Transplant error puts UPMC on probation

Federal agency deals rare discipline

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Because of a botched living donor kidney transplant earlier this year, a federal agency on Tuesday put UPMC's transplant program on probation, a rarely used form of discipline handed down for some of the most serious transplant errors.

The federal Organ Procurement Transplant Network (OPTN) said it meted out the discipline not only because of the kidney transplant error, but because UPMC's transplant program was found to have problems in its communication and documentation procedures before.

"This finding is the result of a series of detailed medical peer reviews," OPTN's president John Lake said in a statement Tuesday after an OPTN board meeting in Atlanta, where the decision to discipline UPMC was reached. "The University of Pittsburgh Medical Center has identified a need for process improvement in communicating key clinical information among transplant staff members. While the center has acted quickly and responsibly to identify and implement a corrective action plan, we believe probation is warranted."

OPTN also said in a statement that the board took note of the fact that previous OPTN "reviews of the center had identified other communication and documentation issues requiring correction."

That apparently refers to at least a March 2010 inspection of the program that found a slew of documentation errors, including failing in some cases to ensure that the blood types of donors and patients were compatible.

Tuesday's discipline "is a big deal," said William Harmon, director of the kidney transplant program at Children's Hospital of Boston and a former board member for United Network for Organ Sharing. "It's a big deal insofar as they're now under pressure to make sure they don't make the same mistake again."

In May, UPMC reported that it discovered it had performed a living kidney donor transplant even though the donor tested positive for hepatitis C prior to the transplant -- a fact that UPMC had overlooked. The mistake led to the recipient also contracting the potentially life-threatening virus.

In September the donor, Christina Meccanic, 40, and male recipient, Michael Yocabet, 50, a Greene County couple with an 18-year-old son, sued UPMC Presbyterian, the University of Pittsburgh Physicians, four doctors and a nurse.

Harry Cohen, the Pittsburgh attorney representing the couple, said he spoke with Ms. Meccanic about the OPTN finding Tuesday and she told him that she was "glad that any actions she took might have caused the appropriate authorities to get involved in the problems at UPMC."

After it discovered the error, UPMC voluntarily shut down its living donor kidney program for two months while OPTN conducted an initial investigation. OPTN's membership and professional standards committee then conducted a peer-review investigation, including interviewing UPMC representatives in July, and holding a hearing with UPMC in September, before recommending discipline to the full OPTN board of directors.

OPTN's discipline will not affect UPMC's ability to perform transplants. But it will require UPMC to spend a year or so being subject to unannounced site visits, notifying kidney transplant patients of its probation status and providing OPTN with detailed monthly reports documenting how it changed its program.

In addition to OPTN/UNOS's investigations, the Centers for Medicare and Medicaid Services also investigated and found that among a variety of violations UPMC committed two "condition" level violations, which is the most serious level.

UPMC's transplant chief, Abhinav Humar, said UPMC could have appealed but decided that it would be best to work to get OPTN's "external validation" that its program is being run as well as it can be.

UPMC has greatly expanded the "sets of eyes" it puts on test results prior to transplantation, Dr. Humar said, increasing the number of people who need to review all test results before a transplant can take place from two to seven.

OPTN, the federally created agency that oversees the nation's more than 250 transplant centers, is run under contract by UNOS, a private not-for-profit group.

Probation is the second highest form of discipline meted out by OPTN/UNOS. The only higher level of discipline is as a member not in good standing, which could result in a recommendation to the U.S. Department of Health and Human Services to shut a program down.

Probation and member not in good standing discipline is rarely taken.

Only three other transplant programs in the country have been placed on probation since probation in its current form was approved in 2005: the University of California Irvine Medical Center in 2006; Sharp Memorial Hospital in San Diego in 2006; and St. Vincent Medical Center in Los Angeles in 2007. All three were released from the discipline after 15 to 17 months.

Only three programs have ever been placed on the member not in good standing list since the discipline was created in the early 1990s: St. Vincent Medical Center in Los Angeles in 2006; Kaiser Permanente San Francisco Medical Center in 2006; and the Nevada Donor Network in June. St. Vincent was later reinstated after moving to probation, Kaiser voluntarily closed its kidney transplant program and Nevada still is on the list.

Jack Silverstein, a transplant recipient and president of the Western PA Kidney Support Groups, was glad UPMC didn't end up on the more onerous list.

"I don't want to see them lose their program because there's a lot of people waiting for a transplant at UPMC," said Mr. Silverstein. "But, now, in a way, maybe it will make it better because they'll have to cross their T's and dot their I's and make sure they're doing it right."

Sean D. Hamill: or 412-263-2579.


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