Читать книгу Transfusion Medicine - Jeffrey McCullough - Страница 52

Blood banks are subject to a number of requirements or licensure systems in addition to the FDA. The Clinical Laboratories Improvement Act (CLIA) of 1988 established a new section of the Public Health Service Act that requires the Department of Health and Human Services (HHS) to establish certification requirements for any laboratory that performs tests on human specimens and to certify that those laboratories meet the requirements established by the HHS. Laboratories participating in the Medicare and Medicaid programs or engaged in testing in interstate commerce must comply with these CLIA requirements. The law makes it possible for HHS to approve certain accreditation bodies and state licensure bodies. Because blood banks carry out testing on human material that is in interstate commerce, and because they provide services to Medicare and Medicaid patients, they must comply with CLIA. Several states also require that blood banks have a license to operate or provide blood in that state. These licenses usually involve a specific application and inspection.