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.

Effective Date: December 6, 2013.

Agency Contact: Susan Tlusty, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7686, or email susan.tlusty@vdh.virginia.gov.

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; and (iii) further defining reporting requirements that include provisions for confirming negative results. Since publication of the proposed amendments, additional changes (i) add new sections to address responsibilities of other birthing places or centers; (ii) stipulate reporting responsibilities to primary health care providers and clarify the program relationship to the Part C system; and (iii) remove language that might go beyond the scope of the authority of the State Board of Health.

Summary of Public Comments and Agency's Response: A summary of comments made by the public and the agency's response may be obtained from the promulgating agency or viewed at the office of the Registrar of Regulations.

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 an audiologist ] 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.

[ "Chief medical officer" means the highest position of authority on the medical staff of the hospital or other birthing place or center as defined in the organization's bylaws or applicable governance structure. ]

"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 [ in Virginia ].

"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 [ in Virginia ].

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

[ "Other birthing place or center" means a place or facility outside of a hospital that provides maternity services. ]

"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 [ services ] program that provides medically necessary speech and language therapy, occupational therapy, physical therapy, and assistive technology services and devices for [ dependents children ] 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) [ and Virginia law ].

"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).

[ "Title V" means the U.S. Department of Health and Human Services, Health Resources and Services Administration, Maternal and Child Health Services Block Grant (Title V of the Social Security Act). ]

"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 [ in ] 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 [ in Virginia ];

a. Infants in general or intermediate newborn services shall have both ears screened [ at the same time ] 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 [ at the same time ] 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 [ at the same time ] 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 health care ] 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, [ of ] 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 [ number ], and relationship type;

c. Primary [ healthcare health care ] provider name, address [ , ] and telephone [ number ];

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 Ensure ] 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 health care ] 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 the other ] birthing [ place or ] 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 [ number ], and relationship type;

c. Primary [ healthcare health care ] provider name, address [ , ] and telephone [ number ];

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 [ other ] birthing [ places or ] centers with a secure reporting system, which may be electronic, that meets all applicable federal and state privacy [ statutes laws ]. 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. Receiving Communicating with audiologists, hospitals, [ other ] birthing [ places or ] centers, primary health care providers, and others as needed to ascertain follow up status and 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 [ other ] birthing [ places or ] centers; and

5. Develop and disseminate protocols for hospitals, audiologists, and primary [ healthcare health care ] 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 [ other ] birthing [ places or ] 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 The goals are ]:

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.

[ The goals shall change as needed to be consistent with federally required performance measures. ]

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 [ or guardian ] 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 [ or guardian ] 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 Reporting responsibilities to ] 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.

A. The chief medical officer of a hospital providing newborn services or his designee shall report hearing screening results to the infant's primary health care provider as defined in 12VAC5-80-80.

B. The chief medical officer of another birthing place or center or his designee or the attending practitioner shall report the status of the hearing screening results including if the infant was not tested to the infant's primary health care provider as defined in 12VAC5-80-85.

C. The Virginia EHDI program shall report infants identified with risk indicators for progressive hearing loss as defined in 12VAC5-80-75 and infants identified with hearing loss to the infant's primary health care provider pursuant to § 32.1-64.2 of the Code of Virginia. The Virginia EHDI program shall provide other hearing screening and resource information to the infant's primary health care provider as defined in 12VAC5-80-90.

D. Persons providing audiological services shall report hearing screening and audiological evaluation results to the infant's primary health care provider as defined in 12VAC5-80-95.

E. Reporting hearing screening and audiological evaluation results to primary health care providers may be done through an electronically secure system that meets all applicable federal and state privacy laws. ]

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)

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

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-80)

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