North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 13 - NC MEDICAL CARE COMMISSION › Subchapter B - LICENSING OF HOSPITALS › Section .5500 - SUPPLEMENTAL RULES FOR HOSPITALS PROVIDING LIVING ORGAN DONATION TRANSPLANT SERVICES › Section 13B .5504 - EVALUATION PROTOCOL FOR LIVING ORGAN DONORS

Current through Register Vol. 39, No. 2, July 15, 2024
Hospitals shall complete the following evaluation protocols
					 prior to living organ donation:
(1)
				  The facility shall confirm the potential donor's ABO blood type.
(2) Only individuals 18 years of age or older
				  shall be considered for living organ donation. The facility shall complete a
				  screening interview with the potential donor which confirms the donor's age,
				  height, weight, demographic information, medical and surgical history,
				  medications, drug or alcohol history, smoking history, and a family or social
				  history. Insurance issues (health and life) shall also be discussed with the
				  potential donor and an attempt shall be made to answer any questions asked by
				  the donor. Written information on the living donor process shall be made
				  available to the potential donor.
(3) The donor surgical team shall determine
				  whether the potential donor shall be excluded based on the medical information
				  or family history: for example, exclusionary criteria may include the presence
				  of diabetes, uncontrolled hypertension, liver, pulmonary or cardiac disease,
				  renal dysfunction or high Body Mass Index (BMI).
(4) An IDAT shall be assigned for the
				  potential donor pursuant to Rule.5502(c) of this Section. The IDAT leader shall
				  not be a physician who is the primary physician of the potential transplant
				  recipient.
(5) The IDAT leader
				  shall conduct a medical evaluation of the potential donor. The medical
				  evaluation shall include a full and frank discussion of the risks associated
				  with the evaluation tests with the potential donor and the donor's chosen
				  designee. If the potential donor wishes to proceed, laboratory and diagnostic
				  tests shall be ordered as necessary.
(6) An IDAT member shall conduct a
				  psychosocial evaluation of the potential donor. The IDAT member shall also
				  discuss financial considerations.
(7) The IDAT shall review the laboratory and
				  diagnostic test results, as well as psychosocial evaluation and discuss them
				  with the donor to decide whether to move forward with the potential donor's
				  evaluation.
(8) The donor surgeon
				  shall evaluate the mortality and morbidity risks associated with donation and
				  disclose those risks to the potential donor with adequate time for any
				  questions to be answered in detail. The donor's designee shall also be present
				  at this appointment.
(9) The IDAT
				  shall perform a final review and makes its recommendation as set out in Rule
				  .5503(i) of this Section.
(10) The
				  hospital shall schedule an appointment for pre-operative screening with the
				  potential donor after the entire process of evaluation is complete. An informed
				  consent as required in Rule.4605(c)(2) of this Subchapter is necessary for the
				  donation and surgical procedure and shall be completed by this time. In
				  addition, where applicable, the potential donor shall be given ample time for
				  autologous blood donation through the American Red Cross.
Authority
					 G.S.
					 131E-75;
					 131E-79;
					 143B-165;
Eff. May
					 1, 2006;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. July 22,
					 2017.