Conditions of participation for hospitals; conditions for coverage of services of independent laboratories; immunohematological testing, transfusion services and bloodbanking: Health Care Financing Administration. Final rule.

This regulation will provide uniformity in the requirements for immunohematological testing, transfusion services and bloodbanking for facilities participating in the Medicare program by adopting by cross-reference the Food and Drug Administration's (FDA) regulations in 21 CFR Parts 606, 610 and 640. The regulations are being adopted to implement a Memorandum of Understanding (MOU) between the Health Care Financing Administration (HCFA) and the FDA which has been signed by the Secretary on January 21, 1980 and was published in the Federal Register on March 25, 1980 (45 FR 19136). This will result in a consolidation of the survey activities in approximately 3,800 facilities now being surveyed by both HCFA and FDA. These facilities consist of hospitals and independent laboratories certified for participation in the Medicare program whose transfusion services are also subject to registration and inspection by the FDA. This regulation will result in the reduction of duplication and result in savings to the Department.