Pathway to Quality-Focused Testing

Version 1.0.2

Scope-

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.

Introduction +

Intended Use +

Five Phases of the Pathway

Prepare for Validation

Review and Finalize Procedures

Perform Validation

Post Validation-Train and Authorize Personnel

Test and Maintain

Phase 1 Description

Personnel Performing Validation

Equipment

Reagents, Media, and Supplies

Laboratory Space and Safety

Phase 1 outlines considerations for how to proceed in preparing for validation. This preparation is vital to the validation process, as it forms the basis for validation itself. In this phase, the laboratory should be meticulous and thorough in identifying and documenting all the criteria needed to prepare for testing. These criteria should include personnel, equipment, reagents/media, and laboratory safety policies and procedures involved in the validation process as defined below.

Progress Tracker

Completion: Pathway to Quality-Focused Testing Tool

You have now completed the Pathway to Quality Focused Testing, a comprehensive roadmap to validation, continued testing, and maintenance of NGS workflows. This Tool is intended to be used as a framework for laboratories to consider when preparing for and completing method validations. Laboratories should refer to their institution’s policies and practices or contact their regulatory body regarding specific requirements for their organization. See the Next Generation Sequencing Quality Initiative (NGS QI) QMS Tools and Resources webpage for additional published NGS QI resources that are agnostic and customizable for laboratories to adopt for their intended use.

The NGS QI requests feedback on this iteration of the Pathway Tool relating to presentation, content, and overall quality improvements. Please send feedback to the NGS QI at NGSQuality@cdc.gov .