52 Blood Banking Protocols: Analysis of Institutional Deviations

Within the blood bank, protocols help ensure our adherence to standards and guidelines that prioritize patient safety and regulatory compliance. These protocols address the entire lifecycle of a blood product or specimen in our blood bank: from product storage to pretransfusion testing to product utilization. Because we cannot anticipate all clinical scenarios, some situations require a deviation from institutional protocols. These events are infrequent and require a deviation report approved and signed by a pathologist. The purpose of this quality study was to assess the variety of deviations reported by our blood bank to identify opportunities to update or propose new protocols, based on the variety and frequency of the deviation. To evaluate our deviations, institutional electronic health records were queried for blood bank deviations between October 2022 and January 2025 and categorized by the nature of the deviation report. Patient demographics including age and sex were also collected. In all, there were 584 deviations reported and signed during the study period. A substantial number of deviations (average 14/month) involved Rh-positive products being issued to Rh-negative recipients. These reports constitute close to 70% of all deviations reported (n = 401/584). Per current procedure, this deviation is required when either Rh-positive red cells or Rh-positive platelet products are released to Rh-negative individuals. Additionally, the reports provide clinical guidance on the appropriateness of RhIg. Women of reproductive age are the population of greatest concern for anti-D formation, and urgency of RhIg administration warrants communication between blood bank physicians and clinical teams. However, among the Rh-related deviations, only 5.7% of Rh deviations (n = 23/401) were females under the age of 50. Other frequent deviations include: approval of immediate spin crossmatch or phenotypic matching due to interference of warm autoantibody or medication (n = 54/584, 9.2%), possible incompatibility of blood products due to emergency release scenarios or lack of historical data (n = 27/584, 4.6%), and declined requests for irradiated products (n = 14/584, 2.4%). Among the other deviations, most occurred at a frequency of < 1%, representing uncommon events. Based on our analysis, the frequency of Rh-related deviations may warrant creation of a new protocol for what has become a frequent practice. The data suggest even limiting Rh-related deviations to women of child-bearing age may be more efficient. Such a change in practice may allow for better standardization and communication so that the blood bank can focus on the less frequent, true deviations that we rarely encounter.