Bill Text: MN SF2047 | 2013-2014 | 88th Legislature | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Newborn screening program modification
Spectrum: Partisan Bill (Democrat 11-0)
Status: (Passed) 2014-05-08 - Secretary of State Chapter 203 05/06/14 [SF2047 Detail]
Download: Minnesota-2013-SF2047-Introduced.html
Bill Title: Newborn screening program modification
Spectrum: Partisan Bill (Democrat 11-0)
Status: (Passed) 2014-05-08 - Secretary of State Chapter 203 05/06/14 [SF2047 Detail]
Download: Minnesota-2013-SF2047-Introduced.html
1.2relating to health; modifying the newborn screening program;amending
1.3Minnesota Statutes 2012, section 144.125, subdivisions 3, 4, 5, 8, 9, 10;
1.4Minnesota Statutes 2013 Supplement, section 144.125, subdivision 7; repealing
1.5Minnesota Statutes 2012, section 144.125, subdivision 6.
1.6BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.7 Section 1. Minnesota Statutes 2012, section 144.125, subdivision 3, is amended to read:
1.8 Subd. 3. Information provided to parents. (a) The department shall make
1.9information and forms available to childbirth education programs and health care
1.10providers who provide prenatal care describing the newborn screening program and the
1.11provisions of this section to be used in a discussion with expectant parents and parents of
1.12newborns. The department shall make information and forms about newborn screening
1.13available to the persons with a duty to perform testing under this section and to expectant
1.14parents and parents of newborns using electronic and other means.
1.15(b) Prior to collecting a sample, persons with a duty to perform testing under
1.16subdivision 1 must:
1.17(1) provide parents or legal guardians of infants with a document that provides
1.18the following information:
1.19(i) the benefits of newborn screening;
1.20(ii) that the blood sample will be used to test for heritable and congenital disorders,
1.21as determined under subdivision 2;
1.22(iii) the data that will be collected as part of the testing;
1.23(iv)the standard retention periods for blood samples and test results as provided in
1.24subdivision 6 the benefits associated with the department's storage of an infant's blood
1.25sample and test results;
2.1(v) that blood samples and test results will be used for program operationsduring
2.2the standard retention period in accordance with subdivision 5, unless the parents or legal
2.3guardians elect not to have the blood samples and test results stored;
2.4(vi) the Department of Health's Web site address where more information and forms
2.5may be obtained;and
2.6(vii) that parents or legal guardians have a right to elect not to have newborn
2.7screening performed and a right to secure private testing; and
2.8(viii) that parents or legal guardians have a right to elect to have the newborn
2.9screening performed, but not to have the blood samples and test results stored;
2.10(2) upon request, provide parents or legal guardians of infants with forms necessary
2.11to request that the infant not have blood collected for testing or to request to have the
2.12newborn screening performed, but not to have the blood samples and test results stored; and
2.13(3) record in the infant's medical record that a parent or legal guardian of the
2.14infant has received the information provided pursuant to this subdivision and has had
2.15an opportunity to ask questions.
2.16(c) Nothing in this section prohibits a parent or legal guardian of an infant from
2.17having newborn screening performed by a private entity.
2.18 Sec. 2. Minnesota Statutes 2012, section 144.125, subdivision 4, is amended to read:
2.19 Subd. 4. Parental options. (a) The parent or legal guardian of an infant otherwise
2.20subject to testing under this section may elect not to have newborn screening performed,
2.21or may elect to have newborn screening tests performed, but not to have the blood samples
2.22and test results stored.
2.23(b) If a parent or legal guardian elects not to have newborn screening performed or
2.24elects not to allow the blood samples and test results to be stored, then the electionshall
2.25 must be recorded on a form that is signed by the parent or legal guardian. The signed form
2.26shall must be made part of the infant's medical record and a copy shall be provided to
2.27the Department of Health. When a parent or legal guardian elects not to have newborn
2.28screening performed, the person with the duty to perform testing under subdivision 1 must
2.29follow that election. A written election to decline testing exempts persons with a duty
2.30to perform testing and the Department of Health from the requirements of this section
2.31and section144.128 .
2.32 Sec. 3. Minnesota Statutes 2012, section 144.125, subdivision 5, is amended to read:
3.1 Subd. 5. Newborn screening program operations. (a) "Newborn screening
3.2program operations" means actions, testing, and procedures directly related to the
3.3operation of the newborn screening program, limited to the following:
3.4(1) confirmatory testing;
3.5(2) laboratory quality control assurance and improvement;
3.6(3) calibration of equipment;
3.7(4) evaluating and improving the accuracy of newborn screening tests for conditions
3.8approved for screening in Minnesota;
3.9(5) validation of equipment and screening methods;and
3.10(6) continuity of operations to ensure testing can continue as required by Minnesota
3.11law in the event of an emergency; and
3.12(7) utilization of blood samples and test results for studies related to newborn
3.13screening, including studies used to develop new tests.
3.14(b) No research, or public health studies, or development of new newborn screening
3.15tests shall be conducted under this subdivision other than those described in paragraph (a)
3.16shall be conducted without written consent as described under subdivision 9.
3.17 Sec. 4. Minnesota Statutes 2013 Supplement, section 144.125, subdivision 7, is
3.18amended to read:
3.19 Subd. 7. Parental options forextended storage and use additional research. (a)
3.20The parent or legal guardian of an infantotherwise subject to testing under this section
3.21may authorize in writing that the infant's blood sample and test results be retained and
3.22used by the Department of Healthbeyond the standard retention periods provided in
3.23subdivision 6 for the purposes described in subdivision 9.
3.24(b) The Department of Health must provide a consent form, with an attached
3.25Tennessen warning pursuant to section13.04, subdivision 2 . The consent form must
3.26provide the following:
3.27(1) information as to the personal identification and use of samples and test results
3.28for studies, including studies used to develop new tests;
3.29(2) (1) information as to the personal identification and use of samples and test
3.30results for public health studies or research not related to newborn screening;
3.31(3) information that explains that the Department of Health will not store a blood
3.32sample or test result for longer than 18 years from an infant's birth date;
3.33(4) (2) information that explains that, upon approval by the Department of Health's
3.34Institutional Review Board, blood samples and test results may be shared with external
3.35parties for public health studies or research; and
4.1(5) (3) information that explains that blood samples contain various components,
4.2including deoxyribonucleic acid (DNA); and
4.3(6) the benefits and risks associated with the department's storage of a child's blood
4.4sample and test results.
4.5 Sec. 5. Minnesota Statutes 2012, section 144.125, subdivision 8, is amended to read:
4.6 Subd. 8.Extended Storage and use of samples and test results. When authorized
4.7in writing by a parent or legal guardian under subdivision 7, The Department of Health
4.8may store blood samples and test resultsfor a time period not to exceed 18 years from
4.9the infant's birth date, and may use the blood samples and test results in accordance with
4.10subdivision9 5, unless a parent or legal guardian elects against the storage of the blood
4.11samples and test results, and in accordance with subdivision 9, if written informed consent
4.12of a parent or legal guardian is obtained. If a parent or legal guardian has elected against
4.13storage, the blood samples must be destroyed within one week of receipt of the request,
4.14and test results must be destroyed within one month of receipt of the request.
4.15 Sec. 6. Minnesota Statutes 2012, section 144.125, subdivision 9, is amended to read:
4.16 Subd. 9. Written, informed consent for other use of samples and test results.
4.17With the written, informed consent of a parent or legal guardian, the Department of Health
4.18may:
4.19(1) use blood samples and test results for studies related to newborn screening,
4.20including studies used to develop new tests; and
4.21(2) use blood samples and test results for public health studies or research not related
4.22to newborn screening, and upon approval by the Department of Health's Institutional
4.23Review Board, share samples and test results with external parties for public health
4.24studies or research.
4.25 Sec. 7. Minnesota Statutes 2012, section 144.125, subdivision 10, is amended to read:
4.26 Subd. 10. Revoking consent for storage and use. A parent or legal guardian,
4.27 or the individual whose blood was tested if the individual is 18 years of age or older,
4.28may revoke approval forextended storage or use of blood samples or test results at any
4.29time by providing a signed and dated form requesting destruction of the blood samples
4.30or test results. The Department of Health shall make necessary forms available on the
4.31department's Web site. Blood samples must be destroyed within one week of receipt of a
4.32requestor within one week of the standard retention period for blood samples provided in
4.33subdivision 6, whichever is later., and test results must be destroyed within one month of
5.1receipt of a requestor within one month of the standard retention period for test results
5.2provided in subdivision 6, whichever is later.
5.3 Sec. 8. REPEALER.
5.4Minnesota Statutes 2012, section 144.125, subdivision 6, is repealed.
1.3Minnesota Statutes 2012, section 144.125, subdivisions 3, 4, 5, 8, 9, 10;
1.4Minnesota Statutes 2013 Supplement, section 144.125, subdivision 7; repealing
1.5Minnesota Statutes 2012, section 144.125, subdivision 6.
1.6BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.7 Section 1. Minnesota Statutes 2012, section 144.125, subdivision 3, is amended to read:
1.8 Subd. 3. Information provided to parents. (a) The department shall make
1.9information and forms available to childbirth education programs and health care
1.10providers who provide prenatal care describing the newborn screening program and the
1.11provisions of this section to be used in a discussion with expectant parents and parents of
1.12newborns. The department shall make information and forms about newborn screening
1.13available to the persons with a duty to perform testing under this section and to expectant
1.14parents and parents of newborns using electronic and other means.
1.15(b) Prior to collecting a sample, persons with a duty to perform testing under
1.16subdivision 1 must:
1.17(1) provide parents or legal guardians of infants with a document that provides
1.18the following information:
1.19(i) the benefits of newborn screening;
1.20(ii) that the blood sample will be used to test for heritable and congenital disorders,
1.21as determined under subdivision 2;
1.22(iii) the data that will be collected as part of the testing;
1.23(iv)
1.24
1.25sample and test results;
2.1(v) that blood samples and test results will be used for program operations
2.2
2.3guardians elect not to have the blood samples and test results stored;
2.4(vi) the Department of Health's Web site address where more information and forms
2.5may be obtained;
2.6(vii) that parents or legal guardians have a right to elect not to have newborn
2.7screening performed and a right to secure private testing; and
2.8(viii) that parents or legal guardians have a right to elect to have the newborn
2.9screening performed, but not to have the blood samples and test results stored;
2.10(2) upon request, provide parents or legal guardians of infants with forms necessary
2.11to request that the infant not have blood collected for testing or to request to have the
2.12newborn screening performed, but not to have the blood samples and test results stored; and
2.13(3) record in the infant's medical record that a parent or legal guardian of the
2.14infant has received the information provided pursuant to this subdivision and has had
2.15an opportunity to ask questions.
2.16(c) Nothing in this section prohibits a parent or legal guardian of an infant from
2.17having newborn screening performed by a private entity.
2.18 Sec. 2. Minnesota Statutes 2012, section 144.125, subdivision 4, is amended to read:
2.19 Subd. 4. Parental options. (a) The parent or legal guardian of an infant otherwise
2.20subject to testing under this section may elect not to have newborn screening performed,
2.21or may elect to have newborn screening tests performed, but not to have the blood samples
2.22and test results stored.
2.23(b) If a parent or legal guardian elects not to have newborn screening performed or
2.24elects not to allow the blood samples and test results to be stored, then the election
2.25 must be recorded on a form that is signed by the parent or legal guardian. The signed form
2.26
2.27the Department of Health. When a parent or legal guardian elects not to have newborn
2.28screening performed, the person with the duty to perform testing under subdivision 1 must
2.29follow that election. A written election to decline testing exempts persons with a duty
2.30to perform testing and the Department of Health from the requirements of this section
2.31and section
2.32 Sec. 3. Minnesota Statutes 2012, section 144.125, subdivision 5, is amended to read:
3.1 Subd. 5. Newborn screening program operations. (a) "Newborn screening
3.2program operations" means actions, testing, and procedures directly related to the
3.3operation of the newborn screening program, limited to the following:
3.4(1) confirmatory testing;
3.5(2) laboratory quality control assurance and improvement;
3.6(3) calibration of equipment;
3.7(4) evaluating and improving the accuracy of newborn screening tests for conditions
3.8approved for screening in Minnesota;
3.9(5) validation of equipment and screening methods;
3.10(6) continuity of operations to ensure testing can continue as required by Minnesota
3.11law in the event of an emergency; and
3.12(7) utilization of blood samples and test results for studies related to newborn
3.13screening, including studies used to develop new tests.
3.14(b) No research
3.15
3.16shall be conducted without written consent as described under subdivision 9.
3.17 Sec. 4. Minnesota Statutes 2013 Supplement, section 144.125, subdivision 7, is
3.18amended to read:
3.19 Subd. 7. Parental options for
3.20The parent or legal guardian of an infant
3.21may authorize in writing that the infant's blood sample and test results be retained and
3.22used by the Department of Health
3.23
3.24(b) The Department of Health must provide a consent form, with an attached
3.25Tennessen warning pursuant to section
3.26provide the following:
3.27
3.28
3.29
3.30results for public health studies or research not related to newborn screening;
3.31
3.32
3.33
3.34Institutional Review Board, blood samples and test results may be shared with external
3.35parties for public health studies or research; and
4.1
4.2including deoxyribonucleic acid (DNA)
4.3
4.4
4.5 Sec. 5. Minnesota Statutes 2012, section 144.125, subdivision 8, is amended to read:
4.6 Subd. 8.
4.7
4.8may store blood samples and test results
4.9
4.10subdivision
4.11samples and test results, and in accordance with subdivision 9, if written informed consent
4.12of a parent or legal guardian is obtained. If a parent or legal guardian has elected against
4.13storage, the blood samples must be destroyed within one week of receipt of the request,
4.14and test results must be destroyed within one month of receipt of the request.
4.15 Sec. 6. Minnesota Statutes 2012, section 144.125, subdivision 9, is amended to read:
4.16 Subd. 9. Written, informed consent for other use of samples and test results.
4.17With the written, informed consent of a parent or legal guardian, the Department of Health
4.18may
4.19
4.20
4.21
4.22to newborn screening, and upon approval by the Department of Health's Institutional
4.23Review Board, share samples and test results with external parties for public health
4.24studies or research.
4.25 Sec. 7. Minnesota Statutes 2012, section 144.125, subdivision 10, is amended to read:
4.26 Subd. 10. Revoking consent for storage and use. A parent or legal guardian,
4.27 or the individual whose blood was tested if the individual is 18 years of age or older,
4.28may revoke approval for
4.29time by providing a signed and dated form requesting destruction of the blood samples
4.30or test results. The Department of Health shall make necessary forms available on the
4.31department's Web site. Blood samples must be destroyed within one week of receipt of a
4.32request
4.33
5.1receipt of a request
5.2
5.3 Sec. 8. REPEALER.
5.4Minnesota Statutes 2012, section 144.125, subdivision 6, is repealed.
