HF 1341

1st Engrossment - 86th Legislature (2009 - 2010) Posted on 02/09/2010 01:48am

A bill for an act
relating to health; changing provisions in the newborn screening program;
amending Minnesota Statutes 2008, sections 13.386, subdivision 3; 144.125,
subdivision 3, by adding subdivisions.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2008, section 13.386, subdivision 3, is amended to read:

Subd. 3.

Collection, storage, use, and dissemination of genetic information.

new text begin (a)
new text end Unless otherwise expressly provided by law, genetic information about an individual:

(1) may be collected by a government entity, as defined in section 13.02, subdivision
7a, or any other person only with the written informed consent of the individual;

(2) may be used only for purposes to which the individual has given written
informed consent;

(3) may be stored only for a period of time to which the individual has given written
informed consent; and

(4) may be disseminated only:

(i) with the individual's written informed consent; or

(ii) if necessary in order to accomplish purposes described by clause (2). A consent
to disseminate genetic information under item (i) must be signed and dated. Unless
otherwise provided by law, such a consent is valid for one year or for a lesser period
specified in the consent.

new text begin (b) Notwithstanding paragraph (a), the Department of Health's collection, storage,
use, and dissemination of genetic information and blood specimens for testing infants for
heritable and congenital disorders are governed by sections 144.125 to 144.128.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 2.

Minnesota Statutes 2008, section 144.125, subdivision 3, is amended to read:

Subd. 3.

deleted text begin Objection of parents to test deleted text end new text begin Information provided to parents new text end .

deleted text begin Persons
with a duty to perform testing under subdivision 1 shall advise parents of infants (1) that
the blood or tissue samples used to perform testing thereunder as well as the results of
such testing may be retained by the Department of Health, (2) the benefit of retaining the
blood or tissue sample, and (3) that the following options are available to them with
respect to the testing: (i) to decline to have the tests, or (ii) to elect to have the tests but to
require that all blood samples and records of test results be destroyed within 24 months
of the testing. If the parents of an infant object in writing to testing for heritable and
congenital disorders or elect to require that blood samples and test results be destroyed,
the objection or election shall be recorded on a form that is signed by a parent or legal
guardian and made part of the infant's medical record. A written objection exempts an
infant from the requirements of this section and section 144.128. deleted text end new text begin (a) Prior to collecting a
sample, persons with a duty to perform testing under subdivision 1 must provide parents
or legal guardians of infants with a document that provides the following information:
new text end

new text begin (1) the blood sample will be used to test for heritable and congenital disorders, the
blood sample will be retained by the Department of Health for a period of two years, and
that blood sample may be used for newborn screening program operations;
new text end

new text begin (2) the data that will be collected as a result of the testing;
new text end

new text begin (3) the alternatives available to the parents or legal guardians in paragraph (c) and
that a form to exercise the alternatives is available to the parent or legal guardian from the
person with a duty to perform testing under subdivision 1;
new text end

new text begin (4) the benefits of testing and the consequences of a decision to permit or refuse
to supply a sample;
new text end

new text begin (5) the benefits of retaining the blood sample and the consequences of a decision
to destroy the blood sample or to permit or decline to have the blood sample used for
newborn screening program operations;
new text end

new text begin (6) the ways in which the samples and data collected will be stored and used at the
Department of Health and elsewhere; and
new text end

new text begin (7) the Department of Health's Web site address where the forms in paragraph (c)
may be obtained.
new text end

new text begin This document satisfies the requirements of section 13.04, subdivision 2.
new text end

new text begin (b) The person with a duty to perform testing must record that parents or legal
guardians of infants have received the information provided under this subdivision and
have had an opportunity to ask questions.
new text end

new text begin (c) The parent or legal guardian of an infant otherwise subject to testing under this
section may object to any of the following:
new text end

new text begin (1) the testing itself;
new text end

new text begin (2) the storage of the infant's blood samples;
new text end

new text begin (3) the storage of the infant's test results for a period longer than 24 months; and
new text end

new text begin (4) the use of the infant's blood samples and test results for newborn screening
program operations.
new text end

new text begin If a parent or legal guardian elects to object to one or more of the alternatives in this
paragraph, the election shall be recorded on a form that is signed by the parent or legal
guardian. The signed form shall be made part of the infant's medical record and shall be
provided to the Department of Health. The signature of the parent or legal guardian is
sufficient and no witness to the signature, photo identification, or notarization shall be
required. When a parent or legal guardian elects an alternative under this subdivision,
the Department of Health must follow the election and section 144.128, to the extent that
section 144.128 pertains to the elected alternative. If the parent or legal guardian objects
to the testing itself, section 144.128 does not apply.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 3.

Minnesota Statutes 2008, section 144.125, is amended by adding a subdivision
to read:

new text begin Subd. 4. new text end

new text begin Storage and use of samples for newborn screening program operations.
new text end

new text begin (a) The department may store and use the newborn screening program blood samples for
up to 24 months for newborn screening program operations and may store samples for an
additional month to carry out the destruction of samples required under subdivision 7.
new text end

new text begin (b) Notwithstanding paragraph (a), the department may use and store the newborn
screening samples for individual health-related studies or any other purpose with a written
informed consent of the parent or legal guardian.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 4.

Minnesota Statutes 2008, section 144.125, is amended by adding a subdivision
to read:

new text begin Subd. 5. new text end

new text begin Newborn screening program operations. new text end

new text begin "Newborn screening program
operations" means actions, testing, and procedures directly related to the improvement,
implementation, and development of the newborn screening program, such as the testing
of the samples, confirmatory testing, laboratory quality control, calibration of equipment,
evaluating and improving the accuracy of newborn screening tests, implementation and
validation of equipment and technology, and studies or research related to the development
of new newborn screening tests.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 5.

Minnesota Statutes 2008, section 144.125, is amended by adding a subdivision
to read:

new text begin Subd. 6. new text end

new text begin Development of new screening tests. new text end

new text begin When samples are used for
program operations to develop new newborn screening tests, the department must remove
information that directly links infants to samples, but may use serial numbers that would
allow a relinkage in case a serious issue is discovered that needs to be communicated to
the parent or guardian of an infant. Such a relinkage may only be done after consultation
with an ethics committee or an institutional review board.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 6.

Minnesota Statutes 2008, section 144.125, is amended by adding a subdivision
to read:

new text begin Subd. 7. new text end

new text begin Destruction of samples within 25 months. new text end

new text begin (a) Unless a parent or legal
guardian has given written informed consent, the department must destroy all newborn
screening blood samples within 25 months of the month of birth.
new text end

new text begin (b) The department must implement this subdivision by July 1, 2010.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 7.

Minnesota Statutes 2008, section 144.125, is amended by adding a subdivision
to read:

new text begin Subd. 8. new text end

new text begin Records retention requirements. new text end

new text begin The department shall retain test results
in compliance with section 138.17.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 8.

Minnesota Statutes 2008, section 144.125, is amended by adding a subdivision
to read:

new text begin Subd. 9. new text end

new text begin Destruction of existing samples. new text end

new text begin Unless a parent or legal guardian has
given written informed consent, the department must destroy all newborn screening blood
samples retained by the department as of June 1, 2009, within 25 months of that date.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 9. new text begin NEWBORN SCREENING REPORT.
new text end

new text begin By January 15, 2010, the Department of Health shall report and make
recommendations to the legislature on its current efforts for ensuring and enhancing how
parents or legal guardians of newborns are fully informed about the newborn screening
program and of their rights and options regarding: (1) testing; (2) storage; (3) public
health practices, studies, and research; (4) the ability to opt out of the collection of data
and specimens related to the testing; and (5) the ability to seek private testing.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end