The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall:

1. A. If the parent or guardian of the newborn infant does not object to newborn screening:

   1. (1) Collect a blood-spot specimen:

      1. (a) As set forth in:

         1. (i) Sections C and D of this regulation; and
         2. (ii) COMAR 10.10.13.13; and
      2. (b) Pursuant to the procedures established in COMAR 10.10.13.14A; and
   2. (2) Submit the collected blood-spot specimen to the Department’s public health laboratory;

2. B. When a parent or guardian objects to newborn screening:

   1. (1) Have the parent or guardian sign a form that states the parent or guardian objects to newborn screening; and
   2. (2) Inform the Follow-Up Unit by telephone, fax, or email of the objection within 12 hours after the objection;

3. C. For full-term healthy newborn infants:

   1. (1) Collect a blood-spot specimen to test for the disorders set forth in Regulation .05 of this chapter not sooner than 24 hours after the onset of milk feeding, regardless of whether the newborn is breast-fed or formula-fed; and
   2. (2) If the newborn infant is discharged before 24 hours after the onset of milk feeding, collect the blood-spot specimen as late as practical before the newborn infant is discharged from the birthing facility; and

4. D. For a newborn infant born prematurely or expected to be ill for longer than 14 days, if the newborn infant’s medical condition permits, collect:

   1. (1) A blood-spot specimen for the newborn screening test upon admission, before the administration of blood products or antibiotics;
   2. (2) A subsequent blood-spot specimen 48 to 72 hours after birth, regardless of milk feeding status;
   3. (3) A subsequent blood-spot specimen by 10 days of age when milk feeding is established or the infant has been receiving additional protein through intravenous fluids; and
   4. (4) An additional subsequent blood-spot specimen at one month of age or at discharge, whichever comes first.

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)