Resources

Published 19 March 2025

• OPTN Comment

The International Society for Heart and Lung Transplantation (ISHLT) welcomes the opportunity to review the OPTN Proposal "Clarify Requirements for Reporting a Potential Disease Transmission.” This proposal attempts to improve patient safety by promoting accurate reporting of potential unexpected disease.

The proposal involves determining if the transplant recipient is “sick” or “non-sick” to decide if a potential disease transmission should be reported. “Sick” and “non-sick” are not defined using objective criteria, but rather the clinical “judgment of the treating physician or team.” Subjective interpretation introduces potential variability in reporting across centers, with some centers may overreport to avoid missing cases, while others may underreport due to differing adjudication practices.

We recommend that the Pathogen of Special Interest (POSI) list be readily available to transplant hospitals and organ procurement organizations (OPOs). It will need to be comprehensive and up-to-date. When the list is modified, notifications will need to go out to centers and OPOs.

Using cross-clamp timing as the threshold for defining an unexpected event is a logical approach, but challenges arise in cases where findings are adjudicated after organ procurement. For example, the policy should clarify if a possibly malignant lesion is identified prior to cross-clamp, should subsequent pathologic confirmation of malignancy be considered expected or unexpected. Although after cross-clamp is defined as the start of the time period to report unexpected findings, the policy proposal does not define the end time. It will need to define when a new finding should no longer be considered donor derived. Some malignancies or infections such as nontuberculous mycobacteria could be identified months after transplant leaving uncertainty whether it is donor derived or acquired post-transplant. There may no longer be utility in reporting a potential donor-derived disease transmission months or years after transplant

Finally, we recommend clarification regarding the 24-hour time limit to report a potential disease transmission when a “non-sick” recipient becomes “sick.” We suggest the 24-hour time period should begin when the recipient becomes “sick,” rather than when the transmission is identified. We also are concerned that the 24 hour time limit will be challenging due to the additional administrative burden.