Massachusetts

Amendments to the Hospital Licensure Regulations (105 CMR 130.000) and

Birth Center Regulations (105 CMR 142.000)

Regarding

Universal Newborn Hearing Screening Programs (UNHSPs)

Required Pursuant to Chapter 243 of the Acts of 1998

 

AMENDMENTS TO THE HOSPITAL LICENSURE REGULATIONS (105CMR130.000)

 

130.629: Universal Newborn Hearing Screening Programs

 

A. Definitions

  1. Audiologist shall mean an audiologist, licensed by the Commonwealth of Massachusetts pursuant to the Board of Registration of Speech‑Language Pathology and Audiology regulations at 260 CMR 1.00 et seq., who meets such requirements for additional experience as defined by the Department in the Universal Newborn Hearing Screening Guidelines.

 

  1. Birth center shall mean either a free‑standing or hospital‑affiliated birth center, as defined at 105 CMR 142.000 et seq..

 

  1. Birth hospital shall mean, for the purposes of regulations regarding universal newborn hearing screening programs in 105 CMR 130.000 et seq. and 105 CMR 142.000 et seq., a hospital with a maternal and newborn service, as designated by the Department pursuant to 105 CMR 130.600 et seq., or a hospital without a maternal and newborn service but with a pediatric service, as designated by the Department pursuant to 105 CMR 130.700 et seq., from which an infant may be initially discharged to home.

 

  1. Hearing screening shall mean a test to detect hearing thresholds of 30 decibels or greater in either ear in the speech frequency range. The methodology shall be one that is defined as acceptable by the American Academy of Pediatrics and the American Speech and Hearing Association for the purposes of newborn infant hearing screening. The hospital's or birth center's screening outcomes shall meet referral rates established by the Department in the Universal Newborn Hearing Screening Guidelines.

 

  1. Newborn infant shall mean, for the purposes of regulations regarding universal newborn hearing screening programs in 105 CMR 130.000 et seq. and 105 CMR 142.000 et seq., an infant less than three months of age.

 

B. Information and Screening Requirements

 

  1. Prior to the hearing screening of a newborn infant, the hospital or birth center shall include information explaining the importance of newborn hearing screening and follow‑up in materials distributed to parents or guardians.

 

    1. This information shall be readily available in the languages of any non‑English speaking group which comprises at least 10% of the birth hospital or birth center's obstetrical services population.
    2. Translation of the information to languages used by a smaller percentage of the obstetrical population shall be provided prior to the hearing screening to the maximum extent possible, but in no event later than discharge.
    3. For a hospital without a maternal newborn service from which a newborn infant may be initially discharged to home, the hospital shall ensure that translation of the hearing screening information is provided to non‑English speaking parents or guardians of a newborn infant prior to discharge to the maximum extent possible.

 

  1. Each birth hospital and birth center shall ensure that a hearing screening is performed on all newborn infants before the newborn infant is initially discharged to home.
    1. If a newborn infant is transferred directly from the birth hospital or birth center to another hospital, the responsibility for screening lies with the hospital from which the infant is initially discharged to home.
    2. By the age of three months, an infant shall receive hearing screening. If an infant cannot be screened by the age of three months due to delayed physiological development or physiological instability as a result of illness or premature birth, the infant shall be screened prior to discharge and as early as physiological development or stability will permit reliable screening.

 

  1. Such screening shall not be performed if the parent or guardian of the newborn infant objects to the screening based upon sincerely held religious beliefs.

 

  1. If an infant is not successfully screened or missed a screening prior to discharge, the birth hospital or birth center shall contact a Department approved screening center to make an appointment for a screening.

 

  1. The birth hospital or birth center shall inform, orally and in writing, a parent or guardian of the newborn infant if the infant was not successfully screened or missed a screening. This information shall also be provided in writing to the newborn infant's primary care physician as well as to the Department through its electronic birth certificate system or such mechanism as specified by the Department.

 

    1. Such notice shall occur prior to discharge whenever possible, but in any case no later than ten days following discharge.
    2. The birth hospital or birth center so informing the parent or guardian and physician shall provide written information to the parent or guardian and physician regarding appropriate follow‑up for an infant who missed a screening or was not successfully screened. This information shall include at a minimum the time and location of the screening appointment that has been scheduled, the telephone number of the screening site, a list of diagnostic test centers approved by the Department, as well as information about the importance of screening and follow‑up. The information shall be provided to the parent or guardian in writing in the language understood by the parent or guardian.

 

  1. If an infant did not pass the hearing screening, the birth hospital or birth center shall contact a Department approved diagnostic test center to make an appointment for a diagnostic test.

 

  1. The birth hospital or birth center shall inform, orally and in writing, a parent or guardian of the newborn infant if the infant did not pass the screening. This‑information shall also be provided in writing to the newborn infant's primary care physician as well as to the Department through its electronic birth certificate system or such mechanism as specified by the Department.

 

    1. Such notice shall occur prior to discharge whenever possible, but in any case no later than ten days following discharge.
    2. The birth hospital or birth center so informing the parent or guardian and physician shall provide written information to the parent or guardian and physician regarding appropriate follow‑up for an infant who did not pass the screening. This information shall include at a minimum the time and location of the diagnostic test appointment that has been scheduled, the telephone number of the diagnostic test site, a list of diagnostic test centers approved by the Department, as well as information about the importance of follow‑up. The information shall be provided to the parent or guardian in writing in the language understood by the parent or guardian.

 

C. Screening Protocols

 

  1. The birth hospital or birth center shall designate a program director who is responsible for the provision of newborn infant hearing screening services. The program director shall be an audiologist, neonatologist, pediatric otolaryngologist, neonatal or perinatal nurse, or pediatrician. The program director may delegate duties related to the oversight of the hearing screening service to appropriately trained staff.

 

  1. A licensed audiologist shall oversee the provision of screening services and shall train the persons performing the screening.

 

  1. Within one hundred and twenty days of the effective date of 105 CMR 130.629, each birth hospital and birth center shall submit to the Department for its approval a protocol for newborn hearing screening. The protocol shall, at a minimum, to the satisfaction of the Department:

 

    1. Identify the staffing of the program and outline the responsibilities of each staff member;
    2. Describe the training and supervision of screening personnel by a licensed audiologist;
    3. Identify the screening methods and equipment to be used to conduct the screening, including provisions for readily available back‑up equipment in the event of an equipment malfunction;
    4. Outline infection control procedures;
    5. Provide samples of information to be provided to parents/guardians regarding the screening, including but not limited to information about coverage of the costs of the screening by third party payers, the potential risks of hearing loss, and the benefits of early detection and intervention;
    6. Outline the procedure for documenting the results of the screening;
    7. Identify the procedure for communicating that the infant did not pass, was unsuccessfully screened or missed the screening to the parent or guardian, primary care physician, and the Department. See 105 CMR 130.629 (B)(5) and (B)(7);
    8. Describe the training and supervision of individuals with responsibility to inform parents or guardians of screening results;
    9. Identify the procedure to ensure an infant who missed a screening or was unsuccessfully screened will receive a screening. See 105 CMR 130.629 (B)(4)‑(5);
    10. Identify the procedure to ensure the parent or guardian of an infant who did not pass the screening will receive information about follow-up and an appointment for diagnostic services. See 105 CMR 130.629 (B)(6)-(7);
    11. Identify the procedure for reporting data on an annual basis or as otherwise required by the Department, including but not limited to, number of live births, number of infants screened, number of infants who passed the screening, number of infants who did not pass the screening in the right ear, number of infants who did not pass the screening in the left ear, number of infants who did not pass the screening in both ears, number of infants who missed screening or were unsuccessfully screened, the number of infants referred for diagnostic testing, and the number of parents or guardians who refused screening;
    12. Describe the screening program's Quality Assurance review process; and
    13. Include a provision for the review of hearing screening status in the discharge plan for all newborn infants required at 105 CMR 130.630(E)(2)(e), 130.640(B)(4)(p), 130.650(B)(4)(i), and 130.663 and in the information concerning the condition at discharge or transfer required at 105 CMR 142.504(D)(7).

 

  1. Prior to implementing a significant change in a hearing screening protocol approved by the Department, a hospital or birth center must request and have received written approval of the change from the Department.

 

 

(27 March 2001)