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007.19.1-6. Exclusion Criteria

AR ADC 007.19.1-6Arkansas Administrative CodeEffective: February 15, 2021

West's Arkansas Administrative Code
Title 007. Department of Health
Division 19. Public Health Laboratory
Rule 1. Rules Pertaining to Milk Bank Standards (Refs & Annos)
Effective: February 15, 2021
Ark. Admin. Code 007.19.1-6
007.19.1-6. Exclusion Criteria
6.1 Note: Potential donors are excluded based on the following clinical issues unique to human milk and infants, and on current AABB, US CDC, and Health Canada Guidelines.
6.2 Receipt of blood transfusion or blood products, except Rhogam®, within the last 6 months. If the donor has received blood products or transfusion, donor has serological testing at 6 months after the receipt. This deferral period is based on current CDC identification of the window period for HIV another blood-borne illnesses -- the period of time from exposure to sero-conversion to a positive HIV or hepatitis status.
6.3 Receipt of an organ or tissue transplant within the last 12 months. If the donor has received an organ or tissue transplant, donor has serological testing as 12 months after the receipt. If testing is negative, she may donate milk that was pumped during the waiting period.
6.4 Within the last 6 months: Ear or other body piercings with other than single-use instruments, tattooing from a nonregulated site, or permanent makeup applied by needle. (Note: Multiple-person dye pots or needles may be used by nonregulated sites, leading to a risk of blood-borne disease transmission.) If any of these situations has occurred, donor has serological testing at 6 months after the event. Refer to section on temporary restrictions on piercings and tattoos obtained from regulated sites.
6.5 Accidental needle stick in the past 6 months requires serological testing at 6 months after the event, unless the donor has access to medical records of person on whom needle was first used, can verify that person was immediately tested for HIV and hepatitis, and results were negative. In such a case, waiting 4 months for serological testing is sufficient. If the patient's testing is positive, wait 6 months for donor's serological testing. If testing is negative, she may donate milk that was pumped during that waiting period.
6.6 Daily use of more than 1.5 ounces of hard liquor, 12 ounces of beer, 5 ounces of wine, and/or 10 ounces of wine cooler in 24 hours. Based on data from the U.S. Centers for Disease Control and Prevention, milk banks must have a chart on specific elimination times per type of alcohol.
6.7 Current use of marijuana for medical or casual use.
6.8 Use of tobacco or nicotine products, including gum, patches, or e-cigarettes. This includes casual or occasional use of such products.
6.9 Secondhand smoke: Little data exist to describe relevance of secondhand smoke; however, it is known to transfer via breast milk. There are insufficient data to determine reasons for exclusion of donors due to exposure to secondhand smoke, therefore individual milk banks must determine if secondhand smoke exposure requires exclusion.
6.10 Daily use of over-the-counter medications or systemic prescriptions.
6.11 Regular use of mega dose vitamins (at least 20 times the RDA) and/or herbal products use as medication, including vitamin/herb combinations.
6.12 Total vegetarians (vegans) who do not supplement their diet with vitamin B12.
6.13 Use of illegal drugs within the past 12 months.
6.14 Chronic infections (e.g., HIV, HTLV, active TB, etc.) relevant to breastfeeding; a history of hepatitis B or C; a history of leukemia or lymphoma; or treatment for any other cancer within the last 3 years. Some low-risk cancers, including squamous or basal-cell cancers of the skin, may be exempted on a case-by-case basis. Critical to allowance is whether or not the cancer was in-situ and removed without further treatment.
6.15 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 nonprescription drugs). This includes sexual partner in the past 12 months who has had, within the same time period, tattoos with nonsterile needles or multi-person use dyes from a nonregulated site, permanent makeup applied with nonsterile needles, ear or other body parts pierced with other than single-use instruments, been accidentally stuck with a contaminated needle or received a transfusion or an organ or tissue transplant. If any of these situations have occurred with the partner, donor must wait the required lengths of time described above.
6.16 Incarceration, or incarceration of sexual partner, for more than 72 consecutive hours in the last 12 months
6.17 Risk of Creutzfeldt-Jakob disease. Note: many public health entities have slight variations on risks of CJD with body fluids. These risks are based on those defined by the AABB and Canadian Blood Services and also on hypothetical risks about who may or may not be able to transmit the disease. CJD has never been fully identified in breast milk, but its transfer cannot yet be ruled out. An adult who, as an infant was exposed to CJD because of her mother's location, is deferred from donating.
6.17.1 Receipt of human pituitary-derived growth hormone, dura mater (or brain covering) graft, or bovine insulin.
6.17.2 Family history of Creutzfeldt-Jakob disease.
6.17.3 Time spent in the following countries is restricted for US. Total of 3 months or more in the United Kingdom between 1980 and 1996. Total of 5 years or more in Europe from 1980 to the present in the following countries:
6.17.3.1 Albania
6.17.3.2 Austria
6.17.3.3 Belgium
6.17.3.4 Bosnia-Herzegovina
6.17.3.5 Bulgaria
6.17.3.6 Croatia
6.17.3.7 Czech Republic
6.17.3.8 Denmark
6.17.3.9 Federal Republic of Yugoslavia (also known as Serbia and Montenegro)
6.17.3.10 Finland
6.17.3.11 France
6.17.3.12 Germany
6.17.3.13 Greece
6.17.3.14 Hungary
6.17.3.15 Italy
6.17.3.16 Lichtenstein
6.17.3.17 Luxembourg
6.17.3.18 Macedonia
6.17.3.19 Netherlands (also known as Holland)
6.17.3.20 Norway
6.17.3.21 Poland
6.17.3.22 Portugal
6.17.3.23 Republic of Ireland (also known as Ireland)
6.17.3.24 Romania
6.17.3.25 Slovak Republic (also known as Slovakia)
6.17.3.26 Spain
6.17.3.27 Sweden
6.17.3.28 Switzerland
6.17.3.29 United Kingdom
6.17.4 Current or former US or Canadian military personnel, civilian military employees, or their dependents who resided at military bases in Northern Europe (Germany, Belgium and the Netherlands [Holland]) for a total of 6 months or more from 1980 through 1990, or elsewhere in Europe (Greece, Turkey, Spain, Portugal, and Italy) from 1980 through 1996.
6.17.5 Received a blood or blood-component transfusion in the UK or France since 1980.
6.18 Exposure to Ebola virus requires a 28-day deferral, at which time donors may resume donating milk if they have not become ill. Ebola has a 21-day window for symptoms to appear; 28 days is used to allow for any question of actual exposure date.
6.19 Exposure to hand, foot and mouth disease is not a reason for deferral unless medication is required.
6.20 Milk may not be donated if it has been heat-treated in any way by the donor. This includes warming, scalding, boiling, or thawed after freezing.

Credits

Adopted Feb. 15, 2021.
<Statutory authority: PROMULGATED UNDER THE AUTHORITY OF ARK. CODE ANN. § 20-7-140>
Current with amendments received through February 15, 2024. Some sections may be more current, see credit for details.
Ark. Admin. Code 007.19.1-6, AR ADC 007.19.1-6
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