MTY1201: PMLS 1
TOPIC 8.11: QUALITY CONTROL
GENERAL GUIDLINES
LEGEND FOR HEADERS
MAIN TOPIC
SUBTOPIC
SUB-SUBTOPIC
QUALITY MANAGEMENT
 Can be defined as “coordinated
activities to direct and control an
organization with regard to quality”. -
This definition is used by the (ISO)
and by the (CLSI).
 All aspects of the laboratory
operation, including the
organizational structure,
processes and procedures, need
to be addressed to assure
quality.
QUALITY ASSURANCE
 Encompasses all activities
performed by laboratory personnel
to ensure reliability of test results.
 It is organized, systematic, well
planned, and regularly done with
the results properly documented
and consistently reviewed.
ISO CERTIFICATION
ISO 9001
International standard that specifies
requirements for a quality management
system (QMS).
ISO 15189
Specifies requirements for quality and
competence in medical laboratories.
QUALITY CONTROL
 In the medical laboratory it is a
statistical process used to monitor
and evaluate the analytical process
that produces patient results. © 2008
Bio-Rad Laboratories, Inc.
 To prevent the reporting of
incorrect patient result.
 Part of performance monitoring.
INTERNAL QUALITY ASSURANCE
SYSTEM
- Includes day to day activities that
are undertaken in order to control
factors or variables that may affect
test result.
EXTERNAL QUALITY ASSURANCE
SYSTEM
- A system for checking performance
among clinical laboratories and is
facilitated by designated external
agencies.
INTERNAL QUALITY ASSURANCE
SYSTEM (IQAS)
- Internal quality control is done by
assaying stable control materials
and comparing their determined
values with their expected values.
• Reagents / Control
• Machines / Equipment
• Personnel
AFUAN, S. 1

PRECISION VS ACCURACY
PRECISION – Reproducibility of an assay
ACCURACY – Ability to detect or produce
result near the true value
- A method used to validate a
particular measurement process
- Used in performance monitoring
NATIONAL REFERENCE LABORATORY
- DOH
NATIONAL REFERENCE LABORATORY

National Kidney and Transplant Institute

- Hematology
- Complete Blood count and platelets
- Coagulation studies

NATIONAL REFERENCE LABORATORY

Lung Center of the Philippines
Clinical chemistry
- •Glucose
- •Creatinine
Quality control results are routinely plotted - •Total protein
in a graph (LJ graph) - •Albumin
- •Blood urea nitrogen
- •Uric acid
- •Cholesterol
- •Sodium
- •Potassium
- •Chloride

East Avenue Medical Center

Drugs of abuse
• Methamphetamine
INTERNAL QUALITY ASSURANCE • Cannabinoids
SYSTEM (IQAS)
Quality control materials Research Institute for Tropical Medicine
Lyophilized Microbiology
- Dehydrated to powder - identification
- Requires reconstitution - antibiotic susceptibility testing
Liquid solution Parasitology
- Do not require reconstitution - identification of ova
- Stabilized frozen - quantitation of malaria

EXTERNAL QUALITY ASSURANCE San Lazaro Hospital- STD-AIDS

SYSTEM (EQAS) Cooperative Laboratory
- A system for checking performance Infectious Immunology
among clinical laboratories and is - Hepatitis B
facilitated by designated external - Hepatitis C
agencies. - HIV

PROFICIENCY TESTING EXTERNAL QUALITY ASSURANCE

SYSTEM (EQAS)

AFUAN, S. 2
 An unknown sample is with known test
results is regularly sent to clinical laboratory
for testing
 Sample should be treated like a
patient sample
 Results are then returned to external
facility
 This will allow each Lab to compare
its test results with those of other
lab.
 A certificate of performance is given
to the participating laboratory

NO RESULT IS BETTER THAN

ERRONEOUS RESULT

AFUAN, S. 3