Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO: KRS 13B.050, 194A.030(5), 200.460-200.499, 211.645,
211.647, 213.046(16), 216.2970, 334A
NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires
the secretary of the Cabinet for Health and Family Services to promulgate
administrative regulations necessary to operate the programs and fulfill the
responsibilities vested in the cabinet, to implement programs mandated by
federal law, or to qualify for federal funds. KRS 194A.030 authorizes the
Office for Children with Special Health Care Needs (OCSHCN) to promulgate
administrative regulations as may be necessary to implement and administer its
responsibilities under KRS 200.460 to 200.490. KRS 211.647(3) authorizes OCSHCN
to promulgate administrative regulations establishing standards for infant
audiological assessment and diagnostic centers. KRS 216.2970(1) requires the
OCSHCN to promulgate administrative regulations establishing approved methods
for auditory screening for all infants born in hospitals offering obstetric
services and alternative birthing centers with at least forty (40) births per
year. This administrative regulation establishes standards, eligibility
criteria, application processes, reporting requirements, and appeal rights for
entities seeking designation as approved infant audiological assessment and
diagnostic centers, and identifies approved methods for auditory screening for
newborn infants in hospitals and alternative birthing centers.
Section 1. Definitions.
(1) "AAA Guidelines" means the "Clinical
Guidance Document Assessment of Hearing in Infants and Young Children"
published by the American Academy of Audiology.
(2) "ASHA Guidelines" means the "Guidelines
for the Audiologic Assessment of Children from Birth to 5 Years of Age"
published by the American Speech-Language-Hearing Association.
(3) "Audiologist" is defined by KRS 334A.020(5).
(4) "Audiology extern"
means a student engaged in the clinical experience component of an audiology
doctoral degree program.
(5)
"Auditory brainstem response" or "ABR" means an objective electrophysiologic
measurement of the brainstem's response to the ear when stimulated with a click
sound or tone burst.
(6) "Automated
auditory brainstem response" or "AABR" means an automatic ABR resulting in a
pass/refer outcome.
(7) "JCIH
Guidelines" means "Year 2019 Position Statement: Principles and Guidelines for
Early Hearing Detection and Intervention Programs" published by the Joint
Committee on Infant Hearing.
(8)
"Office" or "OCSHCN" is defined by KRS 211.645(2).
(9) "Otoacoustic emissions" means an
objective physiological test method for measuring responses elicited directly
from the cochlea.
Section
2. Eligibility Criteria for Centers.
(1) In order to be eligible for designation
as a Level 1 infant audiological assessment and diagnostic center, an entity
located in Kentucky shall:
(a) Employ at least
one (1) audiologist who:
1. Is currently
licensed pursuant to KRS Chapter 334A;
2. Has experience testing children in the age
range newborn to three (3) years; and
3.
a.
Performs all evaluations; or
b.
Directly supervises audiology externs performing evaluations;
(b) Possessess the
capacity to complete the following tests:
1.
Otoscopic examination;
2.
Tympanometry;
3. Ipsilateral
acoustic reflex measurement;
4.
Contralateral acoustic reflex measurement;
5. Ear-specific behavioral observation
audiometry;
6. Speech awareness
threshold;
7. Speech recognition or
reception threshold;
8. Play
audiometry; and
9. Either:
a. Otoacoustic emissions with diagnostic or
screening capabilities; or
b. ABR
screening;
(c)
Annually calibrate all measuring and testing equipment; and
(d) Submit a complete application and
assurance packet in accordance with Section 3 of this administrative
regulation.
(2) In order
to be eligible for designation as a Level 2 infant audiological assessment and
diagnostic center, an entity located in Kentucky shall:
(a) Meet the requirements specified in
subsection (1) of this section; and
(b) Possess the capacity to complete:
1. Otoacoustic emissions with diagnostic or
screening capabilities;
2.
Frequency-specific ABR;
3. Bone
conduction ABR; and
4. Real ear
measures.
Section 3. Application Process.
(1) An entity seeking designation as an
infant audiological assessment and diagnostic center shall submit to OCSHCN a
completed application packet containing:
(a)
Completed and signed form OCSHCN-E106, Potential Infant Audiological Assessment
and Diagnostic Center Questionnaire;
(b) Copies of current professional licenses
for audiologists performing evaluations;
(c) Copies of current calibration
certificates for audiological testing equipment; and
(d) Copies of policies and procedures for
tests and measures requested on the OCSHCN-E106, Potential Infant Audiological
Assessment and Diagnostic Center Questionnaire.
(2) OCSHCN shall review an entity's
application within thirty (30) calendar days of receiving a complete packet
submitted in accordance with subsection (1) of this section.
(3) Upon review of an entity's application
packet, OCSHCN's executive director or designee shall approve the entity as a
Level 1 Infant Audiological Assessment and Diagnostic Center if:
(a) The entity meets the requirements
specified in Section 2(1) of this administrative regulation; and
(b) OCSHCN determines that the entity's
policies and procedures conform to best practice standards as described in JCIH
Guidelines and:
1. AAA Guidelines;
or
2. ASHA Guidelines.
(4) Upon review of an
entity's application packet, OCSHCN's executive director or designee shall
approve the entity as a Level 2 Infant Audiological Assessment and Diagnostic
Center if:
(a) The entity meets the
requirements specified in Section 2(2) of this administrative regulation;
and
(b) OCSHCN determines that the
entity's policies and procedures conform to best practice standards as
described in JCIH Guidelines and:
1. AAA
Guidelines; or
2. ASHA
Guidelines.
(5) If OCSHCN's executive director or
designee determines that the entity does not meet the requirements specified in
Section 2 of this administrative regulation, OCSHCN shall:
(a) Advise the entity and request clarifying
information; or
(b) Deny the
designation as an Infant Audiological Assessment and Diagnostic Center and
notify the entity of appeal rights pursuant to Section 8 of this administrative
regulation.
(6)
Approvals shall expire on December 31 of odd-numbered years. All entities
seeking continued approval shall re-apply by December 1 of that year in
accordance with this section.
Section
4. Publication of Approved List.
(1) In accordance with KRS 211.647, OCSHCN
shall maintain a current listing of all approved Infant Audiological Assessment
and Diagnostic Centers, with contact information.
(2) OCSHCN shall make the listing public
through the following methods:
(a) Posting on
its agency Web site,
http://chfs.ky.gov/agencies/ccshcn;
(b) Providing to the Cabinet for Health and
Family Services, Office of Administrative and Technology Services, for
inclusion on the KY-CHILD electronic information system used by birthing
hospitals and centers;
(c)
Enclosing as an attachment to correspondence with parents; and
(d) Mailing a listing to birthing hospitals
and centers upon request.
Section 5. Removal from Approved List and
Updates Required.
(1) OCSHCN shall remove an
entity from the approved list and notify the entity of the removal if the
entity requests removal.
(2) If
OCSHCN receives a complaint that an entity no longer meets the requirements of
Section 2 of this administrative regulation, OCSHCN shall:
(a) Advise the entity of the
complaint;
(b) Request clarifying
information from the entity;
(c)
Review any information received; and
(d) Determine whether the entity meets the
eligibility requirements of Section 2 of this administrative
regulation.
(3) If
OCSHCN determines that the entity no longer meets the eligibility requirements,
the office shall:
(a) Notify the entity of
appeal rights pursuant to Section 8 of this administrative regulation;
and
(b) Remove the entity from the
approved list.
(4)
Following approval, an Infant Audiological Assessment and Diagnostic Center
shall provide documentation via form OCSHCN-E107, Infant Audiological
Assessment and Diagnostic Center Program Modification, if the changes in
circumstances occur:
(a) Employment or
termination of employment of an audiologist;
(b) Change in licensure status of an
audiologist;
(c) Relocation of
agency, name change, or addition of a location; or
(d) Modification to policy or procedure with
regard to evaluations described in Section 2 of this administrative
regulation.
Section
6. Reporting Requirements.
(1)
Upon completion of diagnostic testing of an infant or child aged birth to three
(3) years described in KRS 211.647(5), an approved Infant Audiological
Assessment and Diagnostic Center shall report to OCSHCN via form OCSHCN-E3:
(a) Identifying and demographic
information;
(b) Results of the
follow-up audiological evaluation; and
(c) Documentation of the referral required by
KRS 211.647(5).
(2) An
approved Infant Audiological Assessment and Diagnostic Center shall submit
information specified in subsection (1) of this section electronically via the
KY-CHILD electronic information system for permanent hearing loss, within
forty-eight (48) hours of evaluation, in accordance with KRS 211.647, via form
OCSHCN-E3.
(3) Scheduled
appointments which are not kept by families shall be marked in the KY-CHILD
electronic information system as no-show within four (4) calendar days if not
rescheduled.
Section 7.
Resource and Informational Materials. OCSHCN shall make available to families
of all newborns and children ages birth to three (3) years identified as having
permanent hearing loss information provided by the Kentucky Commission on the
Deaf and Hard of Hearing.
Section
8. Appeal Rights. An entity denied designation as an Infant
Audiological Assessment and Diagnostic Center or which has been removed from
the approved list may request an administrative hearing in accordance with 911 KAR 1:090.
Section 9. Approved
Methods of Auditory Screening for Newborn Infants and Children Ages Birth to
Three (3) Years.
(1) Auditory screenings
pursuant to KRS 216.2970(1) shall include at least one (1) of the following
physiological tests:
(a) AABR; or
(b) Otoacoustic emissions.
(2) Auditory screening reports
shall:
(a) Document the results of
physiological tests conducted;
(b)
Document the presence of any risk factors pursuant to KRS 211.645(5);
and
(c) Be submitted via the
KY-CHILD electronic information system.
Section 10. Incorporation by Reference.
(1) The following material is incorporated by
reference:
(a) "Clinical Guidance Document
Assessment of Hearing in Infants and Young Children", 1/2020;
(b) "OCSHCN-E106, Potential Infant
Audiological Assessment and Diagnostic Center Questionnaire", 6/2022;
(c) "OCSHCN-E107, Infant Audiological
Assessment and Diagnostic Center Program Modification", 6/2022;
(d) "Guidelines for the Audiologic Assessment
of Children From Birth to 5 Years of Age" 2004 American Speech-Language-Hearing
Association;
(e) "Year 2019
Position Statement: Principles and Guidelines for Early Hearing Detection and
Intervention Programs" Joint Committee on Infant Hearing; and
(f) "OCSHCN-E3 Audiology Update Form (AUF)
Worksheet", 6/2022.
(2)
This material may be inspected, copied, or obtained, subject to applicable
copyright law, at the Office for Children with Special Health Care Needs, 310
Whittington Parkway, Suite 200, Louisville, Kentucky 40222, Monday through
Friday, 8 a.m. to 4:30 p.m. or online at the agency's Web site at
https://chfs.ky.gov/agencies/ccshcn.
STATUTORY AUTHORITY: KRS 194A.030(5), 194A.050(1),
211.647(3), 216.2970(1)