Learn about the NGS Quality Initiative

In 2019, CDC and the Association of Public Health Laboratoriesexternal iconexternal icon (APHL) launched the Next Generation Sequencing (NGS) Quality Initiative Project. Together with state and local public health laboratory partners, they will develop an NGS-focused quality management system (QMS) to address challenges public health laboratories encounter when they develop and implement NGS-based tests.

NGS is evolving quickly, and even though CDC, APHL, and others have published guidance documents, a need persists for additional laboratory resources. The NGS Quality Initiative Project is producing a set of tools and collaboratively-developed support documents to implement a QMS for public health laboratories using NGS. Laboratories will be able to adapt these ready-to-implement tools to their needs to readily train personnel, choose and use appropriate protocols and analyses options, and put effective management and process controls in place. Such tools are especially beneficial to laboratories performing NGS-based tests that are subject to meeting CLIA regulations and other laboratory accreditation standards.

When laboratory professionals use tools and guidance from the NGS Quality Initiative Project to implement a QMS as they develop and implement NGS-based tests, they help establish a foundation of quality across the community of public health laboratories. Products from this project will also complement existing resources and support the development of a laboratory’s current QMS.

The project is funded by CDC’s Office of Advanced Molecular Detection, and is co-led by the Division of Laboratory Systems, the Office of the Deputy Director for Infectious Diseases, and APHL.

A Win for Communities and Our Health

When public health laboratories use a QMS to ensure high-quality NGS data, they can deliver more accurate and reliable test results, which positively affects prognosis and improves the health of patients and communities.

Page last reviewed: November 5, 2019