Thursday, August 5, 2010

$2 Million Fine Small Potatoes for Kaiser Transplant Disaster

Evelyn Pringle August 13, 2006

Although the $2 million fine levied against Kaiser Permanente was the largest ever imposed by the California Department of Managed Health Care, it seems like small potatoes considering the damage caused by the HMO's failed kidney transplant program.

The second largest fine ever levied against an HMO was $1 million back in 2002, following the death of a patient. It also was against Kaiser but obviously did nothing to deter similar misconduct.

In addition to the fine, Kaiser says it will make a $3 million donation through the East Bay Community Foundation to "Donate Life California," a program that encourages California citizens to donate organs and tissues.

While the donation was not a penalty imposed, Kaiser officials said at a press conference, that it was part of a package of responses created by DMHC that Kaiser agreed to implement.

In the DMHC's press conference, the agency's Director, Cindy Ehnes, said the fine and donation were intended to recognize serious problems in the operation, management and oversight of Kaiser's Northern California kidney transplant unit at its San Francisco medical center.

Ms Ehnes said in recent months the DMHC made oversight of Kaiser a main priority, to make sure that no patients lose an opportunity for a kidney transplant or become "a forgotten number."

She cited problems that included failure to provide adequate administrative oversight and enough personnel to accomplish patient transfers, failure to give patients timely access to kidney specialists and treatment referrals, and failure to properly respond to patient complaints.

She said the agency recommended the $3 million contribution to the donor registry program, because the additional payment by Kaiser "reflected the magnitude of the issue."

"We have structured the agreement and penalty with Kaiser in this way because not only will it acknowledge Kaiser's serious failures to adequately administer and operate its transplant center, it will directly benefit the patients who so desperately need help," she said at the press conference. "This funding will save lives."

Ms Ehnes also specifically noted Kaiser's inadequate oversight of its affiliated Permanente Medical Group of doctors, as one of the issues the DMHC was concerned about.

Members of the Kaiser HMO receive health care services from Kaiser hospitals and its affiliated group of doctors. However, prior to 2004, the HMO had contracts with other hospitals to treat patients in need of kidney transplants because Kaiser did not have a transplant program.

Up until 2004, Kaiser contracted with UC San Francisco and UC Davis to provide kidney transplants. When it decided to set up its own program to perform kidney transplants, Kaiser canceled the contracts with UC San Francisco and UC Davis and sent letters to approximately 1,500 transplant patients saying they were being transferred to the new Kaiser program in San Francisco.

Transferring transplant patients involves registration with the United Network for Organ Sharing, the federal contractor responsible for overseeing kidney distribution. Without a proper registration, a patient is ineligible to receive a kidney.

In June 2004, when Kaiser informed patients on waiting lists at UC San Francisco and UC Davis that from then on transplants would take place at Kaiser's hospital, patients were literally forced to participate in the program. One letter to patients said in part: "You will be financially responsible for any kidney transplant services you receive from the University of California, San Francisco, after Sept. 1, 2004."

According to the July 21, 2006, East Bay Business Times, critics say the role of Medical Group's doctors was central to setting up the transplant program. Unlike the rest of Kaiser which is non-profit, the Medical Group is a for-profit entity that splits profits among its physician partners, giving the group a financial incentive to bring services in-house.

A former transplant unit administrator told the Business Times that Kaiser planned to use the San Francisco program as a template for a series of other transplant centers nationwide that would save the HMO huge amounts of money by not having to send patients to outside hospitals for transplants.

Critics told Business Times that the powerful influence of Kaiser's doctors within the organization is little known to the public or to regulators, and that financial incentives sometimes result in clinical decisions that can put patients in jeopardy.

That certainly turned out to be the case with the transplant program. According to a CBS channel 5 news analysis of the national transplant data for 2005, Kaiser performed only 56 kidney transplants that year, but 116, or more than twice as many transplant patients died while on the waiting list.

Overall, the exact opposite occurred with transplant patients statewide in California. CBS found that more than 1,800 patients received successful transplants, while only 866 died.

And the number of transplants completed at Kaiser was less than 3% of the people on the waiting list compared to an average 12% on other waiting lists statewide.

Looking back, during the two years before Kaiser began its program, UC San Francisco and UC Davis combined, performed at least 168 transplants on Kaiser patients, three times as many as Kaiser performed in its first year of operation.

While it may be difficult to come up with the exact number of patients who died as a direct result of Kaiser's failed transplant program, critics say, its clear that many patients were needlessly forced to endure grueling sessions of prolonged dialysis which lessens the chances for a successful transplant.

Ruben Porras had already been waiting for a kidney at UC Davis for 3 years when Kaiser cancelled the program. As a result, Mr Porras was put on inactive status in November 2004, meaning he could not receive a kidney.

In the end, his transfer to Kaiser's program was not completed until September 2005 and because kidneys were more difficult to obtain in the heavily populated San Francisco area than in Sacramento, the waiting period for Mr Porras was expected to be 3 more years.

Several of his relatives were being assessed as potential donors at UC Davis, but when Kaiser ended the contract, the assessments were also cancelled. When the relatives called Kaiser to try and continue the assessments no one returned the calls.

Less than one month after his transfer to Kaiser's list was completed, Mr Porrass died at 47, as a result of an infection caused by extended dialysis treatment.

As it turns out, Mr Porras wasted what little time he had left on dialysis hoping for a transplant. "There's no other life out there for you other than being treated," his wife told the LA Times. "He had no energy to do anything, go anywhere or do things for himself."

In another similar case, 63-year-old James Klinkner sent in his forms when he was told that he would be transferred to Kaiser's list but they too apparently got lost because Kaiser sent him another form to fill out. When he called to find out what happened, his call was not returned. In the meantime, Mr Klinkner also died from complications of prolonged dialysis.

In fact, an investigation by the LA Times found hundreds of other patients at UC Davis and UC San Francisco stranded between programs because of Kaiser's delays and errors in processing paperwork

And if all this wasn't bad enough, on May 4, 2006, the Times reported that 25 Kaiser patients "were denied the chance for new kidneys that were nearly perfectly matched to them last year during the troubled start-up of the giant HMO's kidney transplant program in San Francisco."

The 25 kidneys were offered between January and December 2005, the California Transplant Donor Network told the Times.

"These "zero mismatch" organs from cadavers are prized," according to the Times, "because they offer patients a greater chance of long-term survival and minimize the risk of rejection."

They are considered the best possible option aside from a living donor's kidney. "And they allow patients to get their transplants immediately," the Times wrote, "no matter where they are on the waiting list."

Patients missed the opportunity because Kaiser never completed the paperwork to transfer the patients to its program, and at the same time, Kaiser refused to allow UC San Francisco to transplant the kidneys into Kaiser patients.

On August 4, 2006, the LA Times reported more bad news for patients when California regulators said it would take months longer than expected to transfer about 2,000 patients out of Kaiser's transplant center in San Francisco. Preparing patients and their records for transfer has taken more time than anticipated, officials said, pushing the target to the end of the year.

Not surprisingly, Kaiser is already facing a barrage of litigation over the transplant program debacle.

Ella Haynes filed the first lawsuit in Alameda County Superior Court back in May 2006, alleging the HMO had botched paperwork and caused her husband Ronald to be removed from the transplant waiting list.

In the case of her husband, having to wait so long caused his condition to deteriorate to the point where he could not even be considered for a transplant. Ronald died of a blood infection in March 2005 at 60-years-old.

Ella learned from the LA Times in May 2006, that her husband never had a chance of receiving a transplant because the 2 1/2 years Ronald spent on the waiting list at UC Davis had never been transferred to Kaiser, effectively eliminating him from the program.

On May 3, 2006, the Times reported that many experienced transplant programs accept kidneys from a separate pool of risky donors, such as older patients or people with health problems, in attempt to cut down the waiting time.

The pool supplied kidneys for about 15% of the transplants in the Bay Area last year, the local organ bank told the Times, but said Kaiser only accepted one.

Kaiser's chief surgeon, Dr Arturo Martinez, claimed it was because only one patient signed up for the kidneys, but officials from UC Davis and UC San Francisco told the Times that their records show many Kaiser patients had been interested.

In fact, at UC Davis, before the contracts were cancelled in 2004, 20 Kaiser patients had signed up for the organs, and at UC San Francisco there were 23 more Kaiser patients signed up.

Ella Haynes said her husband Ronald had signed up for two riskier kidneys at UC Davis, but when he was transferred to Kaiser, they were told that Ronald "would be better served to wait it out and get one good kidney."

Ronald was one of approximately 1,500 patients transferred to Kaiser's new transplant program when it opened in 2004, according to an investigation by CBS 5 in May 2006.

A month after Ronald died in April 2005, Ella received a call from Kaiser asking about her husband's transplant status and she told the caller that her husband died.

"I told them, 'well gee, my husband is dead,' " she told CBS. "The doc said, 'I'm so sorry. We didn't have the paperwork that would have told us this. Otherwise I wouldn't have called.' "

Ella's attorney, Stuart Talley says Kaiser lost track of Ronald's case altogether. "We have info that leads us to believe he was actually never put on Kaiser's list," Mr Talley told CBS.

"So he was actually on nobody's list," he noted, "when he passed away and had no chance of getting a kidney."

Fifty-six-year-old, Bernard Burks, also filed a lawsuit against the HMO in Sacramento County Superior Court, for insurance bad faith and breach of contract, after he was unable to obtain a transplant. The lawsuit alleges Kaiser ignored his phone calls and failed to arrange a transplant even though Mr Burks' daughter was a compatible donor and was willing to donate a kidney.

As a result of the lawsuit, Kaiser agreed to pay for Mr Burks' kidney transplant at Stanford University Medical Center, according to National Legal News on June 22, 2006.

Litigants suing Kaiser will certainly have enough witnesses to call and documentary evidence to present to the juries.

The first witness called might well be David Martin, the former administrator of the transplant program, who filed his own lawsuit in San Francisco Superior Court, on July 14, 2006, requesting $5 million in damages, and alleging that he was terminated after only two months on the job for raising concerns about patient care and related issues, including violations of state and federal laws.

Some of the complaint's specific allegations include: (1) Kaiser never attempted to reconcile its end-stage kidney patient records with those at its former contracting hospitals; (2) hundreds of patient charts were lost; (3) perfect match kidneys were refused; (4) nurses gave out inaccurate and false information about the status of patients and their care; (5) patients were given inappropriate medications; (6) surgical and medical decision-making processes were confused; and (7) abuses occurred in the physician review process.

According to the lawsuit, Kaiser's program "was so poorly organized and unprofessionally managed that it failed to comply with state and federal requirements and was compromising patient care, leading to unnecessary suffering and possibly deaths."

After he was terminated, Mr Merlin started the whole ball rolling when he contacted the LA Times and CBS TV-Channel 5 in San Francisco. He also alerted state and federal regulators, the US Department of Justice and the Medical Board of California.

As a result of Mr Merlin's contacts, the Los Angeles Times and CBS 5, broke the story about the failed transplant program in early May 2006, and within weeks Kaiser shut the program down and agreed to transfer the patients to the other facilities.

Another good witness for plaintiff's might be Social worker, Bonnie Jacobson, who resigned from the Kaiser program in July, and said she thought the $2 million fine was justified. "I don't really feel that the really high-up people in the administration at Kaiser got this," she told the LA Times.

"If any of them had to go for even one dialysis treatment," she stated, "they would have a whole new understanding of what it means to these patients to get a kidney transplant."

Federal investigators could also be called to testify. In a highly critical report issued on June 23, 2006, Medicare investigators said the Kaiser program was poorly planned, staffed, and qualified to care for transplant patients. It also said that no one at the HMO even seemed aware that the patients were at risk.

The report says Kaiser staff told Medicare officials that over a period of time there were more than 1,000 incomplete patient records.

In addition, there was "no indication that patients were informed of their rights or of other available options as well as potential consequences of the transfer," the inspectors wrote.

Investigators found staff members on the job with no training including nurses who had "little or no knowledge of the assessment and care of pre-transplant patients." The inspectors also said they found no evidence that anyone made sure the nurses were able to do their jobs.

In another instance cited in the report, the personnel file for the data coordinator who was responsible for processing patients' forms and ensuring that wait time was transferred, "revealed the lack of written evidence of any training" in how to use the computer system for the United Network for Organ Sharing, which oversees the waiting lists and organ allocation.

"There was no evidence," the report said, "that operations and other components of the program were being reviewed and evaluated to ensure the delivery of quality care to patients."

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.

They noted that future unannounced field investigations would likely be utilized to make Kaiser remained in compliance with federal regulations and guidelines.

According to media reports, Kaiser could face additional penalties as a result of a continuing state investigation of its patient grievance procedures and policies.

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