CMS embraces digital modernization to ensure quality laboratory testing

From routine blood work to specialized tests, Americans rely on high-quality laboratories to understand and manage their 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.

Congress passed the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address this issue. The CLIA program establishes federal standards applicable to all facilities (both in the 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 the right tests in the 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 the federal and state level.

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

Challenge

Prior to the digital modernization of the CMS survey and certification system, laboratory certifications were paper-based and relied on a patchwork of systems to coordinate activities between the states and CMS at the 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 the paper-based laboratory certification process into a streamlined digital one, reducing operating expenses and moving human workers to higher-value work along the way.

Solution

Our approach to the CLIA modernization follows the model we have established with CMS: We are thought leaders and collaborators, applying our technical expertise, business analysis acumen, and management skills to help the 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 the process into achievable objectives for CMS, and then deliver them on time and on budget. And finally, we had to show that we are flexible in our thinking, able to pivot and innovate on the 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 the 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 the big picture in mind—while being mindful of short-, mid-, and long-term goals.

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

To achieve these goals, ICF used its expertise in cloud architecture and design as the foundation to the platform solution, which is known as the Internet Quality Improvement and Evaluation System (iQIES). iQIES leverages best-in-class services using the AWS technology stack. The cloud infrastructure allows the 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 the board, CMS is committed to creating transparency, eliminating paper-based processes, and reducing the gap between themselves as a service provider and the different entities that are consuming their services—making it easy and frictionless for providers and laboratories to interact with the 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 the 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 their larger vision with a partner that can understand what is being asked—and execute successfully each time.

The opinions and assertions contained herein are those of ICF