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."

So,

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.

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