1. (a) A certified laboratory is to conduct screening blood tests (HIV-1 and HIV-2, HTLV-1 and HTLV-2, Hepatitis C, Hepatitis B, and syphilis) within six (6) months prior to a woman's becoming a donor.

2. (b)

   1. (1) The prenatal care or postpartum care providers may submit testing if it was done within this time frame.
   2. (2) Negative test results do not require confirmatory testing.

3. (c) Screening tests for the following diseases are required:

   1. (1) HIV-1, HIV-2;
   2. (2) HTLV-1, HTLV-2;
   3. (3) Hepatitis B;
   4. (4) Hepatitis C; and
   5. (5) Syphilis.

4. (d)

   1. (1) Screening tests apply to all individuals who apply to be donors.
   2. (2) If a screening test is positive, the breast milk bank can defer that donor or follow up with a confirmatory diagnostic test.
   3. (3) 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.

   4. (4) Screening tests include:

      1. (A) HIV antibodies for both types (HIV, group O is included in HIV-1);
      2. (B) HTLV antibodies for both types;
      3. (C) Hepatitis B surface antigen;
      4. (D) Hepatitis C antibody; and
      5. (E)

5. (i) Syphilis RPR.

   1. (ii) This test has the highest likelihood of indicating a false positive.

6. (e)

   1. (1) Confirmatory tests may be ordered after obtaining a positive or indeterminate screening test, rather than deferring the potential donor.

   2. (2) Confirmatory tests include:

      1. (A) HIV PCR, measurement of viral particles;
      2. (B) HTLV PCR;
      3. (C) Hepatitis B PCR;
      4. (D) Hepatitis C PCR; and
      5. (E) FTA (fluorescent treponemal antibody), confirmatory test for syphilis.

7. (f)

   1. (1) Breast milk banks are not required to run diagnostic tests.
   2. (2) However, they may do so.
   3. (3) Diagnostic test results override screening test results.

8. (g)

   1. (1) Donors are deferred indefinitely for any positive result on a diagnostic/confirmatory serological test.
   2. (2) A donor deferred for positive blood testing is to be referred to a healthcare provider of her choice.
   3. (3) The follow-up is done in compliance with state/federal rules and regulations.
   4. (4) Any breast milk from this potential donor that has already been donated and is being held at the breast milk bank is disposed of according to institutional protocols.
   5. (5) In the absence of institutional protocols, expressed breast milk may be disposed of in a sink or a trash can.
9. (h) 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 breast milk.

Codification Notes: “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. "PCR" means polymerase chain reaction. "RPR" means rapid plasma regain.