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

1. A. Develop collection and transport procedures to ensure against collecting and submitting unsatisfactory blood-spot specimens for each of the categories of newborn infant listed in §B of this regulation.

2. B. Collect or otherwise have collected:

   1. (1) An additional blood-spot specimen before the newborn is 7 days old for newborn infants discharged before 24 hours of milk feeding in addition to the blood-spot specimen collected before discharge, as set forth in Regulation .07C(2) of this chapter.
   2. (2) The blood-spot specimen before the newborn is 7 days old if a newborn infant is discharged from a birthing facility before a newborn screening blood-spot specimen is collected.
   3. (3) An additional blood-spot specimen within 7 days after notification if the laboratory reports to a birthing facility or a home birth attendant that the initial blood-spot specimen was unsatisfactory.
   4. (4) A blood-spot specimen to be tested for hemoglobins, biotinidase, and galastose -1 phosphate uridyl transferase (GALT) only, four months after the last transfusion if the initial blood-spot specimen was not collected until after the infant was transfused.

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Regulations .01— .12, Screening for Treatable Disorders in the Newborn Child, repealed and new Regulations .01— .15, Newborn Screening, adopted as an emergency provision effective January 1, 2009 (36:2 Md.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