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How digital modernization can foster ongoing innovation in federal agencies

ICF helped CMS expand an early program transformation into the infrastructure for AI-enabled laboratory oversight.

In 2023, CMS and ICF launched the first phase of a modernized solution to manage communications for the agency’s Clinical Laboratory Improvement Amendments (CLIA) program. Since then, CMS and ICF have continued expanding the program’s capabilities, broadening what it can deliver, and building toward a fully digital operating model.

Challenge

CLIA sets the federal standards that keep laboratory testing safe and reliable for more than 300,000 laboratories nationwide. Before the 2023 modernization, CLIA depended on paper-based communications and a patchwork of disconnected systems to coordinate among labs, state agencies, and CMS. This workflow created delays, introduced errors, and limited visibility across the laboratory oversight network.

Solution highlights
  • Digital modernization

Solution

CMS partnered with ICF to convert these manual, paper-driven processes into a cloud-based digital system. We used the CMS-approved iQIES and iQAN platforms to support a secure, electronically enabled framework across the CLIA laboratory oversight network. During the initial phase, we moved 65,000 labs onto electronic notifications and certificates for the first time.

This early modernization work converted CLIA data into a structured, digitally accessible format, creating the foundation for AI-enabled tools that support information access and daily workflows. In June 2026, CMS deployed the CLIA AI Assistant, which helps authorized users locate source documents, reference and interpret policy information, access current operational data, and support tasks such as ad hoc reporting across CLIA’s full network of labs. Together, these capabilities give CLIA staff and stakeholders faster access to the information they need to carry out program operations.

Results

This modernization enabled the CLIA program to go 100% paperless by mid-2026. The expanded digital operating framework has produced measurable results:

  • CLIA’s document processing volume has grown from a few hundred thousand per year to more than 1 million annually.
  • Document processing time has plummeted, from up to two weeks for paper-based printing and mailing to mere minutes for digital delivery.
  • Electronic delivery of certificates has tripled, from under 50,000 in 2023 to more than 150,000 in 2025.
  • The solution’s integrated billing system can now process tens of millions of dollars related to CLIA fees and services each year.

Through this partnership, ICF has helped advance several of CMS’ strategic priorities while delivering measurable financial, operational, and environmental benefits. These aren’t one-time gains; this work represents a permanent shift in how CLIA operates. More importantly, it demonstrates that successful modernization extends beyond digitizing existing processes. By creating a scalable digital operating foundation, agencies can improve current performance while positioning themselves to adopt new capabilities as needs, technologies, and priorities evolve.

300,000+

labs served

3x

growth in certificates delivered digitally between 2023 and 2025

100%

communications sent electronically by 2026

"What began as a modernization initiative evolved into a fundamental reinvention of how CLIA operates. Through the implementation of a growing services portfolio, CMS established a connected digital operating model that streamlines regulatory operations, enhances stakeholder engagement, reduces administrative burden, and positions the program to rapidly adopt emerging technologies and evolving business needs."

Rian Mookencherry
Senior Manager, Product Owner, ICF

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