AABB24: Why is My Blood Product Being Quarantined? Investigations that Happen Behind the Scenes

While there are various reasons requiring blood products to be isolated from the general inventory, recipient safety remains top priority. When a blood center notifies a transfusion service to quarantine blood products, the service often asks, “Why is our product being quarantined? What is the anticipated timeline for the investigation? Is it advisable to discard the product?” In these situations, thorough investigations are conducted to determine the safety and quality of the suspicious product. A cross-functional team assesses the products and may include a comprehensive review of donor eligibility and risk assessment.

A session covering this topic, held Sunday afternoon, was case-based and used real-world examples to illustrate common scenarios involving recipient complications and nonconforming raw materials and products. The audience voted on a question raised in each case study by utilizing the Audience Response System in the Annual Meeting app.

Saqib Alvi, MD, regional medical director of American Red Cross National Capital and Greater Chesapeake Region in Baltimore, guided attendees through the process of investigating recipient complications, including the assessment of donor eligibility and a product’s safety, quality, identity, potency and purity.

When a recipient complication is reported, a systematic approach is initiated. A case investigator is assigned and an initial review of the case report is completed within 24 hours. The case is then categorized into one of three categories: “do not investigate,” “pending further clinical information” or “investigate.” If the case is deemed to be pending, the assessing physician on the case requests certain information: the patient’s clinical history and findings, vital signs, laboratory testing reports, imaging reports, input and outputs and other relevant reports.

If the case is investigated, the donor is temporarily deferred depending on the type of recipient complication. The donor client support center then reaches out to the donor to screen for risk factors depending on the type of recipient complication investigation. Communication is sent to the hospital to quarantine any in-date products if not already transfused. If they have already been transfused, the outcome of the transfusion is obtained and recorded.

Depending on the scope of the investigation, the donor is evaluated with risk assessment questions for the investigation, such as transfusion-related acute lung injury (TRALI) and septic transfusion reactions.

Alvi presented three compelling cases to illustrate this process. The first involved a possible septic transfusion reaction, the second a suspected case of transfusion-transmitted babesiosis and the third a potential case of TRALI. Each case demonstrated the meticulous attention to detail required in these investigations. Audience members had 15 seconds to respond to a question raised by the case using multiple choice answers.

In the first case, despite initial concerns, the investigation led to a P3 classification (septic transfusion reaction unlikely; other etiologies more likely). This resulted in the release of all related products.

The second case was a P6 classification (confirmed transfusion-transmitted infection). In-date products were discarded and the donor was deferred for two years, with a negative NAT rest required before reinstatement. Lookback was also performed.

The final case, involving a stab wound requiring resuscitation with a massive transfusion protocol, which led to worsening respiratory distress one hour after transfusion, was ultimately a P6 classification (definite TRALI). In-date products from all donors were released and cleared by negative TRALI risk assessment.

These real-world scenarios underscore the rigorous processes in place to ensure blood product safety. They also highlight the careful balance between caution and practicality in managing blood supplies. As medical professionals, understanding these processes is crucial for providing the best care to patients while maintaining the integrity of the blood supply system.

The Material Review Board (MRB) plays a crucial role in quality assurance within the American Red Cross Biomedical Services. Barry Siegfried, MD, regional medical director of American Red Cross Great Lakes Region in Lansing, Mich., talked about on the MRB’s responsibilities and processes.

The MRB is a formally established committee that evaluates nonconforming materials and products. It consists of experts from various departments, including quality assurance, operations, collections, manufacturing and medical staff. The board’s primary function is to determine whether these materials impact the safety and quality of blood products.

When addressing nonconformances, the MRB follows a structured approach. It first identifies the nonconforming material and the violated specifications. Next, it reviews the immediate actions taken to contain the issue and investigate its root cause. Based on its findings, the board makes a final disposition decision and provides a rationale for that choice.

To illustrate the MRB’s decision-making process, Siegfried examined three cases. The first involved a collection staff member who performed skin disinfection incorrectly during venipuncture. Despite the procedural deviation, the MRB decided to discard the in-house transfusable products and not recall distributed ones. This decision was based on the lack of recipient complications, no increased donor issues and the staff member’s technique being consistent with published guidance.

The second case dealt with a quality control failure in leukocyte reduction for red cell units. After extensive investigation and additional testing, the MRB chose to release in-house products and not recall distributed ones. This decision was supported by a high overall pass rate (99%) and successful process control testing.

The final case involved an in-house reagent with an out-of-range pH. The MRB opted to discard the reagent because of its unacceptable pH. The manufacturing procedure was revised to include 15 minutes of mixing followed by pH confirmation.

These cases demonstrate the MRB’s critical role in balancing safety concerns with practical considerations. By thoroughly investigating nonconformances and making informed decisions, the MRB ensures the integrity of blood products while minimizing unnecessary waste or recalls. It serves as a vital component in maintaining quality assurance within blood banking operations.