Shands Jacksonville kidney transplant program in disarray

Shands Jacksonville kidney transplant program in disarray
Documents show Shands Jacksonville was failing 6 of 12 federal standards when it ended program voluntarily.
Posted: June 14, 2011 - 12:00am

KELLY JORDAN/The Times-Union
“I am lost in the system” That is how kidney dialysis patient Tammy Patterson of Jacksonville felt after Shands Jacksonville made the decision to shut down its transplant program. She transferred to the Mayo Clinic and is on track to receive a kidney soon from a living donor. Nevertheless, she said she feels betrayed by Shands Jacksonville.

Conditions of participation

The Centers for Medicare and Medicaid Services require existing transplant centers to meet 12 requirements to maintain eligibility for reimbursements. Shands Jacksonville failed to meet half, according to an internal audit in January. Here's what it passed and failed.

Passed

- A transplant program must be in a hospital that is a member of the Organ Procurement and Transplantation Network and follows that organization's rules.

- Centers for Medicare and Medicaid Services must be notified of any significant changes, such as a decrease in survival rates.

- Programs must have written protocols for validation of donor-recipient blood type and other vital data.

- Programs must receive approval to perform transplants on pediatric patients.

- All staff must be qualified to perform their functions.

- Programs must ensure it has a written agreement for the receipt of organs from a qualifying organ-procurement organization.

- Patients' rights must be met.

Failed

- Programs must meet all data submission, clinical experience and outcome requirements.

- Programs must use written patient selection criteria in determining transplant eligibility.

- Programs must follow written patient management policies governing the transplant and discharge phases, as well as keep waiting lists up to date.

- A "quality assessment and performance improvement plan is required.

- Programs must have ways to document and address and document adverse events.

- Kidney transplant programs must keep up communications with local dialysis facilities.

By Jeremy Cox
In the waning days of the kidney transplant program at Shands Jacksonville, the hospital's executives faced a stark decision: Shut down the ailing center themselves or risk it being closed by federal regulators.

Documents obtained by the Times-Union in a public records request show that the 20-year-old program was in disarray leading up to its voluntary Jan. 12 shutdown. The hospital's top compliance officer emailed her bosses six days earlier with a grim internal assessment, revealing that the program failed to meet six of 12 federal standards.

The problems included:

- Patients' three-year survival rates falling to levels lower than regulators would expect given their prior health.

- A failure to follow its own "adverse events" policy. The reviewer investigated two known cases in which a staff error compromised a transplant's success and found that no one followed up to find out what caused the mistakes or took steps to ensure they didn't happen again.

- An abundance of record-keeping issues. In one of the most egregious examples, half of the patients on the waiting list were actually ineligible for a transplant. And nearly half of the surgery files reviewed were missing at least some data pertaining to the patients' eligibility.

As soon as the news of the closure trickled into local media outlets weeks later — there was no public announcement — Shands Jacksonville officials repeatedly insisted that the decision was based solely on low patient volumes. What they knowingly left out: The program's performance and record-keeping problems were piling up.

Emails show that hospital officials intentionally misled local media outlets about the full extent of the program's breakdown. In a memo to Shands spokesman Dan Leveton about how to address the media, Steven Blumberg, vice president of planning and business development, said, "If asked, we will say that a program with low volumes is not economical to operate and that quality can be ensured with higher volumes."

In his statement prepared for local media, Leveton deleted Blumberg's reference to quality, writing that the decision was triggered by "very low surgical volumes ... that no longer allow it to be viable." The former reporter for WJXT TV-4 said in a recent email exchange with the Times-Union that the hospital has been consistent in its position on the program's closure from the beginning.

"I read your note with some surprise," he said. "It would seem that you are making an enormous leap in your assumptions."

Leveton cited a letter to the Times-Union's editorial board that said, "We were concerned about our ability to operate the program at the high quality standards to which we aspire in all of our clinical programs."

The editorial was signed by Jim Burkhart, Shands Jacksonville's CEO, and Robert Nuss, dean of the University of Florida College of Medicine Jacksonville.

The editorial board received the letter May 5, more than two weeks after a Times-Union reporter obtained the public records from the hospital and began asking questions about their contents.

Not enough transplants

In an interview shortly after the Times-Union received the requested documents, Burkhart acknowledged that the problems raised in the internal assessment also played a role in the shutdown.

"The program was closed based upon the information in that report and the low volumes we were seeing," he said. He added that the in-house investigation of the program was a matter of routine, to uncover potential problems before they end up in a regulator's report.

In some ways, the low volumes were the biggest problem, Burkhart said. If a surgical team goes untested for too long, its skills can deteriorate, potentially leading to mistakes. And it only takes a few poor outcomes to make a small program's statistics look bad, he added.

As he read the report, Burkhart said, it became clear that the program's problems were going to be too difficult or costly to fix. For one, all of the waiting-list patients are supposed to be seen by a physician annually, but 83 percent hadn't been checked in over a year, the compliance official, Susan Burgess, found. There was no way to go back in time to fix that, Burkhart said.

Burkhart cautioned against interpreting from the report that a government-mandated closure was imminent.

"Not necessarily," he said, "because at first they would say, 'Here's what you have to do to fix it.' Most agencies don't come in and shut you down that day."

A 'little embarrassing'

However, the results of the internal survey were so poor, wrote Burgess, that the transplant program faced a "high probability" of losing its Medicare certification, snapping its financial lifeline.

Burgess shared her findings in a Jan. 6 meeting with several Shands and University of Florida officials, including Burkhart, Nuss and chief of surgery Michael Nussbaum.

They decided that day to close the program. With a Medicare contractor scheduled to inspect the center in person the following month, hospital officials knew they had to act fast.

So fast, in fact, they didn't alert the 231 waiting-list patients until eight days after their decision, despite a federal rule requiring them to be told "as soon as possible" before shutting down. An ensuing investigation by state health officials found that Shands was in violation of those regulations.

Burkhart said in the interview that the hospital followed the advice of the lead transplant authority.

Hospital officials contacted the United Network for Organ Sharing, a nonprofit that manages the U.S. transplant system, and were told that patients had to be notified within seven days after the closure.

"From our perspective, we did what you told us to do," Burkhart said.

The move left patients scrambling to find alternative transplant centers.

Many, including Jacksonville's Tammy Patterson, transferred across town to the Mayo Clinic. Although she is now on track to receive a kidney from a living donor soon, Patterson said she still feels betrayed by Shands because she didn't get more notice.

"It all comes back to money, even their fear that Medicare was going to pull the rug out from under them," Patterson said. "Shands is supposed to be a hospital for the people. Well, guess what? They're not."

Shands is run by a private not-for-profit company, but it is widely seen as Northeast Florida's safety-net hospital.

The city of Jacksonville gives the facility about $23 million a year to care for the city's poor, and it gets millions more from the state.

Patterson wasn't alone. At least some of the hospital's staff were kept in the dark about the program's closure until Burkhart sent an email to all hands on Jan. 21, a day after the news broke on a local television station.

"Little embarrassing when the staff approached me about the closure when they saw the media on Thursday evening from one of the local news stations," Greg Williams, a registered nurse and director of clinical services, said a few days later in an email to Shands officials closer to the decision. "Still didn't know the specifics until the 'Everyone E-mail' went out from Jim."

Paperwork blamed

At the key Jan. 6 meeting of the hospital's top minds, Burkhart, Nuss and Burgess were most critical of the program's sloppy record-keeping. Nussbaum, the head of surgery, later told a colleague he was "not able to explain or defend why we have not been compliant with these measures."

That colleague was Thomas Peters — the program's lone full-time transplant surgeon, the man who had led it from the beginning.

In his lengthy and detailed response, he conceded some of Burgess' observations and vigorously rebutted others.

The program wasn't following its adverse events policy, he wrote, but he thought that Burgess' audit would be used to lay the groundwork for revamping the program's protocol. He noted that he was "ill-equipped" to handle the matter himself but didn't specify why.

Peters declined to comment on stories related to the program's closure.

The reason most of the waiting-list patients hadn't been re-evaluated in over a year: The program gave up trying to update "older records" and focused on staying up to date with new patients, Peters wrote.

Staff knew that nearly half of the listed patients were no longer eligible for a transplant and were working on purging them from the list, beginning with 30 who never finished the evaluation process. Peters flatly denied the finding that some records were missing eligibility criteria.

Record-keeping is critical to a sound transplant program, said Donna Luebke, a registered nurse and patient advocate from Cleveland who once served on the UNOS board.

"If you can't manage your paperwork which is supposed to be so minor, how are you managing your patients?" she asked.

J.T. Rhodes, former president of the Transplant Recipients International Organization and Jacksonville resident, was taken aback by the audit's findings.

"I think you can go into any program and find faults," said Rhodes, who has been close to Peters for many years. "I find it a little bit unbelievable he would let a program do that."

jeremy.cox@jacksonville.com, (904) 359-4083

Read more at Jacksonville.com: http://jacksonville.com/news/health-and-fitness/2011-06-14/story/shands-jacksonville-kidney-transplant-program-disarray#ixzz1PPBhMzBg