Title: Section 52-7.4 - Donor qualifications

Effective Date

11/01/2000

52-7.4 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, ocular tissue shall not be released for transplant from donors with any of the following conditions or factors:

(1) evidence of disseminated malignant disease, such as lymphoma or leukemia;

(2) malignant disease of the eye;

(3) active hepatitis B or C, or hepatitis of unknown etiology;

(4) syphilis within the past 12 months;

(5) any disease of unknown etiology;

(6) congenital rubella;

(7) subacute sclerosing panencephalitis;

(8) Reye's syndrome; or

(9) bacterial or fungal endocarditis.

(c) The medical director of the comprehensive tissue procurement service shall be responsible for determining that donors and donated ocular tissue are acceptable based on medical history information, the tissue bank's established donor selection criteria and the factors specified in this Part.

(d) A written policy shall specify the range of acceptable donor age limits for eye 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.

(e) Unless intended for lamellar grafts or epikeratoplasty, corneal tissue shall not be released from donors with prior intraocular or anterior segment surgery affecting the corneal endothelium or from donors with intrinsic eye disease affecting the corneal endothelium.

Volume

VOLUME A-1 (Title 10)

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