DAR File No. 43226

Health, Family Health and Preparedness, Children with Special Health Care Needs

Rule R398-2

Newborn Hearing Screening

Notice of Proposed Rule

(Amendment)

DAR File No.: 43226
Filed: 09/28/2018 11:59:51 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

With changes in the federal terminology to the newborn hearing screening requirements, these rule changes will update terminology to be consistent with the federal changes, create consistency with word usage, and clarify follow up and reporting timelines.

Summary of the rule or change:

These changes update terminology to be consistent with the federal changes in newborn hearing screening requirements. The current practice is to use deaf or hard of hearing instead of hearing loss. These changes also create consistency with word usage, and clarify follow up and reporting timelines.

Statutory or constitutional authorization for this rule:

• Section 26-10-6

Anticipated cost or savings to:

the state budget:

May have a minimal cost if reprinting of rule is needed.

local governments:

No cost to local governments as these rule changes have been standard practice for the past several years.

small businesses:

No cost to small businesses as these rule changes have been standard practice for the past several years.

persons other than small businesses, businesses, or local governmental entities:

No cost to individuals as these rule changes have been standard practice for the past several years.

Compliance costs for affected persons:

There are no costs for affected persons as these rule changes have been standard practice for the past several years.

Comments by the department head on the fiscal impact the rule may have on businesses:

These proposed changes update terminology to be consistent with federal changes, create consistency with word usage, and clarify follow-up and reporting timelines. There is no fiscal impact to businesses.

Joseph K. Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Health
Family Health and Preparedness, Children with Special Health Care Needs
44 N MARIO CAPECCHI DR
SALT LAKE CITY, UT 84113

Direct questions regarding this rule to:

• Joyce McStotts at the above address, by phone at 801-584-8239, by FAX at 801-584-8488, or by Internet E-mail at [email protected]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

11/14/2018

This rule may become effective on:

11/21/2018

Authorized by:

Joseph Miner, Executive Director

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs	FY 2019	FY 2020	FY 2021
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Person	$0	$0	$0
Total Fiscal Costs:	$0	$0	$0
Fiscal Benefits
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Persons	$0	$0	$0
Total Fiscal Benefits:	$0	$0	$0
Net Fiscal Benefits:	$0	$0	$0

 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described in the narrative. Inestimable impacts for Non - Small Businesses are described in Appendix 2.

 

Appendix 2: Regulatory Impact to Non - Small Businesses

These rule changes are not expected to have any fiscal impact on non-small businesses' revenues and expenditures because the reporting requirements remain the same. These rule changes update terminology, create consistency with word usage, and clarify follow up and reporting timelines.

 

These rule changes are not expected to have any fiscal impact on hospitals, primary care providers, or audiologists as this has been the standard of practice for the past several years. With changes in the Federal terminology to the newborn hearing screening requirements, these rule changes will update terminology to be consistent with these Federal changes, create consistency with word usage, and clarify follow up and reporting timelines.

 

 

R398. Health, Family Health and Preparedness, Children with Special Health Care Needs.

R398-2. Newborn Hearing Screening : Early Hearing Detection and Intervention (EHDI) Program.

[R398-2-1. Purpose and Authority.

(1) The purpose of this rule is to facilitate early detection, prompt referral, and early habilitation of infants with significant, permanent hearing loss.

(2) Authority for the Newborn Hearing Screening program and promulgation of rules to implement the program are found in Section 26-10-6.]

R398-2-1. Authority and Purpose.

(1) Authority for the Newborn Hearing Screening: Early Hearing Detection and Intervention program and promulgation of rules to implement the program are found in Section 26-10-6.

(2) The purpose of this rule is to facilitate early detection, prompt referral, and early intervention of infants who are deaf or hard of hearing.

 

R398-2-2. Definitions.

[(8)](1) "Audiologist" means a person who is licensed by the state where services are provided and has expertise in infant and pediatric audiology.

[(3)](2) "Auditory brainstem response" means an objective electrophysiologic measurement of the brainstem's response to acoustic stimulation of the ear.

[(4)](3) "Automated auditory brainstem response" means objective electrophysiologic measurement of the brainstem's response to acoustic stimulation of the ear, obtained with equipment which automatically provides a pass/refer outcome.

[(1)](4) "[Hearing loss]Deaf or Hard of Hearing" means a dysfunction of the auditory system of any type or degree that is sufficient to interfere with the acquisition and development of speech and language skills.

[(7)](5) "Department" means the Utah Department of Health , Newborn Hearing Screening: Early Hearing Detection and Intervention (EHDI) program.

(6) "Diagnostic procedures" means audiometric and medical procedures required to diagnose [hearing loss.]an infant as deaf or hard of hearing.

(7) "Early intervention" means auditory habilitation and/or enrollment into a formal early intervention program.

[(5)](8) "Evoked otoacoustic emissions" means an [specific]objective test method which elicits a physiologic response from the cochlea, and may include Transient Evoked Otoacoustic Emissions and Distortion Products Otoacoustic Emissions test procedures.

(9) "Follow-up" means appropriate services and procedures relating to the confirmation of hearing [loss]status and appropriate referrals for [newborn children]infants with abnormal or inconclusive screening or diagnostic results.

[(13)](10) "Institution" means a facility licensed by the State of Utah for birthing babies.

[(12)](11) "Lost to follow-up" means [those newborns]infants who cannot be identified through tracking, and who have not completed the screening, diagnostic [and]or early intervention referral processes.

[(2)](12) " Newborn Hearing Screening" means the completion of an objective, physiological test or battery of tests administered to determine the infant's hearing status and the need for further diagnostic testing by an audiologist with expertise in infant and pediatric audiology or physician with the Department approved instrumentation, protocols and pass/refer criteria.

[(15)](13) "Parent" means a natural biological parent, a step-parent, adoptive parent, legal guardian, or other legal custodian of a child.

(14) "Primary care provider" means the [newborn or ]infant's primary medical caregiver.

[(10)](15) "Referral" means to direct a n [newborn]infant to an [health care professional]audiologist or physician for appropriate diagnostic procedures to diagnose and determine [the existence and extent of a hearing loss;]hearing status and for appropriate [habilitation of a hearing loss.]early intervention.

[(11)](16) "Tracking" means the use of information about the infant's newborn hearing screening status to ensure [that ]the infant receives timely and appropriate services to complete the screening, diagnostic and early intervention referral processes.

 

R398-2-3. Implementation.

Each newborn in the state of Utah shall submit to the Newborn Hearing Screening testing, except as provided in Section 26-10-6(1).

 

R398-2-4. Responsibility for Screening.

(1) Each institution shall designate a person to be responsible for the newborn hearing screening program in that institution.

(2) An audiologist who is licensed by the State of Utah shall oversee each newborn hearing screening program. This audiologist may be full or part time, on or off site, an employee of the institution, or under contract or other arrangement that allows him/her to oversee the newborn hearing screening program. This audiologist shall advise the institution about all aspects of the newborn hearing screening program, including screening, tracking, follow-up, and referral for diagnosis.

(3) [Beginning July 1, 1998, if the newborn is born in an institution with 100 or more births annually, and beginning July 1, 1999, if the newborn is born in an institution with less than 100 births annually, the]The institution must provide newborn hearing screening services as required by this rule prior to discharge, unless the infant is transferred to another institution before screening is completed.

(4) [Beginning July 1, 1998, if]If the [newborn]infant is transferred to another institution before screening is completed, the receiving institution must provide hearing screening services as required by this rule prior to discharge.

(5) [Beginning July 1, 1999, if]If the [newborn]infant is born outside of an institution, the person in attendance at the birth must perform or arrange for the infant's hearing screening before 14 days of age as required by this rule.

(6) [Beginning July 1, 1999, if]If there is no person in attendance at the birth, a parent must have the infant's hearing screened, according to Department protocols, [by the time]before the infant is [one month]14 days of age.

(7) Newborn hearing screening shall be performed by a person who is appropriately trained and supervised, according to [rules]protocols as [may be ]established by the Department with input from Newborn Hearing Screening Committee.

 

R398-2-5. Information to Parents and Primary Care Providers.

(1) Institutions or persons primarily responsible for births shall provide information about newborn hearing screening to parents and primary care providers of [newborns]infants. This shall include:

(a) information, which shall be available to parents at the time of birth, about the purpose of newborn hearing screening, the procedures used for screening, the benefits of newborn hearing screening;[, and the consequences of hearing loss;]

(b) whether each live birth was screened prior to discharge from the institution[,];

(c) the results of the completed newborn hearing screening procedure;

(d) what follow-up screening procedures, if any, are recommended and where those procedures can be obtained[.]; and

(e) cytomegalovirus testing when appropriate.

(2) For [babies]infants who require additional procedures to complete the screening after being discharged from the birthing institution, the institution shall provide parents and the primary care providers with written notice about the availability and importance of the additional screening procedures. For [babies]infants who do not complete additional hearing screening procedures, the institution shall send a second written notice to the parents and the primary care provider.

(3) For [babies]infants who do not pass the complete newborn hearing screening procedure, the institution or the provider who completes the newborn hearing screening procedure shall provide the parents and the primary care provider with written notice about the results of the screening, recommended diagnostic procedures, where those procedures can be obtained, and resources available for infants and toddlers [with hearing loss]who are deaf or hard of hearing.

(4) For [babies]infants who need additional procedures to complete the screening due to a missed test, inconclusive results, or a failure to pass, and who do not return for the needed newborn hearing screening procedures [within 15]before 14 days of age, or for [babies]infants who are "lost to follow-up," the institution or the person in attendance at birth shall make reasonable efforts [within 30 days ]to locate the parents and inform them of the need for [a] testing. To be considered a reasonable effort, the institution must have documentation of at least two attempts to contact the infant's parents by mail or phone, and at least one attempt to contact the infant's primary care provider. If necessary, the institution must use information available from its own records, adoption agencies, and the [newborn's]infant's primary care provider. Contact with the parent may be made by mail, email, telephone, text, primary care provider, or public health worker.

 

R398-2-6. Reporting to Utah Department of Health.

(1) All institutions or persons in attendance at births shall submit information to the Department about the newborn hearing screening procedures being used, the results of the screening, and other information necessary to ensure timely referral where necessary. This information shall be provided to the Department at least [monthly]weekly. This information shall include:

(a) for each live birth, identifying information for the [baby]infant (last name, date of birth, Newborn screening kit number, birth mother's first and last name and/or other information as determined by the Department) and the hearing screening status, e.g., passed, referred, inconclusive, refused, missed, transferred , deceased;

(b) for [babies]infants who did not pass the newborn hearing screening or who were not screened, [the mother's name]this additional information is required: primary contact's first and last name, address, telephone number[if known], and primary care provider 's first and last name, and/or other information as determined by the Department;

(c) any information the institution or practitioner has about the results of follow-up screening, [or ]diagnostic procedures, and cytomegalovirus lab results; including whether the infant has been "lost to follow-up."

(2) All institutions or persons in attendance at births shall submit information to the Department a summary of the procedures used by the institution or screening program to do newborn hearing screening, including the name of the program director, equipment, screening protocols, referral criteria, and parent education materials and other information as determined by the Department. This information shall be provided to the [Utah ]Department [of Health ]bi-annually and within 30 days of any changes to the existing procedures.

(3) Persons who conduct any procedure necessary to complete an infant's hearing screening or audiological diagnostic assessment as a result of a referral from an institution, birth attendant, audiologist or primary care provider, shall report the results of these procedures to the institution where the infant was born and to the Department within 7 days.

(4) The [Utah ]Department [of Health ]shall have access to infant[']s ' medical, diagnostic, and early intervention records to obtain information necessary to ensure the provision of timely and appropriate follow-up diagnostic and intervention services.

 

R398-2-7. Confidentiality of Reported Information.

(1) All information reported to the Department under this rule is confidential and not open to public inspection. The confidentiality of personal information obtained under this rule shall be maintained according to the provisions of Utah Code, Title 26, Chapter 3.

(2) Persons who report information covered by this rule, either voluntarily or as required by rule, may not be held liable for reporting the information to the Department, as provided in Title 26, Chapter 25.

 

R398-2-[7]8. Penalty for Violation of Rule.

Any person who violates any provision of this rule may be assessed a penalty as provided in Section 26-23-6.

 

KEY: newborn hearing screening

Date of Enactment or Last Substantive Amendment: [March 15, 2010]2018

Notice of Continuation: June 19, 2018

Authorizing, and Implemented or Interpreted Law: 26-10-6