Ss. Ehrmeyer et Rh. Laessig, REGULATORY REQUIREMENTS (CLIA-88, JCAHO, CAP) FOR DECENTRALIZED TESTING, American journal of clinical pathology, 104(4), 1995, pp. 40-49
All decentralized testing is regulated according to the Clinical Labor
atory Improvement Amendments of 1988. Two organizations, the Joint Com
mission on Accreditation of Health Care Organizations and the College
of American Pathologists, have received deemed status for their volunt
ary standards from the Health Care Financing Administration. Deemed st
atus 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 se
t of standards, will be used to regulate their testing processes. In t
his article, the authors outline the various regulatory requirements,
provide insight into the relationship of each, and offer a framework f
or decentralized testing sites to follow to meet the requirements.