# Presentation: 232702

## The Laboratory Response Network

## What Is the LRN?

**A Diverse Laboratory Network**
- National network of local, state and federal public health, hospital-based, food testing, veterinary and environmental testing laboratories that provide laboratory diagnostics         and the capacity to respond  to biological and chemical terrorism and other  public health emergencies.

**Multi-agency collaboration**
- The LRN is a partnership involving  key stakeholders in the preparation and response to biological and chemical terrorism. The Centers for Disease Control and Prevention (CDC), the Federal Bureau of Investigation (FBI), and the Association of Public Health Laboratories are its founding partners.

**LRN Structure for Bioterrorism**

## LRN Mission

- 	The LRN and its partners will maintain an integrated national and international network of laboratories that can respond quickly to acts of chemical or biological terrorism, emerging infectious diseases and other public health threats and emergencies.

- Our Mission in Action
**Bioterrorism Preparedness**
- Timely detection of *Bacillus anthracis *during
-   anthrax attacks in 2001
-  BioWatch
**Public Health Emergency Response **
- Developed rapid tests for detection of
-    Severe Acute Respiratory Syndrome
-  Monkeypox

**Notes:**
Talking Points:
About LRN Mission
LRN Mission Statement succinctly answers the question: What is the LRN? 
Mission statement highlights three key goals of the LRN:
Continued development of its laboratory network by supporting existing members and expanding its membership base;
Capacity building, and;
Nurturing its partnerships.

“IT IS NOTEWORTHY TO POINT OUT THAT THE LRN’S MISSION REFLECTS A PUBLIC HEATLH  FOCUS BEYOND CHEMICAL AND BIOLOGICAL TERRORISM AND THAT THE LRN RESPONDS TO OTHER PUBLIC HEALTH CONCERNS.”

“OUR MISSION IS EVIDENT IN SOME OF OUR RECENT PUBLIC HEALTH EMERGENCIES.” 

During the course of the 2001 anthrax investigation, the LRN labs tested more than 125,000 samples, representing about 1 million tests.
Select LRN labs are participating in surveillance for environmental exposures using air samplers. These labs are testing the filters from the air samplers daily for biological agents.
Currently, LRN is helping to develop tests and reagents used to detect coronavirus.

## The Laboratory Network

- More than 140 federal, state and local labs in 50 states and abroad
- National labs – CDC, military – perform definitive testing.
- Reference labs – BSL-3 labs capable of confirmatory testing for agents such as *B. anthracis*, and *C. botulinum *toxin.

**Notes:**
Talking Points:
The foundation of the LRN is its member laboratories.
Points on the map represent both reference and national labs.
National labs represent the CDC and US Army Medical Institute of Infectious Diseases (USAMRIID) at Fort Detrick, MD.
Reference labs are state and local public health labs, and some military labs. The goal is to have at least one BSL3 lab in each state.
LRN is working to establish relationships with private and commercial labs, totaling about 2,500, to act as sentinel labs capable or performing preliminary tests and shipping samples to appropriate reference labs for confirmatory testing. There is also a potential for sentinel labs to handle surge in case reference labs become overwhelmed.
This structure is designed to enhance the public health infrastructure by integrating the expertise and capacity of labs nationwide and globally. 
Rather than a few labs performing rapid lab testing, more labs are capable of such testing in the event of an outbreak.
WHAT FOLLOWS IS AN ILLUSTRATION OF GEOGRAPHICAL COVERAGE AND WHERE STATE, LOCAL, FEDERAL, INTERNATIONAL AND MILITARY LABS ARE LOCATED

## Partnerships

**Founding Partners**
- CDC
- Association of Public Health Laboratories
- The Federal Bureau of Investigation
** **

**Notes:**
Talking Points:
THE LRN SLOGAN IS “PARTNERS IN PREPAREDNESS.” PARTHERSHIPS DRIVE THE ORGANIZATION. 
OUR FOUNDING PARTNERS, FOR EXAMPLE, EACH BROUGHT THEIR UNIQUE STRENGTHS AND PERSPECTIVES THAT HAVE HELPED SHAPE THE LRN INTO WHAT IT IS TODAY: 
CDC-Expertise in handling virulent agents, developing clinical assays, investigating outbreaks of disease, and coordinating development and operation of the LRN; 
APHL—Membership that allows for broad coverage. APHL also coordinates state and local public health labs for the LRN;
FBI – Helped shape chain of custody policies to protect the integrity of criminal investigations amidst often opposing public health investigations.  

## Partnerships Shape the Scope of the LRN

**International Laboratories** – LRN membership includes labs in Australia and  Canada;
**Environmental** – LRN is working with EPA to build testing capacity for measuring biological and chemical agents in environmental samples.
**Food and Water** – LRN includes food and water testing labs to guard against contamination
**Veterinary labs** –The National Animal Health Laboratory Network through USDA’s Animal and Plant Health Inspection Service (APHIS), and the American Association of Veterinary Laboratory Diagnosticians

**Notes:**
LRN partnerships extend beyond its original founding partners. Relationships with federal agencies, such as the EPA, FDA and USDA, are helping to establish preparedness and response policies to protect food and water supplies, guard against chemical exposures and monitor animal populations that are often the first sign of a disease outbreak.

VDL’s may be joining the LRN to serve as Reference Labs under the USDA gatekeeper. 

## Structure for Bioterrorism Response

## National Laboratories

- National laboratories, including those operated by  CDC, are responsible for specialized strain characterizations, bioforensics, select agent activity, and handling highly infectious biological agents and toxic chemicals.

## Reference Labs

- Reference laboratories - responsible for investigation and/or referral of specimens --are made up of more than 140 state and local public health, military, federal, and international laboratories. Lab types include veterinary, agriculture, food and water testing laboratories. In addition to laboratories located in the U.S., facilities located in Australia, Canada, and the United Kingdom serve as reference laboratories abroad.

## Sentinel Laboratories

- Sentinel laboratories provide routine diagnostic services, rule-out and referral steps in the identification process.
- Although these laboratories may not be equipped to perform the same tests as LRN reference laboratories, they can test samples to determine whether those samples should be shipped to
- reference or national laboratories for further testing.

## LRN Structure for Agent Testing & Sample Flow

**Laboratories at CDC**

**LRN Structure for Agent Testing & Sample Flow**

**Anthrax**
** ****Lab**

**Plague**
** ****Lab**

**Other Agent**
**Specific Labs**

**CDC BT Core Lab:**
**Rapid Response  &**
**Advanced Technology**

**O**
**v****e**
**r**
**t**

**Covert**

## Structure for Chemical Terrorism Response

## Chemical Testing Capacity

**CDC**

**Level 1 **
**5 Labs**
**Level 2+ Level 3               activities**
**Mustard Agents**
**Nerve Agents**

**Level 2**
**41 Labs**
**Level 3 Activities **
**Cyanide**
**Toxic Metals**

**Level 3**
**62 Labs**
**Competency in collecting and shipping clinical samples**
**Comprehensive response plan**

## LRN Structure—Chemical Terrorism

- Currently, 62 state, territorial, and metropolitan public health laboratories participate in the chemical portion of the LRN.  A designation of Level 1, 2, or 3 defines member network participation, and each level builds upon the preceding level.
- Every network member participates in Level 3 activities. These **Level 3** laboratories work with hospitals in clinical specimen collection, storage, and shipment.  They also work to develop a coordinated response plan for their state and geographical regions.

## LRN Structure—Chemical Terrorism

- Forty-one labs also participate in **Level 2 activities;** they are trained to detect exposure to a limited number of toxic chemical agents.  Detection of toxic chemicals, such as cyanide or toxic metals, present in human specimens is an example of Level 2 laboratory analysis.
- Five laboratories participate in **Level 1 activities**, and these laboratories are trained to detect exposure to an expanded number of chemicals including all Level 2 laboratory analyses plus analyses that indicate exposure to mustard agents, nerve agents, and ricin.

## Preparing to Respond to a Chemical Event 

- CDC is assisting LRN
- Labs by
- Purchasing instrumentation
- Developing training curricula
- Transferring analytical methods
- Implementing a quality assurance program

**Notes:**
CDC has assisted with purchasing the instruments needed for measuring chemicals in blood and urine to LRN members and is also transferring analytical methods to Network members.  Those laboratories that receive methods and instrumentation must participate in a rigorous quality assurance program to ensure that network labs provide precise, accurate, high-quality data. In an effort to create a skilled workforce, CDC has developed training curricula for network members. This “train-the-trainer” program will give chemical terrorism coordinators information so that they can train hospitals in their jurisdiction.  

## Rapid Toxic Screen

- 	At the onset of an event, a state may request CDC’s assistance.  CDC will deploy a Rapid Response Team to the affected state to assist with specimen collection, packaging, storage, and shipment.  The first 40 samples from people with symptoms are sent to CDC for analysis through the **Rapid Toxic Screen**, which can analyze people’s blood and urine for a large number of chemical agents likely to be used by terrorists. Data produced from the Rapid Toxic Screen analysis will be communicated in a secure, electronic manner to the affected state or states.

## Responding to a Chemical Event

**CDC Contacts **
**LRN Members**

**LRN Members Perform**
**Level-Specific Duties**
** ****and Report Results **
**Back to CDC**

**CDC Sends Results**
** ****to State**

**State Requests**
** ****CDC Assistance**

**CDC Sends Results**
** ****to State**

**CDC Conducts Rapid Toxic Screen**

**Notes:**
At the onset of an event, a state may request CDC’s assistance.  CDC will deploy a Rapid Response Team to the affected state to assist with specimen collection, packaging and/or storage, and shipment.  The first 40 representative samples from people with symptoms are sent to CDC for analysis through the Rapid Toxic Screen, which can analyze people’s blood and urine for a large number of chemical agents likely to be used by terrorists. Data produced from the Rapid Toxic Screen analysis will be communicated in a secure, electronic manner to the affected state or states. Hospitals and laboratories may be inundated by people concerned about exposure.  There will be a need to respond to these concerns and to determine whether an individual has been exposed and at what level.  CDC will contact the appropriate network laboratories, and these laboratories will contribute to the response depending on their level of network participation.  All results will be sent to CDC and CDC will share results with the affected state or states.  

## Provided to Each LRN Lab

**Standardized Reagents & Controls**
**Agent-Specific Protocols**
**Lab Referral Directory**
**Secure Communications **
**Electronic Laboratory Reporting**
**Training & Technology Transfer**
**Proficiency Testing**
**Appropriate Vaccinations for Lab Workers**

**Notes:**
Talking points:

The LRN provides continuous support to its members, ensuring they are trained and proficient at using CDC-developed protocols and reagents.
The LRN provides the necessary reagents, which are produced and validated at the CDC, ensuring that LRN members have a reliable source for their supply needs.

## Information Technology Support

**Provides secure access for more than 1,700 LRN Lab workers**
**Secure communications on emerging and emergency issues**
**Order reagents**
**View protocols for PCR and TRF assays**
**Report and review proficiency tests**
**Receive periodic updates regarding reagent availability,**** ****etc****. **

**Notes:**
Information technology 
LRN reference lab members are granted access to a secure website maintained by the LRN at the CDC where they can order reagents, view protocols and receive important LRN information

## Partners in All Facets of Biological & Chemical Terrorism Preparedness and Response

- The American Association of Veterinary Laboratory Diagnosticians
- The American Society for Microbiology
- The Environmental Protection Agency
- U.S. Department of Agriculture
- U.S. Department of Defense
- U.S. Department of Energy
- U.S. Food and Drug Administration
- The Department of Homeland Security

## Ready to Respond

- In the event of a terrorist act or other public health
- emergency,  the LRN is poised to:
- Test thousands of clinical specimens and environmental samples using its multi-level network of state, food testing, clinical, veterinary, military, and federal  labs.
- Coordinate the laboratory response of CDC, law enforcement agencies, public health, and others.
- Accept and transfer specimens to appropriate facilities, including the CDC where definitive testing can be done.
- Assure a rapid laboratory response to any public health emergency.

**Notes:**
The bottom line

The LRN is ready to respond in the event of a public health emergency, terrorism or otherwise.

## LRN Formula for Success

- Unified operational plan
- Standardized protocols and tests
- Secure communications
- Molecular diagnostics
- Rapid response and reporting
- Safe, secure laboratories
- Trained laboratorians
- Coverage for human, animal, food, environmental specimens
- CDC coordinated support and oversight
- Quality laboratory results

## Slide 24