Biosafety Initiatives in the Division of Laboratory Systems

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 jeopardizing the health of their workers, the environment, or the public. 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 various initiatives geared towards continually improving quality and safety.

Enhance direct communication between CDC and clinical laboratories to distribute guidance on Clinical Laboratory Improvement Amendments (CLIA) regulations, laboratory biosafety recommendations, and training opportunities.

Develop standards and 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.
Manage and support the Clinical Laboratory Improvement Advisory Committee (CLIAC), a federal advisory committee that provides independent scientific guidance to HHS on improving laboratory quality and safety practices.
Collaborate 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.

Biosafety Initiatives

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. The goal of the ECHO Biosafety project is to improve biosafety in clinical and public health laboratories by increasing the knowledge and skills of the biosafety CoP members to address previously identified biosafety gaps.

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.

Supporting CLIAC Laboratory Safety Recommendations

Find CLIAC’s recommendations to the Department of Health and Human Services (HHS) in the 2023 “Clinical Laboratory Improvement Advisory Committee (CLIAC) Recommendations Table.”
In April 2016, CLIAC declared clinical laboratory biosafety “…an urgent, unmet, national need” and called upon the U.S. government to develop a strategy for clinical laboratories focused on substantially increasing the amount of biosafety guidance and training to the clinical laboratory community.
In April 2015, CLIAC made recommendations about laboratory safety stemming from lessons learned during the 2014 Ebola Outbreak in Democratic Republic of the Congo.

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