1. A. The screening of newborn infants pursuant to this chapter is a population based public health surveillance program.

2. B. On request, a laboratory or health care provider shall make available to the Follow-Up Unit medical records, records of laboratory tests, and any other medical information the Follow-Up Unit considers necessary to:

   1. (1) Screen a newborn infant for hereditary and congenital disorders set forth in Regulation .05 of this chapter;

   2. (2) Carry out the State's Newborn Screening Program, including:

      1. (a) Contacting the families and primary health care providers of newborn infants with newborn screening test results indicating a high risk of having a hereditary or congenital disorder;
      2. (b) Providing recommendations regarding the appropriate follow-up and diagnostic evaluation of the newborn infant;
      3. (c) Determining what follow-up evaluations and diagnostic tests were performed and on what date the evaluations and tests were performed;
      4. (d) Determining if and on what date a diagnosis of a specific hereditary or congenital disorder in a newborn infant was made; and
      5. (e) Determining if and on what date treatment and follow-up care have been initiated; and
   3. (3) Ensure compliance with the pertinent regulations set forth in this chapter and in COMAR 10.10.13.

3. C. Information that the Department receives under this chapter is confidential and may only be used or disclosed:

   1. (1) To provide services to the newborn infant and the infant's family;
   2. (2) To study the relationships of the various factors determining the frequency and distribution of the disorders set forth in Regulation .05 of this chapter;
   3. (3) For State or federally mandated statistical reports; and
   4. (4) To ensure that the information received by the Department is accurate and reliable.

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Regulations .01— .12, Screening for Treatable Disorders in the Newborn Child, repealed and new Regulations .01— .15, Newborn Screening, adopted as an emergency provision effective January 1, 2009 (36:2 Md.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)