Sec. 10.30.02.02. Transplant Centers

A. Location and Program Affiliation.

(1) Centers seeking certification as transplant centers, under Health-General Article, Title 13, Subtitle 3, Annotated Code of Maryland, shall be located in hospitals that are accredited by the Joint Commission on Accreditation of Healthcare Organizations and participate in a patient registry program with a certified organ procurement organization.

(2) An agreement shall exist with an established functioning tissue typing laboratory providing 24-hour-a-day service.

(3) The hospital shall provide an active nephrology service to provide for continuity of care.

(4) The transplantation program shall conform to generally accepted medical standards for tissue typing and for transplantation.

(5) For the purpose of protecting patient safety and welfare, a transplant center may not discontinue or phase out patient services until:

(a) The transplant center has notified the Commission of the transplant center's intention;

(b) Patients being treated by that transplant center have been transferred to another transplant center;

(c) Patients' continuing care has been assured to the satisfaction of the patient and the Commission;

(d) The transplant center submits to the Commission evidence that the transfer of patients to another transplant center has been satisfactorily accomplished; and

(e) Patients being treated in a transplant center that is withdrawing from the Kidney Disease Program are provided continued access to the same reimbursement principles of the Kidney Disease Program.

B. Physical Standards. The transplant center shall be located in a hospital that is participating as a provider of services in the Medicare program and is approved by Centers for Medicare and Medicaid Services as a renal transplantation center.

C. Staffing.

(1) Director of Transplantation Center. The renal transplantation center shall be under the general supervision of:

(a) A UNOS qualified transplantation surgeon (42 CFR §405.2102) and a qualified transplant nephrology physician director; or

(b) Another physician meeting UNOS criteria as a physician director for kidney transplantation (42 CFR §405.2102).

(2) The director shall be responsible for planning, organizing, conducting and directing the transplant center and devoting sufficient time to carry out these responsibilities, which include but are not limited to:

(a) Coordinating with the hospital in which the transplant center is located to ensure adequate training of nursing staff and clinical transplant coordinators in the care of transplant patients and living donors;

(b) Ensuring that tissue typing and organ procurement services are available through a UNOS associated OPO and an ASHI certified laboratory;

(c) Ensuring that transplantation surgery is performed by, or under the direct supervision of, a UNOS qualified transplant surgeon; and

(d) Ensuring that the transplant center shall have an adequate number of clinical transplant coordinators to ensure the continuity of care of patients and living donors during the:

(i) Pre-transplant, transplant, and discharge phases of transplant; and

(ii) Donor evaluation, donation, and discharge phases of donation.

(3) The clinical transplant coordinator shall:

(a) Be a registered nurse or clinician licensed by the state in which the clinical transplant coordinator practices; and

(b) Have experience and knowledge of transplantation and living donation issues.

(4) The clinical transplant coordinator's responsibilities include, but are not limited to:

(a) Ensuring the coordination of the clinical aspects of transplant patient and living donor care; and

(b) Acting as a liaison between kidney transplant centers and dialysis facilities.

(5) The transplant center that performs living donor transplantation shall identify either an independent living donor advocate or an independent living donor advocate team to ensure the protection of the rights of living donors and prospective living donors.

(6) The living donor advocate or living donor advocate team may not be involved in transplantation activities on a routine basis.

(7) The kidney transplant center shall:

(a) Directly furnish transplantation and other medical and surgical specialty services required for the care of ESRD patients; and

(b) Have written policies and procedures for ongoing communications with the dialysis patients' local dialysis facilities.

D. Additional Transplant Program Requirements.

(1) Sufficient skilled personnel shall be available to provide 24-hour-a-day coverage for the transplantation service.

(2) A transplantation team shall exist in a certified transplant center consisting of:

(a) The transplant center director;

(b) The director's assistant; and

(c) A UNOS certified transplant surgeon, if not the transplant center director, and a UNOS certified physician director (a transplant nephrologist or physician meeting UNOS criteria to be a physician director for a kidney transplant program).

E. Physical and Medical Standards. The transplant center shall:

(1) Provide support services in clinical immunology, infectious diseases, and immunopathology; and

(2) Be an administratively separate and distinct division or unit.

F. Transplant Activity.

(1) For optimum performance and success of the transplant procedure, transplant centers shall perform a minimum of 10 transplants per year.

(2) The Commission recognizes that the number of transplants performed depends on many variables and the standard specified in §F(1) of this regulation serves only as a guideline.

(3) The guideline specified in §F(1) of this regulation is established to indicate that transplant centers shall remain active in order to improve the success rate and to lower costs.

G. The transplant center shall make arrangements for medical records, patient care policies, dietetic services, sanitation standards, and fire and life safety standards as referenced in Regulation .01B of this chapter and this subtitle.

H. Patient Selection.

(1) In general, the patient selection standards as established for the dialysis program shall apply to the transplantation program, recognizing that constant improvements in the immunology and treatment of the rejection process are increasing the number of disease processes in which transplantation is applicable.

(2) Written recommendations about the mode of therapy shall be kept on file for the review of the Commission.

(3) Since transplantation is at present the best means of treating most patients with irreversible renal failure, transplantation shall be considered for all patients accepted into this program when reasonable benefit and success are anticipated. However, candidacy for transplantation may not be a basic criteria for selection into the overall Kidney Disease Program.

(4) A patient rejecting a transplanted kidney shall automatically receive assistance to gain entry into a dialysis program.

I. Administration.

(1) The transplant center shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the transplant patients.

(2) Before placement on the center's waiting list, a prospective transplant candidate shall:

(a) Receive a psychosocial evaluation; and

(b) Ensure that the candidate's medical record contains documentation that the candidate's blood type has been determined.

(3) When a patient is placed on a center's waiting list or is selected to receive a transplant, the center shall document in the patient's medical record the patient's selection criteria used.

(4) The transplant center shall provide a copy of its patient selection criteria to a transplant patient, or a dialysis facility, as requested by a patient or dialysis facility.

(5) The transplant center shall have written patient management policies for the transplant and discharge phases of transplantation. If a transplant center performs living donor transplants, the center also shall have written donor management policies for the donor evaluation, donation, and discharge phases of living organ donation.

(6) The transplant center's patient and donor management policies shall ensure that:

(a) Each transplant patient is under the care of a multidisciplinary patient care team coordinated by a physician throughout the transplant and discharge phases of transplantation; and

(b) If a center performs living donor transplants, each living donor is under the care of a multidisciplinary patient care team coordinated by a physician through the donor evaluation, donation, and discharge phases of donation.

(7) A transplant center shall keep their waiting lists up to date on an ongoing basis including:

(a) Updating of waiting list patients' clinical information;

(b) Removing patients from the center's waiting list if a patient receives a transplant or dies, or if there is any other reason the patient should no longer be on a center's waiting list;

(c) Notifying the Organ Procurement and Transplant Network not later than 24 hours after a patient's removal from the center's waiting list; and

(d) Notifying the patient and dialysis facility if applicable if the patient is removed from the center's waiting list.

(8) The transplant center shall develop guidelines to ensure adequate patient and freestanding dialysis facility notification of change in patient transplant status.

(9) The transplant center shall maintain up-to-date patient management records for each patient who receives an evaluation for placement on a center's waiting list and who is admitted for organ transplantation.

(10) The transplant center shall make social services available, furnished by qualified social workers, to transplant patients, living donors, and their families.

(11) The transplant center shall develop, implement, and maintain a written comprehensive data driven Quality Assessment and Performance Improvement (QAPI) program designed to monitor and evaluate performance of all transplantation services. The QAPI program shall include, but not be limited to:

(a) Patient and donor selection criteria;

(b) Accuracy of the waiting list;

(c) Assurance of donor and recipient matching;

(d) Patient and donor management;

(e) Consent practices;

(f) Patient education;

(g) Patient satisfaction; and

(h) Patient rights.

(12) The transplant center shall take actions that result in performance improvements and track performance to ensure that improvements are sustained.

(13) The transplant center shall establish and implement written policies to address and document adverse events that occur during any phase of an organ transplantation case.

(14) The hospital shall provide designated administrative personnel to keep the necessary records as well as other information needed for accurate determination of cost.

(15) The hospital or transplant center administration shall assure that patients are informed of the center's internal and external grievance mechanisms.

J. Compliance. Transplant centers shall comply with the provisions set forth in Regulation .01B of this chapter, and with the requirements of this subtitle.