CDC and APHL publish phase 2 guidance on implementing NGS quality management systems
The CDC and APHL report phase 2 efforts to develop practical guidance for implementing quality management systems in clinical and public health laboratories utilizing next generation sequencing. Investigators outline persistent operational challenges, including platform selection, complex bioinformatics, reagent management, and regulatory compliance, while detailing a collaborative framework to standardize sequencing-focused quality assurance. This resource provides laboratory directors with actionable strategies to maintain accreditation, optimize workflow efficiency, and ensure reliable diagnostic and surveillance results. The guidance addresses a critical need for standardized quality protocols as NGS adoption expands across molecular testing laboratories.
The original study
The CDC/APHL next generation sequencing quality initiative: practical guidance to implementing quality management systems in laboratories performing next generation sequencing (phase 2).
- Authors
- Cherney B, Diaz A, Ghattas C, Gregory M, Stow E, Onyewuenyi J, et al.
- Journal
- Journal of clinical microbiology
- Type
- Journal Article, Review
- PMID
- 42474357
Original abstract
Whenever next generation sequencing is used in clinical and public health laboratories, rigorous quality control and quality assurance are key components of a quality management system. However, both the development and maintenance of a quality management system encompassing next generation sequencing present significant challenges, such as selection of appropriate sequencing platforms, complex workflows, allocation of time and resources, kit and reagent management, potential discontinuation of technical support, specialized bioinformatic workflows, compliance with regulatory and/or accreditation bodies, and the necessity of highly trained personnel. In an effort to address such challenges, the Centers for Disease Control and Prevention collaborated with public health partners to establish the Next Generation Sequencing Quality Initiative, which focuses on the development of a sequencing-focused quality management system. Here, we describe the ongoing efforts of the Next Generation Sequencing Quality Initiative to develop a foundational quality management system specific to next generation sequencing, as well as collaborations aimed to assist partners in addressing ongoing and emerging quality-related challenges associated with assay implementation in laboratories for surveillance and diagnostic applications.