Introduction to Laboratory Quality Management

1
Introduction to Laboratory Quality Management
2
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

3
What is Quality?
4
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

5
1 of non quality?
6
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,
  moneypersonnel and patient outcomes

7
Laboratory Quality Management

• Coordinated activities to direct and control an
  organization with regard to quality
• ISO 90002000

8
Path Of Workflow
Post- Examination Phase
Pre- Examination Phase
Examination Phase
9
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

10
There are many factors that influence whether
laboratory tests will be performed accurately
and in a timely manner.
Laboratoryenvironment
Reagentsand equipment
Qualitycontrol
Knowledgeablestaff
Communications
Competentstaff
Process Management
OccurrenceManagement
Records keeping
11
Twelve Quality System Essentials
Quality system essentials Set of coordinated
activities that function as building blocks for
quality management.
12
Path of Workflow
13
The Laboratory shall be legally identifiable

• Name
• Address
• Medical Director
• Contact Information
• Telephone
• Facsimile
• Electronic

Path of Workflow
Clinician know to whom to call about late reports
Workers know to whom to complain about late
salary cheques
Patients know to whom to complain about
inconvenience
14

• A Brief History of
• Laboratory Quality Management

15
Quality Management is not new
Walter Shewhart
W. Edwards Deming
Joseph Juran
Robert Galvin
Phillip Crosby
16
A Short History of Quality Management
Innovator Date Cycle
Walter A Shewhart 1920s Statistical Process Control
W Edwards Deming 1940s Continual Improvement
Joseph Juran 1950s Quality Toolbox
Phillip Crosby 1970s Quality by Requirement
Robert Galvin 1980s Micro Scale Error Reduction
17
Walter Shewhart
Statistical Process Control Chart
18
W. Edwards Deming
The Deming Cycle
19
Joseph Juran
Juran Cost of Quality Curve
20
Joseph Juran
COSTS
DEFECTS
21
Philip Crosby
Absolutes of Quality

• Quality is defined as conformance to
  requirements, not as 'goodness' or 'elegance'.
• The system for causing quality is prevention, not
  appraisal.
• The performance standard must be Zero Defects,
  not "that's close enough".
• The measurement of quality is the Price of
  Nonconformance, not indices.

22
Robert Galvin
Six Sigma
23
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
24
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
1994-2000 ISO issued ISO 90001994 and follows with ISO 90002000.
25
The 30 year March of Quality Management
2004 US Military Replaces Mil-Q-9858 with ISO
90002000
MIL-Q-9858 1959
NATO AQAP-1 1968
BSI 5750 1979
ISO 90001987
26
ISO 151892003 todays cornerstone of
international Medical Laboratory Quality
Management

• ISO 151892003
• Medical laboratories Particular requirements
  for quality and competence

27
Development of ISO 15189
ArgentinaAustralia Austria Belgium Brazil Canada Chile China Czech Republic Denmark Finland France Germany   Iran, Ireland Israel Italy Jamaica Japan  Korea  Mexico Netherlands New Zealand  Norway  PortugalSingapore  Spain Sweden Switzerland Turkey United Kingdom United States
ISO90012000
QualityManagementSystems
ISO170251999
ISO 151892003
28
ISO 151892003

• 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

29
ISO 15189 Family of Documents

• ISO 151892003Medical laboratories -- Particular
  requirements for quality and competence
• ISO 151902003Medical laboratories --
  Requirements for safety
• ISO 228702006Point-of-care testing (POCT) --
  Requirements for quality and competence
• ISO/TR 228692005Medical laboratories -- Guidance
  on laboratory implementation of ISO 15189 2003
• ISO/WD TS 22367Medical laboratories -- Reduction
  of error through risk management and continual
  improvement

30
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

31
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.  

32
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.

33
ISO and Medical Laboratory Quality

• Quality and Competence
• Laboratory Safety
• Point of Care Testing
• Risk Management

34
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.

35
Summary

• Through the good works of organizations including
  WHO, ISO, CLSI, and others
• Laboratories benefit
• Health care benefits
• Patients benefit