Standardization and accreditation of clinical laboratories in the USA

The College of American Pathologists (CAP) is the main accrediting body for clinical laboratories in the USA. In addition to the CAP, the Food and Drug Administration (FDA) accredits transfusion services and blood banks by random inspections, development and standard implementation. Both the CAP and the FDA have been instrumental in the development of standards. These standards apply to scientific, technical and safety aspects of the clinical laboratory. Adherence to these standards enables clinical laboratories in the USA to obtain accreditation biannually through inspection by peers. The National Committee for Clinical Laboratory Standards (NCCLS; also known as ISO Technical Committee 212) has developed standards for almost every aspect of scientific/technical operation in a clinical laboratory. There is, however, a degree of uncertainty built into these standards, which allows laboratories to develop their own definitions and interpretations. Of course, clinical laboratory science is, by nature, a rather inexact field of knowledge, and this level of ambiguity simply increases the existing uncertainty. All clinical laboratories in the USA incorporate a quality-control programme in their daily routine, which we can assume, with a fairly high degree of accuracy, utilizes the Westgard set of rules. This provides another form of standardization, which is applicable only to quality control and is highly variable from laboratory to laboratory. Based on published NCCLS, CAP and FDA standards, it is evident that there is a certain level of standardization in the American clinical laboratories; however, it should be emphasized that this standardization is rather minimal. It is present in a rather liberal fashion, and it differs greatly from laboratory to laboratory. In a great number of clinical-laboratory operations, there is no standardization at all. For example, there is a CAP-imposed requirement for documenting personnel competency within certain time intervals. However, there is absolutely no indication regarding the methodology required to establish such competency or the methodology required to document it. The end result is that each clinical laboratory interprets this requirement in its own way, which significantly differs from other laboratories, even if they are part of the same organization. Some laboratories go to great lengths to make sure that their personnel are competent, while some other laboratories do the bare minimum to just meet the intent of the requirement, with minimal proof that their personnel are competent. Although this does not hinder the accreditation process, it creates significant uncertainty within the laboratory, along with an inordinate amount of paperwork, qualityrelated expenses and significant mistakes. These mistakes could be prevented if a properly formulated and implemented quality-management system (QMS) is in place. The answer to this problem is provided by ISO 9000-based QMSs. Development and implementation of an ISO 9000-based QMS is not an easy task. Primarily, it requires a strong management commitment, team effort and dedicated personnel. The end result is a well-organized laboratory with carefully defined processes and procedures for its pre-analytical, analytical and post-analytical phases. In this case, the end justifies the means. In 1995, NCCLS started preliminary work to develop an ISO 9000 set of standards that were specifically formulated for the clinical Letter from... America