Congenital cytomegalovirus (cCMV) is the most common congenital infection and the leading nongenetic cause of sensorineural hearing loss. Despite growing legislative mandates for newborn screening in parts of the United States, there is no single consensus on the optimal screening strategy, producing wide variability in practice. The program described assessed outcomes and operational lessons from initiating a systemwide cCMV screening and follow-up program in a large health care enterprise.
A multidisciplinary team representing key clinical and laboratory specialties designed and implemented the program. Stakeholders included neonatology, pediatric infectious disease, infection prevention, audiology, otolaryngology, pediatric hospital medicine, pathology and laboratory medicine, and microbial sciences. The team developed standardized protocols for screening, laboratory testing, and follow-up care with the goal of increasing case detection while fitting into existing clinical workflows.
The enterprise adopted a hybrid screening protocol. Infants in neonatal intensive care units (NICUs) underwent universal screening, while infants in the newborn nurseries received targeted screening based on established criteria. This hybrid model sought to balance broad detection capability in high-risk settings with resource-focused targeted testing in the nursery environment.
A coordinated laboratory pathway was developed to support the screening program. Integration of testing procedures with the health system’s pathology and laboratory medicine services enabled scaling from a low baseline volume to substantially higher throughput. The article reports that rapid integration of screening protocols into routine workflows was achievable across the enterprise, facilitated by the multidisciplinary planning effort.
From 2022 to 2025 the health system recorded 50,438 live births. During that interval, 7,491 infants (14.9% of live births) underwent cCMV screening. Annual testing volumes rose markedly after implementation, from roughly 150 infants tested per year before the program to over 2,000 infants tested annually following rollout. This increase reflects operational expansion and uptake of the hybrid protocol across sites.
Thirty-four infants were confirmed to have cCMV among those screened, representing 0.45% of screened infants and an estimated approximately 2.5-fold increase in detected cases compared with prior detection rates reported by the authors. Detection rates varied between the screening approaches: the targeted nursery group had a higher detection rate than the universal NICU group (0.74% vs 0.33%; P = .01).
The most common clinical findings among confirmed cases included:
These findings illustrate the spectrum of abnormalities identified among infants with confirmed infection in this implementation cohort.
The program successfully integrated screening protocols into clinical workflows across a large health system in a relatively short time frame. Multidisciplinary collaboration was essential to align clinical decision making, laboratory capacity, and follow-up procedures. The hybrid approach allowed the system to expand testing volumes substantially while maintaining targeted use of resources in the newborn nursery population.
Although initial screening and diagnostic workflows were rapidly adopted, the authors identified limited audiology follow-up as a significant challenge. Barriers included logistical constraints, socioeconomic factors, and gaps in family education, which impeded timely audiologic evaluation and ongoing surveillance. The article emphasizes that improved access to audiology services and strengthened follow-up pathways are necessary to translate increased detection into meaningful clinical outcomes for affected infants.
The reported experience demonstrates that a hybrid cCMV screening program is feasible to implement across a large hospital system and can substantially increase case detection. Key success factors included multidisciplinary planning and integration with laboratory services. However, the clinical impact of increased detection is limited if post-diagnosis services such as audiology are not accessible. The authors conclude that improved access to follow-up care is required to maximize benefits of screening programs. Details on cost, longer-term clinical outcomes, or specific follow-up metrics beyond those summarized were not reported in the source article.