Bill Text: MN HF2526 | 2013-2014 | 88th Legislature | Engrossed
Bill Title: Newborn screening program modified.
Spectrum: Partisan Bill (Democrat 8-0)
Status: (Introduced - Dead) 2014-04-25 - HF indefinitely postponed [HF2526 Detail]
Download: Minnesota-2013-HF2526-Engrossed.html
1.2relating to health; modifying the newborn screening program;amending Minnesota Statutes 2012, section 144.125, subdivisions 3, 4, 5, 8, 9, 10; Minnesota Statutes 2013 Supplement, section
144.125, subdivision 7; repealing Minnesota 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 and legal guardians. (a) The
1.9department shall make information and forms available to childbirth education programs
1.10and health care providers who provide prenatal care describing the newborn screening
1.11program and the provisions of this section to be used in a discussion with expectant
1.12parents and parents of newborns. The department shall make information and forms about
1.13newborn screening available to the persons with a duty to perform testing under this
1.14section and to expectant parents 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 the Department of Health may store the blood samples and test results unless
2.2the parent or legal guardian elects to not have them stored;
2.3(v) (vi) that blood samples and test results will be used for program operations
2.4during the standard retention period in accordance with subdivision 5, unless the parents
2.5or legal guardians elect not to have the blood samples and test results stored;
2.6(vi) (vii) the Department of Health's Web site address where more information
2.7and forms may be obtained;and
2.8(vii) (viii) that parents or legal guardians have a right to elect not to have newborn
2.9screening performed and a right to secure private testing;
2.10(ix) that parents or legal guardians have a right to elect to have the newborn
2.11screening performed, but not have the blood samples and test results stored; and
2.12(x) that parents or legal guardians have a right to authorize in writing that the blood
2.13samples and test results may be used for public health studies or research; and
2.14(2) upon request, provide parents or legal guardians of infants with forms necessary
2.15to request that the infant not have blood collected for testing or to request to have the
2.16newborn screening performed, but not have the blood samples and test results stored; and
2.17(3) record in the infant's medical record that a parent or legal guardian of the
2.18infant has received the information provided pursuant to this subdivision and has had
2.19an opportunity to ask questions.
2.20(c) Nothing in this section prohibits a parent or legal guardian of an infant from
2.21having newborn screening performed by a private entity.
2.22 Sec. 2. Minnesota Statutes 2012, section 144.125, subdivision 4, is amended to read:
2.23 Subd. 4. Parental options. (a) The parent or legal guardian of an infant otherwise
2.24subject to testing under this section may elect not to have newborn screening performed,
2.25or may elect to have newborn screening tests performed, but not to have the blood samples
2.26and test results stored.
2.27(b) If a parent or legal guardian elects not to have newborn screening performed or
2.28elects not to allow the blood samples and test results to be stored, then the electionshall
2.29 must be recorded on a form that is signed by the parent or legal guardian. The signed form
2.30shall must be made part of the infant's medical record and a copy shall be provided to
2.31the Department of Health. When a parent or legal guardian elects not to have newborn
2.32screening performed, the person with the duty to perform testing under subdivision 1 must
2.33follow that election. A written election to decline testing exempts persons with a duty
2.34to perform testing and the Department of Health from the requirements of this section
2.35and section144.128 .
3.1 Sec. 3. Minnesota Statutes 2012, section 144.125, subdivision 5, is amended to read:
3.2 Subd. 5. Newborn screening program operations. (a) "Newborn screening
3.3program operations" means actions, testing, and procedures directly related to the
3.4operation of the newborn screening program, limited to the following:
3.5(1) confirmatory testing;
3.6(2) laboratory quality control assurance and improvement;
3.7(3) calibration of equipment;
3.8(4) evaluating and improving the accuracy of newborn screening tests for conditions
3.9approved for screening in Minnesota;
3.10(5) validation of equipment and screening methods;and
3.11(6) continuity of operations to ensure testing can continue as required by Minnesota
3.12law in the event of an emergency; and
3.13(7) utilization of blood samples and test results for studies related to newborn
3.14screening, including studies used to develop new tests.
3.15(b) No research, or public health studies, or development of new newborn screening
3.16tests shall be conducted under this subdivision other than those described in paragraph (a)
3.17shall be conducted without written consent as described under subdivision 7.
3.18 Sec. 4. Minnesota Statutes 2013 Supplement, section 144.125, subdivision 7, is
3.19amended to read:
3.20 Subd. 7. Parental options forextended storage and use additional research. (a)
3.21The parent or legal guardian of an infantotherwise subject to testing under this section
3.22may authorize in writing that the infant's blood sample and test results be retained and
3.23used by the Department of Healthbeyond the standard retention periods provided in
3.24subdivision 6 for the purposes described in subdivision 9.
3.25(b) The Department of Health must provide a consent form, with an attached
3.26Tennessen warning pursuant to section13.04, subdivision 2 . The consent form must
3.27provide the following:
3.28(1) information as to the personal identification and use of samples and test results
3.29for studies, including studies used to develop new tests;
3.30(2) (1) information as to the personal identification and use of samples and test
3.31results for public health studies or research not related to newborn screening;
3.32(3) information that explains that the Department of Health will not store a blood
3.33sample or test result for longer than 18 years from an infant's birth date;
4.1(4) (2) information that explains that, upon approval by the Department of Health's
4.2Institutional Review Board, blood samples and test results may be shared with external
4.3parties for public health studies or research; and
4.4(5) (3) information that explains that blood samples contain various components,
4.5including deoxyribonucleic acid (DNA); and
4.6(6) the benefits and risks associated with the department's storage of a child's blood
4.7sample and test results.
4.8 Sec. 5. Minnesota Statutes 2012, section 144.125, subdivision 8, is amended to read:
4.9 Subd. 8.Extended Storage and use of samples and test results. When authorized
4.10in writing by a parent or legal guardian under subdivision 7, (a) The Department of Health
4.11may store blood samples and test resultsfor a time period not to exceed 18 years from
4.12the infant's birth date, and may use the blood samples and test results in accordance with
4.13subdivision9 5, unless a parent or legal guardian elects against the storage of the blood
4.14samples and test results, and in accordance with subdivision 9, if written informed consent
4.15of a parent or legal guardian is obtained.
4.16(b) If a parent, legal guardian, or individual elects against storage or revokes prior
4.17consent for storage, the blood samples must be destroyed within one week of receipt of
4.18the request, and test results must be destroyed at the earliest time allowed under Clinical
4.19Laboratory Improvement Amendments (CLIA) regulations.
4.20 Sec. 6. Minnesota Statutes 2012, section 144.125, subdivision 9, is amended to read:
4.21 Subd. 9. Written, informed consent for other use of samples and test results.
4.22With the written, informed consent of a parent or legal guardian, the Department of Health
4.23may:
4.24(1) use blood samples and test results for studies related to newborn screening,
4.25including studies used to develop new tests; and
4.26(2) use blood samples and test results for public health studies or research not related
4.27to newborn screening, and upon approval by the Department of Health's Institutional
4.28Review Board, share samples and test results with external parties for public health
4.29studies or research.
4.30 Sec. 7. Minnesota Statutes 2012, section 144.125, subdivision 10, is amended to read:
4.31 Subd. 10. Revoking consent for storage and use. A parent or legal guardian, or the
4.32individual whose blood was tested as an infant if the individual is 18 years of age or older,
4.33 may revoke approval forextended storage or use of blood samples or test results at any
5.1time by providing a signed and dated form requesting destruction of the blood samples
5.2or test results. The Department of Health shall make necessary forms available on the
5.3department's Web site. Blood samples must be destroyed within one week of receipt of a
5.4requestor within one week of the standard retention period for blood samples provided in
5.5subdivision 6, whichever is later. and test results must be destroyed within one month of
5.6receipt of a request or within one month of the standard retention period for test results
5.7provided in subdivision 6, whichever is later at the earliest time allowed under Clinical
5.8Laboratory Improvement Amendments (CLIA) regulations.
5.9 Sec. 8. LIMITED OPT-IN EXCEPTION.
5.10Parents and legal guardians of infants born prior to the effective date of this act
5.11may give the Department of Health written consent for storage and use as described in
5.12Minnesota Statutes, section 144.125, subdivisions 5 and 8.
5.13 Sec. 9. REPEALER.
5.14Minnesota Statutes 2012, section 144.125, subdivision 6, is repealed.
5.15 Sec. 10. EFFECTIVE DATE.
5.16Sections 1 to 9 are effective the day following final enactment.
1.7 Section 1. Minnesota Statutes 2012, section 144.125, subdivision 3, is amended to read:
1.8 Subd. 3. Information provided to parents and legal guardians. (a) The
1.9department shall make information and forms available to childbirth education programs
1.10and health care providers who provide prenatal care describing the newborn screening
1.11program and the provisions of this section to be used in a discussion with expectant
1.12parents and parents of newborns. The department shall make information and forms about
1.13newborn screening available to the persons with a duty to perform testing under this
1.14section and to expectant parents 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 the Department of Health may store the blood samples and test results unless
2.2the parent or legal guardian elects to not have them stored;
2.3
2.4
2.5or legal guardians elect not to have the blood samples and test results stored;
2.6
2.7and forms may be obtained;
2.8
2.9screening performed and a right to secure private testing;
2.10(ix) that parents or legal guardians have a right to elect to have the newborn
2.11screening performed, but not have the blood samples and test results stored; and
2.12(x) that parents or legal guardians have a right to authorize in writing that the blood
2.13samples and test results may be used for public health studies or research; and
2.14(2) upon request, provide parents or legal guardians of infants with forms necessary
2.15to request that the infant not have blood collected for testing or to request to have the
2.16newborn screening performed, but not have the blood samples and test results stored; and
2.17(3) record in the infant's medical record that a parent or legal guardian of the
2.18infant has received the information provided pursuant to this subdivision and has had
2.19an opportunity to ask questions.
2.20(c) Nothing in this section prohibits a parent or legal guardian of an infant from
2.21having newborn screening performed by a private entity.
2.22 Sec. 2. Minnesota Statutes 2012, section 144.125, subdivision 4, is amended to read:
2.23 Subd. 4. Parental options. (a) The parent or legal guardian of an infant otherwise
2.24subject to testing under this section may elect not to have newborn screening performed,
2.25or may elect to have newborn screening tests performed, but not to have the blood samples
2.26and test results stored.
2.27(b) If a parent or legal guardian elects not to have newborn screening performed or
2.28elects not to allow the blood samples and test results to be stored, then the election
2.29 must be recorded on a form that is signed by the parent or legal guardian. The signed form
2.30
2.31the Department of Health. When a parent or legal guardian elects not to have newborn
2.32screening performed, the person with the duty to perform testing under subdivision 1 must
2.33follow that election. A written election to decline testing exempts persons with a duty
2.34to perform testing and the Department of Health from the requirements of this section
2.35and section
3.1 Sec. 3. Minnesota Statutes 2012, section 144.125, subdivision 5, is amended to read:
3.2 Subd. 5. Newborn screening program operations. (a) "Newborn screening
3.3program operations" means actions, testing, and procedures directly related to the
3.4operation of the newborn screening program, limited to the following:
3.5(1) confirmatory testing;
3.6(2) laboratory quality control assurance and improvement;
3.7(3) calibration of equipment;
3.8(4) evaluating and improving the accuracy of newborn screening tests for conditions
3.9approved for screening in Minnesota;
3.10(5) validation of equipment and screening methods;
3.11(6) continuity of operations to ensure testing can continue as required by Minnesota
3.12law in the event of an emergency; and
3.13(7) utilization of blood samples and test results for studies related to newborn
3.14screening, including studies used to develop new tests.
3.15(b) No research
3.16
3.17shall be conducted without written consent as described under subdivision 7.
3.18 Sec. 4. Minnesota Statutes 2013 Supplement, section 144.125, subdivision 7, is
3.19amended to read:
3.20 Subd. 7. Parental options for
3.21The parent or legal guardian of an infant
3.22may authorize in writing that the infant's blood sample and test results be retained and
3.23used by the Department of Health
3.24
3.25(b) The Department of Health must provide a consent form, with an attached
3.26Tennessen warning pursuant to section
3.27provide the following:
3.28
3.29
3.30
3.31results for public health studies or research not related to newborn screening;
3.32
3.33
4.1
4.2Institutional Review Board, blood samples and test results may be shared with external
4.3parties for public health studies or research; and
4.4
4.5including deoxyribonucleic acid (DNA)
4.6
4.7
4.8 Sec. 5. Minnesota Statutes 2012, section 144.125, subdivision 8, is amended to read:
4.9 Subd. 8.
4.10
4.11may store blood samples and test results
4.12
4.13subdivision
4.14samples and test results, and in accordance with subdivision 9, if written informed consent
4.15of a parent or legal guardian is obtained.
4.16(b) If a parent, legal guardian, or individual elects against storage or revokes prior
4.17consent for storage, the blood samples must be destroyed within one week of receipt of
4.18the request, and test results must be destroyed at the earliest time allowed under Clinical
4.19Laboratory Improvement Amendments (CLIA) regulations.
4.20 Sec. 6. Minnesota Statutes 2012, section 144.125, subdivision 9, is amended to read:
4.21 Subd. 9. Written, informed consent for other use of samples and test results.
4.22With the written, informed consent of a parent or legal guardian, the Department of Health
4.23may
4.24
4.25
4.26
4.27to newborn screening, and upon approval by the Department of Health's Institutional
4.28Review Board, share samples and test results with external parties for public health
4.29studies or research.
4.30 Sec. 7. Minnesota Statutes 2012, section 144.125, subdivision 10, is amended to read:
4.31 Subd. 10. Revoking consent for storage and use. A parent or legal guardian, or the
4.32individual whose blood was tested as an infant if the individual is 18 years of age or older,
4.33 may revoke approval for
5.1time by providing a signed and dated form requesting destruction of the blood samples
5.2or test results. The Department of Health shall make necessary forms available on the
5.3department's Web site. Blood samples must be destroyed within one week of receipt of a
5.4request
5.5
5.6
5.7
5.8Laboratory Improvement Amendments (CLIA) regulations.
5.9 Sec. 8. LIMITED OPT-IN EXCEPTION.
5.10Parents and legal guardians of infants born prior to the effective date of this act
5.11may give the Department of Health written consent for storage and use as described in
5.12Minnesota Statutes, section 144.125, subdivisions 5 and 8.
5.13 Sec. 9. REPEALER.
5.14Minnesota Statutes 2012, section 144.125, subdivision 6, is repealed.
5.15 Sec. 10. EFFECTIVE DATE.
5.16Sections 1 to 9 are effective the day following final enactment.
