Saturday, May 12, 2018
Deficiencies Cited in PA Transplant Programs
By Walter F. Roche Jr.
Federal inspectors have cited Pennsylvania transplant programs over the past two years for a variety of deficiencies including a program at the Milton S. Hershey Medical Center which was cited for a death rate in the heart transplant program more than twice the expected level,
The Hershey report from the U.S. Center's for Medicare and Medicaid Services is just one of a dozen issued by the federal agency over the past two years on Pennsylvania transplant programs.
A review of those reports shows that many of the programs were found to have the same or similar deficiencies. The inspections are required every three years to maintain certification in the federally funded Medicare program.
Inspectors found only one program, a small one at Saint Christopher's Hospital for Children in Philadelphia, that had no deficiencies. According to CMS officials the responsibility for conducting the inspections alternates between CMS and the state health departments. The Pennsylvania Health Department will be conducting the next round of inspections of transplant programs in the state.
Data from the private agency, the Scientific Registry of Transplant Patients,that gathers details of all approved transplant programs shows that nearly 1,800 transplants were performed in Pennsylvania in the 12 month period ending June 30, 2017.
The Hospital of the University of Pennsylvania reported 484 transplants, the largest number in the state, followed by UPMC with 420. Kidney transplants at HUP totaled 188 while UPMC reported 215. Temple University Hospital had 275 cases with lung transplants topping the list with 105.
Penn State's Milton S. Hershey Medical Center was cited for the number of heart transplant patients who died within one year of surgery. While 3.73 deaths were expected, the actual number was eight during the period from July 1, 2012 t0 Dec. 30 2014.
Hospital spokesman Scott Gilbert noted the report was based on cases handled between 2012 and 2014.
"In the more than three year's since, we have implemented a series of changes that have improved outcomes for our heart transplant patients," he wrote in an email response to questions.
In its response to CMS, Hershey said it had also revised its selection standards for heart transplants.
Gilbert said other improvements include an electronic reporting system to better track adverse events. He said Hershey also engaged an outside consultant to improve the heart transplant program.
Hershey was also cited for failing to notify CMS of a change in the person acting as the primary transplant surgeon. Waiting list deficiencies included failure to update a patient's status for five months while such changes must be made within 24 hours.
At Children's Hospital of Philadelphia surveyors reported that while 1.47 graft failures were expected between July 1, 2012 and Dec. 31 2014, the actual number was 4. Stating that the number was "significantly higher than expected," the report states the number was considered "unacceptable."
Asked about the findings, a CHOP spokeswoman said she could not comment.
Other findings in the report include the lack of all required documentation that the organ donor was found suitable for the recipient prior to surgery.
CHOP also was cited for the apparent lack of participation of some members of a multi-disciplinary team in all phases of each individual case. According to the report, CHOP did not properly screen adverse events and some staffers lacked specific training on transplants. A transplant coordinator, according to the report, was not properly trained.
In its plan of correction the hospital agreed to ensure selection criteria was in place and that documents certifying a blood match of recipient and donor were properly maintained. CHOP also agreed to perform audits to ensure its plan of correction was being followed.
Allegheny General Hospital in Pittsburgh was cited in a March 10, 2016 CMS report for the same lack of verification of blood type matches between recipients and donors. And like CHOP it was cited for failure of all assigned staffers to participate in a multidisciplinary team assigned to oversee each case.
Surveyors found that Allegheny General did not meet requirements for promptly updating waiting lists and did not have a process in place to inform patients or their families of adverse events.
Though the hospital reported there were no adverse events in 2014 and 2015, the surveyors found three cases that should have been in that category. In two cases a death occurred and in a third a patient had to be returned for additional surgery.
Dan Laurent, spokesman for the hospital, said that a plan of correction was approved and implemented and the hospital's certification remains in place. He said some of the changes involved simple language adjustments.
He noted the survey was conducted more than three years ago and major improvements were made in the interim.
Among the improvements, he said, was implementation a more robust process for identifying adverse events.
He said 164 transplants were performed at the hospital in 2017 including 104 kidney transplants.
At Children's Hospital in Pittsburgh surveyors found that the selection criteria for placing transplant patients on a waiting list was not always stated.
As with several other facilities, the hospital, part of UPMC, was cited for failing to properly document the matching of blood types between patients and donors. The hospital also failed to immediately inform a patient or fsmily member promptly of a change in status.
The hospital also was cited for failure to have all assigned staffers participate in all phases of a transplant patient's case, from selection to discharge.
The hospital filed a plan of correction in which it promised to improve its selection criteria and to require that surgeons complete documentation that donors and patients were properly matched by blood type and other criteria. Improvements also were made in the reporting and analysis of adverse events. according to the plan of correction.
AT UPMC's Pinnacle Hospital in Harrisburg CMS surveyors issued a 19-page report citing the facility for failure to notify he agency of a key staff change and failure to properly investigate adverse events. As with several other facilities Pinnacle was cited for failing to promptly remove a patient from the waiting list.
Spokeswoman Kelly McCall said the hospital "fully implemented a corrective action plan, several elements of which were completed during the survey."
At UPMC in Pittsburgh CMS surveyors found that the volume of patients, seven in a three year period, in an an intestinal and multivisceral program was below the desired level.
Spokesman Lawerence Synett said,"UPMC swiftly implemented a detailed corrective action plan, and is fully compliant with all regulations. The program is operational and fully certified, with our team currently following over 100 patients for long-term care."
He said advances in nutritional therapy and non-transplant care have reduced the need for intestinal and multi-visceral transplants nationwide, with only five adult and pediatric centers performing more than 10 in 2017.
Other items in the 113-page UPMC report are the same or similar to several other Pennsylvania programs including delayed removal of patients from waiting lists and failing to properly document the patient and donor have matched blood types prior to surgery. UPMC officials blamed some of those problems on computer programs.
One verification was dated three days after the surgery, according to the report. A patient who had dropped out of the program was not taken off the waiting list for 17 days, surveyors reported.