Agreement Between Hospital And Blood Bank

This agreement may be amended at any time in writing by the Deputy Minister of Health, the Commissioner of Food and Drugs, the Administrator of the Health Care Financing Administration or his authorized delegate. PHS/FDA and HCFA re-examine the MOU within 2 years of its entry into force. In the meantime, each party is entitled to an earlier revision of this agreement or one of its provisions. Since 1966, independent hospitals and laboratories participating in the Health Insurance Program for the Elderly and Persons with Disabilities, created by Title XVIII of the Social Security Act (Medicare), have been questioned by HHS, including the Health Care Financing Administration (HCFA), on compliance with existing provisions of Medicare status and Medicare regulations. These provisions include requirements for blood bank and transfusion services for independent hospitals and laboratories. (Hospitals accredited by the Joint Commission on the Accreditation of Hospitals (JCAH) or the American Osteopathic Association (AOA) are considered to be the most Medicare requirements, in accordance with Medicare Law and regulations. 1. PhS/FDA is responsible for conducting studies on the technical and scientific aspects of the management and regulation of transfusion services and blood transfusion facilities, including studies on standards development, improvements in quality procedures and testing, and evaluation methods. The 21 CFR 606.170 (b) require that fatal transfusion reactions associated with the administration of blood or blood components be reported to PHS/FDA as soon as possible. PhS/FDA evaluates these reports and may, if appropriate, conduct specific research to determine whether the blood system has taken or needs to take corrective action.

For the purposes of the Medicare program, HCFA standards apply to staff (42 CFR 405.1028 (d), g and i) to hospitals and to 42 CFR 405.1310 to 4,05.13 15 for independent clinical laboratories) and aptitude tests (42 CFR 405.1314 (a)) and aptitude tests (42 CFR 405.1314 (a)). For the purposes of the PHS/FDA program, PHS/FDA standards apply to staff (21 CFR 600.10 for licensed facilities and 21 CFR 606.20 for registered blood transfusion facilities) for registered and unlicensed blood transfusion centres.

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