"We Really Did Screw Up"
- Patients Wait—and Wait—for a Kidney
- Kaiser's First Missteps
- Bad Handoff No. 1: Botched Transfer of Records
- Bad Handoff No. 2: A Blizzard of Wait-Time Forms
- Patients vs. Kaiser: Get a Transplant Before It's Too Late
- Finger-Pointing Instead of Action
- Technology, Finally
Also in This Feature:
- Top Players Inside and Outside the Organization
- How Kaiser Stacks Up Against Other Kidney Transplant Facilities
Next page: Patients Wait—and Wait—for a Kidney
Patients Wait--and Wait--for a Kidney
After the third time in a year he thought he was scheduled for surgery to replace his failing kidneys, only to see the date pass by, Bernard Burks had enough. On that day in February 2006, he jumped into a car with friends, he says, and drove 90 miles from his home in Sacramento to the Kaiser Permanente hospital in San Francisco, without an appointment, determined to find a person to talk to him.
At 56, his right forearm bearing two large bumps from the shunts used to connect him to a dialysis machine, he was working to keep his real estate business going while battling the kidney disease that started him on dialysis on Christmas Day 2001. Burks had plenty of reasons to be upset at Kaiser, a $34 billion health maintenance organization headquartered in Oakland. In 2004, Kaiser told him and 1,500 other patients that if they wanted their care covered, they had to transfer from two University of California medical centers where Kaiser was sending them for pre-transplant treatment to a new renal transplant center Kaiser was opening in San Francisco.
Burks moved to the new facility, but then, he says, Kaiser lost records of his transfer, along with credit for the three years he had already spent on the kidney transplant waiting list at UC-Davis. Burks' daughter had offered to give him her kidney, but Kaiser couldn't seem to get the surgery scheduled. He would call the transplant center, he says, but his calls were rarely returned.
At Kaiser's San Francisco medical center, he rode the elevator to the transplant unit and walked down the hall. "I've been calling down here for weeks!" he remembers telling the receptionist. "I'm tired of this!"
He refused to leave until someone agreed to speak with him. After about an hour, he says, transplant coordinator Mary-Pat Sherman came out. "I was just about to call you," he remembers her saying. "We're inundated."
More than a year later, his face still tenses at the memory. "That's not my problem!" he recalls saying. Reached at her office at Kaiser, Sherman refused to talk to Baseline.
Burks, however, would soon discover he was not the only kidney patient struggling with Kaiser.
Kaiser opened its transplant center in 2004, but so bungled paperwork and procedures, according to state and federal investigators, that less than two years later, it shut down the facility.
Trouble at the center came to light last May, after the Los Angeles Times and KPIX-TV in San Francisco, which were tipped by a whistle-blower, reported on increasing wait times for Kaiser patients on the national kidney transplant list and other problems.
Few details about the exact nature of Kaiser's information management problems have been reported. However, in an attempt to document Kaiser's missteps, Baseline, for the past five months, has studied audit reports of the federal Centers for Medicare & Medicaid Services and California's Department of Managed Health Care (DMHC), which investigated Kaiser's transplant center, and reviewed court documents filed in cases against Kaiser. Interviews were conducted with key players, including patient Burks; whistle-blower and former employee David Merlin; officials at the United Network for Organ Sharing (UNOS), which oversees national transplant waiting lists; and health-care and information management consultants familiar with medical data governance and public information about Kaiser.
- An assortment of information management problems plagued Kaiser's kidney transplant center:
- During Kaiser's startup, there was no specific procedure established to transfer data on the initial 1,500 patients to UNOS, acknowledge officials from that organization as well as Kaiser.
- Kaiser compiled no master list or database of patient names to check that it had the records of all the patients who had transferred into its kidney program, according to Medicare and DMHC.
- More than 1,000 patient records had missing or incorrect data, such as erroneous Social Security numbers or missing test results, which delayed re-registrations on the national transplant list, according to Medicare. As of September 2005, a year after the facility opened, 330 Kaiser patients, including Burks, were still not credited with wait-list time they had accrued at the University of California, according to UNOS.
- The center, working mainly from paper records gathered from the University of California medical centers, according to Medicare, could take months to collect a missing data point, such as blood-test results, both Medicare and DMHC found.
- The transplant center, meanwhile, had no systematic way to track and analyze patient complaints, both Medicare and DMHC said, which would have alerted Kaiser to trends in problems.
- Kaiser staff worked with "inadequate" written guidance on how to do their jobs, according to DMHC, which also found that most of the center's staff lacked transplant experience. And while Kaiser named a transplant director, it failed to designate a chief executive responsible for the overall management of the center, a Medicare requirement.
In all, Kaiser failed to adhere to five state and 15 federal regulations.
The problems reflected Kaiser's "lack of effective planning," DMHC concluded, which "placed Kaiser patients at risk for disruption in care and potentially life-threatening delays in care."
In 2005, the center's first full year in business, twice the number of patients died waiting for kidneys at Kaiser as received transplants the reverse of regional trends, according to the Scientific Registry of Transplant Recipients (SRTR), a research group in Ann Arbor, Mich., that tracks U.S. transplant data. All 56 patients who received kidneys at Kaiser that year were still alive one year later, a key metric tracked by SRTR. However, Kaiser managed kidney transplants for just 6% of the patients on its waiting list, while UC-San Francisco, for example, transplanted 7% and UC-Davis 27%.
"I doubt that anything on the scale of the Kaiser problems ever occurs in transplant," David Magnus, director of the Stanford Center for Biomedical Ethics at Stanford University, says in an interview. "It really was an unusual situation fraught with difficulty." Magnus testified on Kaiser and other transplant centers at a California Assembly committee hearing last August.
Clinical and administrative staff at Kaiser either declined to comment for this story or didn't return calls. Matthew Schiffgens, a Kaiser spokesman, declined to make anyone available for interviews. He provided limited information to Baseline, via e-mail, citing "ongoing regulatory and litigation matters." Kaiser attorney Ronald Lamb did not return a call seeking comment.
In public statements, Kaiser executives defend its medicine but admit some administrative mistakes.
"The transplants were good. The transfers were done very badly. We did not anticipate how complicated that was," George Halvorson, chairman and chief executive of Kaiser Permanente, told the Commonwealth Club, a current-events discussion group in San Francisco, in March. "We really did screw up on the administrative side of those transfers."
Most companies don't risk harming customers if they mismanage information. But the potential for data management disaster hides in every organization, according to Tom Redman, president of Navesink Consulting Group, which consults with companies about data quality.
Whether by reeling in business groups previously outsourced, merging with another company or buying a new customer list, companies regularly must collect and make usable massive amounts of customer information never an easy task.
- Data broker ChoicePoint, for example, makes money selling consumers' personal information it collects from various sources. However, the company has been sued in the past by people who say their homeowner's insurance, auto insurance or employment status was messed up by data inaccuracies in reports supplied by ChoicePoint. Those suits have been settled or dismissed. In a Web post addressing "top myths" about the company, ChoicePoint says it can't change public information it didn't create.
- Last year, $1.34 million in tax refunds for Tennessee residents was returned to the Internal Revenue Service as undeliverable, according to Nashville newspaper The Tennessean. The IRS attributed the problem to incorrect or outdated addresses it had stored.
- FedEx last year had to recall 8,500 W-2 forms after workers reported that a portion of the forms contained pay information that wasn't theirs, according to The Orange County Register in Santa Ana, Calif. FedEx told the newspaper that its internal processing center may have misaligned the forms when printing them. The IRS said that although the mishap would cause FedEx to miss its Jan. 31 deadline for getting the forms to employees, the agency considered it "an honest mistake."
- A primary factor in The Hershey Co.'s well-known failure to fill retailers' candy orders at Halloween 1999 was that Hershey hadn't entered into its new SAP enterprise software all the locations where workers routinely warehoused chocolate bars and licorice. The software didn't know about all the product Hershey had available to ship, and stores didn't get the candy they were expecting. "We'd had a real problem with inventory inaccuracy," Kenneth Miesemer, then-director of Eastern distribution operations at Hershey, later acknowledged in a speech. Hershey's sales dropped $134 million that quarter, compared to the same period a year before, in part because of fulfillment problems.
And Redman says that not having detailed processes for moving data and/or not appointing specific people accountable for it can hobble business plans. "You see this over and over," he says.
Technology isn't the hard part of data management. Stewardship is, says Rob Karel, an analyst at Forrester Research in Cambridge, Mass. "It's a governance and process breakdown," he says, "happening all the time, across industries."
Kaiser's First Missteps
Kaiser stopped outsourcing kidney transplants in Northern California and brought them in-house in 2004. Because Kaiser already provided both pre- and post-transplant care for its insurance patients, doing the surgeries in between would "provide greater integration of care and convenience for transplant patients," says Schiffgens, the Kaiser spokesman.
If it could perform the 100 transplants per year it projected, Kaiser, nearly overnight, would preside over one of the largest kidney programs in the country.
After the state and federal investigations last May, regulators determined that Kaiser executives "failed to oversee" the transplant program, DMHC wrote. Nor were they "apparently even aware of the significant planning and other activities that would be required to transfer 1,500-plus members from the transplant lists of external providers, into the new Kaiser renal transplant program."
"The cumulative effect," Medicare concluded, "resulted in failure of the center to deliver statutorily mandated services and comply with federal requirements." At that point, Kaiser gave up on the center. Faced with either fixing it or losing Medicare funding, the company avoided both scenarios: Within days of the inspectors leaving Kaiser's offices, Kaiser said it would transfer all of its patients 2,313 by then back to UC, then shut the center down.
Kaiser has paid a $2 million fine to DMHC for the deficiencies the agency cited after its investigation, the largest fine ever dealt by the state to an HMO. Kaiser also volunteered $3 million in contributions to a transplant education group.
But other investigations may be in the works. Arthur Weatherford, assistant chief of investigations at California's Bureau of Medi-Cal Fraud and Elder Abuse, which investigates medical harm of the elderly, exchanged e-mail about Kaiser with Merlin, a former administrative director of the Kaiser center and, later, the whistle-blower who exposed Kaiser's problems to regulators and the media. Weatherford didn't return Baseline's calls. A source inside the bureau confirmed that it is looking into the matter but wouldn't say on what grounds.
DMHC, meanwhile, continues to investigate how Kaiser handles patient complaints. Burks and at least 50 patients and families of people who died waiting for kidneys at Kaiser are suing the company in separate cases for, among other charges, medical negligence or wrongful death. Kaiser declined to discuss the lawsuits.
"Something went awry here and nobody may ever know what," says Jim Morell, president of Morell & Associates, a health-care consultancy in Northbrook, Ill., that has no direct knowledge of the transplant center, but has been following public accounts of what happened. "Kaiser made a decision going forward that it's not worth what it had to do to clean it up."
Core questions remain, including why it wasn't until Kaiser decided to close the center that it put in information technology, such as custom spreadsheets and a virtual private network between it and UC, to help manage patient data. Why, despite Kaiser's pioneering work in electronic medical records since the early 1990s, the new transplant center apparently managed most incoming patient data on paper. Why it didn't use one of the specialized transplant databases available from health-care technology vendors. Why it wasn't until the end that Kaiser developed basic policies and procedures, such as weekly meetings and monthly reports, to ensure data didn't go missing and appropriate parties stayed apprised of Kaiser's progress with patient records.
The lawsuits may eventually produce answers, through testimony and documents. However, court filings show Kaiser lawyers are working to get the suits out of open court and into arbitration, where the company usually settles legal disputes with patients.
As the story continues to unfold, so do warning lessons, health-care consultant Morell says. In trying, as many companies do, to get information across boundaries, between organizations, and from paper to electronic form, he says, "you have the opportunity for everything to go wrong which it obviously did."
Bad Handoff No. 1: Botched Transfer of Records
What Kaiser attempted to seed a new kidney transplant program by moving 1,500 patients from other hospitals during the course of several months had not been tried before, according to UNOS officials. Usually, new centers grow gradually after opening.
Problems emerged even before Kaiser's first surgery in October 2004, starting with confusion over letters it mailed that summer telling patients of the new venture.
Kaiser wrote that as of Sept. 1, 2004, its insurance side would no longer cover kidney transplants done at other hospitals. Unless they could find another way to pay for what is on average a $210,000 transplant in the U.S., patients should sign forms to drop UC and make Kaiser their new, and only, transplant center.
But getting those patient consents proved difficult, according to DMHC's report. For example, none of the letters DMHC reviewed included explicit instructions for patients about what to do with an enclosed "wait-time transfer form" UNOS requires before it will credit patients with wait time from their prior transplant center when they enlist at a new one.
Sherman, Burks' transplant coordinator, told Medicare investigators that a "large number" of patients failed to respond to the letter, didn't return the required consent forms or faxed forms to UNOS when they should have gone to Kaiser.
Ultimately, "lack of clarity" in those transfer documents, DMHC said, "was a significant factor in delaying members' access to kidney transplant services." Delays then mushroomed when Kaiser tried to set up patients' medical records. For example, Kaiser hired contractors to go to the UC hospitals to get paper copies of patient files. Confusion ensued there, too, Sherman told DMHC, as UC-San Francisco at one time told Kaiser that patients had to sign release forms before it would give out their information. Kaiser, however, thought it was entitled to the data without authorization from individual patients because of the health-care provider contract between it and the UC hospitals, she said.
It's unclear how the issue was resolved. A UC-Davis spokeswoman did not respond to questions by phone or e-mail.
A spokeswoman for UC-San Francisco would not discuss the management of Kaiser patients' data, saying, "These were Kaiser's issues, not our issues." But Kaiser's contractors brought back hundreds of patient histories. Laura de Belen, Kaiser's sole data coordinator, was on the receiving end of that paper tsunami.
De Belen still works at Kaiser and declined to talk about the kidney center. But during questioning by DMHC inspectors, she described working 10 to 16 hours per day, trying to process 100 files daily.
Key to that processing was updating the kidney wait-list database at UNOS, to reflect that patients had moved from UC to Kaiser. Heart, kidney, intestine, pancreas, liver, lung all transplantable organs fall under the purview of UNOS, which oversees 258 transplant centers and 58 organ procurement organizations in the U.S. When a patient moves or changes doctors, he might switch transplant centers and request that his wait time be transferred to the new center. That involves two steps—one electronic and one on paper.
First, as she had learned to do during an hour of UNOS training by telephone, according to Medicare, de Belen would log on to UNOS' secured Web site. With paper files in front her, she picked out the required patient demographics to type in, such as name, birth date and Social Security number. She also entered the needed clinical data, such as blood type, urine test results and dialysis information. This information is necessary to match transplant candidates to donated organs; without it, UNOS won't register patients on the national waiting list to receive organ offers.
Then, as UNOS directs, de Belen would fax in UNOS' wait-list transfer forms. UNOS prefers fax or mail for these forms so it has a physical record of patient and doctor signatures.
In a typical week, nationwide and across organ types, UNOS handles 10 to 15 such requests to change centers. Kaiser was submitting hundreds at once and many were imperfect, says Berkeley Keck, assistant executive director of information technology at UNOS.
Some of the Kaiser files lacked pieces of information, such as blood test results going back several years. One factor: Some patients had been at UC for a long time, as the wait for a kidney can last more than five years. Older data about them wasn't always immediately available from UC, residing in separate laboratory databases or stored offsite, according to Merlin.
Also, transplant centers can differ in how they do particular lab tests, and UC's standards might have been different from Kaiser's. For example, knowing that a patient's naturally occurring antibody proteins fight foreign bodies and could sabotage a new kidney, centers test patients for antibody reactivity levels. The University of Minnesota Medical Center-Fairview, for example, tests at a patient's initial evaluation, then monthly for two months, then quarterly, says Cathy Garvey, a transplant coordinator at the Minneapolis facility.
But other centers don't do it as frequently, Garvey says. Kaiser sometimes had to order fresh tests for incoming patients, Merlin notes, which also delayed registrations.
De Belen told Medicare and DMHC inspectors that she would lay aside each incomplete medical record for Sherman, Kaiser's then-only transplant coordinator, who in addition to her nursing and clinical duties had to hunt down the data by calling and faxing UC.
When Medicare officials asked de Belen about the prevalence of the problem, she estimated that all told, incomplete records numbered more than 1,000 two-thirds of the patients Kaiser was trying to absorb from UC.
Schiffgens, the Kaiser spokesman, would not say what kind of software de Belen used for patient record-keeping inside the kidney center if any at all. He did say de Belen was not using CIPS, or Clinical Information Presentation System, which is Kaiser's homegrown electronic medical records application, built in the mid-1990s. Nor was the transplant center running HealthConnect, he says, software from Epic Systems that is now replacing CIPS.
In comparison, the Tulane Center for Abdominal Transplant in New Orleans has two dedicated technology staffers to support patient databases that track health status, test results, appointments and other items. "It's almost impossible to run even a small transplant program if you don't have a database," says transplant administration director Marian O'Rourke.
At Kaiser, answers about missing or errant data took months in some cases, according to Medicare and DMHC. Merlin attributes the holdup to busy days at UC, which was focused on its own patients, and Kaiser staff being "overwhelmed" by the volume of data to manage. Sometimes, according to the Medicare report, Kaiser would lose track of patients for whom it had already requested, and in some cases received, missing information. For example, an e-mail message from UC-San Francisco to Kaiser in November 2004 urged Kaiser "to re-review your list" so UC staff didn't have "to repeat work that has already been done." UC spokeswomen declined interviews.
But there was no master list of patient data to review, Medicare and DMHC discovered. Why not is a mystery, says Larry Eisenberg, a lawyer in Irvine, Calif., for two of the patients suing Kaiser for medical negligence and other charges in state Superior Court in San Francisco.
Eisenberg wonders whether Kaiser's transplant center could have queried systems at Kaiser's health maintenance organization to generate lists of patients one, for whom the HMO branch of the company provided insurance coverage for kidney services, and two, who were at the time registered for transplants at UC. "They had to have information on the programs their patients are at," he says. "They're paying the bills. They had access to their own database."
Bad Handoff No. 2: A Blizzard of Wait-Time Forms
At UNOS, meanwhile, wait-time transfer forms rained down. Keck remembers hearing the whir of the fax machine for weeks on end. "It's right outside my door," he says.
He and his 98 technology staffers were among the first people outside Kaiser alarmed by mounting data problems.
As wait-time transfer forms arrived, UNOS data analysis workers grabbed them to begin verifying that the person who signed was the same person whose records UNOS already had in its 1-terabyte Microsoft SQL Server database, under UC-Davis or UC-San Francisco. They also checked the data on each person that de Belen had entered electronically into UNOS's system via the Web, to see if it matched.
To do these verifications, UNOS ran a custom-built application whose fuzzy logic a way of programming software to evaluate imprecise and partially missing data appraised the likelihood that a patient new to Kaiser was the same one who had been registered at a UC transplant center, Keck says.
When de Belen's entries were complete and matched existing UNOS data, UNOS then transferred any waiting time, down to the second, the patient had previously accrued to his new listing under Kaiser.
When entries didn't match and hundreds didn't UNOS called Kaiser about the discrepancies, or e-mailed a list of them in an encrypted Excel spreadsheet, according to Keck. Until those were resolved, the patient was unregistered. A Kaiser record might have the same name and date of birth as a UC record, but the Social Security number, for example, would be off. Maybe it was a typo. Maybe it was a different person. As final authority on the wait list, UNOS had to be careful, Keck says.
Kaiser was "adding patients and wanted to immediately grant them large amounts of waiting time accumulated at another center," he explains. "It's extremely important that we get that correct." Taking time from the wrong person "would disadvantage them" in the competition for kidneys, he says.
One Kaiser staff member told DMHC that transplant director Dr. Sharon Inokuchi "stepped forward" and "yelled at" UNOS because Kaiser could not find out why patient registrations weren't being transferred. However, Keck counters, "The ball is in their court to provide some documentation of correct information." Inokuchi did not return Baseline's call for an interview.
Finding correct dates for when patients started dialysis was particularly troublesome for Kaiser, Keck recalls. He doesn't know why, but Kaiser's dialysis data for some patients differed from what UC had provided UNOS for the same patients. Perhaps the dates were not in the files Kaiser had, and if Kaiser asked patients themselves, they remembered incorrectly, he offers as one theory.
Time on dialysis is important in calculating a patient's rank in a match run for a kidney. Several studies, including one in 2000 from the University of Michigan that looked at 10 years of data on 73,000 patients, have shown that the longer someone has been on dialysis, the lower his survival rate after transplant. All other things being equal, wait-list patients who have been doing dialysis longer will be ranked closer to the top of the list when a kidney comes up. The dialysis date "has to be correct," Keck says.
Whatever the reason for discrepancies, he says, it wasn't an impossible puzzle: "Just pick up the phone and call the dialysis center."
Keck grew frustrated when Kaiser wouldn't respond for months with corrected data for so many patients. "I've been here 15 years and this is a first for me," he says. Before going into technology in 1992, Keck was a clinical nurse who helped people cope with stress before and after transplants. "The first half of my career was essentially taking care of patients," he says. "If there's a situation that is compromising the opportunity for a patient to get an organ, it's personally distressing to me."
Patients vs. Kaiser: Get a Transplant Before It's Too Late
Bernard Burks' luck ran out in 2004. His kidneys, which had been temporarily knocked out in 2001 by treatments for the hepatitis he'd acquired as a young man, failed again. He was back on dialysis.
By the time Burks made his unannounced visit to Kaiser's transplant center in 2006, to sit, unbudging, in front of the receptionist, he says he had been battling Kaiser almost from the first day he was sent there from UC-Davis in January 2005. The year had been full of frustrations, according to his lawsuit filed last June in state Superior Court in Sacramento. Kaiser denies Burks' charges. But the experiences he relates in the suit and in interviews mirror many of the problems state and federal regulators would later find.
In addition to losing his records and his time on the transplant waiting list, Burks' lawsuit says, Kaiser lost track of his daughter, Leatha Sims, after she volunteered to give him a kidney. In February 2005, he got a letter from Kaiser asking if he knew anyone who would donate a kidney, even though Kaiser had already assigned a transplant coordinator to Leatha. Upset, he complained to transplant director Inokuchi. "If I ran my business in the same manner, I would have been out of business years ago," says the letter, dated March 8, 2005, in his court file. Burks' lawyer, Michael Bidart, who leads the HMO litigation practice for Shernoff, Bidart & Darras in Claremont, Calif., says he doesn't yet know the cause of Burks' problems with Kaiser. But, he says, the Kaiser kidney transplant cases are "as bad as anything I've seen." Kaiser attorney Lamb did not return a call seeking comment.
Setbacks continued for Burks. He thought he had a transplant date in July 2005, but the month came and went, and in October of that year, he got a letter from Sherman, his transplant coordinator, informing him of several obstacles to surgery. Some were disputes with Kaiser about his treatment, but one chronic lung disease he claims he never had. Furious, he fired off a reply, this time copying Inokuchi; his congresswoman, Doris Matsui; and Sen. Barbara Boxer.
"If you are so busy, Mary-Pat Sherman, hire some help!" says the letter in his court file. "You have lives on the line!"
That second letter produced a small flurry of activity. Pending more tests, he says, he was promised a transplant date in January or February 2006. But those dates also passed with no surgery. And even though Kaiser at some point did find the records of his transfer from UC-Davis, he says, Leatha couldn't get her calls to Kaiser returned, either. By now, she had moved to Texas but continued to be tested for surgery.
Meanwhile, Burks was spending three afternoons a week in dialysis getting a machine to clean his blood because his kidneys couldn't, a process that he says left him feeling "like a limp piece of spaghetti." His lawsuit, which charges negligence, asks for unspecified punitive damages for physical injury and severe emotional distress. "Your body's always racing, trying to replace those nutrients [that, along with the waste the machine sucks out of you," he says. "I think this is what kills you."
Every so often a patient at his clinic, often a friend, would die waiting for a kidney. "All of us are hoping to get a kidney; most of us will not due to our health conditions and the shortage of kidney donors," he wrote about his dialysis experience to Inokuchi on May 1, 2006, 12 days before Kaiser shut down the transplant center. "It's the dead pool, a group of people that meet three times a week and befriend each other, and about every 60 to 90 days one of them dies."
Kaiser is fighting to move Burks' lawsuit to arbitration, but the first ruling favored Burks. In October, a Superior Court judge in Sacramento ruled that when Burks joined Kaiser, he unfairly signed away his Constitutional right to a trial by jury because the arbitration notice Kaiser gave him as a new member was in unobtrusive 7-point type at the bottom of his enrollment form without italics, highlighting or bolding. The notice violated a "prominence" standard of the California Health and Safety Code, the judge ruled. Kaiser has appealed.
Four days before Kaiser's shutdown announcement, Burks was summoned to San Francisco by Kaiser surgeon Dr. Craig Lubbock, who offered to set up a surgery for him within the month, according to his lawsuit. Burks refused. "After what happened,
I didn't want Kaiser operating on me or my daughter," he says.
Now he's a patient at Stanford University Medical Center. But in September, once again his luck ran out. Three days before his transplant was supposed to take place, he says, tests on his daughter revealed high blood sugar, and his doctor said she could no longer donate.
Like 71,311 other people in the U.S., Burks now waits for a cadaver kidney. Stanford called UNOS and got his prior wait time restored, he says, which will put him higher on the waiting list. But his health is uncertain. Concerned about how well his kidneys are working, his doctor may lengthen Burks' dialysis sessions from 3 to 3 1/2 hours, three days a week, if his test results continue to decline.
Burks hopes to live long enough to see his lawsuit through, and win. Fingering the brim of a cap that reads "Panama Canal," he says he'd like to buy a motor home and travel. "Money never helped a dead man," he says.
No Complaint System
Burks never did meet David Merlin, the administrator who blew the whistle on Kaiser's center, even though Merlin started working at Kaiser in December 2005, two months before Burks staged his sit-in. Merlin says he knew when he was hired that the center had a backlog of patients. But he realized the personal impact of that situation a few weeks into the job, when he started taking patients' complaints.
Gazing out the window of a San Francisco coffee shop a few blocks from his old office at Kaiser, Merlin says he heard every day from people unable to get appointments with their doctors, for example, or even get phone calls returned. Phone messages from patients might be passed between the transplant center and patient relations for months, he says. Sometimes they got lost. "I saw hundreds of patients' messages unanswered," he says, his face reddening. "I was horrified and overwhelmed, and spent all of my time on the phone."
State and federal regulators confirmed that Kaiser, unlike other transplant centers, had no systematic way of handling complaints. New York-Presbyterian Hospital in New York City, for example, surveys transplant patients monthly and tracks their complaints in a database to develop plans for improvement, says senior coordinator Dianne LaPointe Rudow. The Tulane abdominal program documents and monitors all processes, according to O'Rourke. "If your program doesn't look at the patient as the absolute primary focus, then you're on the wrong track," she says. But at Kaiser, "patient grievances and complaints were not acknowledged, resolved or tracked in accordance with regulatory requirements, nor were they reported or evaluated," said DMHC, which is still investigating Kaiser's complaint system.
Merlin lasted at Kaiser only two months, until mid-February 2006. Kaiser fired him, he says in his suit for wrongful termination, filed last July in San Francisco Superior Court, after he approached senior administrators and doctors about the lost wait times and other problems he saw at the center. Kaiser denied Merlin's charges and in January settled the suit for an undisclosed sum. The people Merlin spoke to at Kaiser told him to keep quiet about the problems and focus on improving the transplant center's administrative systems, he says, but he refused. He saw patients suffering, and he feared he would be held responsible if he didn't report it to regulators. After he left Kaiser, he hired lawyer Brian Taugher, a former California deputy attorney general who represents whistle-blowers, and together they approached several state and federal agencies.
On May 3, 2006, the workings of the Kaiser kidney transplant center were splashed across the pages of the Los Angeles Times and on the nightly news at KPIX-TV, the CBS affiliate in San Francisco.
Finger-Pointing Instead of Action
Nearly all of the organizations involved blame each other for different aspects of the transplant center's breakdown. Kaiser executives, including Northern California president Mary Ann Thode and national CEO Halvorson, say UNOS shares responsibility for Kaiser's administrative problems. At the March Commonwealth Club meeting, Halvorson said UNOS was unprepared to handle Kaiser's demands. "We said, 'What does it take to transfer people from one list to another?'" he recounted. "They gave us an estimate, we relied on that estimate, and what's interesting about that is they assumed we were talking about transferring one person. They didn't think we were going to transfer 2,000 people."
Keck at UNOS agrees that he and his staff "were completely unaware" that Kaiser would be sending data on so many patients, but that Kaiser should have been clearer. If the launch of the center "had been treated as a major project, with all the players meeting and scheduling their pieces and putting processes in place to accomplish things, it wouldn't have been like it was," he says.
He adds that regulators should have audited Kaiser sooner, based on its transplant surgery record performing operations at a slower rate than other centers in the region, and twice as many wait-listed people dying as getting kidneys. "You have to wonder, how does a health care system evolve to that kind of situation?" he asks. "What are the quality-management processes going on there? Where are the accrediting bodies?" Deborah Romero, Medicare's survey and certification manager for San Francisco, says her agency acts on patients' complaints, and they didn't have any before the stories about Kaiser broke in the media last May. "Our initial survey was triggered by the Los Angeles Times," she says. Patients, she adds, didn't seem to know where to go to complain. DMHC declined to comment. Karel, the Forrester analyst, says regulators define data and process rules, and hospitals must comply, with all parties creating "an information ecosystem." It happens in most industries. In this case, he says, "Kaiser is the care provider and in the end, they're responsible."
In the year since Kaiser said it would close the kidney center, the company has worked to move patients back to the UC facilities and put in new technology and procedures to help. By June 30, 2006, Kaiser had transferred 360 patients. By Dec. 31, 2006, 2,163 patients had been moved. Last month, the last patient left Kaiser's rolls.
A virtual private network between Kaiser and the two UC hospitals allows them read-only access to Kaiser's internal CIPS electronic medical record application. The UC hospitals can print medical records from CIPS, to add to their files as they accept patients back. Kaiser has helped train at least 50 UC people on it and on HealthConnect, Schiffgens says.
UC and Kaiser also agreed on the format and content for data fields in patient records, and Kaiser created a "transfer tracking" spreadsheet to keep a running record of patient information transferred, with daily and weekly status reports generated. Kaiser put in a toll-free line for patient complaints and configured a database for collecting, responding to and analyzing them. Kaiser, the UCs and UNOS met weekly by conference call with DMHC to report progress. Kaiser also underwent monthly audits for compliance to UNOS wait-list policies, added another data coordinator to help de Belen and named a CEO for the center.
This work after the fact, to set up technology and define procedures, shows Kaiser's 2004 launch of the center "wasn't thought through properly," says patients' attorney Eisenberg. "They didn't do proper due diligence on what it would take to open a program of this nature."
For Ed Japitana, a nurse consultant at Medicare who investigated Kaiser, the problems came down to two things: not enough staff and not enough well-considered policies. From the beginning, when Kaiser sent initial paperwork to patients and gathered medical records from UC, more time should have been allowed, and more resources applied, to data management, Japitana says.
"The delay was in staffing and policies and procedures," he points out. "Kaiser should have taken this into account, but didn't."
As Merlin puts it: "They just opened the doors and turned on the phones."