2014 Indiana Code TITLE 16. HEALTH ARTICLE 41. PUBLIC HEALTH MEASURES FOR THE PREVENTION AND CONTROL OF DISEASE CHAPTER 17. PREVENTION AND TREATMENT PROGRAMS: EXAMINATION OF INFANTS FOR PHENYLKETONURIA, HYPOTHYROIDISM, AND OTHER DISORDERS
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IC 16-41-17
Chapter 17. Prevention and Treatment Programs:
Examination of Infants for Phenylketonuria, Hypothyroidism,
and Other Disorders
IC 16-41-17-1
Waste blood specimen
Sec. 1. As used in this chapter, "waste blood specimen" means a
blood sample or a solid, liquid, or semiliquid blood product that:
(1) has served the intended purpose under section 4 of this
chapter; or
(2) has served the natural, biological, medical, or intended
purpose and has been discarded or accumulated for discard from
a use other than as provided under section 10(a)(5) of this
chapter.
As added by P.L.2-1993, SEC.24.
IC 16-41-17-2
Examinations; religious exemption
Sec. 2. (a) Subject to subsection (d), every infant shall be given
examinations at the earliest feasible time for the detection of the
following disorders:
(1) Phenylketonuria.
(2) Hypothyroidism.
(3) Hemoglobinopathies, including sickle cell anemia.
(4) Galactosemia.
(5) Maple Syrup urine disease.
(6) Homocystinuria.
(7) Inborn errors of metabolism that result in mental retardation
and that are designated by the state department.
(8) Congenital adrenal hyperplasia.
(9) Biotinidase deficiency.
(10) Disorders detected by tandem mass spectrometry or other
technologies with the same or greater detection capabilities as
tandem mass spectrometry, if the state department determines
that the technology is available for use by a designated
laboratory under section 7 of this chapter.
(b) Subject to subsection (d), every infant shall be given a
physiologic hearing screening examination at the earliest feasible
time for the detection of hearing impairments.
(c) Beginning January 1, 2012, and subject to subsection (d),
every infant shall be given a pulse oximetry screening examination
at the earliest feasible time for the detection of low oxygen levels.
Section 10(a)(2) of this chapter does not apply to this subsection.
(d) If a parent of an infant objects in writing, for reasons
pertaining to religious beliefs only, the infant is exempt from the
examinations required by this chapter.
As added by P.L.2-1993, SEC.24. Amended by P.L.91-1999, SEC.2;
P.L.149-2001, SEC.3; P.L.229-2011, SEC.165.
IC 16-41-17-3
Educational program
Sec. 3. The state department shall conduct an intensive educational
program among physicians, hospitals, public health nurses, and the
public concerning the disorders listed in section 2 of this chapter. The
educational program must include information about:
(1) the nature of the disorders; and
(2) examinations for the detection of the disorders in infancy;
so that measures may be taken to prevent the mental retardation,
medical complications, or mortality resulting from the disorders.
As added by P.L.2-1993, SEC.24.
IC 16-41-17-4
Tests
Sec. 4. After consultation with medical authorities, the state
department shall require appropriate tests to be used in the detection
of disorders listed in section 2 of this chapter.
As added by P.L.2-1993, SEC.24.
IC 16-41-17-5
Detection plans and procedures
Sec. 5. The state department and all local boards of health shall
encourage and promote the development of plans and procedures for
the detection of the disorders listed in section 2 of this chapter in all
local health jurisdictions of Indiana.
As added by P.L.2-1993, SEC.24.
IC 16-41-17-6
Reports
Sec. 6. (a) The state department shall provide forms on which the
results of tests performed on each child for the disorders listed in
section 2 of this chapter shall be reported to the state department by
physicians and hospitals.
(b) The state department shall ascertain at least quarterly the extent
of such testing and the findings shall be reported to all hospitals,
physicians, and other groups interested in child welfare.
As added by P.L.2-1993, SEC.24.
IC 16-41-17-7
Testing laboratories
Sec. 7. (a) The state department shall designate at least one (1)
laboratory for testing for disorders listed in section 2(a) of this
chapter.
(b) The designated laboratories shall perform tests on all infants
for the detection of disorders under section 2(a) of this chapter.
(c) This section does not prevent other facilities from conducting
tests for disorders under this chapter.
As added by P.L.2-1993, SEC.24. Amended by P.L.91-1999, SEC.3.
IC 16-41-17-8
Blood samples
Sec. 8. Each hospital and physician shall:
(1) take or cause to be taken a blood sample from every infant
born under the hospital's and physician's care; and
(2) transport or cause to be transported each blood sample
described in subdivision (1) to a laboratory designated under
section 7 of this chapter;
for testing for the disorders listed in section 2(a) of this chapter.
As added by P.L.2-1993, SEC.24. Amended by P.L.91-1999, SEC.4.
IC 16-41-17-9
Rules
Sec. 9. The state department shall adopt rules under IC 4-22-2 to
carry out this chapter, including rules to ensure the following:
(1) Proper and timely sample collection and transportation under
section 8 of this chapter.
(2) Quality testing procedures at the laboratories designated
under section 7 of this chapter.
(3) Uniform reporting procedures.
(4) Centralized coordination, tracking, and follow-up.
(5) Appropriate diagnosis and management of affected
newborns and counseling and support programs for newborns'
families.
As added by P.L.2-1993, SEC.24.
IC 16-41-17-10
Follow-up programs; newborn screening fees; waste blood
specimen confidentiality
Sec. 10. (a) The state department shall develop the following:
(1) A registry for tracking and follow-up of all newborns and
individuals for screening.
(2) A centralized program that provides follow-up, diagnosis,
management, and family counseling and support, including
equipment, supplies, formula, and other materials, for all infants
and individuals identified as having one (1) of the disorders
listed in section 2 of this chapter.
(3) A laboratory quality assurance program, including
proficiency testing.
(4) A statewide network of genetic evaluation and counseling
services.
(5) A system for using, for epidemiological survey and research
purposes, any waste blood specimen generated under this
chapter.
(b) The program described in subsection (a) shall be funded by
collection of a newborn screening fee for each newborn screened by
a designated laboratory.
(c) The state department shall set the fee and procedures for
disbursement under rules adopted under IC 4-22-2. The fee must be
based upon the projected cost of the program. The proposed fee must
be approved by the budget agency before the rule is adopted.
(d) The designated laboratory shall assess, collect, and deposit the
fees established under subsection (c) in the newborn screening fund
established under section 11 of this chapter.
(e) The state department shall annually review the newborn
screening fee.
(f) Waste blood specimens used for the purpose of implementing
the system described under subsection (a)(5) may not include the
name or other identifying characteristics that would identify the
individual submitting the specimen.
As added by P.L.2-1993, SEC.24.
IC 16-41-17-11
Newborn screening fund
Sec. 11. (a) The newborn screening fund is established for the
purpose of carrying out this chapter. The state department shall
administer the fund.
(b) The expenses of the newborn screening program shall be paid
from money in the fund.
(c) Money in the fund at the end of a state fiscal year does not
revert to the state general fund.
As added by P.L.2-1993, SEC.24.
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