Appendix I

STATE OF NEW YORK DEPARTMENT OF HEALTH
Corning Tower, The Governor Nelson A. Rockefeller Empire State Plaza, Albany, New York 12237
Antonia C. Novello, M.D., M.P.H., Dr.P.H. Commissioner
Dennis P. Whalen Executive Deputy Commissioner
March 18, 2002

I am writing this letter to the six hospitals in New York State authorized to perform liver transplant surgery as a result of serious quality of care issues that the Department of Health identified during a recent investigation into the death of a living liver donor at the Mount Sinai Medical Center.

All liver transplant programs in New York State need to ensure that the following quality of care and patient support measures are in place for liver transplant donors and recipients:

  1. All policies and procedures for living liver donors must be re-examined to ensure that there are appropriate safeguards for both pre and post-operative care. Informed consent protocols should be included in this assessment to assure that potential donors are not subject to any coercion in making their decision to become a living donor. Hospitals also should assure that staff understands and adheres to these policies and procedures.
  2. There must be sufficient medical and nursing staff to ensure that patient needs are met and quality care is continually provided.
  3. Surgeries should be scheduled only when maximum staffing will be available for the post-operative period. If surgery is scheduled during the latter part of the week, the hospital should ensure that there is adequate attending physician and nursing coverage during the weekend.
  4. There must be continuous supervision and monitoring by senior staff and attending physicians of patient care provided by interns and residents.
  5. There must be continuous monitoring by nurses of patient condition; significant changes in patients’ conditions must be promptly reported to the patient’s attending physician.
  6. There must be periodic review of communication policies within and between medical, nursing and other specialties.
  7. All staff providing care to transplant donors or recipients must be prepared for their responsibilities through education, experience, demonstrated competence and completion of in-service programs.
  8. Hospitals must establish protocols and devote the necessary resources to ensure that there are counseling and support programs for donors and their families.

Hospitals are expected to conduct this re-assessment of their liver transplant programs. Implementation of necessary improvements is to be completed within thirty (30) days. Department staff will monitor hospital compliance with this directive.

The New York State Transplant Council will review all issues involving living liver donations and transplantation. The Council will provide the Department with any necessary policy or regulatory recommendations that will improve the care and well being of individuals who wish to become living donors. I trust that the hospitals performing liver transplants will actively support and be engaged with the Transplant Council in this comprehensive review.

Your cooperation with this directive will ensure that liver transplantation in New York State meets the highest standards of quality and safe patient care.

Thank you.

Sincerely,

Antonia C. Novello, M.D., M.P.H., Dr.P.H.
Commissioner of Health

go to appendix 2