by L. Sutor, M.D., MBA, Vice President of Medical and Technical Services, Carter BloodCare
Confusion frequently arises over the different notifications received from the blood center regarding blood components under suspicion. This article will attempt to clarify the differences between quarantines, market withdrawals, recalls, and lookbacks, the different categories of notification.
- Quarantine notifications are a preliminary notification, often while additional investigation or testing is underway. They may ultimately be released as acceptable again. The intent is to prevent components from being transfused while it is determined if the component is actually safe to use or not. An example might be quarantine of co-components collected at the same donation as a product that is preliminarily identified in a suspected septic transfusion reaction. If the final workup of the transfused component in the septic patient is negative, the co-components can be released back to active inventory. No recipient notification is necessary until the final conclusions are drawn, at which time another notification will be sent.
- Market withdrawals and recalls are similar, but reflect different levels of severity as far as the risk to blood product safety. Both are initiated following a deviation to procedures involving collection or processing of the blood component, or receipt of post-donation information regarding the donor history, health, or behavior. The safety, purity and/or potency of the blood component may be affected. Market withdrawals tend to be more minor infractions of procedures, whereas recalls are the removal from the consignee of a product that the Food and Drug Administration (FDA) considers to be in violation of its laws and against which the agency might actually initiate legal action under 21 CFR part 7. Recalls are divided into class I, II and III depending on their severity, with Class I as the most dangerous. The Code of Federal Regulations (21 CFR part 7) defines a Class I recall as “a situation is which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” Remember that blood centers are required to remove from consignee inventory any product that does not meet all FDA regulations or their own SOPs. So, if information is obtained after shipment that a component is unsuitable, the blood center must notify the consignee and ask for return of that product, either as a recall or market withdrawal. A frequent example of this is donor post-donation information. The donor may remember travel to a malarial area at the time of a subsequent donation. This makes the previous donation not in compliance and must be removed from inventory as a market withdrawal or recall. The unit is not likely to cause malaria in the recipient, but the blood center is mandated to do the notification. The consignee, however, may decide whether to do recipient notification based on physician, transfusion committee, or ethics committee deliberation.
- Lookback is a term that should be reserved for notification of consignees about receipt of previous blood components from a donor that has now tested positive for either HIV, hepatitis C, or Chagas’ disease antibody. The previous units of blood tested negative (or were untested, in the case of Chagas’ testing) but the donor could have been in the serological “window period” at the time of donation and theoretically could have infected the recipient despite the negative tests. FDA has strict rules about HIV and HCV lookback which are outlined in the Code of Federal Regulations (21 CFR 610.46 and 21 CFR 610.47) which both the blood center and transfusing facility must follow. Guidelines about Chagas’ disease lookback are in a document posted on the FDA website (https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/blood/ucm528600.pdf). Recipients must be notified within 12 weeks and offered counseling and testing for the appropriate infection. Consignees often initially get a quarantine notice for any “in date” components following the reactive screening test on the donor. If subsequent testing is also positive and lookback is warranted, then an official lookback notice is also sent.