Application for Initial Listing as a Patient Safety Organization (PSO)
Designation of Puget Sound Blood Center (PSBC) as a Patient Safety Organization (PSO) would allow PSBC to perform patient safety improvement functions undertaken routinely by hospital-based transfusion services.
After blood has been collected, processed into components, tested, and labeled, it is still not yet ready for transfusion. Additional testing must be performed on a sample from the intended recipient to determine that patient’s ABO Group and Rh type and also the presence of any unexpected antibodies. Finally, crossmatching of the unit must be performed for red cell units. These additional steps are referred to as “pre-transfusion testing”.
In almost all hospitals, this testing is performed by a transfusion service laboratory (TSL), part of the hospital’s clinical laboratories. From this intra-institutional location, the laboratory has access to data regarding the performance of not only its functions but also of the “pre-analytic” and “post-analytic” functions performed at the bedside that are critical to a safe transfusion process. These include, for example, identification of the patient at the time of collection of the pre-transfusion specimen and at transfusion. Thus the TSL is in a position to gather data about procedural deviations and near-miss events (“incidents”) in a manner protected in most states by a quality assurance system. After analyzing these occurrences, the TSL staff can work with others to improve care.
Since its formation in 1944, PSBC has served as the centralized TSL for all hospitals in King County, Washington. This metropolitan Seattle area today includes 19 hospitals that transfuse over 100,000 units of red cells annually in addition to 40,000 units of plasma and 25,000 platelet transfusions. All pretransfusion testing is conducted in one of four laboratories operated by PSBC, and blood is delivered to the hospitals ready for transfusion. Medical expertise in transfusion medicine is similarly concentrated at PSBC with its specially trained physicians serving as the transfusion consultants for all 19 hospitals and providing expertise to their transfusion committees.
PSBC has promoted the concept of Transfusion Safety Officers (TSO) throughout King County. Nurses with special training in transfusion medicine work at each of the larger hospitals reconciling problems and investigating incidents as they occur. A TSO headquartered at the blood center seeks to coordinate their activities and interfaces with laboratory operations, investigating transfusion reactions and dealing with clinical hemotherapy issues arising in hospitals.
This system provides efficient, economical use of scarce blood resources and promotes a cohesive approach to transfusion issues across the community. However, it is hampered by multiple institutions being involved in the process, each of which has slightly different approaches and which may not be willing to share information about untoward events. While the PSBC TSL receives reports of (and investigates) transfusion reactions from all hospitals in King County, incidents are usually unknown to the PSBC and are not readily associated with resulting transfusion reactions.
The US Biovigilance Network (USBVN), a public-private partnership involving HHS, CDC and the AABB (among others), provides hospitals across the country the opportunity to capture and categorize transfusion reactions (“events”) and incidents in a standardized way and confidentially compare their institution’s performance with system data. This allows the identification of areas of weakness in their systems and of benchmarks to attain. Accumulation of both event and incident data in one system allows identification of the connectivity between antecedent events with patient outcomes so that system improvements can be sought. (Transfusion 2007;47:1937-42.)
Application of the USBVN is hampered in King County because the multiple parties involved in the transfusion process do not have full access to all data pertaining to their system and may be reticent to let others have access to data, the disclosure of which could later be compelled. Several institutions in King County, for example, are world-renowned for their dedication to patient safety improvement, but their data loses its security when shared outside their own quality improvement system.
Designation of PSBC as a PSO would allow full sharing of transfusion process-related data within our system, maximizing the improvement capabilities of the USBVN. PSBC’s TSL would continue to gather data about patient events and would enter those into the USBVN noting the location (including the institution) where they had occurred. Data regarding incidents would be entered into the USBVN by individual hospitals for national (confidential) compilation as well as local application. The hospitals in King County using the PSBC TSL could then give confidential access to their data to the PSBC PSO. This would allow PSBC to link events with incidents and would also allow compilation of incident data across King County. Just as the USBVN will analyze events and incidents and propose patient safety improvement policies nationally, the PSBC PSO will be able to assess the performance of different hospitals’ systems and work toward improving transfusion safety across all the institutions it serves. In essence, the designation of PSO status to PSBC would give back to this transfusion system the confidential omniscience it loses by having the TSL separated from the institutions in which the remainder of the process occurs. (Transfusion 2003;43:1190-9.)
PSBC already has the medical leadership, staff, and infrastructure to manage data made available through designation as a PSO. The medical director, assisted by eight other transfusion medicine physicians and a registered nurse TSO, would be responsible for assembling data for analysis. PSBC’s standard operating procedures already contain confidentiality requirements regarding personal health information of the patients it serves, and these would be applied to maintain the confidentiality and non-disclosure of data made available to the PSBC PSO by contracted institutions. Aggregate and de-identified data would be shared with the existing medical advisory council (composed of hospital physicians) for discussion and further analysis. All data would be presented so that the origin of individual events or incidents could not be discerned and the institutions’ (and patients’) confidentiality maintained. Analyses would be conducted in a manner similar to that planned for the AABB PSO. Plans for improving transfusion processes and improving patient safety would then be implemented across all King County hospitals on the strength of the PSO’s analysis.