Quality documentation challenges for veterinary clinical pathology laboratories.

Abstract

An increasing number of veterinary laboratories worldwide have obtained or are seeking certification based on international standards, such as the International Organization for Standardization/International Electrotechnical Commission 17025. Compliance with any certification standard or quality management system requires quality documentation, an activity that may present several unique challenges in the case of veterinary laboratories. Research specifically addressing quality documentation is conspicuously absent in the veterinary literature. This article provides an overview of the quality system documentation needed to comply with a quality management system with an emphasis on preparing written standard operating procedures specific for veterinary laboratories. In addition, the quality documentation challenges that are unique to veterinary clinical pathology laboratories are critically evaluated against the existing quality standards and discussed with respect to possible solutions and/or recommended courses of action. Documentation challenges include the establishment of quality requirements for veterinary tests, the use or modification of human analytic methods for animal samples, the limited availability of quality control materials satisfactory for veterinary clinical pathology laboratories, the limited availability of veterinary proficiency programs, and the complications in establishing species-specific reference intervals.