The Next Generation Sequencing Quality Initiative

Overview

In 2019, the 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 developed an NGS-focused quality management system (QMS). It addresses challenges public health laboratories encounter when they develop and implement NGS-based tests. This QMS allows users to develop and publish customizable, ready-to-implement guidance documents, standard operating procedures, forms, and tools.

A powerful diagnostic, surveillance, or research tool like NGS demands a robust QMS to ensure consistent, reliable data at any scale. Producing and maintaining high-quality sequencing data requires significant investments in equipment, materials, personnel, and training.

Clinical and public health laboratory (PHL) personnel can access free tools and resources. These resources help introduce or strengthen quality management in their workflows. Build a foundational QMS from the ground up or use the NGS Quality Initiative’s products to enhance an existing QMS.

Purpose

The NGS Quality Initiative offers a foundational, NGS-focused QMS. It is based on the Clinical & Laboratory Standards Institute's (CLSI) framework of 12 Quality Systems Essentials (QSEs). The Initiative supports implementation of quality management practices in labs by using these QSEs to build effective QMS for NGS-based tests.

Funding and Partners

CDC’s Office of Advanced Molecular Detection funds the NGS Quality Initiative, co-led by the Division of Laboratory Systems and APHL.

Tools and resources

The tools include more than 100 ready-to-implement guidance documents, customizable standard operating procedures, and more to download and use for free.

Laboratory professionals can use these products to create or strengthen pre-analytic, analytic, and post-analytic processes. This ensures that equipment, materials, and NGS methods produce high-quality results that meet quality standards.

These professionals include:

• Quality managers
• Microbiologists
• Bioinformaticians
• Test developers
• Laboratory leaders
• Others involved with development and implementation of NGS-based tests

By utilizing these resources, laboratories can develop or enhance their quality management systems (QMS). This supports creating customizable standard operating procedures and guides the use of NGS technologies for accurate, consistent sequencing data. CDC’s ongoing quality improvement efforts align with all products.

These products complement existing resources and support the development of a laboratory's current QMS or serve 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.
• 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. Download these products to tackle challenges in achieving high-quality results and prepare for future developments in your laboratory.

Impact

The International Organization for Standardization (ISO) and CLSI describe QMSs as "coordinated activities to direct and control an organization with regard to quality."

Robust QMS tools, such as those created by the NGS Quality Initiative, provide the foundation that helps ensure high-quality laboratory data. This data is essential for making informed clinical and public health decisions that significantly impact health and safety.

When clinical and public health laboratories use a QMS to ensure high-quality NGS data, they can deliver more accurate and reliable test results. This improvement:

• Enhances diagnostic accuracy.
• Positively influences prognosis.
• Ultimately benefits patient and community health.

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 efforts on a national viral genomics consortium to map SARS-CoV-2 transmission and enhance Newborn Screening for precision public health.

Contact us

Contact the NGS Quality Initiative at NGSQuality@cdc.gov to request information about:

• Project
• Products
• Process used for developing resources
• Collaboration opportunities

There are quality managers, bioinformaticians, and other experts ready to help your laboratory with your QMS needs!