1. A. All Test Results. For a newborn infant, a permittee shall:

   1. (1) Report all first-tier, supplemental, and second-tier results to:

      1. (a) The person who requested the test; and

      2. (b) An individual who will use the test results in identifying, tracking, caring for, and treating the newborn infant, including:

         1. (i) A physician specialist; and
         2. (ii) Personnel in the Follow-Up Unit;
   2. (2) Report to the persons listed in §A(1) of this regulation within 3 working days after the laboratory obtains the blood-spot specimen, all test results that are within normal limits;
   3. (3) Report to a person requesting a second or subsequent screening the test results from the newborn infant's prior screening if not previously reported to the person;

   4. (4) Include with each report the following information:

      1. (a) Date the blood-spot specimen was received in the laboratory;
      2. (b) Date of the report; and
      3. (c) Cut-off level for each reported analyte; and
   5. (5) Report all abnormal test results to the Follow-Up Unit on the same day that a test result is obtained and reviewed.

2. B. Specific Test results. A permittee may not report a test result as being within normal limits for:

   1. (1) Amino acid levels for disorders specified in Regulation .12C(11)—(24) of this chapter and for a total galactose level for galactosemia as specified in Regulation .12C(3) of this chapter if:

      1. (a) A newborn infant was not on milk or formula feeding at least 24 hours before the blood-spot specimen was collected; or
      2. (b) The time of milk or formula feeding is unknown; or

   2. (2) 17-hydroxy progesterone results for congenital adrenal hyperplasia as specified in Regulation .12C(2) of this chapter and thyroxine and thyroid stimulating hormone for hypothyroidism as specified in Regulation .12C(4) of this chapter if the blood-spot specimen was collected when the newborn infant was:

      1. (a) Younger than 24 hours old; or
      2. (b) Of unknown age.

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)