Federal regulations: compliance and implications.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) are still an evolving process just as they were when formally launched in September 1992. In developing and guiding CLIA '88 programs, the Health and Human Services relied on 2 key agencies; the Health Care Financing Administration, and the Centers for Disease Control and Prevention within the Public Health Service. CLIA '88 established an important key position for laboratory personnel: the consultant with technical and scientific oversight of moderate complexity test performance, who also consults with laboratory clientele regarding diagnosis, treatment, and management of patient care, including the appropriateness of test(s) ordered. With these responsibilities, it is imperative for consultants and laboratory managers to thoroughly understand regulatory issues in consulting to determine the fine line between what is legal and what is not, and to ascertain any fraudulent and abusive over-utilization of laboratory services and claims under government health care programs. Current federal regulatory policies that clinical laboratory practitioners must be aware of and comply with will be discussed in this article.