Utah Administrative Code
The Utah Administrative Code is the body of all effective administrative rules as compiled and organized by the Division of Administrative Rules (see Subsection 63G-3-102(5); see also Sections 63G-3-701 and 702).
NOTE: For a list of rules that have been made effective since October 1, 2019, please see the codification segue page.
NOTE TO RULEFILING AGENCIES: Use the RTF version for submitting rule changes.
R398. Health, Family Health and Preparedness, Children with Special Health Care Needs.
Rule R398-2. Newborn Hearing Screening: Early Hearing Detection and Intervention (EHDI) Program.
As in effect on October 1, 2019
Table of Contents
- R398-2-1. Authority and Purpose.
- R398-2-2. Definitions.
- R398-2-3. Implementation.
- R398-2-4. Responsibility for Screening.
- R398-2-5. Information to Parents and Primary Care Providers.
- R398-2-6. Reporting to Utah Department of Health.
- R398-2-7. Confidentiality of Reported Information.
- R398-2-8. Penalty for Violation of Rule.
- Date of Enactment or Last Substantive Amendment
- Notice of Continuation
- Authorizing, Implemented, or Interpreted Law
(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.
(1) "Audiologist" means a person who is licensed by the state where services are provided and has expertise in infant and pediatric audiology.
(2) "Auditory brainstem response" means an objective electrophysiologic measurement of the brainstem's response to acoustic stimulation of the ear.
(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.
(4) "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.
(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 an infant as deaf or hard of hearing.
(7) "Early intervention" means auditory habilitation and/or enrollment into a formal early intervention program.
(8) "Evoked otoacoustic emissions" means an 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 status and appropriate referrals for infants with abnormal or inconclusive screening or diagnostic results.
(10) "Institution" means a facility licensed by the State of Utah for birthing babies.
(11) "Lost to follow-up" means infants who cannot be identified through tracking, and who have not completed the screening, diagnostic or early intervention referral processes.
(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.
(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 infant's primary medical caregiver.
(15) "Referral" means to direct an infant to an audiologist or physician for appropriate diagnostic procedures to diagnose and determine hearing status and for appropriate early intervention.
(16) "Tracking" means the use of information about the infant's newborn hearing screening status to ensure the infant receives timely and appropriate services to complete the screening, diagnostic and early intervention referral processes.
Each newborn in the state of Utah shall submit to the Newborn Hearing Screening testing, except as provided in Section 26-10-6(1).
(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) 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) If the 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) If the 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) If there is no person in attendance at the birth, a parent must have the infant's hearing screened, according to Department protocols, before the infant is 14 days of age.
(7) Newborn hearing screening shall be performed by a person who is appropriately trained and supervised, according to protocols as established by the Department with input from Newborn Hearing Screening Committee.
(1) Institutions or persons primarily responsible for births shall provide information about newborn hearing screening to parents and primary care providers of 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;
(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 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 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 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 who are deaf or hard of hearing.
(4) For 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 before 14 days of age, or for infants who are "lost to follow-up," the institution or the person in attendance at birth shall make reasonable efforts to locate the parents and inform them of the need for 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 infant's primary care provider. Contact with the parent may be made by mail, email, telephone, text, primary care provider, or public health worker.
(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 weekly. This information shall include:
(a) for each live birth, identifying information for the 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 infants who did not pass the newborn hearing screening or who were not screened, this additional information is required: primary contact's first and last name, address, telephone number, 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, 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 Department 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 Department shall have access to infants' medical, diagnostic, and early intervention records to obtain information necessary to ensure the provision of timely and appropriate follow-up diagnostic and intervention services.
(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.
Any person who violates any provision of this rule may be assessed a penalty as provided in Section 26-23-6.
newborn hearing screening
December 3, 2018
June 19, 2018
For questions regarding the content or application of rules under Title R398, please contact the promulgating agency (Health, Family Health and Preparedness, Children with Special Health Care Needs). A list of agencies with links to their homepages is available at http://www.utah.gov/government/agencylist.html or from http://www.rules.utah.gov/contact/agencycontacts.htm.