Laboratory quality considerations for veterinary practitioners.
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Accreditation↗
Biomedical subjects
Ann L Wiegers
Publications and source records attributed to Ann L Wiegers.
The quality assurance of proficiency testing programs for animal disease diagnostic laboratories.
Laboratory data credibility has 3 major components: 1) valid methods, 2) proficiency testing (PT) to verify that the analyst can conduct the method and to compare results of other laboratories using the same method, and 3) third-party accreditation to verify that the laboratory is competent to conduct testing and that the method validation has been done within the environment and requirements of an effective quality-management system. Participation in external PT programs by a laboratory is strongly recommended in International Organization for Standardization/International Electrotechnical Commission International Standard 17025. Most laboratory accreditation bodies using this standard require that laboratories participate in such programs to be accredited. Internal PT is also recommended for each analyst. Benchmarking, or comparison between laboratories using PT or reference materials, is also recommended as part of the validation and evaluation of test methods. These requirements emphasize the need for proficiency test providers to demonstrate their competence. Requirements for competence are documented in national and international standards and guidelines, and accreditation is available for providers. This article discusses the activities and the components that are necessary and recommended for PT projects and programs for animal disease diagnostic testing. These are based on the requirements of the national and international standards, which address this subject, and on the experience of the author. The accreditation of external PT programs is also discussed. Organizations that accredit PT providers or that provide PT programs are listed. Existing references, guidelines, and standards that are relevant to PT in veterinary diagnostic laboratories are discussed.
Accreditation↗
Valid methods: the quality assurance of test method development, validation, approval, and transfer for veterinary testing laboratories.
Third-party accreditation is a valuable tool to demonstrate a laboratory's competence to conduct testing. Accreditation, internationally and in the United States, has been discussed previously. However, accreditation is only I part of establishing data credibility. A validated test method is the first component of a valid measurement system. Validation is defined as confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. The international and national standard ISO/IEC 17025 recognizes the importance of validated methods and requires that laboratory-developed methods or methods adopted by the laboratory be appropriate for the intended use. Validated methods are therefore required and their use agreed to by the client (i.e., end users of the test results such as veterinarians, animal health programs, and owners). ISO/IEC 17025 also requires that the introduction of methods developed by the laboratory for its own use be a planned activity conducted by qualified personnel with adequate resources. This article discusses considerations and recommendations for the conduct of veterinary diagnostic test method development, validation, evaluation, approval, and transfer to the user laboratory in the ISO/IEC 17025 environment. These recommendations are based on those of nationally and internationally accepted standards and guidelines, as well as those of reputable and experienced technical bodies. They are also based on the author's experience in the evaluation of method development and transfer projects, validation data, and the implementation of quality management systems in the area of method development.
Accreditation↗
The age of competence: an update on the international laboratory accreditation scene for veterinary testing laboratories.
Many changes have recently taken place in the world of laboratory accreditation. These changes include the increased use of voluntary standards in lieu of regulations, a move towards harmonization (equivalent results using voluntary standards) over standardization (using the same procedures or regulations), and an increased focus on competence, which includes the competence of laboratories to conduct testing, the competence of accreditation bodies to operate accreditation programs, the competence of bodies such as the National Cooperation for Laboratory Accreditation (NACLA) to recognize accreditation bodies as meeting the requirements of relevant standards, and the competence of organizations providing services to the accreditation process, such as the operation of proficiency testing programs. To describe these changes, a brief and general description of the International Laboratory Accreditation Cooperation accreditation scheme is provided, including an update on relevant decisions and activities in the United States and a description of the organization and activities of the newly formed NACLA. Following this discussion, with emphasis on veterinary testing, is an overview of several national and international organizations, including accreditation bodies, that promote harmonization, standardization, and analytical excellence. Also outlined are relevant activities of these organizations, an overview of some of the standards and guidelines they produce, and a description of how such organizations interact with each other and with laboratories seeking recognition for competence. Next is a brief discussion of recent developments and trends in laboratory accreditation, the impact of these developments, and the costs and benefits of accreditation to laboratories. Suggestions to veterinary laboratories for formulating strategy for keeping current with developments in accreditation and for determining quality goals are included.
Accreditation↗