The recent Annual Meeting of the Association for the Advancement of Blood and Biotherapies (AABB) in Houston, Texas, was the occasion for the presentation of reviews and new developments in blood banking, transfusion medicine, and biological therapies. The American Red Cross was proud to participate in this event through posters and live presentations. I detail here one of many contributions of Red Cross staff to the meeting.
Blood products should meet criteria for safety, quality, identity, potency, and purity, abbreviated by the Red Cross as “SQuIPP.” When distributed products are suspected of not meeting these standards, this blood center instructs transfusion services to quarantine them–that is, to hold them and not transfuse them–pending our determination of product suitability. Understandably, the transfusion services ask why those products, acceptable at the time of receipt, are not available for patient use. This question was explored in detail during a meeting session moderated by Shraddha Babariya, MD, and featuring discussions by Saqib Alvi, MD, and me, Barry Siegfried, MD.1 We Red Cross medical directors used this center’s procedures to illustrate the circumstances under which products are quarantined, investigation of the situation that triggered quarantine, and final actions (“dispositions”) applied to the quarantined products. Sample cases were presented. After each presentation, the audience was polled regarding what dispositions it would apply to the products. The dispositions chosen by this center were then described.
After a transfusion service reports to the Red Cross that one or more blood products are suspected to have caused a recipient complication, the regional medical director is consulted. If the medical director determines that investigation is warranted, the service is asked for relevant patient information. Donors of involved products may be temporarily deferred. These donors may be screened for factors putting their products at risk for causing the complication by asking them for additional health history or doing additional testing on them. The reporting transfusion service and other services may be asked to quarantine products from involved donors and, if those products have been transfused, to report whether the recipients had associated complications. Involved donors’ products still at our facilities may also be quarantined. The medical director reviews the results of the investigation and determines the probability that one or more of the involved products caused the suspected recipient complication. The medical director also determines the disposition of the quarantined products, which could be retrieval of distributed products, discard of in-house products, both, or neither. The suspected complications in the three cases presented for audience polling were a septic transfusion reaction, transfusion-transmitted babesiosis, and transfusion-related acute lung injury (TRALI).
Another situation in which a transfusion service may be asked to quarantine blood products occurs when a blood center determines on its own that a part of production did not conform to specifications such as accrediting body standards, regulations, or the center’s standard operating procedures. This type of case could be presented to a material review board, a panel of blood center staff knowledgeable in those specifications, transfusion medicine, and aspects of the center’s operations related to the nonconformance. Depending on the nonconformance, quarantined materials could include not only distributed blood products but also in-house products and materials used in the manufacturing process. Using information obtained during an investigation, the board determines the disposition of quarantined materials and provides a rationale for its decision. The three cases presented to the audience were products from collections in which donor skin disinfection varied from the center’s standard operating procedure, red blood cell products for which leukocyte reduction quality control failed, and vials of a reagent with an unacceptable pH.
We thank AABB for the opportunity to present this information. The organization offers access to recordings of this and other meeting sessions.2
References
1. AABB24: Why is My Blood Product Being Quarantined? Investigations that Happen Behind the Scenes [Internet]. AABB–Association for the Advancement of Blood & Biotherapies [cited 2024 Nov 1]. Available from: https://www.aabb.org/news-resources/news/article/2024/10/21/aabb24–why-is-my-blood-product-being-quarantined–investigations-that-happen-behind-the-scenes.
2. AABB Annual Meeting On-Demand [Internet]. AABB–Association for the Advancement of Blood & Biotherapies [cited 2024 Nov 1]. Available from: https://www.aabb.org/annual-meeting/learn/aabb-annual-meeting-on-demand.
