What steps can a laboratory take in anticipation of a biohazardous event? Both the Centers for Disease Control and Prevention (CDC) and the American Society for Microbiology (ASM) provide up-to-date information on their websites to assist every lab according to its level of expertise and capabilities. The CDC offers several links of information for bioterrorism emergencies such as organism-specific information, processing and shipping of specimens, and biosafety. The ASM provides Sentinel Level Clinical Microbiology Laboratory Guidelines which describe common biochemical reactions and morphological information to rule in/out any potential biological threat agents. In the event that a potential agent is isolated, it is referred to a Laboratory Response Network (LRN) reference laboratory for confirmation.
Throughout the military healthcare system, several medical centers participate in this program as reference labs. MLO contacted two Army medical centers: Brooke Army Medical Center (BAMC) in San Antonio, TX, and Walter Reed Army Medical Center (WRAMC) in Washington, DC, for information on how they prepare for such events.
By being enrolled in the LRN as a reference lab, BAMC can use standardized testing methods and reagents, and can coordinate with other public-health labs and higher level facilities. If there were a potential biohazardous event, BAMC would work in conjunction with its infectious-disease physicians and medical staff.
“BAMC is fortunate to have an outstanding infectious-disease group at its hospital that lab personnel interact with regularly,” says LTC Wade Aldous, PhD, chief of microbiology laboratories for BAMC. “If, for example, an unusual organism is isolated or the provider suspects a potential select agent, we generally get together to discuss the situation.”
BAMC has a biosafety level 3 (BSL3) laboratory for use when a potential agent is isolated and needs to be confirmed. “We work in conjunction with both our military and public-health authorities to rapidly make an identification,” Aldous says. One of the College of American Pathologists (CAP) proficiency surveys to which BAMC subscribes annually is its laboratory-preparedness exercise. “We find it useful in helping us to identify pathogens of epidemiological importance.”
As a reference laboratory in the CDC's LRN, the standard operating procedures for specimen processing, workup, preliminary results, final reporting, and transfer and/or destruction of select agents would, in general, be the same regardless of whether the pathogen caused a natural infection or an infection due to intentional release of an agent, says COL Helen B. Viscount, PhD, D(ABMM), medical director of integrated infectious-disease laboratories in the department of pathology at the National Navy Medical Center for WRAMC.
If there were an overt release and a high index of suspicion, the laboratory requires that a chain-of-custody form be submitted along with the specimen. A telephonic alert would be triggered notifying the chain of command and stakeholders. Updates would be given as warranted. Although the CDC National Select Agent Registry requires that isolates of select agents be transferred or destroyed within seven days in clinical laboratories, it is policy within Army clinical/LRN laboratories to transfer or destroy select agents within 72 hours.1
If the healthcare provider suspects the infection is a zoonosis or any type of naturally acquired infection due to a select agent, he would add comments to rule out the suspected disease as specimen testing is ordered in the laboratory information system. If the CDC assays to confirm the identity of select agents in clinical specimens are not approved by the Food and Drug Administration (FDA), the laboratory would have a research protocol and patient consent in place. Otherwise, the LRN reference laboratorian would consult with the FDA prior to testing isolates with the non-FDA cleared assays.
“We would receive detailed information about the case during daily infectious-disease rounds if it was not available earlier,” Viscount says. “Heightened clinical suspicion and close communication between the physician and the laboratory are essential in providing world-class service to our patients and in mitigating the risk of laboratory-acquired infections due to select agents (e.g., brucellosis).”
Every hospital generally has an emergency-response plan in which the laboratory also has a section to address such potential incidents. It is both a Joint Commission and CAP requirement to have a plan and to conduct mock exercises occasionally to determine overall readiness. The scenarios change over time, so the responses will also vary.
Aldous recalls when BAMC practiced a mass-casualty exercise in which many people were rushed into the hospital simultaneously. Something like this could occur if a plane crashed, for example. BAMC needed to determine how to accommodate the large amount of people. “We got as detailed as possible, including how we would inform family members,” he says.
Aldous says the Army views a pandemic and a biohazardous event as one in the same. “Whether the situation is a pandemic or biohazardous, we need to be prepared. We want to make sure that we can respond to it,” he says.
During the 2009 H1N1 influenza outbreak, BAMC became organized as the pandemic was announced. It had ample testing materials and reported results on a weekly basis to public-health authorities.
With regard to a possible pandemic, Viscount says the difference would be in requisitioning enough reagents to last several weeks and in collective-data reporting. As a matter of policy, the laboratory has an alert roster and ensures that there are trained personnel for a surge in workload. The Army Medical Department microbiology laboratories, for example, routinely report weekly respiratory surveillance data from October through May to the Army Medical Command. During the 2009 H1N1 pandemic, reports were also provided as requested by the chain of command.
Karen Lynn is a freelance medical writer.
Reference
- Memorandum for Commanders, MEDCOM Regional Medical Commands. September 8, 2009.
Additional preparation information available online
- CDC Emergency Preparedness and Response
- CDC Emergency Preparedness and Response, The Laboratory Response Network
- CDC Emergency Preparedness and Response, Laboratory Information for Bioterrorism Emergencies
- Association of Public Health Laboratories, Bioterrorism Preparedness
- CDC Pandemic Influenza Resources
- World Health Organization Global Alert and Response
- American Society for Microbiology Sentinel Level Clinical Microbiology Laboratory Guidelines
