San Francisco, CAIn May 2006, following reports by the LA Times and CBS News, Kaiser Permanente closed its 2-year-old San Francisco kidney transplant program amidst allegations that it failed to properly transfer patients on waiting lists, leading to missed opportunities for transplants and patients having to undergo years of unnecessary and grueling dialysis.
Although kidney transplant candidates routinely receive dialysis to keep them alive while they wait for a match, prolonged dialysis can lead to complications and lessen the chances for a successful transplant later.
Upon closing the transplant program, Kaiser agreed to transfer about 2,000 patients on its transplant waiting list to programs at the University of California San Francisco and UC Davis, the same centers that had handled transplants for Kaiser before it decided to bring the transplant program in-house in late 2004.
In June 2006, federal regulators released a report that blamed inadequate staffing and administrative failures for delays that prevented patients from receiving transplants and in August 2006, California regulators concluded that Kaiser's mismanagement of the program endangered patients, and ordered the HMO to pay $5 million in penalties and charitable donations.
The penalty was the largest ever issued by the California Department of Managed Health Care. The previous record of $1 million, was also levied against Kaiser in 2002, after it was determined that lapses in patient care led to the death of a California woman.
The report by Federal investigators indicated that Kaiser patients in the Sacramento region had been particularly disadvantaged by the decision to drop UC Davis as a contractor because UC Davis draws its kidneys from a different pool of donors than hospitals in San Francisco, and the waiting time is considerably shorter.
The report noted that a UC Davis transplant coordinator had warned Kaiser back in May 2004, long before Kaiser launched its own program, that Sacramento patients "would have to wait 1.5 to 3.6 years longer for transplantation, depending on blood type."
The report also said that Kaiser did not notify Sacramento patients of the longer waiting time, and did not inform Medicare patients that they could still obtain transplants at UCSF or UC Davis as long as they were willing to pay the higher deductibles charged for non-Kaiser patients.
The investigators found that at least 25 Kaiser patients were forced to decline "perfect match" kidneys at UCSF in 2005, because Kaiser refused to pay for any transplants at the hospital after September 2004.
The Medicare investigators concluded that Kaiser failed to provide services mandated by law and failed to comply with federal regulations governing patient rights. At no point did Kaiser assess "its ability to continue to meet the needs of the increasing number of patients and those others already in the program, to prevent or minimize service interruptions and facilitate efficient delivery and continuity of care," the inspectors wrote in the report.
Experts say it will take years to determine the full impact of Kaiser's failure to provide adequate care and services to kidney transplant patients. In 2005 alone, 116 patients on Kaiser's waiting list died, while only 56 patients received transplants.
According to CBS News on May 3, 2006, less than 3 percent of people on Kaiser's waiting list got transplants compared to an average 12 percent of people on other lists statewide.
In an example of how transplants should occur, the first patient transferred from Kaiser's program underwent transplant surgery at UC Davis Medical Center in less than a month. Surgeons Richard Perez and John McVicar transplanted a kidney from a live donor to a 28 year-old former student who had been on dialysis for the past five years.
Dr Perez, professor of surgery and director of the UC Davis Transplant Center, said in the UC Davis June 9, 2006, Weekly Update, "The quick transfer of this patient shows that the process can go smoothly and efficiently."
On the other hand, the situation for many other people waiting for transplants has not improved a whole lot. On September 28, 2006, Chris Rauber reported in the San Francisco Business Times, that few transplants have been performed since regulators ordered the HMO to begin transferring patients to other programs on May 12, 2006. The Times said 139 patients awaiting a transplant had died since then, quoting officials at the California Department of Managed Health Care.
In addition to the patients who died, the Business Times reports that about 100 others did not qualify for a transfer or were either too sick or could not be located or had transplants performed elsewhere.
But critics point out that there is no way of knowing whether any statistics offered by Kaiser are accurate. On October 11, 2006, the LA Times reported that state officials discovered that Kaiser had failed to remove the names of 90 dead patients from the national waiting list for organs.
It is now predicted that the transfer process will not be completed until early 2007. David Merlin, the former Kaiser administrator of the transplant program who was fired after raising concerns about the program says the process is not moving fast enough.
"They probably aren't going to get everyone transferred out until February, or maybe later," he told the Business Times. "These patients are helpless, and they're still not being taken care of."
Mr Merlin has since filed a lawsuit against Kaiser with a complaint listing specific allegations about inappropriate patient care and mismanagement of the transplant program including that (1) Kaiser never attempted to reconcile its kidney patient records with those at its former contracting hospitals; (2) hundreds of patient charts were lost; (3) "Perfect match" kidneys were refused "when patients could and should have received them"; (4) Kaiser nurses gave out "inaccurate and false information" about the status of patients and their care; (5) patients were given inappropriate medications; and (6) abuses occurred in the physician review process.
Critics are now pointing a finger of blame, at least in part, at the feds and the United Network for Organ Sharing (UNOS), an organization established by Congress in 1984, to administer the nation's Organ Procurement and Transplantation Network (OPTN), for allowing the Kaiser debacle to happen.
According to UNOS, in its role of monitoring transplant programs the agency: (1) collects and manages data about every transplant event occurring in the US; (2) facilitates the organ matching and placement process using UNOS-developed data technology and the UNOS Organ Center; and (3) brings together medical professionals, transplant recipients and donor families to develop organ transplantation policy.
However, an investigation by the LA Times reveals that the agency is clearly not performing these oversight duties. According to a recent report by the Times, the UNOS "often fails to detect or decisively fix problems at derelict hospitals -- even when patients are dying at excessive rates" and "routinely keeps findings of its investigations secret, leaving patients and their families unaware of the potential risks."
Many critics say the problems stems from the fact that the UNOS "isn't just a regulator; it is a membership organization, run mostly by transplant professionals," according to the Times.
In its investigation, the Times reviewed hundreds of confidential UNOS documents, and interviewed many past and present board members, transplant doctors, and patients and found that even when programs register high death rates, UNOS takes no meaningful action and often does not even order an inspection.
In the case of Kaiser's kidney program, statistics clearly indicated serious trouble in 2005 when twice as many patients died on the waiting list compared to transplants performed, while at the same time, in other California programs twice as many people received transplants as died on waiting lists.
Yet despite these clear indicators of deaths and delays from the start, the UNOS did not initiate an investigation of Kaiser's transplant program until after the New York Times exposed the serious problems in May 2006, the same month that the program was shut down.
Apparently Kaiser was not overly concerned about dealing with the UNOS. The report by Medicare investigators listed inadequate staffing as a major problem and specifically noted that Kaiser placed the responsibility for submitting patient information to the UNOS in the hands of a single clerk who had one hour of telephone training on the UNOS database.
Today overall, the UNOS regulates 259 transplant centers and 58 regional groups that procure and distribute organs. The UNOS is supposed to report centers whose performance does not meet government standards for receiving Medicare funding and the agency also has the authority to issue warnings and recommend the closure of a hospital.
However, the LA Times found that although UNOS has considered its most serious public sanction of revoking a transplant center's ''good standing'' 15 times since 2000, it has only followed through once.
To remain eligible for Medicare funding, CMS requires transplant programs to perform a certain number of transplants each year and to maintain a specific patient survival rate for one year after surgery.
Yet on June 29, 2006, the LA Time reported that the CMS has allowed 20% of the nation's transplant programs to stay in business despite performing too few operations or having low survival rates.
According to the Times, 48 of the 236 programs examined in its investigation continued to operate "despite sometimes glaring and repeated lapses." Those 48 transplant programs, the Times said, accounted for 71 more deaths within one year of transplants than expected under normal conditions.
On June 29, 2006, California Healthline quoted an anonymous CMS official as saying that the agency to date has identified 25 transplant programs "seriously out of compliance."
As far as punishing Kaiser for its failed kidney transplant program and the death and injuries to patients, CMS threatened to cut off Medicare funding in June 2006, but on September 14, 2006, the LA Times reported that Federal regulators said that they had rescinded their threat to cut off Medicare funding for kidney services at Kaiser Permanente's San Francisco hospital.
Kaiser now meets federal requirements, CMS said, though it still must fix some minor problems.
In May 2006, lawsuits against Kaiser Permanente began with the first filed on behalf of the widow of a man who died who after Kaiser refused him a transplant as a result of mishandled paperwork.
In another case, a woman alleges that her condition progressively got worse after Kaiser continually delayed her transplant. A third case was filed on behalf of Phillip Maxson, who has been on dialysis for more than 6 years, and alleges that a Kaiser doctor advised him on several occasions to travel overseas to obtain a transplant.
In June 2006, a lawsuit was filed on behalf of Kaiser patients, Lurena Fiore and Debra Adams, and the attorneys handling the case are seeking class action status to include other persons injured by Kaiser's failed transplant program as well.
If you have been defraud, neglected or feel your kidney transplant was mismanaged, please contact a [Kaiser Permanente] lawyer who will evaluate your claim at no charge.