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

Fisheries & Oceans CanadaGulf Fisheries CentreNew Brunswick, Canada

US Dept of AgricultureNat’l 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

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Why Quality Management?

Instil confidence & create acceptanceSound management

Technical competence

Validity of results

As a testing laboratory:

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Quality management in veterinary testing laboratories

Terrestrial Manual• Chapter 1.1.3

Aquatic Manual• Chapter 1.1.1

A good introduction to QMS

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OIE Quality Standard for Veterinary Laboratories

1st Edition• 2002

2nd Edition• 2008

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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

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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)

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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

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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

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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

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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

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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

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The difference between try and triumph is a little ‘umph’.

If one of your goalsis to become accredited,just remember……

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Standards, Guidelines & Templates

OIE Validation and Certification of Diagnostic Assays

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Quality Management Credo

Say what you do……& do what you say!

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

Has persistence been rewarded ?

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REQUIREMENTS FOR AN ACCREDITED VETERINARY MEDICAL DIAGNOSTIC

LABORATORY

AMERICAN ASSOCIATION OF VETERINARYLABORATORY DIAGNOSTICIANS, INC.

Version 4.3

Adopted as a Benchmark by the AAVLD

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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

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……. 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: mtorres@A2LA.orgWeb: www.A2LA.org

12/08/2008

A2LA adds new Veterinary Accreditation Program requirements.

Incorporated into a Veterinary Specialty by A2LA

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The race for quality has no finish line –so technically, it’s more like an elusive dream

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

Walt Disney

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Quality Management is Central & Essential

QM impacts many lab activities:

Diagnostic testing

Research & development

Information management

Biocontainment & biosecurity

Health & safety

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

Questions ?

The End