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PA Bulletin, Doc. No. 22-1303

NOTICES

DEPARTMENT OF HEALTH

Cytomegalovirus (CMV) Education and Newborn Screening Act

[52 Pa.B. 5579]
[Saturday, August 27, 2022]

 The act of June 27, 2022 (P.L. 388, No. 29), known as the CMV (CMV) Education and Newborn Screening Act (act) was signed into law on June 27, 2022. The act takes effect immediately and provides for the Department of Health (Department) to promulgate regulations within 2 years of the effective date. The act also requires the Department to make certain information and statistics regarding CMV available by means of the Department's web site. This information, including links to relevant resources, a template for capturing CMV screening consent/refusal and the Excel form used for the reporting requirements discussed as follows, can be found on the PA Newborn Hearing web site at https://www.health.pa.gov/topics/programs/Newborn-Screening/Pages/Hearing.aspx. The act additionally requires all newborn care providers (birthing facilities, certified nurse midwives, unlicensed midwives and health care practitioners) to provide CMV information to pregnant persons under their care and to offer a CMV screening to the parent or guardian of any newborn who fails their initial screening before the child turns 21 days of age. The Department created a CMV brochure available on the PA Newborn Hearing web site which can be shared with parents and guardians to meet this informational requirement. If practitioners cannot perform CMV screenings, they must provide referrals for screening.

 Consent must be provided by the newborn's parent or guardian and established by means of a signed consent form. Objection to a CMV screening following a failed initial hearing screening must be established by means of a signed form. Consent and objection forms must then be stored in the medical records of the child and reported on monthly to the Department. Providers are required to submit monthly aggregate screening, referral and CMV consent and objection data to the Department by means of an Excel spreadsheet available on the PA Newborn Hearing web site. Reporting will begin in October 2022, for newborns birthed September 1, 2022, and forward. Aggregate data for each month must be submitted within 7 days of the following month to the resource account at ra-tcnbsadmin_fax@pa.gov.

 The act establishes that the CMV screening is to be performed using polymerase chain reaction (PCR) on saliva or urine, a follow up urine test to a positive PCR saliva test or additional testing measures approved by the Department.

 For additional information, contact Jordan Shover, Program Manager, Division of Newborn Screening and Ge-netics, at (717) 783-8143. Speech and/or hearing-impaired persons use V/TT (717) 783-6514 or the Pennsylvania Hamilton Relay Services at (800) 654-5984 (TT).

DR. DENISE A. JOHNSON, 
Acting Secretary

[Pa.B. Doc. No. 22-1303. Filed for public inspection August 26, 2022, 9:00 a.m.]


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