1. Quality Control in the
Medical laboratory
Introduction and Overview
FD lecture
Adnan S Jaran PhD.
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2. How do we achieve QUALITY
performance in the laboratory?
Adnan S Jaran PhD.
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3. QUALITY is ACHIEVED BY:
Determining the customer’s precise requirements
Ensuring that all resources, facilities and skills required
to meet the customer’s requirements are available
Planning, documenting and implementing management
procedures to ensure that the customer’s requirements
are met consistently
Ensuring that staff are trained and provided with the
resources to do the job right the first time
Adnan S Jaran PhD.
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4. QUALITY is ACHIEVED BY:[cont]
Ensuring that all activities are
undertaken correctly
Ensuring that when things go wrong,
effective corrective action is taken to
avoid repetition of errors
Undertaking regular reviews and audits
of all processes
Total and organised commitment from
management
Adnan S Jaran PhD.
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5. The Quality Assurance Cycle
Patient/Client Prep
Sample Collection
Reporting
•Data and Lab
Management
•Safety
•Customer
Service
Personnel Competency
Test Evaluations
Sample Receipt
and Accessioning
Record
Keeping
Quality Control
Testing
Adnan S Jaran PhD.
Sample Transport
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7. Achieving a 99% level of quality
means
accepting a 1% error rate
1%
Adnan S Jaran PhD.
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8. In France a 1% error rate
would mean everyday
14 minutes without water or electricity
50,000 parcels lost by postal services
22 newborns falling from
midwives’ hands
600,000 lunches contaminated
by bacteria
3 bad landings at Orly Paris airport
Adnan S Jaran PhD.
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11. Organization
How do we
achieve
excellent
performance
in the
laboratory?
Adnan S Jaran PhD.
Personnel
Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety
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12. Quality Management System Definition
Coordinated activities to direct and
control an organization with regard
to quality (ISO,CLSI).
All aspects of the laboratory operation
need to be addressed to assure
quality; this constitutes
a quality management system.
Adnan S Jaran PhD.
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13. QUALITY CONTROL
Every analysis in the lab. generates a result
The validity of that result cannot be taken for
granted, however, without some body of
supporting evidence.
The most convincing evidence is the
establishment of a rigorous comprehensive
Quality control program that is faithfully followed
This is the only way to guard against the possible
deterioration of an analytic system, to become
altered to imprecision of results when they occur,
and have confidence in test result when
everything is in control
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Dr. Adnan S. Jaran
14. QUALITY CONTROL
A comprehensive quality control (QC) program
consist of all the means used by a laboratory to
ensure the reliability of every assay performed
on specimens arriving in the lab.
The program includes much more than the
analysis of a control serum with every run, and
it involves: (1) lab. Director, (2) Technologists,
(3) all other personnel who are an integral part
of the specimen collecting, and
(4) The analytical system.
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Dr. Adnan S. Jaran
15. Essential to all aspects of
health care are laboratory
results that are
accurate,
reliable, and
timely
Adnan S Jaran PhD.
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16. Complexity of a Laboratory System
Reporting
Patient/Client Prep
Sample Collection
Personnel Competency
Test Evaluations
•Data & Laboratory
Management
•Safety
•Customer Service
Sample Receipt and
Accessioning
Record Keeping
Quality Control
Testing
Adnan S Jaran PhD.
Sample Transport
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17. Path of Workflow
THE PATIENT
Test selection
Sample Collection
Preexamination Phase
Sample Transport
Laboratory Analysis
Examination Phase
Report Transport
Result Interpretation
Adnan S Jaran PhD.
Report Creation
Postexamination Phase
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18. Laboratory tests are influenced by
laboratory environment
knowledgeable staff
competent staff
reagents and equipment
quality control
communications
process management
occurrence management
record keeping
Adnan S Jaran PhD.
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32. Key Messages
A laboratory is a complex system and
all aspects must function properly to
achieve quality.
Approaches to implementation will vary
with local situation.
Start with the easiest, implement in
stepwise process.
Ultimately, all quality management
system elements must be addressed.
Adnan S Jaran PhD.
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