Sentinel Laboratory Response to Bioterrorism



Sentinel Laboratory Response to Bioterrorism



Objectives



1. Define and give examples of a biocrime.


2. Define and give examples of select agents.


3. Site two laws that govern the possession of select agents.


4. List the government agencies that must be notified, by registration, before a laboratory may possess a select agent.


5. State the components of a biosecurity plan.


6. Summarize the standard operating procedures required for laboratories that maintain select agents.


7. Diagram and give a brief description of the Laboratory Response Network.


8. Outline the steps microbiology laboratories must follow if a select agent is isolated from a clinical specimen.


9. Explain the requirements for operation as a sentinel laboratory.


10. Name the government agencies responsible for the investigation and management of a bioterrorism event.



General Considerations


The practice of clinical microbiology changed significantly after Bacillus anthracis was intentionally released into the United States postal system in October 2001. Prior to this release there were two events in which microorganisms were used to intentionally harm the civilian population in the United States.


The first incident, in 1984, was a large community outbreak of salmonellosis caused by the intentional contamination of restaurant salad bars in The Dalles, Oregon. In this incident, a cult leader, Baghwan Sri Rajneesh, set out to influence the outcome of a local election by incapacitating voters. Cultures of Salmonella enterica Thyphimurium were grown at a laboratory within the cult’s compound. Ultimately, 751 individuals fell ill; luckily there were no deaths.


In 1996 an outbreak among laboratory workers was caused when a microbiology technologist in Dallas, Texas, purposely contaminated muffins and donuts with Shigella dysenteriae type 2. Forty-five laboratory workers developed gastroenteritis; four individuals were hospitalized.


The event in October 2001 stunned the country. Although there had previously been sporadic instances of suspicious letters, those events proved to be hoaxes. This outbreak resulted from the delivery of weaponized anthrax spores in mailed letters or packages; ultimately there were 11 cases of inhalational anthrax and 11 of cutaneous disease. Five individuals died. The attacks prompted institutions to implement or modify bioterrorism readiness plans. The United States government also reviewed the public health response and identified areas for improvement.




Government Laws and Regulations


The bombings at the World Trade Center in 1993 and the federal building in Oklahoma City in 1995 led Congress to pass the Antiterrorism and Effective Death Penalty Act of 1996. Section 511 (d) restricts the possession and use of materials capable of producing catastrophic damage in the hands of terrorists by requiring their registration. A companion law, the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT) Act of 2001 prohibits any person to knowingly possess any biologic agent, toxin, or delivery system of a type or in a quantity that, under the circumstances, is not reasonably justified by prophylactic, protective, bona fide research, or other peaceful purpose. Later, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 required institutions to notify the Department of Health and Human Services (DHHS) or the United States Department of Agriculture (USDA) of the possession of specific pathogens or toxins called select agents. Therefore, clinical laboratories possessing any select agents must register with the Centers for Disease Control and Prevention (CDC), a branch of the DHHS. Violation of any of these statutes carries criminal penalties. The pathogens and toxins classified as select agents are listed in Box 80-1. List is updated as needed.



Box 80-1   List of Select Agents*






*HHS and USDA Select Agents and Toxins, 7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73.


Bioterrorism agents are divided into three categories: A, B, or C. Category A agents are considered those presenting the highest risk to public health and national security because they are easily disseminated or transmitted from person to person and have high mortality rates. Category A includes pathogens such as Bacillus anthracis and Yersinia pestis. Category B agents are moderately easy to disseminate and have moderate to low mortality rates. This category includes Brucella species and Clostridium perfringens toxin. Category C contains emerging pathogens that could be engineered for mass spread in the future. Additional information may be found in Appendix F of the fifth edition of the CDC and the National Institutes of Health (NIH) manual Biosafety in Microbiological and Biomedical Laboratories (BMBL).



Biosecurity


Biosecurity is the latest issue of concern for microbiology laboratory directors and managers. Laboratories must conduct a risk assessment and threat analysis in order to write a security plan. This plan must include physical security (e.g., electronic card key access and locked freezers and refrigerators), and data system (laboratory information system) security and security policies for personnel.


Most hospital clinical laboratories have made a decision not to store any select agents. Some commercial laboratories, on the other hand, store select agents for use as positive controls for comparison with suspect samples. These laboratories must write standard operating procedures for (1) the access of select agents; (2) specimen accountability; (3) the receipt of select agents into the laboratory; (4) the transfer or shipping of select agents from the laboratory; (5) the reporting of incidents, injuries, and breaches of security; and (6) an emergency response plan if security is breached or the isolate is unintentionally released during an accident. They must also register the agents with the CDC.


Each clinical laboratory should have a bioterrorism response plan. The plan should include policies and procedures to be enacted when a suspicious isolate cannot be ruled out as a biothreat agent. If a laboratory has any questions about isolating, identifying, or submitting an organism that may be an agent of bioterrorism, laboratory personnel should call the state public health laboratory. The select agent must be either sent to a public health laboratory or destroyed within 7 days of identification. If the agent is autoclaved, its destruction must be documented using Animal and Plant Health Inspection Service (APHIS)/CDC Form 4, which can be downloaded at www.selectagents.gov/CDForm.html.

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Aug 25, 2016 | Posted by in MICROBIOLOGY | Comments Off on Sentinel Laboratory Response to Bioterrorism

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