Dear Hospital Administrator Letter: Organ Transplant Services

December 2, 2014

Dear Administrator:

This letter is to inform you of recent amendments to NYCRR Title 10, Sections 405.13 (anesthesia services), 405.22 (critical care and special care services), 405.30 (organ and vascularized composite allograft transplant services) and 405.31 (living donor transplant services). Overall, these amendments were made to make state requirements consistent with the Centers for Medicare and Medicaid Services (CMS) and the United Network for Organ Sharing (UNOS) policies. A copy of the amendments is attached.

The key points of these amendments are:

  • A new section §405.30, sets forth requirements for organ and vascularized composite allograft (VCA) transplant services/programs. When these regulations were last updated in 2004, VCA transplants (e.g., face, hand and arm transplants) did not exist. The procedures have advanced since that time and these regulations make it clear that VCAs, as well as any medical/surgical procedure that requires expertise in transplantation, shall only be performed in a Department approved transplant hospital. These regulations will make it less cumbersome for transplant centers that seek to add VCAs to their services.
  • These regulations set the operational volume requirements for kidney, liver, heart and lungs at ten transplants per year, consistent with CMS requirements.
  • The second new section, §405.31, is related to living donor transplantation services. Current regulations only refer to living liver transplantation. The proposed regulations would expand living donor transplantation services to all living donor transplantation services (liver, kidney, lung, intestine) and retain some of the specialized current requirements for living liver transplant.
  • A new requirement that transplant centers to develop and implement a policy for a formalized process of communication for possible organ donor disease transmission. This includes identification of a 24 hr/7 day/week patient safety contact as the primary contact for disease transmission events and a procedure for prompt notification to the organ procurement agency regarding the suspected transmission.
  • A new requirement of notification to the Department of any significant changes in program operation such as temporary or permanent suspension of transplant services; unavailability of a transplant surgeon for more than fifteen days (consistent with UNOS requirements) and a written closure plan for voluntary closure of a service.
  • Expands and updates the existing regulations for living liver donation to all living donor transplants, such as kidney and lung, while retaining some of the specific requirements for living liver donors. This is consistent with CMS and UNOS requirements.
  • A new requirement that transplant centers develop and implement a policy on travel for transplant that may include informing patients of the medical risks of receiving a transplant in a foreign country and informing them of state and federal laws prohibiting the sale of organs.

These regulations were developed with the guidance of the NYS Transplant Council, an advisory body to the NYS Commissioner of Health. The council consists of transplant and organ donation professionals. The Council and the Department believe these amendments will benefit transplant patients and centers as they care for transplant recipients and living donors.

If you have any questions concerning these regulations, please contact Lisa McMurdo at 518-402-1003.

Ruth Leslie
Division of Hospitals and Diagnostic & Treatment Centers