Learn about the NGS Quality Initiative

The Next Generation Sequencing Quality Initiative: Tools for Today and for The Future

A powerful diagnostic, surveillance, or research tool like next generation sequencing (NGS) demands an equally powerful quality management system (QMS) to assure consistent, reliable data at any scale. The equipment, material, personnel, and training required to derive and maintain production of high-quality sequencing data requires a significant investment of time and resources. Clinical and public health laboratory (PHL) personnel can find free tools and resources to introduce or strengthen quality management in their workflows, available online from the Next Generation Sequencing (NGS) Quality Initiative. Build a foundational QMS from the ground up or use the NGS Quality Initiative’s products to enhance an existing QMS.

Find Tools to Use Now and Look Forward to More Resources

The NGS Quality Initiative is a collaboration between CDC, the Association of Public Health Laboratories (APHL), and state and local PHLs to develop and publish customizable, ready-to-implement guidance documents, standard operating procedures, forms, and tools. These products serve the needs of laboratory professionals, bioinformaticians, quality managers, supervisors, laboratory managers, epidemiologists, and microbiologists who are interested in the quality of NGS data or have a role in quality management. Download products you can start using today to get ready for what tomorrow brings to your laboratory.

A laboratory staff member searching for NGS QI tools on a computer.

Laboratory professionals can download free NGS tools from CDC's website.

Increase Your Impact by Using Our Products and Contacting Us with Questions

Using these products helps laboratories create or strengthen pre-analytic, analytic, and post-analytic processes to ensure their equipment, materials, and NGS methods produce high-quality results consistent with quality standards. Test developers, laboratory leaders, and other stakeholders can use products from the site to create a suite of customizable standard operating procedures to guide use of NGS technologies and production of high-quality sequencing data. Use of these products helps ensure accurate, consistent sequencing results that conform to regulatory requirements, when applicable. All products are aligned with CDC’s ongoing quality improvement efforts.

Tangible Outcomes for Professionals and Public Health Laboratories

NGS Quality Initiative goals include developing new tools and helping members of the laboratory community share resources. Our products complement existing resources and support development of a laboratory’s current QMS or can function as a foundational quality system. Laboratories can customize these ready-to-implement tools to quickly train personnel, choose and use appropriate protocols and analyses options, and put effective management and process controls in place to meet their specific needs. This is especially beneficial to laboratories that perform NGS that is subject to CLIA regulations and other laboratory accreditation standards.

Poised to Serve Every Day

Public health laboratory professionals setting up a bacterial DNA sequencing run on a sequencing instrument.

Public health laboratory professionals setting up a bacterial DNA sequencing run on a sequencing instrument.

QMSs have been described by the International Organization for Standardization (ISO) and the Clinical and Laboratory Standards Institute (CLSI) as “coordinated activities to direct and control an organization with regard to quality.” Robust QMS tools like those created by the NGS Quality Initiative provide the foundation that helps ensure high-quality laboratory data used to inform clinical and public health decisions that impact our health and safety.

Genomic sequence data provides insight into the biology, evolution, and transmission of infectious and non-infectious diseases. CDC has launched national efforts to improve the ways sequencing data is used. These include, but are not limited to, efforts on a national viral genomics consortium to better map SARS-CoV-2 transmission and enhancing Newborn Screening for precision public health.

A Project Founded in Science and Practice

The NGS Quality Initiative promotes implementation of quality management based on the CLSI quality framework for laboratories. Use this website to learn how the Initiative adopted CLSI’s 12 quality system essentials as building blocks for developing a QMS for laboratories performing NGS-based tests.

Increasing the Impact of Our Products

When clinical and 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.

In 2019, CDC and the Association of Public Health Laboratories (APHL) launched the Next Generation Sequencing (NGS) Quality Initiative. Together with state and local public health laboratory partners, they began to develop an NGS-focused quality management system (QMS) to address challenges public health laboratories encounter when they develop and implement NGS-based tests. You can share information with colleagues by sending the Web address to this site or by sharing this PDF.

Contact Us About Partnering

Contact the NGS Quality Initiative at NGSQuality@cdc.gov to request information about the project, our products, the process we use for developing resources, or how your laboratory can collaborate. We have quality managers, bioinformaticians, and other experts ready to help your laboratory with your QMS needs!

NGS QI checkmark graphic element.