1.1 	A bill for an act
1.2 	relating to data practices; modifying the manner of obtaining parental consent 
1.3 	to genetic testing of children; providing for parental direction to destroy testing 
1.4 	results; requiring legislative authorization to revise the kinds of tests to be 
1.5 	administered; amending Minnesota Statutes 2004, sections 144.125, subdivisions 
1.6 	2, 3, by adding a subdivision; 144.128.
1.7 	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.8 	Section 1. Minnesota Statutes 2004, section 144.125, subdivision 2, is amended to read:
1.9 		Subd. 2.Determination of tests to be administered. With the authorization of the 
1.10 	legislature, the commissioner shall periodically revise the list of tests to be administered 
1.11 	for determining the presence of a heritable or congenital disorder. Revisions to the 
1.12 	list shall reflect advances in medical science, new and improved testing methods, or 
1.13 	other factors that will improve the public health. In determining whether a test must be 
1.14 	administered, the commissioner shall take into consideration the adequacy of laboratory 
1.15 	methods to detect the heritable or congenital disorder, the ability to treat or prevent 
1.16 	medical conditions caused by the heritable or congenital disorder, and the severity of the 
1.17 	medical conditions caused by the heritable or congenital disorder. The list of tests to be 
1.18 	performed may be revised if the changes are recommended by the advisory committee 
1.19 	established under section  144.1255, approved by the commissioner, and published in the 
1.20 	State Register. The revision is exempt from the rulemaking requirements in chapter 14, 
1.21 	and sections  14.385 and  14.386 do not apply. 

1.22 	Sec. 2. Minnesota Statutes 2004, section 144.125, subdivision 3, is amended to read:
1.23 		Subd. 3.Objection of parents to test. Persons with a duty to perform testing under 
1.24 	subdivision 1 shall advise parents of infants (1) that the blood or tissue samples used to 
2.1 	perform testing thereunder as well as the results of such testing may be retained by the 
2.2 	Department of Health, (2) the benefit of retaining the blood or tissue sample, and (3) that 
2.3 	the following options are available to them with respect to the testing: (i) to decline to 
2.4 	have the tests, or (ii) to elect to have the tests but to require that all blood samples and 
2.5 	records of test results be destroyed within 24 months of the testing. If the parents of an 
2.6 	infant object in writing to testing for heritable and congenital disorders or elect to require 
2.7 	that blood samples and test results be destroyed, the objection or election shall be recorded 
2.8 	on a form that is signed by a parent or legal guardian and made part of the infant's medical 
2.9 	record. A written objection exempts an infant from the requirements of this section and 
2.10 	section  144.128. (a) Persons with a duty to perform testing under subdivision 1, shall 
2.11 	request the parent's consent before performing testing, provide parents with a form to 
2.12 	direct the state to dispose of test results and blood specimens, and offer parents private 
2.13 	testing options. Parents must be advised in a form separate from the consent form:
2.14 	(1) that the parents are not legally required to consent to any testing; 
2.15 	(2) that the testing is genetic testing; 
2.16 	(3) that the blood or tissue samples used to perform testing thereunder as well as the 
2.17 	results of such testing may be retained by the Department of Health; 
2.18 	(4) the benefit of retaining the blood or tissue sample; 
2.19 	(5) the concerns related to genetic testing and data banking of DNA samples; 
2.20 	(6) that retained blood specimens may be made available for medical and genetic 
2.21 	research; and 
2.22 	(7) that the following options are available to them if they choose to have the testing:
2.23 	(i) PKU only as performed by the commissioner; 
2.24 	(ii) full roster of genetic tests as performed by the commissioner; 
2.25 	(iii) private, nonstate testing options; 
2.26 	(iv) consenting or refusing consent to use of test results in medical or genetic 
2.27 	research; or 
2.28 	(vi) to elect to have the tests done by the state but to require that all blood samples 
2.29 	and records of test results be destroyed within 30 days of the testing or of receipt of a 
2.30 	parent's direction to destroy blood samples and records of test results, whichever is later. 
2.31 	(b) The consent form itself must contain the following: 
2.32 	(1) a statement that it is a consent to genetic testing; 
2.33 	(2) a statement that there is no legal requirement to consent and parents should 
2.34 	consult with their physicians; 
2.35 	(3) the infant's name, birth date, and hospital of birth; 
2.36 	(4) the parent's full name and residence address; 
3.1 	(5) a reference to the separate advice form described in paragraph (a); 
3.2 	(6) the option to choose: 
3.3 	(i) the full roster of tests provided by the Department of Health; 
3.4 	(ii) only PKU testing; 
3.5 	(iii) to seek private genetic testing; 
3.6 	(iv) to consent or refuse consent to allow use of test results and blood samples 
3.7 	in research; or 
3.8 	(v) none of the above; 
3.9 	(7) space for the parent's signature and the date; and 
3.10 	(8) a statement that the form will be retained in the child's and mother's medical 
3.11 	records. 

3.12 	Sec. 3. Minnesota Statutes 2004, section 144.125, is amended by adding a subdivision 
3.13 	to read:
3.14 		Subd. 4. Parental destruction directive.  The commissioner shall prepare a separate 
3.15 	form for parents' use to direct that blood samples and records of test results be destroyed 
3.16 	not later than 30 days after receipt of the form. The form must be provided to the parent 
3.17 	of the newborn. The form must reference available information about data practices 
3.18 	and blood sample storage policies. If the parent elects to have test results and blood 
3.19 	samples destroyed, the form must be signed by the parent and must not require a witness 
3.20 	or notarization of the parent's signature. 

3.21 	Sec. 4. Minnesota Statutes 2004, section 144.128, is amended to read:
3.22 	144.128 COMMISSIONER'S DUTIES.
3.23 	The commissioner shall:
3.24 	(1) notify the physicians of newborns tested of the results of the tests performed;
3.25 	(2) make referrals for the necessary treatment of diagnosed cases of heritable and 
3.26 	congenital disorders when treatment is indicated;
3.27 	(3) maintain a registry of the cases of heritable and congenital disorders detected by 
3.28 	the screening program for the purpose of follow-up services; and
3.29 	(4) provide test results to all parents who elect state testing; 
3.30 	(5) provide a certificate of destruction to all parents who elect to have test results and 
3.31 	blood specimens destroyed; and 
3.32 	(6) adopt rules to carry out sections  144.125 to  144.128.