The Centers for Disease Control and Prevention and the Association of Public Health Laboratories’ Next Generation Sequencing (NGS) Quality Initiative (QI) developed “A Pathway to Quality-Focused Testing” (Pathway). The Pathway is intended to support laboratory personnel responsible for validation, continued testing, and maintenance of NGS workflows. It provides an interactive method to monitor progress and track task completion during a method validation and could be presented to laboratory leadership (or designee) when reviewing validation plans or monitoring progress. The Pathway is intended as one option for approaching method validation. Use does not ensure a successful validation. This Pathway is not intended as a stand-alone document for developing an NGS Quality Management System (QMS) but as a supplement to other published tools and resources that address these topics in more depth. This document identifies additional NGS-related tools and resources that provide additional information and examples (e.g., precision, accuracy). Please visit https://www.cdc.gov/lab-quality/php/ngs-quality-intiative/qms-tools-resources.html. It is expected that each laboratory will use this Pathway, in whole or in individual phases, to guide NGS method validation according to their needs. The phases and resources can help to address considerations and recommend quality checkpoints from pre- through post-analytic phases of the total testing process and are intended to be used as resources for method validation from preparation through continual maintenance. The Pathway is based on guidance from the Clinical and Laboratory Standards Institute (CLSI), the College of American Pathologists (CAP), and others.
NOTE: Additional resources are included in the References section of Phase 5.