SB 607

SENATE BILL NO. 607
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending section 5431 (MCL 333.5431), as amended by
2002 PA 691, and by adding section 5433.
the people of the state of michigan enact:
Sec. 5431. (1) A health professional in
charge of the care of a newborn infant or, if none, the health professional in
charge at the birth of an infant shall administer or cause to be administered
to the infant a test for each of the following:
(a)
Phenylketonuria.
(b) Galactosemia.
(c) Hypothyroidism.
(d) Maple syrup
urine disease.
(e) Biotinidase
deficiency.
(f) Sickle cell
anemia.
(g) Congenital
adrenal hyperplasia.
(h) Medium-chain
acyl-coenzyme A dehydrogenase deficiency.
(i) Other treatable
but otherwise disabling conditions as designated by the department.
(j) Beginning March 1, 2028, congenital cytomegalovirus.
(2) The informed
consent requirements of sections 17020 and 17520 do not apply to the tests
required under subsection (1). The tests required under subsection (1) shall must be
administered and reported within a time and under conditions prescribed by the
department. The department may require that the tests be performed by the
department.
(3) If the results
of a test administered under subsection (1) (1)(a) to (i) are positive, the results shall must be
reported to the infant's parents, guardian, or person in loco parentis. If the results of a test administered under subsection
(1)(j) are positive, the results must be reported to the department as required
under section 5433 and to the infant's parents, guardian, or person in loco
parentis. A person is in compliance with this
subsection the requirement to report the
results of a test to an infant's parents, guardian, or person in loco parentis if
the person makes a good faith good-faith effort to report the positive test results
to the infant's parents, guardian, or person in loco parentis.
(4) Subject to the
annual adjustment required under this subsection and subject to subsection (6),
if the department performs 1 or more of the tests required under subsection
(1), the department may charge a fee for the tests of not more than $53.71. The
department shall adjust the amount prescribed by this subsection annually by an
amount determined by the state treasurer to reflect the cumulative annual
percentage change in the Detroit consumer price
index. Consumer Price Index. As used in
this subsection, "Detroit consumer price
index" Consumer Price Index" means
the most comprehensive index of consumer prices available for the Detroit Detroit-Warren-Dearborn
area from the bureau of labor statistics Bureau of Labor Statistics of the United States department of labor.Department
of Labor.
(5) A person who
violates this section or a rule promulgated under this part is guilty of a
misdemeanor.
(6) The department
shall provide for a hardship waiver of the fee authorized under subsection (4)
under circumstances found appropriate by the department.
(7) The department
shall do all of the following in regard to the blood specimens taken for
purposes of conducting the tests required under subsection (1):
(a) By April 1,
2000, develop a schedule for the retention and disposal of the blood specimens
used for the tests after the tests are completed. The schedule shall must meet at
least all of the following requirements:
(i) Be consistent with nationally recognized
standards for laboratory accreditation and federal law.
(ii) Require that the disposal be conducted
in compliance with section 13811.
(iii) Require that the disposal be conducted
in the presence of a witness. For purposes of this subparagraph, the witness
may be an individual involved in the disposal or any other individual.
(iv) Require that a written record of the
disposal be made and kept, and that the witness required under subparagraph (iii) signs the record.
(b) Allow the blood
specimens to be used for medical research during the retention period
established under subdivision (a), as long as the medical research is conducted
in a manner that preserves the confidentiality of the test subjects and is
consistent to protect human subjects from research risks under subpart A of part 46 of subchapter A of title 45 of the
code of federal regulations.45 CFR 46.101 to
46.124.
(8) The department
shall rewrite its pamphlet explaining the requirements of this section when the
supply of pamphlets in existence on March 15, 2000 is exhausted. When the
department rewrites the explanatory pamphlet, it the department shall include at least all of the
following information in the pamphlet:
(a) The nature and
purpose of the testing program required under this section, including, but not
limited to, a brief description of each condition or disorder listed in
subsection (1).
(b) The purpose and
value of the infant's parent, guardian, or person in loco parentis retaining a
blood specimen obtained under subsection (9) in a safe place.
(c) The
department's schedule for retaining and disposing of blood specimens developed
under subsection (7)(a).
(d) That the blood
specimens taken for purposes of conducting the tests required under subsection
(1) may be used for medical research pursuant to subsection (7)(b).
(9) In addition to
the requirements of subsection (1), the health professional described in
subsection (1) or the hospital or other facility in which the birth of an
infant takes place, or both, may offer to draw an additional blood specimen
from the infant. If such an offer is made, it shall
must be made to the infant's parent,
guardian, or person in loco parentis at the time the blood specimens are drawn
for purposes of subsection (1). If the infant's parent, guardian, or person in
loco parentis accepts the offer of an additional blood specimen, the blood
specimen shall must
be preserved in a manner that does not require special storage
conditions or techniques, including, but not limited to, lamination. The health
professional or hospital or other facility employee making the offer shall
explain to the parent, guardian, or person in loco parentis at the time the
offer is made that the additional blood specimen can be used for future
identification purposes and should be kept in a safe place. The health professional
or hospital or other facility making the offer may charge a fee that is not
more than the actual cost of obtaining and preserving the additional blood
specimen.
(10) The
test described in subsection (1)(j) must be administered by a blood spot,
saliva, or urine specimen test or by another test for congenital
cytomegalovirus that is diagnostically equivalent as determined by the
department.
Sec. 5433. (1) If
the results of a test under section 5431(1)(j) are positive, the health
professional in charge of the care of the newborn infant or, if none, the
health professional in charge at the birth of the infant, the hospital, the local
health department, or other facility shall do both of the following:
(a) Provide the parent, guardian, or person in loco parentis of the
infant with the information described in subsection (2) and information on
available methods of treatment for cCMV.
(b) Report to the department, on a form prescribed by the department,
the results of the test.
(2) The department shall develop and implement a public education
program on CMV and cCMV to provide information to pregnant women and women who
may become pregnant on all of the following:
(a) The incidence of CMV and cCMV.
(b) The transmission of CMV to pregnant women and women who may become
pregnant.
(c) Birth defects caused by cCMV.
(d) Methods of diagnosing cCMV.
(e) Available preventative measures to avoid the infection of women who
are pregnant or may become pregnant.
(3) The department shall post the information described in subsection
(2) on its website and provide the information to all of the following:
(a) A child care program.
(b) An individual serving as a school nurse.
(c) A person that offers health education in a school district.
(d) A health professional, hospital, local health department, or other
facility that offers care to pregnant women or infants.
(4) As used in this section:
(a) "Child care program" means a child care center, group
child care home, or family child care home licensed under 1973 PA 116, MCL
722.111 to 722.128.
(b) "CMV" means cytomegalovirus.
(c) "cCMV" means congenital cytomegalovirus.