OIE Reference Laboratories: Laboratory Quality Control Standards and Requirements

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OIE Reference Laboratories Laboratory Quality
Control Standardsand Requirements

• Jane Pritchard
• LTTA Gansu Shaanxi
• LHESP

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Primary Goals

• Contribute to the improvement of animal health
  services world-wide
• Guarantee the safety of
• and to facilitate
• international trade
• in animals and
• animal products

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Harmonize

• OIE Manual of Diagnostic Tests and Vaccines for
  Terrestrial Animals
• Internationally accepted test methods for
  infectious diseases
• Harmonize methods for national disease control,
  surveillance and survey programs, and for
  international trade.

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Confidence

• Test results at national and international levels
  must be validated
• Laboratories must be proficient
• Standards must be set and met

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Standard and Guidelines

• ISO/IEC 170252005
• ISO 9000 (90012000)
• OIE standards operate in accordance with the ISO
  requirements for testing laboratories

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Management Requirements

• Organization and management
• Management system
• Document control
• Purchasing services and supplies
• Complaints
• Non-conforming test results
• Improvement
• Corrective and preventative action
• Records
• Internal audits
• Management reviews

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Technical Requirements

• Personnel
• Environmental conditions
• Test methods
• Equipment including computers and software
• Measurement traceability
• Specimens and handling of specimens
• Quality of test results
• Reporting test results

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The Role of Reference Laboratories and
Collaborating Centres

• Provide permanent support for the objectives and
  mandates of the OIE.
• Scientific and technical problems related to the
  surveillance and monitoring of OIE named
  diseases.
• Scientific assistance, advice and training for
  OIE Member labs
• Coordinate scientific and technical studies
• Collaborating centres are centres of expertise in
  a named discipline such as epidemiology or risk
  analysis

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Good Governance Veterinary Services

• Crucial need for appropriate legislation and
  strict implementation through appropriate
  national animal health systems allowing
• Early detection
• Transparency
• Notification
• Rapid Response to animal disease
• outbreaks

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OIE Lab Standards

• ISO 17025
• WHO standards
• New in 2008
• Quality Systems

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labs
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Reference Labs

• Centre of expertise and standardization for
  disease or topic
• Storage and distribution of reference material
  and reagents
• Development of new procedures for diagnosis and
  control
• Collect, process, analyze data on animal disease
  outbreaks
• Consult to the OIE
• Provide training for OIE member countries
• Provide diagnostic testing to member countries
• Organize scientific meetings for OIE
• Co-ordinate collaborative studies
• Publish and share information

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Application for OIE Reference lab status

• 1. Name of expert (a brief and informal
  curriculum vitae should be included).
• 2. Name and address of laboratory (telephone and
  fax numbers, e-mail address, Web site).
• 3. Name of Director.
• 4. Experience in diagnostic testing for the
  disease (approximate number of tests performed
  annually for each technique).
• 5. Additional expertise in the disease (agent
  characterization techniques, molecular
  techniques, monoclonal antibody techniques).
• 6. Experience in standardization and validation
  of diagnostic tests.
• 7. Reagent production capability (provide details
  of current stock of reagents for the disease).
• 8. Capability for timely international shipment
  in accordance with the requirements for postage
  and packaging of biological materials described
  in chapter 1.4.5 of the OIE Terrestrial Animal
  Health Code or chapter 1.5.6 of the OIE Aquatic
  Animal Health Code.
• 9. Current and completed research and methods
  development projects on the disease, including a
  list of relevant publications.
• 10. Training and consultation experience for the
  disease in the last two years (courses provided,
  number of people trained, examples of
  international consultation).
• 11. Contribute to the preparation or reviewing of
  reference documents (chapters for the Manual of
  Diagnostic Tests and Vaccines for Terrestrial
  Animals , OIE Manual of Diagnostic Tests for
  Aquatic Animal, disease cards, etc.).

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Twinning of OIE reference Laboratories

• 2002 OIE Resolution to support the partnership
  of OIE Reference Labs with developing and
  in-transition countrys Labs.
• Exchange of scientific information
• Establish focal points of expertise and more
  Reference Labs in developing countries as part of
  capacity building.

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Questions?