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

This is the second of two articles summarizing federal regulation of clinical laboratories and reviewing specific aspects of the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988). This article includes a review of 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 implementation of CLIA 1988.