Member sanction levied against St. Vincent Medical Center
Published on: Thursday, March 2, 2006
CHICAGO, Ill., March 2, 2006 -- At a special meeting held today, the OPTN/UNOS Board of Directors declared St. Vincent Medical Center in Los Angeles to be a "Member Not in Good Standing." This action was based upon findings of serious deficiencies in administrative oversight at the hospital that allowed violations of organ allocation policy within its liver transplant program and the deliberate violation of federal regulations by submission of falsified data in an effort to cover up those violations. This is the first time the OPTN/UNOS has levied the designation of "Member Not in Good Standing," the most severe membership sanction within its independent authority.
St. Vincent will be able to continue listing kidney, pancreas and heart patients for transplantation; receive kidneys, pancreases, and hearts for transplantation; perform such transplants and provide ongoing care for transplant recipients. However, the entire institution will remain designated as a Member Not in Good Standing until St. Vincent has demonstrated conclusively to the satisfaction of the OPTN/UNOS Board of Directors that it has accomplished a plan of corrective action, demonstrating that new institution-wide safeguards are operating effectively to ensure that violations of organ allocation policy and federal data submission regulations will not be permitted to occur in any transplant program in the future.
"The executive leadership of St. Vincent, including its board of directors, has pledged its full commitment to the corrective action plan under review," said Francis L. Delmonico, M.D., president of UNOS and the OPTN and chair of the OPTN/UNOS board of directors. "While these actions are appropriate and commendable, the MPSC and OPTN/UNOS Board of Directors also believe that the Member Not in Good Standing sanction is appropriate to call attention to the failure of the institutional control which allowed these serious violations to occur and be covered up for an extended period. Therefore, the Board's action should send a very clear message to the transplant community, and to the general public, that our responsibilities, as stewards of the gifts of donated organs, cannot be compromised."
Peggy Schaeffer, an OPTN/UNOS patient and donor affairs representative on the Board of Directors, whose own son became a deceased organ donor, commented, "These actions are deplorable. Not only was this an egregious breach of OPTN organ allocation policy, it showed total disregard for the lifesaving care of patients and the importance of the public's trust in organ transplantation."
Summary of Events
On Sept. 7, 2003, St. Vincent Medical Center received an offer of a liver from a deceased donor for transplantation into a specific transplant candidate listed at that institution (Patient A). That candidate was unavailable to receive the transplant. Under OPTN policy, St. Vincent should have indicated to the organ procurement organization (OPO) offering the liver that its candidate was unavailable. That OPO would then have continued offering the liver to other candidates identified in the order of the match run (a computer-generated list of medically compatible candidates, with the highest priority given to medically urgent candidates close to the donor hospital).
Instead, St. Vincent accepted the liver in the name of the unavailable transplant candidate and transplanted it into another candidate (Patient B). This action bypassed consideration of 50 other transplant candidates, some at St. Vincent and others at five liver transplant programs in the Los Angeles area.
On Sept. 9, 2003, St. Vincent submitted information to UNOS stating that the liver was transplanted into Patient B. However, within a few hours the center contacted UNOS again, saying falsely that an error had been made and that the liver had been transplanted into Patient A. It instructed UNOS to remove Patient A from the waiting list as having been transplanted. St. Vincent later wrote to Patient A and stated falsely that the individual was still listed for a transplant. That patient eventually died.
In subsequent data submissions to UNOS, St. Vincent continued this falsification. At least seven St. Vincent employees participated in the organ allocation policy violation and/or the cover up. An internal investigation conducted by St. Vincent cited an atmosphere of fear and retaliation as reasons for the widespread falsification continuing over several years.
Summary of Investigation and Due Process
On a routine basis, UNOS conducts onsite audits at all U.S. liver transplant programs. An audit conducted June 15, 2005 at St. Vincent noted certain irregularities in patient records. Subsequent UNOS inquiries and review of information provided by a St. Vincent employee prompted St. Vincent to conduct its own internal inquiry, after which it admitted the substance of the events as described above. St. Vincent then voluntarily inactivated its liver transplant program on September 23, 2005, and dismissed or suspended staff members who participated in or had knowledge of the violations. The St. Vincent liver program no longer performs transplants, and the candidates who were on the St. Vincent wait list are being transferred to other transplant centers.
As provided in the OPTN By-Laws, the information collected by UNOS staff was conveyed to the OPTN/UNOS Membership and Professional Standards Committee (MPSC) for confidential peer review. At all stages of the review process, the safety of patients and quality of care at St. Vincent were paramount to the MPSC's discussions.
The MPSC undertook a systematic due process review of events, including the following steps:
- an emergency meeting held Sept. 29, 2005
- an interview with representatives of St. Vincent, conducted Nov. 4, 2005
- a hearing before the full MPSC, with representatives of St. Vincent, on Dec. 20, 2005
St. Vincent exercised its right under the By-Laws to an appellate review by the OPTN/UNOS Board of Directors. The Board convened a special meeting for the sole purpose of conducting the appellate review and took the actions described above.
Member Not In Good Standing Designation/Corrective Action
As established in the OPTN By-Laws, the Member Not in Good Standing designation is intended to provide public notice of the failure of St. Vincent's institutional control over its transplant programs. The designation will remain in effect until St. Vincent has demonstrated to the Board's satisfaction that it has taken all necessary corrective actions to prevent further such violations.
St. Vincent has instituted significant changes in the overall management of its remaining transplant programs, in addition to implementing recommendations of the OPTN/UNOS expert peer review team.
The Organ Procurement and Transplantation Network (OPTN) is operated under contract with the U.S. Department of Health and Human Services, Health Resources and Services Administration, Division of Transplantation by the United Network for Organ Sharing (UNOS). The OPTN brings together medical professionals, transplant recipients and donor families to develop organ transplantation policy.