Title: Section 52-4.4 - Donor qualifications

52-4.4 Donor qualifications.

(a) In addition to all the requirements of this Subpart, limited tissue procurement services and comprehensive tissue procurement services shall comply with the donor qualification requirements in Subpart 52-3 of this Part.

(b) Unless specifically authorized by the tissue bank medical director, cardiovascular tissue shall not be released for allogeneic transplant from donors with any of the following conditions:

(1) a disease of unknown etiology;

(2) malaria within the last three (3) years or travel to a malarially endemic area within the last six (6) months;

(3) active or untreated tuberculosis;

(4) history or presence of bacterial endocarditis or semilunar valvular heart disease, except for mitral valve prolapse;

(5) previous cardiac valvular surgery, if donation of the affected valve is considered;

(6) insulin-dependent diabetes mellitus;

(7) death due to drowning, if immersion was for longer than six (6) hours; or

(8) history of rheumatic fever.

(c) In addition to the exclusions outlined in subdivision (b) of this section, saphenous veins shall not be released from donors with any of the following conditions:

(1) varicose veins or other conditions of chronic venous stasis;

(2) trauma to saphenous veins; or

(3) significant phlebitis.

(d) Social history as recorded in the medical chart of the donor, or as provided by a friend or family member shall be considered in the donor selection process.

(e) The medical director of the comprehensive tissue procurement service shall be responsible for determining that the donor and the donated cardiovascular tissue are acceptable based on medical history information and established donor selection criteria as specified in this Part, and a physical examination.

(f) A written policy shall specify the range of acceptable donor age limits for allogeneic cardiovascular tissue donation. This policy shall be determined by the tissue bank medical director in consultation with the medical advisory committee of the comprehensive tissue procurement service.

(g) Written criteria for acceptance of donors of autogeneic tissue shall be specified by the transplantation service director of the tissue transplantation facility, unless such criteria have been specified already by the medical director of a comprehensive tissue procurement service.