Regulation of proficiency testing under the March 14 rule.

Federal authority over clinical laboratories began in 1966 when Medicare independent-laboratory regulations established personnel standards for laboratories that participated in the Medicare and Medicaid programs. The following year, Congress enacted the Clinical Laboratory Improvement Act of 1967, known as ‘tCLIA ‘67,” which required licensure for laboratories testing patients’ specimens in interstate commerce. CLIA ‘67 adopted the Medicare personnel standards and added quality-control and proficiency-testing standards. In 1974, the Medicare program also adopted CLIA’s quality-control and proficiency-testing standards. Before the establishment of the Health Care Financing Administration (HCFA) in 1977, the Public Health Service, acting through the Centers for Disease Control (CDC), was responsible for the regulation of laboratories performing interstate testing. In 1979, through an interagency agreement, HCFA became responsible for the licensing and inspection of the -1700 laboratories licensed under CLIA ‘67. A Memorandum of Understanding between HCFA and CDC further delineated their responsibilities, specifying that HCFA was responsible for developing the regulations relating to Medicare and CLIA ‘67 laboratories and that CDC was responsible for providing the scientific and technical expertise on questions related to advances in instrumentation, new technology, and proficiency testing. CDC was responsible for providing an approved proficiency-testing program and for determining successful participation for those laboratories participating in the CLIA ‘67 program. The proficiency testing managed by CDC was very prescriptive in terms of program content, frequency of shipments or testing events, grading criteria for individual analytes, and the number of challenges; the CDC determined that unsuccessful participation was defined as three consecutive unsatisfactory results or three unsatisfactory results out of four consecutive shipments for specialty, subspecialty, or analyte. Unsuccessful participation in the proficiency-testing program resulted in an action to revoke or limit the CLIA ‘67 license. For laboratories participating in both CLIA ‘67 and the Medicare programs, the results of the CDC proficiency testing and any action to revoke or limit the CLIA ‘67 license based on unsuccessful proficiency-testing performance resulted in the initiation of a termination action under Medicare. In the mid-1980s, CDC discontinued providing proficiency-testing services. Meanwhile, Medicare-only laboratories were not subject to the same national proficiency-testing program