Title 911 | Chapter 001 | Regulation 085
PREVIOUS VERSION
The previous document that this document is based upon is available.
911 KAR 1:085.Early Hearing Detection and Intervention Program.
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; and3.
a.
Performs all evaluations; orb.
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; and9.
Either:a.
Otoacoustic emissions with diagnostic or screening capabilities; orb.
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; and4.
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; or2.
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; or2.
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.HISTORY: (27 Ky.R. 2013; Am. 2469; eff. 3-6-2001; Recodified from 902 KAR 4:085, 8-10-2001; 36 Ky.R. 698; 1228; eff. 1-4-2010; 41 Ky.R. 1226; 1658; eff. 2-5-2015; TAm eff. 8-29-2019; 49 Ky.R. 1366, 1799; eff. 3-16-2023.)
FILED WITH LRC: February 14, 2023
CONTACT PERSON: Krista Quarles, Policy Analyst, Office of Legislative and Regulatory Affairs, 275 East Main Street 5 W-A, Frankfort, Kentucky 40621; phone 502-564-6746; fax 502-564-7091; email CHFSregs@ky.gov.
911 KAR 1:085.Early Hearing Detection and Intervention Program.
Section 1.
Definitions.(1)
"AAA Guidelines" means the "Clinical Guidance Document Assessment of Hearing in Infants and Young Children"(2)
"ASHA Guidelines" means the "Guidelines for the Audiologic Assessment of Children from Birth to 5 Years of Age"(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(8)
"Office(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; and3.
a.
Performs all evaluations; orb.
Directly supervises audiology externs performing evaluations;(b)
Possessess1.
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; and9.
Either:a.
Otoacoustic emissions with diagnostic or screening capabilities; orb.
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; and4.
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(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(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; or2.
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; or2.
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(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(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(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 1:090Section 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(c)
"OCSHCN-E107(d)
"Guidelines for the Audiologic Assessment of Children From Birth to 5 Years of Age"(e)
"Year 2019(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.HISTORY: (27 Ky.R. 2013; Am. 2469; eff. 3-6-2001; Recodified from 902 KAR 4:085, 8-10-2001; 36 Ky.R. 698; 1228; eff. 1-4-2010; 41 Ky.R. 1226; 1658; eff. 2-5-2015; TAm eff. 8-29-2019; 49 Ky.R. 1366, 1799; eff. 3-16-2023.)
FILED WITH LRC: February 14, 2023
CONTACT PERSON: Krista Quarles, Policy Analyst, Office of Legislative and Regulatory Affairs, 275 East Main Street 5 W-A, Frankfort, Kentucky 40621; phone 502-564-6746; fax 502-564-7091; email CHFSregs@ky.gov.