Fed Regist. 1996 Sep 9;61(175):47413-23.
The Food and Drug Administration (FDA) is amending the biologics regulations to require that blood establishments (including plasma establishments) prepare and follow written procedures for appropriate action when it is determined that Whole Blood, blood components (including recovered plasma), Source Plasma and Source Leukocytes at increased risk for transmitting human immunodeficiency virus (HIV) infection have been collected. This final rule requires that when a donor who previously donated blood is tested on a later donation in accordance with the regulations and tests repeatedly reactive for antibody to HIV, the blood establishment shall perform more specific testing using a licensed test, if available, and notify consignees who received Whole Blood, blood components, Source Plasma or Source Leukocytes from prior collections so that appropriate action is taken. Blood establishments and consignees are required to quarantine previously collected Whole Blood, blood components, Source Plasma and Source Leukocytes from such donors, and if appropriate, notify transfusion recipients. The Health Care Financing Administration (HCFA) is also issuing a final rule, published elsewhere in this Federal Register, which requires all transfusion services subject to HCFA's conditions of Medicare participation for hospitals to notify transfusion recipients who have received Whole Blood or blood components from a donor whose subsequent donation test results are positive for antibody to HIV (hereinafter referred to as HCFA's final rule). FDA is requiring transfusion services that do not participate in Medicare and are, therefore, not subject to HCFA's final rule, to take steps to notify transfusion recipients. FDA is taking this action to help ensure the continued safety of the blood supply, and to help ensure that information is provided to consignees of Whole Blood, blood components, Source Plasma and Source Leukocytes and to recipients of Whole Blood and blood components from a donor whose subsequent donation tests positive for antibody to HIV.
美国食品药品监督管理局（FDA）正在修订生物制品法规，要求血液机构（包括血浆机构）制定并遵循书面程序，以便在确定已采集到传播人类免疫缺陷病毒（HIV）感染风险增加的全血、血液成分（包括回收血浆）、源血浆和源白细胞时采取适当行动。本最终规则要求，当按照规定对先前献血的献血者进行后续献血检测且检测结果多次显示HIV抗体呈反应性时，血液机构应使用许可检测方法（如有）进行更具体的检测，并通知接收过先前采集的全血、血液成分、源血浆或源白细胞的收货方，以便采取适当行动。血液机构和收货方必须对来自此类献血者的先前采集的全血、血液成分、源血浆和源白细胞进行隔离，并在适当情况下通知输血接受者。医疗保健财务管理局（HCFA）也在发布一项最终规则，该规则刊登在本《联邦公报》的其他地方，要求所有受HCFA医院医疗保险参与条件约束的输血服务机构通知接受过HIV抗体后续检测结果呈阳性的献血者所献全血或血液成分的输血接受者（以下简称HCFA最终规则）。FDA要求不参与医疗保险且因此不受HCFA最终规则约束的输血服务机构采取措施通知输血接受者。FDA采取这一行动是为了帮助确保血液供应的持续安全，并帮助确保向全血、血液成分、源血浆和源白细胞的收货方以及接受过HIV抗体后续检测结果呈阳性的献血者所献全血和血液成分的接受者提供信息。
