October 1, 2003, Introduced by Reps. Hood, Gaffney, Hune, Nofs, Lipsey, Plakas, Byrum, McConico, Smith, Wojno, Sak, Rivet, Vagnozzi, Accavitti, Tobocman, Cheeks and Dennis and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending section 5431 (MCL 333.5431), as amended by 2002 PA
691.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
1 Sec. 5431. (1) A health professional in charge of the care
2 of a newborn infant or, if none, the health professional in
3 charge at the birth of an infant shall administer or cause to be
4 administered to the infant a test for each of the following:
5 (a) Phenylketonuria.
6 (b) Galactosemia.
7 (c) Hypothyroidism.
8 (d) Maple syrup urine disease.
9 (e) Biotinidase deficiency.
10 (f) Sickle cell anemia.
1 (g) Congenital adrenal hyperplasia.
2 (h) Medium-chain acyl-coenzyme A dehydrogenase deficiency.
3 (i) Other treatable but otherwise disabling conditions as
4 designated by the department.
5 (2) A health care professional in charge of the care of a
6 newborn infant or, if none, the health professional in charge at
7 the birth of an infant shall administer or cause to be
8 administered screening for the detection of hearing loss of all
9 newborn infants. As used in this subsection, "screening" means a
10 test or battery of tests administered to identify a possible
11 hearing impairment and determine the need for a more extensive
12 hearing diagnostic evaluation.
13 (3) (2) The
informed consent requirements of sections 17020
14 and 17520 do not apply to the tests required under subsection (1)
15 or (2). The tests required under subsection (1) or (2) shall be
16 administered and reported within a time and under conditions
17 prescribed by the department. The department may require that
18 the tests be performed by the department.
19 (4) (3) If
the results of a test administered under
20 subsection (1) or (2) are positive, the results shall be reported
21 to the infant's parents, guardian, or person in loco parentis. A
22 person is in compliance with this subsection if the person makes
23 a good faith effort to report the positive test results to the
24 infant's parents, guardian, or person in loco parentis.
25 (5) (4) Subject
to the annual adjustment required under
26 this subsection and
subject to subsection (6) (7), if the
27 department performs 1 or more of the tests required under
1 subsection (1) or (2), the department may charge a fee for the
2 tests of not more than $53.71. The department shall adjust the
3 amount prescribed by this subsection annually by an amount
4 determined by the state treasurer to reflect the cumulative
5 annual percentage change in the Detroit consumer price index. As
6 used in this subsection, "Detroit consumer price index" means the
7 most comprehensive index of consumer prices available for the
8 Detroit area from the bureau of labor statistics of the United
9 States department of labor.
10 (6) (5) A
person who violates this section or a rule
11 promulgated under this part is guilty of a misdemeanor.
12 (7) (6) The
department shall provide for a hardship waiver
13 of the fee authorized
under subsection (4) (5) under
14 circumstances found appropriate by the department.
15 (8) (7) The
department shall do all of the following in
16 regard to the blood specimens taken for purposes of conducting
17 the tests required under subsection (1):
18 (a) By April 1, 2000, develop a schedule for the retention
19 and disposal of the blood specimens used for the tests after the
20 tests are completed. The schedule shall meet at least all of the
21 following requirements:
22 (i) Be consistent with nationally recognized standards for
23 laboratory accreditation and federal law.
24 (ii) Require that the disposal be conducted in compliance
25 with section 13811.
26 (iii) Require that the disposal be conducted in the presence
27 of a witness. For purposes of this subparagraph, the witness may
1 be an individual involved in the disposal or any other
2 individual.
3 (iv) Require that a written record of the disposal be made
4 and kept, and that the witness required under subparagraph (iii)
5 signs the record.
6 (b) Allow the blood specimens to be used for medical research
7 during the retention period established under subdivision (a), as
8 long as the medical research is conducted in a manner that
9 preserves the confidentiality of the test subjects and is
10 consistent to protect human subjects from research risks under
11 subpart A of part 46
of subchapter A of title 45 of the code of
12 federal regulations 45 C.F.R. part 46.
13 (9) (8) The
department shall rewrite its pamphlet
14 explaining the requirements of this section when the supply of
15 pamphlets in existence on
March 15, 2000 the effective date of
16 the amendatory act that added subsection (2) is exhausted. When
17 the department rewrites the explanatory pamphlet, it shall
18 include at least all of the following information in the
19 pamphlet:
20 (a) The nature and purpose of the testing program required
21 under this section, including, but not limited to, a brief
22 description of each
condition or disorder listed in subsection
23 subsections (1) and (2).
24 (b) The purpose and value of the infant's parent, guardian,
25 or person in loco parentis retaining a blood specimen obtained
26 under subsection (9) (10)
in a safe place.
27 (c) The department's schedule for retaining and disposing of
1 blood specimens developed
under subsection (7)(a) (8)(a).
2 (d) That the blood specimens taken for purposes of conducting
3 the tests required under subsection (1) may be used for medical
4 research pursuant to
subsection (7)(b) (8)(b).
5 (10) (9) In
addition to the requirements of subsection (1),
6 the health professional described in subsection (1) or the
7 hospital or other facility in which the birth of an infant takes
8 place, or both, may offer to draw an additional blood specimen
9 from the infant. If such an offer is made, it shall be made to
10 the infant's parent, guardian, or person in loco parentis at the
11 time the blood specimens are drawn for purposes of
12 subsection (1). If the infant's parent, guardian, or person in
13 loco parentis accepts the offer of an additional blood specimen,
14 the blood specimen shall be preserved in a manner that does not
15 require special storage conditions or techniques, including, but
16 not limited to, lamination. The health professional or hospital
17 or other facility employee making the offer shall explain to the
18 parent, guardian, or person in loco parentis at the time the
19 offer is made that the additional blood specimen can be used for
20 future identification purposes and should be kept in a safe
21 place. The health professional or hospital or other facility
22 making the offer may charge a fee that is not more than the
23 actual cost of obtaining and preserving the additional blood
24 specimen.