A: For some administrators, the first realization that bioterrorism has affected the average hospital lab may well have been the notice you read. As that brief but illuminating article indicates, laboratories were required to report by Sept. 10 certain pathogens and toxins that could be used for terrorism or to disrupt the agricultural industry.
For most labs, the obligations imposed by the Public Health Security and Bioterroism Preparedness and Response Act, passed in the wake of 9/11, are not burdensome. Labs reporting that they do not possess any designated agents (select agents or high consequence livestock pathogens and toxins) will not be required to register further. Those labs that do maintain the designated agents only are required to notify the CDC, and must also register to certif[y] that a facility is in compliance with specific safety and security standards designed to prevent diversion of these agents from clinical laboratories (www.cdc.gov/od/ohs/lrsat/guidance.htm). In the wake of last years anthrax attacks, such protections seem not only reasonable, but overdue, especially in light of the breach of security recently at a Salt Lake City plant charged with destruction of neurotoxic gases. The risk of diversion of agents that might be used as weapons cannot be dismissed.
The list of designated select agents (www.cdc.gov/od/ohs/lrsat.htm) is long, including exotic human and animal pathogens that will rarely, if ever, pass through the general hospital lab: Ebola virus, Lassa fever virus, yellow fever, anthrax, goatpox, and camel pox. It also includes toxins that are occasionally encountered in veterinary pathology and in forensic practices, including
ricin, aflatoxin, and botulinum toxins. However, a few of the agents will once in a while pass through the community hospital lab (Eastern equine encephalitis, C. perfringens, staphylococcus enterotoxin, vesicular stomatitis virus, Hantavirus).
It is logical to ask whether the possession of a sample containing such agents for diagnostic purposes carries with it the requirement of registration, and the answer appears to be no. All laboratories already must have provided notification of the presence (or absence) of specified agents, but only those that hold and use them for reference purposes must have registered. In either case, it is important to make a diligent investigation of what is, and is not, maintained as stock in your laboratory, and to ensure that a responsible person is designated to manage notification, registration (if required), and the policy and procedure that will ultimately result from this new regulation. Such a responsibility is not a one-time obligation, but an ongoing one as laboratories change their test menus in response to changing needs.
If a laboratory only occasionally encounters these designated select agents in the course of diagnostic procedures, the intent of the rules exempts it from registering, provided that [it] report[s] the identification of select agents to the Secretary and either promptly transfer[s] the agent to a registered person or destroy[s] the agent on site in accordance with regulations established by the Secretary (www.cdc.gov/od/ohs/lrsat/guidance.htm). This raises the continuing responsibility on the part of your laboratory to establish an early warning system to notify the responsible compliance officer of the presence of such potential specimens, to ascertain where such agents might be transferred, and to know how they might be destroyed. This, of course, means developing appropriate procedures and policies, and training your staff in their implementation before an incident occurs. Dont assume, because youve made the required notification, that your responsibility under the law is fulfilled.
Although it might be tempting to assume that your laboratory is so far removed from the front lines of the war on terrorism that youll never have to bother with this beyond the policy stage, remember that several small community hospitals last year were suddenly faced with the possibility and later the reality of managing diagnostic specimens containing Bacillus anthracis. If it could happen to them, it can happen to you. Best to be prepared.
Barbara Harty-Golder is a pathologist-attorney in Sarasota, FL. She directs the clinical laboratory at Health South Rehabilitation Hospital in Sarasota, and maintains a law practice with a special interest in medical law. She writes and lectures extensively on healthcare law, risk management, and human resources management.
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