Operational, quality, and risk management in the transfusion service: lessons learned.

For general health care, the difference between quality and safety has been unclear for measurable patient outcomes. In contrast, in the transfusion service (TS), the relationship between quality and safety has been direct and demonstrable. Case studies are summarized to illustrate the relationship between operations, quality management, and risk management in the TS. In blood availability for elective surgery over 3 audited intervals, the incidence of patients undergoing elective surgery without available crossmatched blood that had been requested was 1:333, 1:328, and 1:225 for pre-quality improvement, post-quality improvement, and subsequent postintervention audit assessment, respectively. In event discovery reports (EDRs) over 2 years, incidence of biologic product deviation reports (Food and Drug Administration reportable) was successfully reduced from 60 biologic product deviation reports (12%) of 507 EDRs in 2009 to 42 (12%) of 336 EDRs in 2010. In wrong blood in tube, 102 specimens were identified (by a change in patient's ABO/Rh) from 176,711 type and screen/cross-match specimens received over a 5-year interval, detected either by previous patient record of ABO/Rh or by a second specimen for blood type confirmation implemented in our TS for the last 3 years. No known cases of "mismatched" red blood cell transfusion have occurred during this interval. There is an inverse relationship between resources/time expended on quality and risk management relative to volumes of operations in the TS. Laboratory-based initiatives that improve patient safety and clinical outcomes need to have resources aligned with the personnel and time required for quality management and risk management.