State Health Department Fines Albany Medical Center
Albany, May 28, 2004 - The State Health Department today fined Albany Medical Center $18,000 for nine violations identified in a just-concluded Department investigation into the hospital's heart transplant program.
The Department's investigation began in October 2003 after Albany Medical Center (AMC) voluntarily suspended its heart transplant program. The hospital's actions were prompted by a September 2003 audit conducted by the United Network for Organ Sharing (UNOS) that raised serious concerns about the AMC heart transplant program. UNOS maintains the organ transplant waiting list for the entire nation and is responsible for the allocation of organs to the sickest patients on the waiting list.
The violations cited by the Department against the hospital were primarily related to inaccurate patient-specific information submitted by a physician to UNOS to justify a higher priority than warranted on the UNOS transplant waiting list. Specifically, the investigation found that there were 45 heart transplant patients at Albany Medical Center who were given higher priority status on the organ transplant waiting list based on the inaccurate information that the hospital's heart transplant program provided to UNOS. As part of the investigation, the Department cited violations against the hospital in 12 of those cases, including five in which the hospital falsely reported to UNOS that the patients would die within a week without a heart transplant.
In addition, the hospital failed to implement an effective quality assurance system to monitor, identify and address deficient practices related to the transmission of inaccurate patient listing information to UNOS. An effective quality assurance program would have led the hospital to identify these reporting inaccuracies before the UNOS audit.
State Health Commissioner Antonia C. Novello, M.D., M.P.H., Dr.P.H., said, "Make no mistake, these were all sick patients who were appropriate candidates for heart transplantation. Similarly, the quality of the surgical care they received is not in question. I am greatly disturbed, however, that a hospital physician exaggerated patients' medical conditions to place them higher on the UNOS waiting list, and because the hospital did not have effective oversight of the program to detect or prevent this serious violation of well-known transplant rules from occurring.
"UNOS has in place very strict rules that must be followed to ensure that only those patients most in need receive the highest priority on the waiting list. Organ donation is based on a public trust that transplant centers will abide by the rules in place to oversee how organs are allocated. Albany Medical Center failed that public trust."
The hospital is required to submit a written plan of correction (POC) to the Department by Friday, June 11, 2004. The POC must indicate what the hospital will do to correct the specific violations, the systemic issues which led to breakdowns, and what long-range plans the hospital intends to implement to monitor the effectiveness of the care it provides to patients.
Before the hospital can reopen its heart transplant program, the Department will conduct an on-site survey to determine compliance with the State Hospital Code after the POC has been accepted and the hospital has fully implemented the corrective measures.
AMC has already taken appropriate steps to begin correcting the deficiencies. However, the Department will closely review the hospital's heart transplant program for one year after reopening to ensure that all of the corrections are maintained.
In addition, the Department is taking the following action:
- Requiring the hospital to obtain an independent expert consultant to conduct a comprehensive review of its heart transplant program and specifically to develop a process to assure that data provided to UNOS for the purpose of ranking patients on the transplant waiting list accurately reflects the patients' medical conditions. This must include:
- A Department approved process for the hospital to utilize in collecting and reporting patient data to UNOS for transplant waiting list ranking decisions;
- Increased training and education for appropriate hospital staff in regard to UNOS criteria for classifying patients on the transplant waiting list; and
- Monitoring procedures and protocols to ensure the hospital's compliance with UNOS criteria and policies for classifying patients on the transplant waiting list.
- Requiring the hospital to submit quarterly reports to the Department for a period of one year following the full implementation of the POC and the Department approved reinstatement of transplant program.
- The Department will conduct unannounced periodic reviews of Albany Medical Center's heart transplant program for one year after it reopens to assure the hospital is in compliance with the State Hospital Code and UNOS reporting criteria.
From 1999 through 2003 the six hospitals in New York State with heart transplant programs performed a combined total of 745 heart transplant procedures, including 88 by Albany Medical Center. The waiting time for a patient in need of a heart transplant nationwide is approximately 10 months. Nationally there are 3,518 patients on the UNOS waiting list for heart transplants, including 369 New Yorkers.