DLS Secure Labs

About

  • Clinical and public health laboratories are on the frontlines of protecting the nation’s health.
  • By integrating robust biosecurity principles into daily operations, laboratories can safeguard biological material, sensitive technologies, and confidential data from theft, loss, or intentional misuse.

Overview

Laboratories face a growing risk of infiltration by unauthorized individuals with potentially malicious intent. This exposure is of particular concern due to an increasing reliance on informatics and digital systems that are vulnerable to physical and cyber intrusions.

The Division of Laboratory Systems (DLS) works to protect the nation's clinical and public health laboratory system by identifying biosecurity gaps and providing tools and resources to address them. This work helps secure laboratory assets and facilities from deliberate misuse, protecting national security, public health, scientific integrity, and diagnostic testing accuracy.

DLS promotes a proactive, integrated approach to managing laboratory security by:

  • Advancing an Integrated Approach to Biorisk Management:
    • Combining biosafety (preventing accidental exposure or release) and biosecurity (preventing unauthorized access or intentional misuse) into one comprehensive strategy.
  • Supporting Biosecurity Risk Assessment Development:
    • Helping laboratories gather and evaluate information to identify hazards, assess potential consequences, and deploy appropriate strategies to reduce risks to acceptable levels.
  • Promoting Biosecurity Standards and Best Practices:
    • Providing resources to help laboratories create or adopt biosecurity plans that protect personnel, the environment, and biological materials.
  • Sharing Information:
  • Bridging Gaps:
    • Collaborating with CDC's OneLabTM Network to identify and respond to biosecurity training needs by sharing and disseminating resources to help learners prepare for challenges related to public health emergencies.

Initiatives

Elements of Biosecurity

The sixth edition of the CDC and National Institutes of Health publication Biosafety in Microbiological and Biomedical Laboratories (BMBL) provides elements that laboratories may consider when developing a laboratory biosecurity program:

  • Program Management: Establishes institutional commitment, governance, and resource allocation to ensure biosecurity plans are risk-based, implemented, and continuously improved through defined roles, policies, and accountability measures.
  • Physical Security: Measures implemented to protect the safety and security of the laboratory from unauthorized access by individuals without legitimate reason to be there and who may have malicious or otherwise nefarious intent.
  • Personnel Management: Specialized training programs designed to foster an appreciation for biosecurity among individual staff members, bolstered by a commitment to robust pre-employment screenings, access restrictions, and effective succession planning.
  • Inventory and Accountability: Recordkeeping and auditing protocols to ensure that the description, quantity, location, intended use, and responsible personnel for every biological agent are known and accounted for.
  • Information Security: Processes and procedures to identify, label, and safeguard sensitive data (i.e., security plans, access codes, passwords, storage locations, biological agent inventories, unpublished research data, diagnostic results) from unauthorized access.
  • Transport of Biological Agents: Strict adherence to national and international regulations for transporting biological agents, including packaging, marking, and documentation to mitigate potential biosecurity risks.
  • Accident, Injury, and Incident Response: Risk control strategies to effectively prepare for and reduce the consequences of unintended incidents, including detection, communication, assessment, response, and recovery plans.
  • Reporting and Communication: Protocols to recognize and report biosecurity events, including near misses, to ensure that incidents or patterns of concern that signal potential threats to biological material are identified, investigated, and addressed.
  • Training and Practice Drills: Controlled activities based on real-world scenarios to evaluate the effectiveness of plans, procedures, and technical systems and determine how well individuals and teams perform in a simulated emergency.
  • Security Updates and Re-evaluations: Establishes systematic processes to routinely review, audit, and update biosecurity risk assessments and protocols. This includes incident-driven re-evaluations, corrective action implementation, and documentation of audit outcomes to ensure alignment with evolving threats and operational changes.
  • Select Agents: Any laboratory that possesses, uses, or transfers Select Agents is required to fully comply with all regulations set forth by the Federal Select Agent Program.

Laboratories should not view these components as minimum standards or requirements. Instead, they should prioritize them based on site-specific needs, as determined through an appropriate risk assessment process.

Contacts

Contact us at DLSinquiries@cdc.gov

Disclaimer

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.
Print
Content Source: