State of Wyoming
Department of Health
Community and
Rural Health Division
Maternal and Family
Health Section
Rules and Regulations for Mandatory Screening of
Newborn Infants for Inborn Errors of Metabolism and Hearing
Brent D. Sherard, M.D., M.P.H.
Director and State Health Officer
February
2007
State of Wyoming
Department of Health
Rules and Regulations for
Mandatory Screening of
Newborn Infants for Inborn Errors of Metabolism and Hearing
Rules and Regulations for Mandatory
Screening of Newborn Infants for Inborn Errors of Metabolism and Hearing
Community and Rural Health Division
Maternal and Family Health Section
Additional information
and copies may be obtained from:
Community and Rural
Health Division
Maternal and Family
Health Section
6101 N. Yellowstone
Rd., Ste. 420, Cheyenne, WY 82002
Telephone: (307) 777-7941
Facsimile: (307)
777-7215
E-Mail Address: csh@state.wy.uscshinfo@health.wyo.gov
This document is
available in alternative format upon request.
Mandatory
Screening of Newborn Infants for Inborn Errors of Metabolism and Hearing
Intent to Adopt
Statement of
Reasons
The following rules consist
of Chapters 1, Mandatory Screening of Newborn
Infants for Inborn Errors of Metabolism, and Chapter 2,
Mandatory Screening of Newborn Infants for Inborn Errors of Hearing which
replace existing Chapter 1, Mandatory Screening of Newborn Infants for Inborn
Errors of Metabolism. The purpose of these Rrules
is to comply with Enrolled Act 9182, Senate File
# 003786,
which provides for mandatory screening for detection of metabolic diseases and
hearing defects in newborn children. These Rrules
are authorized by W.S. 35-4-801 and W.S. 35-4-802,
as amended.
The Wyoming Department of
Health proposes to adopt the following Amended Rule to
comply with the provisions of W.S. 35-4-801, Chapters 1 and 2. Wyoming
Statute 35-4-801 states “Screening
required for detection of metabolic diseases and hearing defects in newborn
children; conduct of screening; exceptions; fees”. The
Wyoming Department of Health, Wyoming Newborn Metabolic Screening
Program, is authorized to make any changes necessary to
continue to meet the healthcare needs of Wyoming newborn infants.
The Wyoming Department of
Health is amending these Rules due to the
assessments of fees payable to
the Wyoming Newborn Metabolic Screening
Program, approved by legislation, which will cover the
reasonable costs of metabolic and hearing screenings required by this statute.
The Wyoming Newborn Metabolic Screening Program recommended
these fees begin August 1, 2007. This change
will impact both budgets, promoting greater utilization of the metabolic and
hearing programs.
The Rules will
modify the procedure and assure the newborn hearing and metabolic screening
programs remain sustainable by allowing for fees to be charged for these
services. The fee assessed for the hearing screening will be separate from the
fee for the metabolic screening.
As required by W.S. 35-4-801
(d)16-3-103(a)(i)(G), the changes to W.S.
35-4-801 and W.S. 35-4-802, Mandatory
Screening of Newborn Infants for Inborn Errors of Metabolism and Hearing Rules
and Regulations for Wyoming Department of Health meet
minimum substantive state statutory requirements.
Mandatory Screening of Newborn Infants for
Inborn Errors of Metabolism and Hearing
CHAPTER 1
|
Section 1.
|
Authority
|
1-1
|
|
Section 2.
|
Purpose and
Applicability
|
1-1
|
|
Section 3.
|
General Provisions
|
1-1
|
|
Section 24.
|
Definitions
|
1-1
|
|
Section 35.
|
Consent for Screening
|
1-12
|
|
Section 46.
|
Blood Collection
|
1-2
|
|
Section 57.
|
Second Test
|
1-2
|
|
Section 68.
|
Fees
|
1-3
|
CHAPTER 2
|
Section 1.
|
Hearing ScreeningAuthority
|
2-1
|
|
Section 2.
|
Purpose and
Applicability
|
2-1
|
|
Section 3.
|
General Provisions
|
2-1
|
|
Section 4.
|
Hearing Screening
|
2-1
|
|
Section 25.
|
Chronology of Newborn Hearing Screening
|
2-2
|
|
Section 36.
|
Rescreening
|
2-2
|
|
Section 47.
|
Method of Screening
|
2-2
|
|
Section 58.
|
Criteria to Pass Hearing Screening
|
2-23
|
|
Section 69.
|
Consent for Newborn Hearing Screening
|
2-3
|
|
Section 710.
|
Fees
|
2-3
|
MANDATORY SCREENING OF NEWBORN INFANTS FOR INBORN ERRORS OF
METABOLISM
CHAPTER 1
Section 1. Authority. The statutory
authority for these regulations is contained in W.S. 35-4-801 and 35-4-802. The
Statute and Regulations are administered by the Wyoming Department
of Health.
Section 2. Purpose
and Applicability.
(a) This chapter defines the process for the
mandatory newborn metabolic screening for infants.
(b) The
Department may issue materials to providers and/or other affected parties to
interpret the provisions of this Chapter. Such materials shall be consistent
with and reflect the rules and regulations contained within this Chapter. The
provisions contained in the materials shall be subordinate to the provisions of
this Chapter.
Section 3. General
Provisions. Except as otherwise specified, the terminology used
in this Chapter is the standard terminology and has the standard meaning used
in accounting and healthcare, including newborn metabolic and hearing
screening.
Section 24.
Definitions. The following
definitions shall apply in the interpretation and enforcement of these Rules.
Where the context in which words are used in these rules indicates that such is
the intent, words in singular number shall include the plural and vice versa. Specific
genetic and metabolic tests to be done in Wyoming as by the committee
designated in W.S. 35-4-801, Section (b),
are as follows:
(a) “Phenylketonuria
(PKU).” Genetic metabolic disorder characterized by abnormal phenylalanine
metabolism determined.
(b) “Hypothyroidism.”
Metabolic disorder caused by inadequate production or secretion of thyroid
hormone.
(c) “Galactosemia.”
Genetic metabolic disorder characterized by abnormal galactose metabolism.
(d) “Hemoglobinopathies.”
Group of genetic diseases including sickle cell anemia, characterized
by the abnormal production and function of hemoglobin.
(e) “Cystic
Fibrosis.” Genetic disorder characterized by dysfunction of one or more
exocrine systems.
(f) “Biotinidase
Deficiency.” Genetic metabolic disorder characterized by abnormal biotinidase
production.
(g) Any other
genetic metabolic disease for which testing may hereinafter be required on the
basis of action taken by the designated committee.
Section 35.
Consent for Screening. Consent for screening can be from natural
parents, either custodial parent, a sole guardian, single parent having custody,
orprospective
adoptive parents or parent of whom the child’s custody has been released. No
test shall be performed until the written consent of the natural parents, orthe
custodial parent, orthe guardian,
or the adoptive parents is obtained. If any parent or guardian objects to the
mandatory testing for a child, then his the
objection shall be in written form and the child isexempt from
such testing.
Section 46.
Blood Collection.
(a) The optimal
timing for newborn screening in full-term healthy infants is between 48 and 72
hours of
age. In early discharge, the blood
should be collected as late as possible before discharge, but no later
than 72 hours of age.
(b) Any newborn
infants requiring exchange transfusions shall have the blood sample for these
tests taken prior to the exchange transfusion.
(c) If the child
is not born in a hospital, the attending physician, midwife, or person
attending the delivery shall arrange to have the blood sample taken by a
physician, hospital personnel, laboratory personnel, or local public health
representative.
(d) If the child
is to be transferred to another hospital, the transferring hospital shall
conduct the newborn screen prior to discharge, or make
arrangements with the receiving hospital to conduct the screen.
(e) Collection
forms provided by the Department of Health shall be completed for each blood
sample. Each sample shall be sent to the regional laboratory within 24 hours
from the time that the sample was collected.
(f) Hospitals
will record numbers of births and numbers of infants screened. The hospital
record will include the number of infants not screened and the reason why the
screening was not performed. Reports will be made to the Department of Health
on request, not less than once yearly.
(g) The Department
of Health will provide information brochures and consent forms on request.
Section 57.
Second Test. If the initial screen was conducted prior to 24
hours of age, a second (or follow-up) blood sample should be collected when the
infant is approximately ten (10) days to two (2) weeks of age,
and may be collected at a hospital laboratory, physician’s office,
or local public health facility.
Section 68. Fees.
The
Wyoming Department of Health will assess all hospitals a
fee of $70.00 for the initial newborn metabolic screen. Said amount is
assessed to cover the costs of metabolic screening, follow-up care, genetic
counseling, and educational programs and functions. The fees collected also
cover costs associated with handling of specimens, reimbursement of laboratory
costs, and costs of providing other services necessary to maintain
functionality and sustainability of this self-funded program. The Wyoming
Department of Health, in consultation with the designated committee, may
increase the above assessment, if it is determined that the costs of the
program necessitate such increase, but in no instance may this fee be increased
more than ten percent (10%).
MANDATORY SCREENING OF NEWBORN INFANTS FOR INBORN ERRORS OF
HEARING
CHAPTER 2
Section 1. Authority.
The
statutory authority for these regulations is contained in W.S. 35-4801 and
35-4-802. The Statute and Regulations are administered by the Wyoming Department
of Health.
Section 2. Purpose
and Applicability.
(a) This Chapter
defines the process for the mandatory newborn hearing screening for infants.
(b) The Department may
issue materials to providers and/or other affected parties to interpret the
provisions of this Chapter. Such materials shall be consistent with and
reflect the rules and regulations contained within this Chapter. The
provisions contained in the materials shall be subordinate to the provisions of
this Chapter.
Section 3. General
Provisions. Except as otherwise
specified, the terminology used in this Chapter is the standard terminology and
has the standard meaning used in accounting and healthcare, including newborn
metabolic and hearing screening.
Section 14. Hearing
Screening.
(a)
Hearing screening shall be given to every child born in the State of
Wyoming.
(b) If the child
is not born in a hospital, the attending physician, midwife, or person
attending the delivers shall offer to arrange a hearing screening for the child
at a Wyoming birthing hospital.
(c) If a newborn
is transferred to another Wyoming birthing hospital, the hospital that
discharges the child shall be responsible for iensuring
that the hearing screening takes place. If a Wyoming resident newborn is
transferred to a hospital outside if Wyoming, the discharging Wyoming hospital
shall iensure
that hearing screening takes place either prior to discharge or upon the
infant’s return to Wyoming.
(d) Newborn
hearing screening and/or re-screenings may be delayed
due to transfers and/or medical contraindications. The
hospital must document the delays, and iensure
hearing screening has taken place prior to ultimate discharge.
(e) All screening
results shall be reported at least monthly to the State Wyoming
Department of Health and be reviewed by a State approved audiology consultant. The
reported data shall include.:
(i) total number of births;
(ii) the
number of newborns initially screened before discharge;
(iii) the
number of newborns rescreened upon returning to the hospital;
(iv) the
pass-fail results of all screenings;
(v) the number of newborns not screened due to parental/legal
guardian waiver, medical contraindications, or lost to follow-up;
and
(vi)
any other screening results deemed as useful by the State Wyoming
Department of Health.
(e)
Each birthing hospital shall establish a system to facilitate the
referral for diagnostic audiological assessment for neonates who fail the
newborn hearing screening. This includes, but is not limited to:
(i)
Written notification to the primary care physician that the child has
failed the newborn hearing screening and that diagnostic audiological
assessment is recommended;
and
(ii) Written
notification to the parent(s)/legal guardian(s) that the child has
failed the newborn hearing screening, that diagnostic
audiological assessment is recommended, and that the primary
care physician has been notified.
Section
25. Chronology
of Newborn Hearing Screening.
(a) Each
newborn’s hearing shall be screened before discharge from the hospital.
(b) If
a newborn fails the first screening, the screening procedure shall be
immediately repeated before
discharge from the hospital.
Section
36. Rescreening.
(a) Each
newborn failing both initial screen(s) will be rescreened within seven
(7)
to
ten
(10)
days of the initial screen(s).
Section
47. Method
of Screening.
(a) Newborn
screening and the documentation and dissemination of screening results shall be
done by trained personnel, under the supervision of a State approved audiology
consultant. Training procedure information will
be audiologically approved and accepted.
(b) All
screenings shall involve both ears.
(c) Birthing
hospitals shall use one of the following screening methods:
(i) Auditory Brainstem Responses (ABR);
(ii) Automated Auditory Brainstem Responses
(AABR); or
(iii) Otoacoustic Emissions (OAE), either
Transient Evoked OAE (TEOAE) or
Distortion pProduct
OAE (DPOAE).
(d) Instrumentation,
electrode array, and transducer arrangements shall be in accordance with recommendations/specifications
from the manufacturer of the screening device.
Section
58. Criteria
to Pass Hearing Screening.
(a) Normal
ABR for click stimuli at 35 dBnHL (decibels of normal hearing levels) or less
in each ear; or
(b) Normal
TEOAE for click stimulus at 84 dBSPL (decibels of sound pressure levels)
presentation
level or less in each ear; or
(c) Normal
DPOAE for 1500-6000 Hz (hertz) stimuli at 65-55 dBSPL or less in each ear.
Section
69. Consent
for Newborn Hearing Screening.
(a) Parental/legal
guardian consent for screening shall be obtained pursuant to rules
and regulations outlined in Section 3, Chapter 1, Rules and Regulations of for Mandatory
Screening of Newborn Infants for Inborn Errors of Metabolism.
Section 10. Fees.
The
Wyoming Department of Health will assess all hospitals a
fee of $50.00 for the initial newborn hearing screen. Said amount is assessed
to cover the costs of hearing screening, follow-up care, and referrals when the
initial screen detects a potential abnormality, screening equipment costs and
educational programs and training. The assessed fees will only be used to
provide the services necessary to maintain functionality and sustainability of
the Early Hearing Detection and Intervention Program, which is a self-funded
program. The Wyoming Department of Health, in consultation with the designated
committee, may increase the above assessment, if it is determined that the
costs of the program necessitate such increase, but in no instance may this fee
be increased more than ten percent (10%).
