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Clinical Chemistry 38: 1237-1244, 1992;
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Clinical Chemistry, Vol 38, 1237-1244, Copyright © 1992 by American Association for Clinical Chemistry

Limitations of proficiency testing under CLIA '67

RH Laessig, SS Ehrmeyer, BJ Lanphear, BJ Burmeister and DJ Hassemer
State Laboratory of Hygiene, University of Wisconsin, Madison 53706.

Proficiency testing (PT), recognized as a quality-assurance (QA) and quality-improvement tool, also has become the cornerstone of the Health Care Financing Administration's (HCFA) regulatory strategy under the revised Clinical Laboratory Improvement Act of 1967 (CLIA '67) and the proposed Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). Use of PT as a regulatory tool corrupts it for things it can do better. PT as a primary regulatory strategy has severe limitations. We explore the nature of these limitations and their implications for clinical laboratories as they impact on the long-term success of HCFA's approved regulatory PT programs in 1991 and beyond, and CLIA '88 PT, which is to be implemented in 1994.




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Copyright © 1992 by the American Association for Clinical Chemistry.