TITLE 12. HEALTH
REGISTRAR'S NOTICE: The
State Board of Health is claiming an exemption from Article 2 of the
Administrative Process Act in accordance with § 2.2-4006 A 4 a of the Code
of Virginia, which excludes regulations that are necessary to conform to
changes in Virginia statutory law or the appropriation act where no agency
discretion is involved. The State Board of Health will receive, consider, and
respond to petitions by any interested person at any time with respect to
reconsideration or revision.
Title of Regulation: 12VAC5-80. Regulations for
Administration of the Virginia Hearing Impairment Identification and Monitoring
System (amending 12VAC5-80-10, 12VAC5-80-80,
12VAC5-80-85, 12VAC5-80-90; adding 12VAC5-80-150).
Statutory Authority: § 32.1-64.1 of the Code of
Virginia.
Effective Date: September 1, 2020.
Agency Contact: Robin Buskey, Policy Analyst, Virginia
Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804)
864-7253, or email robin.buskey@vdh.virginia.gov.
Summary:
As required by Chapter 423 of the 2019 Acts of Assembly,
the amendments require hospitals and other birthing centers to screen for congenital
cytomegalovirus in newborns who fail the newborn hearing screen and include
changing the notification time for results to the infant's primary care
provider and the department to one week after birth.
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 an audiologist as defined in
§ 54.1-2600 of the Code of Virginia.
"Board" means the State Board of Health.
"CDC" means the Centers for Disease Control and
Prevention.
"CMV" means cytomegalovirus infection.
"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 18 years of
age.
"Commissioner" means the State Health Commissioner,
his duly designated officer, or agent.
"Congenital cytomegalovirus" or "cCMV"
means when an infant is born with cytomegalovirus infection.
"Department" means the Virginia Department of
Health.
"Discharge" means release from the hospital after
birth to the care of the parent or guardian.
"EHDI" means early hearing detection and
intervention.
"Failed newborn hearing screening" means the
final newborn hearing screening that resulted in a refer or fail in one or both
ears prior to discharge from hospital or other birthing place or center.
"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.
"Neonatal intensive care services" means those
services provided by a hospital's newborn services that are designated as
either specialty level or subspecialty level as defined in 12VAC5-410-443 B 3
and B 4 of the 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 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 a biological or parent,
adoptive parent, 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 children from birth to age three who are eligible for services
under Part C of the Individuals with Disabilities Education Act (20 USC
§§ 1431-1444) and Virginia law.
"Primary health care provider" means the person to
whom the infant will go for primary health care following hospital discharge.
"Resident" means an individual who resides within
the geographical boundaries of the Commonwealth.
"Risk indicator" means a factor known to place an
infant at increased risk for being born with or developing a hearing loss.
"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 (42 USC 701 et seq.) 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 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.
12VAC5-80-80. Responsibilities of the chief medical officer of
hospitals.
The chief medical officer of a hospital providing newborn
services or his designee shall:
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 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 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.
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.
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, recommendations for further testing, where further
testing can be obtained, and contact information for the Virginia EHDI program;
6. Notify the infant's primary health care provider,
within two weeks one week of discharge after birth, of (i)
the status of the hearing screening including if the infant was not tested, (ii)
procedures used for hearing screening, (iii) identified risk indicators
associated with hearing loss as defined in 12VAC5-80-75, (iv) the
results of the hearing screening, and (v) the recommendations for
further testing in writing or through an electronically secure method that
meets all applicable state and federal privacy laws;
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 the hearing screening
and risk indicator status of infants born at their hospital. This information
shall be provided within two weeks one week 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 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; and
k. cCMV screening results if performed as defined in
12VAC5-80-150.
8. Report to the department, on a yearly basis,
hospital specific information including (i) the test procedures used by
the newborn hearing screening program, (ii) the name of the program
director, (iii) the name of the advising audiologist, (iv)
equipment calibration records, (v) screening protocols, and (vi)
referral procedures;
9. Develop written policies and procedures to implement
hearing screening in their the chief medical officer's facility
in accordance with 12VAC5-80 including separate protocols for specialty and
subspecialty newborn services; and
10. Ensure that training of staff on newborn hearing screening
test procedures, follow up 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 health care provider,
within two weeks one week after birth, of (i) the
status of the hearing screening including if the infant was not tested, (ii)
identified risk indicators associated with hearing loss as defined in
12VAC5-80-75, and (iii) 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 the other birthing place or center. This information
shall be provided within two weeks one week 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 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; and
k. cCMV screening results if performed as defined in
12VAC5-80-150.
12VAC5-80-90. Scope and content of Virginia Early Hearing
Detection and Intervention Program.
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 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 follow-up and identify infants at
risk for hearing loss pursuant to § 32.1-127.1:04 of the Code of Virginia;
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;
3. Provide follow-up of results of screening for cCMV and
for infants 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 or guardian for those infants
who failed the hearing screening, 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, other birthing
places or centers, primary health care providers, and others as needed to
ascertain follow up status and receive results of audiological evaluations and
intervention referrals, including Part C services;
c. Communicating with the parent 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;
4. Provide training and technical assistance to hospitals and
other birthing places or centers;
5. Develop and disseminate protocols for hospitals,
audiologists, and primary health care providers;
6. Develop and disseminate parent education materials;
7. Maintain an approved list of audiological providers meeting
program criteria;
8. Evaluate Virginia Hearing Impairment Identification and
Monitoring System components, including but not limited to screening,
referral and follow-up rates, referral mechanisms and tracking indicators;
9. Communicate critical performance data to hospitals and
other birthing places or centers on a 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 Pub. L. 103-62), shall be used to establish newborn hearing
screening goals. 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
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.
12VAC5-80-150. Screening for congenital cytomegalovirus.
A. If a newborn has a failed newborn hearing screening,
the discharging hospital or other birthing center shall collect and submit a
sample for cCMV testing prior to discharge. If the newborn is under the care of
a specialty level or subspecialty level nursery, the cCMV screening shall be
performed in accordance with the protocols.
To ensure full implementation of cCMV testing, the
department may establish contracts with a designated testing laboratory to
ensure testing, and the established contracts shall comply with all federal
assurances.
B. The department shall develop or approve and publish
informational materials for the general public, healthcare providers, women who
may become pregnant, expectant parents, and parents of infants regarding:
1. The incidence of CMV;
2. The transmission and prevention of CMV to pregnant women
and women who may become pregnant;
3. Birth defects caused by cCMV;
4. Methods of diagnosing cCMV;
5. Potential benefits of screening for and diagnosis of
cCMV;
6. Available methods of treating cCMV; and
7. Resources available for families of children born with
cCMV.
C. Healthcare providers providing prenatal care are
encouraged to provide patients with information about cCMV.
D. Birthing facilities providing care to an infant who was
screened for cCMV are required to report to the Department of Health
identification and monitoring system within one week of discharge.
VA.R. Doc. No. R20-6070; Filed October 22, 2019, 10:22 a.m.