Lookback and Recipient Notification, and Product Recalls and Withdrawals

Autor: K. Sazama
Rok vydání: 2001
Předmět:
Popis: Publisher Summary Lookback refers to a process of retrospective investigation of either donors or recipients triggered by (1) recognition of disease in a recipient, causing a “looking back” for all donors of transfused components, or (2) newly discovered serologic evidence of infection of a donor, resulting in tracing and notification of all recipients of prior donations. Federal guidance and regulations require that certain transfusion recipients be notified when the donor of their transfused components is found to have seroconverted for selected viruses. Today, human immunodeficiency virus (HIV) and hepatitis C virus (HCV) seroconversion require such notifications, referred to as part of lookback in the existing HIV regulations. When a donor becomes HIV positive, federal regulations require that either the hospital or the treating physician notify the recipient of any component that was donated within 12 months of the last negative donation by that same donor. The transfusion service must inform the treating physician who may choose to notify the patient. When a donor becomes HCV positive, federal regulations require that the hospital and transfusion service notify either the transfusion recipient or the treating physician. The existing regulations for both HIV and HCV lookback acknowledge that there may be reasons why the treating physician is unable to notify or is uncomfortable with notifying the recipient.
Databáze: OpenAIRE