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LOOKBACK AND HOSPITAL NOTIFICATION

Lookback and in-date product retrieval notification is the process of identifying prior donations from donors with positive screening tests and informing hospitals/consignees who received these products.

When a blood donor tests repeatedly reactive (RR) on a subsequent donation for an infectious disease screening test such as HIV, HCV, or Chagas, the possibility exists that the donor may have had an undetectable infection at the time of a previous donation. This is due to the window period or time between donor infection and the appearance of detectable markers of disease. It is important for hospitals/consignees to notify the patients who received the products from these prior donations (recipients) because these donations may have been infectious, even though they tested negative at the time for all required infectious disease markers (IDM).

Lookback and notification is required by the US Food and Drug Administration. Refer to the following links for the regulatory requirements for:

Lookback and in-date product retrieval is performed in three main steps:

1. Retrieval and consignee notification of in-date blood components

Blood centers must perform retrieval and quarantine of in-date blood components from prior donations within 72 hours of subsequent positive screening test results for the following infectious disease markers whether the prior donation’s components are still at the blood center or have been sent to a consignee. This notification is for retrieval and destruction purposes only, not for recipient notification. If the confirmatory testing is completed within the 72-hour timeframe, the blood center may convey both pieces of information in the same notification.

  • HIV
  • HCV
  • Chagas
     

2. Consignee notification of additional test results

Blood center will notify consignees of  applicable additional test results within 45 calendar days of the initial subsequent positive screening test result.


3. Recipient notification, if necessary

Consignees (transfusion services) are required to notify recipients that they received blood and blood components previously collected from a donor later determined to be unsuitable when tested for evidence of infection with HIV, HCV, and Chagas. The transfusion service would notify the recipient's healthcare provider of record (i.e., physician of record or healthcare provider who ordered the blood or blood component) and ask the healthcare provider to inform the recipient of the need for applicable infectious disease testing and counseling. If the healthcare provider is not available or declines to notify the recipient, the transfusion service would be required to notify the recipient and inform the recipient of the need for testing and counseling.

The notification process would include a minimum of three attempts within a maximum of 12 weeks of receipt of the additional test results.

If the recipient is deemed incompetent by a State court, or the recipient is competent but State law permits notification of a legal representative or relative, or if the recipient is a minor, then the transfusion service would notify the legal representative, relative, or recipient's physician of record. If the recipient is deceased, § 610.46(b)(3) for HIV would have the notification process continue, and the transfusion service or the recipient's healthcare provider would notify the legal representative or relative. Under § 610.47(b)(3) for HCV, if the recipient were deceased, then the notification process would be terminated. For Chagas, if the recipient were deceased, then the notification process would also be terminated.

Requiring notification of the legal representative or relative when the recipient is deceased may help prevent the further spread of HIV, which the donor may have spread to a spouse or significant other before death. With this information, the spouse or significant other may be tested for the communicable disease, receive counseling, and take precautions not to spread it to others, if infected. We do not believe that the notification requirement is necessary for HCV “lookback” because direct percutaneous exposure to infectious blood, particularly in the setting of drug abuse, accounts for the majority of HCV infections acquired in the United States; secondary transmission of HCV to sexual partners, care providers, or others with close contact is very unlikely. We do not believe that the notification requirement is necessary for Chagas “lookback” because natural infections are transmitted by infected blood sucking insects (triatomine bugs); other known routes of transmission include oral, congenital (mother to unborn infant), organ transplantation and blood transfusion. Chagas disease is not transmitted from person-to-person like a cold or the flu or through casual contact with infected people or animals.

Vitalant, one of the nation’s oldest and largest nonprofit community blood service providers, supplies comprehensive transfusion medicine services to nearly 1,000 hospitals and health care partners for patients in need across 40 states.