1. (a) Donor qualifications:

   1. (1) Are based on best practices and clinical data; and
   2. (2) Must be updated continuously to reflect emerging diseases and new pharmaceutical agents.

2. (b) Screening:

   1. (1) Must include in-person or on-the-phone contact; and
   2. (2) Must never be limited to electronic communication.
3. (c) Two (2) appropriately trained staff members must review, approve, and sign or document the completed donor screening.

4. (d) Acceptable donors are healthy lactating women with surplus expressed breast milk who meet the following requirements:

   1. (1)

      1. (A) They have been:

5. (i) Screened verbally and in writing; and

   1. (ii) Given educational materials informing them of characteristics of the high-risk groups or activities that might put them at risk for transmitting blood-borne diseases.

      1. (B) In cases where English is not a primary language for the donor applicant and indications are that a translator is required:

         1. (i) The contacted breast milk bank makes efforts to offer an appropriate translator to help with the screening process; or
         2. (ii) A breast milk bank employee who is trained in screening will be present or available by phone during the interview with a third-party translator.

      2. (C) The translator may also be someone who:

         1. (i) Knows the would-be donor; and
         2. (ii) Has the donor's permission to translate.

      3. (D)

         1. (i) This choice is made with discretion, as the breast milk bank screener must feel comfortable that the translator:
6. (a) (a) Is not manipulative of the would-be donor; and

7. (b) (b) Is sufficiently mature to handle content.

   1. (ii)
8. (a) (a) If a suitable translator is not available, the donor applicant can be referred to another donor breast milk bank.

9. (b) (b) If no bank is able to find a suitable translator, the donor applicant is deferred due to inadequate screening;

   1. (2) Potential donors have statements of known health/medical risks signed by their licensed healthcare providers;

   2. (3)

      1. (A) Potential donors are screened serologically for HIV-1 and HIV-2, HTLV-1 and HTLV-2, Hepatitis C, Hepatitis B, and syphilis within six (6) months prior to the first donation.
      2. (B) A CLIA-certified high complexity clinical laboratory or an ISO 15189 accredited clinical laboratory that achieved accreditation from an International Laboratory Accreditation Cooperation-recognized accreditation body does the tests, and results are valid throughout the time of donation unless lifestyle or medical issues suggest an increased risk for donation, in which case deferral or retesting is at the discretion of the individual breast milk bank.

      3. (C)

         1. (i) Communication with a breast milk donor regarding her health and lifestyle is expected to be:
10. (a) (a) No less frequent than every two (2) months; and

11. (b) (b) Documented in the donor's record.

    1. (ii) Donors thought to be at risk for a blood-borne disease are immediately deferred; and

    2. (4)

       1. (A) Certain medications are permitted during donation of milk, and others are a cause for deferral.

       2. (B) Permissible medications should be reviewed by the medical director and approved by the breast milk bank's panel of consultants at least annually and updated based on research and information from:

          1. (i) The Centers for Disease Control and Prevention;
          2. (ii) The Food and Drug Administration;
          3. (iii) Health Canada;
          4. (iv) The pharmaceutical and blood-banking industry; and
          5. (v) Other sources.

       3. (C)

          1. (i) Members of the panel draw from specialties including:
12. (a) (a) Neonatology;

13. (b) (b) Pharmacology; and

    1. (c) (c) Pediatrics.

       1. (ii) The determination of any medication’s risk takes into consideration characteristics such as:
14. (a) (a) Molecular weight of a medication;

15. (b) (b) Lipid solubility and plasma affinity; and

    1. (c) (c) Weight of the likely recipient.

       1. (iii)
16. (a) (a) Prospective donors taking medications on the permissible list but with a deferral time can be accepted.

17. (b) (b) However, breast milk expressed during the deferral period cannot be used to feed babies.

    1. (iv) If a potential donor is donating previously expressed breast milk, medication and herb use during the time of breast milk expression must be investigated.

       1. (v)
18. (a) (a) Donors should be advised that if they begin taking any medication once approved and donating breast milk, they should contact the breast milk bank to discuss deferral dates or the need to retire as a donor.

19. (b) (b) Moreover, if a prospective or approved donor is taking a medication used for a diagnosis that is outside of the category for the medication, please ask for the dose and forward the information to the medical director so that a determination can be made about safety.

    1. (vi) Prospective donors taking medications as determined in this subdivision do not need deferral.

       1. (vii)
20. (a) (a) The use of other medications on a temporary basis may be acceptable if the appropriate deferral period is followed.
21. (b) (b) For most medications, this deferral is five (5) times the half-life of the medications.

Codification Notes: “CLIA” means Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a. "HIV-1" means human immunodeficiency virus type 1. "HIV-2" means human immunodeficiency virus type 2. "HTLV-1" means human T-lymphotropic virus type 1. "HTLV-2" means human T-lymphotropic virus type 2. "ISO" means International Organization for Standardization.