Monday, October 23, 2006

UNOS' Regulation of Organ Transplantation: "A Day Late and a Dollar Short"

The Los Angeles Times just reported on problems in the regulation of organ transplantation in the US by the organization known as UNOS , the United Network for Organ Sharing. "Since 1986, the federal government has contracted with UNOS to oversee everything from how organs are harvested to where they end up." The Times charged that UNOS "often fails to detect or decisively fix problems at derelict hospitals - even when patients are dying at excessive rates." Furthermore, "when it does act, the United Network for Organ sharing keeps findings of its investigations secret...."

The Times article provided bullet points about problems with UNOS operations:

  • "UNOS has never recommended that the government close an active transplant program."
  • "Even after programs log high death rates, years sometimes pass before UNOS takes meaningful action."
  • "UNOS often backs down after being challenged — or even defied — by medical centers it is supposed to regulate."
  • "UNOS officials have missed obvious red flags, including troubling transplant center statistics available on its own website."
The article described several cases in which transplant programs succeeded in delaying action by UNOS for a long time, and then only suffered "confidential probation," seemingly not much of a deterrant. "'It seems like UNOS is often a day late and a dollar short,' said Dr. Mark Fox, associate director of the Oklahoma Bioethics Center and former chairman of the UNOS ethics committee."
UNOS described its enforcement role thus,
Adherence to transplant policy is ensured through a comprehensive, systematic auditing and monitoring process. The policy compliance process is designed to maintain the highest standards in patient safety and foster public trust in the transplant network. Any deviation from policy is corrected quickly and thoroughly to protect patients and ensure that their treatment is not interrupted.

The United Network for Organ Sharing (UNOS) is the non-profit organization that operates the Organ Procurement and Transplantation Network (OPTN) under contract with the U.S. Department of Health and Human Services. In this role UNOS coordinates organ transplant policy development and compliance,...

The OPTN provides the most comprehensive health-care oversight program in the country. Transplantation is the only field of medicine in which every case is monitored.
But according to the Times,

'UNOS is not the FBI,' said board member Dr. Gabriel Danovitch, medical director of UCLA Medical Center's kidney and pancreas transplant program. 'It's not a police force.'

'It was never really designed as an enforcement agency,' said Dr. Dale Distant, a former board member and transplant chief at SUNY Downstate Medical Center in New York.
Although federal contracts give UNOS the role of maintaining "compliance," in fact UNOS is a membership organization. The largest number of its members are the transplant centers whose compliance UNOS is charged with enforcing. And, "it's a relatively small world in which colleagues - even friends - end up in judgment of one another."

Such collegiality is built into UNOS' very structure — and that's the problem, some critics say. UNOS isn't just a regulator; it is a membership organization, run mostly by transplant professionals. Centers, in effect, oversee one another.

'UNOS really can't police itself,' said Dr. John J. Fung, director of the Cleveland Clinic's transplant center and a former UNOS board member. 'Everybody is beholden.'
The Times interviewed Judith Braslow,
who oversaw the federal government's division of transplantation from 1990 to 1998, said that although UNOS generally does a good job, it is difficult for the group to be 'completely objective because they essentially wear two hats.'

'In their capacity as the government contractor, they have responsibility to keep the public informed. In their capacity as a membership organization, they have responsibility and loyalty to their members,' she said.

'Those two roles are really in conflict in terms of the policing function.'
So this turns out in some way to be a familiar story. An organizational structure designed in a more genteel age, when hospitals were smaller, more community oriented organizations, threadbare in finances, and run by "superintendents" or "directors" (as per Kenneth Ludmerer's Time to Heal) may no longer be appropriate for an age when hospitals are multi-billion dollar organizations run like "businesses" by CEOs, and other professional (but usually not health professional) managers, to the latest tunes sung by management consultants. In the new bleeding edge world of health care, collegiality can turn into conflict of interest awfully quickly.

"Collegial" mechanisms to ensure compliance may not work too well for organizations no longer run in a collegial manner.

Unless we can re-establish health care as collegial, instead of cut-throat corporate, we will need considerably tougher methods to keep the system honest.


Anonymous said...

When transplant became about the bottom line and not about patients...good will went out the door. Members who sit on UNOS committies and shape policy are likely to legislate what benefits their patients rather than all patients. Look at the geographic advantaging of patients that takes place on a daily basis. Organ rich areas are reluctant to share and likely never will be made to share with sicker patients in other regions. In an effort to increase the volume of transplant more and more marginal organs (that are likely to fail in a short period of time...necessitating the need for a re transplant) are being used. Organs that would have never have been used 5 years ago are now the norm. The negative effect of this will not be known for 3 years when the stats are in. And that is only if they are reported truthfully. Expanded living donors are being put at risk as well without meaningful data being collected on the living donor and their quality of life. Centers are expected to report on themselves...not likely to happen in a uniform fashion. Some will stand for truth and justice, others wont. There is need for more independent oversite.

Unknown said...

UNOS' policy oversight is no better than its compliance oversight. UNOS has passed up the chance to save thousands of lives every year by making a simple change in its organ allocation rules. UNOS should allocate organs first to registered organ donors.

Following the announcement of this policy change, millions and millions of people would register as organ donors. Anyone who registered as an organ donor would increase their chances of getting an organ if they ever needed one. Anyone who didn’t register would reduce their chances. The decision to register could literally mean the difference between life and death.

Fortunately, Americans don’t need to wait on UNOS to increase the organ supply by changing its allocation rules. We can allocate our own organs to registered organ donors who will do the same for us. That is the idea behind LifeSharers.

LifeSharers is a grass-roots organ donation network. Members agree to donate their organs when they die. Furthermore, they agree to offer their organs first to fellow members, if any member is a suitable match, before offering them to others. Anyone can join for free at or by calling 1-888-ORGAN88. LifeSharers has over 6,200 members, including over 600 minor children enrolled by their parents.

David J. Undis
Executive Director