The Pennsylvania Department of Health has cited four of Temple University Hospital's transplant programs - lung, kidney, heart and liver - for failing to meet federal rules for participating in Medicare.
In a report posted recently on its website, the state said Temple's lung- and kidney-transplant programs had lower-than-expected one-year graft survival rates. The graft is the transplanted organ. Patients may still be alive if they received another transplanted organ.
The state also said Temple had done too few heart transplants. In a less-serious violation, the state said Temple's liver-transplant program had failed to keep some patients informed of their status on the transplant waiting list.
A Health Department spokeswoman said she would "not provide any further comment regarding any possible pending actions involving Temple." The Centers for Medicaid and Medicare Services (CMS) said Temple would have seven months to respond. During that time, the program can operate normally, said Anne Snyder, a nurse consultant with CMS's transplant program.
"We're not taking immediate action, but we expect that the programs are responding to the data immediately," Snyder said. CMS wants to see that the hospital has "looked critically at all their operations," hired the experts it needs, and made changes that will improve results.
Temple has not yet filed a plan of correction to the report, which was based on a site visit in April, according to the state Health Department website.
Rebecca Harmon, director of public relations for Temple University Health System, said the kidney program had not been flagged for any problems with patient survival. "Our practice is to complete an in-depth analysis of every graft failure and make changes, as appropriate - which is what we did during the period reviewed in the CMS report. . . . As a result, the program continually achieves improved processes though ongoing performance-improvement activities."
This month, Temple said it would voluntarily inactivate its lung-transplant program Friday because its primary lung-transplant surgeon was leaving for another job.
Last August, the state said Temple's lung-transplant program had one-year patient and graft survival that were lower than expected for patients transplanted between Jan. 1, 2007, and June 30, 2009. That report was based on data from the Scientific Registry of Transplant Recipients (SRTR), a government-funded database.
The state added that Temple had lower than expected outcomes in two of four prior SRTR reports: in January 2010 and July 2009.
Last summer, Temple told the state that it had hired new surgeons in 2009 and made several other improvements to the program.
The new report covered patients transplanted between July 1, 2007, and Dec. 31, 2009.
The expected number of deaths in the lung-transplant program was 14, while the actual number was 36. Fifteen graft failures were expected and 37 occurred.
In the kidney program, 3.12 graft failures were expected between July 1, 2007, and Dec. 31, 2009. The actual number was seven, the state report said.
In its most recently posted report on that time period, the SRTR did not consider the kidney graft failures higher than expected.
CMS's Snyder said her agency may have used a different measure of statistical significance than SRTR did. She said Temple's kidney-transplant numbers were out of compliance during two of the last four six-month reporting periods, which triggers regulatory action.
CMS requires transplant programs to perform 10 transplants of each type per year. Temple's heart program has averaged five, the state report said. The hospital said it did four heart and two heart-lung transplants last year.
"Experience matters in these kinds of surgeries," Snyder said. "They're very complex."
A new chief of cardiothoracic surgery, T. Sloane Guy, will start at Temple next month and will recruit another transplant surgeon, the hospital said.