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Title: Section 52-9.5 - Donor qualifications

Effective Date


52-9.5 Donor qualifications.

(a) The human milk bank shall initially screen and periodically assess the donor for conditions and behavior that may affect the quality or nutritional value of milk, or impair the donor's health, including, but not limited to, the donor qualification requirements in Subpart 52-3 of this Part, and for:

(1) the use of medications, tobacco, alcohol and/or other substances in quantities likely to be harmful if transmitted through human milk to a recipient;

(2) systemic chronic diseases or nutritional deficiencies;

(3) acute and chronic infectious diseases;

(4) emotional conditions and/or behavioral disturbances;

(5) history of jaundice in the donor's own infant after one week of age;

(6) sources of exposures which may be associated with environmental contaminants;

(7) duration of breast feeding; and

(8) general ability to understand and follow directions regarding sanitary collection and storage of the milk, and contraindications to donation.

(b) Donors with a history or behavior which places them at high risk for human immunodeficiency virus (HIV) infection or other infectious diseases (see Subpart 52-3 of this Part) shall be permanently excluded from donation.

(c) The human milk bank shall have evidence available that the donor has been tested within one month prior to the first donation and found negative for hepatitis B virus, including hepatitis B surface antigen (HBsAg) and antibody to hepatitis B core antigen (anti-HBc); hepatitis C virus; human immunodeficiency virus type 1 (HIV-1); human immunodeficiency virus type 2 (HIV-2); human T-lymphotropic virus type I (HTLV-I); and for syphilis and tuberculosis, and that the donor is immune to rubella. Testing for cytomegalovirus shall also be performed, unless donated milk is subjected to the Holder pasteurization method. All laboratory tests shall be performed by a laboratory operating under a permit issued by the department. For out-of-state milk donations, all required laboratory testing shall be performed by a laboratory which is approved by that state's regulating authority, the United States Health Care Financing Administration, or by the department. Except for rubella and tuberculosis, testing shall be repeated every six months while the donor is participating in the milk banking program, and the donor shall be found negative prior to any subsequent donations. Milk from a donor testing positive for anti-HBc shall not be made available for clinical use.

(d) The milk bank shall obtain the informed signed consent of the donor for participation in the milk banking program.

(e) The milk bank shall implement a donor education program, including, but not limited to:

(1) the purpose of milk banking and responsibilities of the donor;

(2) operating policies and procedures of the milk bank;

(3) guidelines for sanitary collection and storage of milk;

(4) medical conditions, diseases and medications or other substances contraindicating use of the milk;

(5) diet and nutrition;

(6) smoking and alcohol consumption; and

(7) breast care and common problems associated with breast feeding and milk donation.


VOLUME A-1 (Title 10)