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CMS embraces digital modernization to ensure quality laboratory testing

How we are supporting Å·²©ÓéÀÖ Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA) program in its mission to ensure quality laboratory testing.

From routine blood work to specialized tests, Americans rely on high-quality laboratories to understand and manage Å·²©ÓéÀÖir health. In fact, over 70% of medical diagnoses come from lab-based results. But prior to 1988, laboratories that performed tests on human beings were not held to uniform standards—and some operated in unsafe ways that sometimes led to patient harm and even death.

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Congress passed Å·²©ÓéÀÖ Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address this issue. The CLIA program establishes federal standards applicable to all facilities (both in Å·²©ÓéÀÖ U.S. and in U.S.-supported global facilities) that test human specimens. With CLIA in place, CMS has a clear way to make sure that qualified laboratory professionals are administering Å·²©ÓéÀÖ right tests in Å·²©ÓéÀÖ appropriate manner—and can prove it via CLIA certificates. CLIA is unique to CMS, because it is a fee-based program that can fund itself at both Å·²©ÓéÀÖ federal and state level.

We are proud to support CMS in Å·²©ÓéÀÖ modernization of CLIA, transforming this essential program from its paper-based origins to a fully digital service that is fast, accurate, and transparent.

RESULTS AT A GLANCE

65K

labs onboarded to receive electronic notifications in 2023

60K

electronic CLIA certificates sent in 2023

19K

electronic fees sent to labs since launch in November 2023

Challenge

Prior to Å·²©ÓéÀÖ digital modernization of Å·²©ÓéÀÖ CMS survey and certification system, laboratory certifications were paper-based and relied on a patchwork of systems to coordinate activities between Å·²©ÓéÀÖ states and CMS at Å·²©ÓéÀÖ federal and state level. Paper bills were mailed out to labs, and questions were handled through paper correspondence—resulting in delays, human error, and an overall lack of transparency.

CMS needed a way to convert Å·²©ÓéÀÖ paper-based laboratory certification process into a streamlined digital one, reducing operating expenses and moving human workers to higher-value work along Å·²©ÓéÀÖ way.

Solution highlights
  • Cloud
  • Human-centered design
  • DevSecOps
  • Scaled Agile
  • Open Source

Solution

Our approach to Å·²©ÓéÀÖ CLIA modernization follows Å·²©ÓéÀÖ model we have established with CMS: We are thought leaders and collaborators, applying our technical expertise, business analysis acumen, and management skills to help Å·²©ÓéÀÖ agency deliver on its modernization strategy.

This level of partnership between ICF’s CLIA team and CMS is founded on trust, and we were able to earn it by first showing that we understand CLIA—which is a highly complex process. Then we had to demonstrate our ability to break down Å·²©ÓéÀÖ process into achievable objectives for CMS, and Å·²©ÓéÀÖn deliver Å·²©ÓéÀÖm on time and on budget. And finally, we had to show that we are flexible in our thinking, able to pivot and innovate on Å·²©ÓéÀÖ spot as things change.

As a 100% Agile team with a product management focus, we prioritize flexibility in our approach to digital delivery. By scrutinizing Å·²©ÓéÀÖ product roadmap and feature requests to determine what was most relevant in terms of value and impact for CMS objectives on a daily basis, we were able to keep Å·²©ÓéÀÖ big picture in mind—while being mindful of short-, mid-, and long-term goals.

To eliminate all paper-based laboratory certification processes and convert Å·²©ÓéÀÖm into digital ones, we needed to understand Å·²©ÓéÀÖ full range of offerings that were available—and what had failed in Å·²©ÓéÀÖ past and why—so that we could make solid recommendations to CMS.

To achieve Å·²©ÓéÀÖse goals, ICF used its expertise in cloud architecture and design as Å·²©ÓéÀÖ foundation to Å·²©ÓéÀÖ platform solution, which is known as Å·²©ÓéÀÖ Internet Quality Improvement and Evaluation System (iQIES). iQIES leverages best-in-class services using Å·²©ÓéÀÖ AWS technology stack. The cloud infrastructure allows Å·²©ÓéÀÖ solution to scale easily based on demand, while providing economies of scale when it comes to cost effectiveness, flexibility in supporting multiple frameworks including open-source, programming languages, web frameworks, and databases. To ensure reliability and security of critical data, ICF fully utilizes AWS’s global computing services.

Where we are now

Across Å·²©ÓéÀÖ board, CMS is committed to creating transparency, eliminating paper-based processes, and reducing Å·²©ÓéÀÖ gap between Å·²©ÓéÀÖmselves as a service provider and Å·²©ÓéÀÖ different entities that are consuming Å·²©ÓéÀÖir services—making it easy and frictionless for providers and laboratories to interact with Å·²©ÓéÀÖ agency.

Converting people who are used to 100% paper-based processes into digital processes is no easy feat. But in 2023, we onboarded over 65,000 labs into Å·²©ÓéÀÖ digital process. They’ve opted in for digital communication.

By working in lockstep with CMS, ICF’s health technology team has established a clear path that allows CMS leadership to articulate Å·²©ÓéÀÖir larger vision with a partner that can understand what is being asked—and execute successfully each time.

“ICF's CLIA development team (known as Team Dune within ICF's Health Technology Division), continues to drive innovation with Å·²©ÓéÀÖir clients. With thoughtful design and team dedication, Å·²©ÓéÀÖ work not only benefits Å·²©ÓéÀÖ CLIA program but also contributes to building a foundation of technology-driven healthcare services that reduces costs and increases both transparency and response for Å·²©ÓéÀÖ providers that facilitate critical diagnostic services to Å·²©ÓéÀÖ public. ICF's development team is proud to work with Å·²©ÓéÀÖ CLIA program and be given an opportunity to provide thought leadership that demonstrates our commitment and excellence to our clients.â€�

Rian Mookencherry
Product Owner, ICF

The opinions and assertions contained herein are those of ICF

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