12VAC5-80 Regulations for Administration of the Virginia Hearing Impairment Identification and Monitoring System

REGULATIONS

Vol. 27 Iss. 11 - January 31, 2011

TITLE 12. HEALTH

STATE BOARD OF HEALTH

Chapter 80

Proposed Regulation

Title of Regulation: 12VAC5-80. Regulations for Administration of the Virginia Hearing Impairment Identification and Monitoring System (amending 12VAC5-80-10, 12VAC5-80-80, 12VAC5-80-90, 12VAC5-80-95; adding 12VAC5-80-75, 12VAC5-80-85, 12VAC5-80-130, 12VAC5-80-140; repealing 12VAC5-80-20, 12VAC5-80-30, 12VAC5-80-40).

Statutory Authority: §§ 32.1-12 and 32.1-64.1 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: April 1, 2011.

Agency Contact: Susan Tlusty, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone [phone], or email [e-mail].

Basis: The State Board of Health is authorized to make, adopt, promulgate, and enforce regulations by § 32.1-12 of the Code of Virginia.

Section 32.1-64.1 of the Code of Virginia requires the State Health Commissioner to establish and maintain the Virginia Hearing Impairment Identification and Monitoring System.

Purpose: Early identification of hearing loss through screening, identifying, and tracking of infants at risk for acquiring hearing loss is essential to the health, well-being, and eventual language development of infants and children in the Commonwealth, as is providing appropriate early intervention through treatment, therapy, training, and education. In the absence of hearing screening, hearing loss is not usually identified until two to three years of age and language development has already been impacted adversely. The average deaf or hard-of-hearing adult reads at a fourth grade level. Infants can be assessed and diagnosed with hearing loss by several months of age and fitted with hearing devices as early as one month of age. Research suggests that most preschool-age children with hearing loss will have language development within the normal range if diagnosis and intervention begins by six to 12 months of age. Early identification reduces costs associated with special education as well.

The proposed amendments reflect changes in the nationally accepted standards for newborn hearing screening and related state regulations, and recommendations from the Attorney General's Government and Regulatory Reform Task Force. These changes will help improve the newborn hearing screening program in the Commonwealth.

Substance: For consistency with the most recent recommendations from the Joint Committee on Infant Hearing, substantive changes are proposed for hearing screening methodology in 12VAC5-80. The type of screening methodology to be administered has been defined according to level and length of hospital newborn service provision. In addition, details on how to handle transfer and other circumstances are outlined. More details have been added regarding the specifics required for reporting.

Another substantive change relates to identification of infants at risk for hearing impairment. These criteria have been moved out of definitions and into 12VAC5-75. The section outlines the review timeline and process for identifying and maintaining the list of risk indicators. The section specifies the broad categories of risk indicators (for example, syndromes known to be associated with hearing loss); however, the details of the particular category will now be maintained and published as a guidance document. The guidance document will now detail the list of known syndromes associated with hearing loss that are tracked by the program. This approach is necessary to allow flexibility to change with rapidly changing advances in links between genetic disorders and hearing loss as well as new findings regarding the ototoxicity of certain medications.

Other substantive changes include the addition of several sections related to different types of service providers who are part of the system. 12VAC5-85 addresses birthing centers that currently do not fall under other regulations. The Virginia Department of Health has received grant funding to work with these providers and help develop reporting ability. These facilities typically do not conduct hearing screening but refer infants for hearing screening. The department seeks to capture information regarding infants born in these type of facilities to identify those at risk for hearing impairment and to enter those infants in the tracking system. With the number of birthing centers in the state expected to increase, the importance of capturing those infants increases.

12VAC5-100 addresses primary health care providers and simply states that they have a responsibility to receive results and communications from the Virginia Early Hearing Detection and Intervention Program. It may be possible in the future that this provider group will have the ability to electronically access hearing screening results.

12VAC5-110 relates to the Virginia Department of Health statutory responsibility as a partner in the Part C system. The Virginia Early Hearing Detection and Intervention Program is a component of the multi-agency early identification and intervention system in the Commonwealth. As part of this system, certain statutes, regulations, and a formal interagency agreement provide additional guidance for program operations and relationships between service providers.

Definitions have been added to 12VAC5-80-10 to reflect current screening methodologies and affected parties. Other definitions have been modified to be consistent with other similar regulations or to correct citations.

Responsibilities of the Virginia Department of Health in 12VAC5-80-90 have been further refined and provide more direction regarding the reporting system. References related to false-positive and false-negative rates have been deleted.

In addition, amendments are proposed to make these regulations consistent with other relevant state regulations updated within the past several years (12VAC5-71 Regulations Governing Virginia Newborn Screening Services and 12VAC5-191 State Plan for the Children with Special Health Care Needs Program). Recommendations from the Attorney Generals Government and Regulatory Reform Task Force have also been adopted in the proposed text.

Issues: The primary advantages to the public are to families with infants born in Virginia hospitals. By amending the regulations and program practices to be current with the most recent national standard of care recommendations, infants will continue to be screened for hearing loss using the most appropriate technology and assessed for other factors which may put them at risk for hearing loss. Early identification of hearing loss is beneficial to children and their families. Without newborn hearing screening, hearing loss is not typically identified until two to three years of age and serious delays in language and other areas of cognitive development are likely to have occurred. Infants who are diagnosed and enter early intervention between six and 12 months of age can achieve normal language development. In addition, families who have infants identified with hearing loss can be linked with family-to-family support programs, such as Guide by Your Side where families who have had children with hearing loss serve as mentors to those with a newly diagnosed child, and medical support programs such as the Hearing Aid Loan Bank.

The disadvantage to the public for families with infants born in Virginia hospitals would be if an infant or child required further audiological evaluation and the family did not have insurance coverage or could not find a provider willing to accept public insurance (FAMIS plans). Another disadvantage may be stress involved for families of infants who may be identified at risk for hearing loss. These infants may undergo further testing but not be found to have hearing loss at any point during childhood.

The primary advantage for providers of hearing screening (birthing hospitals) is clarified guidance from the state regarding their mandate and to have guidance consistent with most recent national standards of care. Changes in the reporting requirements and changes being made to the current electronic reporting system will provide basic demographic information to hospital users and reduce duplicative data entry.

The primary disadvantage will be for hospitals with neonatal intensive care services that will need to acquire ABR technology to meet the new standard.

The primary advantages to the agency and the Commonwealth are to have a well-defined and managed program that successfully identifies infants with hearing loss as early as possible to meet the mandate in the Code of Virginia. Early identification is key to reducing negative impact on language and cognitive development. Infants who are identified with hearing loss and receive early identification and amplification by six months of age will be one to two years ahead of their later identified peers in first grade in the areas of language, cognitive, and social skills. Children with undetected hearing loss in one ear are more likely to be held back in school than those without hearing loss. It is estimated that $400,000 in special education costs are saved by high school graduation for a child identified early with hearing loss who receives appropriate educational, medical, and audiological services.

There are no disadvantages to the agency and Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health (Board) is proposing to update the Virginia Hearing Impairment Identification and Monitoring System regulations to conform to changes in national standards and incorporate amendments suggested by a 2007 periodic review. In particular, the Board proposes to require infants who receive neonatal intensive care services for longer than five days to be tested with ABR screening technology and to add a new section to address birthing centers.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. By amending the regulations and program practices to be current with the most recent national standard of care recommendations, infants will continue to be screened for hearing loss using the most appropriate technology and assessed for other factors which may put them at risk for hearing loss. Early identification of hearing loss is beneficial to children and their families. Without newborn hearing screening, hearing loss is not typically identified until two to three years of age and serious delays in language and other areas of cognitive development are likely to have occurred. Infants who are diagnosed and enter early intervention between 6 and 12 months of age can achieve normal language development. In addition, families who have infants identified with hearing loss can be linked with family-to-family support programs, such as Guide by Your Side where families who have had children with hearing loss serve as mentors to those with a newly diagnosed child, and medical support programs such as the Hearing Aid Loan Bank.

Early identification is vital to reducing negative impact on language and cognitive development. Infants who are identified with hearing loss and receive early identification and amplification by six months of age will be one to two years ahead of their later identified peers in first grade in the areas of language, cognitive, and social skills.¹ Children with undetected hearing loss in one ear are more likely to be held back in school than those without hearing loss.² White and Maxon (1995)³ estimated that $400,000 in special education costs are saved by high school graduation for a child identified early with hearing loss who receives appropriate educational, medical and audiological services.

According to the Department of Health, two of the 64 birthing hospitals which have specialty neonatal intensive care services would have to purchase ABR equipment to test those infants with stays of greater than five days. It is estimated that new ABR equipment may cost between $15,000 to $25,000. The other hospitals with these types of neonatal intensive care services already have the capability or are using this equipment. In net, the benefits are expected to exceed the costs.

Birthing centers have not previously reported formally to the department although the Code of Virginia has a provision for birthing centers. Risk assessments and referrals for hearing screening are currently being done in practice. Reporting findings to the department may require staff effort of one to three hours per month. Birthing centers typically have 25 or fewer births per month.

Birthing hospitals currently perform testing on all infants. Reporting time will be decreased with provision by the department of certain existing demographic data from births and elimination of monthly report totals, however with the new modified risk indicator list and primary information or confirmation on infants assumed to pass, reporting time and effort may have a net increase by 2 to 30 hours monthly depending on the number of births at the facility.

Businesses and Entities Affected. The proposed amendments affect the 64 birthing hospitals and the two birthing centers in Virginia, as well as the 107 persons providing audiological services for infants and children in the Commonwealth.

Localities Particularly Affected. The proposed amendments do not disproportionately affect specific localities.

Projected Impact on Employment. The proposed amendments will not likely significantly affect total employment.

Effects on the Use and Value of Private Property. The proposed amendments do not significantly affect private property.

Small Businesses: Costs and Other Effects. The proposed amendments do not significantly affect small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments do not produce an adverse impact for small businesses.

Real Estate Development Costs. The proposed amendments do not affect real estate development costs.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 36 (06). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

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¹ Yoshinaga-Itano, C., Sedey, A., Apuzzo, M., Carey, A., Day, D., & Coulter, D. (July 1996). The effect of early identification on the development of deaf and hard-of-hearing infants and toddlers. Paper presented at the Joint Committee on Infant Hearing Meeting, Austin, TX.

² Bess, F. H., & Tharpe, A. M. (1986). Case history data on unilaterally hearing-impaired children. Ear and Hearing, 7(1), 14-19.

³ White, K. R., & Maxon, A. B. (1995). Universal screening for infant hearing impairment: Simple, beneficial, and presently justified. International Journal of Pediatric Otorhinolaryngology, 32, 201-211.

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The Virginia Department of Health concurs with the economic impact assessment regarding the proposed chapter entitled Virginia Hearing Impairment Identification and Monitoring System, 12VAC5-80.

Summary:

The proposed amendments conform the regulation to changes in national standards and incorporate amendments suggested by a 2007 periodic review. Substantive changes include (i) moving risk factor criteria to identify infants at risk for hearing loss from the definitions section to a new section and placing detailed criteria for each category of risk under a guidance document; (ii) requiring infants who receive neonatal intensive care services for longer than five days to be tested with ABR screening technology; (iii) adding a new section to address birthing centers; and (iv) further defining reporting requirements that include provisions for confirming negative results.

12VAC5-80-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"ABR" means an objective, electrophysiologic measurement of the brainstem's response to acoustic stimulation of the ear.

"At risk" means considered to be in a status with a significant probability of having or developing hearing loss as a result of the presence of one or more factors identified or manifested at birth.

"Audiological evaluation" means those physiologic and behavioral procedures required to evaluate and diagnose hearing status.

"Audiologist" means a person licensed to engage in the practice of audiology as defined in § 54.1-2600 of the Code of Virginia.

"Birthing center" means a facility outside of a hospital that provides maternity services.

"Board" means the State Board of Health.

"CDC" means the Centers for Disease Control and Prevention.

"Child" means any person from birth to age 18 years of age.

"Commissioner" means the State Health Commissioner, his duly designated officer, or agent.

"Department" means the Virginia Department of Health.

"Diagnostic audiological evaluation" means those physiologic and behavioral procedures required to evaluate and diagnose hearing status.

"Discharge" means release from the hospital after birth to the care of the parent or guardian.

"EHDI" means early hearing detection and intervention.

"Family-to-family support" means the provision of information and peer support among families having experience with family members having hearing loss.

"Guardian" means a parent-appointed, court-appointed, or clerk-appointed guardian of the person.

"Hearing screening" means an objective physiological measure to be completed in order to determine the likelihood of hearing loss.

"Hospital" means any facility as defined in § 32.1-123 of the Code of Virginia.

"Infant" means a child under the age of one year.

"Missed" means that an infant did not have a required hearing screening prior to discharge.

"Neonatal intensive care services" means those services provided by a hospital's newborn services that are designated as both either specialty level and or subspecialty level as defined in subdivision D 2 of 12VAC5-410-440 12VAC5-410-443 B 3 and B 4 of the Rules and Regulations for the Licensure of Hospitals.

"Newborn" means an infant who is 28 days old or less.

"Newborn services" means care for infants in one or more of the service levels designated in 12VAC5-410-443 B of the Rules and Regulations for the Licensure of Hospitals.

"OAE" means an objective, physiologic response from the cochlea. This term may include transient evoked otoacoustic emissions and distortion product otoacoustic emissions.

"Parent" means (i) a biological or adoptive parent who has legal custody of a child, including either parent if custody is shared under a joint decree or agreement; (ii) a biological or adoptive parent with whom a child regularly resides; (iii) a person judicially appointed as a legal guardian of a child; or (iv) a person who exercises the rights and responsibilities of legal custody by delegation from a biological or adoptive parent, upon provisional adoption or otherwise by operation of law or a stepparent.

"Part C" means the state early intervention program that provides medically necessary speech and language therapy, occupational therapy, physical therapy, and assistive technology services and devices for dependents from birth to age three who are certified by the Department of Behavioral Health and Developmental Services as eligible for services under Part C of the Individuals with Disabilities Education Act of 2004 (20 USC §§ 1431-1444).

"Primary medical health care provider" means the person to whom the infant will go for routine medical primary health care following hospital discharge.

"Resident" means an individual who resides within the geographical boundaries of the Commonwealth.

"Risk factor indicator" means a factor known to place an infant at increased risk for being born with or developing a hearing loss, including, but not limited to, any one of the following:

1. Family history of hereditary, childhood sensorineural hearing loss;

2. In utero infection (e.g., cytomegalovirus, rubella, herpes, toxoplasmosis, syphilis);

3. Craniofacial anomalies including those with morphological abnormalities of the pinna and ear canal;

4. Birthweight less than 1500 grams;

5. Hyperbilirubinemia at a serum level requiring exchange transfusion;

6. Bacterial meningitis;

7. Apgar scores of 0 to four at one minute or 0 to six at five minutes;

8. Ototoxic medications, including but not limited to the aminoglycosides, used in multiple courses or in combination with loop diuretics;

9. Mechanical ventilation lasting five days or longer;

10. Stigmata or other findings associated with a syndrome known to include a sensorineural hearing loss, a conductive hearing loss, or both;

11. Neurofibromatosis Type II; and

12. Persistent pulmonary hypertension of the newborn (PPHN).

"Virginia Hearing Impairment Identification and Monitoring System" means a coordinated and comprehensive group of services including education; screening; follow up; diagnosis; appropriate early intervention including treatment, therapy, training, and education; and program evaluation managed by the department's Virginia Early Hearing Detection and Intervention Program for safeguarding the health of children born in Virginia.

12VAC5-80-20. Authority for regulations. (Repealed.)

Sections 32.1-64.1 and 32.1-64.2 of the Code of Virginia direct the commissioner to establish and maintain a system for the purpose of identifying and monitoring infants with hearing loss and directs the Board of Health to promulgate the regulations necessary for implementation of the system.

12VAC5-80-30. Purpose of chapter. (Repealed.)

This chapter is designed to provide consistent guidelines for implementation of this system in order to assure that infants with hearing loss are identified at the earliest possible age and that they receive appropriate, early intervention.

12VAC5-80-40. Administration and application of chapter. (Repealed.)

A. This chapter is promulgated to implement the system and amended as necessary by the State Board of Health. The State Health Commissioner or his designee is charged with its administration, and the Virginia Department of Health shall provide the staff necessary for its implementation.

B. This chapter has general application throughout the Commonwealth.

12VAC5-80-75. Risk indicators associated with hearing loss.

A. The Virginia EHDI program shall maintain a list of specific risk indicators consistent with, but not necessarily identical to, the most recent recommendations from the Joint Committee on Infant Hearing to identify infants at risk of hearing loss.

B. The Virginia EHDI Program Advisory Group shall provide guidance with the development and maintenance of the list of specific risk indicators.

C. The list of specific risk indicators shall be maintained a guidance document, which shall be reviewed at a minimum biennially. The list of specific risk indicators may be changed or amended more frequently as needed to reflect changes in standards of care or updates to Joint Committee on Infant Hearing recommendations.

D. The guidance document shall contain specific assessment and reporting criteria for the following general categories of risk indicators associated with hearing loss:

1. Family history of permanent childhood hearing loss;

2. Caregiver concerns;

3. In utero and post natal infections;

4. Neonatal intensive care services;

5. Head trauma and craniofacial anomalies;

6. Syndromes, neurodegenerative disorders, and sensory motor neuropathies;

7. Stigmata or other physical findings associated with certain syndromes;

8. Ototoxic medications, treatments, and chemotherapies; and

9. Other indicators as needed.

E. All infants born in Virginia hospitals shall be assessed prior to hospital discharge after birth for risk indicators associated with hearing loss as outlined in this chapter and the corresponding guidance document.

12VAC5-80-80. Responsibilities of the chief medical officer of hospitals.

Hospitals with newborn nurseries and hospitals with neonatal intensive care services The chief medical officer of a hospital providing newborn services or his designee shall:

1. Prior to discharge after birth, but no later than three months of age, screen the hearing, in both ears, of all infants using objective physiologic measures. The methodology used for hearing screening shall have a false-positive rate and false-negative rate no greater than those recommended by the American Academy of Pediatrics in "Newborn and Infant Hearing Loss: Detection and Intervention" (Pediatrics Vol. 103, No. 2, February 1999). If the error rates exceed these recommendations, the hospital shall examine and modify its hearing screening methodology to reduce its error rates below these maximum rates;

1. Cause all infants to be given a hearing screening test prior to discharge after birth as appropriate for the level of newborn services provided as defined in 12VAC5-410-443 B of the Rules and Regulations for the Licensure of Hospitals;

a. Infants in general or intermediate newborn services shall have both ears screened for hearing using either ABR or OAE testing prior to discharge after birth, but no later than one month of age.

b. Infants in neonatal intensive care services who receive this level of newborn service care for more than five days shall have both ears screened using ABR testing prior to discharge after birth or transfer to a lower level of newborn services. Infants should receive newborn hearing screening as early as development or medical stability will permit such screening. The hearing screening performed for infants requiring neonatal intensive care services for more than five days using ABR testing shall be reported as the initial hearing screen regardless of whether the infant is transferred to another lower level of newborn services within the same facility or to another facility.

c. Infants in neonatal intensive care services who receive this level of newborn service care for five days or less shall have both ears screened for hearing using either ABR or OAE testing prior to discharge after birth, but no later than one month of age.

2. Identify all infants who fail hearing screening in one or both ears;

a. Infants who fail hearing screening in one or both ears using ABR testing shall not be rescreened using OAE testing. These infants shall be referred for an audiological evaluation.

b. Infants who fail hearing screening in one or both ears using OAE testing may be rescreened using ABR testing. If the infant fails subsequent ABR testing in one or both ears, the infant shall be referred for an audiological evaluation.

3. Identify all infants not receiving an appropriate hearing screening test;

a. For infants who did not receive a hearing screening test due to transfer to another facility, written notification shall be made upon transfer to the healthcare provider in charge of the infant's care that testing was not completed. The hospital discharging the infant after birth is responsible for conducting an appropriate hearing screening test, except for infants who have been transferred to a lower level of newborn service care from another facility providing neonatal intensive care services to that infant for more than five days.

2. If an infant is missed b. For infants who did not receive a hearing screening test prior to discharge after birth, inform the parent prior to discharge of the need for hearing screening and provide a mechanism by which screening can occur at no additional cost to the family;.

c. For infants who did not receive screening due to refusal by the parent or guardian because the screening conflicts with religious convictions, documentation shall be made in the medical record.

4. Cause all infants to be assessed for risk indicators associated with hearing loss prior to discharge after birth as defined in 12VAC5-80-75. For infants who are found to have one or more risk indicators associated with hearing loss, inform the parent of the need for a diagnostic audiological assessment by 24 months of age.

3. Prior to discharge, give 5. Provide written information to the parent or guardian of each infant that includes purposes and benefits of newborn hearing screening, risk indicators of hearing loss, procedures used for hearing screening, results of the hearing screening, the recommendations for further testing, and where the further testing can be obtained, and contact information for the Virginia EHDI program;

4. Give written information to 6. Notify the infant's primary medical health care provider, within two weeks of discharge after birth, the status of the hearing screening including if the infant was not tested, that includes procedures used for hearing screening, the limitations of screening procedures identified risk indicators associated with hearing loss as defined in 12VAC5-80-75, the results of the hearing screening, and the recommendations for further testing in writing or through an electronically secure method that meets all applicable state and federal privacy laws;

5. Within one week of discharge, complete the Virginia Department of Health report 7. Provide the department with information, as required by the board pursuant to § 32.1-64.1 F of the Code of Virginia and in a manner devised by the department, which may be electronic, on each infant who does not pass the hearing screening and send it to the Virginia Department of Health; on the hearing screening and risk indicator status of infants born at their hospital. This information shall be provided within two weeks of discharge after birth unless otherwise stated and includes, but may not be limited to:

a. Demographic information on infants including name, date of birth, race, ethnicity, and gender;

b. Primary contact information including address, telephone, and relationship type;

c. Primary healthcare provider name, address and telephone;

d. Risk indicators identified as defined in 12VAC5-80-75;

e. Special circumstances regarding infants as needed by the department to provide follow-up;

f. Screening methodology used, date screened, and both right and left ear results;

g. Screening status for pass with risk indicator, fail, unable to test, refusal, and inconclusive results;

h. Status of infants not screened prior to discharge that includes, but may not be limited to, infants who were transferred to other facilities and parents who refused screening;

i. Hearing rescreening information including date, type of screening methodology used, results in both left and right ears, and further recommendations within two weeks after the hospital rescreening date; and

j. Confirmatory data on the status of all infants born in the hospital facility. The department shall receive confirmation that infants not reported as passed with risk, failed, transferred, refused testing, not tested prior to discharge, expired, or other final disposition have had a negative assessment for risk indicators and that physiological hearing screening was conducted with passing results in both ears within 30 days after birth;

6. On a monthly basis, send to the Virginia Department of Health a report of the total number of discharges, the total number of infants who passed the newborn hearing screening, the total number who failed, and the total number not tested due to parents' exercise of their rights under § 32.1-64.1 H of the Code of Virginia; and

7. 8. Report to the Virginia Department of Health department, on a yearly basis, hospital specific information including the test procedures used by the newborn hearing screening program, the name of the program director, the name of the advising audiologist, equipment calibration records, screening protocols, and referral procedures.;

9. Develop written policies and procedures to implement hearing screening in their facility in accordance with 12VAC5-80 including separate protocols for specialty and subspecialty newborn services; and

10. Assure that training of staff on newborn hearing screening test procedures, follow up, and reporting requirements is implemented in a way that an adequately trained and knowledgeable workforce is maintained to conduct hearing screening program requirements.

12VAC5-80-85. Responsibilities of other birthing places or centers.

The chief medical officer of other birthing places or centers or his designee or the attending practitioner shall:

1. Cause all infants to be assessed for risk indicators associated with hearing loss as defined in 12VAC5-80-75;

2. Provide written information to the parent or guardian of each infant that includes purposes and benefits of newborn hearing screening, risk indicators for hearing loss, procedures used for hearing screening, providers where hearing screening can be obtained, and contact information for the Virginia EHDI program;

3. Notify the infant's primary healthcare provider, within two weeks after birth, of the status of the hearing screening including if the infant was not tested, identified risk indicators associated with hearing loss as defined in 12VAC5-80-75, and the recommendations for testing in writing or through an electronically secure method that meets all applicable state and federal privacy laws; and

4. Provide the department with information, as required by the board pursuant to § 32.1-64.1 F of the Code of Virginia and in a manner devised by the department on the hearing screening and risk indicator status of infants born at their birthing center. This information shall be provided within two weeks after birth unless otherwise stated and includes, but may not be limited to:

a. Demographic information on infants including name, date of birth, race, ethnicity, and gender;

b. Primary contact information including address, telephone, and relationship type;

c. Primary healthcare provider name, address and telephone;

d. Risk indicators identified as defined in 12VAC5-80-75;

e. Special circumstances regarding infants as needed by the department to provide follow-up;

f. Screening methodology used, date screened, and both right and left ear results if applicable;

g. Screening status for pass with risk indicator, failures, unable to test, refusals, and inconclusive results if applicable;

h. Status of infants not screened that includes, but may not be limited to, infants who were transferred to other facilities and parents who refused screening;

i. Hearing rescreening information including date, type of screening methodology used, results in both left and right ears, and further recommendations within two weeks after the rescreening date if applicable; and

j. Confirmatory data on the status of all infants born in the birthing place or center. The department shall receive confirmation that infants not reported with a screening status have had a negative assessment for risk indicators and have been referred for a hearing screening.

12VAC5-80-90. Responsibilities of the Virginia Department of Health Scope and content of Virginia Early Hearing Detection and Intervention Program.

The Virginia Department of Health shall:

A. The mission of the Virginia EHDI program is to identify hearing loss at the earliest possible age and to assure that appropriate early intervention services are received to reduce the risk of developmental delays.

B. The scope of the Virginia EHDI program shall include the following:

1. Provide hospitals and birthing centers with a secure reporting system, which may be electronic, that meets all applicable federal and state privacy statutes. This electronic system may include existing demographic data captured by other department population-based systems and the commissioner may authorize hospitals required to report to view existing data to facilitate accurate reporting and increase the department's ability to conduct successful follow up and identify infants at risk for hearing loss pursuant to § 32.1-127.1:04 of the Code of Virginia;

1. 2. Collect, maintain and evaluate hospital newborn hearing screening data in a database including, but not limited to, initial screening, risk indicators, rescreening, and diagnostic audiological evaluations, in a secure data management information system;

2. 3. Provide follow-up for all infants reported whose results indicate screening failure, identified risk indicators, inconclusive or missing results, or other circumstances requiring follow up. Follow-up includes, but is not limited to:

a. Communicating with the parent by mail or guardian for those infants who failed the hearing screening, those who had one or more risk factors identified and were not screened prior to discharge, those who were not screened, and those who are at risk for progressive hearing loss in order to advise of the need for audiological services as well as to provide information on locating an approved center that provides diagnostic audiological services or a licensed audiologist;

b. Communicating with audiologists, hospitals, birthing centers, primary health care providers, and others as needed to ascertain follow up status and Receiving receive results of both the audiological evaluations and the intervention referrals, and adding the information to the database; and including Part C services;

c. Communicating with the parent by mail or guardian for any child found to have a hearing loss in order to provide information about hearing loss and appropriate resources; including family-to-family support and referral to the Part C program; and

d. Communicating to the Part C program regarding any child found to have hearing loss in order to facilitate early intervention services;

3. Supply the reporting format and written information to hospitals;

4. Provide training and technical assistance on this program to hospitals and birthing centers; and

5. Develop and disseminate protocols for hospitals, audiologists, and primary healthcare providers;

6. Develop and disseminate parent education materials;

7. Maintain an approved list of audiological providers meeting program criteria;

5. Conduct a review and evaluation of the 8. Evaluate Virginia Hearing Impairment Identification and Monitoring System components, including but not limited to the false-positive rate, false-negative rate screening, referral rate, and follow-up rate rates, referral mechanisms and effectiveness of tracking, and communicating indicators;

9. Communicate critical performance data to hospitals and birthing centers, on a yearly quarterly basis.; and

10. Collect and report data required annually for Title V national performance measures, CDC national EHDI goals, and other funding sources as needed that measure how well the system functions.

C. Title V national performance measures and the CDC national EHDI goals, as required by the Government Performance and Results Act (GPRA; Public Law 103-62), shall be used to establish newborn hearing screening goals. The following goals shall change as needed to be consistent with federally required performance measures:

1. All infants who are born in Virginia hospitals shall be screened for hearing loss prior to hospital discharge. Residents of Virginia who do not pass screening, do not receive screening, or who have an identified risk indicator shall receive appropriate evaluation, diagnostic, follow up, and early intervention services. Infants who are not residents of Virginia and who do not pass screening, do not receive screening, or who have an identified risk indicator will be referred to their state of residence for appropriate evaluation, diagnostic, follow up, and early intervention services;

2. All infants born in Virginia shall receive a hearing screening prior to one month of age;

3. Infants who are referred shall receive a diagnostic audiological evaluation before three months of age; and

4. All infants identified with a hearing loss shall receive appropriate early intervention services before six months of age.

12VAC5-80-95. Responsibilities of persons providing audiological services after discharge.

Persons who provide audiological services and who determine that a child has failed to pass a hearing screening, was not successfully tested, or has a hearing loss shall:

1. Provide the screening or evaluation results, either in writing or in an electronically secure manner, to the parent or guardian and to the child's primary medical health care provider;

2. Send a Virginia Department of Health report including screening methodology, test results, diagnosis, and recommendations to the Virginia Department of Health department, in a manner devised by the department, which may be electronic, within two weeks of the visit;

3. Advise Provide information to the parent about and offer referral for the child to local early intervention or education programs, including the Part C program; and

4. Give resource information to the parent of any child who is found to have a hearing loss, including but not limited to the degrees and effects of hearing loss, communication options, amplification options, the importance of medical follow up, and agencies and organizations, including the Part C program, that provide services to children with hearing loss and their families.

12VAC5-80-130. Responsibilities of primary health care providers.

Persons who provide primary healthcare services to infants shall:

1. Receive hearing screening, risk indicator findings, and evaluation results from hospitals, audiological providers, and the Virginia EHDI program.

2. Receive information from the Virginia EHDI program regarding available resources to assist practitioners and families whose child is at risk or diagnosed with hearing loss.

12VAC5-80-140. Relationship to the Part C system.

A. The department is a participating agency in the state Part C system as defined in § 2.2-5300 of the Code of Virginia. The Virginia Hearing Impairment Identification and Monitoring System is a component of this statewide system to identify infants and children who may be eligible for Part C early intervention services. The Virginia EHDI program shall develop policies and operating procedures that are consistent with the Individuals with Disabilities Education Act of 2004 (20 USC §§ 1431-1444); 34 CFR Part 303; § 2.2-5303 of the Code of Virginia; and the most recent state interagency agreement.

B. The state interagency agreement shall contain policies and procedures related to identification of resources, coordination of services, resolution of interagency disputes, and data exchange activities necessary for the department and the Virginia EHDI program to fulfill responsibilities and implementation activities required as part of the state early intervention system.

FORMS (12VAC5-80) (Repealed.)

Report of Follow-Up (eff. 7/99).

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-80) (Repealed.)

Newborn and Infant Hearing Loss: Detection and Intervention, Pediatrics Vol. 103, No. 2, February 1999, American Academy of Pediatrics.

VA.R. Doc. No. R08-1334; Filed January 6, 2011, 10:41 a.m.