• Title
 Number
 Version
 Date
• Purpose
• Principle
• Procedure instruction
 Pre-analytic
 Analytic
 Post-analytic
• Materials required (including QC materials)
• Safety
• Reference
• Author(s)
• Approval signature(s)
 Management
 QA officer
 Technologist(s)

Content of SOPs
• Depend on the analytical phase for which the SOP is written, for example:
 Pre-analytic Processes
o Test ordering
o Specimen collection
o Specimen transport
o Specimen receipt
o Processing
 Analytic Processes
o Testing
o Results review & follow-up
o Interpretation
 Post-analytic Processes
o Result reporting & archiving
o Specimen management & follow-up

SOPs for Pre-Analytical Key Processes

• Two types of SOPs are generally recommended
 SOPs for specimen collection and transport
o Contents

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  Specimen type
 Positive patient identifications & preparation
 Procedure for collection
 Verification of test request for completeness & correctness
 Date and time of collection
 Correct labelling
 Equipment and materials required
 Specimen transportation
 Specimen rejection criteria
 Correct action to be taken for rejected specimen
 Registration (dated) of specimen collected
 Received and rejected (include type)
 Safety & waste disposal
 Urgent tests identifications to be processed on STAT basis
 Posting updated list of available tests
 Should be available at a collection site of a
- Central laboratory
- Distributed to wards
- Carried by field specimen collectors
 SOPs for specimen receipt and processing
o Contents
 Checking for proper specimen for requested test(s)
 Specimen rejection
- Unlabeled
- Insufficient volume
- Wrong containers
 Registration (dated) of both accepted and rejected specimen
 Corrective actions to be taken for rejected samples
 Turnaround time for specimen preparation

SOPs for Analytic and Post-Analytic Processes

• Generally, a single SOP is prepared for a test in the analytic and post-analytic phases by
combining documented procedures required for the execution of each key process.
• SOP Format
 Title
o Number
o Version
o Date
 Purpose of the test
 Test principle
 Type and quality of specimen
 Equipment and materials required...
 Test procedure
 Result calculation
 Alert, critical or panic value definition
 Turnaround time
 Specimen storage/preservation requirements
 Specimen referral and shipment requirements
 Results documentation and reporting system should include all required elements

296
 o Patient’s name, unique identifier dates and time of sample collection and result
reporting
o Name and address of the laboratory
o All required signatures
 Comments/notes on procedural limitations and corrective actions, obtaining
information from
o Validation and evaluation procedures
o Experience
o Package inserts
 Reference internal or any other correlative or interpretive information
 Specimen retention requirements
 Safety concerns including waste and left-over specimen disposal system
 References
 Signatures
o Author(s)
o Person authorising the SOP
o Person implementing the SOP (QC Officer)
o Employee(s) acknowledgement

Who Writes SOPs?

• SOPs should be written by a group of personnel who are very familiar with the procedure
in the laboratory where it is to be used
• Guidance for content and format that is appropriate of testing procedures such as
automated, manual, quantitative, and qualitative tests is very important
 NCCLS (CLSI) document GP2 – Clinical, Laboratory Technical Procedure, Manual
4th edition, 2002

Writing a Good SOP

• Are comprehensive, covering all aspects of details making analytical processes error-
proof and failsafe
• Are written clearly and concisely
• Because complex procedures are
 Misunderstood
 Quickly forgotten
 User unfriendly
 Ignored and susceptible to short cutting
• Provide an easy, efficient means to document complicated techniques
• Communicate what is exactly done in the laboratory
• Do not use more words than necessary
• Do not require frequent updates and corrections
• Follow standard outline
• Are easily understood by new personnel
• Are annually reviewed and kept up-to-date
• Are accepted by laboratory director, QA manager and employee

Common Problems with SOPs

• Inadequate
 Not comprehensive, complex, or difficult to comprehend
• Lost
• Are not meticulously followed

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• Are not reviewed and up-dated regularly
• SOP deviations as evidenced by QC results are not documented and discussed
• SOPs are often destroyed (wear and tear)
• Old SOP versions are not removed from the worksite
 SOPs should be reviewed once per year and whenever necessary
 Old SOPs should be stored and filed in an appropriate location in the laboratory
• Absence or weak management support for compliance programs
• Adherence to SOPs as a job requirement is not defined or not communicated to laboratory
staff
• Poor or absent supervision and documentation of gaps
• Difficulty in dealing with change
• “We have always done it this way” attitude

Successful Implementation of SOPs

• Organisation’s policy on quality laboratory practice and commitment to implement
• Identification of areas that need strengthening
 Prioritise by considering the quick fixes first, which also have the greatest positive
impact
• Establishing QA unit / team / task force
• Provide orientation, training and continuing education programs
• Allocate sufficient resources to establish and maintain quality clinical laboratory service
 Equipment
 Reagents and supplies
 Maintenance service
 Information Technology
 Others
• Develop, distribute, implement a Quality Manual
• Have sufficient qualified personnel with documented training and experience to carry out
laboratory work to the required standard
• Make knowledge and adherence to SOPs a job requirement and include in the standard
performance appraisal system
• Involve all persons in the organization
• Clearly written regulations and ensuing consequences for departures from standard
procedures
• Frequent departures from preset standard procedures should necessitate retraining
programs

Step 5: Distinguish between QA and QC (5 minutes)

• Quality Assurance in a clinical or pathology laboratory is a system that encompasses pre-
analytical, analytical, and post-analytical factors.
• Quality control is part of a quality assurance system and is used to monitor both the
precision and the accuracy of the assay in order to provide reliable results.

Step 6: Describe how to perform QC of any test (15 minutes)

 Using a control sample serve as a check on the accuracy of the test
 Control samples are similar to standards in that they are like those taken from patient and
have known values
 Control samples are used every time a patient sample is processed
 If both control samples and specimens yield irregular results, there may be an error in test
procedure

298
 Proficiency testing program measure the accuracy of test results and adherence to
Standard Operating procedures; generally it include two parts
 A control sample from the proficiency testing organization engaged by the individual
laboratory
 Forms that must be completed to record the steps in the testing procedure
 The control sample is processed normally, under the same conditions as any patient
sample.
 The results, the forms, and sometimes the control samples are returned to the proficiency
testing organization, which then give feedback whether the laboratory has passed or failed
the test.
 A passing mark can mean that the laboratory can continue to perform that particular test.
 A failing mark can mean that the laboratory must discontinue that test and possibly other
tests as well

Step 7: Define accuracy, precision, mean, median, mode, standard deviation and
coefficient of variation (15 minutes)

ACTIVITY: In class exercise (5 minutes)

ASK the students: To define accuracy, precision, mean, median, mode, standard deviation
and coefficient of variation

SUMMARIZE their responses and confirm correct answers using notes below

 Definition terms
 Accuracy
o How close the “test” method results compare to the “true” value based on
reference method results or currently accepted method

 Precision,
o Reproducibility or closeness of results to each other

 Mean (x)

299
 o The calculated average of values
 Median
o Relating to a value or quantity lying at the mid point of a frequency distribution of
observed values or quantities such that there is an equal probability of falling
above or below it
 Mode
o A way in which something occurs or is done
 Standard deviation (SD)
o The principle calculation used in the laboratory to measure dispersion/scattering
of a group of values around a mean

 Coefficient of variation
o CV is a number expressed as per cent to simplify the comparison of standard
deviations of QC test results.
o CVs of highly precise analyzers can be lower than 1%.
o The formula for CV = SD x 100
X

Step 8: Explain how to interpret QC results (5 minutes)

• Qualitative Tests:
 Running one known positive and one known negative patient before using the lot to
assure there is not a problem with the new lot must check new lots.
 New lots of reagents must give the same results as obtained with the old lot.
 QC material may be used as an alternative.
 Quantitative Tests:
 Changes in lot numbers of reagents may cause the need to recalibrate the system and
then rerun the controls to verify proper calibration.
 The assayed control mean and standard deviation often takes into consideration
changes in reagent lot numbers since the values are calculated as lot-to-date.

Step 9: Explain how to document laboratory procedures and results (10 minutes)
 Laboratories must examine all specimens received to ascertain that they meet the proper
criteria for data entry and processing
 There must be verification that the results are correct and for the intended patient
 Correct data entry and processing is extremely important to assure that the results are
given out in a correct and efficient manner
 Proper record keeping of patient results is vital for providing optimal patient care and
gaining knowledge from patient data collected
 Quality depends on having a good document and record control system in place for:
 Formatting and maintaining various versions of documents

300
  Assuring well written standard operating procedures
 Assuring proper record retention
 Assures a standardized format for all documents and records (procedures, results, forms)
 Establishes change controls for revising documents
 Assures all departments have the most accurate, current, and approved documents
 Records are any data or information recorded by the laboratory including:
 Test requisition forms
 Patient result forms (may be the same as requisition) initial and corrected/amended
 Accession logs
 Instrument printouts (function checks etc.)
 Maintenance logs
 Temperature checks
 QC and QA records
 Specimen rejection logs
 Result worksheets with calculations

Format of Records
 Forms should include at minimum:
 Title
 Date
 Results
 Tolerance limits/acceptable range
 Comments
 Performing staff initials/date

Record Storage Systems

• Record system must allow one to reconstruct the entire process from beginning to end
• Paper Storage Systems
 Data entry on manual records must be accurate, legible, permanent ink, and complete
 File cabinets organized alphabetically and by month/year
 Bound books of records
• Electronic Storage Systems

Step 10: Key Points (5 minutes)

 Analytical phase of the quality assurance cycle
 List quality system essentials of the analytical phase
 Describe SOP
 Distinguish between QA and QC
 Performing QC of any test
 Define accuracy, precision, mean, median, mode, standard deviation and coefficient of
variation)
 Interpretation of QC results
 Documenting laboratory procedures and results

Step 11: Evaluation (10 minutes)

 Difference between quality control and quality assurance
 List components of good SOPs

References:

301
1. MOHSW (July 2008) Training Modules for CD4, Haematology and Clinical Chemistry
for Laboratory Health Care Workers in Tanzania, Joint Modules 3A
2. NCCLS (CLSI) document GP2 – Clinical, Laboratory Technical Procedure, Manual 4th
edition, 2002
3. Denise M. Harmening (2003); Laboratory Management, 2nd edition

302
Session 3: Quality Systems Essentials At Post-Analytical Phase

NTA Level 6, Semester 1, Module Code: MLT 06107 – Name: Laboratory Quality
Management Systems

Total Session Time: 120 minutes

Pre-requisites
 MLT04208: Occurrence Management and Record Keeping
 MLT04103: Laboratory Safety and Waste Management

Learning Objectives
By the end of this session, students are expected to be able to:
1. Explain Post-analytical phase of the Quality Assurance cycle
2. List quality system essentials of the post-analytical phase
3. Describe how to disseminate / transmit laboratory results to an appropriate client
4. Describe how to chart turnaround time
5. Explain how to interpret Levy Jennings’s chart

Step 2: Explain Post-analytical phase of the Quality Assurance cycle

 The post-analytical phase include:
 Results recording
o Electronic
o Paper based
 Reporting/communication (to reach client/patient)
o Electronic
o Paper based
o Phone
o Fax
 Storage/archive
o Electronic
o Paper based
o Films

303
Source: Module 5: Laboratory Process Management, Training Modules for Managers of
HIV/AIDS Care and Treatment Centres in Tanzania, Laboratory Management, MOHSW,
July 2008

Step 3: List quality system essentials of the post-analytical phase (5 minutes)

 Result recording
 Record keeping
 Reporting to client/patient

Step 4: Describe how to disseminate / transmit laboratory results to an appropriate

client (35 minutes)
 Transmission/dissemination of laboratory results can be made through the following
means:
 Written report
 Verbal reporting if necessary especially for critical values but this type of
communication has to be documented
 Assure that referral specimen are property tracked
 Correctly communicate discrepancies or problems with samples due to haemolysis,
lipemia, drugs, biological variables, age of specimen, identification, improper specimen
collection and handling
 Correct format, decimal place and units
 Guard patient confidentiality
 Communicate sample discrepancies and delays in patient testing due to s

Pitfalls of written communications

 Results not communicated in timely manner
 Results are lost
 Critical values not reported
 Confidentiality breached
 Failure to track referral specimen or
 Failure to follow up on overdue specimens

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ACTIVITY:

CASE STUDY 1:
 The SGPT (ALT) from a patient taking Nevirapine, anti-viral medication, was reported
today as 350 IU/L, while SGOT (AST) was 28 IU/L.
 The clinician called to verify the SGPT (ALT) result since SGOT (AST) was within
reference ranges.

CORRECT ANSWER:
 After viewing the results from the chemistry analyser, it was determined that the patient’s
SGPT (ALT) printed out as 35.0 IU/L and that was transcribed onto the report sheet with
a barely legible decimal point.
 This brings up the necessity of reporting chemistry results to the expected decimal place
and units as indicated by the manufacturer supplying the test method and the current
reference ranges in use.

Step 5: Describe how to chart turnaround time (15 minutes)

Source: Module 5: Laboratory Process Management, Training Modules for Managers of

HIV/AIDS Care and Treatment Centres in Tanzania, Laboratory Management, MOHSW,
July 2008

 Turnaround time (TAT) is the interval from the time the examination was ordered by the
physician or responsible caregiver to the time the results reach the patient record.
 Turnaround times are often monitored on a monthly basis. However, such an interval
usually means that not all causes for delay in test reporting can be unequivocally
identified for institution of remedial action.
 Daily chart that graphically displays the test turnaround times by laboratory receipt time
must be developed and used. Different symbols can be used to designate specimens
reported within the test’s turnaround time limit, those within the limit, and those well
outside the limit
 Collect manually from result reports received by laboratory users: wards in the main
hospital, OPD, Clinics etc. Combine the data from the departmental computer files to
create a spreadsheet detailing different time points in the processing of a specimen, from
venepuncture to receipt of result report
 100% of results audited will reflect that documentation of notification was performed for
all results

305
 At least 90% of results audited will reflect that laboratory to clinician/nursing notification
occurred within 30 minutes of result availability
 At least 90% of results audited will reflect that clinician notification (if applicable)
occurred within 60 minutes of result availability

Step 6: Explain how to interpret Levey Jenning’s chart (40 minutes)

 Levy Jennings chart is a graph that quality control data is plotted on to give a visual
indication whether a laboratory test is working well.
 Tool used to detect variation of particular parameters through instrumentation
 It detects shifts and trends

Interpretation of Levey Jenning’s Chart:

 In routine operation of a quality control (QC) procedure, the control materials are
analyzed before or during the analytical run, the control results are recorded and plotted
on control charts, and control status is determined by inspecting the control data using the
control rules (control limits) selected.
 If the control results are “in,” the run is accepted and patient samples can be assayed or
reported.
 If the control results are “out,” the run is rejected, the problem is identified and resolved,
and the new run can begin or, in the case of batch assays, a run of patient samples can be
repeated. This is the way control procedures are “supposed” to work

Example of blank LJ charts; Source: SLMTA Trainer’s Guide

306
Example of plotted Levey Jenning’s chart; Source: MOHSW

Levey Jenning’s showing shifts

Levey Jenning’s chart showing trends

307
Levey Jenning’s showing Basic QC rules

Levey Jenning’s showing Outside the Normal Values

308
 Levey Jenning’s chart showing 68%, 95% and 99% confidence limit “Bell
shape”

Basic QC Rules
• Reject analytical run if
 One control result exceeds the mean + 3SD
 Both control results exceed the mean + 2SD
 A shift or trend occurs
 One control exceeds the mean + 2SD for a second time within 20 days
These always indicate the need to reject the patient results and to solve the problem before
the patient results reported.

Step 7: Key Points (5 minutes)

 Explain Post-analytical phase of the Quality Assurance cycle
 List quality system essentials of the post-analytical phase
 Dissemination / transmission laboratory results to an appropriate client
 Turnaround time
 Interpretation of Levey Jennings’s chart

Step 8: Evaluation (5 minutes)

 List quality system essentials of the post-analytical phase
 Describe how to chart turnaround time

References:
1. MOHSW (July 2008) Training Modules for CD4, Haematology and Clinical Chemistry
for Laboratory Health Care Workers in Tanzania, Joint Modules, Module 4:
Communicating Results
2. MOHSW (July 2008) Training Modules for CD4, Haematology and Clinical Chemistry
for Laboratory Health Care Workers in Tanzania, Joint Modules, Module 3a: Quality
Control
3. SLMTA Trainer’s Guide
4. CLSI (2004), Application of a quality management system model for laboratory services;
approved guideline, GP26-A3, Vol. 24 No. 36 – 3rd edition

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Session 4: Internal Quality Assurance (IQA) Samples

NTA Level 6, Semester 1, Module Code: MLT 06107 – Name: Laboratory Quality
Management Systems

Total Session Time: 120 minutes

Pre-requisites

Learning Objectives
By the end of this session, students are expected to be able to:
1. Prepare IQA samples for laboratory test
2. Perform proficiency testing
3. Perform re-testing as part of IQA
4. Perform spot checking using IQA sample
5. Document IQA procedures and results

Step 2: Activity: Prepare Internal Quality Control (IQC) samples for laboratory test (60
minutes)

• Definition of IQC
 Internal Quality Control (IQC) is a set of procedures undertaken by the laboratory
staff for the continuous and immediate monitoring of laboratory work in order to
decide whether the results are reliable to be released

EXAMPLE 1: SOP FOR PREPARATION OF IQC OF SERUM SAMPLES FOR

SYPHILIS SEROLOGY

Principle and purpose

 Plasma is prepared from blood samples of known syphilis sero-status. An agreed number
of aliquoted samples are then prepared from the evaluated material for use in the
laboratory as Internal Quality Control material. A random sample of aliquots is then
tested to determine the presence of syphilis antibody. Samples that are negative for
syphilis are also required for IQC.

SCREENING OF BLOOD FOR SUITABILITY FOR SYPHILIS TESTING

 Equipment, materials and reagents
 Serum/plasma samples
 Rapid Plasma Reagin test kits
 TPPA or TPHA kits
 Centrifuge tubes
 Centrifuge
 Serum tubes and racks
 Indelible markers, labels
 Micropipettes and tips

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  Transfer pipettes
 Disinfectant (Jik®)
 Cryovials
 Gloves
 Laboratory coats
 Biohazard bags
 Mechanical shaker
 Water bath
 Refrigerator
 Freezer
 Register books
 Levey Jenning’s charts
 U-shaped microtitre plates for TPHA

 Sample required
 Collect fresh blood or plasma donations known syphilis sero-status from national or
regional blood bank.

Method for preparing and testing the material

(a) Procedure for preparing and testing plasma:
1. Centrifuge the samples (if whole blood) and distribute the clear supernatant (plasma)
into a sterile reagent bottle.
2. Test the plasma using a VDRL screening test, and if positive, test with the TPHA
confirmatory test.
(b) Procedure for treating plasma
1. If the sample is syphilis positive, heat inactivate by placing in a water bath at 56°C for
1 hour.
2. Store samples at -20°C until ready to use

Procedural notes
 Follow the storage instructions for each test kit. Some test kits may be stored at room
temperature in a cool dry place; other kits require refrigeration.
 Check carefully the expiry dates on the test kits.

Quality control
 Performance of test kits
 Use positive and negative controls to ensure the tests kits are performing properly.

 Interpretation
 Positive: large or fine clumps of particles or agglutination in the test sample
 Negative: no clumping of particles or agglutination in the test sample

PREPARATION OF ALIQUOTED SERUM SAMPLES FOR SYPHILIS TESTING

 Method for preparing sample aliquots

 Prepare two categories of plasma: syphilis negative and syphilis positive, as follows:
o Assign identification numbers to each sample.
o Re-test samples with screening and confirmatory tests (VDRL and TPHA).
o Record the characteristics of each sample/batch.
o Aliquot 0.5 ml of each sample into the required number of cryovials.

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 o Label the cryovials and samples and store at -20°C or -80°C.

 Validating the material

 See accompanying QC guidelines

 Packing and transportation

 Pack the cryovials in the triple pack containers provided. Pack the documentation in a
separate plastic re-sealable bag and place in the outer-most container. Clearly mark
the outside container: FRAGILE, PATHOLOGICAL MATERIAL, HANDLE
WITH CARE. Label with the name and address of the consignee and sender. Deliver
the parcel to courier for transportation. Sign the delivery documents and maintain a
copy in your file.

 Record keeping
 For each batch of serum samples, record the complete procedure including:
 Preparation and testing techniques used
 Results of each batch
 Number of prepared vials and samples
 Dates of preparation
 Dates of shipping vials
 Means of shipping vials

EXAMPLE 2: SOP FOR PREPARATION OF IQC MATERIAL OF PUS SMEARS

FOR GRAM STAIN MICROSCOPY (GENITAL, EYE, EAR, WOUND)

Principle and purpose

 A smear is prepared from pus samples containing organisms of known Gram reaction and
stained with Gram stain. The smear is examined to confirm the presence of organisms,
evaluate the appearance of the organisms, and determine their density. Multiple slides are
then prepared from the evaluated material for distribution in the IQC.
 A sample of the smears is examined to determine the average and range of values for
density of organisms, and to ensure organisms showing the relevant morphology are
present. Pus samples that are NEGATIVE for organisms are also required for IQC.

Equipment, materials and reagents

 Gentian violet
 Potassium iodide
 Iodine crystals
 Acetone
 Absolute methanol
 Strong Carbol Fuchsin
 Sodium chloride
 Distilled water
 Conical flasks
 Reagent bottles
 Filter paper
 Bijou bottles, sterile
 Pasteur pipette, sterile
 Frosted glass slides

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 Cotton wool/gauze
 Grease pencil/lead pencil
 Gloves
 Microscope
 Weighing scale
 Immersion oil
 Xylene

Preparation of Reagents
 0.5% Gentian violet: Dissolve 2.5g gentian violet powder in 500 ml distilled water in a
conical flask. Stir using a glass rod until the powder has completely dissolved. Filter into
a reagent bottle and label with the name of the reagent and date of preparation. For daily
use, transfer 100 ml into dropper bottle and label.
 Lugol’s iodine: Dissolve 10g potassium iodide in about 100 ml distilled water and add 5 g
of iodine. Stir using a glass rod until the iodine crystals dissolve. Make up the volume to
500ml with distilled water. Transfer to a brown bottle and label with the name of the
reagent and date of preparation. For daily use, transfer 100 ml into a brown dropper
bottle.
 50% acetone/alcohol: Measure 500 ml acetone and pour into a reagent bottle. Measure
475 ml of absolute methanol and 25 ml distilled water and add to the acetone and mix.
Label with the name of the reagent and date of preparation. For daily use transfer 100 ml
to a dropper bottle and label.
 Dilute Carbol Fuchsin: Pour 95 ml of distilled water into a dropper bottle and add 5 ml of
strong Carbol Fuchsin. Mix and label.
 Physiological saline: Dissolve 0.85 g of sodium chloride in 100 ml distilled water in a
reagent bottle. Label with the name of the reagent and date of preparation. Sterilise by
autoclaving, making sure the cap is loosely fitted. After autoclaving, tighten the cap. Use
a sterile Pasteur pipette to dispense the sterile saline.

Sample required
 Collect pus samples from the following sites into a sterile specimen container: infected
eyes, ears, wounds or urethral discharge, prior to treatment with antibiotics.

Method of preparing the material

(i) Screening the sample for suitability:
 Label the Bijou bottle with the patient's laboratory number using a grease pencil. Note
and record the appearance of the specimen.
 Add an equal volume of sterile saline and emulsify by mixing with a vortex mixer.
 Clean a slide using gauze or dry cotton wool. Label the slide with the patient's
laboratory number using a lead pencil on the frosted end of the slide.
 Make a smear on the slide by placing 10 l of the emulsion in the centre of the slide
and spreading in a circle to 10 mm diameter. Allow to air dry horizontally on a flat
surface.
 Fix the smear by passing the slide (smear uppermost) momentarily over a flame 3
times.
 Place a staining rack over a sink or basin. Place the slide on the staining rack. Cover
the smear with 0.5% gentian violet. Leave for 1 minute.

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  Wash the smear in a thin stream of clean water to remove the excess stain. Cover the
smear with Lugol's iodine and leave for 1 minute. Wash the smear in a thin stream of
clean water.
 Decolorise the smear by adding 50% acetone alcohol solution slowly, one drop at a
time, and stop as soon as no more blue colour comes out of the smear.
 Counterstain by covering the smear with dilute Carbol Fuchsin. Leave for 30 seconds.
Wash the smear in a thin stream of clean water to remove excess stain. Allow the
smear to drain dry on a slide drying rack.
 Place a drop of immersion oil on the smear, and place on the microscope stage. Focus
the smear using the x10 objective and examine systematically using the x100
objective for pus cells and bacteria. Note the Gram reaction of the bacteria.
 Place used cotton wool and swabs in the bucket marked "INCINERATION". Keep
positive stained slides for reference. Place negative slides in the container of 5%
Lysol marked "SLIDES".
(ii) Preparing slides for IQC
 Prepare the required number of slides and fix only (do not stain) following the
method used in the screening stage.
 For every 50 slides prepared, stain and examine 5 smears to ensure pus cells and
bacteria are present and correctly stained.

Procedural notes
 Use a brown bottle to store Lugol’s iodine. Iodine deteriorates when exposed to light.
 Do not prepare dilute Carbol Fuchsin in large quantities. Dilute Carbol Fuchsin becomes
colourless when stored on the shelf for prolonged periods.
 50% acetone/alcohol decolorizes smears very quickly. Take care not to over-decolorise
the smears.
 For some distributions, unstained smears (fixed only) will be required.

Quality control
 Quality of the stain
 Prepare two smears from pus containing known Gram positive and Gram negative
organisms:
 Stain with the old stock.
 Stain with the newly prepared stock.
 Compare the staining reactions.
 If the staining reaction is not good, discard stock and prepare a new stock solution.

Validating the material

 For every 50 smears prepared, randomly select 5 smears and examine them to ensure the
organisms showing relevant morphology are present.

Evaluating stability
 Establish the stability of the stained smears at –20oC, ambient temperature and 37oC for
two months by weekly examinations. Store the slides in boxes and label clearly.

Morphological features
 The following organisms may be used:
 N. gonorrhoeae: In Gram stained preparations, N. gonorrhoeae appears as red, bean-
shaped cocci in pairs with the biconcave sides facing each other. The cocci are

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 typically seen inside neutrophils (intracellular diploccocci). Some cocci are seen
outside cells (extracellular diplococci). N. gonorrhoeae is indistinguishable
morphologically from N. meningitidis.
 Staphylococcus aureus: in Gram stained preparations, S. aureus appear as purple
round cocci in clusters, typically seen outside, but together with, neutrophils.
 Streptococcus pneumoniae: in Gram stained preparations, S pneumoniae appear as
purple round flame-shaped cocci in pairs (diplococci).

Transportation
 Arrange the prepared slides in the slide boxes provided. Close and seal the slide boxes
and place in a box or carton with padding, e.g. newspaper, shredded paper. Pack the
documentation in a separate plastic re-sealable bag and place in the box or carton. Clearly
mark the box: FRAGILE, HANDLE WITH CARE. Label the box with the name and
address of the consignee and sender. Deliver the parcel to courier for transportation. Sign
the delivery documents and maintain a copy in your file.

Record keeping
 For each batch of smears, record the complete procedure including:
 Preparation and staining techniques used
 Bacteria and pus cells seen
 Counts of bacterial and pus cells in prepared slides: average and range of values
 Number of prepared slides
 Dates of slide preparation
 Dates of shipping slides
 Means of shipping slides

Step 3: Perform proficiency testing (15 minutes)

 Proficiency testing (PT) is the most common form of EQA and involves development of
specimen panels by the reference laboratory for distributing to testing sites. Laboratories
administering PT panels should strive to adhere to international guidelines, e.g., ISO
Guide 43. There are standard methods available to develop PT samples and might be the
easiest type of program for implementation at sites where serum-based tests are
performed. The limitations of PT are that it usually involves only a few specimens and
the test results may not represent the routine test performance. This may be due in part to
the greater care in handling PT specimens

 Traditional proficiency testing is organized and conducted by a reference laboratory or

center. At regular intervals, a panel of specimens with known reactivity is sent to all
participants who test the specimens and return results to the reference laboratory. The
data is analyzed and information is provided back to the participant testing sites.

 Proficiency testing has some limitations. All staff will not necessarily test the panel of
specimens sent to the testing site, so it is not a good measure of individual performance.
The sample size is small, so the ability to detect errors is impaired. Also, preparing and
distributing specimens for proficiency testing may be burdensome for national reference
laboratories. Proficiency testing is provided in some locations, and when available it is a
useful tool in combination with on-site monitoring.
 Panel for proficiency testing must be tested according to SOP used in the routine
examination of the desired test

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Step 4: Perform re-testing as part of IQC (10 minutes)
 With this EQA technique, serum or dried blood spots are collected from the client at the
time of testing. The serum or the dried blood spots are tested using EIA, at a reference
laboratory, and the results of this test, or “re-test,” are compared with that obtained from
the final HIV rapid test result. A common model in use is the re-testing of 5% - 10% of
rapid test specimens, randomly selected.
 The ability to perform EIA on dried blood spots (DBS) has made it easier to collect
specimens for re-testing in areas where personnel who can perform venipuncture are not
available, or where reliable transport of serum specimens is not available. However, the
dried blood spots must be carefully collected, dried, and properly stored in order to
produce reliable results. The EIA testing performed on these specimens requires an
elution step prior to specimen analysis, thus requiring additional time and introducing a
new source of error.
 Re-testing of specimens has limitations. In many countries there is lack of capacity at the
national reference laboratory for re-testing the large number of samples and for
conducting the needed analysis of data. Long delays in completing the re-testing results in
delayed identification of problems. Finally, statistical analysis reveals that for low-
volume sites, a very large percentage of samples would have to be re-tested in order to
detect errors. The following table summarizes the statistical information
 Samples for re-testing must be tested according to SOP used in the routine examination of
the desired test

(Note: The number of specimens tested is independent of time.)

Re-test size (and %) needed to provide 95% confidence of detecting at least one
discrepant result, when the underlying error rate is 1%or 5%Error

Volume (per site) 1%* error 5%* error Re-testing

feasibility

Very low Re-test 48 specimens Re-test 31 specimens No

50 specimens (96%) (62%)

Low Re-test 225 Re-test 56 specimens Possible

specimens (45%)
500 specimens (11%)

High Re-test 290 Re-test 59 specimens Yes

specimens (5.8%)
5000 specimens (1.2%)

*95% confidence

Recommendation for re-testing

 If on-going re-testing is performed, it must be based upon statistical considerations and a
recognition that it will only be feasible in high-volume test sites
 The outcome of re-testing must be analyzed for effective and timely feedback
 In order to determine cost-effectiveness
 To determine if corrective action can be taken if problems are identified

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 If errors are not found as a result of re-testing, established sites should consider
discontinuing re-testing.

Step 5: Perform spot-checking using IQC sample (10 minutes)

 IQC should provide onsite evaluation of each testing site in addition to methods that will
assess testing performance. Having onsite evaluation is necessary to review QC, record
keeping, and observation of test performance. Additionally, this evaluation is an
opportunity to directly administer a proficiency test to each individual performing testing
during the visit. A program of onsite evaluation should include a standard checklist of
laboratory indicators and evaluators should be trained to perform consistent reviews of
laboratories and other testing sites. Standard checklists and evaluation methods allow for
collecting and comparing consistent information from multiple sites.
 Samples for spot-checking must be tested according to SOP used in the routine
examination of the desired test

Step 6: Document IQC procedures and results (10 minutes)

 IQC results obtained for each quantitative or qualitative test should be recorded and
documented by plotting the values onto the control charts or recorded as positive or
negative
 Documentation of the IQC results will provide evidence of routine monitoring of the
system
 IQC measurements from out-of-control runs must be documented
 Corrective actions to bring the test system back into control must be documented

Procedures for out-of-control situations

 The patient run with out-of-control quality control values must be rejected
 Rerun the control using a new control vial
 Identify the problem using instrument or method troubleshooting process
 Resolve the problem and implement appropriate corrective action
 Rerun QC and if control is within limits, rerun and report patient samples from rejected
run

Step 7: Key Points (5 minutes)

 Preparation of IQC samples for laboratory test
 Performing proficiency testing
 Performing re-testing as part of IQC
 Performing spot checking using IQC sample
 Documenting IQC procedures and results

Step 8: Evaluation (5 minutes)

 Define IQC

References:
1. Baker F.J., Silverton, R.E. and Pallister P.J. (1998). Introduction to Medical Laboratory
Technology, 7th Edition, Butterworth-Heinemann, England

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2. Barror G, Felthan R K A (1993). Cowan and Steel’s Manual for the Identification of
Medical Bacteria, Third Edition. Cambridge University Press, England.
3. Carter J, Lema O (1994). Practical Laboratory Manual for Health Centres in Eastern
Africa, AMREF
4. Forbes Betty A, Weissfeld Alice S (1998). Bailey’s and Scott’s Diagnostic Microbiology,
Tenth Edition. Mosby Inc., USA.
5. Cheesbrough, Monica (2000). Medical Laboratory Manual for Tropical Countries, Part 2:
Microbiology, Butterworth & Co Ltd, UK
6. Munafu C, Tenywa T, Musoke Bukenya M (1998). Validation of Syndromic
Management of Sexually Transmitted Infections, Volume 1, AMREF
7. Constantine Niel T, Callahan Johnny D, Watts Douglas M, (1991). HIV Testing and
Quality Control, a Guide for Laboratory Personnel. Family Health International.
8. Munafu C, Guma G B, Igune M, Rwandembo M W, Olupot-Olupot P, et al (2000).
Management and Control of Diseases of Epidemic Potential in Uganda. Ministry of
Health, WHO, AMREF.
9. World Health Organization. Guidelines for Organizing National External Quality
Assessment Schemes for HIV Serological Testing. UNAIDS/96.5.

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Session 5: Laboratory Quality System To Monitor Improvement

NTA Level 6, Semester 1, Module Code: MLT 06107 – Name: Laboratory Quality
Management Systems

Total Session Time: 120 minutes

Pre-requisites

Learning Objectives
By the end of this session, students are expected to be able to:
1. Plan for laboratory quality system activities
2. Use quality monitoring tools (TAT chart, Levey Jenning’s chart, temperature chart)
3. Assess sample rejection rate
4. Apply corrective measures to address identified gaps

Step 2: Plan for laboratory quality system activities (25 minutes)

• Organization – Define the roles in Hematology – particularly the quality assurance tech
role and supervisor role
• Personnel – Define the instrument orientation training checklist, core competencies, and
competency assessment (for example: interpreting data, and calibrating instrument)
• Equipment – Define a decision matrix for instrument selection; define SOPs for
calibration and maintenance
• Process Control – Define instrument validation procedures; write quality control policy
and procedures; enroll in PT or other EQA; write and enforce criteria for specimen
rejection
• Supplies – Define a good vendor relationship and inventory management process.
Monitor critical supply levels.
• Information Management – Develop policies that address patient confidentiality and
privacy issues to ensure results are reported to authorized individuals only. Develop a
system for reporting lab results including critical hematology results.
• Document and Record Control – Develop a procedure that outlines the storage,
retrieval, and destruction of hematology reports. Maintain instrument maintenance and
function check logs.
• Occurrence Management – Document all instrument malfunctions/failures, complaints,
and quality assurance problems in an occurrence log and have quality assurance tech and
management investigate. Take corrective action.
• Internal Assessment – Define quality control criteria used to regularly assess analyzer
operations. Collect and review data. Report the results to management.
• Process Improvement – Evaluate the data from occurrence reports. Modify procedures
to decrease the number of erroneous hematology report results.
• Customer Service – Develop a customer survey to measure the physician satisfaction
with the turnaround time for receiving hematology results.
• Facilities and Safety – Develop a procedure to properly dispose of analyzer biohazard
waste.

Step 3: Use quality monitoring tools (TAT chart, Levey Jenning’s chart, temperature
chart) (25 minutes)

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It is a good laboratory practice to use quality-monitoring tools to ensure the laboratory
produces quality results and reports
 Turnaround Time (TAT):
 To meet customer satisfaction
 To ensure work efficiency
 To monitor panic value reporting
 To monitor rejection rate
 Levey Jenning’s Chart:
 To monitor QC
 To monitor instrument performance
 To detect systemic and/or random errors
 To ensure good laboratory practice
 Temperature Chart:
 To environment
 To refrigerators, freezers, cold rooms, incubators

Step 4: Assess sample rejection rate (25 minutes)

 Assessment of specimen quality and integrity
 FOLLOW THE SOP for Specimen Receiving
 Inspect the tube and it’s contents immediately upon arrival, carefully checking for
leakage or damage
 Reject the specimen and request another, if the following occurs
 The blood is haemolysed or frozen
 Clots are visible
 If specimen is > 48 hours old (from the time of draw
 Use of wrong anticoagulant for test order
 Quantity not sufficient (QNS)
 Label does not follow criteria from SOP
 Communication is an important component of managing laboratory specimens and
handling problems.
 It is important to have clearly written policies for specimen rejection.
o You must communicate with those who provide inadequate specimens concerning
quality specimen collection.
 Delays in testing must also be communicated.
 Rejection criteria:
 Every laboratory should have written rejection criteria that should be distributed to all
specimen collection points
 Inadequate specimen identification
 Inadequate specimen volume
 Dilution with fluids
 Inappropriate collection tube
 Haemolysis
 Improper conditions of transport
 Clotted specimen
 Rejection rate:
 Laboratory Specimen Acceptability: A substantial amount of rework, diagnostic
and therapeutic delay, and patient inconvenience can result from specimen rejection.
Patient redraws may be due to issues including:
o Unlabeled,
o Mislabeled

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 o Incompletely labeled specimens;
o Clotted and/or hemolyzed specimens;
o Insufficient specimen quantity
 By continuously monitoring specimen acceptability, collection, and transport,
problems can be promptly identified and corrected, leading to improved patient care.
Participation in this monitor can help satisfy the checklist question, “Are preanalytic
variables monitored?”
 Monitor Objective: Identify and characterize unacceptable blood specimens that are
submitted to the chemistry and hematology sections of the clinical laboratory for
testing.
 Data Collection: This monitor includes all blood specimens submitted for testing to
the chemistry and hematology departments of the clinical laboratory. Weekly tallies
on the total number of specimens received, the number of rejected specimens, and the
primary reason each specimen is rejected will be recorded.
 Performance Indicators
o Specimen Rejection Rate (%)
o Breakdown of Rejection Reasons (%)
 Input forms for quarterly data will be sent to participants approximately three weeks
prior to the quarter.

Step 5: Apply corrective measures to address identified gaps (20 minutes)

 The laboratory quality system provides the means to ensure that the laboratory does
things right. Policies and procedures are in place, people are trained and competent,
processes are assessed for weaknesses, and corrective action is taken when problems are
identified.
 Monitoring laboratory operations on a routine basis is essential in order to maintain
control, and develop a high quality of service
 The effectiveness of a Quality Laboratory System is measured against benchmarks
 Manager will document:
 Remedial actions taken to solve immediate problem
 Corrective actions to be taken to solve system or people issues identified
 Audit the system later in time to assure stability of the fix
 Occurrence documentation is part of quality reporting system
 Occurrence data and trends are used to identify problems for process improvement
activities
 Management prioritizes the problems
 Management assigns the process improvement (PI) team to develop solutions
 Occurrence data must be monitored with a focused audit after intervention to assure the
fix is stable

The Role of Assessments

 Assessments are a major component of the Quality Laboratory Systems framework
 Assessments are a systematic and ongoing examination of processes within the quality
system
 Internal Audits
 Periodically conducted to assess if management has implemented adequate and
effective controls of laboratory operations and quality systems
 Define and report on quality indicators/monitors with benchmarks
 External Assessments

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  Used to identify systematic error or methodological problems
 Usually performed by an outside organization

What to Audit
 High volume procedures
 High risk procedures
 Problem-prone processes
 Issues highlighted in occurrence documentation

Internal Audit Methods

 Tracer Methodology
 Follow the path of the workflow for an activity from the beginning to the end
 Confirmation/Corroboration
 Asking employees or others to verify that collected information is accurate
 Sampling
 Selecting a statistically valid smaller number of records to review

Example: Internal Audit

 Process to be audited
 Blood collection for transfusion testing
 Methodology
 Tracer Methodology

Audit Steps
 Examine the request slip and tube labels for complete information
 Review the SOP for accuracy and completeness
 Compare the SOP with performance by observing blood drawn and labeled in multiple
areas
 Check final labeled tubes for criteria defined in SOP
 Review data on specimen rejections in Blood Bank
 Examine training and competency assessment records on phlebotomists

Step 6: Key Points (10 minutes)

 Plan for laboratory quality system activities
 Use quality monitoring tools (TAT chart, Levey Jenning’s chart, temperature chart)
 Assess sample rejection rate
 Apply corrective measures to address identified gaps

Step 7: Evaluation (10 minutes)

 In laboratory practice, where do you apply these:
 Turnaround Time (TAT):
 To meet customer satisfaction
 To ensure work efficiency
 To monitor panic value reporting
 To monitor rejection rate
 Levey Jenning’s Chart:
 To monitor QC
 To monitor instrument performance
 To detect systemic and/or random errors

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  To ensure good laboratory practice
 Temperature Chart:
 To environment
 To refrigerators, freezers, cold rooms, incubators

References:
1. MOHSW (July 2008) Training Modules for CD4, Haematology and Clinical Chemistry
for Laboratory Health Care Workers in Tanzania, Joint Modules, Module 1: Specimen
Management
2. Module 7: Occurrence Management Internal and External Assessment, Training Modules
for Managers of HIV/AIDS Care and Treatment Centers in Tanzania, Laboratory
Management, MOHSW, July 2008
3. Module 2: Overview of Quality Systems, Training Modules for Managers of HIV/AIDS
Care and Treatment Centers in Tanzania, Laboratory Management, MOHSW, July 2008

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Session 6: External Quality Assessment (EQA) to verify Laboratory
Performance

NTA Level 6, Semester 1, Module Code: MLT 06107 – Name: Laboratory Quality
Management Systems

Total Session Time: 120 minutes

Prerequisites

Learning Objectives
By the end of this session, students are expected to be able to:
1. Supervise the preparation of EQA samples for laboratory tests
2. Supervise laboratory personnel for performance of proficiency testing using EQA
samples
3. Prepare supervision report of EQA sample preparation and the performance

Step 2: Supervise the preparation of EQA samples for laboratory tests (60 minutes)

• Definition of EQA
 External Quality Assessment (EQA) is a set of procedures undertaken by the
laboratory staff for the continuous and immediate monitoring of laboratory work in
order to decide whether the results are reliable to be released

EXAMPLE 1: SOP FOR PREPARATION OF EQA SERUM SAMPLES FOR

SYPHILIS SEROLOGY

Principle and purpose

 Plasma is prepared from blood samples of known syphilis sero-status. An agreed number
of aliquoted samples is then prepared from the evaluated material for use in the laboratory
as Internal Quality Control material. A random sample of aliquots is then tested to
determine the presence of syphilis antibody. Samples that are negative for syphilis are
also required for IQC.

SCREENING OF BLOOD FOR SUITABILITY FOR SYPHILIS TESTING

 Equipment, materials and reagents
 Serum/plasma samples
 Rapid Plasma Reagin test kits
 TPPA or TPHA kits
 Centrifuge tubes
 Centrifuge
 Serum tubes and racks
 Indelible markers, labels
 Micropipettes and tips
 Transfer pipettes

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  Disinfectant (Jik®)
 Cryovials
 Gloves
 Laboratory coats
 Biohazard bags
 Mechanical shaker
 Water bath
 Refrigerator
 Freezer
 Register books
 Levey Jenning’s charts
 U-shaped microtitre plates for TPHA

 Sample required
 Collect fresh blood or plasma donations known syphilis sero-status from national or
regional blood bank.

Method for preparing and testing the material

(a) Procedure for preparing and testing plasma:
1. Centrifuge the samples (if whole blood) and distribute the clear supernatant (plasma)
into a sterile reagent bottle.
2. Test the plasma using a VDRL screening test, and if positive, test with the TPHA
confirmatory test.
(b) Procedure for treating plasma
1. If the sample is syphilis positive, heat inactivate by placing in a water bath at 56°C for
1 hour.
2. Store samples at -20°C until ready to use

Procedural notes
 Follow the storage instructions for each test kit. Some test kits may be stored at room
temperature in a cool dry place; other kits require refrigeration.
 Check carefully the expiry dates on the test kits.

Quality control
 Performance of test kits
 Use positive and negative controls to ensure the tests kits are performing properly.

 Interpretation
 Positive: large or fine clumps of particles or agglutination in the test sample
 Negative: no clumping of particles or agglutination in the test sample

PREPARATION OF ALIQUOTED SERUM SAMPLES FOR SYPHILIS TESTING

 Method for preparing sample aliquots

 Prepare two categories of plasma: syphilis negative and syphilis positive, as follows:
o Assign identification numbers to each sample.
o Re-test samples with screening and confirmatory tests (VDRL and TPHA).
o Record the characteristics of each sample/batch.
o Aliquot 0.5 ml of each sample into the required number of cryovials.
o Label the cryovials and samples and store at -20°C or -80°C.

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 Validating the material
 See accompanying QC guidelines
o Ensure that the Quality Manual with quality assurance policies and procedures is
accessible to and reviewed by all staff
o Ensure that QC material is tested according to SOP
o Establish acceptable ranges for control material
o Validate new equipment, reagents, and supplies
o Track test performance (e.g., Levy-Jennings chart) for trends
o Review discordant rates and determine appropriate action
o Review records of environmental checks & QC trends to assess impact on testing
and take corrective action
o Review occurrence log for patterns/trends and take corrective action
o Monitor reagent performance
o Customize site-specific SOPs as needed
o Ensure that SOP are read and understood by staff
o Enrol in EQA program, monitor results, and take corrective actions
o Periodically observe/assess accuracy of staff performance and take corrective
action

 Packing and transportation

 Pack the cryovials in the triple pack containers provided. Pack the documentation in a
separate plastic re-sealable bag and place in the outer-most container. Clearly mark
the outside container: FRAGILE, PATHOLOGICAL MATERIAL, HANDLE
WITH CARE. Label with the name and address of the consignee and sender. Deliver
the parcel to courier for transportation. Sign the delivery documents and maintain a
copy in your file.

 Record keeping
 For each batch of serum samples, record the complete procedure including:
 Preparation and testing techniques used
 Results of each batch
 Number of prepared vials and samples
 Dates of preparation, time, concentration/status
 Name and signature (preparer and Quality Officer)
 Dates of shipping vials
 Means of shipping vials

EXAMPLE 2: SOP FOR PREPARATION OF EQA MATERIAL OF PUS SMEARS

FOR GRAM STAIN MICROSCOPY (GENITAL, EYE, EAR, WOUND)

Principle and purpose

 A smear is prepared from pus samples containing organisms of known Gram reaction and
stained with Gram stain. The smear is examined to confirm the presence of organisms,
evaluate the appearance of the organisms, and determine their density. Multiple slides are
then prepared from the evaluated material for distribution in the EQA.
 A sample of the smears is examined to determine the average and range of values for
density of organisms, and to ensure organisms showing the relevant morphology are
present. Pus samples that are NEGATIVE for organisms are also required for EQA.

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Equipment, materials and reagents
 Gentian violet
 Potassium iodide
 Iodine crystals
 Acetone
 Absolute methanol
 Strong Carbol Fuchsin
 Sodium chloride
 Distilled water
 Conical flasks
 Reagent bottles
 Filter paper
 Bijou bottles, sterile
 Pasteur pipette, sterile
 Frosted glass slides
 Cotton wool/gauze
 Grease pencil/lead pencil
 Gloves
 Microscope
 Weighing scale
 Immersion oil
 Xylene

Preparation of Reagents
 0.5% Gentian violet: Dissolve 2.5g gentian violet powder in 500 ml distilled water in a
conical flask. Stir using a glass rod until the powder has completely dissolved. Filter into
a reagent bottle and label with the name of the reagent and date of preparation. For daily
use, transfer 100 ml into dropper bottle and label.
 Lugol’s iodine: Dissolve 10g potassium iodide in about 100 ml distilled water and add 5
g of iodine. Stir using a glass rod until the iodine crystals dissolve. Make up the volume
to 500ml with distilled water. Transfer to a brown bottle and label with the name of the
reagent and date of preparation. For daily use, transfer 100 ml into a brown dropper
bottle.
 50% acetone/alcohol: Measure 500 ml acetone and pour into a reagent bottle. Measure
475 ml of absolute methanol and 25 ml distilled water and add to the acetone and mix.
Label with the name of the reagent and date of preparation. For daily use transfer 100 ml
to a dropper bottle and label.
 Dilute Carbol Fuchsin: Pour 95 ml of distilled water into a dropper bottle and add 5 ml of
strong Carbol Fuchsin. Mix and label.
 Physiological saline: Dissolve 0.85 g of sodium chloride in 100 ml distilled water in a
reagent bottle. Label with the name of the reagent and date of preparation. Sterilise by
autoclaving, making sure the cap is loosely fitted. After autoclaving, tighten the cap. Use
a sterile Pasteur pipette to dispense the sterile saline.

Sample required
 Collect pus samples from the following sites into a sterile specimen container: infected
eyes, ears, wounds or urethral discharge, prior to treatment with antibiotics.

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Method of preparing the material
(i) Screening the sample for suitability:
 Label the Bijou bottle with the patient's laboratory number using a grease pencil. Note
and record the appearance of the specimen.
 Add an equal volume of sterile saline and emulsify by mixing with a vortex mixer.
 Clean a slide using gauze or dry cotton wool. Label the slide with the patient's
laboratory number using a lead pencil on the frosted end of the slide.
 Make a smear on the slide by placing 10 l of the emulsion in the centre of the slide
and spreading in a circle to 10 mm diameter. Allow to air dry horizontally on a flat
surface.
 Fix the smear by passing the slide (smear uppermost) momentarily over a flame 3
times.
 Place a staining rack over a sink or basin. Place the slide on the staining rack. Cover
the smear with 0.5% gentian violet. Leave for 1 minute.
 Wash the smear in a thin stream of clean water to remove the excess stain. Cover the
smear with Lugol's iodine and leave for 1 minute. Wash the smear in a thin stream of
clean water.
 Decolorise the smear by adding 50% acetone alcohol solution slowly, one drop at a
time, and stop as soon as no more blue colour comes out of the smear.
 Counterstain by covering the smear with dilute Carbol Fuchsin. Leave for 30 seconds.
Wash the smear in a thin stream of clean water to remove excess stain. Allow the
smear to drain dry on a slide drying rack.
 Place a drop of immersion oil on the smear, and place on the microscope stage. Focus
the smear using the x10 objective and examine systematically using the x100
objective for pus cells and bacteria. Note the Gram reaction of the bacteria.
 Place used cotton wool and swabs in the bucket marked "INCINERATION". Keep
positive stained slides for reference. Place negative slides in the container of 5%
Lysol marked "SLIDES".
(ii) Preparing slides for EQA
 Prepare the required number of slides and fix only (do not stain) following the method
used in the screening stage.
 For every 50 slides prepared, stain and examine 5 smears to ensure pus cells and
bacteria are present and correctly stained.

Procedural notes
 Use a brown bottle to store Lugol’s iodine. Iodine deteriorates when exposed to light.
 Do not prepare dilute Carbol Fuchsin in large quantities. Dilute Carbol Fuchsin becomes
colourless when stored on the shelf for prolonged periods.
 50% acetone/alcohol decolorizes smears very quickly. Take care not to over-decolorise
the smears.
 For some distributions, unstained smears (fixed only) will be required.

Quality control
 Quality of the stain
 Prepare two smears from pus containing known Gram positive and Gram negative
organisms:
 Stain with the old stock.
 Stain with the newly prepared stock.
 Compare the staining reactions.

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 If the staining reaction is not good, discard stock and prepare a new stock solution.

Validating the material

 For every 50 smears prepared, randomly select 5 smears and examine them to ensure the
organisms showing relevant morphology are present.

Evaluating stability
 Establish the stability of the stained smears at –20oC, ambient temperature and 37oC for
two months by weekly examinations. Store the slides in boxes and label clearly.

Morphological features
 The following organisms may be used:
 N. gonorrhoeae: In Gram stained preparations, N. gonorrhoeae appears as red, bean-
shaped cocci in pairs with the biconcave sides facing each other. The cocci are
typically seen inside neutrophils (intracellular diploccocci). Some cocci are seen
outside cells (extracellular diplococci). N. gonorrhoeae is indistinguishable
morphologically from N. meningitidis.
 Staphylococcus aureus: in Gram stained preparations, S aureus appear as purple
round cocci in clusters, typically seen outside, but together with, neutrophils.
 Streptococcus pneumoniae: in Gram stained preparations, S pneumoniae appear as
purple round flame-shaped cocci in pairs (diplococci).

Transportation
 Arrange the prepared slides in the slide boxes provided. Close and seal the slide boxes
and place in a box or carton with padding, e.g. newspaper, shredded paper. Pack the
documentation in a separate plastic re-sealable bag and place in the box or carton. Clearly
mark the box: FRAGILE, HANDLE WITH CARE. Label the box with the name and
address of the consignee and sender. Deliver the parcel to courier for transportation. Sign
the delivery documents and maintain a copy in your file.

Record keeping
 For each batch of smears, record the complete procedure including:
 Preparation and staining techniques used
 Bacteria and pus cells seen
 Counts of bacterial and pus cells in prepared slides: average and range of values
 Number of prepared slides
 Dates of slide preparation
 Dates of shipping slides
 Means of shipping slides
 Dates of preparation, time, concentration/status
 Initial and signature of preparer and Quality Officer

Step 3: Supervise laboratory personnel for performance of proficiency testing using

EQA samples (25 minutes)
 When performing laboratory procedures/tests:
 Adhere to personal health and safety practices
 Assign test according to test request
 Collect and label specimens properly
 Log specimens properly
 Inspect quality of all specimens and record rejected samples

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  Process and aliquot specimens
 Test specimens according to SOPs
 Validate and interpret results
 Record any failed test runs and take corrective action

 After the laboratory procedures/tests

 Record individual test results in site logbook and patient report form immediately
 Check accuracy of your own work
 Check each other for transcription errors and sample mix-up
 Check against test orders to confirm all tests are completed
 Report/return test results in a timely fashion
o (If individual test) Report result to test requestor, patient, or client
o (If multiple tests) Consolidate and return all test findings for a patient to test
requestor/ patient records – write, sign off, send to proper people
 Document test results have been properly reported

Step 4: Prepare supervision report of EQA sample preparation and the performance
(15 minutes)
• The report shall include the following information:
 Site Name & Location
 Date of Visit
 Assessment Team Members
 Major Findings
 Recommendations for corrective actions
 Submit complete

Step 5: Key Points (10 minutes)

• Supervise the preparation of EQA samples for laboratory tests
• Supervise laboratory personnel for performance of proficiency testing using EQA
samples
• Prepare supervision report of EQA sample preparation and the performance

Step 6: Evaluation (5 minutes)

• What are they key components of an EQA supervision report?
 Site Name & Location
 Date of Visit
 Assessment Team Members
 Major Findings
 Recommendations for corrective actions
 Submit complete

References:
1. Baker F.J., Silverton, R.E. and Pallister P.J. (1998). Introduction to Medical Laboratory
Technology, 7th Edition, Butterworth-Heinemann, England
2. Barror G, Felthan R K A (1993). Cowan and Steel’s Manual for the Identification of
Medical Bacteria, Third Edition. Cambridge University Press, England.
3. Carter J, Lema O (1994). Practical Laboratory Manual for Health Centres in Eastern
Africa, AMREF
4. Forbes Betty A, Weissfeld Alice S (1998). Bailey’s and Scott’s Diagnostic Microbiology,
Tenth Edition. Mosby Inc., USA.

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5. Cheesbrough, Monica (2000). Medical Laboratory Manual for Tropical Countries, Part 2:
Microbiology, Butterworth & Co Ltd, UK
6. Munafu C, Tenywa T, Musoke Bukenya M (1998). Validation of Syndromic
Management of Sexually Transmitted Infections, Volume 1, AMREF
7. Constantine Niel T, Callahan Johnny D, Watts Douglas M, (1991). HIV Testing and
Quality Control, a Guide for Laboratory Personnel. Family Health International.
8. Munafu C, Guma G B, Igune M, Rwandembo M W, Olupot-Olupot P, et al (2000).
Management and Control of Diseases of Epidemic Potential in Uganda. Ministry of
Health, WHO, AMREF.
9. World Health Organization. Guidelines for Organizing National External Quality
Assessment Schemes for HIV Serological Testing. UNAIDS/96.5.
10. MOHSW (January 2007), Module 13: External Quality Assessment, Training in HIV
Rapid Testing for Laboratory and Non-Laboratory Health Workers, Facilitator’s Manual
11. SLMTA, Trainer’s Guide 2009

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Session 7: Validate Laboratory Diagnostic Technology

NTA Level 6, Semester 1, Module Code: MLT 06107 – Name: Laboratory Quality
Management Systems

Total Session Time: 120 minutes

Prerequisites

Learning Objectives
By the end of this session, students are expected to be able to:
1. Describe methods of validation in the laboratory (accuracy study, precision analysis,
carryover study linearity, reference range)
2. Perform laboratory reagent validation
3. Perform laboratory equipment validation using Standards
4. Document validation results

Step 2: Describe methods of validation in the laboratory (accuracy study, precision

analysis, carryover study, linearity, reference range) (40 minutes)

Process Validation
A policy for process validation should include a written statement that new equipment, test
methodologies, and computer system upgrades will undergo a validation process prior to
performance of patient testing. Validation provides evidence and assurance that the process
will perform to its predetermined specifications before patient testing is conducted. The
quality procedure describes how a validation process is conducted and documented.

Process Control Activities

• Pre-analytic:
 Specimen collection and transport guidelines; criteria for acceptability of specimens
• Analytic:
 Method evaluation and validation
 Calibration, calibration verification, periodic linearity checks
 Use of calibrator and control materials at defined frequencies for the method
 Quality control program with defined rules; performing and documenting corrective
action
 Statistical evaluation of QC data; shifts and trends identified
 Repeat of questionable results
• Post-analytic
 Result review criteria and/or delta checks (limits set for significant change in results)
• All Phases:
 Well written policies and procedures under document control
 Clear documentation of all steps

Major Process Control Activities

• Specimen Management
• Process/Method Validation
• Quality Control

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  Statistical Quality Control
 Reagent lot validation

Process/Method Validation
• Process validation includes method evaluation and validation of pre-analytic and post-
analytic processes
• Prior to reporting test results, each method must have performance characteristics
validated to assure the quality of the expected results

How is it done?
• Laboratory can perform process validation but it is very time-consuming and requires
special technical expertise
• Vendor may perform and document the performance aspects of the instrument during the
evaluation
• Laboratory leaders must review and approve the method validation regardless of how it is
done

Why do it?
• Quality control is used to monitor the precision and the accuracy of the assay in order to
provide reliable results
• Quality control statistics (i.e. Mean and SD) indicate whether observed results are within
the expected limits of the analytical process

Stable Control Materials

• Commercial controls (assayed or unassayed)
• Patient or employee controls (controls internally obtained)
• Statistical measurement using patient data

Types of Quality Control

• Qualitative – run at least one positive and negative control each day
• Quantitative – run at least 2 controls (normal and abnormal) once per shift

Accuracy study
• Determine the “accuracy” or a specific test or a cluster of tests and measures toward the
1) diagnosis, 2) prognosis, or 3) best intervention method
• Accuracy is scored from 0 to 100% and is calculated (TP+TN)/(TP+TN+FN+FP)
• (Where: TP = true positive, TN = true negative, FN = false negative and FP = false
negative)

Precision analysis
• The degree of fluctuation on repeated measurements is indicative of the “precision” of the
assay.
• Note these are not accurate as the closeness of measurements to the true value is
indicative of the “accuracy” of the assay.
• This is inaccurate, but is precise

Carryover study
• Carryover is the interaction of the previous sample with the current sample
• High to low carryover checks to verify the high results of one sample do not affect the
low results of the next sample

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• If carryover check does not pass, consult the instrument manual for how to troubleshoot
• Portion of previous sample affects the next sample results; can be a problem with
continuous flow or anytime wash solution is empty

Linearity
• Definition: "The difference of bias throughout the expected operating (measurement)
range of the equipment is called linearity."
• The steps in a linearity study are given below. The key starting point is selecting samples
to include in the study. These samples must span the range of the measurement variation
in the process. For example, if your process output varies from 70 to 100, you want to
select samples that span that range. You don't want to only include samples in the 90 to
100 ranges. You linearity study will not be valid for the entire range. It is best to have at
least 5 samples over the range.
• Another problem is determining the reference value for the samples. This can be done, for
example, if you have a master tool room. You may have to send out the samples to
another laboratory, which you know has better precision than your laboratory.
• The last issue is to be sure that one operator measures each sample at least 10 times. The
samples should be measured in a random order.
• Thus, the steps in conducting a linearity study are:
 Select at least 5 samples the measurement values of which cover the range of
variation in the process
 Determine the reference value for each sample
 Have one operator measure each sample at least 10 times using the measurement
system

Reference range
• Results of the normal donor control are expected to be within the established reference
range. If results exceed reference range limits, follow corrective action:
 Repeat test using same antibody aliquot
 If the results still exceed the limits, do not automatically invalidate patient results
 Due to the 95% confidence interval, 1 in 20 specimens from healthy individuals
drawn at random can be outside reference range limits due to biological factors
 May be true result - misrepresentation of healthy status (especially true in highly
endemic areas)
 If still exceeds limits, repeat with new antibody aliquot
 If this corrects the problem, all patient specimens must be repeated using the new
antibody aliquot
• Document all these steps on a corrective action log

Establishing Reference Ranges

 Reference ranges should be established for manual and automated methods
 The service engineer should establish reference ranges for automated methods
 Determine “healthy” patient range for each method for adults and paediatrics
 If gender difference in test values, should establish for both genders
 Materials used
 20 healthy patient samples previously obtained are run over a period of at least 3
consecutive days
 Calculation of Reference Ranges
 Calculate mean (x) and standard deviations (s) for the data points
 Use ± 2 standard deviations to determine the reference range for the healthy patients

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Step 3: Perform laboratory reagent validation (15 minutes)
 For both qualitative and quantitative batch of reagents prepared, randomly select 10% and
test them according to the specific test SOP to ensure that the indicated status (positive or
negative) or the intended analyte concentration is within ±10% of the intended value
 Validation can be done in-house or referred to higher level laboratories
 Follow SOP (daily PPM of instruments must be done) and perform analysis using
new reagents and quality control samples
 If quality control samples fall outside of expected ranges, review steps of reagent
preparation
 New reagent may need to be prepared and quality control samples run to verify
reagent is acceptable to use

Step 4: Perform laboratory equipment validation using standards (30 minutes)

Before Instrument Validation
• Permit instrument to stabilize/equilibrate
 Let all components reach proper temperature
• Set in any parameters that may be required by following manufacturer’s
recommendations in Operator’s Manual:
 Ranges
 Temperatures
• Primary Standard
 A standard solution of exactly known concentration that is prepared by weighing or
measuring a highly purified chemical (solute) and dissolving in appropriate solvent.
They should be 99.98% pure according to International Union of Pure and Applied
Chemistry (IUPAC).
• Secondary Standard
 A standard solution whose concentration is determined by analysis of an aliquot of the
solution by a highly accurate method, using a primary standard to calibrate the
method.
• Calibrator
 A substance or mixture dissolved in a matrix used to calibrate an instrument. May be
a primary or a secondary type
• QC samples
 Similar in makeup to patient samples used for verifying validity
 Have statistically established target values and ranges (usually up to target value + 3s)
that may vary from method to method
 Adhere to instructions of QC sample pack insert

Initial Instrument Calibration

• Follow manufacturers recommendation for reagent and control preparation
 Make a habit of reading package inserts
• Place reagents on instrument as required
• Place calibrator(s) on instrument in proper order sequence
• Run prepared calibrator(s) on both automated and reliable existing methods
• Once an analyte is proved to follow Beer's Law at a specific wavelength (i.e.: a linear plot
of ABS vs. concentration with a zero intercept is obtained), an unknown concentration
relates to a single standard by: ABS (STD)/ABS (Unknown) = Conc (STD)/Conc
(Unknown)

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 Therefore: Conc (Unknown) = [ABS (Unknown)/ABS (STD)] x Conc (STD)

Note: Beer's Law doesn’t apply when very elevated concentrations are measured

• If calibration is unsuccessful, then troubleshoot

 1st determine if it is instrument or reagent problem
 Verify proper preparation of calibrator
 If all trouble shootings fail, contact manufacturer for support
• If calibration is successful, then run controls using both automated and reliable existing
methods
 Verify that results are acceptable for
o Slope
o Intercept (where the curve crosses the y axis)
o Correlation factor
 Formula for determining slope and intercept:
y = bx + a, where: y = absorbance, b = slope, x = conc., a = intercept
 Be sure to print out the calibration results and keep the printout for future reference
(calibration curve, correlation factor, slope and intercept)
• Determine QC results by standard curve or factor established during calibration using
standards or a standard
• If controls are within stated value for analyzer and methodology, then move to instrument
validation
• Test calibration will be repeated
 When there is a new lot number of reagent or
 In accordance with manufacturer’s recommendations or
 On more frequent basis as indicated by quality control

Step 5: Document validation results (10 minutes)

 Record the complete procedure including:
 Preparation and techniques used
 Standards/controls used (commercial or in-house)
 Dates of validation
 Initial and signature of preparer and Quality Officer

Step 6: Key Points (10 minutes)

 Methods of validation in the laboratory (accuracy study, precision analysis, carryover
study linearity, reference range)
 Perform laboratory reagent validation
 Perform laboratory equipment validation using Standards
 Document validation results

Step 7: Evaluation (10 minutes)

 How do establish a local haemoglobin reference range for your district?

References:
1. Module 5: Laboratory Process Management, Training Modules for Managers of
HIV/AIDS Care and Treatment Centers in Tanzania, Laboratory Management, MOHSW,
July 2008
2. http://www.spcforexcel.com/variable-measurement-systems-part-3-
linearity#linearityStudy

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3. Arcan (2006) Teaching Module, Part 6 Chemistry

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Session 8: Turnaround Time As A Measure Of Client Satisfaction

NTA Level 6, Semester 1, Module Code: MLT 06107 – Name: Laboratory Quality
Management Systems

Total Session Time: 120 minutes

Prerequisites

Learning Objectives
By the end of this session, students are expected to be able to:
1. Determine turn-around time for a particular laboratory investigation
2. Chart turnaround time for a particular laboratory investigation
3. Assess turnaround time for a particular laboratory investigation
4. Adjust turnaround time for a particular laboratory investigation

Step 2: Determine turnaround time for a particular laboratory investigation (10

minutes)
 Define turnaround time (TAT)
 Period for completing a process cycle commonly expressed as an average of previous
such periods.

Determination of turnaround time

 Choice of appropriate analytes for monitoring. These should be chosen to reflect different
service needs of the areas served by the laboratory but should probably be restricted to no
more than four. A variety of different tests, priorities and locations should be chosen to
cover the range of work provided by the laboratory.
 Clear definition of TAT in terms of start points and end points. Despite the attraction of
assessing both intra-laboratory and extra-laboratory TAT, such data are often not
available and the laboratory must use the data that can be gathered easily, reliably and on
an on-going basis. With increasing availability of electronic timestamp data of clinician
requesting and result reviewing times, a closer approximation to therapeutic TAT
becomes possible. Intra-laboratory TAT may be the easiest to define, using start points of
specimen receipt (or registration) and end points of result availability to requester (or
hardcopy printing). However laboratories should ensure that the choice of timing points is
relevant in their local context and that practices such as sample registration prior to
sample collection (as is possible in an outpatient setting) or the addition of a test request
to an existing sample requisition do not result in misleading time interval calculations.
TAT histograms should be studied carefully to identify any unexpected patterns or the
presence of anomalous data points.
 Clear definition of measures to be measured. Medians, 90% (or 95%) completion times
and outlier rates are preferred over Gaussian-based mean and standard deviation
measures. Despite their attraction, 90% completion times are often not routinely
calculated by laboratory information systems and may require offline analysis of
extracted raw data. Outlier rates may be easy to obtain on an on-going basis and can also
be a source of cases for further investigation on a regular schedule (e.g. root cause
analysis of delay for the slowest 20 troponin samples every month). Similarly median
values are less commonly available than mean values–the laboratory should work with

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 the available measures while appreciating any inherent shortcomings.
 Clear definitions of acceptable and unacceptable performance based on clinical evidence,
benchmarking data and local expectations. These goals should be negotiated with users. A
sample registration to result reporting 90% completion time of <60 minutes for common
laboratory tests is a good starting point for discussion.
 Establishment of a system for long term monitoring of performance using available data.
 Regular review (e.g. monthly) of performance measures looking for unacceptable
performance and trends.
 Regular review of performance goals whenever systems, workflow or equipment change
and on an annual basis.
 Consider supplementation of internal TAT monitoring with enrolment in external
programs. Present programs available include urgent test turnaround time outliers,
morning rounds inpatient test availability and TAT of troponin.

Activity: In class exercise (10 minutes)

ASK the students:

SUMMARIZE: their responses and confirm correct answers using notes below

Step 3: Chart turnaround time for a particular laboratory investigation (30 minutes)

Fig 1: TAT Monitoring Form

Source: ASCP

Direction for Use:

 Selection of Samples for TAT Monitoring
 Select 5 samples per day for a week every month to track. The samples selected
should span the whole day e.g. one from the first samples of the day and one from the
last samples received, the rest interspaced in between.
 Number (#)

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  Record the sequence number of the samples selected for TAT monitoring. If
following 12 specimens for TAT monitoring (with 3 pages of TAT monitoring tables)
the far left column will, in sequence, be populated with #’s 1-12.
 Day & Date
 Record the day of the week and date that the samples selected for monitoring were
collected.
 Lab ID/Patient Name
 Record the Lab ID and/or patient name for the samples selected for monitoring.
 Sample Reception
 Record the date the sample was received. Record the specific time received (e.g.,
10:07)
 Testing Bench
 Record the date the sample arrived at the testing bench. Record the specific time
received.
 Processing
 Record the date the pre testing processing of the sample started. Record the specific
time processing began (e.g., the time that pipetting for CD4 testing began or the time
the work list is created for FBC testing).
 Testing
 For automated tests, record the date and time on the results printout. For manual
testing, record the date and time when actual testing is done.
 Result Dispatching
 Record the date the results were dispatched. Record the time the results were
dispatched.
 Time
 To determine the TAT, summarize above each arrow the time elapsed between the
steps/stages represented in the table (see example below). Start by determining the
amount of time elapsed between the ‘Time In’ at sample reception and the ‘Time In’
at the testing bench.
 Add the times above the arrows from left to right. The resulting sum should be
recorded in the column marked “Total Time”.

Step 4: Assess turnaround time for a particular laboratory investigation (30 minutes)

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 Fig 2: TAT Tracking Form; Source: ASCP

 Section heads to assess and record all TAT parameters

 Use tracking form (see example above)
 Form a team to analysis the assessment report
 Determine mean TAT for the particular laboratory test
 Identify areas of improvement
 Write a report (see example of format below)

Writing Turnaround Time Improvement Report Format

 Make a project write up (in Microsoft word if computer is available or handwritten using
the following format. The report becomes the Laboratory’s own record of improvement
projects conducted
 Introduction
 A brief description of the TAT project being investigated
 What led the lab to selecting the project
o What you intend to achieve out of the project (Aim and Objectives) e.g.
 Aim: To measure TAT of CD4 from Lab X to improve customer satisfaction
to at least 80% by July 2012
 Objectives
To measure TAT of CD4 using a TAT tracking form
To improve TAT to above 80% as measured by the TAT form over several
months prior to July 2012
 Methodology
 Where was the project being conducted?
 How was the IP conducted (data collection methods, data collection tools, frequency
of collection and who was collecting and how the data will be analyzed)
 What improvements were implemented, by whom and how?
 For how long was the project conducted?
 Results
 Describe the results: Baseline and final

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  Analysis of the results baseline and final
 Conclusion
 What are/is the conclusion(s) based on results
 Challenges
 Write challenges of TAT recording and charting
 Recommendations
 For Reporting, summarize your improvement project. Making a 10-minute computer
presentation (power point or handwritten) may also be useful.

Step 5: Adjust turnaround time for a particular laboratory investigation (30 minutes)

Fig 3: Approximate blood draw time in minutes

Source:
http://www.systemdynamics.org/conferences/2005/proceed/../QUINN233.pdf

 Improving the Process

 With the discoveries made in the report, the team brainstorm and arrive at the
following steps to follow on a daily basis to improve the process (refer to fig 3
above):
 The set (target) TAT for daily average blood draw time is between 6 and 10 minutes
 The report indicates that on Monday, Friday and Saturday (indicated by red arrows),
the draw times exceeded the set TAT.
 Identify the phlebotomist who was on duty at the time of three occurrences
 Determine root cause that contributed to the occurrences
 Team designs plan for improvement
 Develop required counter measures and make an implementation plan.
 Implement plan (using PDCA approach, where P = Plan, D = Do, C = Check and A =
Act)

Step 6: Key Points (5 minutes)

 Turn-around time for a particular laboratory investigation
 Charting turnaround time for a particular laboratory investigation

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 Assessing turnaround time for a particular laboratory investigation
 Adjusting turnaround time for a particular laboratory investigation

Step 7: Evaluation (10 minutes)

 Define TAT and PDCA

References:
1. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2282400/
2. http://www.systemdynamics.org/conferences/2005/proceed/../QUINN233.pdf
3. ASCP TAT Training materials

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Session 9: Quality Of Reagents And Culture Media

NTA Level 6, Semester 1, Module Code: MLT 06107 – Name: Laboratory Quality
Management Systems

Pre-requisites

Learning Objectives
By the end of this session, students are expected to be able to:
1. Describe verification of reagents and culture media
2. List requirements for verification of reagents (control sample i.e. negative and positive,
unexpired reagent
3. List requirements for verification of culture media (Control organisms, culture media,
incubator)
4. Describe interpretation of the verification findings

Step 2: Describe verification of reagents and culture media (50 minutes)

 Describe verification of reagents:
 What analytes should be detected?
 What are the expected concentration levels?
 What are the sample matrices?
 Are there interfering substances expected, and, if so, should they be detected and
quantified?
 Are there any specific legislative or regulatory requirements?
 Should information be qualitative or quantitative?
 What are the required detection and quantitation limits?
 What is the expected concentration range?
 What precision and accuracy is expected?
 How robust should the method be?
 Which type of equipment should be used? Is the method for one specific instrument,
or should all instruments of the same type use it?
 Will the method be used in one specific laboratory or should it be applicable in all
laboratories at one side or around the globe?
 What skills do the anticipated users of the method have?

 Describe verification of culture media:

 Test each batch of prepared media for sterility, ability to support growth, and ability
to produce appropriate biochemical reactions
 Sterility
 For every 20 plates in a lot, incubate one plate at 35oC for 48 hours.
 Ability to support growth
 For selective medium: use at least one strain to test for ability to support growth of the
target pathogen; it should also be noted if this strain produces the appropriate
biochemical reactions/color on the test medium (e.g., Shigella on MacConkey agar)
 Ability to produce appropriate biochemical reactions

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  For selective media: use at least one pathogen and one non-pathogen to test for the
medium’s ability to differentiate target organisms from competitors (e.g., for MAC,
use E. coli and Shigella)
 For biochemical media: use at least one organism that will produce a positive reaction
and one organism that will produce a negative reaction (e.g., for urea medium, use
Proteus and E. coli)
 Inoculation of quality control media
 Direct Inoculation
 Use of standardized suspension (dilution of QC organisms in sterile physiologic saline
(0.85%)
 For selective media, use 1:10 dilution
 For non-selective media, use 1:100
 Use calibrated loop (10µl) to inoculate media
 Sources of Quality Control Organisms
 Should be derived from well-characterized strains
 American Type Culture Collection (ATCC) reference strains
 Commercial sources (ATCC strains also from commercial suppliers)
 Proficiency testing programs
 Incubation of quality control media
 Incubate all test media under conditions normally used for media inoculated with
clinical specimens
 Interpretation of Results
 Non-selective media perform satisfactorily if the quality control organisms exhibit
adequate growth, expected colony size, and typical colony morphology
 Selective media perform satisfactorily if the quality control organisms exhibit
adequate growth, expected colony size, typical colony morphology, and inhibition of
growth of certain organisms
 Prior to use of culture media
 Ensure that media performance has been tested
 Allow media to equilibrate at room temperature
 Visually inspect each medium lot for obvious problems such as: cracked or damaged
plates; agar detached from the petri plates; frozen or melted agar; unequal filling of
the plates; insufficient agar in the plates (<3mm); haemolysis of blood containing
media; change in the expected colour of the media (possible pH problem)

Step 3: List requirements for verification of reagents (15 minutes)

 Control sample i.e. negative and positive
 Unexpired reagent
 Standards and control of known strength or concentration
 Pipettes
 Pipette tips
 Test tubes
 Worksheet
 Markers/pens
 Specific SOP for reagent verification
 Safety SOPs

Step 4: List requirements for verification of culture media (15 minutes)

 Control organisms from reputable sources

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 Standardized organism suspension (dilution of QC organisms in sterile physiologic saline
(0.85%)
 For selective media, use 1:10 dilution
 For non-selective media, use 1:100
 Calibrated loop (10µl) to inoculate media (disposable or reusable)
 Culture media
 Incubator with desired temperature range
 Bunsen burner
 Autoclave
 pH meter
 Autoclave indicators
 Thermometers
 Culture plates (disposable or re-usable)
 Markers/pens
 Simple stains (Gram’s stain reagents)
 Worksheet
 Specific SOP for culture media verification
 Safety SOPs

Step 5: Describe interpretation of the verification findings (20 minutes)

 Culture media verification:
 Non-selective media perform satisfactorily if the quality control organisms exhibit
adequate growth, expected colony size, and typical colony morphology
 Selective media perform satisfactorily if the quality control organisms exhibit
adequate growth, expected colony size, typical colony morphology, and inhibition of
growth of certain organisms

Source: Tanzania Basic Microbiology Training Modules 2010 (MOHSW)

 Reagent verification:
 Perform satisfactory reaction according to manufacturer’s package insert

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  Conforms to desired specifications such as pH, concentration, stability, homogeneity

Step 6: Key Points (5 minutes)

 Verification of reagents and culture media
 Requirements for verification of reagents
 Requirements for verification of culture media
 Interpretation of the verification findings

Step 7: Evaluation (10 minutes)

List requirements for:
 Verification of reagents
 Verification of culture media

References:
1. Tanzania Basic Microbiology Training Modules 2010
2. http://www.labcompliance.com/tutorial/methods/default.aspx

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Session 10: Reagents And Culture Media For Use In Specific Laboratory
Techniques

NTA Level 6, Semester 1, Module Code: MLT 06107 – Name: Laboratory Quality
Management Systems

Total Session Time: 120 minutes

Prerequisites

Learning Objectives
By the end of this session, students are expected to be able to:
1. Describe specificity and sensitivity
2. Determine the specificity and sensitivity of reagents
3. Determine the specificity and sensitivity of culture media
4. Interpret findings of validation procedure for reagents and culture media

Resources Needed:
 Computer/Laptop, LCD projector, Laser pointer, Flip charts, Marker pens, Masking tape,
Black/white board and chalk/whiteboard markers, Laboratory supplies, Policy manual,
SOPs, forms and other relevant documents

SESSION OVERVIEW
Steps Time Activity/Method Contents
Presentation of Session Title and Learning
1 5 minutes Presentation
Objectives
2 30 minutes In Class Exercise Describe sensitivity and specificity
Determine the sensitivity and specificity of
3 20 minutes Presentation
reagents
Determine the sensitivity and specificity of
4 20 minutes Presentation
culture media
Interpret findings of validation procedure
5 20 minutes Presentation
for reagents and culture media
6 15 minutes Presentation Key Points
7 10 minutes Evaluation Question and answers

Step 1: Presentation of Session Title and Learning Objectives (5 minutes)

 READ or ASK students to read the learning objectives and clarify

Step 2: Describe specificity and sensitivity (30 minutes)

ACTIVITY 1: In class exercise

ASK the students: to define sensitivity and specificity

SUMMARIZE their responses and confirm correct answers using notes below

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Definitions:
 Sensitivity:
 Is capacity of a test to correctly identify people that are infected
 This is expressed in percentage
 Specificity:
 Is capacity of a test to correctly identify people that are NOT infected
 This is expressed in percentage

Table 1: Calculation of sensitivity and specificity of reagents and culture media

Gold Standard
Negative test
Test Positive test results results Total

Positive TP FP TP+FP

Negative FN TN FN+TN

Total TP+FN FN+TN TP+FP+FN+TN

Sensitivity TP/(TP+FN) x 100%

Specificity TN/(FN+TN) x 100%

Where:
TP = True positive
TN = True negative
FP = False positive
FN = False negative

Step 3: Determine the sensitivity and specificity of reagents (20 minutes)

ACTIVITY 2: In class exercise (20 minutes)

GIVEN the following data:

TP = 296
TN = 298
FP = 2
FN = 0
ASK the students: to calculate sensitivity and specificity of reagent based on following data:

DETERMINE if the reagent is suitable for laboratory use

SUMMARIZE their responses and confirm correct answers using notes below

Table 2: Calculation sensitivity and specificity of reagent or media

Gold Standard
Total
Positive Negative
Positive TP FP TP+FP
s
e
T
t

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 296 2 298
FN TN FN+TN
Negative
0 298 298
TP+FN FP+TN TP+FP+FN+TN
Total 296 300 596
Sensitivity 100%
Specificity 99.3%

ANSWER:
 With a sensitivity of 100% and specificity of 99.3%, the test (reagent) is suitable for use
in the laboratory

Step 4: Determine the sensitivity and specificity of culture media (20 minutes)
• Points to consider:
 Correct growth characteristics of the standard against prepared culture media
 Correct media composition
 Reputable source/manufacturer
 Expiry date
 Correct preparation guidelines
• Refer to table 2 in Step 3

Step 5: Interpret findings of validation procedure for reagents and culture media (20
minutes)
• Reagents:
 If the reagent gives the expected results in units/concentration, then reagent is
SATISFACTORY for use in the laboratory
 If the reagent DOES NOT give the expected results in units/concentration, then
reagent is UNSATISFACTORY for use in the laboratory
o Discard and prepare fresh reagent according to SOP
• Culture media:
 If the quality control organisms exhibit adequate growth, expected colony size, and
typical colony morphology, the non-selective media perform satisfactorily
 If the quality control organisms exhibit adequate growth, expected colony size, typical
colony morphology, and inhibition of growth of certain organisms, the selective
media perform satisfactorily
 If the quality control organisms DOES NOT exhibit adequate growth, expected
colony size, typical colony morphology, and inhibition of growth of certain
organisms, THEN the selective media is UNSATISFACTORY
o Discard and prepare fresh media according to SOP
 If the quality control organisms DOES NOT exhibit adequate growth, expected
colony size, typical colony morphology, and inhibition of growth of certain
organisms, then selective media is UNSATISFACTORY
o Discard and prepare fresh media according to SOP

Step 6: Key Points (15 minutes)

 Specificity and sensitivity
 Determine the specificity and sensitivity of reagents
 Determine the specificity and sensitivity of culture media

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 Interpret findings of validation procedure for reagents and culture media

Step 7: Evaluation (10 minutes)

 Define:
 Sensitivity
 Specificity
 True positive
 True negative
 False positive
 False negative

References:
1. MOHSW, Tanzania HIV Rapid Test Training Modules (2007), Module 4: HIV Testing
Strategies and Algorithms

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Session 11: Monitoring Compliance With Guidelines

NTA Level 6, Semester 1, Module Code: MLT 06107 – Name: Laboratory Quality
Management Systems

Total Session Time: 120 minutes

Prerequisites

Learning Objectives

By the end of this session, students are expected to be able to:

1. List methods of monitoring compliance with guidelines (inspection, supervision,
interview)
2. Explain advantage and disadvantage of each method of monitoring compliance with
guidelines
3. Select a particular method for use in monitoring compliance with guidelines

Step 2: List methods of monitoring compliance with guidelines (inspection, supervision,

interview) (15 minutes)

Activity: In class exercise (15 minutes)

ASK the students to define:
- Inspection
- Supervision
- Interview
SUMMARIZE their responses and confirm correct answers using notes below

ANSWERS:
 Inspection - Critical appraisal involving examination, measurement, testing, gauging, and
comparison of materials or items. An inspection determines if the material or item is in
proper quantity and condition, and if it conforms to the applicable or specified
requirements. Inspection is generally divided into three categories: (1) Receiving
inspection, (2) In-process inspection, and (3) Final inspection. In quality control (which is
guided by the principle that "Quality cannot be inspected into a product") the role of
inspection is to verify and validate the variance data; it does not involve separating the
good from the bad.
 Supervision - Periodic site visits to systematic assessment of laboratory practices
 Focuses on how the laboratory monitors its operations and ensures testing quality
 Provides information for internal process improvement
 Also referred to as audits, assessments
 Learn “where we are”
 Part of every laboratory quality system
 Measures gaps or deficiency
 Collect information for:
o Planning & implementation
o Monitoring
o Continuous improvement

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 Interview - is a conversation between two people (the interviewer and the interviewee)
where questions are asked by the interviewer to obtain information from the interviewee.

Step 3: Explain advantage and disadvantage of each method of monitoring compliance

with guidelines (20 minutes)

Monitoring compliance: is collecting and analyzing information on the compliance status of

the regulated guidelines
 Advantages of monitoring compliance
 Detect and correct violations
 Provide evidence to support enforcement actions
 Evaluate program progress by establishing compliance status
 There are four primary sources of compliance information:
o Inspections conducted by program inspectors/assessors
o Self-monitoring, self-recordkeeping, and self-reporting by guidelines
o Clients’ complaints
o Monitoring environmental conditions near a facility
 Disadvantages of monitoring compliance
 Can be very resource-intensive especially in areas of multiple sources.
 Must be carefully targeted and planned.
 Rely on integrity and capability of source to provide accurate data.
 Increases the paperwork for the compliance program.
 Sporadic, cannot control the amount, frequency, or quality of information received.
 Only clients notice a few violations.
 Can be difficult to demonstrate a connection between the non-compliance detected
and a specific source.
 Difficult or impossible to obtain precise information.
 Resource-intensive

Step 4: Select a particular method for use in monitoring compliance with guidelines (40
minutes)

Inspection:
 Inspections are the backbone of most enforcement programs.
 Inspections are conducted by inspectors or by independent parties hired by and reporting
back to the responsible agency
 Inspectors plan inspections, gather data in and/or around a particular facility, record and
report on their observations, and (sometimes) make independent judgments about whether
the facility is in compliance.
 By standardizing inspection procedures, enforcement officials can help ensure that all
facilities are treated equally and that all the appropriate information is gathered.
 By specifying deadlines for preparing inspection reports, program managers can help
ensure that reports can be made available to enforcement personnel without delay if there
is a possibility of noncompliance.

Types of Inspections:
 Inspections may be routine (i.e., there is no reason to suspect that the facility is out of
compliance),

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 "For cause" (i.e., a particular facility is targeted because there is reason to believe it is out
of compliance).

Levels of inspection:
 At the simplest level, an inspector can simply walk through a plant.
 Inspections get progressively more complex and time-consuming as inspectors spend time
in the facility to observe operations, interview plant personnel, and take samples for
analysis. Inspection goals include:
 Identifying specific environmental problems.
 Making the source aware of any problems.
 Gathering information to determine a facility's compliance status.
 Collecting evidence for enforcement.
 Ensuring the quality of self-reported data
 Demonstrating the government's commitment to compliance by creating a credible
presence.
 Checking whether facilities that have been ordered to comply have done so.
 Inspections may focus on one or more of the following:
 Does the facility have an up-to-date permit or license
 Has required pollution monitoring or control equipment been installed?
 Is the equipment being correctly operated?
 Are records of self-reported data properly prepared and maintained?
 Is the facility properly conducting any required sampling and analysis
 Do the facility's management plans and practices support the required compliance
activities?
 Are there any signs of willful violation of regulations and/or falsification of data?
(Signs of willful violation or falsification include conflicting data, conflicting stories
from different employees at the same facility, monitoring data for which there is no
supporting record or documentation, claims that employees are ignorant of the
regulations when company files show a knowledge of these requirements, and tips
from employees or citizens in the local community.)
 Inspectors may notify the facility prior to inspection or simply arrive unannounced
 Inspections usually begin with an opening conference to explain the inspection process to
the source.
 Some inspections end with a closing conference, in which the inspector may make facility
managers aware of any violations, how to correct those violations, and what the future
consequences of continuing noncompliance may be.
 Some enforcement programs do not allow closing conferences because they want to avoid
the risk that information given by the inspector to the facility may somehow compromise
future legal action.

Gathering information
 The inspector is responsible for gathering information to determine whether a facility is in
compliance and collecting and documenting evidence that a violation may have occurred.
 This evidence is used to support the development of enforcement cases, as well as to help
the inspector prepare for and give testimony when required. Therefore, inspectors are
required to follow certain procedures to ensure that whatever evidence they collect will be
admissible in a court of law.

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 If standard procedures are not followed, there is a risk that the evidence may be rejected
in a court of law and that the time and expense invested in building a case will have been
wasted.
 Standard checklists are often developed for different types of inspections to ensure that
the inspections properly cover all the necessary aspects and that inspections are fair and
objective.
 Sometimes inspectors are responsible for determining whether a violation has occurred;
sometimes this decision is made by program staff; in other cases, legal staff makes this
decision.
 Involvement of legal staff is essential when the requirement must be interpreted to
determine whether there has been a violation. Because of concern about jeopardizing
future enforcement cases, most inspectors do not make decisions about whether a
violation has occurred.

Writing inspection report

 During the inspection, the inspector records notes on every aspect of the inspection. The
inspector may also gather additional evidence, such as physical samples, photographs,
and copies of facility documents.
 As soon as possible following the inspection, the inspector prepares and files an
inspection report, which references any additional evidence collected (photographs (may
be taken with approval of subjects), documents, etc.).
 Any samples collected are sent to a laboratory for analysis.
 Analytical data are interpreted and presented in the final inspection report.
 This report serves as the basis for any testimony by the inspector and will likely be used,
as evidence should the case go to trial. Elements of an inspection report may include:
 The specific reason for the inspection.
 Who participated in the inspection?
 That all required procedures for conducting an inspection were complied with.
 The actions taken during the inspection, including the chronology of the actions.
 The evidence obtained during the inspection.
 Observations made during the inspections
 The results of sample analyses related to the inspection

Inspection plan
 An inspection plan developed before going on site helps ensure the quality and value of
the inspection.
 An inspection plan provides an organized step-by-step approach to conducting the
inspection. However, some flexibility is also important to allow the inspector to adapt to
unanticipated situations at the facility.

Levels of inspection
 Level 1: Walk through inspection
 This type of inspection is limited to a quick survey of the facility. Inspectors simply
walk through the facility, for example to check for the existence of control equipment,
observe work practices and housekeeping, and verify that there is a records repository.
 These inspections establish an enforcement presence, and can also serve as a
screening process to identify facilities that should be targeted for more intensive
inspection.
 Level 2: Compliance evaluation inspection

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  This level involves a thorough inspection of the facility, but does not include
sampling.
 It may include visual observations like those in Level 1, review and evaluation of
records, interviews with facility personnel, review and critique of self-monitoring
methods, instruments, and data, examination of process and control devices, and
collection of evidence of noncompliance.
 Level 3: Sampling inspection
 This includes the visual and record reviews of the other inspection levels, as well as
preplanned collection and analysis of physical samples. These inspections are the
most resource-intensive.

Step 5: List methods of monitoring compliance with guidelines (10 minutes)

 Inspection
 Supervision
 Interview

Step 6: Key Points (15 minutes)

 Methods of monitoring compliance with guidelines (inspection, supervision, interview)
 Advantage and disadvantage of each method of monitoring compliance with guidelines
 Method for monitoring compliance with guidelines

Step 7: Evaluation (15 minutes)

 What is inspection?
 What is supervision?
 What is interview?

References:
1. MOHSW, Tanzania HIV Rapid Test Training Modules (2007), Module 13: External
Quality Assessment
2. Monitoring compliance (internet search)
3. www.businessdictionary.com/definition/inspection.html

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