Previous articles1,2,3,4 in this series on quality management for in-clinic laboratories have introduced the need for a total quality management system for in-clinic laboratory testing, quality planning, and a quality plan; discussed some aspects of facilities, instrumentation, health and safety, training, and improvement opportunities; discussed standard operating procedures; and considered various aspects of equipment or instrument maintenance and analytic performance assessment. The purpose of this final article is to provide additional information and examples regarding statistical QC for in-clinic laboratory testing and to expand on the quality-assurance concepts introduced in the
The first article in this series introduced the concepts of a total quality management system and a quality plan for in-clinic laboratories. The purpose of this second article is to introduce aspects of quality assurance related to laboratory facilities, laboratory equipment, health and safety, staff training, and improvement opportunities. A brief description of the various topics discussed further in this article should be included in the quality plan, with more detail added within laboratory SOPs (the topic of the third article in the series).
The in-clinic laboratory should be in an area of the veterinary practice that provides
All human clinical laboratory testing in the United States is regulated by the Clinical Laboratory Improvement Amendments of the US FDA,1 and other countries have similar regulations. Failure of such laboratories to correct issues of noncompliance with legislation results in lack of accreditation and termination of laboratory services. In contrast, veterinary laboratories are not uniformly regulated by government entities. Laboratory accreditation is offered by the American Association of Veterinary Laboratory Diagnosticians and is optional. This accreditation is “restricted to publicly funded, full-service laboratories, full service being defined as offering necropsy, histopathology, bacteriology, and virology or equivalent services
Written SOPs are an essential part of ensuring production of accurate and reliable results in the in-clinic laboratory. Previous articles in this 5-part series summarized the overarching framework of the total quality management system, importance of quality planning, and important aspects of the facilities, training, and documentation needed for in-clinic laboratory testing. The purpose of this article is to provide information about SOPs, including their definition, purpose, and benefits; the various types of SOPs; and the headings and content commonly addressed in SOPs as relevant to in-clinic laboratories.
Definition of SOP
Standard operating procedures are defined as written documents
Point-of-care devices, also referred to as patient-side or in-clinic devices, are laboratory equipment and automated instruments used to perform laboratory testing in proximity to patients outside of a commercial or reference laboratory.1 In veterinary clinics, POC instruments include automated instruments such as hematology and clinical chemistry instruments, microscopes, and refractometers.
All POC devices require regular maintenance as part of a quality management plan (see second article in this series), and POC instruments also require calibration and use of QCMs to ensure accurate performance. The purpose of this article is to introduce quality-assurance concepts regarding POC instruments and