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Chapter 16.1 : General Introduction to Bioterrorism and Emerging Infectious Diseases
Following the events of 11 September 2001 and the subsequent release of anthrax in October 2001, laboratory preparedness became a major priority for the nation. One of the major lessons learned from the anthrax release was the need for improving laboratory response time, laboratory diagnostics, training of personnel, and partnering between the public and private health sectors. Although this section is primarily focused on laboratory preparedness for bioterrorism-associated biological agents, the challenges posed by emerging infectious diseases (severe acute respiratory syndrome, pandemic influenza) serve to highlight the importance of, and the need for, maintaining an integrated network of diagnostic laboratories that are capable of providing rapid detection of biothreat and emerging agents of infectious diseases. To this end, the Laboratory Response Network (LRN), created in 1999, continues to play an ever more important role in meeting this challenge. Since many microbiologists have not experienced or been involved with bioterrorism-related activity as well as encountered agents of emerging infectious diseases, the following definitions are provided as background information. Terms such as “bioterrorist agents,” “biothreat agents,” “biocrime,” and biothreat” are used interchangeably and are defined as follows: “bioterrorist agent” or “biothreat agents” refers to microbial pathogens and/or toxins that have been considered for, or used in, biological warfare and recent terrorists events; “biothreat” is the suspected but unconfirmed release of a biological agent(s); and “biocrime” is a criminal act involving the use of biological agents as weapons. As an integral member of the “first-responder” team in suspecting, recognizing, and detecting biothreat and/or emerging agents of infectious diseases, the clinical laboratory, specifically the microbiology laboratory, will play an integral role as a sentinel in the detection, recovery, characterization, and identification of these and many other biological agents. In preparation for responding to a biological incident, be it bioterrorism or an emerging infectious disease, the LRN was created and continues to evolve as a network of integrated laboratories (public health, military, food, water, chemical, veterinary, and community and commercial institutions). The primary function of the LRN for Biological Threat Preparedness and Response is to provide rapid detection of biothreat and emerging agents of infectious diseases. In preparation for responding to biological events, the clinical microbiologist should be formally trained and knowledgeable in the following areas: (i) the BSL of his or her laboratory; (ii) principles of specimen collection, preservation, packaging, labeling, and shipment; (iii) criteria for recognizing or suspecting a potential biothreat or emerging infectious disease event; (iv) biothreat levels as designated by the LRN; (v) application of consensus-based testing protocols; (vi) timely and accurate testing and reporting; (vii) the chain of communication linking local, state, and federal agencies; and (viii) although not a major factor or concern, the microbiology staff should have an understanding of the chain-of-custody guidelines being practiced in their institution. It is vital that the laboratory be familiar with its specific role in response to a suspected or confirmed biological event that requires the development and maintenance of standard operation procedures (SOPs) which describe how the laboratory will function in the event of a biological incident. The SOP should be part of an institution-wide SOP that is a multidisciplinary document comprising policies representing infection control, public relations, risk management, pharmacy, security, medical staff, and administration. The primary role of the clinical microbiology laboratory in responding to a biological event will be no different from its present role: to detect, recover, and characterize or identify the etiological agent(s). Of utmost importance is maintaining awareness that an event may have occurred and raising suspicion that requires further investigation. Under no circumstances should the laboratory declare that an event has occurred. This is the responsibility of the Federal Bureau of Investigation (FBI), and the laboratory should adhere to its institutional chain of communication, who in turn will notify local health authorities and/or the epidemiologist. Secondary roles of the clinical laboratory include maintaining an active surveillance and monitoring program.