LM QM

CHAPTER 7
QUALITY MANAGEMENT
QUALITY MANAGEMENT AND QUALITY CONTROL
DEFINE
Quality management and Quality Control (QC)
QUALITY CONTROL PROGRAMS
Quality control programs have been an integral part of the inspection systems
by the Bureau of Health Facilities and Services, Department of Health. The supervising
pathologists should ensure that the Quality Control program is organized for periodic
review or every major portion of the Clinical Laboratories and that the program can be
documented for the inspector.
Quality Assurance (QA) is the planned or systematic actions necessary to

provide enough confidence that a product or service will satisfy the given requirements
for quality. Overall activities conducted by the Institution that are directed toward
assuring the quality of services provided.
Quality Assessment and Improvement is the purposeful change of a process

to improve the reliability of achieving an outcome. This is a quality management
program that focuses on the success of the organization in designing and achieving its
set of goals and objectives.
DIVISION OF LABORATORY PRACTICE IN QUALITY CONTROL
A. Preventive Procedures
B. Assessment Practices
C. Corrective Practices
CONTROL OF TESTS
1. Precision
2. Accuracy (efficiency)
3. Sensitivity
4. Specificity
CONTROL OF SPECIMENS
The laboratory is responsible for providing information for the proper collection
and transport of specimens. These instructions should be available to the hospital staff
for use when specimens are collected. The written collection instructions should include:
• Test purpose and limitation

• Patient selection criteria
• Timing of specimen collection
• Optimal specimen collection sites
• Approved specimen collection methods
• Specimen transport medium, time and temperature
• Availability of test (on site or sent to a reference laboratory
• Hour’s test performed (daily or batch), turn- around- time
• Result reporting procedures
CONTROL OF REAGENTS AND SUPPLIES
Laboratories should purchase reagents and supplies from reliable sources.

Containers of reagents should be labelled as to contents, concentration, date opened,
expiration date, source, lot number, and storage requirements. All supplies and
reagents should be stored according to manufacturer’s recommendations and tested
with positive and negative controls before use. There should be no incidence of lack of
supplies for the lab tests offered and the first in first out must always be followed.
Outdated supplies and reagents that failed QC should be discarded immediately.
A good inventory system is necessary to determine the high and low limits of the
reagents and supplies needed for the operation of the clinical laboratory taking into
consideration the following factors: delivery time, available storage pace, the shelf
life and rate of usage for each item.
CONTROL OF STAFF
Appropriately trained and experienced personnel are essential for the
performance of quality laboratory testing. All employees should know what they are
supposed to do, and every laboratory should have written job descriptions to provide to
them. Standards of performance should be developed so that the employee knows how
he or she will be judged when rated on job performance.
CONTROL OF EQUIPMENT
Performance checks should be done periodically to avoid major variations in the
performance of lab equipment. Equipment and instrument logs should contain the
following information:
• Equipment or instrument name; serial number, and date
• Procedure and periodicity (daily, weekly, monthly, quarterly) for routine function
checks
• Acceptable performance ranges
• Instrument function failures, including specific details of steps taken for corrective
action
• Date and time of service request and response
• Date of routine preventive maintenance which should follow manufacturer’s
recommendations
Maintenance records should be retained in the laboratory for the life of the equipment.
NON-ANALYTIC QUALITY CONTROL FACTORS
A. Physician’s order or request

B. Request Specifications
Time Specifications:
a. Routine
b. Today
c. STAT
d. Specific time
C. Worksheet/Work Card
D. Patient Identification
E. Sample Reassignment
F. Distribution of Test Result
QUALITY CONTROL CHARTS
These charts assist in monitoring avoidable and unavoidable error. It is important

in identifying sporadic errors that are generally caused by the analyst. Control values
falling out of acceptable range are rejected as avoidable errors that must be identified
and corrected. All unknown tests belonging to this batch are repeated. In the absence of
avoidable error, 95% of analysis should be within control values.
PROFICIENCY TESTING
All analytical laboratories should operate a quality assurance system which

includes internal quality control procedures, participation in proficiency testing schemes,
use of reference standards and certification/accreditation to a recognized standard such
as ISO 9001 or BS EN ISO/IEC 17025. Proficiency testing schemes operate by
providing participating laboratories with samples containing specified material but the
actual quantity of the substance is known only to the organizers. The laboratory
analyses the samples, preferably as part of their normal routine, and reports the results
to the scheme organizers. The laboratory is then provided with a report showing how
closely their results agree with the accepted value, and where necessary, can then take
appropriate action to improve performance.
Regular participation in a proficiency-testing scheme provides independent

verification of the analytical competence of a laboratory and shows a commitment
to the maintenance and improvement of performance.
Because “International Organization for Standardization” would have

different languages (“IOS” in English, “ION” in French for Organisation
Internationale de Normalization), its founders decided to give it also a short, all-
purpose name. They chose “ISO”, derived from the Greek isos, meaning “equal”
and the organization responsible for thousands which benefit the world is ISO.
BENEFITS OF ISO STADARDS
a. Make the development, manufacturing and supply of products and services more
efficient, safer and cleaner.
b. Provide governments with technical base health, safety and environmental
legislation, and conformity assessment.
c. Share technological advances and good management practice
d. Safeguard consumers, and users in general, of products and services
e. Standards establishing an international consensus on terminology make technology
transfer easier and safer. They are an important stage in the advancement of new
technologies and dissemination of innovation.
f. Standardization of performance or safety requirements of diverse equipment makes
sure that users’ needs are met while allowing individual manufacturers the freedom to
design their own solution on how to meet those needs.
g. Standardized computer protocols allow products from different vendors to “talk” to
each other.
h. Standardized documents speed up the transit of goods, or sensitive or dangerous
cargoes that may be handled by people speaking different languages.
ISO 9001 2008 QUALITY MANAGEMENT REQUIREMENTS
1. Manage Quality Management System Document.

2. Prepare Quality Management System Manual
3. Control and Establish Quality Management System Records
4. Support your Quality Policy
5. Control Monitoring and Measuring Quality

LM QM

Uploaded by

Copyright:

Available Formats

LM QM

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

LM QM

Uploaded by

Copyright:

Available Formats

CHAPTER 7

QUALITY MANAGEMENT AND QUALITY CONTROL

Quality management and Quality Control (QC)

QUALITY CONTROL PROGRAMS

Quality Assurance (QA) is the planned or systematic actions necessary to

Quality Assessment and Improvement is the purposeful change of a process

DIVISION OF LABORATORY PRACTICE IN QUALITY CONTROL

• Test purpose and limitation

CONTROL OF REAGENTS AND SUPPLIES

Laboratories should purchase reagents and supplies from reliable sources.

NON-ANALYTIC QUALITY CONTROL FACTORS

A. Physician’s order or request

QUALITY CONTROL CHARTS

These charts assist in monitoring avoidable and unavoidable error. It is important

All analytical laboratories should operate a quality assurance system which

Regular participation in a proficiency-testing scheme provides independent

Because “International Organization for Standardization” would have

BENEFITS OF ISO STADARDS

ISO 9001 2008 QUALITY MANAGEMENT REQUIREMENTS

1. Manage Quality Management System Document.

You might also like