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007.19.1-8. Serological Tests

AR ADC 007.19.1-8Arkansas 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 007.19.1-8
007.19.1-8. Serological Tests
8.1 A certified laboratory is to conduct screening blood tests (HIV-1 and -2, HTLV-1 and -2, hepatitis C, hepatitis B, and syphilis) within 6 months prior to a woman's becoming a donor.
8.2 The prenatal care or postpartum care providers may submit testing if it was done within this time frame. Negative test results do not require confirmatory testing.
8.3 Screening tests for the following disease are required:
8.3.1 HIV-1, HIV-2
8.3.2 HTLV-1, HTLV-2
8.3.3 Hepatitis B
8.3.4 Hepatitis C
8.3.5 Syphilis
8.4 Screening tests apply to all individuals who apply to be donors. If a screening test is positive, the milk bank can defer that donor or follow up with a confirmatory diagnostic test. A confirmatory diagnostic test cannot be a repeat of the same test but must be more specific and less subject to a false positive, according to medical standards. Screening test include:
8.4.1 HIV antibodies for both types (HIV, group O is included in HIV-1)
8.4.2 HTLV antibodies for both types
8.4.3 Hepatitis B surface antigen
8.4.4 Hepatitis C antibody
8.4.5 Syphilis RPR (this test has the highest likelihood of indicating a false positive)
8.5 Confirmatory tests may be ordered after obtaining a positive or indeterminate screening test, rather than deferring the potential donor. Confirmatory tests include:
8.5.1 HIV PCR (measurement of viral particles)
8.5.2 HTLV PCR
8.5.3 Hepatitis B PCR
8.5.4 Hepatitis C PCR
8.5.5 FTA (florescent treponemal antibody -- confirmatory test for syphilis)
8.6 Milk banks are not required to run diagnostic tests; however, they may do so. Diagnostic test results override screening test results.
8.7 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. The follow-up is done in compliance with the state/federal regulations. Any milk from this potential donor, that has already been donated and is being held at the milk bank, is disposed of according to institutional protocols. In the absence of institutional protocols, expressed milk may be disposed of in a sink or a trash can.
8.8 In all cases, whether or not screening tests are negative, a donor is deferred if her lifestyle or medical risks suggest that she could have harmful substances in her milk.

Credits

Adopted Feb. 15, 2021.
<Statutory authority: PROMULGATED UNDER THE AUTHORITY OF ARK. CODE ANN. ยง 20-7-140>
Current with amendments received through February 15, 2024. Some sections may be more current, see credit for details.
Ark. Admin. Code 007.19.1-8, AR ADC 007.19.1-8
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