DLS Safe Labs

About

  • Clinical and public health laboratories are on the frontline for protecting the nation’s health.
  • The application of biosafety principles enables laboratories to conduct accurate and timely patient diagnostic tests without while protecting the health of their workers, the environment, and the public.

Overview

Robust laboratory biosafety is fundamental to an effective and efficient national response to an emerging infectious disease outbreak.

The Division of Laboratory Systems (DLS) works to strengthen the nation's clinical and public health laboratory system through ongoing efforts to towards continually improve quality and safety. These efforts include:

  • Developing guidelines to implement and support the CLIA regulations, which govern all healthcare-related laboratory testing performed on people in the United States to ensure the accuracy, reliability, and timeliness of laboratory test results.
  • Collaborating with CDC's OneLab Network to identify and respond to safety training needs; share and disseminate resources to help learners prepare for challenges related to public health emergencies.

Initiatives

In addition to these core functions, DLS leads several key initiatives to strengthen clinical and public health laboratories and address emerging challenges, including:x

Convening a CLIAC Biosafety Workgroup

In 2023, CLIAC convened a Biosafety Workgroup including diagnostic instrument manufacturers, clinical and public health laboratory professionals, federal partners, and industrial hygienists to inform future CLIAC recommendations for improving the safe working environment of the nation's clinical and public health laboratories. The workgroup is CDC's response to CLIAC laboratory safety recommendations made between 2001 and 2019, some of which are listed on this page, and to inform future recommendations.

Hosting an ECHO Biosafety Program

In 2023, CDC launched the Extension for Community Healthcare Outcomes (ECHO) Biosafety Program to address challenges in clinical and public health laboratories through the development of a community of practice (CoP). This Program is based on the ECHO Model™, developed by the University of New Mexico Health Sciences Center. The ECHO Model™ invites peers to engage in a virtual environment on a regular basis where they share support, guidance, and feedback. In 2023 the ECHO Biosafety sessions focused on increasing the knowledge and skills of the biosafety CoP members to address previously identified biosafety gaps. In 2024, the sessions addressed the implementation of biorisk management components in clinical and public health laboratories. The ECHO Biosafety Program will relaunch in 2026.

Holding a Laboratory Biosafety Town Hall

In 2022, CDC held a Town Hall Meeting on Laboratory Biosafety – Use of Laboratory Instruments. The agency hosted this meeting in collaboration with clinical and public health laboratory partners and instrument manufacturers. The goal was to co-develop practical solutions to address issues or gaps and improve pandemic preparedness. Visit the web page for more information.

Raising Awareness of ISO 35001:2019

ISO 35001:2019 Biorisk management for laboratories and other related organizations implementation project aim is to increase awareness and use of resources to support the implementation of ISO 35001 among public health laboratories.

Presenting a Biannual Biosafety Symposium

Every two years, CDC hosts an International Symposium on Biosafety in collaboration with external partners. The next symposium will be in 2026.

Contacts

For more information about biosafety initiatives, contact DLSbiosafety@cdc.gov.

Disclaimer

The Centers for Disease Control and Prevention (CDC), or the Department of Health and Human Services (HHS) cannot attest to the accuracy of a non-federal site and the listing of non-federal resources and tools below does not constitute an endorsement by HHS or any of its employees of the sponsors of the information or products.
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Division of Laboratory Systems