Current quality assurance concepts and considerations for quality control of in-clinic biochemistry testing

• Autores: Sally Lester, K. E. Harr, Mark Rishniw, Paul Pion
• Localización: JAVMA: Journal of the American Veterinary Medical Association, ISSN-e 0003-1488, Vol. 242, Nº. 2, 2013, págs. 182-192
• Idioma: inglés
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• Resumen

  • Quality assurance is an implied concept inherent in every consumer's purchase of a product or service. In laboratory testing, quality assurance encompasses preanalytic (sampling, transport, and handling prior to testing), analytic (measurement), and postanalytic (reporting and interpretation) factors. Quality-assurance programs require that procedures are in place to detect errors in all 3 components and that the procedures are characterized by both documentation and correction of errors. There are regulatory bodies that provide mandatory standards for and regulation of human medical laboratories. No such regulations exist for veterinary laboratory testing. The American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards Committee was formed in 1996 in response to concerns of ASVCP members about quality assurance and quality control in laboratories performing veterinary testing. Guidelines for veterinary laboratory testing have been developed by the ASVCP. The purpose of this report was to provide an overview of selected quality-assurance concepts and to provide recommendations for quality control for in-clinic biochemistry testing in general veterinary practice.

    All clinicians expect that the results obtained from the diagnostic tests they perform on their patients are accurate and precise, so that correct clinical decisions can be made to manage their patients. Obtaining results that are inaccurate or imprecise can lead to incorrect diagnoses, inappropriate courses of action, and, potentially, patient harm. These expectations apply to in-clinic biochemistry analyzer systems, which have proliferated in general veterinary practice over the past decade. However, despite the popularity of these analyzers, quality-assurance programs and QC systems have been largely neglected in general veterinary practice, with most clinicians relying on manufacturers' claims and occasional calibration of equipment to ensure diagnostic test quality.

    Quality assurance is an implied concept inherent in every consumer's purchase of a product or service. Many of the initial quality-assurance procedures came from the manufacturing sector and were the result of the need to produce products that were cost effective and did not fail.1 Quality-assurance systems were then discussed and applied over time in human diagnostic laboratories beginning in the 1950s2 and subsequently implemented in veterinary laboratories. These programs have changed and evolved along with new procedures, statistical concepts, and evaluations of system flaws, with the goal of ensuring that each and every result is correct.

    In laboratory testing, quality assurance encompasses 3 major components: preanalytic (sampling, transport, and handling prior to testing), analytic (measurement), and postanalytic (reporting and interpretation) factors. Quality-assurance programs require that procedures are in place to detect errors in all 3 components and that the procedures are characterized by both documentation and correction of errors.

    There are regulatory bodies that provide mandatory standards for and regulation of human medical laboratories as well as numerous accreditation bodies.3,4 In concert with the regulation of these laboratories, there are regulations governing the production of medical testing devices, including standards of performance.5,6 No such regulations exist for veterinary laboratory testing.

    The ASVCP Quality Assurance and Laboratory Standards Committee was formed in 1996 in response to concerns of ASVCP members about quality assurance and QC in laboratories performing veterinary testing. The committee was charged as follows: “to encourage and promote the establishment of standards for the performance of laboratory procedures” on veterinary samples. Guidelines for veterinary laboratory testing have been developed by the ASVCP, the most recent of which are now posted on the ASVCP website7 and as summary reports in the veterinary literature.8 Laboratory quality assurance is a robust field of inquiry and interest in human medicine, and there has recently been increased interest in laboratory quality assurance in veterinary medicine.9–18 Most recently, a study19 examined the real-world precision, accuracy, and sources of error of in-clinic and reference laboratory biochemistry testing. On the basis of evidence provided in that study19 and the current resurgence of interest in QC and quality assurance by various veterinary hospital–certifying organizations and other veterinary organizations,20–23 specific recommendations for quality assurance and QC for in-clinic biochemistry testing are warranted.

    The purpose of this report is to provide an overview of selected quality-assurance concepts and to provide recommendations for QC for in-clinic biochemistry testing in general veterinary practice.