UPMC gets approval to restart living donor transplant programs

[Clark]

http://www.post-gazette.com/pg/11195/1160437-100.stm

UPMC gets approval to restart living donor transplant programs
By Sean D. Hamill

UPMC said today that the federal agency overseeing transplants said it could restart its living donor kidney and liver transplant programs immediately.

The transplant programs were shut down in early May after a bungled kidney transplant resulted in a kidney being transplanted that came from a donor who was infected with hepatitis C.

UPMC also shut down its living donor liver program shortly therafter because the people who evaluated donors for both transplant programs were the same for both organs.

After meeting Thursday with the United Network for Organ Sharing and its Membership and Professional Standards Committee and reviewing changes UPMC will make to its program, "We are able to resume live donor transplants immediately," said Abhinav Humar, chief of UPMC's transplant division.

The kidney from the infected donor was transplanted despite a positive test for hepatitis C that was missed by as many as six people on the transplant team, including a transplant coordinator, Mimi Funovits, who was suspended for two weeks, and a surgeon, Henkie Tan, who was stripped of his title as head of the living donor program at UPMC because of the error.

The changes UPMC will make to its programs includes adding multiple layers of checks and balances to ensure that such a test result is not missed in the future, Dr. Humar said.

UPMC postponed four scheduled kidney transplants during the shutdown, and waiting for the restart -- which took about a month longer than UPMC thought it would -- was difficult, Dr. Humar said.

"No question, it was stressful," he said. "I'm most sympathetic to the patients that have had this period of time of uncertainty."

Sean D. Hamill: shamill@post-gazette.com or 412-263-2579

[Clark]

http://www.pittsburghlive.com/x/pittsburghtrib/news/pittsburgh/s_746765.html

UPMC will resume live-donor liver and kidney transplants
By Luis Fabregas

UPMC reopened its live-donor liver and kidney transplants on Thursday, more than two months after acknowledging its surgeons transplanted a kidney from a donor infected with hepatitis C.

Federal reviewers with United Network for Organ Sharing concluded human error was responsible for the oversight, said Dr. Abhi Humar, chief of transplantation at UPMC's Thomas E. Starzl Transplantation Institute.

"I think ultimately we accept responsibility as a team. It was an error of the team," Humar told the Tribune-Review.

The live-donor kidney transplant program at Children's Hospital, which was shuttered temporarily by the suspension of the UPMC programs because it relies mostly on adult donors, also will restart immediately, he said.

The reactivation of the UPMC programs caps a tumultuous period at one of the country's best-known transplant programs. The incident prompted some patients to seek treatment elsewhere and put officials on the defensive about the quality of the programs operated at UPMC Montefiore.

"It's obviously something that we would not have liked to happen," Humar said. "It's been a stressful time for all of us, including most especially for our patients. "

UPMC voluntarily suspended the programs on May 9 without explanation. The Trib first reported the program's suspension and later that it was the result of a hepatitis C-infected liver donor whom officials had missed.

UPMC officials have not identified the kidney recipient.

"He is doing fine, and we continue to monitor him closely," said hospital spokeswoman Jennifer Yates.

A nurse who was suspended and a surgeon who was demoted are now working, Yates said. The surgeon remains demoted, she said.

The two overlooked a chart that contained information about the donor's infection. UPMC's transplant screening process includes blood tests to check donors for infectious diseases such as HIV and hepatitis.

UPMC officials have not received a final report from the UNOS membership and professional standards committee, which met yesterday in Chicago and gave UPMC clearance to restart the programs. UNOS officials, who reviewed the UPMC program in May, likely could conduct additional, unscheduled reviews of the program, Humar said.

The state Health Department will continue to monitor UPMC through its normal procedures after the health system submits a corrective action plan.

The plan includes establishing additional checks and balances so that multiple, independent workers will review donor records, Humar said.

"We now have multiple folds of redundancy built into the system to pick up these issues and problems," he said. "If it gets missed by one person, then there's someone else to be there -- sort of as a safety net."

At least eight patients waiting for transplants at UPMC chose to get listed at rival Allegheny General Hospital in the North Side in the wake of the UPMC developments, Allegheny General officials said.

UPMC should be able to overcome any damage the incident may have inflicted on the program's reputation, said Dr. John Fung, chairman of surgery at the Cleveland Clinic and UPMC's chair of transplantation until 2004.

"It's more important what you're going to do in the future," Fung said. "They're going to need to assess and reassess all the time if there are points in the process that can be improved."

Humar said the programs' primary goals remain patient safety and delivery of quality care.

"I'm very confident that the alterations and changes that we've made will only make the evaluation process and the whole transplant process that much better and stronger," he said.

UPMC surgeons in 2010 performed 62 living-donor kidney transplants out of a total of 152 kidney transplants, according to UNOS data. Yates could not immediately say if UPMC will be on pace to perform the same number of transplants this year. Officials might have a better sense of that once the program restarts, she said.

[Clark]

http://www.bizjournals.com/pittsburgh/news/2011/07/15/upmc-resumes-liver-kidney-transplants.html

UPMC resumes liver, kidney transplants
by Kris B. Mamula

An oversight group on Thursday cleared the way for the University of Pittsburgh Medical Center to restart is liver and living donor kidney transplant programs, two months after the services were voluntarily suspended over a quality control problem.
The United Network for Organ Sharing approved restarting the transplant programs after accepting UPMC’s corrective action plans, spokeswoman Jennifer Yates said. Both programs were suspended May 10 after a kidney from a person with hepatitis was transplanted into a patient without the disease.
The incident spotlighted a breakdown in quality control measures, which were designed to prevent such events. UPMC’s corrective active plan addressed those issues.
UPMC performed 152 kidney transplants last year, including 62 from living donors, according to UNOS. The fewest number of kidney transplants were performed at UPMC last year since 2001 when 150 transplants were done.

[Clark]

http://www.post-gazette.com/pg/11200/1161338-114.stm

Transplant error finds more at fault
A probe into the UPMC kidney transplant error found a nephrologist was also to blame
By Sean D. Hamill

The results of a positive hepatitis C test sat in a living donor's medical record at UPMC for more than two months before her kidney was transplanted into a man who did not have the virus, according to the findings of a federal investigation into the case.

But despite at least six chances to review the test result and possibly stop the transplant because of the potentially lethal hepatitis C infecting the donor, none of the doctors or nurses involved in the case did so, according to the Centers for Medicare and Medicaid Services (CMS) investigation.

Though UPMC has pegged the blame for the bungled transplant on the lead surgeon, who was demoted, and the transplant coordinator, who was suspended, CMS investigators say the transplant nephrologist, who reviewed the donor's condition prior to surgery, also was at fault. It is not known if the nephrologist was also disciplined.

  » See a draft of the Health and Human Services Centers for Medicare and Medicaid Services' report on
  UPMC's live donor program.
  http://www.post-gazette.com/pg/pdf/201107/20110719draft_hhs_upmc.pdf

CMS's investigation found UPMC committed two violations that are "condition" level, which is the most serious level and require that CMS do a follow-up with the hospital to ensure it has corrected the problems. CMS also found six lesser violations -- two of them "standard" level and four "element" level.

In the report, UPMC detailed its plan of correction and the various steps it has taken to ensure such a mistake doesn't occur again, most of which included adding additional people and checks and balances.

Dr. Abhinav Humar, UPMC's transplant chief, said Monday in emailed responses to questions: "We are however confident that our plan of correction is sound as it was approved by UNOS."

UNOS is the United Network for Organ Sharing, which oversees the nation's transplant centers and on Thursday gave UPMC to go-ahead to restart its kidney program. It had been closed since May 6, when UPMC voluntarily shut down the program because of the medical error.

The investigation's findings were made following CMS's on-site investigation June 7 and 8 at UPMC Presbyterian-Shadyside hospital -- which is how CMS in its report described the location of the transplant center.

CMS did not have the power to decide if UPMC could continue to do transplants or not. But it does have the power to decide if transplant centers like UPMC's get Medicare funding for surgeries -- a financial blow that could shut down most kidney transplant programs since more than 50 percent of kidney transplants are funded by Medicare.

CMS's investigation found that the donor, a woman who did not know that she was hepatitis C positive, was tested the morning of Jan. 26 and the positive hepatitis C test results came back the same day "with recommended follow-up testing to be completed," according to CMS's report.

That information was found in the donor's medical record. But the report does not indicate if the test was done in-house, when UPMC received the report, or whether the results were returned in a paper form or sent electronically to UPMC's computers.

"From our perspective, it's really irrelevant whether it's from a printout from a computer or written in ink," said CMS spokesman Martin Kennedy.

CMS's mandate is to follow Medicare rules for the standard of care for patients, and the standard of care does not consider what role paper or electronic records played in a medical error, Mr. Kennedy said, just whether the information was documented.

CMS also does not dwell on why something happened, so the report also does not indicate what excuses, if any, the doctors and nurse gave investigators for why they missed the results.

Dr. Humar said Monday in his statements that there was no other explanation for why everyone missed the test result.

Last week, Dr. Humar said that despite UPMC having one of the nation's most celebrated electronic records system, the surgeon and nurse in the case missed the result in the paper record. The paper test result was scanned in and was part of the electronic medical record, he said, but it also was not checked.

Sources have said that there was a highlight on the hepatitis C test result when it was put into UPMC's electronic medical record system but that everyone involved in the case missed it.

After the test result came in Jan. 26, there were two forms in the medical record that should have included the hepatitis C result, but it was never included on them, CMS reported.

There were then two meetings -- Feb. 17 and March 23 -- of the multidisciplinary selection committee to review the donor's status, but she was given final approval at the March 23 meeting, with no documentation of her hepatic C status.

Then on April 1, the lead surgeon in the case -- whom sources say was nationally known laprascopic nephrectomy expert Henkie Tan -- completed a "Transplant Surgery Consultation" note, but he showed no documentation of evidence of a possible hepatitis C result.

The woman's kidney was then removed April 6 and transplanted into the man. The woman and the man are a couple who live together. It is not known if he has been infected with the virus.

UPMC discovered the woman was hepatitis C positive after a follow-up test on April 22 came back on May 2. Four days later, the living donor kidney program was shut down.

Sometime early in the process, the transplant nephrologist met with the patient for an evaluation. UPMC's own policies required the nephrologist to take part so that the donor is "screened and evaluated ... with a complete history and physical examination."

In an interview by CMS investigators, the unnamed nephrologist said he "did not see the living donor patient or review the medical record after the initial visit."

CMS found that this was an element level violation on par with the errors by Dr. Tan and the nurse -- whom sources say is nationally known transplant coordinator Mimi Funovits.

But Dr. Humar said in an email reply to a question that UPMC's practice was for the nephrologist "to review the patient and the results that were available at the time of the initial evaluation. The donor surgeon and coordinator would review the labs that came back later, before verbally presenting it to the committee."

Dr. Humar wrote, "our protocol now has the coordinator, nephrologist and surgeon independently review all the tests when they are back before the patient is presented to the committee."

CMS will make an unannounced return visit to UPMC sometime within the 60 days after the report was completed on June 24.

Sean D. Hamill: shamill@post-gazette.com or 412-263-2579.

[Clark]

http://pittnews.com/newsstory/upmc-transplant-center-reopens-after-two-months/

UPMC transplant center reopens after two months
By: Andrew Shull

After being closed for more than two months, UPMC’s Living Donor Kidney and Liver Transplant Center has permission to re-open immediately.
The center has been closed since May 12 after a patient received a kidney infected with Hepatitis C from a live donor.
UPMC announced in June that they had demoted a doctor and suspended a nurse as a result of the incident. But UPMC will not release the names of the individuals.
Jennifer Yates — a UPMC spokeswoman — confirmed that the Living Donor Transplant Center had re-opened after a United Network for Organ Sharing committee met in Chicago Thursday to review UPMC’s case. The network is a private, nonprofit organization that manages the nation’s organ transplant system under contract with the federal government.
“We are eager to get back to doing what we do best, which is serving patients and providing the highest quality [of] care,” Yates said in an email.
UPMC’s website details the screening processes for donors. In addition to screening for infectious diseases, patients will also undergo a physical examination, a review of medicines they are taking, blood tests, tissue typing, an electrocardiogram, chest X-rays and even psychological counseling.
This screening process makes the situation at UPMC a very rare one. The UPMC website for living-donor kidney transplantation explicitly mentions that the medical center screens for HIV and hepatitis. But there is no national standard for testing transplant organs, each hospital sets its own.
Anne Paschke, a spokeswoman for the UNOS, said that the nonprofit would only discuss an investigation if it put a member on probation or deemed it to be “not in good standing.”
Paschke said that though she couldn’t confirm the existence of the investigation, neither action was taken against UPMC.
The original press release from UPMC in May named the UNOS as one of the bodies investigating the incident, and Yates said the UNOS gave UPMC the go-ahead to re-open immediately.
The Pennsylvania State Department of Health also completed an investigation of UPMC. Christine Cronkright — the Department’s press secretary — confirmed that it had concluded its investigation and that UPMC submitted a “plan of correction,” which UPMC plans to make available online in early August.
Cronkright was unable to provide any specifics at this time on the investigation or the plan of correction.
Yates also said that UPMC has introduced “redundancies” in its screening process to prevent a similar issue from arising again. The transplant center — which UPMC voluntarily closed for the duration of the investigations — has performed over 600 living donor transplants since 2002, when living donor transplantation became available at the hospital.
Yates would not say how many transplants had been postponed due to the closing.
Even prior to the incident, UPMC’s website explicitly said that they test for HIV and Hepatitis as part of the intensive screening process that all patients go through before receiving an organ.
While incidents like this are rare, they aren’t necessarily unheard of.
Statistics provided by the United Network for Organ Sharing show that from 2005 to 2010, there were nine cases of Hepatitis C transmission due to organ donation. One of those incidents resulted in a patient’s death.
Sue Simon, the president of the Hepatitis C Association characterized the test for Hepatitis C as “excellent.”
Simon also said that Hepatitis C — while it is the most recent variation of the virus— is the most dangerous, as it becomes chronic 70 percent of the time. In contrast, Hepatitis A is self-remitting, and Hepatitis B only becomes chronic 10 percent of the time.
Of the three types, Hepatitis C is also the only one that doesn’t currently have a vaccine.
The Hepatitis virus attacks the liver, and it damages the organ by causing scarring. Given enough time, Hepatitis can cause cirrhosis, which the NIH’s website defines as a life-threatening scarring of the liver and loss of function.
Simon said the most common way for Hepatitis C to be transferred is through contaminated needles. Hepatitis C — unlike Hepatitis B — is not often transmitted sexually, as Hepatitis C is only transmitted via blood and not through any sexual fluids.
Prior to 1992, blood transfusions were also a common route of infection. Until 1989, doctors thought that Hepatitis C was benign, and referred to it as Non-A, Non-B Hepatitis.
According to the Center for Disease Control and Prevention, 3.2 million people in the U.S. are infected with Hepatitis C.

[lawphi]

Having been approved as a donor at two different centers, I always received a courtesy copy of any lab results performed, with exception of my final hep c that lab corp lost....

[Donna Luebke]

Clark,

It is clear from this UMPC story that when qualified CMS auditors go in to investigate an adverse event, they they find things.  Bench audits accomplish nothing.  Do you know why CMS did not go to Boston to review the liver donor death at Lahey?  Was there any discussion at the OPTN/UNOS Board level about this??  Whatever UNOS auditors find is sealed from the public.  For some reason, there was lots of reporting on this case. 

Donna