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Review
. 2019 Jul 26;57(8):e00261-19.
doi: 10.1128/JCM.00261-19. Print 2019 Aug.

Practical Guidance to Implementing Quality Management Systems in Public Health Laboratories Performing Next-Generation Sequencing: Personnel, Equipment, and Process Management (Phase 1)

Rebecca J Hutchins  1 , Kristy L Phan  1 , Adeeba Saboor  2 , Joseph D Miller  3 , Atis Muehlenbachs  4 ; CDC NGS Quality Workgroup
Collaborators, Affiliations
Review

Practical Guidance to Implementing Quality Management Systems in Public Health Laboratories Performing Next-Generation Sequencing: Personnel, Equipment, and Process Management (Phase 1)

Rebecca J Hutchins et al. J Clin Microbiol. .

Abstract

Quality standards as part of an effective quality management system (QMS) are the cornerstone for generating high-quality test results. Next-generation sequencing (NGS) has the potential to improve both clinical diagnostics and public health surveillance efforts in multiple areas, including infectious diseases. However, the laboratories adopting NGS methods face significant challenges due to the complex and modular process design. This document summarizes the first phase of quality system guidance developed by the Centers for Disease Control and Prevention (CDC) NGS Quality Workgroup. The quality system essentials of personnel, equipment, and process management (quality control and validation) were prioritized based on a risk assessment using information gathered from participating CDC laboratories. Here, we present a prioritized QMS framework, including procedures and documentation tools, to assist laboratory implementation and maintenance of quality practices for NGS workflows.

Keywords: next-generation sequencing; public health; quality management systems; quality system essentials.

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Figures

FIG 1
FIG 1
NGS workflow with QC checkpoints in the wet laboratory (A) and dry laboratory (B).
See this image and copyright information in PMC

References

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