![]() The guidance provided here is not intended to set regulatory precedents or to address biosafety requirements but, rather, to serve as a resource to public health and clinical laboratories adopting and implementing NGS technologies. The NGS quality guidance developed and presented here should easily integrate into most foundational laboratory QMSs. Therefore, the NGS Quality Workgroup chose to adopt the CLSI QSE framework to develop procedures, guidance, and tools to assist laboratories in implementing and maintaining quality practices for their NGS workflows. These 12 QSEs are the foundational components of a QMS and align with quality system elements described in the International Organization for Standardization’s ISO 15189 requirements ( 5). Many laboratories utilize the 12 quality system essentials (QSEs) identified by the Clinical and Laboratory Standards Institute (CLSI) as their QMS framework ( 4): organization, customer focus, facilities and safety, personnel, purchasing and inventory, equipment, process management, documents and records, information management, nonconforming events management, assessments, and continual improvement. The NGS Quality Workgroup wanted to ensure that any NGS-specific guidance could be integrated into existing laboratory QMSs. The goal of the workgroup was to leverage best practices from across the agency and to develop practical guidance for laboratories implementing NGS within a quality management system (QMS). This workgroup brought together laboratory scientists, bioinformaticians, and quality managers from across the agency for a multidisciplinary and consensus-based approach. Workgroup formation was concomitant with a survey sent to members of the CDC NGS community to gather information on challenges faced by laboratories developing and implementing NGS methods. To address the challenges of developing and implementing quality NGS methods within Centers for Disease Control and Prevention (CDC) laboratories, the CDC NGS Quality Workgroup was formed in 2015. These challenges include (i) a multistep process with many potential sources of variation, (ii) difficulty setting up and troubleshooting protocols, (iii) Significant personnel training requirements, (iv) frequent updates to sequencing platforms, chemistries, and software, and (v) difficulty assessing the quality of materials and data as they progress through the NGS workflow. However, public health laboratories implementing NGS methods face a number of challenges ( 2, 3). Next generation sequencing (NGS) has contributed to the improvement of both clinical diagnostics and public health surveillance efforts ( 1). ![]()
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