Mr. JANKLOW. Why do you think it can't be sent? What's holding that up? Dr. FLEMING. There's a wide range of systems that are out there, and, in fact, some aspects of the health care system still aren't computerized. Mr. JANKLOW. Isn't that what we started out talking about today? Does that take a mandate to get that done? If we've still got some aspects of the health care system that aren't computerized, and if there are no mandates in place, how's it ever going to get there? Dr. FLEMING. I was hearing the question about mandates relative to a mandate on the public health system from the Federal level relative to the State level. There's a separate question about the need for electronic medical records and the development of clinical standards to create those records. That's a bit beyond my domain of expertise, but it is an active part of this, active part of this process. Mr. JANKLOW. But, sir, aren't we-what-we're talking about a reporting basically, either a diagnosis or a symptom; isn't that correct? Dr. FLEMING. It's actually a bit more complicated, when you think about the range of information that is being collected in the health care setting. Mr. JANKLOW. I understand. But when we're talking about looking at this from a national sense, aren't we really talking about, one, diagnoses that have been made, and, two, symptoms that would lead one to the conclusion someplace else as you gathered this from all over that there may be a problem that we need to look into? Dr. FLEMING. I think you might hear from the clinical sector that they would want that system integrated into their overall way of doing business so that they did not have to go off just for this purpose to enter information. But rather it needs to be part of the therapy that's being given and the monitoring of the patient. Mr. JANKLOW. Doctor, if you had the money you needed, how long would it take to get a system in place? Dr. FLEMING. Again, there is a working system in place. We do have the ability to detect these events. We can make substantial progress over the next year to 2 to 3 years, but I don't want to make it sound like it is an on/off Mr. JANKLOW. Are people like me then unnecessarily concerned that we don't have a coordinated system in place? Dr. FLEMING. I think that I've tried to express the level of concern we have, which is we see that this is important, and substantial progress has been made. The system is working. We can make it better. It's not broken, but it can be improved. Mr. JANKLOW. In terms of improving it, are we where we need to be in a world that deals with terrorism focused toward us? Dr. FLEMING. That's the critically important question we need to address, as we've been talking about. There are things that can and do need to be done to improve our security. Mr. JANKLOW. Is that a yes or a no, sir? Dr. FLEMING. Ask your question again, please. Dr. FLEMING. Ask your question again. Mr. JANKLOW. In terms of the world that we live in where terrorism is directed toward us, are we where we need to be? Dr. FLEMING. No. Mr. JANKLOW. OK. Thank you. Mr. SHAYS. Let me just-before we go to our next panel, this is Emerging Infectious Diseases. I think it is a peer review journal tracking and analysis disease trends, and it's done by the CDC; is that right? In the first article it has Planning Against Biological Terrorism: Lessons From Outbreak Investigations. Is this an article you're familiar with at all? Dr. FLEMING. I've not looked at it. Mr. SHAYS. In the first paragraph it says, for six outbreaks in which intentional contamination was possible, reporting was delayed for up to 26 days. We confirm that the most critical component for bioterrorism outbreaks detection reporting is the frontline health care professional and the local health departments. Bottom line, though, it—you know, I'm going to take a better look at this article. Well, actually I have to take a look at it. I haven't looked at it other than that quote. But you can't respond to that issue of Dr. FLEMING. I would also need to review the article to respond in detail. Mr. SHAYS. Well, why don't we just submit it for the record then. [The information referred to follows:] PERSPECTIVE Planning against Biological David A. Ashford,* Robyn M. Kaiser,* Michael E. Bales,* Kathleen Shutt,* Amee Patrawalla,* We examined outbreak investigations conducted around the world from 1988 to 1999 by the Centers for Lisease Control and Prevention's Epidemic Intelligence Service. In 44 (4.0%) of 1,099 investigations, identified causative agents had bioterrorism potential. In six investigations, intentional use of infectious agents was considered. Healthcare providers reported 270 (24.6%) outbreaks and infection control practitioners reported 129 (11.7%); together they reported 399 (36.3%) of the outbreaks. Health departments reported 335 (30.5%) outbreaks. For Six outbreaks in which bioterrorism or intentional contamitration was possible, reporting was delayed for up to 26 days. We confirmed that the most critical component for bioterrorism outbreak detection and reporting is the frontline healthcare professional and the local health departments. Bioterrorism preparedness should emphasize education and support of this frontline as well as methods to shorten the time between outbreak and reporting. disease in humans, animals, or plants on which we depend In 2001, Bacillus anthracis was disseminated through the U.S. postal system (1). Before that event, concern about bioterrorism had led to preparedness efforts, including strategic planning (2). As part of these efforts, we examined investigations conducted by the Centers for Disease Control and Prevention's (CDC) Epidemic Intelligence Service (EIS). EIS was established after World War II, in part to protect the United States against bioterrorism. We reviewed characteristics and trends of EIS investigations conducted from 1988 to 1999 (3). Outbreak investigations from 1946 to 1987 had already been reviewed (4). We focused on field investigations involving agents that could potentially be used for bioterrorism because understanding how these outbreaks were detected and reported might improve carly detection and reporting of bioterrorism. Each EIS field investigation follows an official request from a state or international health agency. States and "Centers for Disease Control and Prevention, Atlanta, Georgia, USA international health agencies receive reports of cases or outbreaks from many sources, including local public health agencies, hospitals, healthcare providers, private citizens. or other federal or international agencies (4). We describe lessons learned from outbreak investigations that involved biologic agents with potential for bioterrorism. In addition, we review investigations in which intentional contamination was considered as a potential cause of the outbreak. Methods A standardized form was used to collect data from each investigation from 1988 to 1999. Trip reports submitted by EIS officers after the investigations served as primary sources of information. We focused on outbreaks caused by biologic agents with high potential for bioterrorism, such as B. anthracis, Yersinia pestis, Francisella tularensis, variola virus, viral hemorrhagic fever viruses, Clostridium botulinum toxin, Vibrio cholerae, Rickettsia rickettsiae, encephalitis viruses, Brucella species, Burkholderia mallei and B. pseudomallei, and others according to our preparedness plans (2). We also identified outbreaks in which bioterrorism or intentional contamination was considered. Because each outbreak represented possible bioterrorism, we examined outbreaks in which the etiologic agent remained unidentified. From the trip reports, we abstracted information on possible bioterrorism, causative agent, location, time from first case to first report of the outbreak, and source of recognition and reporting of the outbreak. We defined the source of recognition and reporting as the person, persons, or institution that originally brought the outbreak or health emergency to the attention of health authorities, as recorded in the trip report. While diagnosis and reporting may be ongoing during an investigation, the initial recognition of an outbreak is a singular event that can occur at the peripheral or primary care setting or at the local, state, or federal level. We defined the beginning of the outbreak as onset of illness in the first case of the outbreak cluster. Diagnosis of the first illness in an outbreak may occur before the epi PERSPECTIVE demic is recognized and is often determined retrospectively. Epi Info 6 software (CDC, Atlanta, GA) was used to enter the data from the abstractions of the trip reports. SAS software, release 6.12, (SAS Institute Inc., Cary, NC) was used to generate descriptive statistics Results Several agents have been identified as likely to be used in bioterrorism (2). Of the 1,099 investigated outbreaks, 44 (4.0%) were caused by an agent with potential for bioterronism (Table 1). V. cholerae was responsible for 18 out breaks, Y pestis for 11, viral hemorrhagic fever for 7, Bacillus anthracis for 3, and C betulinum toxin for 3. F tularensis and R. rickettsiae accounted for one outbreak investigation each. The causative agent was not identified in 41 (3.7%) investigations. The 44 outbreaks involving an agent with potential for bioterrorism and the 41 caused by unknown infectious agents are summarized by location, year, disease agent, and conclusion (Table 2). All botulism outbreaks (two in the United States) were linked to contaminated food. Ten of the 11 plague outbreaks occurred in U.S. areas of known endemic plague in animals. Of the 18 cholera investigations, 4 were in the United States and involved nursing home patients, imported food, raw fish, and contaminated food on an international flight. Twelve (29%) of the 41 outbreaks caused by unknown agents involved cruise ships. Intentional use of infectious agents to cause harm to civilians (ie., bioterrorism) was considered in six investigations (Table 3) (5-8). Although the event did not occur during the period of this review, we included an outbreak of salmonellosis associated with contamination of a salad bar in Oregon in 1984. Several years after the investigation, contamination was (during the study period) determined to be intentional. Healthcare providers were the source of 270 (24.6%) reports, and infection control practitioners were the source of 129 (11.7%). Together, these two categories of healthcare professionals were the most common source of outbreak recognition and reporting, accounting for 399 (36.3%) reports. Health departments accounted for 335 (30.5%) reports. Some of these 335 outbreaks may have been originally reported to local health departments by clinicians or clinical laboratories, but the original reporting source may have been missing from the trip report. Other sources of recognition and reporting of these outbreaks were existing surveillance systems (55, 5.0%), foreign ministries of health (30, 2.7%), nongovernmental organi zations (22, 2.0%), the World Health Organization (16, 1.5%), and the Indian Health Service (12, 1.1%). Fortynine (4.5%) outbreaks were reported by other sources. such as private clinics, laboratories, or private citizens. More than one reporting source was found in 58 (5.3%) "In these cases, the outbreak was considered to be caused by an mfectious agent because of the characteristics of the itness and outbreak. cases. In 123 (11.2%) outbreaks, no mention was made of the recognition and reporting source, the method of recognition and reporting was unclear, or both the source and the method of recognition and reporting were unclear. The number of days from the beginning of the outbreak to the date the problem was first identified by the agency requesting CDC assistance was 0 to 26 days (Table 4). The time from the date the initial patient became ill to the date the initial contact was made to the requesting agency for the unexplained critical illness investigation was 26 days (Epi-Aid 99-59). The number of days from the date the problem was identified by the requesting agency to the date of initial CDC contact was 0 to 6 days. Discussion Investigations from 1988 to 1999 included outbreaks caused by B. anthracis spores, V. cholerae, Y. pestis, F tularensis, Coxiella burnetii, Venezuelan equine encephalitis virus, viral hemorrhagic fever virus, and Clostridium botulinum; all of these agents might pose a bioterrorism threat, were responsible for 4% of all outbreaks from 1988 to 1999, and are not common causes of outbreaks investigated by CDC. A single case of illness or death caused by any of these organisms should suggest intentional exposure (or accidental exposure in which the perpetrators inadvertently exposed themselves to the causative agent.) However, not all bioterrorism has involved or will involve these high-threat (formerly identified as weaponized) agents. In 1997, a laboratory worker intentionally contaminated his co-workers' food with a strain of Shigella stolen from the laboratory (9). While the Shigella strain did cause severe gastroenteritis and several hospitalizations, the use of this strain deviates from the popular idea of a bioterrorist's preferred weapon. However, viewing the bioterrorist's preferred weapon as a high-threat, aerosolizable, infectious agent that may cause immediate, widespread outbreaks may mislead preparedness efforts. PERSPECTIVE Table 2. Tap reports, involving unknown infectious agents or potential agents of bioterrorism (ultimately not considered bioterrorism), the Centers for Disease Control and Prevention, January 1988-December 1999 In 1984, the outbreak of salmonellosis associated with intentional contamination of a salad bar in Oregon was not initially considered intentional (8); however, further investigation proved that it was. Intentional contamination may resemble naturally occurring outbreaks, may spread slowly through a population, and may involve endemic pathogens. Because of the potential similarity between naturally occurring and intentional outbreaks and the increased threat of bioterrorism in the United States, the index of suspicion for intentional exposure should be high. Despite advances in the identification of pathogens, outbreaks of unexplained illnesses continue to occur. In this review, we found 41 outbreaks in which the causative agent remained undetermined Intentional contamination should be considered in these cases because 1) unusual or not easily explained outbreaks are more likely to be caused by intentional contamination, 2) outbreaks resulting from Cholera in two nursing home patients, cutbreak involving imported food, outbreak involving consumption of raw fish, and outbreak involving contaminated food on internationa! flight Gastroenteritis outbreaks in which infectious agent was not identified by laboratory testing Gastroenteritis outbreaks, acute illness after surgical procedures, and other outbreaks in which no infectious agent was identified by laboratory testing bioengineered pathogens may have unusual or unexpected characteristics, and 3) bioengineered pathogens may not be easily detected by existing assays. For these reasons, outbreaks with unexpected or unusual clinical or epidemiologic characteristics should be pursued with added urgency, and investigators should consider the possibility of previously unidentified or newly engineered pathogens. While CDC is often notified about outbreak investigations by a state or national health department, the origins of these reports are diverse and include local health departments, surveillance systems, physicians, veterinarians, infection control practitioners, organizations (e.g., the U.S. Food and Drug Administration or the World Health Organization), laboratories, private citizens, ship doctors, vessel sanitation programs, and others. We found that physicians and infection control practitioners reported more than one third of outbreaks. This estimate is probably |