1. A. Normal Screening Results.

   1. (1) The Department’s public health laboratory shall report normal newborn screening test results to the submitter of the blood-spot specimen within 3 business days after receipt of the blood-spot specimen.

   2. (2) A birthing facility representative, health care provider, or the individual who is responsible for filing the certificate of birth if the birth occurs outside a birthing facility, or other submitter of the blood-spot specimen shall:

      1. (a) Enter the results in the newborn infant's medical record; and
      2. (b) Make the results available to the parent, guardian, or primary care providers upon request.

2. B. Abnormal Screening Results.

   1. (1) The Department’s public health laboratory shall immediately report abnormal newborn screening test results to the Follow-Up Unit.
   2. (2) The Department’s public health laboratory shall report to the Follow-Up Unit all known demographic and clinical data on the newborn infant in an electronic format compatible with the Department’s information system databases operated by the Department’s public health laboratory, as set forth at COMAR 10.10.13.25.
   3. (3) The Follow-Up Unit shall enter results in the Department’s database and initiate follow-up procedures as specified in Regulation .12 of this chapter.

   4. (4) The submitter of the blood-spot specimen shall:

      1. (a) Enter the results in the newborn infant's medical record; and
      2. (b) Make the abnormal results available immediately to the newborn's parent, guardian, or primary care providers.

Authority: Health-General Article, §§13-109, 13-111, and 13-601—13-605, Annotated Code of Maryland

Effective date: December 24, 1975 (2:29 Md. R. 1738)

Chapter revised and recodified from COMAR 10.39.01, Testing for Hereditary Metabolic Disorders in the Newborn Child, to COMAR 10.52.12, Screening for Treatable Disorders in the Newborn Child, effective November 20, 1994 (21:23 Md. R. 1934)

Regulations .01— .12, Screening for Treatable Disorders in the Newborn Child, repealed and new Regulations .01— .15, Newborn Screening, adopted as an emergency provision effective January 1, 2009 (36:2 Md.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 .03B amended effective March 14, 2016 (43:5 Md. R. 385)

Regulation .07E amended effective March 14, 2016 (43:5 Md. R. 385)

Regulation .08B amended effective March 14, 2016 (43:5 Md. R. 385)

Chapter revised effective April 24, 2017 (44:8 Md. R. 404)

Regulation .05B 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)