10A NCAC 14C .3002 INFORMATION REQUIRED OF APPLICANT
(a) An applicant proposing to establish a new solid organ transplantation service or to expand an existing solid organ transplantation service shall use the Acute Care Facility/Medical Equipment application form.
(b) The applicant shall provide a copy of its procedures for selecting transplant candidates and for distributing organs which are consistent with UNOS guidelines.
(c) The applicant shall provide letters of agreement or contracts with either an independent organ procurement organization or a hospital-based organ procurement organization. The letters shall demonstrate the capability to provide sufficient numbers of organs to support the minimum activity level for the applicable type of organ transplantation proposed in the application.
(d) The applicant shall document collaboration with experts in the fields of hepatology, cardiology, pediatrics, infectious disease, nephrology, renal dialysis, pulmonary medicine, respiratory therapy, pathology, immunology, anesthesiology, physical therapy, and rehabilitation. The documentation shall include, but not be limited to, a plan of operation detailing the interaction of the transplant service and the stated specialty areas.
(e) An applicant that proposes to establish a joint sharing arrangement for organ transplantation services which involves more than one hospital shall demonstrate all of the following:
(1) all hospitals in the joint sharing arrangement are geographically proximate to permit cost-effective sharing of resources; and
(2) a single hospital site has been designated where the organ transplant surgical procedures shall be performed which involves both adult and pediatric organ transplant procedures, except one hospital site may be designated where all adult organ transplant procedures will be performed and another hospital site may be designated where all pediatric organ transplant procedures will be performed if both hospital sites are part of the joint sharing arrangement.
(f) The applicant shall demonstrate that transplantation services shall be offered in a physical environment that conforms to the requirements of federal, state and local bodies.
(g) An applicant proposing to establish a new solid organ transplantation service or to expand an existing solid organ transplantation service shall include drawings or schematics of the proposed project that identify the location of the operating rooms in the hospital where transplantation procedures will be performed.
(h) An applicant proposing to establish a new solid organ transplantation service or to expand an existing solid organ transplantation service shall project the number and type of transplantations by CPT code or ICD-9-CM procedure code by distinct transplantation service for each of the first twelve calendar quarters following completion of the proposed project.
(i) An applicant proposing to establish a new solid organ transplantation service or to expand an existing solid organ transplantation service shall project patient origin by state and by county for North Carolina residents and shall indicate the percentage of total patients to originate from each State and county.
History Note: Filed as a Temporary Adoption Eff. September 1, 1993 for a period of 180 days or until the permanent rule becomes effective, whichever is sooner;
Authority G.S. 131E-177(1); 131E-183;
Eff. January 4, 1994;
Amended Eff. November 1, 1996.