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1. Introduction
2. Laboratory organisation
3. Environment
4. Human resources
5. Equipment
6. Sample handling
7. Test methods and procedures
8. Record keeping and reporting
9. External recognition
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Extracted from Report of OIE Standards Commission, September
1995
1. Introduction
1.1 Purpose
This document provides guidelines for evaluation of laboratory quality
and is to supplement the OIE Guidelines for the Evaluation of Veterinary
Services (Rev. Sci. Tech Off. Int. Epiz. 1993, 12 (4), 1291-1313).
1.2 Scope
These guidelines are intended for use by OIE Member Countries for the
evaluation of laboratories that are carrying out tests to qualify animals
and animal products for international movement. A Member Country can supplement
this guide with more detailed requirements to meet specialised situations.
This could include the monitoring of laboratory performance by the use
of proficiency testing or inter-laboratory comparisons for specific assays.
This guide is based on the relevant requirements of the ISO 9000 series
of standards and ISO/IEC Guide 25.
1.3 Formal Accreditation
Laboratories may seek formal accreditation to standards compliant with
ISO 9000 and ISO/IEC Guide 25 General Requirements for the Competence
of Calibration and Testing Laboratories (1990). Accreditation to the above
standards should provide sufficient reassurance to Member Countries of
the competence of a testing laboratory. Nevertheless it is recognised
that in many circumstances such a high level of accreditation may be difficult
to achieve for a variety of reasons. Accordingly, the present guidelines
have been prepared to facilitate removal of trade barriers by the acceptance
of test results between countries. They are also intended to facilitate
cooperation between laboratories by assisting in the exchange of information
and the harmonisation of test procedures.
2. Laboratory organisation and management
The laboratory should be legally identifiable.
It should have documented procedures to ensure the protection of proprietary
rights and confidential information.
A technical manager should have overall responsibility for technical operations
within the laboratory.
A quality manager should have overall responsibility for the laboratory
quality system and its implementation, and should have direct access to
the technical manager and to senior management.
The quality manager and technical manager roles may be carried out by
the same person.
Employees should be free from pressure or inducements which might adversely
influence their judgement or the results of their work.
Adequate supervision should be provided by staff familiar with calibration,
test methods and procedures, the objectives of the procedures and the
assessment of the results.
3. Environment
The laboratory should provide a suitable environment for the proper performances
of the test and this environment should not adversely affect or invalidate
the outcome of the test.
The laboratory should provide and maintain essential utilities such as
power, lighting, heating/ventilation/air conditioning, water and waste
disposal.
The laboratory should provide suitable work space for testing procedures
with effective separation of areas in which incompatible activities may
adversely influence the outcome of the test.
The laboratory should provide adequate measures to ensure the cleanliness
of the work environment.
The laboratory should control authorized access in order to ensure the
security of the facility.
The laboratory should comply with national standards of health and safety.
4. Human resources
The laboratory should have an adequate member of staff for the functions
they undertake. They should have the necessary education, training, technical
knowledge, skills and experience for the range of testing carried out.
The training of all laboratory staff should be kept up-to-date, and records
should be maintained of the relevant qualifications, training, skills
and experience of the technical personnel.
A member of staff with appropriate skills should be nominated as supervisor
of the day-to-day running of the laboratory in the absence of the technical
manager.
Unskilled staff must be adequately supervised and should not undertake
tasks normally assigned to skilled personnel.
5. Equipment
The laboratory should possess or have access to all the equipment necessary
for the correct performance of calibrations and tests.
All equipment should be properly maintained and calibrated. Maintenance
and calibration procedures should be documented in terms both of technical
specifications and frequency with which they are carried out. Defective
or suspect equipment must be taken out of service until repaired, tested
and recalibrated.
Each item of equipment should be labelled in an identifiable manner so
that its maintenance and calibration record can be referenced.
Records should be maintained for each item of equipment including its
name, manufacturer, model, serial number, date of acquisition, previous
history (if not new), manufacturer's operating instructions, dates and
results of calibrations, details and dates of maintenance, history of
malfunctions, damage, modification or repair.
Wherever possible and applicable, calibration of equipment should be traceable
to national or international standards of measurement.
Where traceability to national standards of measurement is not applicable,
the laboratory should provide evidence of satisfactory performance in
a programme of interlaboratory comparisons or proficiency testing.
6. Sample handling
The laboratory should have a documented system for logging and uniquely
identifying test samples on receipt, such that there can be no confusion
regarding the identity of the samples at any time.
The condition of samples should be examined on receipt at the laboratory.
Any abnormalities or departures from standard conditions (as prescribed
in the relevant test method) should be recorded. If the condition of the
sample is such as to cast doubt on the validity of the test, the person
submitting the sample should be consulted and any test result marked with
an appropriate warning.
Samples should be kept in appropriate containers and environmental conditions
throughout their time at the laboratory to avoid or minimise deterioration
of the analyte(s) under investigation. The storage conditions, procedures
and maximum duration of storage should be documented where appropriate
for each type of sample and each assay.
All procedures for the receipt, handling, storage and disposal of samples
should provide adequate biological and chemical protection for personnel.
Biological containment procedures should take into account both human
and animal health hazards.
Guidelines for the transport, handling and storage of samples are provided
in the OIE Manual of Standards for Diagnostic Tests and Vaccines.
7. Test methods and procedures
The OIE Manual of Standards for Diagnostic Tests and Vaccines will provide
the principal source of standard methodologies for tests carried out under
these guidelines. When standard methodologies have been modified by an
individual laboratory or when tests not appearing in the Manual are used,
they must be fully documented and validated, and the laboratory should
have such information available if requested.
Each reagent, chemical or biological used in the test, shall be appropriately
labelled and its history should be documented. Documentation should include
information with respect to:
a) origin and date of receipt
b) date of preparation for use
c) storage conditions
d) expiry dates where applicable
A demonstrable internal quality control programme for each assay should
be documented and in use. Documentation should include:
a) detailed bench protocol
b) work sheets
c) internal quality control and raw sample data
d) quality control charts, where applicable
e) positive and negative cut-off criteria
f) details of internal check sample programme, if performed.
8. Record keeping and reporting
The laboratory shall maintain a record system for all laboratory procedures
outlined in this guideline which specify a requirement for documentation
(e.g., general laboratory operation, maintenance and calibration of equipment,
staff qualification, sample tracking, quality assurance, etc.).
Test results should be reported accurately, clearly and objectively, in
accordance with the Manual of Standards and must include all information
necessary for sample tracking and the correct interpretation of the test
results.
9. External recognition
Wherever possible, the laboratory should participate in national and international
programmes which recognise laboratory diagnostic proficiency. This usually
requires participation in external check sample programmes or other interlaboratory
comparisons.
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