Transfusion medicine

Quality and compliance

Lookbacks



Last author update: 19 December 2023
Last staff update: 19 December 2023

Copyright: 2022-2024, PathologyOutlines.com, Inc.

PubMed Search: Lookbacks

Chinelo P. Onyenekwu, M.D.
Evelyn M. Potochny, D.O.
Page views in 2023: 39
Page views in 2024 to date: 62
Cite this page: Onyenekwu CP, George MR, Potochny EM. Lookbacks. PathologyOutlines.com website. https://www.pathologyoutlines.com/topic/transfusionmedlookbacks.html. Accessed April 14th, 2024.
Definition / general
  • Traces the source of a relevant transfusion transmissible infection (RTTI) or transfusion transmitted disease (TTD) by a recipient of blood product(s) or notifies a recipient who was transfused with blood product(s) from a donor who is currently confirmed positive for a RTTI, in accordance with Food and Drug Administration (FDA) regulations
  • Additionally, recalls / market withdrawals may be issued in situations such as improper donor testing or postdonation information
Essential features
  • Performed to find previously distributed units from donors who are considered positive / reactive for a given infectious disease
  • Hepatitis C virus (HCV) and human immunodeficiency virus (HIV) require a lookback according to the U.S. FDA
  • If blood or a blood product / component implicated in a lookback has been transfused, consignees of the product must have a process to notify a recipient, their physician of record, their legal representative or in the case of HIV, next of kin
Terminology
  • Nonconformance
Applications
  • Receipt of consignee notification for a product disposition from a collection facility
  • Provider notifies transfusion services that a patient has tested positive for a possible TTD after receiving a blood component transfusion at their facility
  • TTD or RTTI is identified during a transfusion reaction investigation, RTTIs are defined by the FDA (eCFR: Code of Federal Regulation Title 21 [Accessed 9 November 2023])
Implementation
Diagrams / tables

Contributed by Melissa R. George, D.O. and Chinelo P. Onyenekwu, M.D.
Lookbacks for TTI

Lookbacks for TTI

TTIs without approved tests

TTIs without approved tests

Steps in a lookback

Steps in a lookback

Board review style question #1
Which of the following includes 3 relevant considerations for the risks / benefits of notification of a recipient for a TTI?

  1. Existence of a test for donors, moderate risk and existence of a possible intervention
  2. Existence of a test for recipients, existence of a test for donors and presence of a probable risk
  3. Presence of small theoretical risk, existence of a test for donors and existence of a possible intervention
  4. Presence of well established risk, existence of a test for recipients and existence of a possible intervention
Board review style answer #1

D. Presence of well established risk, existence of a test for recipients and existence of a possible intervention. In recalls without mandatory notification of recipients of a transfused blood component, relevant considerations that may guide the decision to notify include the presence of a well established risk, the existence of a test for recipients and existence of a possible intervention in the case of a positive test result. When these 3 are not present, the risk of the psychological harm associated with notifying a recipient or their relative may outweigh the benefit of such notification. Answers A and C are incorrect as the risk to the donor must be well established. Answer B is incorrect since both the possibility for intervention and the presence of a well established risk to the donor must be present in addition to an available test.

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Reference: Lookbacks
Board review style question #2
What transfusion transmitted infections listed in the FDA's code of federal regulations require lookbacks?

  1. Babesia and HIV
  2. Ebola and HCV
  3. HIV and HCV
  4. Trypanosoma cruzi
Board review style answer #2
C. HIV and HCV. Only HIV and HCV are listed in the FDA's code of federal regulations as having required lookbacks. Answer A is incorrect because Babesia is not addressed in the FDA's code of federal regulations as a lookback. Answer B is incorrect because FDA's code of federal regulations does not require a lookback for Ebola; however the recommendation is to inform the recipient's physician. Answer D is incorrect because a lookback is also not required for Trypanasoma cruzi according to the FDA's code of federal regulations; however it is recommended that consignees of transfused products notify the recipient's physician.

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Reference: Lookbacks
Board review style question #3
What is the time limit within which notification to the recipient, their physician, legal representative or next of kin should be done when a blood component has been implicated in a lookback mandated by the FDA?

  1. 72 hours
  2. 2 weeks
  3. 12 weeks
  4. 12 months
Board review style answer #3
C. 12 weeks. Notification to the recipient, their physician, legal representative or next of kin when it applies should be done within 12 weeks. Lookbacks require notification of transfusion recipients in receipt of blood or blood components collected during the 12 months before the date of reactive testing. Answers A and B are incorrect because 12 weeks allows for further testing to confirm the presence of HCV or HIV if screening results are reactive. Answer D is incorrect because 12 months may increase the risk of viral transfer to others.

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Reference: Lookbacks
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