Background The events of fall 2001, with the deliberate

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1 education [management/administration and training microbiology and virology] Training Laboratory Personnel To Identify the Agents of Bioterrorism Louise S. Barden, PhD, MT(ASCP), 1 Judy R. Delany, MS, MPH, MT(ASCP), 1 Steven Glenn, MS, SM(ASCP), 1 Sam R. Perry, MPH, 1 Harvey Lipman, PhD, 1 Shoolah H. Escott, MS, MT(ASCP), 2 Diane Luck, MHS, MT(ASCP)SC 1 1 Centers for Disease Control and Prevention, Atlanta, GA, 2 Association of Public Health Laboratories, Washington, DC The Centers for Disease Control and Prevention (CDC) in partnership with the Association of Public Health Laboratories (APHL), the Federal Bureau of Investigation (FBI), the Department of Defense (DoD), and state public health laboratories, established a collaborative and voluntary system of laboratories, the Laboratory Network (LRN) to address the threat of bioterrorism. The goal of the LRN, through targeted training programs, will ultimately be to strengthen the nation s public health laboratories and their response to bioterrorism. Success of the LRN as the keystone of the laboratory arm of the federal and state government response to bioterrorism requires laboratory professionals trained in the isolation, recognition, and confirmation of the critical agents of bioterrorism. Personnel in clinical laboratories serving at Level A in the LRN provide sentinel surveillance and are expected to be trained in isolation techniques and rule-out criteria. At the next levels, the Level B and Level C laboratories are state and certain local public health laboratories that have the capability to receive suspect isolates from the Level A laboratories and provide definitive identification. To establish this capability, training of Level B laboratory personnel was conducted by the CDC during the fall of Course participants were asked to evaluate the content, effectiveness, and format of this training. Highly significant improvement in skills and confidence in confirming the identification of bioterrorism agents was reported by the participants. This core of capability was effective in confirming the identity of Bacillus anthracis from both clinical samples and environmental samples collected during the intentional release of B. anthracis spores in the fall of The training efforts made during this program, in courses given to Level A laboratories, and ongoing advanced training, will strengthen the national response to bioterrorism. Background The events of fall 2001, with the deliberate release of anthrax spores and subsequent diagnosis of 11 cases of inhalation and 4 suspected and 7 confirmed cases of cutaneous anthrax, 1 highlighted the need for a national bioterrorism response capability supported by public health system laboratories. Prior to these events, concern about the ability of these laboratories to respond to the threat of bioterrorism, in light of the well-documented need to rebuild the long-neglected public health infrastructure, 2-5 led to the establishment of the national Bioterrorism Preparedness Initiative. Laboratories are integrated into this 4-tiered network - from Level A to Level D - based on diagnostic capabilities and safety facilities. 6 During August and September of 1999, the CDC conducted 8 regional seminars funded through the Bioterrorism Preparedness Initiative. These seminars, attended by 726 clinical laboratory professionals, served to present the concept of the LRN and to generate interest in laboratory participation. To ensure that the LRN would function as intended, training designed specifically for laboratories at each level was developed. The first phase of training involved preparation and distribution of educational materials on the agents of bioterrorism for the laboratories likely to first encounter an agent of bioterrorism, the Level A, or clinical laboratories. The responsibility of the Level A laboratory is to evaluate bacterial isolates from clinical specimens and either rule out the isolate as an agent of bioterrorism, or refer the isolate to a higher level LRN laboratory for further characterization and confirmation. The National Laboratory Training Network (NLTN) conducted this training in various formats throughout the United States, and between October 1999 to December 2001 it trained approximately 4,200 additional health care professionals in Level A procedures. Beginning in the fall of 2000, the CDC, the APHL, and the NLTN implemented a second phase of training, designed specifically for the Level B and Level C laboratories. The training course, titled Agents of Bioterrorism Level B Laboratory Training, was developed to provide these laboratories with the capability, as envisioned in the LRN, to offer organism identification confirmation using standardized methods and reagents. The Level B training course is the subject of this paper. The central goals of the course were 1) to build or enhance the capacity of state public health laboratories to effectively respond to bioterrorism events, and 2) to ensure that performance of laboratory testing and interpretation of results were consistent nationally. These goals would be achieved by providing information about the clinical and epidemiological characteristics of the bacterial agents of bioterrorism, introducing new skills to laboratory professionals who would perform tests on these organisms, reinforcing the need for safe handling of samples and cultures, and strengthening the communications network between these laboratories and the federal government laboratories. Finally, all participants were expected to train other technical staff in their laboratories in these procedures who would then serve as staffing backup as well as assist 699

2 700 with the likely increased workload following a real or suspected bioterrorism event. Materials and Methods Development of Level B training began with planning sessions in January 2000, culminating in the first course conducted in October The logistics of conducting such complex training required mobilizing the resources of the Georgia State Department of Health Laboratories for sophisticated training facilities and CDC laboratory personnel from the National Center for Infectious Diseases, the Office of Health and Safety, and the Public Health Practice Program Office for lectures, demonstrations, exclusive reagents, materials, and laboratory exercises. This effort produced the unique and comprehensive training experience needed to establish the Level B laboratory capability. The 1-week course was conducted 4 times during the fall of 2000 in the training facilities at the Georgia Public Health Laboratory in Atlanta. Four bacterial organisms considered among the primary agents of bioterrorism - Yersinia pestis (plague), Francisella tularensis (tularemia), Bacillus anthracis (anthrax), and Brucella spp. (brucellosis) - were the focus of this course. Topics included the disease (clinical); epidemiological and microbiological characteristics of these organisms; proper laboratory safety practices; packaging and shipping requirements; and protection of evidence gathered during an actual or suspected event. A team teaching approach was used, involving a total of 36 instructors, including subject matter experts (SMEs) from the CDC. The training content comprised distance learning activities, didactic lectures, and laboratory exercises. Distance learning activities consisted of reading assignments from reference materials such as relevant journal articles, book chapters, and web sites containing materials on the agents of bioterrorism. The intent was to enable participants to understand the concept of bioterrorism, to become familiar with existing bioterrorism resources, and to bring them as a group to a common level of knowledge about these organisms in order to maximize the effectiveness of training time spent at the Atlanta facility. In addition to the reading assignments, 2 videos - Biosafety Strategies for Laboratories Working with Select Agents and Packaging and Shipping of Biological Materials - produced by the course designers, were sent to each participant. These videos presented an overview of biosafety requirements for processing different microbiological agents and detailed instruction on the regulations and techniques for safely packaging and shipping infectious agents. After viewing these videos, the course participants completed an evaluation and submitted any questions they had regarding the video content. Questions were forwarded to SMEs who addressed them during the course. Approximately 14 hours of lecture and 18 hours of laboratory activities were presented. The laboratory activities included both demonstrations and hands-on exercises. An additional 5 hours were spent in informal discussions and in a guided tour of the laboratory facilities at the Georgia Department of Public Health and at the Centers for Disease Control and Prevention. Course goals were: 1) to increase the participants skills and confidence in performing and interpreting the results of the procedures for confirming the identification of B. anthracis, Y. pestis, F. tularensis, and Brucella spp.; 2) to facilitate the dissemination of the information learned in the course to others; and 3) to provide a forum that would foster a professional working relationship among the course participants and between the course participants and the SMEs who taught the course. At the end of the course, participants were expected to be able: 1) to perform and interpret the results of all laboratory tests defined as Level B procedures, 2) to isolate and identify each organism from simulated specimens, 3) to describe how to safely handle and process specimens and list the safety equipment needed for these procedures, 4) to describe any special hazards associated with reagents, chemicals, or equipment, 5) to list the steps in packing and labeling a specimen for transport, 6) to explain the role of his or her laboratory in the Laboratory Network, 7) to describe how and when to refer samples or specimens to Level C laboratories or the CDC, 8) to list the CDC experts who can provide technical consultation, 9) to describe the role of the CDC Rapid and Advanced Technology Laboratory, and 10) to describe the FBI procedures for ensuring that the chain of custody is maintained. Course faculty members were either from the CDC or the FBI. Those from the CDC are recognized as experts in the identification of the bacteria that might be used in a bioterrorism incident and provided technical expertise in the specific subject areas for which they presented lectures or conducted laboratory activities. The faculty who gave lectures on the individual organisms were all from the CDC National Center for Infectious Diseases, including staff from the Division of Vector-Borne Infectious Diseases, Bioterrorism Rapid and Advanced Technology Laboratory, Technical Services Branch of the Division of Healthcare Quality Promotion, and the Division of Bacterial and Mycotic Diseases. Safety topics were presented by staff from the CDC Office of Health and Safety, while the criminal aspects of bioterrorism events and maintaining evidence chain of custody were discussed by agents from the FBI. Course design, facilitation, and evaluation were provided by staff of the CDC Laboratory Practice Training Branch, Division of Laboratory Systems, Public Health Practice Program Office, and the APHL. Sixty-four laboratory professionals participated in the course, representing all 50 state public health laboratories, some large county and city public health laboratories, and the FBI. One student was from the CDC s counterpart in Canada, the Canadian Science Centre for Human and Animal Disease. The course sponsors required that the participants be experienced microbiologists who were designated as responsible for handling and processing specimens and samples from a known or suspected bioterrorism event. The group had an av-

3 erage of 16 years in microbiology experience and spent a mean of 26 hours a week performing testing procedures (see T1). Twenty-five percent of the students had master s degrees, and 11% had doctoral degrees. Approximately 60% of the students had been involved in testing samples from a known or suspected bioterrorism event. A large proportion of the students (75%) indicated that they had no experience with some of the procedures for the 4 agents, such as direct fluorescent antibody tests for surface antigens, slide agglutination, ELISA, bacteriophage lysis, and antimicrobial susceptibility testing. The participant profile is summarized in T1. Evaluation instruments included a written, general subject knowledge, multiple-choice test that was given to the participants before the course began and paired for comparison with the same test administered on the final day of the course. In addition to an overall course evaluation given on the last day of the program, all course participants completed daily evaluations of the lectures and the laboratory sessions. Measurements were made using a series of 1 to 5 choice Likert scale question sets covering 1) lecture format presentation - the presentation quality, applicability of content to job description, and delivery of new information, and 2) an assessment of the participant s change in confidence in knowledge of subject matter and laboratory skills. Space was provided on each evaluation form for comments. A laboratory practical exam was completed on the last day. Those who had viewed the 2 videos were asked to complete an evaluation of these products. The statistical analysis of the data from these evaluation instruments was performed using SAS software (SAS Institute M, Cary, NC) Results At the conclusion of the 5-day course, participants were asked to rate the course s success in reaching its stated goals and objectives. The responses of all 64 participants are summarized in T2. At the beginning of the course, self-reported skills and confidence levels rated as good or excellent for all classes ranged from as Course Participant Profile Mean number of years of relevant laboratory experience 16 Mean number of years in current laboratory 13 low as 7% for Y. pestis and F. tularensis to as high as 68% for B. anthracis. At the end of the course, the range of increase in skills and confidence levels to either good or excellent for each class was: 1) B. anthracis, 32% to 63%; 2) Brucella spp., 57% to 71%; 3) F. tularensis, 51% to 81%; and 4) Y. pestis, 68% to 81%. Comparison of participants scores on the general subject knowledge, multiplechoice test given to the participants before and after the course revealed that the students scored an average of 15.5 points higher on the posttest than they scored on the pretest. By class, scores increased an average of 14.6 (class 1), 14.1 (class 2), 17.3 (class 3), 16.0 (class 4) points. As summarized in T3, the participants reported a significant increase their skills in your lab focus Function as senior technologist or supervisor 77% Currently train other laboratory or health care professionals 71% Have developed plans for training for others 94% Have been involved in a suspected bioterrorism event 57% Participants Rating of the Course The course was good or excellent in fostering a 97 professional working relationship between the students and the experts. They could perform and interpret Level B tests. 95 They could explain the role of their laboratory in the 89 Laboratory Network. They could describe the FBI procedures for ensuring 92 chain of custody. They understood the role of the CDC Rapid 92 and Advanced Technology (RRAT) laboratory. The course was rated good or excellent in increasing 98 skills and confidence in performing and interpreting the results of the procedures. The course was rated good or excellent in facilitating the 98 dissemination of information to others. They could list the experts to ask for consultation. 92 The course was about the right length. 86 The ratio of laboratory time to lecture time was about right. 85 Percent of Total s T1 T2 confirming the identification of the 4 organisms taught in the course. The participants indicated that the 2 videos prepared for the course were helpful in providing them with information about laboratory safety and packaging and shipping infectious materials that was directly applicable to their work. Data from the evaluations of the 2 videos were analyzed. Results are presented in T4 and T5. Discussion After completing the course, all participants stated that their skills and confidence in performing procedures for identifying the agents of bioterrorism covered in the course were increased. This self-reported improvement was significant, and paralleled a significant improvement in overall 701

4 702 Overall Improvement in Laboratory Skills for Confirming Organism Identification Topic Median Improvement Significance (P value) B. anthracis laboratory 1.58 < Brucella species laboratory 1.27 < Yersinia and Francisella laboratory* 1.63 < All laboratories and 1.44 < lectures * The organisms were presented together at the request of the instructional staff. The values in this column indicate improvement between scoring categories poor, marginal, acceptable, good, and excellent. Evaluation of Video Biosafety Strategies for Laboratories Working with Select Agents The presentations were clear and well organized The graphics and demonstrations were helpful The video was directly applicable to their work The video increased their knowledge of laboratory safety Evaluations of the Video Packaging and Shipping Biological Materials The presentations were clear and well organized The graphics and demonstrations were helpful The video was directly applicable to their work The video increased their confidence in their ability 66.7 to correctly package and ship infectious agents or diagnostic specimens. Agreed or Strongly Agreed (%) Agreed or Strongly Agreed (%) T3 T4 T5 knowledge of these organisms reflected in the test scores posted at the end of the course. Many of the laboratory techniques presented in the course were not new to the participants, but were new in the context of the organisms discussed. Further, because a number of participants had some experience culturing these organisms, or processing materials from a suspected bioterrorist event, the magnitude of change was likely moderated. By providing information in both lecture format and opportunities to observe and practice laboratory methods and skills, the course design was considered optimal by most of the participants. In addition, the experience fostered creation of a collaborative network among the public health laboratorians, the CDC, and the FBI. It is evident that the Level B training program increased awareness among these public health practitioners of the clinical, epidemiological, and cultural characteristics of the microorganisms discussed; produced improvement of their laboratory skills for culturing and identifying these organisms; and clarified the support for these laboratories provided by the CDC. The practical success of this approach was evident when the first case of inhalation anthrax diagnosed in the recent bioterrorist event in Florida was confirmed by a laboratory professional who had attended the Level B training course (Phillip Lee, personal communication). Although this demonstrates the effectiveness of the Level B training when put into practice within the framework of the LRN, it should be considered part of a broader effort to restore the ability of the long-neglected public health system to effectively respond to actual or suspected bioterrorism events. Finally, the pressure placed on the public health system laboratories following the recent release of anthrax spores revealed the need for improving communication among federal, state, and local public health and law enforcement agencies; developing clearer polices for specimen triage, processing, and transport; and better coordinating of interpretation and distribution of laboratory results. Addressing these issues within the LRN through targeted training programs will ultimately strengthen the nation s public health laboratories and their response to bioterrorism. Acknowledgements The CDC Bioterrorism Level B Laboratory SMEs who provided instruction: Bacillus anthracis and Brucella species: Tanja Popovic, MD, PhD; Robbin Weyant, PhD; Sandra Bragg, PhD; Leslye LaClaire, MS; Chung Marston, BS, Alex Hoffmaster, PhD; Barun De, PhD - National Center for Infectious Diseases, Division of Bacterial and Mycotic Diseases, Meningitis and Special Pathogens Branch. Yersinia pestis and Francisella tularensis: May Chu, PhD; Leon Carter, BA; Brook Yockey, BS - National Center for Infectious Diseases, Division of Vector Borne Infectious Diseases, Zoonotic Diseases Branch. The training described in this article was funded by the Laboratory Manage-

5 ment and Support Branch, Bioterrorism Preparedness and Program of the National Center for Infectious Diseases, Centers for Disease Control and Prevention. 1. Update: Investigation of Bioterrorism-Related Anthrax, Connecticut MMWR Morb Mortal Wkly Rep.2001;50: Centers for Disease Control and Prevention. Public health s infrastructure: A status report. Report for the Appropriations Committee of the United States Senate General Accounting Office. Emerging infectious diseases: Consensus on needed laboratory capacity could strengthen surveillance Bryan JL, Fields HF. An ounce of prevention is worth a pound of cure - shoring up the public health infrastructure to respond to bioterrorist attacks. Am J Infect Control. 1999;27: McDade JE. Addressing the potential threat of bioterrorism - value added to an improved public health infrastructure. Emerg Infect Dis. 1999;5: Reports and Recommendations - biological and chemical terrorism: Strategic plan for preparedness and response. MMWR Morb Mortal Wkly Rep. 2000;50: