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2nd Global Conference, Paris, 21-23 June 2010 1 OIE Quality Standard for Veterinary Laboratories OIE Quality Standard for Veterinary Laboratories Fisheries & Oceans Canada Gulf Fisheries Centre New Brunswick, Canada US Dept of Agriculture Nat’l Institute for Food & Agriculture Washington, DC Peter Wright Peter Wright Mark Robinson Mark Robinson OIE Collaborating Centre for ELISA and Molecular Techniques in Animal Disease Diagnosis

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  • 2nd Global Conference, Paris, 21-23 June 2010 1

    OIE Quality Standard for Veterinary Laboratories OIE Quality Standard for Veterinary Laboratories

    Fisheries & Oceans CanadaGulf Fisheries CentreNew Brunswick, Canada

    US Dept of AgricultureNatl Institute for Food & AgricultureWashington, DC

    Peter WrightPeter Wright

    Mark RobinsonMark Robinson

    OIE Collaborating Centre for ELISA and Molecular Techniques in Animal Disease DiagnosisOIE Collaborating Centre for ELISA and Molecular Techniques in Animal Disease Diagnosis

  • 2nd Global Conference, Paris, 21-23 June 2010 2

    Why Quality Management?

    Instil confidence & create acceptanceSound management

    Technical competence

    Validity of results

    As a testing laboratory:

  • 2nd Global Conference, Paris, 21-23 June 2010 3

    Quality management in veterinary testing laboratories

    Terrestrial Manual Chapter 1.1.3

    Aquatic Manual Chapter 1.1.1

    A good introduction to QMS

  • 2nd Global Conference, Paris, 21-23 June 2010 4

    OIE Quality Standard for Veterinary Laboratories

    1st Edition 2002

    2nd Edition 2008

  • 2nd Global Conference, Paris, 21-23 June 2010 5

    OIE Quality Standard and Guidelines for Veterinary Laboratories:Infectious Diseases

    OIE Standard for Management and Technical Requirementsfor Laboratories Conducting Tests for Infectious Diseases

    OIE Guide 1: Validation of diagnostic assays for infectious diseases

    OIE Guide 2: Validation and quality control of polymerase chain reaction methodsused for the diagnosis of infectious diseases

    OIE Guide 3: International reference antibody standards for antibody assays

    OIE Guide 4: Laboratory proficiency testing

    Glossary of Terms

  • 2nd Global Conference, Paris, 21-23 June 2010 6

    A Brief Historical Perspective

    ISO/IEC Guide 25:1990 (3rd Edition)

    ISO/IEC Guide 25 (Period of Transition)

    ISO/IEC 17025:1999 (1st Edition)

    ISO/IEC 17025:2005 (2nd Edition)

    OIE Quality Standard (1st Edition:2002)

    OIE Quality Standard (2nd Edition:2008)

  • 2nd Global Conference, Paris, 21-23 June 2010 7

    OIE Standard for Management and Technical Requirementsfor Laboratories Conducting Tests for Infectious Diseases

    ISO/IEC 17025:2005 - General requirements for the competence of testingand calibration laboratories

    OIE Standard represents an interpretation of the generally stated requirements of the ISO Standard

    OIE Standard may be used by accreditation bodies

    Labs in compliance with the OIE Standard also operate in accordance withthe ISO Standard

    Unique to laboratories conducting tests for infectious animal diseases

    Special emphasis on Clause 5 - Technical requirements

  • 2nd Global Conference, Paris, 21-23 June 2010 8

    Clause 5 - Technical requirements

    5.4 Test Methods

    5.4.1 General

    Relevance of the test method and test results to a specific diagnosticinterpretation or application:

    Suitability or fitness for purpose

    Acceptability by scientific and regulatory communities

    Acceptability to the client / customer

    Feasibility given laboratory resources

  • 2nd Global Conference, Paris, 21-23 June 2010 9

    Clause 5 - Technical requirements

    5.4 Test Methods

    5.4.3 Validation of test methods

    Validation according to the principles outlined in the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals

    Analytical sensitivity & specificity

    Precision & accuracy

    Diagnostic sensitivity & specificity

    Other parameters

  • 2nd Global Conference, Paris, 21-23 June 2010 10

    Principles of validation of diagnostic assays for infectious diseases

    Validation and quality control of polymerase chain reaction methodsused for diagnosis of infectious diseases

    Validation of Diagnostic Tests

    Terrestrial Manual Chapters 1.1.4 & 5

    Aquatic Manual Chapters 1.1.2 & 3

    Combined into one document

    OIE Ad hoc Group on Validation of diagnostic assays

  • 2nd Global Conference, Paris, 21-23 June 2010 11

    OIE Validation and Certification of Diagnostic Assays

    Validation Pathway for Diagnostic Test Methods

    Stage 1 - Analytical characteristics (Bench)

    Stage 2 - Diagnostic characteristics (Field)

    Stage 3 - Reproducibility (Ruggedness)

    Stage 4 - Applications (Repertoire)

    http://www.oie.int/vcda/eng/en_background_vcda.htm

  • 2nd Global Conference, Paris, 21-23 June 2010 12

    The difference between try and triumph is a little umph.

    If one of your goalsis to become accredited,just remember

  • 2nd Global Conference, Paris, 21-23 June 2010 13

    Standards, Guidelines & Templates

    OIE Validation and Certification of Diagnostic Assays

  • 2nd Global Conference, Paris, 21-23 June 2010 14

    Quality Management Credo

    Say what you do& do what you say!

  • 2nd Global Conference, Paris, 21-23 June 2010 15

    "Challenges are what make life interesting; overcoming them is what makes life meaningful. - Mark Twain

    Has persistence been rewarded ?

  • 2nd Global Conference, Paris, 21-23 June 2010 16

    REQUIREMENTS FOR AN ACCREDITED VETERINARY MEDICAL DIAGNOSTIC

    LABORATORY

    AMERICAN ASSOCIATION OF VETERINARYLABORATORY DIAGNOSTICIANS, INC.

    Version 4.3

    Adopted as a Benchmark by the AAVLD

  • 2nd Global Conference, Paris, 21-23 June 2010 17

    4. Licensure/ certification - Must be an American Association of Veterinary Laboratory Diagnosticians (AAVLD) accredited laboratory or other public, not-for-profit, animal disease diagnostic laboratory with an established quality assurance system meeting OIE/ISO 17025 standards and selected by the USDA.

    A.1 Evaluation Criteria

    The NAHLN Steering Committee develops criteria for entry into and maintenance of all veterinary diagnostic laboratories in the NAHLN. If a decision is made to introduce a laboratory into the NAHLN in a state, the laboratory must first meet the following criteria:

    Excerpt from: Policy Regarding Evaluation of Veterinary Diagnostic Laboratories for Membership in the National Animal Health Laboratory Network - Version 2.0 (Rev. August 25, 2008)

    Recognized for qualification by NAHLN

    NAHLN- A State and Federal Partnership to Safeguard Animal Health

  • 2nd Global Conference, Paris, 21-23 June 2010 18

    . Veterinary laboratories world-wide may choose to meet the ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories as a stand-alone requirement for accreditation or the combined criteria of ISO/IEC 17025:2005 and the OIE Quality Standard and Guidelines for Veterinary Laboratories:Infectious Diseases, 2008. (excerpt)

    American Association for Laboratory Accreditation

    PRESS RELEASE

    Contact Information:Matthew TorresAmerican Association for Laboratory Accreditation (A2LA)Phone: 301 644 3225Email: [email protected]: www.A2LA.org

    12/08/2008

    A2LA adds new Veterinary Accreditation Program requirements.

    Incorporated into a Veterinary Specialty by A2LA

  • 2nd Global Conference, Paris, 21-23 June 2010 19

    The race for quality has no finish line so technically, its more like an elusive dream

    "All our dreamscan come true...if we have the courage..."

    Walt Disney

  • 2nd Global Conference, Paris, 21-23 June 2010 20

    Quality Management is Central & Essential

    QM impacts many lab activities:

    Diagnostic testing

    Research & development

    Information management

    Biocontainment & biosecurity

    Health & safety

  • 2nd Global Conference, Paris, 21-23 June 2010 21

    JOURNEYA bend in the road is not the end of the road... unless you fail to make the turn!

    Questions ?

    The End