(a) As a condition of its licensure, each hospital shall establish a Universal Newborn Hearing Screening (UNHS) program. Each UNHS program shall:

(1) Provide a hearing screening test for every newborn born in the hospital, for identification of hearing loss, regardless of whether or not the newborn has known risk factors suggesting hearing loss.

(2) Develop screening protocols and select screening method or methods designed to detect newborns and infants with a significant hearing loss.

(3) Provide for appropriate training and monitoring of the performance of individuals responsible for performing hearing screening tests. These individuals shall be trained properly in:

a. The performance of the tests required by this chapter;

b. The risks of the tests, including psychological stress for the parent or parents;

c. Infection control practices; and

d. The general care and handling of newborns and infants in hospital settings.

e. [Repealed.]

(4) Perform the hearing testing prior to the newborn’s discharge; if the newborn is expected to remain in the hospital for a prolonged period, testing shall be performed prior to the date on which the child attains the age of 3 months.

(5) Develop and implement procedures for documenting the results of all hearing screening tests and the scheduling of follow-up appointments to help reduce loss to follow-up.

(6) Inform the newborn’s or infant’s parents and primary care physician, if 1 is designated, of the results of the hearing screening test, or if the newborn or infant was not successfully tested. Whenever possible, such notification shall occur prior to discharge; if this is not possible, notification shall occur no later than 10 days following the date of testing. Notification shall include information regarding appropriate follow-up for a screening failure or a missed screening, and referral information for confirmatory testing. If a hearing screening test indicates the possibility of a significant hearing loss, the hospital shall ensure that the physician or other person attending the newborn or infant is made aware of the community resources available for confirmatory testing and process of referral to early intervention services.

(7) Collect performance data specified by the Division of Public Health to ensure that each UNHS program is in compliance with this section, including the number of infants born, the proportion of all infants screened, the referral rate, the follow-up rate, the false-positive rate, and the false-negative rate.

a. Testing performance standards. — 1. Each UNHS program should have a false-positive rate of 5% or less.

2. Each UNHS program should have a false-negative rate of 5% or less.

b. Oversight responsibility. — The Division of Public Health shall exercise oversight responsibility for UNHS programs, including establishing a performance data set and reviewing performance data collected pursuant thereto by each hospital.

(b) Audiologists shall report all results of newborn, infant, and child hearing screenings and/or testing to the state EHDI program at the Division of Public Health. Reporting of results must be the same day as testing if at all possible. If this is not possible, results must be reported no later than 10 days following the testing date. Notification shall include information regarding appropriate follow-up for a screening failure or a missed screening, and referral information for confirmatory testing if not already complete.

75 Del. Laws, c. 116, § 1; 70 Del. Laws, c. 186, § 1; 78 Del. Laws, c. 389, § 1; 81 Del. Laws, c. 79, § 21.