77 Ill. Adm. Code 661.610
Responsibilities of Medical Care Facilities
Section 661.610Â Responsibilities of Medical Care
Facilities
a)Â Â Â Â Â Â Â Â All
medical care facilities shall provide written information to all parents, legal
guardians or caregivers before the newborn hearing screening is administered.Â
The written information shall include:
1)Â Â Â Â Â Â Â Â Purpose
and benefits of the hearing screening;
2)Â Â Â Â Â Â Â Â Description
of typical auditory development;
3)Â Â Â Â Â Â Â Â Description
of the procedures used for hearing screening;
4)Â Â Â Â Â Â Â Â Risk
factors for hearing loss;
5)Â Â Â Â Â Â Â Â Factors
that could result in a referral for further hearing screening; and
6)Â Â Â Â Â Â Â Â Importance
of timely follow-up for hearing testing and intervention.
b)Â Â Â Â Â Â Â Â After
completion of the newborn hearing screening, medical care facilities shall
provide to parents, legal guardians, or caregivers, orally and in writing, the
following information:
1)Â Â Â Â Â Â Â Â Time,
date, screening technology and individual-ear screening results for the final
screening session prior to discharge; and
2)Â Â Â Â Â Â Â Â Follow-up
plan of care, including the coordination of follow-up screening or diagnostic
appointments and service locations.
c)Â Â Â Â Â Â Â Â The
medical care facility shall maintain written documentation of the newborn
hearing screening in the newborn, infant or child's medical record, including
the following information:
1)Â Â Â Â Â Â Â Â Time,
date, screening technology and individual-ear screening results for the final
screening session prior to discharge;
2)Â Â Â Â Â Â Â Â Individual
administering each screening test;
3)Â Â Â Â Â Â Â Â Follow-up
plan of care, including the coordination of follow-up screening or diagnostic
appointments and service locations; and
4)Â Â Â Â Â Â Â Â Documentation
of screening refusal, if applicable.
d)Â Â Â Â Â Â Â Â Newborn
hearing screening shall be performed by an individual who is supervised by a
licensed healthcare professional (recommended to be a licensed audiologist per
2019 Joint Committee on Infant Hearing Statement). The supervising healthcare
professional and screener shall be trained in the following areas:
1)Â Â Â Â Â Â Â Â Anatomy
and physiology of the ear;
2)Â Â Â Â Â Â Â Â Nature
of responses being measured;
3)Â Â Â Â Â Â Â Â Patient
and non-patient factors that influence responses;
4)Â Â Â Â Â Â Â Â Hearing
screening procedures;
5)Â Â Â Â Â Â Â Â Documentation
of results;
6)Â Â Â Â Â Â Â Â Type
of screening equipment to be used;
7)Â Â Â Â Â Â Â Â Operation
of the screening equipment;
8)Â Â Â Â Â Â Â Â Time
frames for screening;
9)Â Â Â Â Â Â Â Â Provision
of results to the parents, legal guardian or caregiver, the primary medical
care provider, and the Department;
10)Â Â Â Â Â Â Â Â Confidentiality
requirements;
11)Â Â Â Â Â Â Â Â Communicating
accurate and appropriate information;
12)Â Â Â Â Â Â Â Â The
plan of care if the newborn or infant passed the hearing screening; and
13)Â Â Â Â Â Â Â Â The
plan of care if the newborn or infant did not pass the hearing screening.
e)Â Â Â Â Â Â Â Â A
medical care facility shall identify a primary and secondary liaison to the
EHDI Program at the Department.
f)Â Â Â Â Â Â Â Â A
medical care facility shall identify, no later than January 1, 2023, the items
listed below and shall report any changes thereafter, within 7 days, to the Department:
1)Â Â Â Â Â Â Â Â primary
and/or secondary EHDI liaison;
2)Â Â Â Â Â Â Â Â hearing
screening protocol; and/or
3)Â Â Â Â Â Â Â Â hearing
screening equipment.
g)Â Â Â Â Â Â Â Â A
medical care facility shall inform the Department no less than 30 days before
any changes related to the outsourcing of newborn hearing screening services.
h)Â Â Â Â Â Â Â Â A
medical care facility shall designate a manager or coordinator employed by the
facility who is responsible for the oversight of newborn hearing screening
services. The manager or coordinator shall be a licensed healthcare
professional. The manager or coordinator shall be responsible for the
following:
1)Â Â Â Â Â Â Â Â Documentation
of medical care facility EHDI policy and protocols;
2)Â Â Â Â Â Â Â Â Maintenance,
operation, and replacement of the hearing screening equipment within the
equipment manufacturer's guidance;
3)Â Â Â Â Â Â Â Â Documentation
of a hearing screening plan to ensure the continuation of hearing screening
when the equipment is out of service for greater than 48 hours;
4)Â Â Â Â Â Â Â Â Training
and supervision of newborn hearing screening personnel, including retraining
and competency monitoring of newborn hearing screening personnel;
5)Â Â Â Â Â Â Â Â Monitoring
reporting to the Department; and
6)Â Â Â Â Â Â Â Â Medical
facility EHDI data management.
i)Â Â Â Â Â Â Â Â Â A
medical care facility shall maintain newborn hearing screening equipment that is
approved by the Food and Drug Administration for Newborn Hearing Screening and meets
the following requirements:
1)Â Â Â Â Â Â Â Â Screening
technology that measures a physiologic response; is implemented with objective
response criteria; uses a procedure that measures the status of the peripheral
auditory system and is highly correlated with auditory function; and is
approved for newborn hearing screening; and
2)Â Â Â Â Â Â Â Â Screening
methodology that detects, at a minimum, any unilateral or bilateral hearing
losses equal to or greater than 35dB HL. The methodology used should have a
false-positive rate and no less than 1% and no greater than 4%. For this
purpose, false positive rate means the proportion of newborns or infants
without hearing loss who are identified incorrectly by the screening process as
having significant hearing loss.
j)Â Â Â Â Â Â Â Â Â Medical
care facilities shall calibrate hearing screening equipment in the timeframe
and manner recommended by the manufacturer. Calibration should occur annually
or more frequently per manufacturer guidelines. Newborn hearing screening
equipment per manufacturer guidance.
k)Â Â Â Â Â Â Â Â A
medical care facility shall report to the Department when equipment is out of
service for greater than 48 hours.