State Health Department Cites Strong Memorial Hospital for Deficient Care in Liver Transplant Program

Albany, April 23, 2004 - State Health Department Commissioner Antonia C. Novello, M.D., M.P.H., Dr.P.H., today fined Strong Memorial Hospital in Rochester, New York $20,000 for violations the State has cited in its liver transplant program.

As part of the investigation, the State Health Department (the Department) cited the hospital for violations primarily related to quality of care issues, including: incomplete or inappropriate assessment of patients undergoing liver transplantation; failure to implement an effective quality assurance system to monitor, identify and address deficient practices; incomplete documentation demonstrating the need to perform high-risk liver transplant procedures; and lack of informed patient consent and full disclosure to patients and their families of the risks associated with such procedures.

Dr. Novello said, "We are very concerned with the severity of the patient care violations cited by the Department against Strong Memorial Hospital's liver transplant program. We are troubled by the gaps in the hospital's quality assurance system and its failure to take appropriate action to correct significant breakdowns in its liver transplant program. Although the hospital has put new leadership in place and made improvements in the areas of informed patient consent and pre-transplant documentation requirements, we are requiring the hospital to take additional steps to address all of the violations, including the implementation of quality assurance policies and protocols that will prevent similar problems from happening in the future."

The Statement of Deficiencies (SOD) issued to Strong Memorial Hospital by the Department identified 10 violations under the categories of Governing Body, Medical Staff, Quality Assurance, Patient Rights, Medical Records, Critical Care and Special Care Services. New York State law permits a maximum fine of $2,000 per violation for the 10 deficiencies identified as part of this latest investigation.

The Department's investigation found the following:

  • A patient required two additional transplant procedures after suffering serious post-operative complications following the initial transplant surgery in which a liver with an incompatible blood type was used. There was no documented evidence that the recipient's condition was life-threatening, which may have justified the use of the incompatible liver in the first procedure.
  • A second patient underwent a second liver transplant procedure after experiencing post-operative complications following an initial transplant surgery in which an extended criteria liver was used. The hospital failed to document a rationale justifying the initial high-risk procedure that was performed on the patient, who had a favorable, short-term survival rate without a transplant.
  • In another case, an anesthesiologist's concerns regarding potential problems with the placement of a tube inserted in the patient to redirect blood flow around the liver during the surgical procedure were not addressed.
  • The hospital failed to complete a thorough pre-operative work-up on a patient to determine the patient's need for transplant surgery prior to obtaining a priority listing on the transplant waiting list.
  • There was no evidence, in specific cases, that patients were provided fully informed consent prior to receiving extended criteria livers.
  • The hospital failed to implement and maintain adequate quality assurance policies and practices for continuously evaluating the quality and appropriateness of patient care in the liver transplant program.
  • The hospital lacked written policies and procedures related to organ acceptance and recipient selection.

In response to the State's investigative findings regarding Strong Memorial Hospital, Dr. Novello announced the creation of a liver transplant workgroup to study issues related to the use of extended criteria livers, including donor and recipient selection. The workgroup will be comprised of members from the New York State Transplant Council and the New York Center for Liver Transplantation, representatives from each of the five liver transplant programs in New York, as well as national experts on liver transplantation and donation.

Extended criteria livers are ones that are not considered to be ideal. Liver donations that may be considered less than ideal by medical professionals may include organs from older donors, or those from donors who had medical conditions such as hypertension or histories of prior infections. Hospital transplant centers across the nation are increasingly using less than ideal organs in patients in critical need of transplants because of the severe shortage of available organs.

"It is clear that as waiting lists for liver transplants increase and donation rates remain stable, there could be an increased demand for and use of extended criteria livers not only in New York State, but across the nation as well," Dr. Novello said. "The lessons learned from the State's investigation of Strong Memorial Hospital have provided us with an important opportunity to further strengthen the quality of care for patients undergoing liver transplant surgery. To help accomplish this goal, we are asking the workgroup members to develop guidelines that will specifically address the use of extended criteria livers in patients undergoing transplant surgery." The liver transplant workgroup is expected to hold its first meeting in June 2004.

New York State, under the direction of the State Transplant Council's expertise, implemented landmark live adult liver donor regulations in March of this year to help improve the quality of care for donors and recipients undergoing liver transplant surgery. Dr. Novello said, "The implementation of these unprecedented regulations puts New York State in a tremendous leadership position and better enables us to provide future recommendations regarding the use of extended criteria livers in transplant procedures to further improve the quality of care for patients."