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CDC Responds: Coping with Bioterrorism—The Role of the Laboratorian

(November 9, 2001)

(View the webcast on the University of North Carolina School of Public Health site.)

Segment 4 of 9
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Dr. Tenover:
Richard, can you describe for us now the Laboratory Response Network?

Mr. Richard Kellogg:
Yes, thank you, Fred, and thanks to all for this opportunity to speak today about the Laboratory Response Network. The LRN, as we call it, is a multilevel system designed to link frontline clinical microbiology laboratories and hospitals and other institutions to state and local public health laboratories in supporting advanced capacity public health, military, veterinary, agricultural, water, and food testing laboratories at the federal level. The key to the Laboratory Response Network is its partnership coalition, currently composed of clinical laboratories, state and local public health laboratories, the Association of Public Health Laboratories, the American Society for Microbiology, the Center for Clinical Laboratory Medicine in the Department of Defense, United States Army Medical Research Institute for Infectious Diseases, the Federal Bureau of Investigation, the Centers for Disease Control and the Food and Drug Administration, the Lawrence Livermore National Laboratory in the Department of Energy, the National Veterinary Service Laboratory, and the Environmental Protection Agency.

The LRN concept of operations is based on a system of safety and proficiency such that Level A laboratories at the BSL-2 provide the rule-out or referral of suspect specimens, with Level B and C labs at BSL-2 and 3 performing the rule in testing by rapid screening and confirmatory identification. Finally, Level D labs are reserved for the highest level of characterization and isolate archiving with BSL-4 capabilities.

An important point to remember is that the specific biological agent drives the challenges for handling, detection, and identification, and therefore, LRN laboratory ratings are actually agent-specific. Whereas Bacillus anthracis and Yersinia pestis are confirmed at Level B, Francisella tularensis and the Brucella species are confirmed at Level C, and variola major, the agent of smallpox, is restricted to Level D. Future challenges for the Network involve other agents on the critical biological agent list, including the filoviruses Ebola and Marburg; the arenaviruses Lassa fever and Junin; the alphaviruses, causing Venezuelan, eastern, and western equine encephalitis; Coxiella burnetii; ricin toxin; Burkholderia mallei; and staphylococcal enterotoxin B. The Network structure, which gives us the needed flexibility, starts with Level A labs, which will be on the front line in a covert release, and as patients begin to present clinically, Level B and C labs will directly receive clinical specimens and environmental samples in an announced release, with Level D labs being able to support the Network as events require.

This map represents the approximately 100 Laboratory Response Network B and C level labs in 50 states which are in place to support the Network. The supporting B and C level labs are tied together by a secure Web site which facilitates access to specialized testing protocols, specialized test reagents, select agent test controls, a facility referral directory, and a proficiency testing program. Frontline Level A labs have access to rule-out and presumptive identification procedures, which use standard methods and which are available on the CDC Web site as well as the Web site at the American Society for Microbiology.

What are some of the important requirements for Level A labs? One is to maintain awareness. Much of that information can be found on the CDC Web site, which is listed below. Also, clinical laboratories with BSL-2 facilities should be using Class 2 biological safety cabinets, and be ready to safely perform rule-out testing on clinical specimens with standard methods. The methods are publicly available on the ASM Web site, and important safety guidelines on the CDC Web site are updated by the Office of Health and Safety. And then also, they should be ready to transport specimens and refer testing as needed to the closest state public health laboratory or other approved facility.

In wrapping up, I’d like to mention some of the 2001 objectives which we’ve been working on. First is transferring rapid technology (polymerase chain reaction and time-resolved fluorescence) to local LRN Level B labs for biodetection. We are also standardizing the testing algorithm at the suspect, presumptive, and confirmatory levels of agent identification for result reporting, as well as rolling out the proficiency testing to certify laboratory readiness for the specialized testing.

Lastly, I’d like to mention additional future objectives which are in progress. Those are supporting increased state-based training of Level A clinical laboratories; standardizing the notification schemes to communicate with the Laboratory Response Network and law enforcement, as well as enhancing the secure Web site to support secure communications, Web-based laboratory reporting, sentinel surveillance, and Geographic Information Systems, and most important, building the LRN partnership as a forum for input and planning.

Dr. Tenover:
Richard, thank you very much.

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