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Administrative Rules
Rule 44:19:01 DEFINITIONS

CHAPTER 44:19:01

DEFINITIONS

Section

44:19:01:01        Definitions.

44:19:01:02        Transferred.

44:19:01:03        Repealed.

44:19:01:04        Required tests.




Rule 44:19:01:01 Definitions.

          44:19:01:01.  Definitions. Terms used in this article mean:

 

          (1)  "Days of age," the measurement of the age of a newborn in 24-hour periods; i.e., a newborn is one day of age 24 hours following the hour of birth;

 

          (2)  "Department," the South Dakota Department of Health;

 

          (3)  "Designated laboratory," a laboratory or laboratories authorized by the department pursuant to § 44:19:02:03.01 to perform newborn screening services for infants born in South Dakota;

 

          (4)  "Filter paper specimen," a sample of blood collected from an infant by saturating marked areas of a filter paper card with blood obtained by skin puncture of the heel;

 

          (5)  "Initial specimen," the first newborn screening specimen collected subsequent to birth;

 

          (6)  "Metabolic disorder," a malfunction in the processes that convert compounds to protoplasm, energy, and waste;

 

          (7)  "Newborn," an infant 28 days of age or under;

 

          (8)  "Newborn's physician," the physician responsible for the care of a newborn;

 

          (9)  "Newborn screening," a laboratory testing performed on newborn blood specimens to identify newborns with a metabolic, inherited, or genetic disorder;

 

          (10)  "Secretary," the Secretary of the Department of Health; and

 

          (11)  "Submitter," the attending physician, other health professional, hospital, or public health facility who sends the newborn screening requisition form to the designated laboratory for initial, repeat, or confirmatory screening tests.

 

          Source: 12 SDR 167, effective April 20, 1986; 15 SDR 59, effective October 19, 1988; 18 SDR 67, effective October 16, 1991; 23 SDR 91, effective December 9, 1996; 31 SDR 164, effective May 9, 2005; 41 SDR 109, effective January 5, 2015; 42 SDR 14, effective August 10, 2015.

          General Authority: SDCL 34-24-25.

          Law Implemented: SDCL 34-24-23.

 




Rule 44:19:01:02 Transferred.

          44:19:01:02.  Transferred to § 44:19:02:03.




Rule 44:19:01:03 Repealed.

          44:19:01:03.  Deadlines for reporting test results.Repealed.

          Source: 12 SDR 167, effective April 20, 1986; repealed, 15 SDR 59, effective October 19, 1988.




    44:19:01:04.  Required tests. In addition to the metabolic disorder tests required in SDCL 34-24-18, a designated laboratory shall screen any infant born in this state for the following newborn screening disorders:

    (1)  Hemoglobinopathies;

    (2)  Biotinidase deficiency;

    (3)  Classical congenital adrenal hyperplasia;

    (4)  Fatty acid oxidation disorders;

    (5)  Amino acid disorders;

    (6)  Organic acid disorders;

    (7)  Cystic fibrosis;

    (8)  Severe combined immunodeficiency disorder;

    (9)  Spinal muscular atrophy;

    (10)  Glycogen storage disease type II or Pompe disease; and

    (11)  X-linked adrenoleukodystrophy (X-ALD).

    Each physician, nurse practitioner, physician assistant, certified nurse midwife, or certified professional midwife providing childbirth services shall perform a newborn hearing screening on any infant the provider or midwife delivers in this state.

    Source: 31 SDR 164, effective May 9, 2005; 33 SDR 180, effective May 7, 2007; 42 SDR 14, effective August 10, 2015; 47 SDR 137, effective June 28, 2021; 49 SDR 16, effective September 1, 2022; 50 SDR 139, effective June 2, 2024.

    General Authority: SDCL 34-24-25.

    Law Implemented: SDCL 34-24-22.

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