United States Department of Health & Human Services Office of the Assistant Secretary for Preparedness and Response Day to Day Emergency Care as the Foundation of Preparedness John F. Koerner,, MPH, CIH Chief CBRNE Branch Division of Operations and Preparedness Coordination Office of Preparedness & Emergency Operations FDA/CDRH Public Meeting Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices September 27-28, 2012 1
The views and opinions expressed in this presentation are strictly that of the presenter and are not necessarily the views of ASPR, the Department of Health and Human Services, or the United States Government. No endorsement of products is implied. ASPR: Resilient People. Healthy Communities. A Nation Prepared.
Goals Purpose: To provide background and describe important characteristics and factors that are anticipated for the operational environment. ASPR: Resilient People. Healthy Communities. A Nation Prepared. 3
Radiation Dispersal Device (RDD) RDD made with 1.5 tones of Ammonium nitrate/fuel oil (ANFO) explode in an urban area releasing 2,300 curies of 137 Cs (CsCl). The explosion collapses the front of one building and causes severe damage to three others. Windows are blown out of five other buildings. 137 Cs contamination covers the scene and the contaminated detonation aerosol is lifted more than 100 feet into the air and spread across a wide area. Area for restoration is tens of square miles, including hundreds of contaminated facilities Casualty Summary (as of Day 4) Total deceased 180 Cases, symptomatic and/or hospitalized.270 Number with contamination detected on site 20,000 10,000 4 Evacuated (potentially FOR 100 s EXERCISE of thousands PURPOSES self evacuate) ONLY / 25,000 Shelter-in-place ASPR: Resilient People. Healthy Communities. A Nation Prepared. 4
Improvised Nuclear Device (IND) Assumptions Improvised device 10Kt ground detonation Blast damage extends from.5 to 5km Large fallout plume is dynamic Immediate fatalities 250,000 Casualties up to 200,000 Injuries include blast, radiation, multiple trauma Responders are at particular risk to all hazards ASPR: Resilient People. Healthy Communities. A Nation Prepared. 5
NICOLE LURIE, M.D., M.S.P.H. Assistant Secretary for Preparedness and Response RADM, U.S. Public Health Service U.S. Department of Health and Human Services Mission: Prevent, prepare for, respond, and recover from the adverse health effects of public health emergencies and medical disasters Vision: The nation s health and response systems and communities will be prepared, responsive and resilient to limit the adverse health impact of emergencies and disasters. ASPR coordinates and directs the HHS public health & medical emergency preparedness and response programs ASPR: Resilient People. Healthy Communities. A Nation Prepared. 6
Federal Medical Response HHS, as the primary agency for ESF #8, coordinates with its Federal partners to provide assistance to state, local, tribal and territorial governments in identifying and meeting public health and medical requirements resulting from incidents of national significance. Assessment of public health/medical needs To include mental health Public health surveillance Medical personnel Medical equipment and supplies ASPR: Resilient People. Healthy Communities. A Nation Prepared. 7 7
The Spectrum of Care & Phased Deployment Volunteers APHT-Applied Applied Public Health Team MHT-Mental Mental Health Team RDF-Rapid Rapid Deployment Team DMAT-Disaster Disaster Medical Assistance Team DMORT-Disaster Disaster Mortuary Operational Response Team NDMS-National National Disaster Medical System USPHS RDF NDMS Hospitals NDMS DMATs NDMS DMORT USPHS MHT Medical Reserve Corps USPHS APHT Food / Water Safety Health Surveillance Drug / Blood Safety Basic First Aid Outpatient Care Emergency Departments ICU/ Trauma Critical Care Nursing Hospital Pre-hospital Fatalities Mental Home Inpatient Care Management Health ASPR: Resilient People. Healthy Communities. Care A Nation Care Prepared. 8
HHS Assets National Disaster Medical System (NDMS) 1700+ Hospitals Patient movement Disaster Medical Assistance Teams (DMAT) ~8000 professionals Public Health Service ~ 4200 deployable professionals Medical Reserve Corps (MRC) Primarily local / Community Based. Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP) National system of State-based programs for managing health professional volunteers ASPR: Resilient People. Healthy Communities. A Nation Prepared. 9
Patient Evacuation DOD links to aeromedical evacuation FEMA coordinates ambulance surge with ASPR Provide patient movement and regulation from the disaster area and return to home For IND Utilize all types of transportation ASPR: Resilient People. Healthy Communities. A Nation Prepared. 10
DMAT Field Deployment 11 ASPR: Resilient People. Healthy Communities. A Nation Prepared. 11
Federal Medical Station ASPR: Resilient People. Healthy Communities. A Nation Prepared. 12 12
ESF #8 Operations Centers HHS Secretary s Operations Center Washington, DC Activated 24/7 since 2002. Used for oversight of all major operations. US hub for international health information reporting CDC Emergency Operations Center Atlanta, GA Tracks and manages public health information. Serves as a centralized facility to gather and disseminate public health information. ASPR: Resilient People. Healthy Communities. A Nation Prepared. 13
ESF #8 / HHS Coordination Department Of Homeland Security (DHS) National Operation Center (NOC) ESF#8 Federal Emergency Management Agency (DHS/FEMA) National Response Coordination Center ESF#8 Regional Response Coordination Center (RRCC) Joint Field Office (JFO) ESF#8 Disaster Resiliency Group (DRG) Emergency Management Group Regional IRCT State/Territory EOC County/City EOC Joint Information Center (JIC) ESF#8 County/City Health Departments FBI Joint Operations Center (JOC) ESF#8 Incident Site Hospitals/Clinics/ Shelters/Staging Areas Incident Site Incident Site ASPR: Resilient People. Healthy Communities. A Nation Prepared. 14
Informing the Issues ASPR: Resilient People. Healthy Communities. A Nation Prepared. 15
REMM http://www.remm.nlm.gov/ ASPR: Resilient People. Healthy Communities. A Nation Prepared. 16
ASPR: Resilient People. Healthy Communities. A Nation Prepared. 17
RITN Prime example of multi-use The Radiation Injury Treatment Network (RITN) provides comprehensive evaluation and treatment for victims of radiation exposure or other marrow toxic injuries. RITN develops treatment guidelines, educates health care professionals, works to expand the network, and coordinates situation response. RITN is a cooperative effort of the National Marrow Donor Program (NMDP) and The American Society for Blood and Marrow Transplantation (ASBMT). ASPR: Resilient People. Healthy Communities. A Nation Prepared. 18
AMA Journal of Disaster Medicine and Public Health Preparedness March 2011, Volume 5, Issue Supplement 1 Nuclear Preparedness http://www.dmphp.org/content/vol5/supplement_1/index.dtl ASPR: Resilient People. Healthy Communities. A Nation Prepared. 19
Key principles - medical and public health response to nuclear detonation A partnership of SME s from the Nuclear Detonation Scarce Resources Working Group Offered as a guide to link State, local, and ESF #8 planning Web-based, interactive format or downloadable A living document - updated periodically we want your comments Reference - Murrain-Hill P, Coleman CN, Hick JL, Redlener I, Weinstock DM, Koerner JF, Black D, Sanders M, Bader JL, Forsha J, Knebel AR. Medical Response to a Nuclear Detonation: Creating a Playbook for State and Local* Planners and Responders. Disaster Med Pub Health Prep. 2011. ASPR: Resilient People. Healthy Communities. A Nation Prepared. 20
What do I do? ASPR: Resilient People. Healthy Communities. A Nation Prepared. 21
Action Steps Sequential guidance to coordinate the medical response to a nuclear detonation Detailed time-phased, sector-oriented approaches to response activities with linked references. General Readiness Planning and Emergency Management Emergency Medical Services (EMS) Health and Facility Response, Public Health Medical System Response Evacuee Medical Care and Fallout-related Illness Recovery ASPR: Resilient People. Healthy Communities. A Nation Prepared. 22
Typical Action Screen ASPR: Resilient People. Healthy Communities. A Nation Prepared. 23
Biodosimetry in Practice ASPR: Resilient People. Healthy Communities. A Nation Prepared. 24
Lessons Learned Mission: Save lives, prevent further casualties Decisions are best made with timely, accurate information Medical response must be fully coordinated with other response activities Scarce resources it is most important to efficiently use what you have and to limit reduction in capabilities ASPR: Resilient People. Healthy Communities. A Nation Prepared. 25
Key Factors to Success ASPR: Resilient People. Healthy Communities. A Nation Prepared. 26
Critical Capabilities How we handle these will impact how quickly & completely we recover Behavioral Health Communication Laboratory Surge Baseline Resilience ASPR: Resilient People. Healthy Communities. A Nation Prepared. 27
Triage System Organizing the Medical Response ASPR: Resilient People. Healthy Communities. A Nation Prepared. 28
Victim/Patient Flow ASPR: Resilient People. Healthy Communities. A Nation Prepared. 29
Biodosimetry Architecture Conceptual Draft Do Not Copy BARDA CMCRs Industry New molecular diagnostics Pipeline development for emerging and high-throughput technologies International biodosimetry labs & groups, including WHO (World Health Organization) and others Hematology Biodosimetry Architecture Cytogenetics Immediate triage and long term follow-up Definitive dose determination and long term follow-up Biodosimetry Core Labs Satellite readers Hematology & surge capacity Mobile or Other Surge Radio-bioassay CDC Urine Radionuclide Screen Lab Hospitals Commercial Labs Decontamination and MCM therapy determination Surge labs: state & federal ASPR: Resilient People. Healthy Communities. A Nation Prepared. 30
Biodosimetry Architecture - Medically Relevant Timing Triage and diagnostics Acutely, Point of Care is ideal Conceptual Draft Do Not Copy Transition to traditional and commercial facilities for medical management and epidemiology. Novel Molecular Diagnostics Biodosimetry Architecture Potential Venues for Capacity Surge assets (POC) Mobile facilities Community health/skilled nursing Private Drs. Offices Government Hospitals (POC and Lab) Commercial labs (Lab) Hematology Triage Dose Estimate Cytogenetic Biodosimetry TIME Medical Management Radiobioassay Epidemiology ASPR: Resilient People. Healthy Communities. A Nation Prepared. 31 31
Operational Focus Area of Lymphocyte Depletion Kinetics Required Capability 100,000 per day 40,000 per day Hematology Resources N/A Surge Hospital and Commercial Proposed RTR site RTR 3 + Conceptual Draft Do Not Copy RTR 1 RTR 2 Incident Triage Dose Estimate Medical Management Epidemiology TIME & DISTANCE ASPR: Resilient People. Healthy Communities. A Nation Prepared. 32
Operational Considerations Damaged Infrastructure Power Routes Food and water Banking and money Communication Command and Control Situational awareness Families behavioral health Data Supplies Standards of Care Likely to require tough decisions ASPR: Resilient People. Healthy Communities. A Nation Prepared. 33
Influencing Factors Simplicity, volume, & speed Reliability and accuracy Routine usability Scarce resources & staff Scope of practice (EMS, Lab, Nurse, PA, MD/DO, etc.) Willingness to conduct the task in austere environs What is the intended (and most useful) location of use? Triage H&P with diagnostics will inform proximal or distal care what/when is the treatment which patients should move to palliative care requires clarity in decision criteria and who makes them ASPR: Resilient People. Healthy Communities. A Nation Prepared. 34
Location, Location, Location A driver for: Available diagnostics & purpose Triage/sorting decisions Treatment decisions Medical relevance Time to biological changes Window of measurable effect Actionable treatment options Overall fidelity of the system Doing the right thing at the right location is important RTR1 site Treat trauma and use H&P Definitive care Proximal ED may have less resources and more general care RITN center staffed by specialists ASPR: Resilient People. Healthy Communities. A Nation Prepared. 35
Capability v. Capacity Patient Movement and Regulation Multi-modal transportation Attended transport criteria, unattended (?), non- patient Patient regulation For latent ARS outpatient v. inpatient Optimizing existing capabilities requires a systemic approach Cooperation (public/private at all levels) and leadership Capabilities analysis and assessment Data collection and management Leverage expertise for interpretation Integrated SOPs Test, Evaluate, and Exercise ASPR: Resilient People. Healthy Communities. A Nation Prepared. 36
Ideally ASPR: Resilient People. Healthy Communities. A Nation Prepared. 37
Closing Thoughts What is known is the foundation of new knowledge. Careful preservation of and access to that knowledge is the lynchpin to progress. It is with knowledge, ingenuity, will, and vision that we can lead into the future. ASPR: Resilient People. Healthy Communities. A Nation Prepared. 38