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Introduction to Laboratory Quality Management


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 ... – PowerPoint PPT presentation

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Title: Introduction to Laboratory Quality Management

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
  • Define the principal terms used in the field of
  • List the essential elements of a laboratory
    quality system
  • Describe the development of quality principles
    during the last centuries

What is Quality?
99 High Quality level?
  • Accepting 1 non-quality, means everyday in
  • -- 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

1 of non quality?
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
  • Revision of laboratory procedures eradicated the
  • Laboratory errors cost in time, energy,
    money personnel and patient outcomes

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

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

There are many factors that influence whether
laboratory tests will be performed accurately
and in a timely manner.
Laboratory environment
Reagents and equipment
Quality control
Knowledgeable staff
Competent staff
Process Management
Occurrence Management
Records keeping
Twelve Quality System Essentials
Quality system essentials Set of coordinated
activities that function as building blocks for
quality management.
Path of Workflow
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
  • A Brief History of
  • Laboratory Quality Management

Quality Management is not new
Walter Shewhart
W. Edwards Deming
Joseph Juran
Robert Galvin
Phillip Crosby
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
Walter Shewhart
Statistical Process Control Chart
W. Edwards Deming
The Deming Cycle
Joseph Juran
Juran Cost of Quality Curve
Joseph Juran
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
  • The performance standard must be Zero Defects,
    not "that's close enough".
  • The measurement of quality is the Price of
    Nonconformance, not indices.

Robert Galvin
Six Sigma
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
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.
The 30 year March of Quality Management
2004 US Military Replaces Mil-Q-9858 with ISO
MIL-Q-9858 1959
NATO AQAP-1 1968
BSI 5750 1979
ISO 9000 1987
ISO 151892003 todays cornerstone of
international Medical Laboratory Quality
  • ISO 151892003
  • Medical laboratories Particular requirements
    for quality and competence

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
ISO 90012000
Quality Management Systems
ISO 170251999
ISO 151892003
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

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

CLSI Essential Documents
  • National Committee for Clinical Laboratory
  • 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

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

CLSI Today
  • Today, 40 years later
  • A committed forum for laboratory improvement
    through consensus, guidelines, and
  • 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.

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

  • Quality management is not new.
  • Quality management grew from the good works of
    innovators who defined quality over a spam of 80
  • Quality management is applicable for the medical
    laboratory as it is for manufacturing and

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