Congenital Cytomegalovirus (cCMV)

Conditions

OVERVIEW

Florida began in January a targeted cCMV screening program for newborns who do not pass their hearing test. cCMV is the most common viral infection and the leading non-genetic cause of hearing loss in infants born in the United States. cCMV infection is harmless to most people. However, when contracted during pregnancy, cCMV can cause symptoms in infants including hearing loss and developmental disabilities. This new screening is intended to identify infants with cCMV and connect families with appropriate medical treatments and therapies.

Please review the information below to learn more about cCMV and how Florida plans to provide targeted screening, family follow-up, and early intervention to infants with cCMV.

Is cCMV screening state-mandated just like the newborn hearing screening?

Per section 383.145, Florida Statutes,  hospitals that provide maternity and newborn care are required to conduct cCMV screening prior to discharge for newborns who fail the newborn hearing screening. Birthing centers are required to refer newborns for a hearing screening prior to discharge and home birth providers are required to refer newborns for a hearing screening within seven days of birth. Primary care providers (PCP) are required to refer newborns born at birthing centers and at home who fail an initial outpatient hearing screening for a cCMV screening.

Where can I find general recommendations for implementing targeted cCMV screening?

The cCMV Screening Guidelines, published in November 2022, are available to view and download on https://floridanewbornscreening.com/.

What kind of cCMV test can we use?

Each facility is responsible for selecting the cCMV test that will be used. Per section 383.145, F.S., a test approved by the U.S. Food and Drug Administration (FDA) or another diagnostically equivalent test can be used to test for cCMV. FDA approved tests can be found using the Clinical Laboratory Improvement Amendments search database at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm.

Should a facility screen a newborn for cCMV after failure of the first (initial) hearing screening or the second (repeat) hearing screening?

Section 383.145, F.S., requires hospitals to complete a cCMV screening when a newborn is being discharged with a failed hearing screening, whether it be the first or second inpatient hearing screening. Each facility is responsible for creating a protocol for cCMV screening, including which inpatient hearing screening will trigger cCMV screening.

 

Examples of screening flows have been provided in the cCMV Guidelines.

  • Page 6 of the guidelines is a screening flow designed for facilities who choose to use the initial inpatient screening as the trigger for a cCMV screening.
  • Page 7 of the guidelines is a screening flow designed for facilities who choose to use the repeat inpatient screening as the trigger for a cCMV screening.

What are the reporting requirements for cCMV screening?

Per section 383.145, F.S., results of newborn hearing loss screening, cCMV screening, and any related diagnostic testing, must be reported to the Florida Newborn Hearing Screening (NBHS) Program within seven days after receipt of such results.

How will cCMV screening results be reported to the NBHS Program?

All cCMV screening results must be submitted through the electronic reporting portal, eReports™. Account requests can be made by completing the eReports Online Registration Form. cCMV screening results required to be reported to the NBHS Program within seven days of receiving the results.

What results are required to be reported to the Newborn Hearing Screening Program?

All positive, negative, inconclusive, unsatisfactory, missed, and parent refusals are required to be reported to the NBHS Program through eReports. For detailed instructions on reporting cCMV results, visit eReports Training – How to Enter cCMV Screening Results.

What are the next steps if a newborn tests positive for cCMV?

Facilities and PCPs should consult with an infectious disease specialist for recommendations for medical management. Additionally, the National CMV Foundation developed a Roadmap for Newborn Congenital CMV Work-up and other resources to assist providers with medical management of newborns who screen positive for cCMV. Other provider resources are available for download at  under the Resources section.