What is quality? Importance of a quality management system in the laboratory Quality system essential elements The history of development of quality principles Discuss relationship of this quality model to ISO and CLSI standards

1. LABORATORY QUALITY
CONTROL
MANAGEMENT
MLS 302 Dr ASSOB PHD Associate Professor

2. 2
OWhat is quality?
OImportance of a quality management system
OQuality system essential elements
OThe history of development of quality principles
ODiscuss relationship of this quality model to ISO
and CLSI standards
CONTENT

3. Introduction Laboratory Quality Management System-Module 1 3

4. Why it is important to
implement a quality
management system?
4

5. Laboratory errors cost in
time
personnel
effort
patient
outcomes
5

6. expenses caused by wrong decisions, or
costs of analysis
too many mistakes
can make analysis
very costly; due to
• repeating analysis of samples
• investigation of problems
• revision of procedures
 loss of good reputation

7. Introduction Laboratory Quality Management System-Module 1 7
Achieving a 99% level of quality
means
accepting a 1% error rate
7
1%

8. In France a 1% error rate
would mean everyday
O14 minutes without water or electricity
O50,000 parcels lost by postal services
O22 newborns falling from
midwives’ hands
O600,000 lunches contaminated
by bacteria
O3 bad landings at Orly Paris airport
8

9. Introduction Laboratory Quality Management System-Module 1 9
9
Result: 1% failure

10. 10
Essential to all aspects of health care
are laboratory results that are
 accurate,
 reliable, and
 timely

11. Prevention is Better than
cure! ‘It costs less to prevent a problem than it
does to correct it’
A formal quality system in the
laboratory should prevent
mistakes by means of:
• quality assurance measures
• quality control of the analytical results
• thorough documentation of the system
• efficient maintenance of records
• regular audits of all aspects of the system

12. 12
LQSM

13. QA and QC systems
Quality Control:
planned activities designed to provide a quality
product.
Quality Assurance:
planned activities designed to ensure that the
quality control activities are being properly
implemented.
(As defined by the Association of Official Analytical Chemists)

14. 14
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.

15. 15
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.

16. 16
How do we
achieve excellent
performance in
the laboratory?
Organizatio
n
Personne
l
Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Manageme
nt
Assessmen
t
Process
Improvement
Customer
Service
Facilities
&
Safety

17. Introduction Laboratory Quality Management System-Module 1 17
Complexity of a Laboratory System
•Data & Laboratory
Management
•Safety
•Customer Service
Patient/Client Prep
Sample Collection
Sample Receipt and
Accessioning
Sample Transport
Quality Control
Testing
Record Keeping
Reporting
Personnel Competency
Test Evaluations

18. Introduction Laboratory Quality Management System-Module 1 18
Path of Workflow
THE PATIENT Test selection Sample Collection
Sample Transport
Laboratory Analysis
Examination Phase
Report CreationReport Transport
Preexamination Phase
Result Interpretation Postexamination Phase

19. 19
WHY is the Path of Workflow essential
to consider in health laboratories?
The entire process of managing a sample must
be considered:
 the beginning: sample collection
 the end: reporting and saving of results
 all processes in between.

20. 20
Laboratory tests are influenced by
 laboratory environment
 knowledgeable staff
 competent staff
 reagents and equipment
 quality control
 communications
 process management
 occurrence management
 record keeping

21. 21
Twelve Quality System Essentials
set of
coordinated
activities that
function as
building blocks
for
quality
management
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety

22. 22

23. 23
Organization
Responsibilities, Authorities
CommunicationProvision
of
resources
Quality
Policy

24. 24
Personnel
human resources
job qualifications
job descriptions
orientation
training
competency assessment
professional development
continuing education

25. 25
Equipment
acquisition
installation
validation
maintenance
calibration
troubleshooting
service and repair
records

26. 26
Purchasing and Inventory
vendor qualifications
supplies and reagents
critical services
contract review
inventory management

27. 27
Process Control
quality control
sample management
method validation
method verification

28. 28
Information Management
 confidentiality
 requisitions
 logs and records
 reports
 computerized laboratory
information systems (LIS)

29. Introduction Laboratory Quality Management System-Module 1 29
Documents Records
creation collection
revisions and review review
control and distribution storage
retention

30. 30
Occurrence Management
complaints
mistakes and problems
documentation
root cause analysis
immediate actions
corrective actions
preventive actions

31. 31
Laboratory Assessment
External
Proficiency
testing (EQA)
Inspections
Accreditations
InternalInternal

32. 32
Process Improvement
opportunities for improvement (OFIs)
stakeholder feedback
problem resolution
risk assessment
preventive actions
corrective actions

33. Introduction Laboratory Quality Management System-Module 1 33
Customer Service
customer group identification
customer needs
customer feedback

34. Introduction Laboratory Quality Management System-Module 1 34
Facilities and Safety
safe working environment
transport management
security
containment
waste management
laboratory safety
ergonomics

35. Introduction Laboratory Quality Management System-Module 1 35
Implementing
Quality Management
does not
guarantee
an
ERROR-FREE
Laboratory
But it detects
errors that may
occur and
prevents them
from recurring

36. Introduction Laboratory Quality Management System-Module 1 36
Organizatio
n
Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Manageme
nt
Assessmen
t
Process
Improvement
Customer
Service
Facilities
&
Safety
Laboratories not
implementing a
quality management
system guarantees
UNDETECTED
ERRORS

37. 37
Laboratory
Quality Management System
Coordinated activities to direct and
control an organization with
regard to quality.
ISO 9000:2000

38. Innovators of Quality
38
Walter
Shewhart
1891-1967
W. Edwards
Deming
1900-1993
Joseph Juran
1904-2008 (103 years)
Philip Crosby
1926-2001
Robert Galvin
b. 1922

39. Introduction Laboratory Quality Management System-Module 1 39
Standards Organizations
ISO
International Organization
for Standardization
CLSI
Clinical and Laboratory
Standards Institute
(formerly known as NCCLS)
Guidance for quality in
manufacturing and service
industries
Standards, guidelines, and
best practices for quality in
medical laboratory testing
Broad applicability; used
by many kinds of
organizations
Detailed; applies
specifically to medical
laboratories
Uses consensus process in
developing standards
Uses consensus process in
developing standards

40. Introduction Laboratory Quality Management System-Module 1 40
ISO Documents - Laboratory
ISO 9001:2000 Quality Management
System Requirements
Model for QA in design, development
production, installation, and servicing
ISO/IEC 17025:2005 General
requirements for the competence of
testing and calibration laboratories
ISO 15189:2007 Quality management
in the clinical laboratory

41. ISO 15189:2007
OThe foundation of international
medical laboratory quality managemen
OMedical laboratories–Particular
requirements for quality
and competence
41
ISO Documents - Laboratory

42. 42
CLSI Quality Documents
HS1-A2 A Quality Management System Model
for Health Care
describes quality system model, 12 essentials
aligns to ISO 15189 and parallels ISO 9000
applies to all health care systems
GP26-A3 Application of Quality Management
System Model for Laboratory Services
describes laboratory application of quality system model
relates the path of workflow to the quality system essentials
assists laboratory in improving processes
relates to HS1-A2 and ISO 15189

43. 43
OA laboratory is a complex system and all
aspects must function properly to achieve
quality.
OApproaches to implementation will vary with
local situation.
OStart with the easiest, implement in
stepwise process.
OUltimately, all quality management system
elements must be addressed.
Key Messages

44. Questions?
Comments?
44
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety