BY DAVID M. LADD and CHERYL GAUTHIER
Ever since the “Amerithrax” attacks of 2001, a debate has raged throughout much of the collective homeland security community regarding field testing of biological agents. Despite multiple reports and mandates citing a priority of need to develop an improved biodetection capability, no national strategy presently exists.
The following commentary offers the hypothesis that we as the homeland security community, collectively, need to step back and reevaluate our approach, shifting from a technology-driven solution to a deliberated strategy. For nine years, the “national” effort has been narrowly focused on finding the “perfect” technology without resolving the fundamental questions of what we are seeking to accomplish. Although it is late, it isn’t too late to take the lessons learned and work to provide America with what it expects from us and what it has invested tens of billions of dollars to achieve.
WHAT WENT WRONG
In October 2001, vast differences in preparedness became suddenly and boldly apparent as communities, institutions, and states responded to a national panic generated by a relatively small-scale bioterrorism attack. In some locations, well-planned responses using “advanced” detection techniques were the order of business, while others did the best that they could with what they could pull together. Every conceivable level between these extremes was demonstrated.
For a myriad of reasons, those who had invested in preparedness for bioterrorism and believed that they were highly capable quickly found themselves under harsh criticism and their detection methods being termed as unreliable and even irresponsible. Scientists and government agencies lined up to literally warn the public against responders using field detection. The effort and objective of preparedness was now more severely criticized than was the failure to plan and prepare.
(1) Bioterrorism Lab Director Cheryl Gauthier evaluates a hazmat technician on downrange sample screening. (Photos courtesy of Massachusetts Department of Fire Services.)
In retrospect, what had transpired was a national planning failure. The focus of this failure became the field detection technology; thus, the answer was sought through more technology. All eyes were on the development of an “assay” that worked. Yet, fundamental questions, such as the following, went unasked and unanswered:
- What was/is the role of emergency response in bioterrorism?
- Why do we need detection at all?
- What will we do with the information?
- How do we conduct testing yet preserve a sample for laboratory confirmation?
- What level of fidelity is required of field detection?
- Who is qualified to conduct field testing?
- How do the responders in the field and the bioterrorism response laboratory work together to better protect the public?
In effect, responders were attempting to fill an undefined mission with equipment that had no performance expectation, all of which was not supported by specific experience in the field.
The direct result was that responders who had purchased equipment for biodetection operated on principles and expectations based largely on the performance cited in sales and promotional literature. Honest and well-intentioned developers, manufacturers, and sales forces sold equipment to responders to meet what they thought the responder mission was without fully comprehending the implications of its use and need for reliability and accuracy.
While we need not revisit the result in detail, it is now clear that the proverbial cart had gained a substantial lead on the proverbial horse. The essential relationship among public health, Laboratory Response Network (LRN) laboratories, and the responders and the very effort to develop and deploy an effective bioterrorism response remain as the predominant casualties.
Sadly, if the events of 2001 were repeated today, we would be in the uncomfortable position of advising the American public that, some $85 billion and nine years later, we are no better off in detecting biological threats than we were in 2001. In fact, some would argue that we are in worse condition, as large numbers of field testing devices have been purchased and fielded since 2001 in the absence of joint planning and training. Such claims foresee a possibility of more widespread confusion and more frequent disagreement with response actions and field testing results.
PARALLELS FROM OUR PAST
Older responders in America may have memories of the 1960s and 1970s, when provocative advances in emergency response were emerging across the country. In various locations throughout America, and supported by a national study,1 a new approach was taking shape to improve survival from out-of-hospital medical emergencies and traumatic injury. The practitioners of this new capability became known as paramedics. The story of how paramedics came to be, the efforts to overcome opposition, and the successes and even the failures should have served as a roadmap to developing an effective bioterrorism response. It did not.
Today, paramedics are available in nearly every area of the country, though response times vary by population density. In the early days, many dedicated physicians were firmly convinced that it was neither prudent nor possible to train firefighters and “ambulance drivers” to provide sophisticated medical care including invasive procedures and the administration of dangerous medications. Many others held the position that, although potentially useful where long-distance transports were required, this level of care was unnecessary to counterproductive in urban environments with multiple fine teaching hospitals.
Ultimately, the concept and practice proved to be highly effective and has now become the standard across America. Although there is a vast difference from bioterrorism response in that medical and traumatic injuries happen every day in staggering numbers, the approach, evolution, and deliberate narrow focus of paramedicine should have been applied or now should be applied to the development of a national bio-terrorism response strategy.
When paramedics were trained in those early days, they were told that it was not their job to cure patients but rather to deliver a stable patient to the emergency department. The lack of a clear and consistent mission in bioterrorism response is the first fundamental flaw. Absent a clear mission, every other aspect is open to broad interpretation and expectation.
(2) The Hazard Assessment Field Isolation System (HAFIS) invented by Mass Hazmat for field analytics. The HAFIS is a negative-pressure, HEPA-filtered shelter with a disposable liner.
The mission directly impacts the training and competency of the responder in both procedures and technology. The mission also drives what technology is needed and its performance requirements. The mission should be scalable, proving an appropriate and sustainable capability level that can be assumed and targeted in large, resource-rich and high-risk jurisdictions through small, low-probability rural communities.2
(3) A view inside the HAFIS, where analytical instruments can be used. It’s like a glove box, only bigger.
By analogy, the hazmat responder’s mission is not to “cure the patient” or resolve the entire issuee.g., initiate prophylaxis of those potentially exposed or decontaminate a building. The medical practitioners tell us that where medical care is indicated, it need not be initiated in less time than is required to conduct confirmatory testing and that prophylaxis itself poses some health risks. Decontamination and clearance of a contaminated building can be a multimillion-dollar and long-term process. So it is necessary, then, to examine the appropriate mission of response.
As a continuum, the priorities are protection of the public and responders, collection and transport of a suspicious substance to an LRN laboratory for testing, and providing the necessary data and materials to healthcare to make its decisions on medical treatment. An aspect of protecting the public that must also be addressed in the strategy is the support of criminal investigations through the preservation of the potential crime scene/evidence and support to law enforcement in investigative operations.
The stabilization activities required of the responder mostly revolve around public protection and “short-term tactical decision making.” Among the decisions are matters such as the following:
- Committing emergency resources for an extended period of time to the scene, pending confirmatory testing.
- Activation and commitment of additional resources from the state or federal levels, including law enforcement.
- Prioritization of samples for laboratory testing in the face of multiple incidents.
- Denying reoccupancy, with its associated impacts on infrastructure and commerce.3
- Risk communication.
- Identifying for future contact all “exposed” persons.
If limited to these objectives, the responder mission in biothreat situations is, as in prehospital care, limited to stabilization and protection. With this narrowed mission, training and technology requirements become clearer and more realistic.
TRAINING AND THE NEED FOR A NATIONAL STANDARD
As the benefits of extending medical care into the field were recognized, so, too, were the risks. Clearly, the need existed for confidence from both patients and the medical community in the training and competence of those providing invasive medical care under austere and critical conditions. To address the critical matter of confidence, a national training curriculum was developed and state certification and optional national registry created.
Adherence to a national standard training curriculum and demonstrated competency through examination, internship, and skill performance evaluation were critical elements to ensuring competency and gaining confidence from the collaborators and “customers” of these services. Although the paramedics have vast responsibility for a single patient under their care, the hazardous materials technicians carry the responsibility for the safety and security of populations in the accuracy of hazard and risk analysis and in the responsible use of information.
Demonstrated competency assessment: (4) A hazmat technician examines a packaged sample.
Generally, it can be assumed that hazardous materials technicians undergo a certification process at the conclusion of training. In accordance with Occupational Health and Safety Administration regulations,4 however, the only recognized certification is the certification by the employer of competency without definition or scope. In fact, certified hazardous materials technicians vary widely in training duration, depth, and content. Thus, it cannot be stated with any documented support that a hazmat technician has a singular training standard.
Significantly, for the discussion of detection, modern detection technologies in use for chemical, biological, radiological, and nuclear (CBRN) detection have not been in existence long enough to have been included in the primary training and certification for a probable significant percentage of hazardous materials technicians. Thus, new technologies have likely been introduced as in-service or annual continued training, which is even less defined in standards or regulations.
(5) A team of hazmat technicians collects a small sample from a desktop.
Anecdotally, it is widely accepted that the manufacturer or seller provides training for most new detection technologies. While this is often excellent training, its objectivity is often questioned and diminishes confidence in responder knowledge among laboratories and others.
The complete retraining of all hazmat technicians to a single, national standard, hazmat technician curriculum is an unrealistic objective. However, the development and delivery of a national program of training and certification, specifically in detection, should be achievable. Given the potential national implications of reported results from advanced detection technologies, the ability of a responder organization to report that detection methods were conducted, interpreted, and acted on in accordance with a standard that is accepted and familiar nationally will prevent or limit the present conflict and assumed inaccuracy. Removing the doubt and lack of confidence expressed by laboratories and public health will improve public confidence and thereby its sense of security.
(6) A hazmat technician uses two sterile plastic cards to collect trace samples.
An additional lesson learned from the past should be applied with regard to who provides training in sampling and detection. In the early days of paramedicine, the very nurses and physicians who would be working with the paramedics in day-to-day practice provided training. The trainers were often the same clinicians who would be communicating with them by radio, recommending or directing care and receiving patients and continuing that care. The mutual trust and confidence gained during training then translated to the communication and trust in actual emergencies. Since hazmat teams responding to bioterrorism threat incidents are effectively an extension of the LRN laboratory, this principle should strongly carry into detection training.
The LRN lab for the jurisdiction being trained must be actively involved in the training. Such involvement clearly creates the desired understanding, trust, and communication between the lab and the hazmat team.5 By extension, the Association of Public Health Laboratories (APHL) is a well-suited and logical home for the national delivery and certification. The APHL includes chemical and biological laboratories and presently delivers training to laboratories under contract to the Centers for Disease Control and Prevention (CDC). As a national vehicle, delivering training in conjunction with local or regional LRN laboratories, the APHL would be in a position to support the validity of training conducted in one region to all regions and thereby support national confidence in the strategy.
TECHNOLOGY, THE LAST FRONTIER
It’s not by accident that technology appears here, as the last portion of a strategy. This placement is largely because technologies, or devices, have driven our response to such a degree that we find ourselves in the current dilemma. For the past nine years, a successful and coordinated bioterrorism response strategy has been effectively stalled in this country as we argued over and awaited “the perfect detection device.” Public health laboratories want responders to use detection technologies that are comparable in sensitivity and specificity with those that are used in the LRN laboratory. Responders sought reliable, affordable, simple-to-use technologies that required little to no maintenance and limited training and worked under any condition. Both groups have had to learn to deal with disappointment.
The ability of any field detection technology to meet all of the desired, or necessary, characteristics of responders and public health laboratories has proven to be, thus far, impossible. It is entirely likely that no single system will meet these requirements until experience and an active market provide the means to do so. Moreover, just what technology needs to do remains unclear as the objectives of detection have not been defined. Two analogies can be used to demonstrate the technology question: the smoke detector and the defibrillator.
Smoke detectors are highly unreliable instruments when compared with the standards sought in biodetection. The false positive alarm rate of smoke detectors is astronomical, likely exceeding the correct detection rate on orders of magnitude in the tens or hundreds. Yet smoke detectors are encouraged, and even required in some states, in every occupancy. Smoke detectors clearly save lives!
When a smoke detector alarms, the fire department does not arrive and start breaking windows and spraying water. The smoke detector alerts us to take protective actions (such as evacuation) and to have qualified persons look further for a cause. So it is with biological handheld assays. In a deliberated strategy, handheld assays may not indicate the need for medical prophylaxis but can be used as part of a risk assessment to provide qualitative support for short-term tactical decision making such as the following:
- Securing a building.
- Holding companies (hazmat).
- Accounting for potentially exposed persons.
- Expediting sample delivery and testing at a qualified LRN laboratory.
- Advising more senior officials of an increased suspicion.
All of these actions can be taken without delaying sample delivery to an LRN laboratory, consuming the sample in field screening, or actually declaring a “positive” test result. Although the technology is not conclusive, all of these actions are better supported by testing with some established level of reliability. The field test then becomes one of several indicators, not the sole indicator, for the incident commander to make decisions regarding protective actions and commitment of resources, pending laboratory confirmation.
In the early days of paramedics, defibrillation was undertaken with great concern. Prior to administering the electric shock, a paramedic was required to obtain a doctor’s order over the radio. Today, defibrillators are found hanging in airports and shopping malls so as to be readily available for the general public’s use.
We have evolved this life-saving measure from a guarded skill of a specialist to that of a layperson because we found out, through experience, that it saves lives. Companies invested heavily in advancing the technology because there was a market. The end result is clear: Advancement saves lives!
The development of technology and the testing to prove its performance are expensive. Had we not studied the outcomes, including error rates and losses, from defibrillation, we would not have advanced this life-saving treatment. Had we said that we could not introduce early defibrillation in cardiac arrest until a perfect defibrillator was produced that the layperson could use, we would never have seen it. No one would have invested the cost of development for an uncertain market. So it is with biodetection. To support the development of better detection technology, we need to use what acceptable technology exists to meet our needs and thereby gain experience and create a market to support further development.
This analogy should not be taken to imply that we should embrace every device or technology. We should independently test every technology used to influence decision making in a potential bioterrorism scheme to established and accepted performance standards. It is not sufficient to market a device by saying it was “evaluated” by a particular user (e.g. military) as the methods, parameters, and intended use may not be the same for civil responders and the protection of the general public.
Throughout this debate, we have also overlooked an area of technology that supports the integration of all other aspects: communication. In the comparison provided in this article, the need for collaboration and communication has been a constant thread. Communication is the area of technology that has made, perhaps, the greatest gain in the past 40 years. Yet communication is completely missing in the technology discussion of biodetection.
In 1967, Dr. Eugene Nagel built the first electrocardiogram (ECG) radio telemetry unit from two police motorcycle radios in his garage in Miami, Florida. This invention allowed a physician to be “virtually” on-scene with paramedics, discussing medical care and actually reading the ECG in real time from a remote base station hospital.
Today teenagers carry on televised conversations with each other from pocket-sized devices around the worldmillions at a time. Whatever the technology, with any level of detection, sensitivity, and specificity to be used, it can be enhanced as a tool for decision making by adding the means to share its data with more specialized personnel. This relatively simple addition can increase the confidence in detection and interpretation and substantially improve the confidence in field biodetection.
As a nation, and as those entrusted to protect the public, we cannot simply refuse to resolve the issues impeding an effective bioterrorism response. The “we” in this instance refers to the entire body of the “homeland security community.” It is vital to this discussion to recognize that technology alone will not be our solution and that no single solution can be applied in every community.
We must come together, as was accomplished in the ’60s and ’70s, to define our bioterrorism strategies from deterrence, through detection, and to recovery. Along the way, we need to be mindful of the need for confidence in each other and, most importantly, from the public and take steps to provide that confidence from coast to coast and with consciousness of the effect of the instant media. And in this process, we will identify what our real technology needs are, but not until we first determine what we need to know and how we will use that information to meet our overarching objective of protecting the public and maintaining their confidence in our ability to do so.
1. Research paper “Accidental Death & DisabilityThe Neglected Disease of Modern Society,” The National Research Council, 1966.
2. The “low probability” referenced in rural areas should only be viewed with regard to target. Rural areas are actually a high probability for clandestine laboratories, smuggling, and weapon development and, as such, cannot be ignored or underserved in the strategy.
3. Consider the extended international economic impacts of securing the international flight terminal of a major hub airport, for example.
4. OSHA 29 CFR 1910.120.
5. Based on the Massachusetts experience in the development of the Joint Biological Threat Response System.
DAVID M. LADD is the director of the Hazardous Materials/Counter Terrorism Response Division for the Massachusetts Department of Fire Services.
CHERYL GAUTHIER, MA, MT (ASCP, NCA), is the director of the Bioterrorism Response Laboratory for the Massachusetts Department of Public Health.