About
- Clinical and public health laboratories are on the frontline for protecting the nation’s health.
- By applying biosafety principles, laboratories can conduct accurate and timely patient diagnostic tests 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 continually improve quality and safety. These efforts include:
- Enhancing direct communication between CDC and clinical laboratories to distribute resources and technical expertise on Clinical Laboratory Improvement Amendments (CLIA) regulations, laboratory biosafety recommendations, and training opportunities.
- Developing guidelines to implement and support CLIA regulations 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; sharing and disseminating 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:
Hosting an ECHO Biosafety Program
In 2023, CDC launched the Extension for Community Healthcare Outcomes (ECHO) Biosafety Program to develop a community of practice (CoP) to address challenges in clinical and public health laboratories. The University of New Mexico Health Sciences Center developed the ECHO Model™ to invite peers to regularly engage and share support, guidance, and feedback in a virtual environment. The 2023 ECHO Biosafety sessions focused on increasing the knowledge and skills of the biosafety CoP members to address previously identified biosafety gaps. The 2024 sessions addressed implementing biorisk management components in clinical and public health laboratories. The ECHO Biosafety Program will relaunch in 2026.
Providing Technical Expertise
CDC hosted a Town Hall Meeting on Laboratory Biosafety – Use of Laboratory Instruments in collaboration with clinical and public health laboratory partners and instrument manufacturers. The purpose of this meeting was to provide an overview and discussion on laboratory biosafety when using laboratory instruments to test human and biologic specimens. As a result, we collaborated with the Association of Public Health Laboratories (APHL) Biosafety and Biosecurity Committee to provide technical expertise on the development of the Laboratory Instrument Pre-purchase Risk Assessment Checklist. Enhancing Laboratory Safety and Security Through Structured Biorisk Management Implementation.
The Biorisk Management Pilot (BMP) program supports the implementation of biorisk management in clinical and public health laboratories. Through this initiative, more than 160 laboratories have received the ISO 35001:2019 Biorisk Management Standard, which provides a structured framework for identifying, assessing, controlling, and monitoring risks associated with hazardous biological materials. The BMP makes resources available to enhance biosafety and biosecurity practices, and additional efforts are underway to expand these resources on the Biorisk Management webpage, further strengthening the capacity of clinical and public health laboratories.
Presenting a Biannual Biosafety Symposium
CDC hosts an International Symposium on Biosafety every two years in collaboration with external partners. The next symposium will be in 2027.
Contacts
For more information about biosafety initiatives, contact DLSbiosafety@cdc.gov.