Bill Text: MN SF2047 | 2013-2014 | 88th Legislature | Engrossed
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-Engrossed.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 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 promote the materials describing
1.13the newborn screening program and encourage providers and education programs to
1.14thoroughly discuss the program with expectant parents and parents with newborns. The
1.15department shall make information and forms about newborn screening available to the
1.16persons with a duty to perform testing under this section and to expectant parents and
1.17parents of newborns using electronic and other means.
1.18(b) Prior to collecting a sample, persons with a duty to perform testing under
1.19subdivision 1 must:
1.20(1) provide parents or legal guardians of infants with a document that provides
1.21the following information:
1.22(i) the benefits of newborn screening;
1.23(ii) that the blood sample will be used to test for heritable and congenital disorders,
1.24as determined under subdivision 2;
1.25(iii) the data that will be collected as part of the testing;
2.1(iv)the standard retention periods for blood samples and test results as provided in
2.2subdivision 6 the benefits associated with the department's storage of an infant's blood
2.3sample and test results;
2.4(v) that the Department of Health may store the blood samples and test results unless
2.5the parents or legal guardians elect to not have them stored;
2.6(v) (vi) that blood samples and test results will be used for program operations
2.7during the standard retention period in accordance with subdivision 5, unless the parents
2.8or legal guardians elect not to have the blood samples and test results stored, in which
2.9case the blood samples and test results will be destroyed in accordance with subdivision
2.108, paragraph (b), and until destroyed will only be used for program operations described
2.11under subdivision 5, paragraph (a), clauses (1) to (7);
2.12(vi) the Department of Health's Web site address where more information and forms
2.13may be obtained; and
2.14(vii) that parents or legal guardians have a right to elect not to have newborn
2.15screening performed and a right to secure private testing;
2.16(viii) that parents or legal guardians have a right to elect to have the newborn
2.17screening performed, but not have the blood samples and test results stored;
2.18(ix) that parents or legal guardians have a right to authorize in writing that the blood
2.19samples and test results may be used for public health studies or research; and
2.20(x) the Department of Health's Web site address where more information and forms
2.21may be obtained; and
2.22(2) upon request, promptly provide parents or legal guardians of infants with forms
2.23necessary to request that the infant not have blood collected for testing or to request to
2.24have the newborn screening performed, but not have the blood samples and test results
2.25stored; and
2.26(3) record in the infant's medical record that a parent or legal guardian of the
2.27infant has received the information provided pursuant to this subdivision and has had
2.28an opportunity to ask questions.
2.29(c) Nothing in this section prohibits a parent or legal guardian of an infant from
2.30having newborn screening performed by a private entity.
2.31 Sec. 2. Minnesota Statutes 2012, section 144.125, subdivision 4, is amended to read:
2.32 Subd. 4. Parental options. (a) The parent or legal guardian of an infant otherwise
2.33subject to testing under this section may elect not to have newborn screening performed,
2.34or may elect to have newborn screening tests performed, but not to have the blood samples
2.35and test results stored.
3.1(b) If a parent or legal guardian elects not to have newborn screening performed or
3.2elects not to allow the blood samples and test results to be stored, then the electionshall
3.3 must be recorded on a form that is signed by the parent or legal guardian. The signed form
3.4shall must be made part of the infant's medical record and a copy shall be provided to
3.5the Department of Health. When a parent or legal guardian elects not to have newborn
3.6screening performed, the person with the duty to perform testing under subdivision 1 must
3.7follow that election. A written election to decline testing exempts persons with a duty
3.8to perform testing and the Department of Health from the requirements of this section
3.9and section144.128 .
3.10 Sec. 3. Minnesota Statutes 2012, section 144.125, subdivision 5, is amended to read:
3.11 Subd. 5. Newborn screening program operations. (a) "Newborn screening
3.12program operations" means actions, testing, and procedures directly related to the
3.13operation of the newborn screening program, limited to the following:
3.14(1) confirmatory testing;
3.15(2) laboratory quality control assurance and improvement;
3.16(3) calibration of equipment;
3.17(4) evaluating and improving the accuracy of newborn screening tests for conditions
3.18approved for screening in Minnesota;
3.19(5) validation of equipment and screening methods;and
3.20(6) continuity of operations to ensure testing can continue as required by Minnesota
3.21law in the event of an emergency;
3.22(7) follow-up services for the cases of heritable and congenital disorders identified
3.23by newborn screening; and
3.24(8) utilization of blood samples and test results for studies related to newborn
3.25screening, including studies used to develop new tests.
3.26(b) No research, or public health studies, or development of new newborn screening
3.27tests shall be conducted under this subdivision other than those described in paragraph (a)
3.28shall be conducted without written consent as described under subdivision 7.
3.29(c) Any sale of bloodspots, test results, or other data collected in the newborn
3.30screening program is strictly prohibited.
3.31 Sec. 4. Minnesota Statutes 2013 Supplement, section 144.125, subdivision 7, is
3.32amended to read:
3.33 Subd. 7. Parental options forextended storage and use additional research. (a)
3.34The parent or legal guardian of an infantotherwise subject to testing under this section, or
4.1an individual who was tested as an infant if the individual is 18 years of age or older may
4.2authorize in writing that the infant's blood sample and test results be retained and used by
4.3the Department of Healthbeyond the standard retention periods provided in subdivision 6
4.4 for the purposes described in subdivision 9.
4.5(b) The Department of Health must provide a consent form, with an attached
4.6Tennessen warning pursuant to section13.04, subdivision 2 . The consent form must
4.7provide the following:
4.8(1) information as to the personal identification and use of samples and test results
4.9for studies, including studies used to develop new tests;
4.10(2) (1) information as to the personal identification and use of samples and test
4.11results for public health studies or research not related to newborn screening;
4.12(3) information that explains that the Department of Health will not store a blood
4.13sample or test result for longer than 18 years from an infant's birth date;
4.14(4) (2) information that explains that, upon approval by the Department of Health's
4.15Institutional Review Board, blood samples and test results may be shared with external
4.16parties for public health studies or research; and
4.17(5) (3) information that explains that blood samples contain various components,
4.18including deoxyribonucleic acid (DNA); and
4.19(6) the benefits and risks associated with the department's storage of a child's blood
4.20sample and test results.
4.21 Sec. 5. Minnesota Statutes 2012, section 144.125, subdivision 8, is amended to read:
4.22 Subd. 8.Extended Storage and use of samples and test results. When authorized
4.23in writing by a parent or legal guardian under subdivision 7, (a) Except as limited under
4.24paragraph (b), The Department of Health may store blood samples and test resultsfor a
4.25time period not to exceed 18 years from the infant's birth date, and may use the blood
4.26samples and test results in accordance with subdivision9 5. If written informed consent of
4.27a parent, legal guardian, or individual is obtained under subdivision 7, the Department of
4.28Health may use the blood samples and test results in accordance with subdivision 9.
4.29(b) If a parent, legal guardian, or individual elects against storage, or revokes prior
4.30consent for storage, the blood samples must be destroyed within 30 days after receipt of
4.31the request, and test results must be destroyed within 30 days after receipt of the request,
4.32or the earliest time allowed under Clinical Laboratory Improvement Amendments (CLIA)
4.33regulations, whichever is later. Until destroyed, the blood samples and test results may be
4.34used for program operations described under subdivision 5, paragraph (a), clauses (1) to (7).
5.1 Sec. 6. Minnesota Statutes 2012, section 144.125, subdivision 9, is amended to read:
5.2 Subd. 9. Written, informed consent for other use of samples and test results.
5.3With the written, informed consent of a parent or legal guardian, the Department of Health
5.4may:
5.5(1) use blood samples and test results for studies related to newborn screening,
5.6including studies used to develop new tests; and
5.7(2) use blood samples and test results for public health studies or research not related
5.8to newborn screening, and upon approval by the Department of Health's Institutional
5.9Review Board, share samples and test results with external parties for public health
5.10studies or research.
5.11 Sec. 7. Minnesota Statutes 2012, section 144.125, subdivision 10, is amended to read:
5.12 Subd. 10. Revoking consent for storage and use. A parent or legal guardian, or the
5.13individual whose blood was tested as an infant if the individual is 18 years of age or older,
5.14 may revoke approval forextended storage or use of blood samples or test results at any
5.15time by providing a signed and dated form requesting destruction of the blood samples
5.16or test results.The Department of Health shall make necessary forms available on the
5.17department's Web site. Blood samples must be destroyed within one week of receipt of a
5.18request or within one week of the standard retention period for blood samples provided
5.19in subdivision 6, whichever is later. test results must be destroyed within one month of
5.20receipt of a request or within one month of the standard retention period for test results
5.21provided in subdivision 6, whichever is later Blood samples and test results must be
5.22destroyed as specified under subdivision 8, paragraph (b).
5.23 Sec. 8. REPEALER.
5.24Minnesota Statutes 2012, section 144.125, subdivision 6, is repealed.
5.25 Sec. 9. EFFECTIVE DATE.
5.26Sections 1 to 8 are effective August 1, 2014, and apply to blood samples collected
5.27on or after that date, and to the test results obtained from those samples.
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 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 promote the materials describing
1.13the newborn screening program and encourage providers and education programs to
1.14thoroughly discuss the program with expectant parents and parents with newborns. The
1.15department shall make information and forms about newborn screening available to the
1.16persons with a duty to perform testing under this section and to expectant parents and
1.17parents of newborns using electronic and other means.
1.18(b) Prior to collecting a sample, persons with a duty to perform testing under
1.19subdivision 1 must:
1.20(1) provide parents or legal guardians of infants with a document that provides
1.21the following information:
1.22(i) the benefits of newborn screening;
1.23(ii) that the blood sample will be used to test for heritable and congenital disorders,
1.24as determined under subdivision 2;
1.25(iii) the data that will be collected as part of the testing;
2.1(iv)
2.2
2.3sample and test results;
2.4(v) that the Department of Health may store the blood samples and test results unless
2.5the parents or legal guardians elect to not have them stored;
2.6
2.7
2.8or legal guardians elect not to have the blood samples and test results stored, in which
2.9case the blood samples and test results will be destroyed in accordance with subdivision
2.108, paragraph (b), and until destroyed will only be used for program operations described
2.11under subdivision 5, paragraph (a), clauses (1) to (7);
2.12
2.13
2.14(vii) that parents or legal guardians have a right to elect not to have newborn
2.15screening performed and a right to secure private testing;
2.16(viii) that parents or legal guardians have a right to elect to have the newborn
2.17screening performed, but not have the blood samples and test results stored;
2.18(ix) that parents or legal guardians have a right to authorize in writing that the blood
2.19samples and test results may be used for public health studies or research; and
2.20(x) the Department of Health's Web site address where more information and forms
2.21may be obtained; and
2.22(2) upon request, promptly provide parents or legal guardians of infants with forms
2.23necessary to request that the infant not have blood collected for testing or to request to
2.24have the newborn screening performed, but not have the blood samples and test results
2.25stored; and
2.26(3) record in the infant's medical record that a parent or legal guardian of the
2.27infant has received the information provided pursuant to this subdivision and has had
2.28an opportunity to ask questions.
2.29(c) Nothing in this section prohibits a parent or legal guardian of an infant from
2.30having newborn screening performed by a private entity.
2.31 Sec. 2. Minnesota Statutes 2012, section 144.125, subdivision 4, is amended to read:
2.32 Subd. 4. Parental options. (a) The parent or legal guardian of an infant otherwise
2.33subject to testing under this section may elect not to have newborn screening performed,
2.34or may elect to have newborn screening tests performed, but not to have the blood samples
2.35and test results stored.
3.1(b) If a parent or legal guardian elects not to have newborn screening performed or
3.2elects not to allow the blood samples and test results to be stored, then the election
3.3 must be recorded on a form that is signed by the parent or legal guardian. The signed form
3.4
3.5the Department of Health. When a parent or legal guardian elects not to have newborn
3.6screening performed, the person with the duty to perform testing under subdivision 1 must
3.7follow that election. A written election to decline testing exempts persons with a duty
3.8to perform testing and the Department of Health from the requirements of this section
3.9and section
3.10 Sec. 3. Minnesota Statutes 2012, section 144.125, subdivision 5, is amended to read:
3.11 Subd. 5. Newborn screening program operations. (a) "Newborn screening
3.12program operations" means actions, testing, and procedures directly related to the
3.13operation of the newborn screening program, limited to the following:
3.14(1) confirmatory testing;
3.15(2) laboratory quality control assurance and improvement;
3.16(3) calibration of equipment;
3.17(4) evaluating and improving the accuracy of newborn screening tests for conditions
3.18approved for screening in Minnesota;
3.19(5) validation of equipment and screening methods;
3.20(6) continuity of operations to ensure testing can continue as required by Minnesota
3.21law in the event of an emergency;
3.22(7) follow-up services for the cases of heritable and congenital disorders identified
3.23by newborn screening; and
3.24(8) utilization of blood samples and test results for studies related to newborn
3.25screening, including studies used to develop new tests.
3.26(b) No research
3.27
3.28shall be conducted without written consent as described under subdivision 7.
3.29(c) Any sale of bloodspots, test results, or other data collected in the newborn
3.30screening program is strictly prohibited.
3.31 Sec. 4. Minnesota Statutes 2013 Supplement, section 144.125, subdivision 7, is
3.32amended to read:
3.33 Subd. 7. Parental options for
3.34The parent or legal guardian of an infant
4.1an individual who was tested as an infant if the individual is 18 years of age or older may
4.2authorize in writing that the infant's blood sample and test results be retained and used by
4.3the Department of Health
4.4 for the purposes described in subdivision 9.
4.5(b) The Department of Health must provide a consent form, with an attached
4.6Tennessen warning pursuant to section
4.7provide the following:
4.8
4.9
4.10
4.11results for public health studies or research not related to newborn screening;
4.12
4.13
4.14
4.15Institutional Review Board, blood samples and test results may be shared with external
4.16parties for public health studies or research; and
4.17
4.18including deoxyribonucleic acid (DNA)
4.19
4.20
4.21 Sec. 5. Minnesota Statutes 2012, section 144.125, subdivision 8, is amended to read:
4.22 Subd. 8.
4.23
4.24paragraph (b), The Department of Health may store blood samples and test results
4.25
4.26samples and test results in accordance with subdivision
4.27a parent, legal guardian, or individual is obtained under subdivision 7, the Department of
4.28Health may use the blood samples and test results in accordance with subdivision 9.
4.29(b) If a parent, legal guardian, or individual elects against storage, or revokes prior
4.30consent for storage, the blood samples must be destroyed within 30 days after receipt of
4.31the request, and test results must be destroyed within 30 days after receipt of the request,
4.32or the earliest time allowed under Clinical Laboratory Improvement Amendments (CLIA)
4.33regulations, whichever is later. Until destroyed, the blood samples and test results may be
4.34used for program operations described under subdivision 5, paragraph (a), clauses (1) to (7).
5.1 Sec. 6. Minnesota Statutes 2012, section 144.125, subdivision 9, is amended to read:
5.2 Subd. 9. Written, informed consent for other use of samples and test results.
5.3With the written, informed consent of a parent or legal guardian, the Department of Health
5.4may
5.5
5.6
5.7
5.8to newborn screening, and upon approval by the Department of Health's Institutional
5.9Review Board, share samples and test results with external parties for public health
5.10studies or research.
5.11 Sec. 7. Minnesota Statutes 2012, section 144.125, subdivision 10, is amended to read:
5.12 Subd. 10. Revoking consent for storage and use. A parent or legal guardian, or the
5.13individual whose blood was tested as an infant if the individual is 18 years of age or older,
5.14 may revoke approval for
5.15time by providing a signed and dated form requesting destruction of the blood samples
5.16or test results.
5.17
5.18
5.19
5.20
5.21
5.22destroyed as specified under subdivision 8, paragraph (b).
5.23 Sec. 8. REPEALER.
5.24Minnesota Statutes 2012, section 144.125, subdivision 6, is repealed.
5.25 Sec. 9. EFFECTIVE DATE.
5.26Sections 1 to 8 are effective August 1, 2014, and apply to blood samples collected
5.27on or after that date, and to the test results obtained from those samples.
