A ‘No Wrong Door’ system makes safety concerns easier to report

The U.S. organ donation system is complicated — doctors, hospitals, OPOs, labs and multiple federal agencies all play a role. When safety concerns arise, figuring out where to report them shouldn’t be confusing.

The U.S. organ donation and transplant system is a complex network of doctors, hospitals, organ procurement organizations (OPOs) and histocompatibility labs, operating under policies and regulations managed primarily by three entities: Centers for Medicare and Medicaid Services (CMS ), Health Resources and Services Administration (HRSA) and the Organ Procurement and Transplantation Network (OPTN). Navigating this system can be challenging for patients and families, especially when there’s the compounded stressful urgency of a patient safety concern.

That’s why UNOS is advocating for a “No Wrong Door” comprehensive patient safety reporting system. The idea is simple: Anyone — whether that’s a patient, physician, nurse, family member or friend — should be able to report safety concerns easily, effectively and anonymously, without needing to know what agency is in charge or who to talk to when an issue arises.

In July, UNOS CEO Maureen McBride called on Congress to direct HRSA and CMS to work together to create a No Wrong Door reporting system. If someone experiences poor care or witnesses a problem related to organ donation or transplant, they shouldn’t have to navigate a maze of agencies to speak up, be heard and get a resolution. A No Wrong Door system would serve as a central reporting hub and route reports to the correct regulatory authority.

Currently, people can report concerns and allegations of misconduct anonymously by email at [email protected]. There is also a secure online portal and OPTN Member Reporting Phone Line available to OPTN members (OPOs, transplant hospitals and histocompatibility labs) who are required to report certain events in accordance with OPTN policy, and many also submit voluntary reports. However, anyone who is not an OPTN member, such as a donor, family member or a patient, would have to do research to find options for reporting.

For this system to work, a No Wrong Door reporting system must be well-publicized and easy for the American public to understand. It must route all safety concerns to the correct authority, regardless of where the incident occurred or where it got reported. The system must protect the anonymity of individuals who make a report. It should also track and publicly report outcomes of safety investigations to strengthen trust and accountability.

A No Wrong Door reporting system would help preserve and strengthen trust and ensure that organ donation and transplantation in the U.S. remains fair, effective and safe. Patients, families and other stakeholders deserve a reporting process that’s accessible and does not require them to understand the transplant and donation system’s complex governance structure.

What could a No Wrong Door system look like?

1. The system should have ONE entry point. No matter who you are or what role you play in the organ donation and transplantation community, all submissions should go through a central hub.
2. There should be multiple ways to access the entry point. Even though there should be only one intake point, contact information should be published everywhere it’s likely a person in the community may try to find it. For example, the same information should be on the HHS website, the HRSA website, the CMS website and the OPTN website.
3. One team should triage the reports. This team should be highly skilled and highly collaborative. It should evaluate each claim to determine how it should be investigated, and whether CMS, HRSA or the OPTN is responsible. If multiple entities need to investigate, the investigations should be collaborative, and information should be shared amongst the entities.
4. There should be public reporting about the outcome of an investigation. The high-level outcome of a complaint should be reported by the relevant organizations, and a report or dashboard of such outcomes should be on their websites and updated regularly.