Laboratory Services

Y presenters
X venue
Date

FEDERAL DEMOCRATIC REPUBLIC OF ETHIOPIA

MINISTRY OF HEALTH
Outline of the presentation
 Learning objective
 Introduction
 Operational Standard
 Implementation Guidance
 Assessment checklist
 indicators

2
Learning Objective
 At the end of this session, participants will be able to:
◦ Describe Concepts of laboratory service management and
organization
◦ Expect to understand operational standards of laboratory
services management
◦ Explain the important steps, or elements, of a laboratory
document management system
◦ Describe the hierarchy of lab service and the role of each
level;
◦ Describe resources needs for Blood Transfusion Service
◦ Describe indicators to measure laboratory service quality
Chapter Contents
Section 1 Introduction
Section 2 Operational Standards for Laboratory Services
Section 3 Implementation Guidance

3.1 Organization and Management

3.1.1 Laboratory management structure
3.1.2 Laboratory Management role
3.2 Laboratory Quality management
3.2.1 Quality Manual/Policy
3.2.2 Standard Operating Procedures
Chapter Contents (2)

3.3 Customer Service

3.3.1 Laboratory Handbook
3.3.2 Advisory service
3.3.3 Information notification
3.4 Documentation and reporting
3.4.1 Laboratory Information Management
System (LIMS)
3.4.1.1 Document management
3.4.1.2 Record management
Chapter Contents (3)
3.5 Blood Transfusion Service
3.5.1 Facility and systems requirements
3.5.2 Storage Devices for Blood and Blood Components
3.5.3 Awareness creation and mobilization strategy in hospitals
3.5.4 Issue and Transport of Blood Components
3.6 Laboratory Equipment Management
3.6.1 Equipment Life book and Inventory
3.6.2 Laboratory Equipment Maintenance
3.6.2.1 Preventive Maintenance
3.6.3 Equipment calibration
Chapter Contents (4)
3.7Laboratory Reagents and Supplies Management System
3.7.1Inventory control of Reagent and supply
3.7.2Reagent and supply storage condition
3.8 Process control
3.8.1Pre-analytical phase
3.8.2Analytical phase
3.8.2.1Internal Quality Control (IQC) programme
3.8.2.2External Quality Assessment (EQA) programme
3.8.3Post analytical Phase
3.9 Internal audit
3.10 Occurrence/Incidence management
3.11 Facility and safety
Chapter Contents (5)
Section 4 Implementation Checklist and Indicators

4.1 Assessment tool for Operational Standards

4.2 Implementation Check-list

4.3 Indicators
Appendices
 Appendix A The Laboratory Network: Responsibilities of
Laboratories at Different Tier Levels in Ethiopia
 Appendix B List of minimum available tests, equipment
and consumables shall be available in each hospital tier
system according to FMHACA minimum standard
 Appendix C Sample Preventive Maintenance Log
 Appendix D Sample Corrective Maintenance Log
 Appendix E Sample SOP for Microscope
 Appendix F National SOP Template
 Appendix G Sample Laboratory Risk Assessment Form
 Appendix H List of Notifiable Diseases
Introduction
 Laboratory services have always play an essential role in
determining clinical decisions and providing clinicians with
information to end users
◦ Accurately assess the status of a patient’s health,
◦ Make accurate diagnoses,
◦ Formulate treatment plans, and
◦ Monitor the effects of treatment and
◦ Management of diseases
 laboratory service structure that follows the general health
care delivery system
 Main purpose:
 To provide high level quality laboratories provide accurate,
reliable and timely test results for patient care


2. Operational Standards
1. The hospital has a clear laboratory management structure and
accountability arrangement with well-defined roles and
responsibilities for the provision of laboratory services organized
into central, emergency and inpatient laboratory services.

2. The hospital laboratory management shall have a system for

management of documents and records for use and maintenance of
controlled, reviewed and approved to ensure the provision of quality
laboratory services

3. The hospital laboratory has established system to monitor the

effectiveness of its customer service programme.

4. The hospital laboratory has and implements a proper management

system for its equipment that includes the calibration, maintenance
and inventory to ensure the provision of accurate, reliable and
timely test results.
5. The hospital has a laboratory supplies management system.
Operational Standards
6. The hospital laboratory shall implement a process control
system that monitors the processes from pre analytical to
post analytical phases of testing, including an established
internal quality control (IQC) and participation in external
quality assurance (EQA).
7. The hospital laboratory has established incident handling
and reporting system which includes errors or near errors
(also called near misses).
8. The hospital has established laboratory management
information system.
9. The hospital laboratory should be designed and organized at
least for bio safety level 2 or above and work environment is
clean and well maintained at all times.
10. The laboratory shall design a backup laboratory service
through availing back laboratory equipment or and through
backup laboratory facility.
Operational Standards
11.The hospital laboratory has appropriate storage and
stock management systems for blood and blood
products received from blood banks
12. The hospital laboratory blood bank service in
collaboration with respective regional blood back
service shall have mobilization of blood donation
strategy through community awareness programs.
13. The hospital laboratory blood bank service shall have
appropriate cold chain system for blood and blood
products received from blood bank service until used
by prescribers.
14. The hospital laboratory blood bank service shall
report blood administration and patient safety
information to respective regional blood banks.
Implementation Guidance
Organization and Management of lab services
Laboratory management structure
 The laboratory shall have its own organizational
structure
 Enables the laboratory to communicate internally
and externally
 To create collaboration and partnership and EQA
program providers by working under the
organizational umbrella of the hospital.
 An organizational chart (organ gram) that describes
the management and supervisory
Implementation Guidance
 Functional central, emergency and inpatient
laboratories
 Emergency and inpatient laboratories provide

services 24hrs a day

 A functional overview of all other labs to

ensure the provision of quality services

Implementation Guidance

Laboratory Management role

 Provide effective leadership of the medical

laboratory service, including

 planning, budgeting and overall financial
management, in accordance with organizational
assignment
 Implement and monitor standards of
performance and quality improvement
 Maintain strongcommunication/relationship

among clinical and non-clinical staff.

Implementation Guidance
Competency assessment
 To check the knowledge and skill
 Theoretical, practical
 To ensure readiness for effective delivery of

those processes and procedures

 Identified with employee performance,

retraining and reassessment of employee as

on regular scheduled bases
Implementation Guidance
Document and Records
 Policies, processes, and testing procedures
 laboratory quality manual
 Are a reflection of the laboratory’s

organization and its quality management.

 A well-managed laboratory will always have

a strong set of documents to guide its work

Implementation Guidance
Standard Operating Procedures
 A technical and managerial procedures for all

processes. “how to do a test”, and shows the

step-by-step instructions
 laboratory staff should meticulously follow

for each activity.

 Is often used to indicate these detailed

instructions on how to do it.

 created for regularly recurring work

processes
 ensure that activities are performed
Implementation Guidance

Procedures - The “HOW TO DO IT”

Standard operating procedures (SOP)

 step-by-step instructions for performing a single

activity

Job aid
 a shortened version of the SOP
 does not replace the SOP

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Implementation Guidance
SOPs
 SOPs should be available for:
 Specimen management
 All testing procedures:
Implementation Guidance

 Documents should be present in the laboratory:

 SOP manual
 Quality assurance manual
 Health and safety manual
 Approved laboratory test request and report forms
 Laboratory registration books
 Daily test record form
 Specimen referral form
 Report form (monthly, quarterly)
 Stock inventory form
 Fridge/Freezer charts
 Equipment Maintenance Logs
 QA Charts and External QA Records
 Error logs
 Accident Logs
Implementation Guidance
Customer Service
 A system to collect and measure data on how much the

laboratory services satisfy

 Take steps to address any problems identified from

/suggestion boxes, suggestion books and/or satisfaction/

 A mechanism to record complaints from patients, staff and

clients.
 All complaints and problems reported to the laboratory as well

as corrective action taken should be documented

 complaint handling and management system as a part of the

overall hospital’s
Implementation Guidance
Laboratory Handbook

 For the benefit of clinical staff ordering

diagnostic tests.


 Describe a list of all tests available in the

laboratory and appropriate turn-around
time for each test.
 A list of tests that may be taken by the

laboratory and referred to a higher tier for

analysis, and turn-around time for each
 Implementation Guidance

Advisory service
 interpretation of results and to provide advice on

the process of decision making for clinical staff.

 comments on the result report, either commenting

on the interpretation of the results and/or

suggesting additional investigations that might aid
the diagnosis.
 available to answer queries from clinical staff about

individual test results or the need for further

investigation.
 Identify ‘panic results’
Information notification
 An update of clinical staff and others on

areas such as a start of new tests,

discontinuation of tests and if there is a
delay in test results etc.
 A forum through which laboratory staff can

discuss individual patient care with

clinicians when necessary.
 Possible mechanisms include:


a.‘In house’ education sessions at which all

laboratory staff
b.Clinical review meetings of all clinical staff
Implementation Guidance

Laboratory Equipment Management

 Laboratory Equipment Management

◦ Equipment Life book and Inventory

◦ Laboratory Equipment Maintenance
 Preventive Maintenance
◦ Equipment calibration
Implementation Guidance
Laboratory Reagents and Supplies Management
System
 Inventory control of Reagent and supply

 Reagent and supply storage condition

Implementation Guidance
Process control
 Pre-analytical phase
 Sample management
 Analytical phase
 Internal Quality Control (IQC)
programme
 External Quality Assessment (EQA)
programme
 Post analytical Phase
Implementation Guidance
Occurrence/Incidence management
 is any event that has a negative impact on an
organization, including
 its personnel,
 the product of the organization,
 equipment,
 environment in which it operates.
 All such events must be addressed in an occurrence
management program.
Implementation Guidance
Laboratory Information Management System (LIMS)
 the processes needed for effectively
managing data—both incoming and outgoing
patient information
 paper-based, computer-based, or a

combination of both.
 in order to achieve accessibility, accuracy,

timeliness, security, confidentiality and

privacy of patient information
Implementation Guidance
Facility and safety
 to protect the lives of employees and
patients, to protect laboratory equipment and
facilities, and to protect the environment.
 minimum requirement for a hospital to have a

biosafety level 2 laboratories.

 Assign a laboratory safety officer
Implementation guidance
 Develop a safety manual for
 to provide written procedures for safety and biosafety
in the laboratory;
 organizing safety training and exercises that teach
staff to be aware of potential hazards
 how to apply safety practices and techniques—training
 universal precautions,
 infection control,
 chemical and radiation safety,
 use personal protective equipment (PPE),
 dispose of hazardous waste, etc
Implementation guidence
Backup laboratory services
 Improves the provision of the service to
deliver results through avoiding interrupted
service.
 MOU with other nearby facilities and uses

back up service
 Avail back up lab equipment to avoid service

interruption
Implementation guidance
Blood Transfusion Service
• a mini blood bank with appropriate facility
• Blood received from the regional blood bank
• Quality assurance measures in place to ensure the correct
storage temperature is maintained at all times.
• Refrigerators or freezers for blood storage have a back- up
electricity supply in case of mains failure
Facility and systems requirements
• A transfusion committee established
• MOU signed with respective blood bank service
• Enough space, equipment, to perform compatibility test and
to store blood and blood products received from the blood
bank service
Implementation guidance
Documents and Records of blood bank services
◦ The mini blood bank have well created, reviewed,
approved and authorized documents like
 policies ,process .procedures ,job aids and forms.
 Records
Implementation guidance
Storage Devices for Blood and Blood Components
• Storage device
• Refrigerator 2-6 0c
• Deep freezer <-18 0c
•Plat late agitator and incubator at 20-24 0c
• Thermometer

Blood and Blood components

• Whole blood
• Concentrated Red cell
• Fresh frozen plasma
• Platelets
• Cryoprecipitate
Implementation guidance ----
Recording a maximum and minimum temperature at ever 6
hours
Awareness creation and blood donation mobilization
strategy in hospitals
 Benefits of blood donation
 Awareness of community about blood donation
 collaboration of hospitals with blood banks
Implementation guidance ----
Transport and Issue of Blood and Blood
Components
o Cold chain management
o Transport blood from blood bank to hospitals
 CRC,whole blood

 FFP and cryo precipitates

 Palates
Implementation Checklist and Indicators

Assessment Tool for Operational Standards

 criteria for the attainment of a Standard and a

method of assessment.
 used by hospital management or by an

external body such as the RHB or FMOH to

measure attainment of each Operational
Standard.
Implementation Checklist
S. No
Activities yes No
The hospital has a clear laboratory management structure and accountability arrangement with well-defined roles
and responsibilities for the provision of laboratory services organized into central, emergency and inpatient
laboratory services.

The hospital laboratory management shall have a system for management of documents and records for use and
maintenance of controlled, reviewed and approved to ensure the provision of quality laboratory service

The hospital laboratory has established system to monitor the effectiveness of its customer service programme

The hospital laboratory has and implements a proper management system for its equipment that includes the
calibration, maintenance and inventory to ensure the provision of accurate, reliable and timely test results

The hospital has a laboratory supplies management system

The hospital laboratory shall implement a process control system that monitors the processes from pre analytical
to post analytical phases of testing, including an established internal quality control (IQC) and participation in
external quality assurance (EQA

The hospital laboratory has established incident handling and reporting system which includes errors or near
errors (also called near misses).
The hospital has established laboratory management information system
The hospital laboratory should be designed and organized at least for bio safety level 2 or above and work
environment is clean and well maintained at all times.
The laboratory shall design a backup laboratory service through availing back laboratory equipment or and
through backup laboratory facility,
The hospital laboratory has appropriate storage and stock management systems for blood and blood products
received from blood banks
The hospital laboratory blood bank service in collaboration with respective regional blood back service shall have
mobilization of blood donation strategy through community awareness programs.

The hospital laboratory blood bank service shall have appropriate cold chain system for blood and blood products
received from blood bank service until used by prescribers

The hospital laboratory blood bank service shall report blood administration and patient safety information to
Indicators
Indicator Formula Frequency Performance
Target
Proportion of laboratory samples Total number of samples rejected by laboratory Monthly
rejected services (inpatient, outpatient and emergency) ÷ <1%
Total number of samples received (inpatient,
outpatient and emergency) x 100
Test interruption: Quarterly
a) Proportion of test interruptions a) Test interruption days due to supply <1%
due to supply shortage shortage/12 months *100
b) Proportion of test interruption due b) Test interruption days due to equipment
to equipment failure failure/12 months *100

Number of tests with internal quality Total number of laboratory tests with routine Monthly 100%
control quality control performed/Total tests available
a) Proportion of External quality a) Total number of tests enrolled with external Quarterly a) 100%
assessment (EQA) participation quality assessment program/total tests b) 100%
b) Percentage of EQA performance available *100
b) EQA feedbacks greater or equal to 80%.
Proportion of equipment downtime in The number of days in a month that the equipment Quarterly 0%
the year is not functional due to breakdown/ 365 days*100
a) Proportion of uninterrupted power a) Presence of uninterrupted power supply /365 Quarterly 100%
supply days*100
b)Proportion of uninterrupted water b) Presence of uninterrupted water supply /365
supply days*100
Proportion of laboratory staff with Number of staff with competency evaluation file / Annually 100%
competency evaluation total number of staff*100
Proportion of laboratory tests meets pre- Number of tests meets TAT/total number of tests Monthly ≥80 %
set Turnaround time (TAT) *100
Proportion of customer satisfaction in Number of customers satisfied ÷ total number Quarterly ≥80 %
laboratory services upheld of customers participated in satisfaction survey
x 100
 END

Thank You

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