Kaiser Transplant Program Could Spur More Oversight

With Kaiser Permanente’s announcement last month that it would shut down its San Francisco kidney transplant center, consumers, health care advocates and state regulators are concerned that the complex web of failures and miscommunications could portend more widespread problems at Kaiser or elsewhere in California’s health care framework.

“If this kind of mess-up can happen at what everybody says is one of the best HMOs, then we all better be pretty vigilant about keeping tabs on everybody,” Anthony Wright — director of Health Access, a statewide consumer advocacy organization — said.

Peter Lee, CEO of the Pacific Business Group on Health, one of Kaiser’s largest customers representing many employers, said the program’s failure has larger implications than just at Kaiser.

“Health care in America is deeply flawed,” Lee said. “The odds of getting the right care at the right time are about 50-50 in our country. Large, sophisticated purchasers of health care understand that, but the fact that a good, integrated system like Kaiser had these kinds of problems is a reminder to all of us that our health system is far from perfect. Those kinds of errors are probably happening 10,000 times a day all over California and we only hear about a fraction of them.”

“What makes (Kaiser’s failure) such an important issue is that it’s an apparent systems flaw that raises the question of whether there are other areas where there are quality-control systems that are not in place,” Lee said.

The answer to that question is almost certainly yes. Two other California organ transplant programs shut down last year in the wake of serious foul-ups.

The University of California-Irvine Medical Center’s long-troubled liver transplant program is under investigation stemming from mismanagement that may have cost many patients their lives. The UCI center in Orange closed its liver transplant program in November and still has a decade’s worth of other problems to deal with, including accusations of nepotism and favoritism in other programs, closure of a fertility clinic after embryos were reported stolen, lost cadavers and stolen body parts and research violations in its cancer clinic. Investigators are also looking into alleged fraudulent billing practices at UCI.

Another California facility — St. Vincent Medical Center in Los Angeles — closed its liver transplant program in September and is under investigation by the U.S. Attorney’s Office. Officials admitted that in 2003, St. Vincent doctors improperly arranged a liver transplant for a Saudi Arabian, diverting an organ intended for a high-priority St. Vincent patient.

With the collapse of Kaiser’s kidney transplant program, California has had three organ transplant system failures in a row.

The Problem at Kaiser

The Kaiser program’s end comes after media reports revealed that care for hundreds of patients was delayed or otherwise compromised because of a series of clerical and bureaucratic errors.

Until a couple of years ago, Kaiser members needing dialysis and kidney transplants were sent to other facilities and Kaiser paid the bill. Wanting to bring the work “in-house,” Kaiser in 2004 transferred about 1,500 patients from the kidney programs at UC-San Francisco and UC-Davis to its new transplant center in San Francisco.

Hundreds of patients were not properly transferred because of incomplete or inaccurate paper shuffling. Essentially, some patients were unknowingly sent to a sort of bureaucratic limbo where they were effectively cut off from the possibility of being matched with a transplant donor for months.

There were signs of trouble earlier this year. In January, with two of Kaiser’s three nephrologists — physicians who treat kidney patients before and after transplant — on personal leave, Kaiser leaders received a clear message that the program was troubled. One of the nephrologists, James Chon, wrote a 12-page letter to Kaiser leaders, detailing problems in the kidney program, including “numerous resignations” and other internal issues he called “very serious.”

David Merlin, director of Kaiser’s department of transplantation, left abruptly in February after only eight weeks on the job. In a television interview in which he described the program as “disorganized,” Merlin said “entire patients were lost for long periods of time.”

“I had administrative staff and nursing staff bringing me phone messages and bringing me patient charts to say, ‘Here’s another one. Here’s another one. Here’s another one that fell through the cracks,’ and that was a term that they used often,” Merlin said.

In March, acting on the strength of two “whistleblower letters,” the Department of Managed Health Care launched an investigation of Kaiser’s kidney transplant program.

“We were, in fact, at a point where we thought we needed to move further toward some action,” Cindy Ehnes, director of the department, said. “I won’t say we were ready to shut them down, but we were ready to take the next step to resolve the problems. We attempt to resolve issues without creating disruptions in clinical procedures.”

Television and newspaper reports in early May, although not the first signs of problems, focused public scrutiny on the issue and ultimately led to the program’s demise. San Francisco television station KPIX (Channel 5) and the Los Angeles Times reported that Kaiser’s new program was jeopardizing patients’ health.

The reports showed that for each patient who received a kidney at Kaiser in 2005, two patients on the waiting list died. That’s the reverse of the statewide statistical pattern: twice as many patients received kidneys as those who died waiting.

Kaiser announced shortly after the initial reports that it would shut down its transplant program and send its patients once again to UCSF and UC-Davis.

“The publicity certainly sped things up and I’m not sorry about that,” Ehnes said. “We only had two complaints — both internal whistleblower letters — and we had nothing from patients. We depend on patients telling us what’s wrong before we can start investigating.”

Kaiser representatives say administrative problems were limited to this one “start-up” program.

“Kaiser will continue to be a leader in clinical outcomes and in patient satisfaction,” spokesperson Matthew Shiffgens said. “We don’t expect the specifics of the administrative problems in this one program to carry over to any other parts of the organization.”

Addressing the Problem

The problem with depending on patient complaints is that sometimes patients — especially those waiting for organ donations — have nothing to compare their treatment to and have no basis for assessment, let alone complaint.

In such situations, checks and balances are typically built into the system to prevent patients from getting “lost for long periods of time,” as Merlin had said happened at Kaiser. Some observers who say that’s where Kaiser failed assign some of the blame to the Permanente Medical Group, the for-profit business representing about 6,000 Kaiser doctors. The medical group should be responsible for monitoring clinical quality and keeping tabs on administrative policies, they say.

The Department of Managed Health Care’s investigation continues and fines or other penalties may yet be imposed.

The United Network of Organ Sharing, the national organization that oversees transplant programs, is working with both University of California hospitals, Kaiser and DMHC during the transitional period.

The slow and complex process of transferring 2,000 Kaiser kidney patients began last week with more than 100 patients in critical need moving to one of the other two hospitals.

“I think this whole episode does suggest the need for additional oversight over insurers and providers,” Wright of Health Access said. “We’re talking about patients here who are literally entrusting their lives to these insurers and providers.”

“I understand it was a complicated set of mistakes that led to this, but we have to find some way to make sure those kinds of mistakes aren’t made again,” Wright said. “I don’t know if it’s a legislative solution or a matter of more aggressive oversight, but we need to work toward some kind of global answer.”

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