1. A. Department's Responsibilities.

   1. (1) The Follow-Up Unit shall investigate each abnormal result indicative of increased risk for a hereditary or congenital disorder by contacting the infant’s health care provider, or other appropriate individual to notify the parent or guardian, or if the health care provider cannot be contacted, by contacting the infant’s parent or guardian directly regarding:

      1. (a) Results of first-tier, supplemental, and second-tier tests;
      2. (b) The importance of identifying and locating a newborn infant with test results indicative of increased risk for an hereditary or congenital disorder;
      3. (c) The urgent need for follow-up; and
      4. (d) The need to share newborn screening information between hospitals, healthcare providers, treatment centers, and laboratory personnel.

   2. (2) If the parent or guardian fails to respond to the birthing facility, health care provider, or other responsible individual acting as set forth in §B(1) of this regulation, the individual in charge of the birthing facility or the individual’s designated representative, health care provider, or other responsible individual shall notify the Follow-Up Unit, which shall then try to notify the parent or guardian of the need for follow-up by using at least one of the following means, in the indicated order of priority:

      1. (a) Telephone;
      2. (b) Certified mail, if medically appropriate;
      3. (c) Public health nurse visit; or
      4. (d) Law enforcement contact.
   3. (3) The Follow-Up Unit shall provide recommendations to the responsible birthing facility, health care provider, and the parent or guardian, as appropriate, regarding the appropriate follow-up and diagnostic evaluation of the newborn infant.

   4. (4) The Follow-Up Unit shall recommend:

      1. (a) Sources of diagnostic evaluation, specialty care, and treatment; and
      2. (b) That no treatment be administered to the newborn infant until the results of the follow-up evaluation have established that the infant has a hereditary or congenital disorder.

   5. (5) The Follow-Up Unit shall inform health care personnel and parents or guardians of:

      1. (a) The nature, cost, benefits, and risks of any therapy; and
      2. (b) The availability of any programs to assist individuals affected by a hereditary or congenital disorder.

2. B. Responsibilities of the Birthing Facility or Health Care Provider. The individual in charge of the birthing facility or individual’s designated representative or health care provider shall:

   1. (1) Evaluate the infant for signs, symptoms, and biochemical evidence of a hereditary or congenital disorder;

   2. (2) Refer the newborn infant for further evaluation:

      1. (a) To the appropriate specialists; and
      2. (b) For the appropriate diagnostic tests;
   3. (3) Collect and submit any required blood-spot specimens for repeat screening or diagnostic testing; and
   4. (4) Report the results of diagnostic testing to the Follow-Up Unit.

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)