4.1 Donor qualifications are based on best practices and clinical data, and must be updated continuously to reflect emerging diseases and new pharmaceutical agents.

4.2 Screening must include in-person or on-the-phone contact, and must never be limited to electronic communication.

4.3 Two appropriately trained staff members must review, approve, and sign or document the completed donor screening.

4.4 Acceptable donors are healthy lactating women with surplus expressed milk, and who meet the following requirements:

4.4.1 They have been screened verbally and in writing, and 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.

4.4.1.1 In cases where English is not a primary language for the donor applicant, and indications are that a translator is required, the contacted milk bank makes efforts to offer an appropriate translator to help with the screening process, or a milk bank employee who is trained in screening will be present (or available by phone) during the interview with a third-party translator. The translator may also be someone who knows the would be donor and has the donor's permission to translate. This choice is made with discretion, as the milk bank screener must feel comfortable that the translator is not manipulative of the would-be donor and is sufficiently mature to handle content.

4.4.1.1.1 If a suitable translator is not available, the donor applicant can be referred to another donor milk bank. If no bank is able to find a suitable translator, the donor applicant is deferred due to inadequate screening.

4.4.2 Potential donors have statements of known health/medical risks signed by their licensed health care providers and their baby's licensed health care provider (exception: their baby is not in their care, such as in the case of mothers whose babies have died or been given up for adoption).

4.4.3 Potential donors are screened serologically for HIV-1 and -2, HTLV-1 and -2, Hepatitis C, Hepatitis B, and syphilis no more than 6 months prior to the first donation. A CLIA certified high complexity clinical laboratory or an ISO 17025 accredited clinical laboratory does the tests, and results are valid throughout the time of donation unless life-style or medical issues suggest an increased risk for donation, in which case deferral or retesting is at the discretion of the individual milk bank.

4.4.3.1 Communication with a milk donor regarding her health and lifestyle is expected to be no less frequent than every 2 months and documented in the donor's record. Donors thought to be at risk for a blood-borne disease are immediately deferred.

4.4.4 Certain medications are permitted during donation of milk, and others are a cause for deferral. Permissible medications should be reviewed by the Members of the Medications Committee at least annually and updated based on research and information from the U.S. Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, Health Canada, pharmaceutical and blood-banking industry and other sources. Members of the Medications Committee draw from specialties including neonatology, pharmacology, and pediatrics.

4.4.4.1 The determination of any medication's risk takes into consideration characteristics such as molecular weight of a medication, lipid solubility and plasma affinity, and weight of the likely recipient.

4.4.4.2 Prospective donors taking medications on the permissible list but with a deferral time can be accepted. However, milk expressed during the deferral period cannot be used to feed babies.

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

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

4.4.4.5 Prospective donors taking medications that are limited to the following list do not need deferral:

4.4.4.5.1 Topical medications applied to the skin away from the breast; topical medications applied to the breast should be washed off before expressing milk for donation

4.4.4.5.2 Drugs given to mothers orally that are not absorbed systemically (e.g., aluminum, calcium, or magnesium antacids, stool softeners, fibers, simethicone)

4.4.4.5.3 Inhaled drugs for asthma, colds, and allergies

4.4.4.5.4 Non-sedating antihistamines:

4.4.4.5.4.1 Allegra (fexofenadine) (Canadian equivalent--Allegra, Fexidine, Telfast, Fastofen, Tilfur, Vifas, Tel-fexo, Allerfexo)

4.4.4.5.4.2 Clarinex (desloratadine) (Canadian equivalent--Neo-Calrityn, Deselex, Aviant, Delot)

4.4.4.5.4.3 Claritin (loratadine)

4.4.4.5.4.4 Zyrtec (cetirizine) (Canadian equivalent-- Zyrtec Reactine) or Xyzal

4.4.4.5.5 Eye drops

4.4.4.5.6 Selected birth control methods:

4.4.4.5.6.1 Spermicides

4.4.4.5.6.2 Copper IUDs--Mirena or ParaGard, for example

4.4.4.5.6.3 Progestin-only or low-dose estrogen (<25mcg) birth control methods. Common examples of these include Depo Provera (medroxyprogeste one injection), micronor or Nor-QD (norethindrone), Yaz and Beeyaz (drospironome, Implanon or Nexplanon FDA (estonogestrel implant)

4.4.4.5.6.4 Seasonale, Seasonique, and Lybrel (longacting norgestral oral contraceptive pills), ortho tricycline lo, and Lo/Ovral 28

4.4.4.5.7 Hormonal replacement drugs that are normally found in milk:

4.4.4.5.7.1 Thyroid replacement

4.4.4.5.7.2 Hydrocortisone

4.4.4.5.7.3 Insulin

4.4.4.5.7.4 Inactivated vaccines, intranasal influenza vaccine, toxoids, and allergy shots

4.4.4.5.8 Selected human immune globulin products

4.4.4.5.8.1 Intravenous immunoglobulin

4.4.4.5.8.2 Rhogam

4.4.4.5.8.3 Tetanus

4.4.4.5.8.4 Rabies

4.4.4.5.9 Selected supplements:

4.4.4.5.9.1 Vitamins

4.4.4.5.9.2 Minerals

4.4.4.5.9.3 Fish oils

4.4.4.5.9.4 Omega-3-fatty acids

4.4.4.5.9.5 Lecithin

4.4.4.5.9.6 Probiotics

4.4.4.6 The use of other medications on a temporary basis may be acceptable if the appropriate deferral period is followed. For most medications, this deferral in 5 times the half-life of the medications.