HF 2526

1st Engrossment - 88th Legislature (2013 - 2014) Posted on 03/19/2014 12:34pm

A bill for an act
relating to health; modifying the newborn screening program; amending Minnesota Statutes 2012, section 144.125, subdivisions 3, 4, 5, 8, 9, 10; Minnesota Statutes 2013 Supplement, section 144.125, subdivision 7; repealing Minnesota Statutes 2012, section 144.125, subdivision 6.

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

Section 1.

Minnesota Statutes 2012, section 144.125, subdivision 3, is amended to read:

Subd. 3.

Information provided to parents new text begin and legal guardians new text end .

(a) The
department shall make information and forms available to new text begin childbirth education programs
and new text end health care providers who provide prenatal care describing the newborn screening
program and the provisions of this section to be used in a discussion with expectant
parents and parents of newborns. The department shall make information and forms about
newborn screening available to the persons with a duty to perform testing under this
section and to expectant parents and parents of newborns using electronic and other means.

(b) Prior to collecting a sample, persons with a duty to perform testing under
subdivision 1 must:

(1) provide parents or legal guardians of infants with a document that provides
the following information:

(i) the benefits of newborn screening;

(ii) that the blood sample will be used to test for heritable and congenital disorders,
as determined under subdivision 2;

(iii) the data that will be collected as part of the testing;

(iv) deleted text begin the standard retention periods for blood samples and test results as provided in
subdivision 6 deleted text end new text begin the benefits associated with the department's storage of an infant's blood
sample and test results new text end ;

new text begin (v) that the Department of Health may store the blood samples and test results unless
the parent or legal guardian elects to not have them stored;
new text end

deleted text begin (v) deleted text end new text begin (vi) new text end that blood samples and test results will be used for program operations
deleted text begin during the standard retention period deleted text end in accordance with subdivision 5 new text begin , unless the parents
or legal guardians elect not to have the blood samples and test results stored new text end ;

deleted text begin (vi) deleted text end new text begin (vii) new text end the Department of Health's Web site address where more information
and forms may be obtained; deleted text begin and
deleted text end

deleted text begin (vii) deleted text end new text begin (viii) new text end that parents new text begin or legal guardians new text end have a right to elect not to have newborn
screening performed and a right to secure private testing;

new text begin (ix) that parents or legal guardians have a right to elect to have the newborn
screening performed, but not have the blood samples and test results stored; and
new text end

new text begin (x) that parents or legal guardians have a right to authorize in writing that the blood
samples and test results may be used for public health studies or research; and
new text end

(2) upon request, provide parents or legal guardians of infants with forms necessary
to request that the infant not have blood collected for testing new text begin or to request to have the
newborn screening performed, but not have the blood samples and test results stored new text end ; and

(3) record in the infant's medical record that a parent or legal guardian of the
infant has received the information provided pursuant to this subdivision and has had
an opportunity to ask questions.

(c) Nothing in this section prohibits a parent or legal guardian of an infant from
having newborn screening performed by a private entity.

Sec. 2.

Minnesota Statutes 2012, section 144.125, subdivision 4, is amended to read:

Subd. 4.

Parental options.

(a) The parent or legal guardian of an infant otherwise
subject to testing under this section may elect not to have newborn screening performed new text begin ,
or may elect to have newborn screening tests performed, but not to have the blood samples
and test results stored new text end .

(b) If a parent or legal guardian elects not to have newborn screening performed new text begin or
elects not to allow the blood samples and test results to be stored new text end , then the election deleted text begin shall
deleted text end new text begin must new text end be recorded on a form that is signed by the parent or legal guardian. The signed form
deleted text begin shall deleted text end new text begin must new text end be made part of the infant's medical record and a copy shall be provided to
the Department of Health. When a parent or legal guardian elects not to have newborn
screening performed, the person with the duty to perform testing under subdivision 1 must
follow that election. A written election to decline testing exempts persons with a duty
to perform testing and the Department of Health from the requirements of this section
and section 144.128.

Sec. 3.

Minnesota Statutes 2012, section 144.125, subdivision 5, is amended to read:

Subd. 5.

Newborn screening program operations.

(a) "Newborn screening
program operations" means actions, testing, and procedures directly related to the
operation of the newborn screening program, limited to the following:

(1) confirmatory testing;

(2) laboratory quality control assurance and improvement;

(3) calibration of equipment;

(4) evaluating and improving the accuracy of newborn screening tests for conditions
approved for screening in Minnesota;

(5) validation of equipment and screening methods; deleted text begin and
deleted text end

(6) continuity of operations to ensure testing can continue as required by Minnesota
law in the event of an emergency new text begin ; and
new text end

new text begin (7) utilization of blood samples and test results for studies related to newborn
screening, including studies used to develop new tests new text end .

(b) No research deleted text begin , deleted text end new text begin or new text end public health studies deleted text begin , or development of new newborn screening
tests shall be conducted under this subdivision deleted text end new text begin other than those described in paragraph (a)
shall be conducted without written consent as described under subdivision 7 new text end .

Sec. 4.

Minnesota Statutes 2013 Supplement, section 144.125, subdivision 7, is
amended to read:

Subd. 7.

Parental options for deleted text begin extended storage and use deleted text end new text begin additional research new text end .

(a)
The parent or legal guardian of an infant deleted text begin otherwise deleted text end subject to testing under this section
may authorize new text begin in writing new text end that the infant's blood sample and test results be retained and
used by the Department of Health deleted text begin beyond the standard retention periods provided in
subdivision 6 deleted text end for the purposes described in subdivision 9.

(b) The Department of Health must provide a consent form, with an attached
Tennessen warning pursuant to section 13.04, subdivision 2. The consent form must
provide the following:

deleted text begin (1) information as to the personal identification and use of samples and test results
for studies, including studies used to develop new tests;
deleted text end

deleted text begin (2) deleted text end new text begin (1) new text end information as to the personal identification and use of samples and test
results for public health studies or research not related to newborn screening;

deleted text begin (3) information that explains that the Department of Health will not store a blood
sample or test result for longer than 18 years from an infant's birth date;
deleted text end

deleted text begin (4) deleted text end new text begin (2) new text end information that explains that, upon approval by the Department of Health's
Institutional Review Board, blood samples and test results may be shared with external
parties for public health studies or research; new text begin and
new text end

deleted text begin (5) deleted text end new text begin (3) new text end information that explains that blood samples contain various components,
including deoxyribonucleic acid (DNA) deleted text begin ; and
deleted text end

deleted text begin (6) the benefits and risks associated with the department's storage of a child's blood
sample and test results deleted text end .

Sec. 5.

Minnesota Statutes 2012, section 144.125, subdivision 8, is amended to read:

Subd. 8.

deleted text begin Extended deleted text end Storage and use of samples and test results.

deleted text begin When authorized
in writing by a parent or legal guardian under subdivision 7, deleted text end new text begin (a) new text end The Department of Health
may store blood samples and test results deleted text begin for a time period not to exceed 18 years from
the infant's birth date deleted text end , and may use the blood samples and test results in accordance with
subdivision deleted text begin 9 deleted text end new text begin 5, unless a parent or legal guardian elects against the storage of the blood
samples and test results, and in accordance with subdivision 9, if written informed consent
of a parent or legal guardian is obtained new text end .

new text begin (b) If a parent, legal guardian, or individual elects against storage or revokes prior
consent for storage, the blood samples must be destroyed within one week of receipt of
the request, and test results must be destroyed at the earliest time allowed under Clinical
Laboratory Improvement Amendments (CLIA) regulations.
new text end

Sec. 6.

Minnesota Statutes 2012, section 144.125, subdivision 9, is amended to read:

Subd. 9.

Written, informed consent for other use of samples and test results.

With the written, informed consent of a parent or legal guardian, the Department of Health
may deleted text begin :
deleted text end

deleted text begin (1) use blood samples and test results for studies related to newborn screening,
including studies used to develop new tests; and
deleted text end

deleted text begin (2) deleted text end use blood samples and test results for public health studies or research not related
to newborn screening, and upon approval by the Department of Health's Institutional
Review Board, share samples and test results with external parties for public health
studies or research.

Sec. 7.

Minnesota Statutes 2012, section 144.125, subdivision 10, is amended to read:

Subd. 10.

Revoking consent for storage and use.

A parent or legal guardian new text begin , or the
individual whose blood was tested as an infant if the individual is 18 years of age or older,
new text end may revoke approval for deleted text begin extended deleted text end storage or use of blood samples or test results at any
time by providing a signed and dated form requesting destruction of the blood samples
or test results. The Department of Health shall make necessary forms available on the
department's Web site. Blood samples must be destroyed within one week of receipt of a
request deleted text begin or within one week of the standard retention period for blood samples provided in
subdivision 6, whichever is later. deleted text end new text begin and new text end test results must be destroyed deleted text begin within one month of
receipt of a request or within one month of the standard retention period for test results
provided in subdivision 6, whichever is later deleted text end new text begin at the earliest time allowed under Clinical
Laboratory Improvement Amendments (CLIA) regulations new text end .

Sec. 8. new text begin LIMITED OPT-IN EXCEPTION.
new text end

new text begin Parents and legal guardians of infants born prior to the effective date of this act
may give the Department of Health written consent for storage and use as described in
Minnesota Statutes, section 144.125, subdivisions 5 and 8.
new text end

Sec. 9. new text begin REPEALER.
new text end

new text begin Minnesota Statutes 2012, section 144.125, subdivision 6, new text end new text begin is repealed.
new text end

Sec. 10. new text begin EFFECTIVE DATE.
new text end

new text begin Sections 1 to 9 are effective the day following final enactment.
new text end