Qualification criteria

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Exclusion criteria

Potential donors are excluded based on the following clinical issues unique to human milk:

Receipt of blood transfusion or blood products within the last 4 months;
Receipt of an organ or tissue transplant within the last 12 months;
Ears or other body piercings with other than single-use instruments, tattooing from a non-regulated site, permanent makeup applied by needle, or an accidental stick with a contaminated needle within the last 12 months;
Daily use of more than 2 ounces of hard liquor, or its equivalent, in 24 hours;
Daily use of over-the-counter medications or systemic prescriptions not permitted for donor milk;
Regular use of megadose vitamins [at least 20 times the RDA] and/or herbal products used as medication, including vitamin/herb combinations;
Total vegetarians [vegans] who do not supplement their diet with vitamin B12;
Use of illegal drugs;
Use of tobacco or nicotine products, including gum and patches;
Chronic infections [for example, HIV, HTLV, malaria, active TB, etc.], a history of hepatitis B or C, or a history of leukemia or lymphoma, or treatment for any other cancer within the last 3 years;
A sexual partner in the past 12 months who is at risk for HIV, HTLV, or hepatitis [including anyone with hemophilia or anyone who has used a needle for injection of illegal or non-prescription drugs];
A sexual partner in the past 12 months who has had within the same time period tattoos with non-sterile needles or multi-person use dyes from a non-regulated site, permanent makeup applied with non-sterile needles, ear or other body parts pierced with other than single-use instruments, or been accidentally stuck with a contaminated needle;
Incarceration or incarceration of sexual partner for more than 72 consecutive hours in the last 12 months;
Receipt of human pituitary-derived growth hormone, dura mater [or brain covering] graft, bovine insulin, or has a family history of Creutzfeldt-Jakob disease;
Spent a total of 3 months or more in the United Kingdom between 1990 and 1996;
Spent a total of five years or more in Europe from 1980 to the present;
Current or former US military personnel, civilian military employees or their dependents who resided at US military bases in Northern Europe [Germany, UK, Belgium, and the Netherlands] for a total of six months or more from 1980 through 1990, or elsewhere in Europe [Greece, Turkey, Spain, Portugal, and Italy] from 1980 through 1996;
Received a blood or blood components transfusion in the UK or France since 1980.

Medications

Use of the following medications is acceptable:

Human insulin;
Thyroid replacement hormones;
Nasal sprays;
Asthma inhalers;
Topical treatments;
Eye drops;
Progestin-only birth control products and low-dose estrogen birth control products [Under 25mcg estrogen] including Loestrin 1/20, Alesse, Lybrel, Yaz, and Mercette;
The use of other medications on a temporary basis may be acceptable if the appropriate deferral period is followed. For most medications, the deferral is five times the half-life of the medication. All use of medications must be reported and approved.

Temporary disqualification

Potential donors are excluded based on the following clinical issues unique to human milk:

Receipt of blood transfusion or blood products within the last 4 months;
Receipt of an organ or tissue transplant within the last 12 months;
Ears or other body piercings with other than single-use instruments, tattooing from a non-regulated site, permanent makeup applied by needle, or an accidental stick with a contaminated needle within the last 12 months;
Daily use of more than 2 ounces of hard liquor, or its equivalent, in 24 hours;
Daily use of over-the-counter medications or systemic prescriptions not permitted for donor milk;
Regular use of mega dose vitamins [at least 20 times the RDA] and/or herbal products used as medication, including vitamin/herb combinations;
Total vegetarians [vegans] who do not supplement their diet with vitamin B12;
Use of illegal drugs;
Use of tobacco or nicotine products, including gum and patches;
Chronic infections [for example, HIV, HTLV, malaria, active TB, etc.], a history of hepatitis B or C, or a history of leukemia or lymphoma, or treatment for any other cancer within the last 3 years;
A sexual partner in the past 12 months who is at risk for HIV, HTLV, or hepatitis [including anyone with hemophilia or anyone who has used a needle for injection of illegal or non-prescription drugs];
A sexual partner in the past 12 months who has had within the same time period tattoos with non-sterile needles or multi-person use dyes from a non-regulated site, permanent makeup applied with non-sterile needles, ear or other body parts pierced with other than single-use instruments, or been accidentally stuck with a contaminated needle;
Incarceration or incarceration of sexual partner for more than 72 consecutive hours in the last 12 months;
Receipt of human pituitary-derived growth hormone, dura mater [or brain covering] graft, bovine insulin, or has a family history of Creutzfeldt-Jakob disease;
Spent a total of 3 months or more in the United Kingdom between 1990 and 1996;
Spent a total of five years or more in Europe from 1980 to the present;
Current or former US military personnel, civilian military employees or their dependents who resided at US military bases in Northern Europe [Germany, UK, Belgium, and the Netherlands] for a total of six months or more from 1980 through 1990, or elsewhere in Europe [Greece, Turkey, Spain, Portugal, and Italy] from 1980 through 1996;
Received a blood or blood components transfusion in the UK or France since 1980.

Blood tests

Donors must undergo a blood test conducted by a certified CLIA laboratory to test for the following:

HIV I/II
HTLV I/II
Hepatitis C
Hepatitis B
Syphilis

Negative test results do not require confirmatory testing. Positive or indeterminate result of a screening test is a reason for deferral and/or donor disqualification. Donors are deferred indefinitely for any positive result on a diagnostic/confirmatory serological test. A donor deferred for positive blood testing is to be referred to a health care provider of her choice for follow-up, and a copy of the lab work sent to her provider. Any milk held from a potential donor under these circumstances is disposed of according to institutional protocols.

Drug tests

Donors must undergo a blood test conducted by a certified CLIA laboratory to test for the following:

Amphetamines;
Opiates;
Cocaine metabolites;
Phencyclidine;
Marijuana metabolites (via a urine screen at the same appointment time and location as the blood test).

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