1. A. Reporting Requirements. A permittee shall immediately report an abnormal or diagnostic test result to the Follow-Up Unit by:

   1. (1) Telephoning and personally speaking to an individual in the Follow-Up Unit;
   2. (2) Telephoning and personally speaking to a back-up individual representing the Follow-Up Unit, if an attempt to make in-person contact with an employee of the Follow-Up Unit fails; and
   3. (3) Following up a telephonic report within 24 hours with a report by facsimile or electronic mail to the Follow-Up Unit.
2. B. Verification Requirement. A permittee shall contact the Follow-Up Unit by telephone at least once every 6 months to ensure that the permittee is able to meet the requirements in §A of this regulation.

3. C. Reporting Requirements; General. A permittee shall provide with each abnormal result, where applicable, the:

   1. (1) Identity or name of each analyte measured;

   2. (2) Measured numerical concentration or range of:

      1. (a) Each analyte measured; and
      2. (b) All related analytes measured;
   3. (3) Value of any relevant ratios used to determine abnormality;
   4. (4) Postnatal age of the newborn infant;
   5. (5) Appropriate gestational age/birth weight control range;
   6. (6) Cut-off level for the analyte of a hereditary or congenital disorder; and
   7. (7) Measure of the degree of abnormality of the test result.

4. D. Reporting Requirements; Sickle Cell Disease Hemoglobin. A permittee shall report results for hemoglobin disorders as specified in Regulation .12C(7)—(10) of this chapter for sickle cell disease in terminology that includes:

   1. (1) The alleles present in decreasing quantitative order; and

   2. (2) Specifying trait states and possible disease states for at least the following alleles:

      1. (a) Hemoglobin C;
      2. (b) Hemoglobin D;
      3. (c) Hemoglobin E;
      4. (d) Hemoglobin G;
      5. (e) Hemoglobin O; and
      6. (f) Hemoglobin S.

Authority: Health-General Article, §§13-101—13-103, 13-108—13-112, 13-601—13-605, 17-201—17-206, 17-210,
17-211, 17-215, and 17-216, Annotated Code of Maryland

Effective date:

Regulations .01— .27 adopted as an emergency provision effective January 1, 2009 (36:2 Md. R. 97); adopted permanently effective March 23, 2009 (36:6 Md. R. 490)

Regulation .02A amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .03B amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .04B amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .06B amended as an emergency provision effective July 1, 2012 (39:15 Md. R. 962); amended permanently effective August 20, 2012 (39:16 Md. R. 1080)

Regulation .06B amended effective April 27, 2015 (42:8 Md. R. 608); April 14, 2025 (52:7 Md. R. 321)

Regulation .12 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .12C amended effective August 23, 2021 (48:17 Md. R. 669); April 14, 2025 (52:7 Md. R. 321); May 25, 2026 (53:10 Md. R. 454)

Regulation .13 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .14 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .15 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .16 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .17 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .18B amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .20A, C amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .21 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .23 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .24A, D amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .25 amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .26A amended effective April 24, 2017 (44:8 Md. R. 404)

Regulation .27C amended effective April 24, 2017 (44:8 Md. R. 404)