A review of patient safety situations reported to the OPTN, summarized in the December 2015 edition of the American Journal of Transplantation, details the importance of such reporting for improvement of OPTN policies and processes, while noting that more frequent reporting of patient safety situations helps promote quality management throughout the transplant community.
Six UNOS staff members were coauthors of the article, which is the first comprehensive, published report of such cases reported to the OPTN. Additional coauthors were current and former members of the OPTN/UNOS Operations and Safety Committee. They studied trends in reporting to the OPTN of safety situations from March 2006 through December 2014 to assess trends and patterns, with a more detailed analysis of situations reported from 2012 to 2013.
“Safety situations” are defined as any transplant-related event that either harmed or had the potential to harm transplant recipients, patients awaiting a transplant, or actual or potential living donors. While OPTN policy requires reporting of some specific situations, reporting is voluntary in many other circumstances.
In nearly 10 percent of the situations reported, one or more organs intended for transplantation were not used due (at least in part) to the reported error or mishap. In addition, from 2012 to 2013 there was one living donor death within 30 days of donation and an additional two reported cases of loss of native organ function in a living donor.
Nearly one-fourth of safety situations involved a breakdown in communication during the donation and/or transplant process. Other categories associated with more than 10 percent of cases included issues related to donor and/or patient testing, transplant hospital procedures or processes, or data entry.
Not all reported situations resulted in actual harm; in a number of instances, additional safety processes prevented adverse outcomes either for patients or potentially transplantable organs. However, while the number of situations reported to the OPTN continues to increase, potential “near-miss” occurrences may be reported less often than sentinel events. In addition, the reporting of safety situations varied widely by individual institution, suggesting that safety situations are still vastly underreported at the national level.
The OPTN/UNOS Operations and Safety Committee routinely studies safety data reporting and shares key “lessons learned” based on these reviews to help transplant institutions improve their quality and performance. The OPTN also issues safety alerts as needed to address specific safety-related concerns, such as product or device recalls. The authors encourage more complete reporting to help the transplant community better anticipate potential safety situations and seek to reduce the risk of future, preventable events.
To view the entire article, consult the following citation (UNOS staff members noted with an asterisk):
D.E. Stewart*, S.M. Tlusty*, K.H. Taylor*, R.S. Brown*, H.N. Neil*, D.K. Klassen*, J.A. Davis, T.M. Daly, P.C. Camp and A.M. Doyle. Trends and Patterns in Reporting of Patient Safety Situations in Transplantation. American Journal of Transplantation: Volume 15, No. 12, pages 3123-3133.