Blood Product Lookback

Blood components are regulated by FDA as drugs and are subject to recalls and market withdrawals. Strict donor screening and infectious disease testing during donations keep the number of such events down to a very small percent of total collections.

When such events happen, the FDA regulations (21 CFR 610.46-48 and 42 CFR 482.27(c)) and AABB standards require that blood collection agencies notify hospitals (transfusion services). Recalls and market withdrawals are needed when donors are subsequently found to have or to be at risk for transmissible disease (positive infectious disease marker or high risk behavior) or later recalled information that would have rendered them ineligible at the time of donation (e.g. history of a prior malignant condition, risk of CJD, travel to a malaria endemic area, medications, tattoo, etc). In both situations, the donor is apparently well and had negative infectious disease testing at the time of donation.

Look-back refers to the process of identifying the location and/or final disposition of components from a particular donor, and removing from inventory any components that are potentially infectious or harmful. For components that were transfused, the recipient is identified so that, if indicated, appropriate treatment and/or counseling can be provided.

The regulations mandate the following responsibilities of the physician regarding recipient notification for possible HIV or HCV exposure:

  • Notify the patient, either verbally or in writing, that they received a unit, potentially infected with HIV/HCV and of the need for HIV/HCV testing and counseling. This information should be sufficient for the patient to make an informed decision about whether to obtain testing and how/where to obtain counseling.
  • If the patient is judged incompetent by a state court, the physician should notify a legal representative designated in accordance with state law.
  • If the patient is a minor (at the time of notification), the physician should notify the patient’s legal representative or a relative.
  • If the patient is deceased, the regulations require that the patient’s legal representative or relative be informed (Only for HIV).

For other look-back instances, the notification is not mandated. The ordering physician can determine the need for medically appropriate notification, patient counseling and additional testing.

The legal and ethical responsibility of notifying the patient falls on the ordering physician because this physician has taken into account the risk associated with transfusion before obtaining consent and ordering blood components. In cases where the ordering physician cannot be contacted, the primary care physician or the physician who most recently saw the patient

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