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S.F. No. 2047 - Newborn Screening Program Modifications (First Engrossment)
 
Author: Senator John Marty
 
Prepared By:
 
Date: March 20, 2014



 

SF 2047 modifies the newborn screening program.

Section 1 (144.125, subd. 3) requires the Commissioner of Health to provide information and forms describing the newborn screening program to childbirth education programs.  This section also modifies the information that must be provided to a parent or legal guardian of a newborn prior to collecting a sample.

Section 2 (144.125, subd. 4) specifies that a parent or legal guardian may elect to have the screening performed, but not to have the sample and test results stored.

Section 3 (144.125, subd. 5) modifies the definition of “newborn screening program operations” to include the utilization of blood samples and test results for studies related to newborn screening, including studies used to develop new tests.

Section 4 (144.125, subd. 7) specifies that a parent or legal guardian may authorize in writing that a blood sample and test results may be retained and used by the Department of Health for public health studies or research not related to newborn screening, and may upon the approval of the Department of Health’s Institutional Review Board, share samples and test results with external parties for public health studies or research.

Section 5 (144.125, subd. 8) permits the Department of Health to store the samples and test results indefinitely, and to use the samples and test results for newborn screening operations, unless a parent or legal guardian elects against the storage of the samples and results, and for public health studies and research not related to newborn screening if written informed consent has been provided.  If a parent or legal guardian elects against storage or revokes prior consent for storage, the department is required to destroy within one week of receipt of the request, and the test results at the earliest time allowed under CLIA regulations.

Section 6 (144.125, subd. 9) specifies that  the department may use samples and test results for public health studies or research not related to newborn screening and share the samples and test results with external parties for public health studies or research if written informed consent has been obtained from the parent or legal guardian.

Section 7 (144.125, subd. 10) states that a parent, legal guardian ,or an individual whose blood was tested as an infant if the individual is 18 years of age or older, may revoke approval for extended storage or use of the samples or test results. This section also requires that if such a request is made that the samples must be destroyed within one week of receipt of the request and test results must be destroyed at the earliest time allowed under CLIA regulations.

Section 8 permits parents and legal guardians of infants born before the effective date of the act to give written consent to the Department of Health for storage and use as described under section 144.125, subdivisions 5 and 8.

Section 9 repeals 144.125, subd. 6.

Section 10 provides an effective date of the day following final enactment.

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