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THE CDC's Public Health Practice Program Office (PHPPO) has been providing scientific and technical assistance to help the Health Care Financing Administration (HCFA) devise "reasonable" standards that, for the first time, may subject physician office laboratories to federal regulation.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) requires the HCFA to develop regulations for ensuring the quality of testing done in heretofore unregulated laboratories. As part of its mission to promote the development, implementation, and evaluation of national standards for laboratory practice, says division director Ronald Valdiserri, MD, MPH, the PHPPO's Division of Laboratory Systems must help the HCFA devise reasonable standards applicable to a wide variety of settings.
CLIA '88 requires the HCFA to issue regulations based on the complexity of tests performed, exempting from regulation only laboratories that perform "simple" tests that will not harm a patient if done incorrectly.
PHPPO deputy director Joyce D. K. Essien,
Skolnick A. Office Helps Laboratories Pass the Test. JAMA. 1990;263(19):2617. doi:10.1001/jama.1990.03440190073036