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.

 

          44:19:02:03.01.  Designation of laboratories. The department shall designate the laboratories that are authorized to perform newborn screening services for infants born in South Dakota. The number of laboratories to be designated at any one time is at the discretion of the secretary.

 

          Source: 23 SDR 91, effective December 9, 1996; 31 SDR 164, effective May 9, 2005; 41 SDR 109, effective January 5, 2015.

          General Authority: SDCL 34-24-25.

          Law Implemented: SDCL 34-24-25.

 

          44:19:02:03.02.  Criteria for designation of laboratories. Repealed.

 

          Source: 23 SDR 91, effective December 9, 1996; repealed, 41 SDR 109, effective January 5, 2015.

 

          44:19:02:04.01.  Designated laboratory responsibilities. Repealed.

 

          Source: 31 SDR 164, effective May 9, 2005; repealed, 41 SDR 109, effective January 5, 2015.

 

          44:19:02:05.  Responsibilities of parents. The parent, guardian, or custodian of each infant is responsible for having blood tests as identified in § 44:19:01:04 performed within the first 48 hours of an infant's life. If a parent, guardian, or custodian refuses to have a newborn tested pursuant to § 44:19:01:04, despite having been notified of the need for testing, the parent, guardian, or custodian shall sign a written statement regarding the refusal.

 

          Source: 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 34-24-17, 34-24-23, 34-24-24.

 

          44:19:02:06.  Responsibilities of hospitals, physicians, and other health professionals. The attending physician, other health professional, hospital, or public health facility shall notify the parents, guardian, or custodian of each infant of the responsibility and need to have the newborn screening tests performed. The submitter shall place all newborn screening test results in the newborn patient's record. If a parent, guardian, or custodian refuses to have the newborn tested, the attending physician, other health professional, hospital, or public health facility shall obtain a written signed statement from the parent, guardian, or custodian of the infant regarding the refusal and place it in the newborn patient's record, notify the department within 24 hours of the refusal.

 

          Source: 31 SDR 164, effective May 9, 2005; 41 SDR 109, effective January 5, 2015.

          General Authority: SDCL 34-24-25.

          Law Implemented: SDCL 34-24-17, 34-24-23, 34-24-24.

 

          44:19:03:01.  Specimen submission to designated laboratory. Specimens must be submitted to the designated laboratory pursuant to the designated laboratory's protocol.

 

          Source: 15 SDR 59, effective October 19, 1988; 18 SDR 67, effective October 16, 1991; 23 SDR 91, effective December 9, 1996; 41 SDR 109, effective January 5, 2015.

          General Authority: SDCL 34-24-25.

          Law Implemented: SDCL 34-24-18.

 

          44:19:03:02.  Collection of filter paper specimens. Filter paper specimens for submission to the designated laboratory must be collected pursuant to the designated laboratory's protocol.

 

          Source: 15 SDR 59, effective October 19, 1988; 23 SDR 91, effective December 9, 1996; 31 SDR 164, effective May 9, 2005; 33 SDR 180, effective May 7, 2007; 41 SDR 109, effective January 5, 2015.

          General Authority: SDCL 34-24-25.

          Law Implemented: SDCL 34-24-18.

 

          44:19:03:03.  Specimen disposition, retention, and disposal. The designated laboratory shall maintain each specimen in a manner that provides security, confidentiality, and stability of temperature and humidity. Upon completion of newborn screening testing, the designated laboratory is responsible for specimen destruction in a secure manner. No specimen may be used for any purpose other than the screening of newborn infants pursuant to SDCL 34-24-17.

 

          Source: 41 SDR 109, effective January 5, 2015.

          General Authority: SDCL 34-24-25.

          Law Implemented: SDCL 34-24-18.