The FDA has proposed to extend its current error and accident reporting requirements to all blood collection and transfusion facilities. This is in response to concerns expressed in recent Office of the Inspector General reports, congressional hearings and public concerns whether the current reporting procedures for blood safety events are adequate. The development and operation of near-miss event reporting systems in other error critical fields such as aviation and nuclear power represent one approach to dealing with error. The Medical Event Reporting System for Transfusion Medicine (MERS-TM) was developed at the University of Texas Southwestern Medical Center as a reporting system to collect and classify incidents with the potential for compromising the safety of blood transfusion. MERS-TM has been implemented in three blood centers and three hospital based transfusion services. It is proposed that the MERS-TM project be continued over a four year period of time to meet the following specific aims: (1) to validate the effectiveness of near-miss reporting through MERS-TM as a potential national standard for reporting error and safety hazards in all major blood provider organizations, including American Red Cross, Blood Systems, Inc., participating members of America's Blood Centers, and American Blood Resources Association; (2) to validate MERS-TM as an event reporting standard for hospital- based transfusion services in a convenience sample of representative hospitals from across the country; (3) to determine national trends and unique causal patterns from near-miss incidents and adverse events through a variety of analysis techniques applied to the MERS-TM database; (4) to develop and demonstrate analysis techniques that can be applied to gain further insight to problem areas identified by near- miss reporting in donor suitability and in transfusion administration; (5) to evaluate the effectiveness of MERS-TM, document the implementation process and the impact of MERS-TM on participating organizations and the field of transfusion medicine. A strong project staff is in place and there has been a high degree of consensus among the major organizations in the field that MERS-TM should be evaluated as a potential national standard for reporting incidents within the field of transfusion medicine. The validation and continued operation of MERS-TM is an appropriate response to the public's interest and to meet the needs of transfusion medicine.
