Minnesota Legislature
HF 2697
as introduced - 87th Legislature (2011 - 2012) Posted on 03/13/2012 12:33pm
Current Version - as introduced
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A bill for an act
relating to health; changing provisions of the newborn screening program;
amending Minnesota Statutes 2010, sections 144.125, subdivision 3, by adding
subdivisions; 144.128.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
Section 1.
Minnesota Statutes 2010, section 144.125, subdivision 3, is amended to read:
Subd. 3.
deleted text begin Objection of parents to testdeleted text end new text begin Information provided to parentsnew 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) The department shall
make information and forms available to 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. The department shall make information and
forms about newborn screening available to expectant parents and parents of newborns
using electronic and other means.
new text end
new text begin
(b) Prior to collecting a sample, persons with a duty to perform testing under
subdivision 1 must:
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(1) provide parents or legal guardians of infants with a document meeting the
requirements of section 13.04, subdivision 2, that provides the following information:
new text end
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(i) the benefits of testing and the risks of a decision to refuse to supply a blood
sample;
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(ii) that the blood sample will be used to test for certain heritable and congenital
disorders;
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new text begin
(iii) the data that will be collected as part of the testing;
new text end
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(iv) that the blood sample will be stored for 71 days from the date of sample receipt
in order to assure completion of the newborn screening process and the test results will be
stored for 24 months from the date of reporting as required by federal law and regulations
unless otherwise authorized;
new text end
new text begin
(v) that the blood sample and data for a positive test result will be stored by the
Department of Health;
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new text begin
(vi) the use of blood samples and test results for quality assurance and improvement
during the standard retention period;
new text end
new text begin
(vii) the benefits for longer storage of blood samples and test results; and
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(viii) the Department of Health's Web site address where more information and
forms may be obtained;
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(2) provide parents or legal guardians of infants with forms to request one or more of
the following:
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(i) that the infant not have blood collected for testing; and
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(ii) that the infant's blood sample and test results be retained by the Department of
Health after the standard retention period; and
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(3) record in the infant's medical record that a parent or legal guardian of the infant
has received the information and the forms required under this subdivision and has had
an opportunity to ask questions.
new text end
Sec. 2.
Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
to read:
new text begin Subd. 4. new text end
new text begin Parental options. new text end
new text begin
(a) The parent or legal guardian of an infant otherwise
subject to testing under this section may:
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(1) choose not to have blood collected for testing; and
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(2) authorize the infant's blood sample and test results be retained by the Department
of Health after the standard retention period.
new text end
new text begin
(b) If a parent or legal guardian elects and alternative in this subdivision, 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 a copy shall be provided to the
Department of Health. When a parent or legal guardian elects an alternative under this
subdivision, the Department of Health must follow the election and section 144.128. A
written election to decline testing exempts an infant from the requirements of this section
and section 144.128.
new text end
Sec. 3.
Minnesota Statutes 2010, 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
(a) "Newborn screening quality
assurance and improvement operations" means actions, testing, and procedures directly
related to the operation of the newborn screening program, such as:
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(1) confirmatory testing;
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(2) laboratory quality control assurance and improvement;
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(3) calibration of equipment;
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(4) evaluating and improving the accuracy of newborn screening tests for conditions
approved for screening in Minnesota;
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(5) validation of equipment and screening methods; and
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(6) continuity of operations to ensure testing can continue in the event of an
emergency.
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(b) Newborn screening quality assurance and improvement does not include research
or the development of new newborn screening tests.
new text end
Sec. 4.
Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
to read:
new text begin Subd. 6. new text end
new text begin
Storage and use of samples and test results for newborn screening
quality assurance and improvement.
new text end
new text begin
During the standard retention period, the
Department of Health may use blood samples and test results for newborn screening
quality assurance and improvement. When authorized in writing by a parent or legal
guardian under subdivision 4, the department may store blood samples and test results for
the time period authorized by the parent or legal guardian. Blood samples and positive test
results of infants shall be stored by the Department of Health.
new text end
Sec. 5.
Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
to read:
new text begin Subd. 7. new text end
new text begin Standard retention period for samples and test results. new text end
new text begin
Blood samples
without authorization for further storage shall be destroyed within a week of 71 days of
the date of sample receipt. Test results without authorization for further storage shall be
destroyed within one month of 24 months of the date of reporting.
new text end
Sec. 6.
Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
to read:
new text begin Subd. 8. new text end
new text begin
Written informed consent for other use of samples and test results.
new text end
new text begin
With written informed consent of the parent or legal guardian, the Department of Health
may:
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(1) use newborn screening samples and test results for newborn screening related
studies including studies used to develop new newborn screening tests;
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(2) use newborn screening samples and test results for non-newborn screening
public health studies or research;
new text end
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(3) share the samples and test results with external parties for public health studies or
research following approval by the Department of Health's institutional review board; and
new text end
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(4) allow a parent or legal guardian to authorize ongoing consent for studies and
research or authorize consent for a single study.
new text end
Sec. 7.
Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision
to read:
new text begin Subd. 9. new text end
new text begin Revoking consent for storage and use. new text end
new text begin
A parent or legal guardian or an
adult who was tested as a minor may revoke approval for storage and use for newborn
screening quality assurance and improvement or for other uses of samples and test results
at any time by providing a signed and dated request for destruction form. The Department
of Health shall make the form available on the department's Web site. Blood samples shall
be destroyed within one week of receipt of the request or after 71 days from the date of
sample receipt, whichever is later. Test results will be destroyed within one month of
receipt of the request or after 24 months from the date of reporting, whichever is later.
new text end
Sec. 8.
Minnesota Statutes 2010, section 144.128, is amended to read:
144.128 COMMISSIONER'S DUTIES.
The commissioner shall:
new text begin
(1) collect, use, disseminate, and store blood samples and test results in order
to administer the newborn screening program for heritable and congenital disorders as
described in sections 144.125 to 144.128;
new text end
deleted text begin (1)deleted text end new text begin (2)new text end notify the physicians of newborns tested of the results of the tests performed;
deleted text begin (2)deleted text end new text begin (3)new text end make referrals for the necessary treatment of diagnosed cases of heritable and
congenital disorders when treatment is indicated;
deleted text begin (3)deleted text end new text begin (4)new text end 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 (4)deleted text end new text begin (5)new text end prepare a separate form for use by parents or by adults who were tested as
minors to direct that blood samples deleted text begin anddeleted text end new text begin ornew text end test results be destroyed;
deleted text begin (5)deleted text end new text begin (6)new text end comply with a destruction request deleted text begin within 45 days after receiving itdeleted text end new text begin as
described in section 144.125new text end ;
deleted text begin (6)deleted text end new text begin (7)new text end notify individuals who request destruction of samples and test results that the
samples and test results have been destroyed; and
deleted text begin (7)deleted text end new text begin (8)new text end adopt rules to carry out sections 144.125 to 144.128.
Sec. 9. new text begin EFFECTIVE DATE.
new text end
new text begin
This act is effective the day following final enactment and applies to blood samples
and test results collected on or after that date.
new text end