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Rule 44:19 NEWBORN SCREENING

ARTICLE 44:19

NEWBORN SCREENING

Chapter

44:19:01             Definitions.

44:19:02             Newborn screening laboratory.

44:19:03             Time sequence for testing.

44:19:04             Consultation.


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44:19:01:03        Repealed.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 metabolic 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 metabolic disorders;

 

          (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.

          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.


Rule 44:19:01:04 Required tests.

          44:19:01:04.  Required tests. In addition to those metabolic disorders required in SDCL 34-24-18, any infant born in South Dakota shall be screened for the following metabolic disorders by a laboratory designated by the department to perform such testing:

 

          (1)  Hemoglobinopathies;

          (2)  Biotinidase deficiency;

          (3)  Classical congenital adrenal hyperplasia;

          (4)  Fatty acid oxidation disorders;

          (5)  Amino acid disorders;

          (6)  Organic acid disorders; and

          (7)  Cystic fibrosis.

 

          Source: 31 SDR 164, effective May 9, 2005; 33 SDR 180, effective May 7, 2007.

          General Authority: SDCL 34-24-25.

          Law Implemented: SDCL 34-24-22.

 


CHAPTER 44:19:02

NEWBORN SCREENING LABORATORY

Section

44:19:02:01        Repealed.

44:19:02:02        Repealed.

44:19:02:03        Repealed.

44:19:02:03.01   Designation of laboratories.

44:19:02:03.02   Repealed.

44:19:02:04        Public notice of designated laboratories.

44:19:02:04.01   Repealed.

44:19:02:05        Responsibilities of parents.

44:19:02:06        Responsibilities of hospitals, physicians, and other health professionals.

44:19:02:07        Responsibilities of Department of Health.


Rule 44:19:02:01 Repealed.

          44:19:02:01.  Newborn screening laboratory test requisition.Repealed.

          Source: 15 SDR 59, effective October 19, 1988; repealed, 23 SDR 91, effective December 9, 1996.


Rule 44:19:02:02 Repealed.

          44:19:02:02.  Standards for laboratory operation.Repealed.

          Source: 15 SDR 59, effective October 19, 1988; 18 SDR 67, effective October 16, 1991; repealed, 23 SDR 91, effective December 9, 1996.


Rule 44:19:02:03 Repealed.

          44:19:02:03.  Reporting requirements.Repealed.

          Source: 12 SDR 167, effective April 20, 1986; transferred from § 44:19:01:02, 15 SDR 59, effective October 19, 1988; 18 SDR 67, effective October 16, 1991; repealed, 23 SDR 91, effective December 9, 1996.


Rule 44:19:02:03.01 Designation of laboratories.

          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.

 


Rule 44:19:02:03.02 Repealed.

          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.

 


Rule 44:19:02:04 Public notice of designated laboratories.

          44:19:02:04.  Public notice of designated laboratories. The department shall publish the names and addresses of the designated laboratories authorized to conduct newborn screening tests.

          Source: 15 SDR 59, effective October 19, 1988; 23 SDR 91, effective December 9, 1996.

          General Authority:SDCL 34-24-25.

          Law Implemented:SDCL 34-24-25.


Rule 44:19:02:04.01 Repealed.

          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.

 


Rule 44:19:02:05 Responsibilities of parents.

          44:19:02:05.  Responsibilities of parents. The parents, guardian, or custodian of each infant is responsible for having blood tests for metabolic disorders performed within the first 48 hours of an infant's life. If a parent, guardian, or custodian refuses to have a newborn tested for metabolic disorders 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.

          General Authority: SDCL 34-24-25.

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

 


Rule 44:19:02:06 Responsibilities of hospitals, physicians, and other health professionals.

          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.

 


Rule 44:19:02:07 Responsibilities of Department of Health.

          44:19:02:07.  Responsibilities of Department of Health. Upon notification by a designated laboratory of a positive screening result for an infant, the department shall work with the newborn's physician to locate the infant and facilitate the entry of the infant into further diagnostic and medical management services.

          Source: 31 SDR 164, effective May 9, 2005.

          General Authority: SDCL 34-24-25.

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


CHAPTER 44:19:03

TIME SEQUENCE FOR TESTING

Section

44:19:03:01        Specimen submission to designated laboratory.

44:19:03:02        Collection of filter paper specimens.

44:19:03:03        Specimen disposition, retention, and disposal.


Rule 44:19:03:01 Specimen submission to designated laboratory.

          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.

 


Rule 44:19:03:02 Collection of filter paper specimens.

          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.

 


Rule 44:19:03:03 Specimen disposition, retention, and disposal.

          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.

 


Rule 44:19:04 CONSULTATION

CHAPTER 44:19:04

CONSULTATION

Section

44:19:04:01        Consultation services.


Rule 44:19:04:01 Consultation services.

          44:19:04:01.  Consultation services. The department shall contract with a consulting physician to provide interpretation of test results and consultation to the attending physician on request.

          Source: 15 SDR 59, effective October 19, 1988; 23 SDR 91, effective December 9, 1996.

          General Authority:SDCL 34-24-25.

          Law Implemented:SDCL 34-24-21, 34-24-24.


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