Jeffrey McCullough - Transfusion Medicine

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.

The AABB operates a voluntary accreditation system. This Inspection and Accreditation (I&A) program, initiated in 1958, involves a biannual inspection by AABB volunteers. The major intent of the I&A program is to increase the safety in obtaining and transfusing human blood and components. The program is also designed to assist directors of blood banks and transfusion services to determine that knowledge, equipment, and the physical plant meet established requirements; to detect deficiencies in practice; and to provide consultation for their correction. The I&A program can be used to eliminate duplicate inspections by state governments. Many states accept AABB inspection of blood banks and transfusion services to satisfy their licensing requirements. The US Armed Services and Humana, Inc., also maintain an equivalency program with the AABB. The AABB has established a coordinated inspection program with the CAP in which the CAP and AABB inspections are usually done simultaneously.

The CAP, through its Hospital Laboratory Accreditation Program (HLAP), also certifies hospital blood banks, but not community blood centers. The HLAP was initiated in 1961 with the primary objective of improving the quality of clinical laboratory services throughout the United States. The HLAP has grown considerably in size, complexity, and effectiveness since its inception, but the primary goal remains that of laboratory improvement through voluntary participation, professional peer review, education, and compliance with established performance standards. The CAP accredits approximately 4,300 laboratories throughout the United States, as well as several foreign countries.

The HLAP examines all aspects of quality control and quality assurance in the laboratory, including test methodologies, reagents, control media, equipment, specimen handling, procedure manuals, test reporting, and internal and external proficiency testing and monitoring, as well as personnel safety and overall management practices that distinguish a quality laboratory.

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