26.1 Donor Records include:

26.1.1 Initial donor screening form, documenting:

26.1.1.1 Medical history

26.1.1.2 History of communicable diseases

26.1.1.3 Lifestyle choices that are risks for donated milk, including alcohol and nicotine use

26.1.1.4 Use of medications and/or herbs

26.1.2 Confirmation of negative serology tests within 6 months of donation for HIV-1 and -2, HTLV-1 and 2, Hepatitis B, Hepatitis C, and syphilis, and any additional screening required by the individual bank

26.1.3 Healthcare provider medical release form for both the donor and her infant (unless infant is not in mom's care or is deceased), acknowledging that the provider(s) knows of no risks to the potential donor or the infant should milk be collected for donation.

26.1.4 Birth date and gestational age of donor's infant

26.1.5 Documentation of each donation (deposit)

26.1.6 Signed donor consent form

26.2 Administrative records are confidential. Electronic records must be secure (password-protected or encrypted). Paper records must be kept in a secure private area. Milk banks inform donors and recipients of privacy policies and procedures.

26.3 Donor records are maintained for 10 years if an adult recipient -- or until every recipient who has received milk from a specific batch reaches a minimum age of 21, or longer, according to individual state or hospital rules or regulations.

26.4 Milk bank administrative records include:

26.4.1 Identification of donors whose milk deposits comprise each pool, and the destination of each pool.

26.4.2 Batch information, including date of heat treatment, volume of milk treated, aliquots per batch, and heat-treatment times and temperatures.

26.4.3 Bacteriologic test results by batch after pooling and heat treatment.

26.4.4 Freezer, refrigerator, and pasteurizing temperatures.

26.4.5 Calibration records for all equipment, with calibration cycle and process according to manufacturers' instructions.

26.4.6 Milk bank financial records as appropriate per institution, documenting processing fees per volume of milk dispensed, financial donations and in-kind gifts, and financial audits, if appropriate.

26.5 Recipient records include:

26.5.1 Name of receiving entity and purchase-order number. If ordered by a medical provider with prescription, name of provider and medical necessity.

26.5.2 Dispensing date, batch numbers, number of bottles, and ounces per bottle of all supplied milk.

26.5.3 Other pertinent information (such as diagnoses and medical outcome(s) of recipients, when available).

26.5.4 Documentation of quarterly communication with family or prescriber of outpatient recipients.