Introduction to Laboratory
Quality Management
Learning Objectives
At the end of this activity, you will be able to:
 Relate the importance of a laboratory quality
system
 Define the principal terms used in the field of
quality
 List the essential elements of a laboratory
quality system
 Describe the development of quality
principles during the last centuries
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What is Quality?
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99%: High Quality level?

Accepting 1% non-quality, means everyday in
France :
-- 14 minutes without water or electricity
-- 50 000 parcels lost by postal services
-- 4 bad landings at Orly Paris airport
-- 20 newborns falling from midwives’ hands
-- 600 000 lunches contaminated by bacteria
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1% of non quality?
5
A laboratory occurrence and its
consequences
A 83 year old male was admitted to hospital with fever, weight loss and
cough being investigated for possible tumor. Sputum was reported to be
positive for tuberculosis, but on later review, found to be false positive
culture due to in-laboratory contamination. Further investigation found 14
additional patients with falsely positive TB culture






Delay in correct diagnosis
Unnecessary treatment
Treatment complications.
Pattern of other contaminations discovered
Problem resolution required 6 months of investigation, contacting of more
than 200 patients, many requiring culture and X-Ray re-examination.
Revision of laboratory procedures eradicated the problem.
Laboratory errors cost in time, energy, money
personnel and patient outcomes
6
Laboratory Quality Management
Coordinated activities to direct and
control an organization with
regard to quality
ISO 9000:2000
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The
Patient
Result
Interpretation
PostExamination
Phase
Sample
Collection
Path
Report
Transport
Sample
Transport
Of
Workflow
Report
Creation
PreExamination
Phase
Laboratory
Analysis
Examination Phase
8
Why the Path of Workflow is essential to
consider in health laboratories
 A sample that is damaged or altered as a result
of improper collection, or without consideration
of the effects of transport will always result in an
inaccurate result.
 A medical report that is delayed, or lost, or sent
to the wrong clinician, or written in a method that
results in misinterpreted negates all the time and
energy and finances that were spent in
collecting, transporting and performing the
examination properly
9
There are many factors that influence whether laboratory
tests will be performed accurately
and in a timely manner.
Reagents
and equipment
Knowledgeable
staff
Laboratory
environment
Quality
control
Communications
Competent
staff
Process
Management
Records
keeping
Occurrence
Management
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Twelve Quality
System Essentials
Organization
Personnel
Equipment
Process
Control
(Quality Control
& Specimen
Management)
Information
Management
Documents
& Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Facilities &
Safety
Purchasing
& Inventory
Quality system
essentials
Set of coordinated
activities that function
as building blocks for
quality management.
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Organization
Personnel
Equipment
Purchasing
& Inventory
Process
Control
(Quality Control
& Specimen
Management)
Information
Management
Path
of
Workflow
Documents
& Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Facilities &
Safety
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The Laboratory shall be
legally identifiable
Name
Address
Medical Director
Contact Information
Telephone
Facsimile
Electronic
Path of Workflow
Patients know to
whom to
complain about
inconvenience
Workers know
to whom to
complain about
late salary
cheques
Clinician know to
whom to call
about late
reports
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A Brief
History of
Laboratory Quality Management
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Quality Management is not new
Walter Shewhart
W. Edwards Deming
Robert Galvin
Joseph Juran
Phillip Crosby
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A Short History of Quality Management
Innovator
Walter A Shewhart
Date
1920’s
W Edwards Deming 1940’s
Cycle
Statistical Process Control
Continual Improvement
Joseph Juran
1950’s
Quality Toolbox
Phillip Crosby
1970’s
Quality by Requirement
Robert Galvin
1980’s
Micro Scale Error Reduction
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Walter Shewhart
Statistical Process Control Chart
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W. Edwards Deming
The Deming Cycle
PLAN
DO
ACT
CHECK
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Joseph Juran
Juran Cost of Quality Curve
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Joseph Juran
Juran Defect-Cost Curve (modified)
COSTS
DEFECTS
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Philip Crosby
Absolutes of Quality
1. Quality is defined as conformance to
requirements, not as 'goodness' or 'elegance'.
2. The system for causing quality is prevention,
not appraisal.
3. The performance standard must be Zero
Defects, not "that's close enough".
4. The measurement of quality is the Price of
Nonconformance, not indices.
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Robert Galvin
DEFINE
CONTROL
Six Sigma
MEASURE
6∑
ANALYSE
IMPROVE
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Six Sigma
A modern tool that
blends statistical
process control and
structured project
planning
Total
Error
Error
Percent
Process
Sigma
1,000,000 100,000
10%
2.78
1,000,000 10,000
1%
3.83
1,000,000 5,000
0.5%
4.08
1,000,000 1,000
0.1%
4.59
1,000,000 500
0.05%
4.79
1,000,000 100
0.01%
5.22
1,000,000 50
0.005%
5.39
1,000,000 10
0.001%
5.76
1,000,000 5
0.0005%
5.92
1,000,000 1
0.0001%
6.25
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The March of Quality Management
1942-52
US Military develop requirements for contractors for shell, aircraft, missile
suppliers (Quality without 100% inspection)
1959
US Department of Defense established MIL-Q-9858 quality management
1963
MIL-Q-9858 is internationalized as an ABCA standard
1968
NATO adopts MIL-Q-9858A as Allied Quality Assurance Publication 1 (AQAP-1)
1979
British Standards Institute (BSI) developed AQAP-1 for civilian use BS 5750
1987
ISO modifies and adopts BC5750 for international civilian use ISO 9000
19942000
ISO issued ISO 9000:1994 and follows with ISO 9000:2000.
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The 30 year March of Quality Management
2004
US Military Replaces
Mil-Q-9858 with ISO
9000:2000
MIL-Q-9858
1959
NATO AQAP-1
1968
1967, 1988
BSI 5750
1979
ISO 9000
1987
25
ISO 15189:2003
today’s cornerstone of international
Medical Laboratory Quality Management
ISO 15189:2003
Medical laboratories –Particular
requirements for quality and
competence
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Development of ISO 15189
Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
China
Czech Republic
Denmark
Finland
France
Germany
Iran,
Ireland
Israel
Italy
Jamaica
Japan
Korea
Mexico
Netherlands
New Zealand
Norway
Portugal
Singapore
Spain
Sweden
Switzerland
Turkey
United Kingdom
United States
Quality
ISO
Management
9001:2000 Systems
ISO
17025:1999
General requirements for
the competence of testing and
calibration laboratories
ISO
15189:2003
Medical laboratories –
Particular requirements for
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quality and competence
ISO 15189:2003
Management Requirements
 Organization
 Quality Management System
Document control
Contract review
Referral laboratories
Supplier review
Complaint resolution
Identification of Nonconformities
Control of Nonconformities
Preventive Actions
Corrective Actions
Management review
Continual Improvement
Technical Requirements
 Personnel authorities and
responsibilities
 Accommodation and
Environment
 Equipment and supplies
Testing Cycle Events
•Pre-Examination procedures
•Examination procedures
Standard Operating Procedures
Quality Control
External Quality Assessment
•Post-Examination procedures
Reporting
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ISO 15189
Family of Documents
 ISO 15189:2003Medical laboratories -- Particular requirements
for quality and competence
 ISO 15190:2003Medical laboratories -- Requirements for safety
 ISO 22870:2006Point-of-care testing (POCT) -- Requirements for
quality and competence
 ISO/TR 22869:2005Medical laboratories -- Guidance on
laboratory implementation of ISO 15189: 2003
 ISO/WD TS 22367Medical laboratories -- Reduction of error
through risk management and continual improvement
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CLSI Essential Documents
National Committee for Clinical Laboratory Standards
Clinical and Laboratory Standards Institute
HS01-A2
2004
A Quality Management System Model for Health Care
GP26 – A3
2004
Application of a Quality Management System Model
for Laboratory Services;
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CLSI Beginning
Started in 1967
31 clinicians and laboratory scientists
representing 15 organizations met:


to discuss ways of improving patient care
to develop a formal consensus process for
standardization.
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CLSI Today
Today, 40 years later
A committed forum for laboratory improvement through
consensus, guidelines, and standardization.
International in scope and participation


World Health Organization Collaborating Centre
Secretariat – ISO Technical Committee2.12
 Ten area committees addressing the full range of
laboratory activities.
Current catalogue contains over 180 titles that address the
quality and competence of practice in the medical
laboratory.
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ISO and Medical Laboratory Quality




Quality and Competence
Laboratory Safety
Point of Care Testing
Risk Management
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Summary
 Quality management is not new.
 Quality management grew from the good
works of innovators who defined quality
over a spam of 80 years.
 Quality management is applicable for the
medical laboratory as it is for
manufacturing and industry.
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Summary
Through the good works of organizations
including WHO, ISO, CLSI, and others…
Laboratories benefit
Health care benefits
Patients benefit
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