The American (USA) perspective six years after implementation of CLIA'88 (Federal) regulations |
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Authors: | S S Ehrmeyer Ronald H Laessig |
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Institution: | (1) Department of Pathology and Laboratory Medicine University of Wisconsin Madison, WI 53706, USA Tel.: +608-262-0859 Fax: +608-262-9520 e-mail: ehrmeyer@facstaff.wisc.edu, US |
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Abstract: | On September 1, 1992 all testing sites in the United States were required to comply with the Clinical Laboratory Improvement
Amendments of 1988 (CLIA'88). These regulations, based on both total quality management (TQM) and continuous quality improvement
(CQI) principles, reshaped the environment for more than 90% of laboratories. CLIA'88 represented a revolutionary change by
imposing universal, uniform regulations based on test complexity for all sites examining materials derived from the human
body for the purpose of providing information for the diagnosis, prevention, or treatment of disease. CLIA'88 specifies minimum
requirements for personnel, quality control, and proficiency testing (PT). In addition, laboratories are required to follow
manufacturers' directions and comply with other specified good laboratory practices. PT is mandated for most of the frequently
run analyses and quality assurance requirements integrate the principles of CQI as well as TQM into the regulatory process.
Biannual inspection is integral to CLIA'88, however, laboratories can choose other federally approved ("deemed") professional
organizations, such as the Commission on Office Laboratory Accreditation, the College of American Pathologists, or the Joint
Commission on Accreditation of Healthcare Organization, having standards that meet or exceed those of CLIA'88. CLIA'88 has
still not been finalized. This article discusses the impact and changes since CLIA's implementation in 1992.
Received: 5 October 1998 · Accepted: 20 October 1998 |
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Keywords: | Clinical laboratory improvement amendments (CLIA'88) United States (Federal) laboratory regulations Quality mandates Total quality management Laboratory accreditation |
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