SF 3344

as introduced - 84th Legislature (2005 - 2006) Posted on 12/15/2009 12:00am

A bill for an act
relating to data practices; modifying the manner of obtaining parental consent
to genetic testing of children; providing for parental direction to destroy testing
results; requiring legislative authorization to revise the kinds of tests to be
administered; amending Minnesota Statutes 2004, sections 144.125, subdivisions
2, 3, by adding a subdivision; 144.128.

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

Section 1.

Minnesota Statutes 2004, section 144.125, subdivision 2, is amended to read:

Subd. 2.

Determination of tests to be administered.

new text begin With the authorization of the
legislature, new text end the commissioner shall periodically revise the list of tests to be administered
for determining the presence of a heritable or congenital disorder. Revisions to the
list shall reflect advances in medical science, new and improved testing methods, or
other factors that will improve the public health. In determining whether a test must be
administered, the commissioner shall take into consideration the adequacy of laboratory
methods to detect the heritable or congenital disorder, the ability to treat or prevent
medical conditions caused by the heritable or congenital disorder, and the severity of the
medical conditions caused by the heritable or congenital disorder. deleted text begin The list of tests to be
performed may be revised if the changes are recommended by the advisory committee
established under section 144.1255, approved by the commissioner, and published in the
State Register. The revision is exempt from the rulemaking requirements in chapter 14,
and sections 14.385 and 14.386 do not apply.
deleted text end

Sec. 2.

Minnesota Statutes 2004, section 144.125, subdivision 3, is amended to read:

Subd. 3.

Objection of parents to test.

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) Persons with a duty to perform testing under subdivision 1, shall
request the parent's consent before performing testing, provide parents with a form to
direct the state to dispose of test results and blood specimens, and offer parents private
testing options. Parents must be advised in a form separate from the consent form: new text end

new text begin (1) that the parents are not legally required to consent to any testing;
new text end

new text begin (2) that the testing is genetic testing;
new text end

new text begin (3) 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;
new text end

new text begin (4) the benefit of retaining the blood or tissue sample;
new text end

new text begin (5) the concerns related to genetic testing and data banking of DNA samples;
new text end

new text begin (6) that retained blood specimens may be made available for medical and genetic
research; and
new text end

new text begin (7) that the following options are available to them if they choose to have the testing:
new text end

new text begin (i) PKU only as performed by the commissioner;
new text end

new text begin (ii) full roster of genetic tests as performed by the commissioner;
new text end

new text begin (iii) private, nonstate testing options;
new text end

new text begin (iv) consenting or refusing consent to use of test results in medical or genetic
research; or
new text end

new text begin (vi) to elect to have the tests done by the state but to require that all blood samples
and records of test results be destroyed within 30 days of the testing or of receipt of a
parent's direction to destroy blood samples and records of test results, whichever is later.
new text end

new text begin (b) The consent form itself must contain the following:
new text end

new text begin (1) a statement that it is a consent to genetic testing;
new text end

new text begin (2) a statement that there is no legal requirement to consent and parents should
consult with their physicians;
new text end

new text begin (3) the infant's name, birth date, and hospital of birth;
new text end

new text begin (4) the parent's full name and residence address;
new text end

new text begin (5) a reference to the separate advice form described in paragraph (a);
new text end

new text begin (6) the option to choose:
new text end

new text begin (i) the full roster of tests provided by the Department of Health;
new text end

new text begin (ii) only PKU testing;
new text end

new text begin (iii) to seek private genetic testing;
new text end

new text begin (iv) to consent or refuse consent to allow use of test results and blood samples
in research; or
new text end

new text begin (v) none of the above;
new text end

new text begin (7) space for the parent's signature and the date; and
new text end

new text begin (8) a statement that the form will be retained in the child's and mother's medical
records.
new text end

Sec. 3.

Minnesota Statutes 2004, section 144.125, is amended by adding a subdivision
to read:

new text begin Subd. 4. new text end

new text begin Parental destruction directive. new text end

new text begin The commissioner shall prepare a separate
form for parents' use to direct that blood samples and records of test results be destroyed
not later than 30 days after receipt of the form. The form must be provided to the parent
of the newborn. The form must reference available information about data practices
and blood sample storage policies. If the parent elects to have test results and blood
samples destroyed, the form must be signed by the parent and must not require a witness
or notarization of the parent's signature.
new text end

Sec. 4.

Minnesota Statutes 2004, section 144.128, is amended to read:

144.128 COMMISSIONER'S DUTIES.

The commissioner shall:

(1) notify the physicians of newborns tested of the results of the tests performed;

(2) make referrals for the necessary treatment of diagnosed cases of heritable and
congenital disorders when treatment is indicated;

(3) maintain a registry of the cases of heritable and congenital disorders detected by
the screening program for the purpose of follow-up services; deleted text begin and
deleted text end

(4) new text begin provide test results to all parents who elect state testing;
new text end

new text begin (5) provide a certificate of destruction to all parents who elect to have test results and
blood specimens destroyed; and
new text end

new text begin (6) new text end adopt rules to carry out sections 144.125 to 144.128.