Laboratory Response Network

This section addresses the crucial roles of the regional laboratory and the Laboratory Response Network (LRN) in the context of BSL-3 pathogens and Select Agents, specifically focusing on bioterrorism preparedness and response

Understanding the Threat and the Response System

• Bioterrorism Threat: The intentional use of biological agents (bacteria, viruses, toxins) to cause harm or death. This poses a significant threat to public health, national security, and economic stability
• Importance of Preparedness: Effective preparedness is essential to minimize the impact of a bioterrorism attack. This includes:
  • Surveillance and early detection
  • Rapid and accurate laboratory identification
  • Coordination and communication
  • Public health response (e.g., treatment, containment)
• The Role of the Laboratory: Clinical and public health laboratories play a critical role in:
  • Detecting and identifying biological agents
  • Providing timely information to public health officials
  • Supporting the public health response

Laboratory Response Network (LRN)

• What is the LRN?: A national network of laboratories, established and coordinated by the Centers for Disease Control and Prevention (CDC) in collaboration with other federal agencies, state and local health departments, and clinical laboratories
• LRN’s Mission: To provide a national infrastructure to rapidly respond to acts of bioterrorism and other public health emergencies involving biological agents
• LRN’s Structure: The LRN is organized into different tiers of laboratories, each with specific capabilities and responsibilities:
  • National Laboratories
    • CDC (Atlanta, GA)
    • U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)
    • National Animal Health Laboratory Network (NAHLN)
    • Provide advanced diagnostic testing, reference services, and research
  • Regional Laboratories
    • Serve as a regional resource for diagnostic testing, surge capacity, and training
    • Generally have BSL-3 capabilities and are equipped to handle Select Agents
    • Coordinate activities within their region
    • Provide confirmatory testing for clinical laboratories
  • State and Local Public Health Laboratories
    • Perform routine diagnostic testing for infectious diseases
    • Conduct initial screening for potential bioterrorism agents
    • Forward suspect samples to regional or national laboratories for confirmatory testing
    • Serve as a communication hub within their jurisdiction
  • Clinical Laboratories
    • Provide routine diagnostic testing for infectious diseases
    • May perform initial screening for potential bioterrorism agents
    • Report any suspect findings to public health authorities
    • Forward suspect samples to state or regional laboratories

The Role of the Regional Laboratory

• Central Hub: The regional laboratory serves as a critical link between clinical laboratories and the national laboratories
• Key Responsibilities
  • Surge Capacity: The ability to handle a sudden increase in the number of samples during a public health emergency
  • Confirmatory Testing: Provide definitive identification of potential bioterrorism agents
  • Training: Train personnel from clinical and state/local laboratories on:
    • Proper specimen collection and handling
    • Use of rapid diagnostic tests
    • BSL-3 laboratory practices
    • Reporting procedures
  • Surveillance: Monitor for unusual patterns of disease or outbreaks
  • Communication: Serve as a communication hub within the region, relaying information between clinical laboratories, state/local health departments, and the CDC
  • Quality Assurance: Ensure the accuracy and reliability of testing through quality control, quality assurance, and proficiency testing
  • Reagent and Supply Management: Maintain a sufficient supply of reagents and materials needed for testing
  • Equipment Maintenance: Ensure that laboratory equipment (e.g., biosafety cabinets, autoclaves) is properly maintained and functioning
  • Collaboration: Collaborate with other regional laboratories, state/local health departments, and clinical laboratories within the region
  • Select Agent Expertise: Possess the necessary permits, training, and expertise to safely handle Select Agents
• Capabilities
  • BSL-3 laboratory
  • Advanced diagnostic testing (e.g., PCR, real-time PCR, sequencing)
  • Ability to culture and identify a wide range of bacterial and viral agents
  • Access to reference materials and reagents
  • Expertise in epidemiology and public health
• Communication and Coordination
  • Establish clear lines of communication with clinical laboratories and state/local health departments
  • Develop and maintain communication plans for emergencies
  • Participate in regular drills and exercises to test response capabilities
  • Coordinate with other regional laboratories to ensure a consistent and coordinated response

The Role of the Clinical Laboratory

• First Line of Defense: Clinical laboratories are often the first point of contact for patients with potential bioterrorism-related illnesses
• Key Responsibilities
  • Awareness: Be aware of the signs and symptoms of potential bioterrorism-related illnesses
  • Specimen Collection: Collect appropriate specimens from patients, following established protocols
  • Initial Screening: Perform initial screening tests (e.g., Gram stains, rapid tests) to identify potential agents
  • Reporting: Report any suspect findings to the state/local health department immediately
  • Specimen Handling: Properly handle and transport specimens to the appropriate laboratory (state, regional, or national)
  • Communication: Maintain open communication with the patient’s healthcare provider and the public health authorities
  • Training: Train laboratory personnel on:
    • Recognizing potential bioterrorism agents
    • Proper specimen collection and handling
    • Use of rapid diagnostic tests
    • Reporting procedures
  • Participation: Participate in LRN training and proficiency testing programs

The Response Process

1. Suspicion/Detection: A clinical laboratory or healthcare provider suspects a case of a bioterrorism-related illness
2. Notification: The clinical laboratory reports the suspect case to the state/local health department
3. Investigation: The state/local health department investigates the case and collects additional information
4. Specimen Submission: If the case is highly suspect, specimens are sent to the state or regional laboratory for testing
5. Initial Testing: The state/regional laboratory performs initial screening tests
6. Confirmatory Testing: If the initial tests are positive or suspicious, the state/regional laboratory may perform confirmatory testing or forward the samples to the CDC or another national laboratory
7. Identification and Reporting: The pathogen is identified, and the information is reported to the CDC and other relevant authorities
8. Public Health Response: The public health authorities implement appropriate measures to control the outbreak and protect public health
9. Communication: Information is communicated to healthcare providers, the public, and other stakeholders

Challenges and Future Directions

• Surge Capacity: The need to rapidly scale up testing capacity during a public health emergency
• Rapid Diagnostics: The development and implementation of faster, more sensitive, and specific diagnostic tests
• Training and Workforce Development: The need to train a sufficient number of qualified laboratory professionals
• Integration of Technologies: The integration of new technologies (e.g., next-generation sequencing) into the LRN
• Collaboration and Communication: The need for improved communication and collaboration among all LRN partners
• Global Surveillance: The importance of global surveillance to detect and respond to emerging infectious diseases and potential bioterrorism threats

Key Terms

• Bioterrorism: The intentional use of biological agents (bacteria, viruses, toxins) to cause harm or death to humans, animals, or plants
• Laboratory Response Network (LRN): A national network of laboratories (clinical, state, regional, and federal) organized to rapidly respond to bioterrorism and other public health emergencies involving biological agents
• Regional Laboratory: A laboratory within the LRN that serves as a regional resource for diagnostic testing, surge capacity, training, and coordination. Typically has BSL-3 capabilities
• Clinical Laboratory: A laboratory that performs routine diagnostic testing for infectious diseases and may participate in the LRN by performing initial screening and reporting suspect findings
• State/Local Health Department: Public health agencies responsible for investigating disease outbreaks, providing public health services, and coordinating the response to public health emergencies
• Surge Capacity: The ability of a laboratory or healthcare system to rapidly increase its capacity to handle a sudden increase in the number of samples, patients, or other demands during a public health emergency
• Select Agent: A biological agent or toxin that has been identified by the U.S. government as posing a severe threat to public health and safety, animal or plant health, or to the safety of animal or plant products
• Biosafety Level 3 (BSL-3): A laboratory containment level required for working with infectious agents that can cause serious or potentially lethal disease through inhalation
• Chain of Custody: A documented process that tracks the movement of a specimen or isolate from collection to disposal, ensuring its integrity and providing a record of who handled it and when
• Surveillance: The systematic collection, analysis, and interpretation of data related to health events (e.g., disease outbreaks) for the purpose of public health action
• PCR (Polymerase Chain Reaction): A molecular biology technique used to amplify (make many copies of) a specific DNA sequence, allowing for the detection of small amounts of a pathogen’s genetic material
• DFA (Direct Fluorescent Antibody): A rapid diagnostic test that uses antibodies labeled with a fluorescent dye to directly detect the presence of a specific pathogen in a sample
• CDC (Centers for Disease Control and Prevention): The U.S. federal agency responsible for protecting public health and safety by providing information and support to respond to public health emergencies
• USAMRIID (U.S. Army Medical Research Institute of Infectious Diseases): A U.S. Army laboratory that provides research, development, and diagnostic support for the detection and treatment of infectious diseases, including potential bioterrorism agents
• NAHLN (National Animal Health Laboratory Network): A network of laboratories that focuses on animal health and the detection of diseases that could affect both animal and human health (zoonotic diseases)