Bill Text: MN SF2463 | 2011-2012 | 87th Legislature | Introduced
Bill Title: Newborn screening program provisions modifications
Spectrum: Bipartisan Bill
Status: (Introduced - Dead) 2012-03-19 - Author added Sheran [SF2463 Detail]
Download: Minnesota-2011-SF2463-Introduced.html
1.2relating to health; changing provisions of the newborn screening program;
1.3amending Minnesota Statutes 2010, sections 144.125, subdivision 3, by adding
1.4subdivisions; 144.128.
1.5BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.6 Section 1. Minnesota Statutes 2010, section 144.125, subdivision 3, is amended to read:
1.7 Subd. 3.Objection of parents to test Information provided to parents. Persons
1.8with a duty to perform testing under subdivision 1 shall advise parents of infants (1) that
1.9the blood or tissue samples used to perform testing thereunder as well as the results of
1.10such testing may be retained by the Department of Health, (2) the benefit of retaining the
1.11blood or tissue sample, and (3) that the following options are available to them with
1.12respect to the testing: (i) to decline to have the tests, or (ii) to elect to have the tests but to
1.13require that all blood samples and records of test results be destroyed within 24 months
1.14of the testing. If the parents of an infant object in writing to testing for heritable and
1.15congenital disorders or elect to require that blood samples and test results be destroyed,
1.16the objection or election shall be recorded on a form that is signed by a parent or legal
1.17guardian and made part of the infant's medical record. A written objection exempts an
1.18infant from the requirements of this section and section
144.128. (a) The department shall
1.19make information and forms available to health care providers who provide prenatal
1.20care describing the newborn screening program and the provisions of this section to be
1.21used in a discussion with expectant parents. The department shall make information and
1.22forms about newborn screening available to expectant parents and parents of newborns
1.23using electronic and other means.
2.1(b) Prior to collecting a sample, persons with a duty to perform testing under
2.2subdivision 1 must:
2.3(1) provide parents or legal guardians of infants with a document meeting the
2.4requirements of section 13.04, subdivision 2, that provides the following information:
2.5(i) the benefits of testing and the risks of a decision to refuse to supply a blood
2.6sample;
2.7(ii) that the blood sample will be used to test for certain heritable and congenital
2.8disorders;
2.9(iii) the data that will be collected as part of the testing;
2.10(iv) that the blood sample will be stored for 71 days from the date of sample receipt
2.11in order to assure completion of the newborn screening process and the test results will be
2.12stored for 24 months from the date of reporting as required by federal law and regulations
2.13unless otherwise authorized;
2.14(v) that the blood sample and data for a positive test result will be stored by the
2.15Department of Health;
2.16(vi) the use of blood samples and test results for quality assurance and improvement
2.17during the standard retention period;
2.18(vii) the benefits for longer storage of blood samples and test results; and
2.19(viii) the Department of Health's Web site address where more information and
2.20forms may be obtained;
2.21(2) provide parents or legal guardians of infants with forms to request one or more of
2.22the following:
2.23(i) that the infant not have blood collected for testing; and
2.24(ii) that the infant's blood sample and test results be retained by the Department of
2.25Health after the standard retention period; and
2.26(3) record in the infant's medical record that a parent or legal guardian of the infant
2.27has received the information and the forms required under this subdivision and has had
2.28an opportunity to ask questions.
2.29 Sec. 2. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
2.30to read:
2.31 Subd. 4. Parental options. (a) The parent or legal guardian of an infant otherwise
2.32subject to testing under this section may:
2.33(1) choose not to have blood collected for testing; and
2.34(2) authorize the infant's blood sample and test results be retained by the Department
2.35of Health after the standard retention period.
3.1(b) If a parent or legal guardian elects and alternative in this subdivision, the election
3.2shall be recorded on a form that is signed by the parent or legal guardian. The signed form
3.3shall be made part of the infant's medical record and a copy shall be provided to the
3.4Department of Health. When a parent or legal guardian elects an alternative under this
3.5subdivision, the Department of Health must follow the election and section 144.128. A
3.6written election to decline testing exempts an infant from the requirements of this section
3.7and section 144.128.
3.8 Sec. 3. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
3.9to read:
3.10 Subd. 5. Newborn screening program operations. (a) "Newborn screening quality
3.11assurance and improvement operations" means actions, testing, and procedures directly
3.12related to the operation of the newborn screening program, such as:
3.13(1) confirmatory testing;
3.14(2) laboratory quality control assurance and improvement;
3.15(3) calibration of equipment;
3.16(4) evaluating and improving the accuracy of newborn screening tests for conditions
3.17approved for screening in Minnesota;
3.18(5) validation of equipment and screening methods; and
3.19(6) continuity of operations to ensure testing can continue in the event of an
3.20emergency.
3.21(b) Newborn screening quality assurance and improvement does not include research
3.22or the development of new newborn screening tests.
3.23 Sec. 4. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
3.24to read:
3.25 Subd. 6. Storage and use of samples and test results for newborn screening
3.26quality assurance and improvement. During the standard retention period, the
3.27Department of Health may use blood samples and test results for newborn screening
3.28quality assurance and improvement. When authorized in writing by a parent or legal
3.29guardian under subdivision 4, the department may store blood samples and test results for
3.30the time period authorized by the parent or legal guardian. Blood samples and positive test
3.31results of infants shall be stored by the Department of Health.
3.32 Sec. 5. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
3.33to read:
4.1 Subd. 7. Standard retention period for samples and test results. Blood samples
4.2without authorization for further storage shall be destroyed within a week of 71 days of
4.3the date of sample receipt. Test results without authorization for further storage shall be
4.4destroyed within one month of 24 months of the date of reporting.
4.5 Sec. 6. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
4.6to read:
4.7 Subd. 8. Written informed consent for other use of samples and test results.
4.8With written informed consent of the parent or legal guardian, the Department of Health
4.9may:
4.10(1) use newborn screening samples and test results for newborn screening related
4.11studies including studies used to develop new newborn screening tests;
4.12(2) use newborn screening samples and test results for non-newborn screening
4.13public health studies or research;
4.14(3) share the samples and test results with external parties for public health studies or
4.15research following approval by the Department of Health's institutional review board; and
4.16(4) allow a parent or legal guardian to authorize ongoing consent for studies and
4.17research or authorize consent for a single study.
4.18 Sec. 7. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
4.19to read:
4.20 Subd. 9. Revoking consent for storage and use. A parent or legal guardian or an
4.21adult who was tested as a minor may revoke approval for storage and use for newborn
4.22screening quality assurance and improvement or for other uses of samples and test results
4.23at any time by providing a signed and dated request for destruction form. The Department
4.24of Health shall make the form available on the department's Web site. Blood samples shall
4.25be destroyed within one week of receipt of the request or after 71 days from the date of
4.26sample receipt, whichever is later. Test results will be destroyed within one month of
4.27receipt of the request or after 24 months from the date of reporting, whichever is later.
4.28 Sec. 8. Minnesota Statutes 2010, section 144.128, is amended to read:
4.29144.128 COMMISSIONER'S DUTIES.
4.30The commissioner shall:
4.31(1) collect, use, disseminate, and store blood samples and test results in order
4.32to administer the newborn screening program for heritable and congenital disorders as
4.33described in sections 144.125 to 144.128;
5.1(1) (2) notify the physicians of newborns tested of the results of the tests performed;
5.2(2) (3) make referrals for the necessary treatment of diagnosed cases of heritable and
5.3congenital disorders when treatment is indicated;
5.4(3) (4) maintain a registry of the cases of heritable and congenital disorders detected
5.5by the screening program for the purpose of follow-up services;
5.6(4) (5) prepare a separate form for use by parents or by adults who were tested as
5.7minors to direct that blood samplesand or test results be destroyed;
5.8(5) (6) comply with a destruction request within 45 days after receiving it as
5.9described in section 144.125;
5.10(6) (7) notify individuals who request destruction of samples and test results that the
5.11samples and test results have been destroyed; and
5.12(7) (8) adopt rules to carry out sections
144.125 to
144.128 .
5.13 Sec. 9. EFFECTIVE DATE.
5.14This act is effective the day following final enactment and applies to blood samples
5.15and test results collected on or after that date.
1.3amending Minnesota Statutes 2010, sections 144.125, subdivision 3, by adding
1.4subdivisions; 144.128.
1.5BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.6 Section 1. Minnesota Statutes 2010, section 144.125, subdivision 3, is amended to read:
1.7 Subd. 3.
1.8
1.9
1.10
1.11
1.12
1.13
1.14
1.15
1.16
1.17
1.18
1.19make information and forms available to health care providers who provide prenatal
1.20care describing the newborn screening program and the provisions of this section to be
1.21used in a discussion with expectant parents. The department shall make information and
1.22forms about newborn screening available to expectant parents and parents of newborns
1.23using electronic and other means.
2.1(b) Prior to collecting a sample, persons with a duty to perform testing under
2.2subdivision 1 must:
2.3(1) provide parents or legal guardians of infants with a document meeting the
2.4requirements of section 13.04, subdivision 2, that provides the following information:
2.5(i) the benefits of testing and the risks of a decision to refuse to supply a blood
2.6sample;
2.7(ii) that the blood sample will be used to test for certain heritable and congenital
2.8disorders;
2.9(iii) the data that will be collected as part of the testing;
2.10(iv) that the blood sample will be stored for 71 days from the date of sample receipt
2.11in order to assure completion of the newborn screening process and the test results will be
2.12stored for 24 months from the date of reporting as required by federal law and regulations
2.13unless otherwise authorized;
2.14(v) that the blood sample and data for a positive test result will be stored by the
2.15Department of Health;
2.16(vi) the use of blood samples and test results for quality assurance and improvement
2.17during the standard retention period;
2.18(vii) the benefits for longer storage of blood samples and test results; and
2.19(viii) the Department of Health's Web site address where more information and
2.20forms may be obtained;
2.21(2) provide parents or legal guardians of infants with forms to request one or more of
2.22the following:
2.23(i) that the infant not have blood collected for testing; and
2.24(ii) that the infant's blood sample and test results be retained by the Department of
2.25Health after the standard retention period; and
2.26(3) record in the infant's medical record that a parent or legal guardian of the infant
2.27has received the information and the forms required under this subdivision and has had
2.28an opportunity to ask questions.
2.29 Sec. 2. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
2.30to read:
2.31 Subd. 4. Parental options. (a) The parent or legal guardian of an infant otherwise
2.32subject to testing under this section may:
2.33(1) choose not to have blood collected for testing; and
2.34(2) authorize the infant's blood sample and test results be retained by the Department
2.35of Health after the standard retention period.
3.1(b) If a parent or legal guardian elects and alternative in this subdivision, the election
3.2shall be recorded on a form that is signed by the parent or legal guardian. The signed form
3.3shall be made part of the infant's medical record and a copy shall be provided to the
3.4Department of Health. When a parent or legal guardian elects an alternative under this
3.5subdivision, the Department of Health must follow the election and section 144.128. A
3.6written election to decline testing exempts an infant from the requirements of this section
3.7and section 144.128.
3.8 Sec. 3. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
3.9to read:
3.10 Subd. 5. Newborn screening program operations. (a) "Newborn screening quality
3.11assurance and improvement operations" means actions, testing, and procedures directly
3.12related to the operation of the newborn screening program, such as:
3.13(1) confirmatory testing;
3.14(2) laboratory quality control assurance and improvement;
3.15(3) calibration of equipment;
3.16(4) evaluating and improving the accuracy of newborn screening tests for conditions
3.17approved for screening in Minnesota;
3.18(5) validation of equipment and screening methods; and
3.19(6) continuity of operations to ensure testing can continue in the event of an
3.20emergency.
3.21(b) Newborn screening quality assurance and improvement does not include research
3.22or the development of new newborn screening tests.
3.23 Sec. 4. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
3.24to read:
3.25 Subd. 6. Storage and use of samples and test results for newborn screening
3.26quality assurance and improvement. During the standard retention period, the
3.27Department of Health may use blood samples and test results for newborn screening
3.28quality assurance and improvement. When authorized in writing by a parent or legal
3.29guardian under subdivision 4, the department may store blood samples and test results for
3.30the time period authorized by the parent or legal guardian. Blood samples and positive test
3.31results of infants shall be stored by the Department of Health.
3.32 Sec. 5. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
3.33to read:
4.1 Subd. 7. Standard retention period for samples and test results. Blood samples
4.2without authorization for further storage shall be destroyed within a week of 71 days of
4.3the date of sample receipt. Test results without authorization for further storage shall be
4.4destroyed within one month of 24 months of the date of reporting.
4.5 Sec. 6. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
4.6to read:
4.7 Subd. 8. Written informed consent for other use of samples and test results.
4.8With written informed consent of the parent or legal guardian, the Department of Health
4.9may:
4.10(1) use newborn screening samples and test results for newborn screening related
4.11studies including studies used to develop new newborn screening tests;
4.12(2) use newborn screening samples and test results for non-newborn screening
4.13public health studies or research;
4.14(3) share the samples and test results with external parties for public health studies or
4.15research following approval by the Department of Health's institutional review board; and
4.16(4) allow a parent or legal guardian to authorize ongoing consent for studies and
4.17research or authorize consent for a single study.
4.18 Sec. 7. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
4.19to read:
4.20 Subd. 9. Revoking consent for storage and use. A parent or legal guardian or an
4.21adult who was tested as a minor may revoke approval for storage and use for newborn
4.22screening quality assurance and improvement or for other uses of samples and test results
4.23at any time by providing a signed and dated request for destruction form. The Department
4.24of Health shall make the form available on the department's Web site. Blood samples shall
4.25be destroyed within one week of receipt of the request or after 71 days from the date of
4.26sample receipt, whichever is later. Test results will be destroyed within one month of
4.27receipt of the request or after 24 months from the date of reporting, whichever is later.
4.28 Sec. 8. Minnesota Statutes 2010, section 144.128, is amended to read:
4.29144.128 COMMISSIONER'S DUTIES.
4.30The commissioner shall:
4.31(1) collect, use, disseminate, and store blood samples and test results in order
4.32to administer the newborn screening program for heritable and congenital disorders as
4.33described in sections 144.125 to 144.128;
5.1
5.2
5.3congenital disorders when treatment is indicated;
5.4
5.5by the screening program for the purpose of follow-up services;
5.6
5.7minors to direct that blood samples
5.8
5.9described in section 144.125;
5.10
5.11samples and test results have been destroyed; and
5.12
5.13 Sec. 9. EFFECTIVE DATE.
5.14This act is effective the day following final enactment and applies to blood samples
5.15and test results collected on or after that date.
