1. Quality Control in the
Medical laboratory
Introduction and Overview
FD lecture
Adnan S Jaran PhD.
1

2. How do we achieve QUALITY
performance in the laboratory?
Adnan S Jaran PhD.
2

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.
3

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.
4

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
5

6. What is Quality?
Adnan S Jaran PhD.
6

7. Achieving a 99% level of quality
means
accepting a 1% error rate
1%
Adnan S Jaran PhD.
7
7

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.
8

9. Result:
Adnan S Jaran PhD.
1% failure
9
9

10. Laboratory errors cost in
time
personnel
effort
patient
outcomes
Adnan S Jaran PhD.
10

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
11

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.
12

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
16/11/13
13
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.

16/11/13
14
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.
15

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
16

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
17

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.
18

19. Organization
Responsibilities, Authorities
Quality
Policy
Provision
of
resources
Adnan S Jaran PhD.
Communication
19

20. Personnel
human resources
job qualifications
job descriptions
orientation
training
competency assessment
professional development
continuing education
Adnan S Jaran PhD.
20

21. Equipment
 acquisition
 installation
 validation
 maintenance
 calibration
 troubleshooting
 service and repair
 records
Adnan S Jaran PhD.
21

22. Process Control
quality control
sample management
method validation
method verification
Adnan S Jaran PhD.
22

23. Information Management
fidentiality
uisitions
and records
orts
mputerized laboratory
rmation systems (LIS)
Adnan S Jaran PhD.
23

24. Documents
creation
revisions and review
control and distribution
Adnan S Jaran PhD.
Records
collection
review
storage
retention
24

25. Occurrence Management
complaints
mistakes and problems
documentation
root cause analysis
immediate actions
corrective actions
preventive actions
Adnan S Jaran PhD.
25

26. Laboratory Assessment
External
Internal
Internal
Proficiency
testing (EQA)
Inspections
Accreditations
Adnan S Jaran PhD.
26

27. Process Improvement
opportunities for improvement (OFIs)
takeholder feedback
problem resolution
isk assessment
preventive actions
orrective actions
Adnan S Jaran PhD.
27

28. Facilities and Safety
safe working environment
ransport management
security
containment
waste management
aboratory safety
ergonomics
Adnan S Jaran PhD.
28

29. Implementing
Quality Management
does not
guarantee
an
ERROR-FREE
Laboratory
Adnan S Jaran PhD.
But it detects
errors that may
occur and
prevents them
from recurring
29

30. Organizatio
n
Personnel
Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Manageme
nt
Assessmen
t
Process
Improvement
Customer
Service
Adnan S Jaran PhD.
Facilities
&
Safety
Laboratories not
implementing a
quality management
system guarantees
UNDETECTED
ERRORS
30

31. Laboratory
Quality Management System
Coordinated activities to direct
and control an organization
with regard to quality.
ISO 9000:2000
Adnan S Jaran PhD.
31

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.
32

33. Organization
Personnel
Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Adnan S Jaran PhD.
Questions?
Comments?
Facilities
&
Safety
33