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