10A NCAC 13B .5504      EVALUATION PROTOCOL FOR LIVING ORGAN DONORS

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.

History Note:        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.