Despite what you may have heard or seen in pop culture, waiting for an organ transplant is not like taking a number and waiting for your turn. People often refer to “the waitlist” to describe how the system works, but the reality of how it all works, and who is involved in the process, is significantly more complicated.

The United Network for Organ Sharing (UNOS), in its role as a federal contractor, helps pair donated organs with patients in need.

Is it really a list?

To better understand how patients are matched with lifesaving organs, it’s helpful to think of the people in need of an organ transplant as being grouped into a “pool” of patients. Patients get added to the “pool” by transplant teams at the patient’s transplant hospital. Those teams evaluate patients and make the final decision on whether or not an organ transplant is the proper treatment. Each time an organ becomes available, UNet – UNOS’ organ matching technology – searches the entire pool for the patients who are a match for the organ based on factors such as blood type, immune system characteristics, organ size and health status. Medical urgency and time spent actively waiting for an organ are also considered. This means every time an organ is available for a transplant, the system creates a new prioritized list, known as a “match run,” from the people in the pool, in the order determined by Organ Procurement and Transplantation Network (OPTN) policy.

Who decides how organs are offered to patients?

When an organ becomes available for transplant and an offer is made to a patient in need, the decision to accept or decline the offer is made by the patients’ transplant team who care for them at their transplant hospital. How organs are allocated is determined by policy, built by independent, volunteer committees made up of donation and transplant professionals, doctors, patient and donor families and members of the public. Those committees are established by the OPTN to write policy and improve the national system. Once a match run is created, organ procurement organizations, or OPOs, use UNet to send offers to patient transplant teams in the order prescribed by OPTN policy. Important decisions about patients, such as accepting an offered organ for a patient, are made by the transplant doctors and teams at transplant hospitals across the country.

What does UNOS do?

As part of its OPTN contract with the federal government, UNOS created and maintains a secure web-based application to collect relevant information about transplant candidates and donors, creates matching algorithms that execute OPTN policies, and connects OPOs with transplant teams. UNOS, under its federal contract, also maintains databases of post-transplant information about patients and living donors to help monitor patients’ health following their transplant. These data can provide feedback to transplant hospitals and OPOs and help the OPTN monitor how policy is working, improve patient safety and write future policy changes.

Let’s take a closer look at how donation and transplant work, and the role UNOS plays in it.

How does this process work?

UNOS is responsible for the work designated in its OPTN contract, which is determined by the Health Resources and Services Administration (HRSA), in accordance with the National Organ Transplant Act, OPTN Final Rule and all OPTN policies. That work, which includes building and maintaining the software that connects a lifesaving organ donation from a generous donor to a potential recipient, is just one piece of the complex network that saves lives through organ donation and transplant every day. UNOS is dedicated to helping people live life without limits by helping people get the lifesaving transplant they need.

Read more about the ways UNOS aims to save and transform lives through research, innovation and collaboration.

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.

Another promising medical trial that could save lives thanks to genetically modified pigs: The FDA has given a select group of companies permission to use modified pig livers as a dialysis-like treatment for people with liver failure.

The process would involve circulating a patient’s blood through the pig liver to help clean the blood of contaminants, excess fluids and waste products to improve or stabilize the health of a patient. The clinical trial would include up to 20 patients who don’t qualify for a liver transplant.

UNOS Chief Medical Officer and former liver transplant surgeon Dr. Andrew Klein says this new advancement is based on a treatment that was first used in the 1970s called xenoperfusion. He spoke recently about what this new FDA trial could mean for saving lives.

How does this compare to a kidney dialysis machine?

Dr. Klein: One of the things that distinguishes a liver transplant from a kidney transplant, which happens more frequently, is in most cases with kidney failure, there are other therapies which can take over the kidney’s function for a period of time, such as dialysis. You don’t really have anything that could take over liver function aside from a new liver. That’s what this new development is trying to become, a sort of dialysis function for people experiencing liver failure.

Do you have experience with xenoperfusion?

Dr. Klein: In 1993 or 1994, I had a patient at John’s Hopkins, a woman who had acute liver failure, was comatose, and was listed as a candidate for a liver transplant. We didn’t have an organ available, but I had a young surgeon working with me who recalled xenoperfusion from the 1970’s as a viable potential treatment for this patient.

So, we got in touch with a farm that housed pigs in an appropriate way for research and went through a whole process. We got consent, procured a liver from the pig, brought it up to the ICU and started the process of perfusing the patient’s blood through the pig liver and then returning it to the patient.

Within 20 minutes, the patient woke up out of her coma and she improved clinically for a number of hours. Eventually the pig liver deteriorated but the good news is we got extra time to find a liver transplant for her. She was transplanted with a donated (human) liver, and she survived and went home.

So, this treatment is not entirely new, but what probably makes it novel and perhaps more durable is the fact that they’re using genetically modified pigs.

How could this be applied to patients today?

Dr. Klein: Two applications come to mind immediately. It could serve as a bridge to transplant, buying a patient time while transplant teams wait for a viable donated organ to become available. It could also be used as a standalone treatment that makes transplantation not necessary, giving the patient’s liver time to regenerate a certain amount and resume functions.

The companies running the FDA trial will need to determine what functions will be restored by this dialysis, will the treatment act as a liver cleanse, removing the body of toxins and waste products, and/or will it restore synthetic functions, such as resupplying the body with substances livers normally produce? I am really intrigued by this second potential application; it could be something that saves someone from being on the transplant waitlist entirely.

Positive results from this FDA trial could mean another step towards saving the lives of patients experiencing organ failure. Read how UNOS is building technology to connect patients with lifesaving organs and how else doctors are using genetically modified animals to save lives.