SubPart 52-9 - Human Milk Banks

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.1 - Definitions

Section 52-9.1 Definitions. As used in this Part:

(a) Human milk bankmeans an organized service for the selection of donors and the collection, processing, storage or distribution of human breast milk for infants or children other than the donor's own infant.

(b) Donormeans a lactating woman who voluntarily contributes milk to a human milk bank for use by an infant or child other than her own. A donor shall not receive remuneration for the donation of milk.

(c) Human milk transfer stationmeans the location at which containers of human breast milk are held temporarily between the donation site and the human milk bank.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.2 - Construction

52-9.2 Construction.

Terms not defined in this Subpart are defined in Subpart 52-1 of this Part. Human milk banks shall apply for licensure and otherwise comply with Subpart 52-2 of this Part, and shall meet all general technical standards for tissue banks specified in Subpart 52-3 of this Part.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.3 - Administrative responsibility

52-9.3 Administrative responsibility.

The director of a human milk bank shall ensure the development and implementation of policies and procedures consistent with this Part for the operation of the bank, and the appointment of a medical director and a medical advisory committee composed of physicians with experience in pediatrics, neonatology, blood banking, nutrition and/or other appropriate fields, including at least one member with expertise in infectious diseases, as well as other allied health personnel.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.4 - Medical direction

52-9.4 Medical direction.

(a) Medical direction of a human milk bank shall be provided by a physician, who may also be the director of the bank, in consultation with the medical advisory committee. Such physician shall be licensed and currently registered with the New York State Education Department, and possess a minimum of four years' experience in neonatology, pediatrics, blood banking or a related field.

(b) The medical director and the medical advisory committee shall establish operating procedures and monitor the medical efficacy of milk banking services, and shall, consistent with this Part, develop:

(1) medical criteria for donor participation;

(2) quality standards for the milk, including methodologies and criteria for heat-processing; and

(3) policies for priority distribution of milk when demand exceeds the supply.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.5 - Donor qualifications

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.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.6 - Collection and storage of human milk

52-9.6 Collection and storage of human milk.

(a) The human milk bank shall supply presterilized, leak-proof containers and container seals to the donor.

(b) Containers shall be accompanied by an affixed tag which shall show the donor's identification number, and the date and time the milk was collected. When frozen milk is held at a transfer station, this tag shall also identify the station, and the date and time of receipt and transport of the milk.

(c) Milk shall be transported and stored so that it is protected from contamination, thawing and refreezing. Milk in liquid form shall be maintained at a temperature between one and six degrees Celsius, but shall be stored in liquid form for no longer than 48 hours. If milk is frozen, it shall be maintained at minus 20 degrees Celsius or below for a maximum storage period of six months, unless the medical advisory committee specifically approves a longer storage period. Household freezers with automatic defrost cycles shall not be used for such storage. Frozen milk shall be utilized within 48 hours of thawing and discarded thereafter if not utilized.

(d) The physical facilities of the human milk bank shall minimize the potential for contamination, as follows:

(1) the human milk bank shall be located in a distinct, identifiable area with a separate refrigerator and/or freezer provided for human milk; and

(2) refrigerators and freezers shall be equipped with a thermometer calibrated at least annually against a National Institute of Standards and Technology (NIST)-certified thermometer, or with a thermometer that has been tested against, and found to be in agreement with, an NIST-certified thermometer. The thermometer shall be either visually or mechanically monitored daily for fluctuations in temperature affecting the quality of the milk. Temperature records shall be maintained and made available for inspection for at least one year after collection of the milk.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.7 - Maintenance of records

52-9.7 Maintenance of records.

(a) The human milk bank shall maintain an individual file on each milk donor. For all donated human milk, the donor's name, address and any other information which would directly or indirectly identify the donor shall not be disclosed or released by the human milk bank to any person or entity except upon the written consent of the donor or except to the department. Records to be kept by the human milk bank shall include, but not be limited to, those required in Subpart 52-2of this Part and documentation of instructions given to the donor for collecting, storing and preserving the wholesomeness of donated milk.

(b) Records of milk donations shall be filed by donor identification number and shall include, but not be limited to:

(1) information from the identification tag affixed to the container at the time of collection, showing the date and time of collection, amount collected, and, if applicable, the identification of the transfer station with recorded date, and time of receipt and transport of the milk;

(2) results of all clinical laboratory tests performed on the donor preparatory to and during participation in the milk banking program;

(3) the date of pasteurization of the milk, if applicable; and

(4) the date the milk was distributed or used, and, if applicable, identifying information regarding milk pooled from multiple donors.

(c) Records shall be maintained on each recipient, including, but not limited to:

(1) the infant's or child's age, birth weight and/or weight history, and diagnosis indicating the medical need for human milk;

(2) the dates the milk banking service began and terminated;

(3) identification by donor identification number of the source of all milk given to the recipient;

(4) documentation that the risks of consumption by an infant or child of donated milk have been disclosed to the person(s) legally responsible for such infant or child;

(5) recipient health status at the time of discontinuation of milk banking service and reason for such discontinuation.

(d) Donor and recipient records shall be maintained for at least three (3) years after a recipient's age of majority (18 years) or for at least six (6) years after a recipient's death.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.8 - Distribution of human milk

52-9.8 Distribution of human milk.

Facilities shall distribute human milk only upon receipt of a written order from a licensed physician.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete