Abstract

Organ transplantation is vulnerable to serious adverse reactions and events, which require a system for their monitoring and management, as required of EU Member States by Directive 2010/53/EU. A management system was implemented in Poland using modern network technologies through the following steps: 1) the development of a catalogue of events and reactions, 2) the preparation and implementation of the network module, 3) the operational procedures, 4) the evaluation system. The catalogue consists of reactions and events in recipients and living donors related to organ procurement. A referral system was introduced as a module of a web tool www.rejestry.net (400 participated institutions). Notification includes information regarding the location, type, description, analysis, and measures taken to resolve and prevent problems. During the period 2012–2013, 17 serious adverse events and 112 reactions were documented among 3223 transplanted organs (events in 0.5% and reactions in 3.4% of the cases). The major cases included: transplantation from a donor with neoplasia, early recipient death, early graft loss, and transmission of severe infection. Evaluation revealed underestimated number of notifications of “death of recipient within 30 post-transplant days”, which reported 74 of the 92 reactions (80%) occurring in reality. The system is a platform for self-assessment and the dissemination of information regarding the potential dangers, including alarms in cases in which an event/reaction in one center is accessible to others. However, the system is not punitive, because the fear of disclosing failures in the transplant centers plays an important role in the monitoring process.

Keywords: Patient safety, Quality of Health Care, Registries, Tissue and Organ Procurement