Learn about the NGS Quality Initiative

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

A powerful diagnostic and surveillance 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.

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 that develops and publishes customizable, ready-to-implement guidance documents, standard operating procedures, forms, and tools. These products serve the needs of laboratory professionals, bioinformaticians, quality managers and supervisors, laboratory managers, epidemiologists, and microbiologists who are interested in NGS data quality or have a role in quality management. Download products you can start using today to get ready for what tomorrow brings to your laboratory.

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. Commercial 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.

Contact the NGS Quality Initiative at NGSQuality@cdc.gov to request information about the project, our products, and the process we use for developing resources. The Initiative continues to build a foundation for the national laboratory community’s capacity to implement and improve sequencing quality. This includes publishing more training products and supporting laboratories already using our resources.

Tangible Outcomes for Professionals and Public Health Laboratories

Initiative goals include developing new tools and helping members of the laboratory community share resources. Our products complement existing resources and support the development of a laboratory’s current QMS or can act as a foundational quality system. Laboratories can adapt 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. This is especially beneficial to laboratories that perform NGS-based tests subject to CLIA regulations and other laboratory accreditation standards.

Poised to Serve Every Day and In Public Health Emergencies

QMSs have been described by the International Organization for Standardization 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 this 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.

The NGS Quality Initiative and its products are ready to assist with improving identification of new and emerging pathogens like SARS-CoV-2 and monitoring circulation of variants. Using Initiative resources to implement a new QMS, or expand an existing one, will help laboratories have confidence in their sequencing results.

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.

A Win for Communities and Our Health

When public health laboratories (PHLs) use a QMS to ensure high-quality NGS data, they can deliver more accurate and reliable test results, which can improve 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 Project. 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.