(a) Donor records include:

1. (1) Initial donor screening form, documenting:

   1. (A) Medical history;
   2. (B) History of communicable diseases;
   3. (C) Lifestyle choices that are risks for donated breast milk, including alcohol and nicotine use; and
   4. (D) Use of medications and/or herbs;
2. (2) Confirmation of negative serology tests within six (6) months of donation for HIV-1 and HIV-2, HTLV-1 and HTLV-2, Hepatitis B, Hepatitis C, and syphilis, and any additional screening required by the individual bank;
3. (3) Healthcare provider medical release form for both the donor, acknowledging that the provider or providers know of no risks to the potential donor should milk be collected for donation;
4. (4) Birth date and gestational age of donor's infant;
5. (5) Documentation of each donation (deposit); and
6. (6) Signed donor consent form.

(b)

1. (1) Administrative records are confidential.
2. (2) Electronic records must be secure (password-protected or encrypted).
3. (3) Paper records must be kept in a secure private area.
4. (4) Breast milk banks inform donors and recipients of privacy policies and procedures.

(d) Breast milk bank administrative records include:

1. (1) Identification of donors whose breast milk deposits comprise each pool, and the destination of each pool;

2. (2) Batch information, including:

   1. (A) Date of heat treatment;
   2. (B) Volume of breast milk treated;
   3. (C) Aliquots per batch; and
   4. (D) Heat-treatment times and temperatures;
3. (3) Bacteriologic test results by batch after pooling and heat treatment;
4. (4) Freezer, refrigerator, and pasteurizing temperatures;
5. (5) Calibration records for all equipment, with calibration cycle and process according to manufacturers' instructions; and
6. (6) Breast milk bank financial records as appropriate per institution, documenting processing fees per volume of breast milk dispensed, financial donations and in-kind gifts, and financial audits, if appropriate.

(e) Recipient records include:

1. (1)

   1. (A) Name of receiving entity and purchase-order number.
   2. (B) If ordered by a medical provider with prescription, name of provider and medical necessity;
2. (2) Dispensing date, batch numbers, number of bottles, and ounces per bottle of all supplied breast milk;
3. (3) Other pertinent information, such as diagnoses and medical outcome or outcomes of recipients, when available; and
4. (4) Documentation of quarterly communication with family or prescriber of outpatient recipients.