Regulatory requirements (CLIA '88, JCAHO, CAP) for decentralized testing

All decentralized testing is regulated according to the Clinical Laboratory Improvement Amendments of 1988. Two organizations, the Joint Commission on Accreditation of Health Care Organizations and the College of American Pathologists, have received deemed status for their voluntary standards from the Health Care Financing Administration. Deemed status means that the organizations' voluntary standards meet or exceed the federal requirements. The decentralized testing sites can exercise several options in determining which organization, and hence which set of standards, will be used to regulate their testing processes. In this article, the authors outline the various regulatory requirements, provide insight into the relationship of each, and offer a framework for decentralized testing sites to follow to meet the requirements.