(A) Each provider of a solid organ transplant service shall have a medical director that is certified in the appropriate specialty and that actively performs solid organ transplant procedures at the hospital where the HCS is located.
(B) Each provider of a solid organ transplant service shall have on staff:
(1) At least one primary transplant surgeon and at least one primary transplant physician, for each type of organ transplanted, that:
(a) Meet the personnel criteria for transplant surgeons and physicians, which are in effect on the effective date of this rule, as adopted by the national organ procurement and transplantation network, currently the united network for organ sharing; and
(b) Are not dedicated to more than one solid organ transplant service provider unless the solid organ transplant service have credentialed more than one transplant surgeon or transplant physician to provide transplant services for the appropriate type of organ; and
(2) A qualified surgeon with an appropriate level of expertise for the procedure being performed must be present in the operating room at all solid organ transplant surgeries.
(C) Each provider of a solid organ transplant service shall have a transplant surgeon and transplant physician for each type of organ transplanted available on a twenty-four hour a day, seven day a week basis to provide program coverage as follows:
(1) A transplant surgeon shall be readily available to timely facilitate organ acceptance and implantation;
(2) A transplant surgeon or transplant physician shall be available on site within one hour to address urgent patient issues; and
(3) When this coverage is not available, the program shall be temporarily suspended and the provider of the solid organ transplant service shall provide written notice of the temporary suspension of the service and the expected date of the reinstatement of services to the HCS patients and the director. A dated sample of the form letter provided to patients shall be provided to the director in addition to the director's notice. The written notice shall be provided to patients and the director as follows:
(a) For planned temporary suspensions, the notice required in this rule shall be provided at least five business days prior to the temporary suspension; and
(b) For unexpected temporary suspensions, the notice required in this rule shall be provided within five business days after the temporary suspension.
(D) Each provider of a solid organ transplant service shall ensure that transplant services are delivered by a multidisciplinary team that, at a minimum, includes representatives from the following:
(1) Surgical (transplant surgeon);
(2) Medical (transplant physician);
(4) Clinical transplant coordinator;
(5) Social services;
(6) Nutritional services;
(7) Pharmacology; and
(8) Financial coordination.
(E) Each provider of a solid organ transplant service shall have staff with the expertise needed to manage organ rejection and the problems of immunosuppressed patients.
(F) The following staff, exclusive of the transplant surgeons and physicians, shall meet the criteria set forth in this rule and shall be available at all times to the hospital where the service is located:
(1) For extra-renal transplant services, a designated anesthesiologist who:
(a) For heart transplantation, has training in open heart surgery anesthesia;
(b) For lung transplantation, has training in cardiopulmonary anesthesia; or
(c) For liver transplantation, has had an on-site visit to an established liver transplant service and documented experience participating in liver transplant anesthesia or has formal training in liver transplantation anesthesia;
(2) A pathologist with training in detecting rejection in the transplanted organ;
(3) A nursing team trained in hemodynamic support and immunosuppression management. The training in immunosuppression management shall include training in isolation techniques and infection control methods;
(4) A nephrologist on site;
(5) An established division or section of infectious disease with physicians who are available for consultation and direct service;
(6) A full-time transplant patient coordinator with appropriate experience as a patient coordinator with a transplant service;
(7) A psychiatrist and a licensed independent social worker who are available for evaluation and ongoing support of both the patient and family;
(8) Available physicians specializing in radiology, respiratory disease, and physical medicine; and
(9) Available on-site specialties of cardiovascular disease, endocrinology, gastroenterology, hematology, pediatrics (if applicable), pulmonary disease, general surgery, orthopedics, urology, neurosurgery and ophthalmology.
(G) Each provider of a solid organ transplant service shall provide sufficient staff to adequately monitor patients during the post-transplant period.
(H) Each provider of a solid organ transplant service that performs living donor transplantation must identify either an independent living donor advocate or an independent living donor advocate team to ensure protection of the rights of living donors and prospective living donors.
Five Year Review (FYR) Dates: 03/01/2022
Promulgated Under: 119.03
Statutory Authority: 3702.11, 3702.13
Rule Amplifies: 3702.11, 3702.12, 3702.13 , 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Prior Effective Dates: 3/1/1997, 3/24/03, 6/1/07, 5/15/08, 6/21/12