1.1.................... moves to amend H.F. No. 2526 as follows:
1.2Delete everything after the enacting clause and insert:

1.3    "Section 1. Minnesota Statutes 2012, section 144.125, subdivision 3, is amended to read:
1.4    Subd. 3. Information provided to parents and legal guardians. (a) The
1.5department shall make information and forms available to childbirth education programs
1.6and health care providers who provide prenatal care describing the newborn screening
1.7program and the provisions of this section to be used in a discussion with expectant
1.8parents and parents of newborns. The department shall make information and forms about
1.9newborn screening available to the persons with a duty to perform testing under this
1.10section and to expectant parents and parents of newborns using electronic and other means.
1.11(b) Prior to collecting a sample, persons with a duty to perform testing under
1.12subdivision 1 must:
1.13(1) provide parents or legal guardians of infants with a document that provides
1.14the following information:
1.15(i) the benefits of newborn screening;
1.16(ii) that the blood sample will be used to test for heritable and congenital disorders,
1.17as determined under subdivision 2;
1.18(iii) the data that will be collected as part of the testing;
1.19(iv) the standard retention periods for blood samples and test results as provided in
1.20subdivision 6 the benefits associated with the department's storage of an infant's blood
1.21sample and test results;;
1.22(v) that the Department of Health may store the blood samples and test results unless
1.23the parent or legal guardian elects to not have them stored;
1.24(v) (vi) that blood samples and test results will be used for program operations
1.25during the standard retention period in accordance with subdivision 5, unless the parents
1.26or legal guardians elect not to have the blood samples and test results stored;
2.1(vi) (vii) the Department of Health's Web site address where more information
2.2and forms may be obtained; and
2.3(vii) (viii) that parents or legal guardians have a right to elect not to have newborn
2.4screening performed and a right to secure private testing;
2.5(ix) that parents or legal guardians have a right to elect to have the newborn
2.6screening performed, but not have the blood samples and test results stored; and
2.7(x) that parents or legal guardians may authorize in writing that the blood samples
2.8and test results may be used for public health studies or research; and
2.9(2) upon request, provide parents or legal guardians of infants with forms necessary
2.10to request that the infant not have blood collected for testing or to request to have the
2.11newborn screening performed, but not have the blood samples and test results stored; and
2.12(3) record in the infant's medical record that a parent or legal guardian of the
2.13infant has received the information provided pursuant to this subdivision and has had
2.14an opportunity to ask questions.
2.15(c) Nothing in this section prohibits a parent or legal guardian of an infant from
2.16having newborn screening performed by a private entity.

2.17    Sec. 2. Minnesota Statutes 2012, section 144.125, subdivision 4, is amended to read:
2.18    Subd. 4. Parental options. (a) The parent or legal guardian of an infant otherwise
2.19subject to testing under this section may elect not to have newborn screening performed,
2.20or may elect to have newborn screening tests performed, but not to have the blood samples
2.21and test results stored.
2.22(b) If a parent or legal guardian elects not to have newborn screening performed or
2.23elects not to allow the blood samples and test results to be stored, then the election shall
2.24 must be recorded on a form that is signed by the parent or legal guardian. The signed form
2.25shall must be made part of the infant's medical record and a copy shall be provided to
2.26the Department of Health. When a parent or legal guardian elects not to have newborn
2.27screening performed, the person with the duty to perform testing under subdivision 1 must
2.28follow that election. A written election to decline testing exempts persons with a duty
2.29to perform testing and the Department of Health from the requirements of this section
2.30and section 144.128.

2.31    Sec. 3. Minnesota Statutes 2012, section 144.125, subdivision 5, is amended to read:
2.32    Subd. 5. Newborn screening program operations. (a) "Newborn screening
2.33program operations" means actions, testing, and procedures directly related to the
2.34operation of the newborn screening program, limited to the following:
3.1(1) confirmatory testing;
3.2(2) laboratory quality control assurance and improvement;
3.3(3) calibration of equipment;
3.4(4) evaluating and improving the accuracy of newborn screening tests for conditions
3.5approved for screening in Minnesota;
3.6(5) validation of equipment and screening methods; and
3.7(6) continuity of operations to ensure testing can continue as required by Minnesota
3.8law in the event of an emergency; and
3.9(7) utilization of blood samples and test results for studies related to newborn
3.10screening, including studies used to develop new tests.
3.11(b) No research, or public health studies, or development of new newborn screening
3.12tests shall be conducted under this subdivision other than those described in paragraph (a)
3.13shall be conducted without written consent as described under subdivision 7.

3.14    Sec. 4. Minnesota Statutes 2013 Supplement, section 144.125, subdivision 7, is
3.15amended to read:
3.16    Subd. 7. Parental options for extended storage and use additional research. (a)
3.17The parent or legal guardian of an infant otherwise subject to testing under this section
3.18may authorize in writing that the infant's blood sample and test results be retained and
3.19used by the Department of Health beyond the standard retention periods provided in
3.20subdivision 6 for the purposes described in subdivision 9.
3.21(b) The Department of Health must provide a consent form, with an attached
3.22Tennessen warning pursuant to section 13.04, subdivision 2. The consent form must
3.23provide the following:
3.24(1) information as to the personal identification and use of samples and test results
3.25for studies, including studies used to develop new tests;
3.26(2) (1) information as to the personal identification and use of samples and test
3.27results for public health studies or research not related to newborn screening;
3.28(3) information that explains that the Department of Health will not store a blood
3.29sample or test result for longer than 18 years from an infant's birth date;
3.30(4) (2) information that explains that, upon approval by the Department of Health's
3.31Institutional Review Board, blood samples and test results may be shared with external
3.32parties for public health studies or research; and
3.33(5) (3) information that explains that blood samples contain various components,
3.34including deoxyribonucleic acid (DNA); and
4.1(6) the benefits and risks associated with the department's storage of a child's blood
4.2sample and test results.

4.3    Sec. 5. Minnesota Statutes 2012, section 144.125, subdivision 8, is amended to read:
4.4    Subd. 8. Extended Storage and use of samples and test results. When authorized
4.5in writing by a parent or legal guardian under subdivision 7, (a) The Department of Health
4.6may store blood samples and test results for a time period not to exceed 18 years from
4.7the infant's birth date, and may use the blood samples and test results in accordance with
4.8subdivision 9 5, unless a parent or legal guardian elects against the storage of the blood
4.9samples and test results, and in accordance with subdivision 9, if written informed consent
4.10of a parent or legal guardian is obtained.
4.11(b) If a parent, legal guardian, or individual elects against storage or revokes prior
4.12consent for storage, the blood samples must be destroyed within one week of receipt of
4.13the request, and test results must be destroyed at the earliest time allowed under Clinical
4.14Laboratory Improvement Amendments (CLIA) regulations.

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, or the
4.27individual whose blood was tested as an infant if the individual is 18 years of age or older,
4.28 may revoke approval for extended 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
4.32request or 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 request or within one month of the standard retention period for test results
5.2provided in subdivision 6, whichever is later at the earliest time allowed under Clinical
5.3Laboratory Improvement Amendments (CLIA) regulations.

5.4    Sec. 8. LIMITED OPT IN EXCEPTION.
5.5Parents and legal guardians of infants born prior to the effective date of this act
5.6may give the Department of Health written consent for storage and use as described in
5.7Minnesota Statutes, section 144.125, subdivisions 5 and 8.

5.8    Sec. 9. REPEALER.
5.9Minnesota Statutes 2012, section 144.125, subdivision 6, is repealed.

5.10    Sec. 10. EFFECTIVE DATE.
5.11Sections 1 to 9 are effective the day following final enactment."
5.12Amend the title accordingly