CMS modernizes nationwide laboratory oversight

From routine blood work to specialized tests, Americans rely on high-quality laboratories to understand and manage their health. Lab results inform more than 70% of medical diagnoses, yet before 1988, labs testing human specimens were not held to uniform standards.

Congress passed the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to establish federal standards for all facilities that test human specimens, both in the U.S. and at U.S.-supported sites abroad. CLIA gives the Centers for Medicare & Medicaid Services (CMS) a clear way to ensure that qualified professionals administering tests in the appropriate manner and can prove it through CLIA certification.

CMS partnered with ICF to modernize CLIA, replacing paper-based processes with a secure, digital operating model that improves efficiency, transparency, and service delivery across the laboratory oversight system. This program has since become fully paperless and introduced AI-supported capabilities.

Challenge

Historically, CMS laboratory certification relied on paper-based processes and multiple systems to coordinate activities between states and the agency. Operational documents were mailed to laboratories, and questions were handled through paper correspondence, resulting in delays, human error, and an overall lack of transparency.

CMS needed a way to convert laboratory certification into a streamlined digital process that could reduce operating expenses and allow staff to focus on higher-value work.

Solution

To support CMS’s modernization goals, the team used an Agile, product-focused approach that prioritized high-value capabilities while adapting to changing program needs.

We first evaluated the full certification process, available technology options, and lessons from earlier efforts. That analysis informed recommendations for converting paper-based processes into an integrated digital experience.

We applied cloud architecture and design expertise to support the platform solution, known as the Internet Quality Improvement and Evaluation System, or iQIES. Built using AWS technologies, the infrastructure enables the solution to scale with demand and accommodate multiple open-source frameworks, programming languages, web frameworks, and databases. The architecture also supports the reliability and security requirements associated with critical program data. 

Where we are now

This work marked the first phase of a broader CLIA modernization effort, establishing the digital foundation for expanded capabilities. In 2023 alone, more than 65,000 laboratories were onboarded to receive electronic communications. By 2026, CLIA had achieved 100% electronic communications, expanded digital services across the laboratory oversight network, and increased annual document-processing volume to more than 1 million transactions.

This digital foundation created new opportunities for innovation across the program. Read the next chapter: How CMS built a paperless foundation for AI-enabled oversight.