Federal regulation of clinical laboratories and the Clinical Laboratory Improvement Amendments of 1988--Part I.

In this first part of a two-part article, we have summarized some of the pertinent features of CLIA 1988 with review of the complexity model, waived testing, personnel standards, proficiency testing and quality control requirements, and patient test management. In addition to a survey of other Federal regulations applicable to clinical laboratories, we have briefly reviewed events subsequent to the publication of the Final Rule in February of 1992, specifically the recommendations of CLIAC and the Technical Corrections published on January 19, 1993. The second part of this paper will discuss sanctions and enforcement; how laboratory inspections are likely to be performed, accreditation of private organizations, state exemptions, cytology and other specialty regulations, and the evolving interaction between CLIAC, FDA, CDC, DHHS, and the regulated laboratory community.