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ATTACHMENT D Briefing Slides
Pages 17-35

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From page 17... ... ATTACHMENT D Briefing Slides Briefing of the Approach to the Medical Countermeasures Test and Evaluation Facility (MCMT&EF) Site‐Specific Risk Assessment (SSRA) Read the entire page →
From page 18... ... • Our goal is to develop a SSRA that is comprehensive, transparent, and practical by focusing on reasonably foreseeable events, and maximum credible events that could cause adverse health effects to people working in and around the laboratory, members of the community and the environment • Assembled a diverse team of highly qualified experts who will employ the best and most innovative methods, and are seeking guidance/concurrence on our approach from NAS to achieve this goal 21 Mar. 2011 NAS Briefing 2 BSA Environmental Services, Inc. • Barbara Johnson, Ph.D. Read the entire page →
From page 19... ... • Present the approach to site‐specific issues/risks topics that were stated in the final report for the "Evaluation of the Health and Safety Risks of the New U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) High‐Containment Facilities at Fort Detrick Maryland" by NAS • The following slides present the issue/risk topics followed by the Proposed Quantitative and/or Qualitative approach • Seeking NAS concurrence/comments on the approach on each issue/risk topic 21 Mar. 2011 NAS Briefing 4 • Throughout the presentation, references to USAMRIID will be used to highlight that this new facility will operate using the increased safety procedures and policies that USAMRIID uses • The MCMT&EF will establish similar agreements that USAMRIID has with local government and healthcare • USAMRIID will not own or oversee the MCMT&EF 21 Mar. 2011 NAS Briefing 5 19 Read the entire page →
From page 20... ... • Systematically stratify the risks of different pathogens to the general public and lab personnel by disease mechanism Bacillus anthracis ‐ Anthrax – Ebola/Marburg virus – Francisella tularensis ‐ Tularemia – Brucella – Brucellosis – Arboviruses: – • VEE ‐ Venezuelan Equine Encephalitis • EEE ‐ Eastern Equine Encephalitis • WEE ‐ Western Equine Encephalitis – Yersinia pestis ‐ Plague 21 Mar. 2011 NAS Briefing 6 • Focus modeling effort where evidence of plausible mechanisms exists for agent and route combinations, as illustrated below – Model aerosol release for anthrax, not tularemia – Model person‐to‐person transmission for plague, not anthrax or tularemia 21 Mar. 2011 NAS Briefing 7 20 Read the entire page →
From page 21... ... Potential actions taken by a laboratory employee that may circumvent biosecurity measures and maliciously expose members of the community to infectious agents • Anthrax findings: – Retrospective case review – Negate future occurrences as the use of dry powders is outside of the mission  Drying equipment will be specifically and intentionally excluded from the facility • Identify a few other ‘biocrimes' as case reviews that are possible 21 Mar. 2011 NAS Briefing 8 • Biosurety Program: Current robust regulations Biosafety – Biosecurity – Biological personnel reliability program – Agent Accountability – 21 Mar. 2011 NAS Briefing 9 21 Read the entire page →
From page 22... ... • Tier II for "Reasonably foreseeable"/Maximum Credible Events (MCE) scenarios – Target efforts for agent and disease mechanism • Include appropriate quantitative measure of per‐ person risk – Order of magnitude estimates of initial external release and location of susceptible population 21 Mar. 2011 NAS Briefing 10 • Develop dispersal models (puff and/or plume models) Read the entire page →
From page 23... ... • Use puff and plume models in determining regions where surveillance will be important • Model dilution and atmospheric decay based on agents and simulants • Develop plausible secondary transmission scenarios – reservoir‐human, human‐human 21 Mar. 2011 NAS Briefing 12 • Simulate, for agent and route combinations selected, solutions based on best available evidence – How likely is a release and how large would it be? – What's the risk that a release will cause an index case? Read the entire page →
From page 24... ... • Address potential concerns that an escape leads to the establishment of pathogen in a native animal or vector reservoir and result in long‐term elevation in disease risk to the general public • Summarize statistics on releases that have occurred and the results 21 Mar. 2011 NAS Briefing 14 • Analyze potential transport of Biological Select Agents and Toxins (BSAT) as part of the biosecurity chain‐of‐custody – Address whether/how shipping poses a risk to the community by accidental/intentional release, or diversion of BSAT – Review Regulatory Processes in Shipping • CDC Form 2 and process • CDC Division SAT Internal tracking/follow through • DOD Interim Guidance for Shipping BSAT 10/08 21 Mar. 2011 NAS Briefing 15 24 Read the entire page →
From page 25... ... • Develop outsider terrorist act scenarios considering – Engineering features of facility – Physical security of facility • Physical security of Fort Detrick • Site‐specific characteristics – New regulatory requirements 21 Mar. 2011 NAS Briefing 16 • Develop natural disaster scenarios – Earthquakes, hurricanes, tornados • Frequency of events in the area • Wind shear that could cause airflow reversals • Engineering features of facility – Statistics on past data of engineering failures (industry wide) 21 Mar. 2011 NAS Briefing 17 25 Read the entire page →
From page 26... ... • Develop potential environmental exposure scenarios considering – Special indoor air quality engineering features – Special engineering features of the wastewater treatment system • MCMT&F Self‐contained Steam Sterilization • FD Wastewater Treatment System – Performance of post‐autoclave solid waste treatment systems, autoclave infrastructure and load testing – Statistics on past data of engineering failures (industry wide) 21 Mar. 2011 NAS Briefing 18 • Review literature involving Laboratory Acquired Infections (LAIs) Read the entire page →
From page 27... ... • Summarize key case study exposures Involving BSAT at USAMRIID – Glanders (2000) ‐ lack of Personal Protective Equipment (PPE) Read the entire page →
From page 28... ... • Draft List of Exposure Scenarios most likely for person in the lab and community members (should illness be unreported) . For Example: – Aerosol exposure to Y. pestis, F. tularensis: faulty BSC use, unrecognized illness, risk to community member – Needle stick Ebola or Marburg: medical containment suite (MCS) Read the entire page →
From page 29... ... • Standard/special engineering controls (primary containment; retracting needles) per BMBL • Additional engineering controls per DA/USAMRIID • Engineering controls prompted by lessons learned and their effectiveness (reduced incidents) Read the entire page →
From page 30... ... • Continue research and practice for effective pre‐ exposure Immunization Recommended immunizations per BMBL – Additional immunizations per DA/USAMRIID – Efficacy data/break through cases involving immunizations – Vaccine Efficacy of immunizations – Reduction in LAIs since immunizations began – • Rusnak papers 21 Mar. 2011 NAS Briefing 26 • Expand practice for post‐exposure controls/reporting – Special Immunizations Program (SIP) • Describe SIP and reporting triggers • Describe SIP staffing on/off duty hours • Improvements since Nov 2009 to ensure prompt/appropriate ‘self‐ reporting' – Transport of Laboratory Personnel Potentially Exposed to Infectious Agents From Fort Detrick, Frederick, MD to the National Institutes of Health Mark O. Hatfield Clinical Research Center, Bethesda, MD 21 Mar. 2011 NAS Briefing 27 30 Read the entire page →
From page 31... ... • Consider biological accident and incident reporting – Describe how/when U.S. Army Medical Research and Materiel Command, Maryland Public Health Lab, CDC, Frederick Memorial Hospital, Press, and others will be notified of LAIs – Describe Memorandum of Agreements (MOAs) and/or written procedures – CDC Form 3 21 Mar. 2011 NAS Briefing 28 • Consider post‐exposure medical evaluation, prophylaxis and follow up – Briefly describe diagnostic methods and Post‐exposure prophylaxis (PEP) Read the entire page →
From page 32... ... • Consider USAMRIID Biosafety Program – Briefly describe staffing, chain of reporting, roles/responsibilities – Training program – Proficiency demonstration/exams/records – BSL‐4 Internship and approval to work – Special training provided – Non‐compliance (reporting, remediation, retraining, removal) 21 Mar. 2011 NAS Briefing 30 • Consider annual incident response drills Describe last two drills – What is the regulatory requirement – Who plays – Tabletop vs. live – Duration – Analysis of findings – Remedial activities and outcomes – 21 Mar. 2011 NAS Briefing 31 32 Read the entire page →
From page 33... ... • Develop Tier II modeling for transmission of disease from an infected laboratory worker to family or community members – Course of infection for the agent – Likely transmission patterns following the index case – Surveillance, mitigation and management of secondary infections • Consider data sufficient for constructing a robust model with biological fidelity • Derive quantitative estimates of the risks and consequences of secondary infections that may occur subsequent to index cases 21 Mar. 2011 NAS Briefing 32 • MOA between Garrison, FMH, Barquist, USAMRIID • Garrison relationship with Frederick County Health Department • Review how this information will be relayed to the local government and the media in a timely manner 21 Mar. 2011 NAS Briefing 33 33 Read the entire page →
From page 34... ... • Clarify intent of National Academy of Science Committee – Require cumulative risk over proposed life span of the building... To individuals in labs and the community? – Prepare quantitative and retrospective statistical analysis from i.e. 1991‐2001 with and without anthrax letters, and 2001‐2011 (as current as feasible) Read the entire page →
From page 35... ... • Comprehensive • Transparent • Practical The views expressed are those of the authors and should not be construed to represent the positions of the Department of the Army or Department of Defense. 21 Mar. 2011 NAS Briefing 36 • Does the committee concur: – With the approach to site‐specific issues/risks topics that were stated in the final report for the "Evaluation of the Health and Safety Risks of the New USAMRIID High‐Containment Facilities at Fort Detrick Maryland"? Read the entire page →

From page 17...

... ATTACHMENT D Briefing Slides Briefing of the Approach to the Medical Countermeasures Test and Evaluation Facility (MCMT&EF) Site‐Specific Risk Assessment (SSRA)

ATTACHMENT D Briefing Slides Pages 17-35

ATTACHMENT D Briefing Slides
Pages 17-35