Veterinary laboratories throughout the world are obtaining or are seeking to obtain laboratory certification. Many standards are based on guidelines from the International Organization for Standardization/International Electrotechnical Commission. One important aspect of compliance with these standards is complete documentation of all processes. However, a major stumbling block for veterinary laboratories seeking certification has been the inadequacy of written documentation. (Documentation is also a common deficiency in human medical laboratories.) Documentation encompasses all levels of the organization, such as standard operating procedures, daily forms and reports, meeting minutes, reference intervals, instructions, laboratory plans, and textbooks. Quality documentation can then be further split into plans that address laboratory environment/community (physical setting of the laboratory, equipment, personnel) and philosophy/vision (scope of testing, type of clientele, quality standards, ongoing quality improvement). Among other specific challenges for veterinary clinical pathology laboratories are absence of compulsory quality requirements for veterinary tests, use of human analytic methods or modified methods for animal species, lack of availability of quality control materials and proficiency testing programs, and inclusion of species-specific reference intervals. These unique challenges should be addressed when any type of quality system is being implemented, whether the laboratory is seeking certification or not.
COMMENTARY: This article highlights some of the unique challenges of quality documentation in veterinary laboratories and discusses possible solutions and courses of action that may help overcome them. The authors address each of these challenges in detail (providing examples and definitions) and then provide some solutions.
Quality documentation challenges for veterinary clinical pathology laboratories. Sacchini F, Freeman KP. J VET DIAGN INVEST 20:266-273, 2007.