The Medicare and Clinical Laboratories Improvement Act of 1967 proficiency testing requirements and its relationship to the private sector

The Health Care Financing Administration of the US Department of Health and Human Services is the federal agency that has the responsibility for the administration of the Medicare and Clinical Laboratories Improvement Act of 1967 programs, including the promulgation of standards for clinical laboratories. The Health Care Financing Administration has been working with the Centers for Disease Control of the US Public Health Service to develop uniform standards for proficiency testing programs for the two regulatory programs. The current standards were developed on the premise that a combination of factors, including personnel standards, record-keeping, management requirements, quality control standards, and external quality assurance measures such as proficiency testing, could be used to make decisions on reimbursing facilities for tests or to allow a facility to test in interstate commerce. These programs were regulatory in nature and provided punitive actions for failure to comply with the standards established for participation or licensure. The provision of consultation and training was not the primary focus of the program, even if it was a desirable outcome. The private sector organizations and the regulated industry, on the other hand, viewed their programs as designed for educational and self-improvement purposes rather than for any regulatory or punitive functions. Therefore, the approaches for the regulatory agencies and the professional community have differed.