Discussions and data from a recent Food and Drug Administration workshop indicated that quarantine release errors, or QREs, are most frequently the result of human error and defects in process control. FDA held the workshop on QREs on Sept. 13, 2011. AABB co-sponsored the workshop with America’s Blood Centers and the U.S. Department of Health and Human Services. For the purposes of this workshop, a QRE was defined as an instance in which a facility released a blood product despite having information at the time of release that should have caused it to quarantine the product pending further action.
This workshop resulted from discussions about potential changes to the FDA’s donor deferral policies for males having sex with males. The issue under consideration was whether current blood manufacturing processes are sufficiently secure to prevent the release of an unsuitable unit if donations by higher-risk individuals are allowed, or whether the processes need to be enhanced.
Sharon O’Callaghan, MT(ASCP), consumer safety officer with the FDA’s Division of Inspections and Surveillance, presented a summary of the last five years of biological product deviation, or BPD, reports. Based on the BPD data, O’Callaghan concluded that the overall number of QREs has remained relatively steady — suggesting that computerized systems have not fully solved this problem — and that most QREs resulted from human and process control errors.
Following O’Callaghan’s presentation, Ruth Sylvester, MS, MT(ASCP)SBB, director, Regulatory Affairs, at ABC, provided a comparison of the rate of QREs to the number of collections. Discussing a survey of ABC members (with a response rate representing 26 percent of collections), Sylvester reported a downward trend of QREs over the last five years, with the majority of QREs identified before release of product into final inventory. Sylvester recommended that industry and the FDA prioritize the risk of QREs to focus on the high-risk errors rather than lower-risk ones (e.g., malaria travel). This recommendation was reiterated by participants during the afternoon panel discussion/wrap-up session.
Mary Beth Bassett, MT(ASCP), senior vice president, Quality Management/Regulatory Affairs, Blood Systems Inc., and Kathryn Waldman, senior vice president, Quality and Regulatory Affairs, the American Red Cross, discussed their experiences in dealing with and mitigating QREs. Bassett presented BSI’s quarantine process flow and controls, including process, facility, management and material controls. In her summary, Bassett said that blood centers should initially focus on fixing the process failure: Good solid processes and forms will help alleviate QREs. Waldman presented ARC’s process of identifying suspect products and controlling and preventing their release. Waldman’s recommendations to industry for reducing QREs included reducing deviations that require products to be quarantined; improving identification of affected products; and ensuring that processes support appropriate product management.
Representatives from Stanford Blood Center, the National Institutes of Health, and Johns Hopkins and Massachusetts General Hospital discussed the risk points and needs of hospital transfusion services. Highlighted risk points leading to human errors included the lack of defined workspaces for technologists and the fact that they are being asked to do more with fewer people. The representatives agreed that individual hospitals and transfusion services are quite different. Therefore, they stated, blood establishment computer systems need to be flexible and able to handle a variety of services, including clinical trials.
The afternoon presentations focused on how to monitor QREs. The first presentation was from Harold Kaplan, MD, professor of health evidence and policy at Mount Sinai School of Medicine. Kaplan reviewed the history of the medical event reporting system for transfusion medicine (MERS-TM), which holds that “errors are not so much causes as consequences.” Kaplan stated that more attention must be given to the precursor of the event rather than to the outcome and stressed that near-miss reporting is a proactive approach that helps to unlink the causal chain of the event investigation. He recommended that facilities need to capture and classify the events, perform a risk assessment for prioritization, investigate the event and finally react to the event.
The remaining presentations reflected the medical device perspective. Representatives from the Center for Devices and Radiological Health discussed the importance of using human factor methods for studying events and testing potential solutions. A representative from the BloodCenter of Wisconsin reviewed the use of process and pain point analysis to identify areas for system improvement and to target the appropriate application of technology to help reengineer processes to reduce errors and increase efficiency.
At the conclusion of the workshop, Jay Epstein, MD, director of the Office of Blood Research and Review at the Center for Biologics Evaluation and Research, summarized the program, highlighting the following points:
- Although release of unsuitable units has many causes, the two most frequently identified issues are defects in process control and human factors (due to multitasking, inadequate training and/or the interface between computers and humans).
- In order to reduce QREs, there is a need to better understand environmental and human factors, including the following: standardization, computerization, process engineering, new technologies, and how human factors interface with processes.
- Process controls need to be redesigned to ensure overlapping safeguards.
Epstein also noted the need for improved data collection and analysis, including development of a common vocabulary, increased data sharing, and greater efforts to report near-misses and adverse events. Echoing a point made in many of the presentations, Epstein agreed that not all QREs pose the same level of risk to patients. He then raised the possibility of creating an industry task force to develop a process to stratify risks of different QREs as a next step.
Transcripts from the workshop will be posted on the FDA website in the coming weeks.