Proposal Overview
Status: Implemented
Sponsoring Committee: Ad Hoc Disease Transmission Advisory (DTAC)
Strategic Goal: Promote living donor and transplant recipient safety
Effective dates: (see policy notice and information below for details)
- 4/6/2017 - Required toxoplasmosis testing of all donors
- 9/1/2016 - Improving post-transplant communication of new donor information
Pathogens of special interest (PDF - 239 KB)
Policy notice (PDF - 594 KB) (6/2016)
Executive Summary
The Ad Hoc Disease Transmission Advisory Committee (DTAC) has been reviewing cases of potential donor-derived transmission events since 2006 to learn and the share lessons learned behind these transmissions and recommend processes to prevent unnecessary transmissions.
Communication delays or failures regarding new donor information learned post-transplant have led to transplant recipient morbidity and mortality. A statistically significant association between having a proven or probable donor-derived transmission event and the presence or absence of a communication gap was documented in a recent 2015 published article1.
Policy implemented in 2011 established reporting guidelines and patient safety contacts. Reporting behaviors since that implementation have demonstrated an increase in reporting, yet wide variation in reporting practices. Data analyzed suggest that some of these reporting behaviors have not led to overall system improvements.
Current policy requires OPOs to report results received post-transplant. However, OPO interpretations of what results must be reported to transplant hospital patient safety contacts and the OPTN vary greatly. An unintended consequence has been a shift away from focusing on recipient disease reports and spending more time on donor cultures with wide variations in types of disease reporting and, in some areas, over-reporting of results with little benefit to the system goal. Over-reporting may lead to reporting fatigue or desensitization, thus taking away from the critical and important intent of the system. Communication delays or failures in the current process can also lead to negative consequences for patients.
This proposal adds clarity and essential details to the current reporting policy. Specifying what conditions must be reported and how they must be reported should add more reliability and consistency to the process. This proposed policy will aim to reduce unnecessary reporting to both the OPTN and transplant hospital patient safety contacts. By triaging reporting requirements, fatigue from over-reporting should be reduced and help focus time and energy on reporting and following relevant and critical results.
1. R Miller et al, “Communication Gaps Associated with Donor-Derived Infections,” American Journal of Transplantation 15 (2015): 259-264.
Background
Board briefing paper (PDF - 789 KB) (6/2016)
Public comment proposal (PDF - 793 KB) (1/2016)
Feedback requested
The DTAC requested community feedback on the following issues:
- Vascularized composite allograft (VCA) is a relatively new field in transplant. The Committee is seeking specific feedback on relevant tests that may be reported post-transplant and suggested requirements for communication guidelines.
- Current policy requires that either OPOs perform donor toxoplasmosis testing or send a tube of blood to the heart center for testing. Anecdotal reports suggest that completion of toxoplasmosis testing on a red top tube of blood sent to heart centers is challenging. Further, recent data have shown toxoplasmosis transmissions to non-heart recipients with adverse consequences. Policy does not, however, require positive results completed at the heart center to be communicated to centers transplanting other organs from the same donor. The committee is interested in hearing transplant community experiences with toxoplasma testing. Specifically, the committee is considering proposing that OPOs conduct toxoplasmosis testing for all deceased donors. This would be more consistent with other testing and promote safe practice for all recipients, particularly for non-heart recipients that we now know can be negatively impacted and die from donor-derived toxoplasmosis infection.
Policy and bylaws changes
Policy notice (PDF - 594 KB) - Effective 9/1/2016 and 4/6/2017
Pathogens of special interest (PDF - 239 KB) - Effective 9/1/2016
Effective 4/6/2017: Required toxoplasmosis testing of all donors
On April 6, 2017, we added a Toxoplasma IgG field to the Infectious Diseases tab in DonorNet®. All OPOs are now required to conduct this additional test and report the results.
Education
Access a learning module on UNOS Connect to learn more about this new requirement. You’ll find it in the Course Catalog under the Patient Safety category. Search for Toxoplasma Screening and Reporting of Test Results.
For a table summarizing all of the infectious disease reporting requirements for OPOs, see the policy notice.
Background
At its June 2016 board meeting, the OPTN approved several measures to improve the post-transplant communication of new donor information. One of these measures was the new requirement for OPOs to test all donors for Toxoplasma IgG.