United States Health Security National Action Plan: Strengthening Implementation of the International Health Regulations based on the 2016 Joint External Evaluation October 2018 TABLE OF CONTENTS EXECUTIVE SUMMARY 4 PURPOSE AND SCOPE 10 U.S. GOVERNMENT INTERAGENCY STAKEHOLDERS 11 BACKGROUND 13 SUMMARY OF THE 2016 U.S. JEE RESULTS 14 THE IHR WORKING GROUP AND NATIONAL ACTION PLAN PROCESS 17 The IHR and the JEE Tool 2016 U.S. JEE 13 13 OVERALL STRUCTURE OF THE U.S. HEALTH SECURITY NATIONAL ACTION PLAN 17 PREVENT 1 — National Legislation, Policy, and Financing 18 PREVENT 2 — IHR Coordination, Communication, and Advocacy 20 PREVENT 3 — Antimicrobial Resistance 22 PREVENT 4 — Zoonotic Disease 33 PREVENT 5 — Food Safety 40 PREVENT 6 — Biosafety and Biosecurity 45 PREVENT 7 — Immunization 50 DETECT 1 — National Laboratory System 53 Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Page 2 of 115 18 18 19 20 20 21 22 22 23 33 33 34 40 40 41 45 45 46 50 50 51 53 53 54 DETECT 2 — Real-Time Surveillance 61 DETECT 3 — Reporting 65 DETECT 4 — Workforce Development 68 RESPOND 1 — Preparedness 73 RESPOND 2 — Emergency Response Operations 84 RESPOND 3 — Linking Public Health and Security Authorities 88 RESPOND 4 — Medical Countermeasures and Personnel Deployment 90 RESPOND 5 — Risk Communication 93 OTHER IHR HAZARDS — Points of Entry (PoE) 97 OTHER IHR HAZARDS — Chemical Events 99 Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items OTHER IHR HAZARDS — Radiation Emergencies Summary of U.S. Self-Assessment 2016 JEE Recommendations from the External Evaluators Action Items Page 3 of 115 61 61 62 65 65 66 68 68 69 73 73 74 84 84 85 88 88 89 90 90 91 93 93 94 97 97 98 99 99 100 105 105 105 106 EXECUTIVE SUMMARY The International Health Regulations (2005) (IHR), 1 overseen by the World Health Organization (WHO), seek “to prevent, protect against, control, and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.” The IHR reflect countries’ commitment to building national capacities required to rapidly identify threats to human health and undertake quick action to prevent a public health event from becoming a public health emergency of international concern (PHEIC). In late 2015, WHO adopted the Joint External Evaluation (JEE) as a voluntary mechanism to evaluate IHR implementation through a multisectoral approach. 2 Based on the evaluation methodology developed for the Global Health Security Agenda (GHSA), the JEE is a voluntary, peer-to-peer, collaborative process that combines GHSA infectious disease targets with the all-hazards approach to public health preparedness and response required for implementation of IHR. The JEE Tool consists of four thematic areas: Prevent, Detect, Respond, and Other IHR-Related Hazards and Points of Entry, which cover 19 technical areas with specific targets and performance indicators. The JEE of the United States, conducted in May 2016, identified strengths and gaps in U.S. capacities to prevent, detect, and respond to public health emergencies. Following the 2016 JEE, an interagency, multisectoral IHR Working Group developed the “United States Health Security Action Plan: Strengthening Implementation of the International Health Regulations based on the 2016 Joint External Evaluation”. On behalf of the U.S. government, the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR), which maintains the U.S. National Focal Point (NFP) for the IHR, led the development of the National Action Plan in collaboration with over 40 federal departments and agencies with a role in human, animal, plant, and environmental health across the 19 technical areas. ASPR continues to work with these federal partners to coordinate the plan’s implementation until the next JEE of the United States in 2021. 3 During the 2016 JEE, U.S. and international subject-matter experts identified high priorities for improvement in technical areas with lower capacities, but also identified actions that would reinforce, sustain, and further optimize capacities that are already highly rated according to the JEE Tool. As such, the National Action Plan contains actions items for all JEE technical areas, which take into account the unique aspects of the United States systems that support national health security. These unique aspects of the U.S. systems include, among other things, the size and diversity of our country and our population, the nature of the federal system of government and the criticality of state and local capacities, as well as the amount of global travel and trade to/from the United States. The National Action Plan is intended to be a dynamic framework that can evolve with new legislation, policies, programs, technologies, and financial resources. During the implementation period, individual departments and agencies will continue to apply a multisectoral approach to address each action item while utilizing established programs or developing new programs to collaborate with state, local, tribal, and territorial WHO. International Health Regulations, 3rd edition. See WHO. Partnership Portal: IHR Monitoring and Evaluation Framework. 3 See The White House. “Executive Order -- Advancing the Global Health Security Agenda to Achieve a World Safe and Secure from Infectious Disease Threats” (November 4, 2016). 1 2 Page 4 of 115 (SLTT) authorities. All activities listed in the National Action Plan are subject to the availability of funds as authorized and/or appropriated by the U.S. Congress, as well as funding limitations faced by SLTT authorities. Importantly, the National Action Plan derives from, maintains alignment with, underscores, and supports the goals and implementation plans of other federal statutory and policy obligations, including the United States’ National Security Strategy, the National Health Security Strategy (NHSS), the National Biodefense Strategy (NBS), and other important federal initiatives and partnerships that aim to strengthen public health emergency preparedness, response, and recovery capacities in the United States. The National Action Plan not only shares similar objectives, but also includes activities that seek to coordinate and align implementation efforts with those undertaken in those strategies. At the technical level, the National Action Plan contains action items derived from and consistent with national plans and initiatives that include, among others, the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB), and those plans and initiatives at the national-international interface, such as the GHSA, the North American Plan for Animal and Pandemic Influenza (NAPAPI), and the Global Health Security Initiative (GHSI). The synergetic relationship with other key health security efforts is critical to maximizing implementation of the National Action Plan. Consistent with WHO and GHSA goals for international transparency, action items for all 19 technical areas are listed in detail in the full National Action Plan. The following sections provide high-level descriptions of the priority actions within the ten areas that received either a capacity level indicator of “3” (the lowest capacity level for the United States) or mostly “4s” on the JEE scale of 1 to 5. 4 The priority capacities for strengthening are described below in the order that they appear in the WHO JEE Tool and the National Action Plan. Antimicrobial Resistance (AMR) The JEE Self-Assessment indicated the availability of federal and state-level capacities to detect antimicrobial resistant bacteria, though many SLTT authorities had insufficient access to laboratories that can detect and characterize resistance according to published standards; that the implementation of a One Health approach to surveillance and reporting of resistance required alignment and coordination; and that antimicrobial stewardship programs were being developed, although implemented inconsistently and not fully monitored. Efforts will focus on expanding capabilities at existing public health laboratories; characterizing and following trends in AMR, including the emergence of new bacterial strains and resistance mechanisms; fostering multisectoral and multidisciplinary collaboration, including through publicprivate partnerships; and strengthening antimicrobial stewardship activities. The action items align with the CARB, a comprehensive national plan for the federal government developed through an interagency process that identifies critical actions necessary to combat the emergence and spread of antibiotic-resistant bacteria. 4 1- No Capacity, 2- Limited Capacity, 3- Developed Capacity, 4- Demonstrated Capacity, 5- Sustainable Capacity Page 5 of 115 Zoonotic Disease Although there are programs connecting human, animal, and environmental health (some of which are well coordinated for specific zoonoses), the overall federal approach to One Health currently remains informal. Surveillance and information systems across sectors are largely separate from one another. Departments and agencies involved in public health security need to formally share and align their priorities for zoonotic disease prevention, detection, and response. Efforts will focus on incorporating the One Health approach to addressing zoonotic diseases nationally and through collaboration across departments and agencies. The first priority is to create a shared vision and roadmap for a more formal approach to One Health. Multiple federal departments and agencies will convene a multisectoral One Health Zoonotic Disease Prioritization workshop to: (a) prioritize the zoonotic diseases of greatest national concern for human, animal, and environmental health sectors that are responsible for federal zoonotic disease programs to address; and (b) develop plans for implementing and strengthening multisectoral approaches to address these diseases in the United States. This work will allow departments and agencies to develop jointly a list of necessary action items and next steps for strengthening One Health approaches to integrate surveillance systems, laboratory systems, joint outbreak response capacity, preparedness planning, and cross-sector prevention and control strategies. Food Safety Food safety programs are largely effective, but there are still challenges in detecting multistate outbreaks with lack of access to specialized laboratories at all local levels. Efforts focus on enhancing detection and reporting of foodborne illness outbreaks and progressively developing additional, state-of-the-art laboratory testing capabilities in state and local public health laboratories. These include next-generation whole genome sequencing (WGS) and related technologies, methods and platforms, and advanced computational and bioinformatics tools for enhanced pathogen identification. Biosafety and Biosecurity Overall, systems for biosafety and biosecurity in the United States are strong, yet there remain areas for improvement with respect to federal oversight and the availability of standardized training. The focus will be on implementing two sets of recommendations, one from the Federal Expert Security Advisory Panel (FESAP), 5 which conducted an internal federal government review of biosafety and biosecurity practices, and another from the Fast Track Action Committee on Select Agent Regulations (FTAC-SAR), 6 which conducted an external review that focused on the effects of the select agent regulations on researchers and laboratories. Recommendations made by both the FESAP and FTAC-SAR address the culture of responsibility, oversight, outreach, and education; applied biosafety research; incident reporting; See Report of the Federal Experts Security Advisory Panel (FESAP) (December 2014). See Fast Track Action Committee Report: Recommendations on the Select Agent Regulations Based on Broad Stakeholder Engagement (October 2015). 5 6 Page 6 of 115 material accountability; inspection processes; regulatory changes; and guidance to improve biosafety and biosecurity. Implementing the FESAP and FTAC-SAR recommended actions is anticipated to strengthen biosafety and biosecurity practices and oversight activities. The United States is committed to fostering progress in the life sciences, including peaceful research involving Biological Select Agents and Toxins (BSAT) 7 and non-BSAT, while at the same time ensuring that such work is being conducted in a safe and secure manner. The United States will also continue to implement policies regarding dual use research of concern. Real-Time Surveillance The United States has an extensive system for public health surveillance that is capable of quickly detecting major outbreaks. However, there are inconsistent linkages between key aspects of the human and animal surveillance systems, and there could be significant improvements in the rapid acquisition, processing, and interpretation of electronic data. Efforts will focus on further integration and rapid exchange of surveillance information among departments and agencies, testing and improving interoperability of electronic health care records, and increasing trained personnel at the SLTT levels to strengthen surveillance systems. Activities will also include the development and promotion of indicator-based surveillance tools and strategies for the rapid detection and characterization of emerging and reemerging pathogens at the animal-human interface. Preparedness The United States has complex federal and SLTT structures for public health emergency preparedness and response, which necessitate consistency and coordination in response plans and systems. Efforts will focus on continuing to strengthen emergency preparedness through technology platforms; developing new—and enhancing existing—multi-platform tools and resources; coordinating planning for responding to complex incidents that do not receive Stafford Act declarations through such activities as exercises linked to the Biological Incident Annex to the Response and Recovery Federal Interagency Operational Plans and the National Response Framework that include state and local partners in exercises (e.g., the Pandemic Influenza exercise, Gotham Shield nuclear/radiological response exercise, and recent past exercises linked to Zika Virus responses); developing formal guidance that standardizes postevent/exercise corrective action plans (CAP) and the after action review/reporting (AAR) processes used by federal and SLTT public health planners; and collaborating among federal and SLTT partners to develop higher quality and more inclusive public health concept of operations (CONOPS), documents, and exercises. Emergency Response Operations Most federal departments and agencies have well-established emergency operations center (EOC) capacities, and those centers are connected and coordinated centrally during a major public health emergency. However, not all of the centers perform as effectively or efficiently as Biological agents and toxins that HHS and USDA have determined to have the potential of posing a severe threat to both human and animal health, plant health, or animal and plant products. 7 Page 7 of 115 possible, and many of the state-level EOCs do not consistently plan or exercise adequately for public health emergencies. Efforts will focus on involving more federal and SLTT jurisdictions in national level exercises (NLE) and ensuring that best practices and lessons learned are shared at all levels of government, in order to improve outcomes, internal and external communication, information sharing, and situational awareness, and to establish a common operating picture during events and exercises. Federal departments and agencies will also work to establish EOC standards and incident management systems (IMS) for situational awareness, staffing, and staff education and training; provide federal support to SLTT programs to increase local capacities to identify, hold, treat, and transport patients with a highly infectious disease (HID) or who are physically contaminated; and assist local medical networks to identify facilities capable of receiving such patients and coordinate with EMS providers. Risk Communication The United States has a very effective system for developing risk communications at the federal level that involves all of the key departments and agencies. However, during the earliest stages of a response, various departments and agencies may conduct communication operations more independently and less cohesively. There are not enough personnel trained in handling major emergencies, with too few who can surge where and when needed. Efforts will focus on promoting community engagement and evaluating the current capacities and challenges among SLTT partners, and working with them to develop training and staffing plans to improve the number of qualified risk communicators. Action items will include training around complex situations and specific (rare) hazards; surveying national risk communication partners and media outlets to develop a plan to address existing gaps and shortfalls in community engagement and readiness; and conducting exercises to test those plans. Chemical Events The United States has an adequate system in place to identify chemical events quickly. However, local laboratories and health departments require improvements in their capacity for rapid risk assessments and diagnostics. Efforts will focus on federal government departments and agencies developing additional guidance for preparedness at the SLTT level, and developing and stockpiling improved medical countermeasures (MCMs) for chemical exposures; expanding the number of laboratories in the Environmental Response Laboratory Network (ERLN); evaluating the variations in SLTT capacities; and developing tools to assist them in reviewing and improving their local capacities to provide a medical response to a large-scale chemical event. Radiation Emergencies While early radiation detection is generally available across the country, few locations have the ability to assess dose and conduct post-event risk assessments. Efforts will focus on developing laboratory bioassays for the remaining priority radionuclides and disseminating the tests to designated labs across the country; increasing the overall capacity within DOE and DoD to conduct radiobiodosimetry testing including characterization and validation of new methods; Page 8 of 115 collaborating with U.S. hospitals to identify locations that could potentially adopt standardized biodosimetry methods and coordinate to enable responses to larger-scale exposures; increase number of radiation professionals through education, work experience, and increasing awareness of the profession; and collaborating with SLTT health departments and Public Health Emergency Preparedness (PHEP) grant awardees to raise awareness of their potential role in a radiation emergency response, to provide them with guidance on emergency response preparations, and to enhance situational awareness between partners in a radiological response. Page 9 of 115 PURPOSE AND SCOPE The JEE of the United States, conducted in May 2016, identified strengths and gaps in U.S. capacities to prevent, detect, and respond to public health emergencies based on the Joint External Evaluation Tool: International Health Regulations (2005) (JEE Tool). The purpose of the United States Health Security National Action Plan: Strengthening Implementation of the International Health Regulations based on the 2016 Joint External Evaluation is to describe how the United States will continue to address the highest priority gaps identified during the 2016 JEE. The Joint External Evaluation of the United States of America Self-Assessment Report (originally published May 2016 and revised in September 2016) (JEE Self-Assessment) describes the United States health security capacities, strengths, gaps, and challenges in great detail. The Joint External Evaluation of IHR Core Capacities of the United States of America – Mission Report (June 2016) (JEE Mission Report) also describes the essential elements of that assessment as well as the recommendations received from the panel of external subject-matter experts during the 2016 JEE. The Office of the Assistant Secretary for Preparedness and Response (ASPR), which maintains the U.S. IHR NFP and performs the required monitoring and evaluation of U.S. compliance with the IHR, led the development of the National Action Plan and will continue coordinate the plan’s implementation until the next U.S. JEE in 2021. During this period, federal government departments and agencies will continue to follow established program cycles to work with state, local, tribal, and territorial (SLTT) authorities, operating within their own mission areas, mandates, and budgets. As such, all activities listed in the National Action Plan were included without consideration of potential competing priorities and are subject to the availability of funds as authorized by the U.S. Congress. The National Action Plan captures programs and activities of individual departments and agencies or groups that have been approved under the current budget and that specifically support reaching the JEE targets. The U.S. Government’s self-assessment in 2016 and the discussion with the external assessors resulted in areas for improvement in all 19 technical areas, including those where the United States capacities are already rated highly according to the JEE Tool. The U.S.-specific gaps and challenges were subsequently discussed among interagency partners in 2017, and those priority areas that require further action (including some of the areas that received a “5”) are now reflected in the National Action Plan. The National Action Plan aims to optimize the health security of the United States based on the country’s unique risks, challenges, and resources while using the JEE indicators as guidance. The National Action Plan aligns with and fully supports the goals and activities of the United States’ National Security Strategy, NHSS, NBS, and other important federal initiatives and partnerships that aim to strengthen public health emergency preparedness, response, and recovery capacities in the United States. Other examples of such alignment include the CARB, GHSA, NAPAPI, and GHSI, among many others. The National Action Plan is intended to be a dynamic framework that can evolve as a result of development of new legislation, policies, programs, technologies, and budget changes. The National Action Plan is not intended to be a budget or commitment document. All activities included in this document are subject to budgetary constraints and other approvals, including the weighing of priorities and available resources by the Administration in formulating its annual budget and by Congress in legislating appropriations. Page 10 of 115 U.S. GOVERNMENT INTERAGENCY STAKEHOLDERS The following federal government stakeholders are currently involved in the development, coordination, and/or implementation of the National Action Plan: Department of Health and Human Services (HHS) ASPA Office of the Assistant Secretary for Public Affairs ASPR Office of the Assistant Secretary for Preparedness and Response (Lead Coordinator) AHRQ Agency for Healthcare Research and Quality CDC Centers for Disease Control and Prevention CMS Centers for Medicare & Medicaid Services FDA Food and Drug Administration HRSA Health Resources and Services Administration IHS Indian Health Service NIH National Institutes of Health NVPO National Vaccine Program Office OASH Office of the Assistant Secretary for Health OGA Office of Global Affairs OGC Office of the General Counsel OSG Office of the Surgeon General Department of Agriculture (USDA) AMS Agricultural Marketing Service APHIS Animal and Plant Health Inspection Service ARS Agricultural Research Service FSIS Food Safety Inspection Service NIFA National Institute of Food and Agriculture Department of Commerce (DOC) Department of Defense (DoD) ASDHA Office of the Assistant Secretary of Defense for Health Affairs OUSDP Office of the Under Secretary of Defense for Policy Department of Energy (DOE) NNSA National Nuclear Security Administration Department of Homeland Security (DHS) CBP U.S. Customs and Border Protection FEMA Federal Emergency Management Agency CWMD Countering Weapons of Mass Destruction Office Department of the Interior (DOI) FWS U.S. Fish and Wildlife Service NPS National Park Service OEM Office of Emergency Management USGS U.S. Geological Survey Page 11 of 115 Department of Justice (DOJ) FBI Federal Bureau of Investigation Department of Labor (DOL) OSHA Occupational Safety and Health Administration Department of State (DOS) IHB Office of International Health and Biodefense Department of Transportation (DOT) Department of Veterans Affairs (VA) VHA Veterans Health Administration Environmental Protection Agency (EPA) OCSPP Office of Chemical Safety and Pollution Prevention OLEM Office of Land and Emergency Management ORIA Office of Radiation and Indoor Air ORD Office of Research and Development OW Office of Water Executive Office of the President NSC National Security Council OMB Office of Management and Budget OSTP Office of Science and Technology Policy Nuclear Regulatory Commission (NRC) Page 12 of 115 BACKGROUND The IHR and the JEE Tool In May 2005, the 58th World Health Assembly adopted significant revisions to the 1969 edition of the IHR. The revised IHR, which entered into force on June 15, 2007, seek “to prevent, protect against, control, and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.” The IHR reflect countries’ commitment to building national capacities required to rapidly identify threats to human health and undertake quick action to prevent a public health event from becoming a public health emergency of international concern (PHEIC). The IHR Article 54 requires that each country conduct a self-assessment and report the results to the WHO. In late 2015, the WHO adopted the JEE Tool and an external assessment process as a voluntary mechanism to evaluate IHR implementation through a multisectoral approach. 8 Other health security organizations such as the World Organisation for Animal Health (OIE) and the Food and Agriculture Organization of the United Nations (FAO) also support this mechanism. The JEE Tool consists of four thematic areas: Prevent, Detect, Respond, and Other IHRRelated Hazards and Points of Entry, which cover 19 technical areas with specific targets and performance indicators. 2016 U.S. JEE The United States conducted a self-assessment of IHR capacities, using the JEE Tool in May 2016, followed by an external evaluation visit later that month. ASPR, in close coordination with the Centers for Disease Control and Prevention (CDC) and with the support from more than 20 federal government departments and agencies, conducted the self-assessment. On May 12, 2016, the external assessment team received the self-assessment. ASPR and CDC co-hosted the JEE technical area discussions with the external assessors from May 23 – 24, 2016, in Washington, DC, and from May 25 – 27, 2016, in Atlanta, GA. During the visit, the external assessors met with more than 120 national subject-matter experts, program leaders, and decision- and policy-makers in smaller groups for each JEE technical area. Both activities resulted in the publication of the U.S. Self-Assessment Report and the U.S. Mission Report. According to current WHO policy, external evaluations should take place approximately every five years. The United States has committed to volunteering for another JEE in 2021. 8 See WHO. Partnership Portal: IHR Monitoring and Evaluation Framework. Page 13 of 115 SUMMARY OF THE 2016 U.S. JEE RESULTS On a scale from 1 to 5 (1- No Capacity, 2- Limited Capacity, 3- Developed Capacity, 4Demonstrated Capacity, 5- Sustainable Capacity), the United States had a capacity level of “5” in 20 indicators, a “4” in 21 indicators, and a “3” in seven indicators. Table 1 summarizes the technical areas, indicators, and U.S. capacity levels, as determined jointly with the external assessors. The U.S. self-assessment and the discussion with the external assessors identified areas for improvement in all 19 technical areas, including those for which the United States received the highest capacity levels. Table 1. Summary of 2016 JEE Scores for the United States9 Technical Area Indicator P1.1 Legislation, laws, regulations, administrative requirements, policies, or other government instruments PREVENT in place are sufficient for implementation of the IHR P1. National P1.2 The state can demonstrate that it has adjusted Legislation, Policy, and aligned its domestic legislation, policies, and and Financing administrative arrangements to enable compliance with the IHR P2. IHR Coordination, P2.1 A functional mechanism is established for the Communication, and coordination and integration of relevant sectors in the Advocacy implementation of the IHR P3.1 Antimicrobial resistance (AMR) detection P3.2 Surveillance of infections caused by AMR P3. Antimicrobial pathogens Resistance P3.3 Health care-associated infection (HCAI) prevention and control programs P3.4 Antimicrobial stewardship activities P4.1 Surveillance systems in place for priority zoonotic diseases/pathogens P4. Zoonotic Diseases P4.2 Veterinary or animal health workforce P4.3 Mechanisms for responding to infectious zoonoses and potential zoonoses are established and functional P5.1 Mechanisms are established and functioning for P5. Food Safety detecting and responding to foodborne disease and food contamination P6.1 Whole-of-government biosafety and biosecurity system is in place for human, animal, and agriculture P6. Biosafety and facilities Biosecurity P6.2 Biosafety and biosecurity training and practices 9 All of the indicators in Table 1 and throughout this document are taken verbatim from the JEE Tool. Page 14 of 115 Capacity Level 5 5 5 4 4 4 3 3 4 4 4 4 4 Technical Area P7. Immunization DETECT D1. National Laboratory System D.2 Real-Time Surveillance D.3 Reporting D.4 Workforce Development RESPOND R.1 Preparedness R.2 Emergency Operations Centers R.3 Linking Public Health and Security Authorities Indicator P7.1 Vaccine coverage (measles) as part of the national program P7.2 National vaccine access and delivery D1.1 Laboratory testing for detection of priority diseases D1.2 Specimen referral and transport system D1.3 Effective modern point-of-care and laboratorybased diagnostics D1.4 Laboratory quality system D2.1 Indicator and event based surveillance systems D2.2 Interoperable, interconnected, electronic real-time reporting system D2.3 Analysis of surveillance data D2.4 Syndromic surveillance systems D3.1 System for efficient reporting to WHO, FAO, and OIE D3.2 Reporting network and protocols in country D4.1 Human resources are available to implement IHR core capacity requirements D4.2 Applied epidemiology training program in place, such as Field Epidemiology Training Program (FETP) D4.3 Workforce strategy R1.1 Multi-hazard national public health emergency preparedness and response plan is developed and implemented R1.2 Priority public health risks and resources are mapped and utilized R2.1 Capacity to activate emergency operations R2.2 Emergency Operations Center operating procedures and plans R2.3 Emergency operations program R2.4 Case management procedures are implemented for IHR relevant hazards R3.1 Public health and security authorities, (e.g., law enforcement, border control, and customs) are linked during a suspected or confirmed biological event Page 15 of 115 Capacity Level 5 5 5 4 5 5 5 3 5 4 5 4 5 5 4 5 4 5 4 4 3 5 Technical Area Indicator R4.1 System is in place for sending and receiving R.4 Medical medical countermeasures (MCM) during a public health Countermeasures and emergency Personnel R4.2 System is in place for sending and receiving Deployment health personnel during a public health emergency R5.1 Risk communication systems (e.g., plans, mechanisms, etc.) R5.2 Internal and partner communication and R.5 Risk coordination Communication R5.3 Public communication R5.4 Communication engagement with affected communities R5.5 Dynamic listening and rumor management OTHER IHR HAZARDS PoE.1 Routine capacities are established at PoE Points of Entry (PoE) Chemical Events Radiation Emergencies PoE.2 Effective public health response at PoE CE.1 Mechanisms are established and functioning for detecting and responding to chemical events or emergencies CE.2 Enabling environment is in place for management of chemical events RE.1 Mechanisms are established and functioning for detecting and responding to radiological and nuclear emergencies RE.2 Enabling environment is in place for management of radiation emergencies Page 16 of 115 Capacity Level 5 4 4 5 4 3 4 4 5 4 5 3 3 THE IHR WORKING GROUP AND NATIONAL ACTION PLAN PROCESS Previously created in 2016 as the JEE Working Group, today’s federal IHR Working Group continues to be chaired by ASPR and consists of representatives from federal government departments and agencies who collaborated in the development of the U.S. self-assessment and the external evaluation under the JEE. The IHR Working Group is responsible for developing, updating, implementing, and tracking progress of the National Action Plan, with members coordinating implementation of activities under their relevant technical areas in collaboration with other federal bodies, SLTT partners, and non-governmental partners, as needed. The following is the initial follow-up process and timeline for the implementation of the National Action Plan: • Beginning of the federal monitoring and evaluation process for the United States Health Security National Action Plan – November 2018. • First interagency comprehensive National Action Plan Review and Progress Report Meeting – January 2019 • Online publication of the 2018 National Action Plan Progress Report and publication of a revised National Action Plan (if needed) – February 2019. • Second biannual IHR Working Group Action Item Review Meeting – July 2019. This annual schedule of activities iterates until the second JEE of the United States, tentatively planned for mid-2021. OVERALL STRUCTURE OF THE U.S. HEALTH SECURITY NATIONAL ACTION PLAN The National Action Plan summarizes the gaps identified in the U.S. self-assessment and the plans to address the external assessors’ recommendations for each technical area. The proposed action items in each technical area form the framework for the National Action Plan. Action items are listed according to the JEE recommendations and indicators. Each section consists of: • • • • A description of the original JEE target and indicators, as provided in the JEE Tool, and the 2016 capacity levels; A short summary of the U.S. self-assessment extracted from the U.S. Self-Assessment Report; A summary of the recommendations made by the external assessors based on the 2016 JEE; and Action items to complete during 2018 – 2020. Each action item lists the main department(s) or agency(ies) that lead its implementation and that are responsible for coordinating with intra- and interagency partners and for reporting on its status on behalf of all involved stakeholders. All actions items will be worked within the context of the National Response Framework and other appropriate interagency emergency planning, preparedness, response, and recovery frameworks. Such efforts will include coordination with all relevant regulatory agencies for the activities involved. Page 17 of 115 PREVENT 1 — National Legislation, Policy, and Financing JEE Target States Parties should have an adequate legal framework to support and enable the implementation of all of their obligations and rights to comply with and implement the IHR. In some States Parties, implementation of the IHR may require new or modified legislation. Even where new or revised legislation may not be specifically required under the State Party’s legal system, States may still choose to revise some legislation, regulations, or other instruments in order to facilitate their implementation and maintenance in a more efficient, effective, or beneficial manner. States Parties should ensure provision of adequate funding for IHR implementation through national budget or other mechanism. Indicators P.1.1 Legislation, laws, regulations, administrative requirements, policies, or other government instruments in place are sufficient for implementation of the IHR. 2016 Capacity Level: 5 P.1.2 The state can demonstrate that it has adjusted and aligned its domestic legislation, policies, and administrative arrangements to enable compliance with the IHR. 2016 Capacity Level: 5 Summary of U.S. Self-Assessment While there are no specific references to the IHR in U.S. legislation, many federal, state, and local laws and policies are sufficient to support implementation of IHR core requirements. However, not all subnational jurisdictions have the same capacities to respond quickly and effectively to emerging public health events because of inadequate policies and financing for public health systems. Federal systems are in place to provide rapid supplementation where needed, but there is a need for comprehensive strategic planning and partner engagement to prepare for modern threats and challenges. 2016 JEE Recommendations from the External Evaluators 10 1. Continue the evaluation of existing legislation, regulations, and policies to review opportunities that would help improve mechanisms for interagency coordination and response. All of the recommendations in the U.S. Health Security National Action Plan are from the Joint External Evaluation of IHR Core Capacities of the United States of America – Mission Report (WHO, 2017). 10 Page 18 of 115 2. Engage relevant stakeholders to develop the legislation, regulations, and/or policies that facilitate coordination among sectors at all levels of pre-disaster or pre-emergency situations. Summary of Actions Items There are efforts to develop and adjust legal and policy instruments to strengthen the health security of the United States and improve the country’s compliance with the IHR. Efforts will focus on the implementation of the NBS, which Congress required through the National Defense Authorization Act (Section 1086). 11 Under guidance from the National Security Council, HHS will host the Biodefense Coordination Team to develop the NBS Implementation Plan, with ASPR designated as the primary manager for the coordination mechanisms. Additionally, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) may be reauthorized by Congress in 2018 and a new direction is under development for the next 2019 quadrennial NHSS. To the extent possible, activities in the National Action Plan will support implementation of the NBS and the NHSS. Action Items Table 2. JEE RECOMMENDATION 1 (JEE INDICATOR P.1.2): Continue the evaluation of existing legislation, regulations, and policies to review opportunities that would help improve mechanisms for interagency coordination and response; and JEE RECOMMENDATION 2 (JEE INDICATOR P.1.2): Engage relevant stakeholders to develop the legislation, regulations, and/or policies that facilitate coordination among sectors at all levels of pre-disaster or pre-emergency situations. CY DEPARTMENTS 12 2018 HHS 2018 HHS 2019 2020 HHS HHS ACTION ITEMS Coordinate with federal leads and other stakeholders to evaluate congruency between the U.S. National Action Plan and the NHSS and NBS implementation plans. Coordinate with relevant actors regarding the reauthorization of PAHPRA and seek new authorities as needed. Complete the first NBS Public Report through interagency collaboration. Complete annual NBS Public Report. AGENCIES 13 ASPR HHS Office of the Secretary ASPR ASPR U.S. Congress. National Defense Authorization Act of 2017 (December 23, 2016). Listed in alphabetical order, these are the primary departments of the federal government that have authorities, policies, and programs in place relevant to the specific action items. Other departments (not listed) may also maintain or support functions that are relevant overall in the technical area. 13 The agency or agencies within the listed departments that are responsible for coordinating the specific action item and reporting progress for the National Action Plan. The coordinating agency may work with multiple other federal and SLTT departments/agencies and non-governmental entities. Other agencies (not listed) may also support implementation of the action item and/or maintain programs that are relevant overall in the technical area. 11 12 Page 19 of 115 PREVENT 2 — IHR Coordination, Communication, and Advocacy JEE Target The effective implementation of the IHR requires multisectoral and multidisciplinary approaches through national partnerships for effective alert and response systems. Coordination of nationwide resources including the sustainable functioning of an IHR NFP, which is a national center for IHR communications, is a key requisite for IHR implementation. The NFP should be accessible at all times to communicate with the WHO IHR Regional Contact Points and with all relevant sectors and other stakeholders in the country. States Parties should provide WHO with contact details of NFPs and continuously update and annually confirm them. Indicator P.2.1 A functional mechanism is established for the coordination and integration of relevant sectors in the implementation of the IHR. 2016 Capacity Level: 5 Summary of U.S. Self-Assessment A high-quality public health “system of systems” that has evolved over time is the basis for the implementation of the IHR in the United States. Despite implementation since the beginning of 2007, there remain some inconsistent understandings of the roles and responsibilities for IHR implementation among federal and SLTT authorities and stakeholders. 2016 JEE Recommendations from the External Evaluators 1. Bring together stakeholders (federal, state, and local) to discuss the U.S. IHR obligations and identify opportunities to make improvements. 2. Improve training opportunities for state and federal officials to support communication of cases/events between the local level and state officials who understand the implications of IHR. 3. Streamline processes for “pre-assessment” evaluation to determine if a full (federal) IHR assessment is needed. 4. Enhance consistency among federal agencies to ensure that each has an internal IHR protocol that aligns with the IHR NFP processes. 5. Improve the ability of the IHR NFP to communicate health risk information within the federal and state networks. Page 20 of 115 Summary of Actions Items Efforts will focus on further strengthening of the U.S. IHR NFP and creating and/or improving awareness, training, processes, and mechanisms that facilitate interagency collaboration across the federal government and integration with SLTT partners towards greater IHR implementation. Action Items Table 3. JEE RECOMMENDATION 1 (JEE INDICATOR P.2.1): Bring together stakeholders (federal, state, and local) to discuss the U.S. IHR obligations and identify opportunities to make improvements; JEE RECOMMENDATION 2 (JEE INDICATOR P.2.1): Improve training opportunities for state and federal officials to support communication of cases/events between the local level and state officials who understand the implications of IHR; JEE RECOMMENDATION 3 (JEE INDICATOR P.2.1): Streamline processes for “pre-assessment” evaluation to determine if a full (federal) IHR assessment is needed; and JEE RECOMMENDATION 5 (JEE INDICATOR P.2.1): Improve the ability of the IHR NFP to communicate health risk information within the federal and state networks. CY DEPARTMENTS 2018 Multiple 2018 Multiple 2019 2019 Multiple Multiple 2019 Multiple 2020 2020 Multiple Multiple 2020 Multiple ACTION ITEMS Develop a series of review fora for national stakeholders based on the National Action Plan to support and refine program implementation. Formally review and publish the National Action Plan with updates based on changes to the 2019-2020 priorities. Publish the fiscal year 2018 National Action Plan Progress Report. Conduct National Action Plan review fora to address technical areas and special topics, as needed. Formally review and reissue the National Action Plan with updates based on changes to the 2020 priorities, and determine whether to continue the action plan beyond 2020. Publish the fiscal year 2019 National Action Plan Progress Report. Conduct National Action Plan review fora to address technical areas and special topics as needed. Begin preparations for the follow-up JEE. AGENCIES ASPR ASPR ASPR ASPR ASPR ASPR ASPR ASPR JEE RECOMMENDATION 4 (JEE INDICATOR P.2.1): Enhance consistency among federal agencies to ensure that each has an internal IHR protocol that aligns with the IHR NFP processes. Page 21 of 115 PREVENT 3 — Antimicrobial Resistance JEE Target Support work being coordinated by WHO, FAO, and OIE to develop an integrated global package of activities to combat antimicrobial resistance, spanning human, animal, agricultural, food, and environmental aspects (i.e., a One Health approach) including: a) Each country has its own national comprehensive plan to combat antimicrobial resistance; b) Strengthen surveillance and laboratory capacity at the national and international level following agreed international standards developed in the framework of the Global Action Plan, considering existing standards; and, c) Improved conservation of existing treatments and collaboration to support the sustainable development of new antibiotics, alternative treatments, preventive measures, and rapid, point-of-care diagnostics including systems to preserve new antibiotics. Indicators P.3.1 Antimicrobial resistance (AMR) detection 2016 Capacity Level: 4 P.3.2 Surveillance of infections caused by AMR pathogens 2016 Capacity Level: 4 P.3.3 Health care-associated infection (HCAI) prevention and control programs 2016 Capacity Level: 4 P.3.4 Antimicrobial stewardship activities 2016 Capacity Level: 3 Summary of U.S. Self-Assessment While there are federal and state-level capacities to detect antimicrobial resistant bacteria, many SLTT authorities have insufficient access to laboratories that can detect and characterize resistance according to published standards. The implementation of a One Health approach to surveillance and reporting of resistance requires alignment and coordination. Antimicrobial stewardship programs are being developed, although implemented inconsistently and not fully monitored. 2016 JEE Recommendations from the External Evaluators 1. Build an animal and human public health laboratory capacity to detect and characterize antimicrobial resistant pathogens to inform public health action. 2. Further enhance multisectoral and multidisciplinary coordination and collaboration, particularly the agricultural plant and environment sector including the EPA, and strengthen private-public partnerships. Page 22 of 115 3. Increase overall assessment and evaluation of antibiotic use in humans and animals. 4. Strengthen and document the effectiveness of AMR stewardship activities. Summary of Actions Items Efforts will focus on expanding capabilities at existing public health laboratories; characterizing and following trends in AMR, including the emergence of new bacterial strains and resistance mechanisms; fostering multisectoral and multidisciplinary collaboration, including through public-private partnerships; and strengthening antimicrobial stewardship activities. The action items align with the CARB a comprehensive national plan for the federal government developed through an interagency process that identifies critical actions necessary to combat the emergence and spread of antibiotic-resistant bacteria. Action Items Table 4. JEE RECOMMENDATION 1 (JEE INDICATORS P.3.1 and P.3.2): Build an animal and human public health laboratory capacity to detect and characterize antimicrobial resistant pathogens to inform public health action. CY DEPARTMENTS ACTION ITEMS AGENCIES 2018 DoD, HHS, USDA DoD, CDC, APHIS 2018 HHS 2018 HHS 2018 HHS 2018 HHS Share resistance detection strategies and protocols among network partners. (CARB 2.1.1) Develop an implementation plan for the Antibiotic Resistance Lab Network (AR Lab Network) 14 that considers all aspects of operation including specimen transport, testing, reporting, and data sharing. (CARB 2.1.1) Decrease by 50% the time required to detect and characterize drug-resistant enteric pathogens through National Antimicrobial Resistance Monitoring System (NARMS) surveillance, and communicate results to stakeholders. Improve the detection, investigation, and mitigation of multistate outbreaks caused by resistant enteric bacteria through a 25% reduction in time from the initial notification to NARMS to reporting of susceptibility testing results. Identify resistance patterns for Salmonella by analyzing near-real-time data from all Salmonella isolates sent to public health laboratories. CDC CDC CDC CDC The AR Lab Network is in charge of the rapid detection of outbreaks caused by drug-resistant pathogens, characterization of resistance mechanisms, tracking resistance trends, and identifying emerging forms of resistance. 14 Page 23 of 115 CY DEPARTMENTS 2018 HHS 2018 USDA 2018 USDA 2018 USDA 2018 USDA 2018 USDA 2019 HHS 2019 HHS 2019 HHS 2019 HHS 2019 USDA ACTION ITEMS Conduct susceptibility testing on an increased proportion of Campylobacter isolates to help identify outbreaks and determine the sources of drug-resistant Campylobacter infections. Engage with the American Association of Veterinary Laboratory Diagnosticians (AAVLD) to develop a pilot project that creates a national-level surveillance stream with standardized antimicrobial susceptibility testing (AST) protocols for monitoring resistance in antibiotics of importance to both animal and human public health. (CARB 2.3.2) Perform WGS and AST on all the FSIS, NARMS, and other regulatory isolates, and upload all data into the National Center for Biotechnology Information (NCBI). Conduct real-time WGS on all ready-to-eat product isolates and all the isolates from foodborne investigation sample isolates (Salmonella, Shiga toxigenic Escherichia coli (STEC), Campylobacter and Listeria monocytogenes). Expand AMR susceptibility-testing program on isolates derived from its Pathogen Reduction (PR)/ Hazard Analysis and Critical Control Point (HACCP) program and baseline programs, including pork and chicken parts. Seek opportunities to collaborate with the USDA/APHIS Center of Epidemiology and Animal Health and the USDA/APHIS One Health Office to better understand the epidemiology of resistant bacteria from farm to table. Designate at least five public health laboratories as part of the AR Lab Network. (CARB 2.1.1) Assist Association of Public Health Laboratories (APHL), SLTT laboratories, and other partners to provide technical assistance and guidance to the AR Lab Network as needed. (CARB 2.1.1) Develop a partnership between NARMS and the National Healthcare Safety Network (NHSN) to obtain drug-resistance data from clinical laboratories on bacteria isolated from persons with invasive Salmonella, Campylobacter, or Shigella infections with completion in FY 2020. Develop a pilot project (to be implemented in FY 2020) to evaluate the association between antibiotic-resistant urinary tract infections and foodborne bacteria. Continue to perform WGS and AST on all the FSIS, NARMS, and other regulatory isolates, and upload all data into the NCBI. Page 24 of 115 AGENCIES CDC APHIS FSIS FSIS FSIS APHIS, FSIS CDC CDC CDC CDC FSIS CY DEPARTMENTS 2019 USDA 2019 USDA 2019 USDA 2020 HHS 2020 HHS ACTION ITEMS Continue to conduct real-time WGS on all ready-to-eat product isolates and all the isolates from foodborne investigation sample isolates (STEC, Campylobacter and Listeria monocytogenes). Continue to expand AMR susceptibility-testing program on isolates derived from its PR/HACCP program and baseline programs, including pork and chicken parts. Continue to seek opportunities to collaborate with the USDA/APHIS Center of Epidemiology and Animal Health and the USDA/APHIS One Health Office to better understand the epidemiology of resistant bacteria from farm to table. Integrate the five laboratories previously designated as part of the AR Lab Network into an AMR communications network that posts early warning alerts and reports urgent results and trends. (CARB 2.1.2) Implement the pilot project to evaluate the association between antibiotic-resistant urinary tract infections and foodborne bacteria. AGENCIES FSIS FSIS APHIS, FSIS CDC CDC Table 5. JEE RECOMMENDATION 2 (JEE INDICATORS P.3.1, P.3.2, and P.3.3): Further enhance multisectoral and multidisciplinary coordination and collaboration, particularly the agricultural plant and environment sector including the EPA, and strengthen private-public partnerships. CY DEPARTMENTS 2018 EPA 2018 EPA, USDA Identify microbial gene markers for AMR in wastewater effluents discharged into the environment and used for reuse purposes. EPA, ARS HHS, USDA Strengthen multisectoral coordination and collaboration through public-private partnerships and continued involvement in the Presidential Advisory Council on CARB (CARB) and CARB Task Force including basic research areas underpinning AMR in humans and animals. (CARB 4.2) ASPR, NIH, ARS, NIFA 2018 ACTION ITEMS Test the ability to remove antibiotic resistant bacteria/genes in wastewater by various water treatment processes such as ultraviolet light emitting diodes and advanced oxidation. Page 25 of 115 AGENCIES EPA CY DEPARTMENTS 2019 EPA, HHS 2019 HHS, USDA 2020 HHS, USDA ACTION ITEMS Evaluate the risk of environmental uses of antibiotics on human health. 15 (CARB 2.4.3) Strengthen multisectoral coordination and collaboration through public-private partnerships and continued involvement in the Presidential Advisory Council CARB and the CARB Task Force, including basic research areas underpinning AMR in humans, animals, and the environment. (CARB 4.2) Strengthen multisectoral coordination and collaboration through public-private partnerships and continued involvement in Presidential Advisory Council on CARB and CARB Task Force including basic research areas underpinning AMR in humans, animals, and the environment. (CARB 4.2) AGENCIES EPA, CDC, FDA NIH, ARS, NIFA NIH, ARS, NIFA Table 6. JEE RECOMMENDATION 3 (JEE INDICATOR P.3.2): Increase overall assessment and evaluation of antibiotic use in humans and animals. CY DEPARTMENTS 2018 DoD, HHS, VA 2018 HHS 2018 HHS 2018 USDA 2018 USDA ACTION ITEMS Define programmatic steps and resource-needs to support NHSN data submission by DoD and VHA facilities to ensure timely analysis of trends in antibiotic use and antibiotic resistance. (CARB 2.2.1) Submit a proposal for new measures for hospital reporting of data on antibiotic use to the National Quality Forum (NQF). (CARB 2.2.1) Begin the process of proposing new Inpatient Quality Reporting (IQR) rules following analysis and approval of the new NQF measures. (CARB 2.2.1) Implement on-farm data collection on antimicrobial use practices in various animal production settings. (CARB 2.4.3) Include biological sampling for Salmonella, E. coli, and Enterococcus as part of the 2017-2018 National Animal Health Monitoring System beef cow-calf study. (CARB 2.4.4) AGENCIES DoD, CDC, VHA CDC CDC, CMS APHIS APHIS For antibiotic pesticides, resistant species in or on food, the skin of workers, or indirectly through the environment or clothing can spread resistance. EPA is not only addressing the development of resistance in the bacteria causing plant disease, but also in the potential for these agricultural uses to contribute to the development of antibiotic-resistant diseases in humans. While pathogens rarely share the same hosts, human pathogens and plant pathogens may exist concurrently, allowing for the potential for resistance to develop in human pathogens as a result of antibiotic use on crops. However, a quantified potential for any resistance traits to move from environmental bacteria into bacteria of human health concern has not been established. 15 Page 26 of 115 CY DEPARTMENTS 2018 USDA 2019 HHS 2019 HHS 2019 HHS 2019 HHS 2019 HHS 2019 USDA 2020 HHS 2020 HHS 2020 HHS 2020 HHS 2020 HHS ACTION ITEMS Plan longitudinal studies of antimicrobial use (AMU) and AMR on swine grower/finisher and cattle feedlot operations for a period of up to five years starting in 2019. Establish systems in at least 25 states, the District of Columbia, and Puerto Rico to measure the incidence of at least one regionally important multidrug-resistant organism (MDRO), provide health care facilities with feedback on local and regional MDRO rates, and provide health care facilities with technical assistance to advance MDRO prevention. (CARB 1.1.2) Expand user-support and validation programs to accommodate expected increases in hospital reporting through the NHSN AU/AR modules. (CARB 2.2.1) Establish up to 10 additional EIP sites, including sites in the West and Midwest that will monitor drug-resistant pathogens. Evaluate the contribution of data from those new sites to improved national analysis. (CARB 2.2.3) Initiate a study at EIP sites to evaluate populations at risk for carbapenem-resistant Enterobacteriaceae (CRE). (CARB 2.2.3) Validate molecular assays to support surveillance for drug-resistant gonorrhea at HHS/CDC research partners and EIP sites. (CARB 2.2.3) Continue to conduct longitudinal studies of AMU and AMR on swine grower/finisher and cattle feedlot operations for a period of up to five years starting in 2019. Expand user-support and validation programs to accommodate expected increases in hospital reporting through the NHSN AU/AR modules. (CARB 2.2.1) Determine the need for additional reporting incentives among hospital consortia and state-based hospital networks in place of (or in addition to) HHS/CMS-required reporting. (CARB 2.2.1) Develop an electronic AU clinical-quality reporting measure for NHSN in a standard file format that hospitals can use to achieve the Stage 3 Meaningful Use objective and accelerate reporting. The timing of this activity will depend on the timeframe of the HHS/CMS Meaningful Use certification program. (CARB 2.2.2) Submit the measure to NQF for review and endorsement and to HHS/CMS for consideration as a reporting requirement of the HHS/CMS IQR following development of an electronic AU clinical-quality reporting measure for NHSN. (CARB 2.2.2) Expand EIP activities to include surveillance for additional urgent and serious antibiotic resistance threats. (CARB 2.2.3) Page 27 of 115 AGENCIES APHIS CDC CDC CDC CDC CDC APHIS CDC CDC, CMS CDC, CMS CDC, CMS CDC CY DEPARTMENTS 2020 HHS 2020 HHS 2020 USDA ACTION ITEMS Develop a public health surveillance study with EIP investigators to explore the impact of bacterial populations within the human microbiome on attack rates of drugresistant pathogens (e.g., Clostridium difficile, CRE, methicillin-resistant Staphylococcus aureus, Candida, Salmonella, Shigella, Campylobacter, and Streptococcus pneumoniae) with implementation completed in 2020. (CARB 2.2.3) Analyze the resistance of bacteria in the intestines of healthy people with a variety of diets, lifestyles, and antibiotic-use histories. (CARB 2.2.3) Continue to conduct longitudinal studies of AMU and AMR on swine grower/finisher and cattle feedlot operations for a period of up to five years starting in 2019. AGENCIES CDC CDC APHIS Table 7. JEE RECOMMENDATION 4 (JEE INDICATOR P.3.4): Strengthen and document the effectiveness of AMR stewardship activities. CY DEPARTMENTS ACTION ITEMS Support research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship activities in multiple healthcare settings including ambulatory care, long-term care, and acute care. Support translation of findings into antibiotic-resistance prevention tools that can be implemented by healthcare providers. (CARB 1.1.4) Provide guidance on antibiotic stewardship to hospitals, long-term care facilities, and ambulatory care settings through AHRQ’s Safety Program for Improving Antibiotic Use, as well as guidance to long-term care facilities through AHRQ’s Nursing Home Antimicrobial Stewardship Guide posted on the AHRQ website (CARB 1.1.1A) AGENCIES 2018 HHS 2018 HHS 2018 HHS Develop new diagnostic tools to inform appropriate treatment including tests that rapidly distinguish between viral and bacterial pathogens and detect antibioticresistance. (CARB 3.1) NIH 2018 HHS Support clinical trials to identify new treatment strategies to optimize and preserve the use of existing antibiotics for bacterial infections. (CARB 4.4) NIH Page 28 of 115 AHRQ AHRQ CY DEPARTMENTS ACTION ITEMS AGENCIES 2018 USDA Continue USDA’s AMR global education and outreach efforts through two National Veterinary Accreditation Program (NVAP) modules: Use of Antibiotics in Animals and the Veterinary Feed Directive. APHIS HHS Support research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship activities in multiple healthcare settings including ambulatory care, long-term care, and acute care. Support translation of findings into antibiotic-resistance prevention tools that can be implemented by healthcare providers. (CARB 1.1.4) AHRQ HHS Provide guidance on antibiotic stewardship to hospitals, long-term care facilities, and ambulatory care settings through AHRQ’s Safety Program for Improving Antibiotic Use, as well as guidance to long-term care facilities through AHRQ’s Nursing Home Antimicrobial Stewardship Guide posted on the AHRQ website. (CARB 1.1.1A) AHRQ HHS Ensure that state and large local health departments establish or enhance, through the HHS/CMS Quality Innovation Network, State AR Prevention (Protect) Programs for Healthcare to guide providers’ antibiotic use and reduce transmission of resistant pathogens. (CARB 1.1.2) CDC 2019 HHS Issue guidance on antibiotic stewardship and best practices for ambulatory surgery centers, dialysis centers, nursing homes and other long-term care facilities, doctors’ offices and other outpatient settings, pharmacies, emergency departments, and medical departments at correctional facilities. (CARB 1.1.1A) CDC 2019 HHS Propose expanded quality measures for antibiotic prescribing. (CARB 1.1.1B) CDC HHS Ensure that at least 25 States, the District of Columbia, and Puerto Rico establish or enhance antibiotic stewardship activities in inpatient health care delivery settings, in accordance with the HHS/CDC Core Elements, supported via the Protect Programs for Healthcare. (CARB 1.1.1A) CDC 2019 2019 2019 2019 Page 29 of 115 CY DEPARTMENTS ACTION ITEMS AGENCIES 2019 HHS Provide technical assistance to federal facilities (e.g., those operated by DoD, VA/VHA, and IHS) and other large health systems in scaling up implementation and assessment of interventions to improve outpatient antibiotic prescribing, extending effective interventions to long-term care settings, and ensuring long-term sustainability of antibiotic stewardship efforts. (CARB 1.1.1B) 2019 HHS Expand training and support to acute care facilities and nursing homes to improve antibiotic stewardship as part of the Get Smart for Healthcare project. (CARB 1.1.1B) CDC 2019 HHS Provide annual national estimates of aggregated inpatient antibiotic use using data collected through the NHSN AU module along with feedback to health care facilities on antibiotic use, to indicate whether antibiotic use rates are above or below the national average. (CARB 2.1.3) CDC 2019 HHS Establish routine reporting of antibiotic use and resistance data from select hospital systems via the NHSN AU and AR modules. (CARB 2.1.3) CDC 2019 HHS Support clinical trials to identify new treatment strategies to optimize and preserve the use of existing antibiotics for bacterial infections. (CARB 4.4) NIH 2019 HHS Develop new diagnostic tools to inform appropriate treatment including tests that rapidly distinguish between viral and bacterial pathogens and detect antibioticresistance. (CARB 3.1) NIH 2019 HHS, VA Ensure that public health departments establish statewide programs to identify health care facilities with high antibiotic-prescribing rates and use lessons learned from the HHS/CDC and VA/VHA pilot project and other best practices to improve antibiotic prescribing in these facilities. (CARB 1.1.1B) Page 30 of 115 CDC CDC, VHA CY DEPARTMENTS ACTION ITEMS Support research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship activities in multiple healthcare settings including ambulatory care, long-term care, and acute care. Support translation of findings into antibiotic-resistance prevention tools that can be implemented by healthcare providers. (CARB 1.1.4) Provide guidance on antibiotic stewardship to hospitals, long-term care facilities, and ambulatory care settings through AHRQ’s Safety Program for Improving Antibiotic Use, as well as guidance to long-term care facilities through AHRQ’s Nursing Home Antimicrobial Stewardship Guide posted on the AHRQ website. (CARB 1.1.1A) AGENCIES 2020 HHS 2020 HHS 2020 HHS Initiate Protect Programs for Healthcare in 25 additional states, with all 50 states fully involved by the end of 2020. (CARB 1.1.2) CDC 2020 HHS Expand antibiotic use reporting and stewardship implementation among selected hospital systems. (CARB 1.1.1A) CDC 2020 HHS Assist nursing care organizations develop and implement stewardship programs and interventions. (CARB 1.1.1A) CDC 2020 HHS Ensure that an additional 25 states establish or enhance antibiotic stewardship activities in health care delivery settings, with all 50 states involved, by 2020. (CARB 1.1.1A) CDC 2020 HHS Evaluate the impact of quality measures on antibiotic use and provide feedback to health care partners, when sufficient data are available. (CARB 1.1.1B) CDC 2020 HHS 2020 HHS Use data collected through the NHSN AU module, when sufficient data are available, to provide annual national estimates of aggregated inpatient antibiotic use and feedback to health care facilities on antibiotic use, indicating whether antibiotic use rates are above or below the national average. (CARB 2.1.3) Develop routine reporting of antibiotic use and resistance data via the NHSN AU and AR modules from among those hospital systems with aligned stewardship programs. (CARB 2.1.3) Page 31 of 115 AHRQ AHRQ CDC CDC CY DEPARTMENTS ACTION ITEMS 2020 HHS Develop new diagnostic tools to inform appropriate treatment including tests that rapidly distinguish between viral and bacterial pathogens and detect antibioticresistance. (CARB 3.1) NIH 2020 HHS Support clinical trials to identify new treatment strategies to optimize and preserve the use of existing antibiotics for bacterial infections. (CARB 4.4) NIH Page 32 of 115 AGENCIES PREVENT 4 — Zoonotic Disease JEE Target Adopted measured behaviors, policies, and/or practices that minimize the transmission of zoonotic diseases from animals into human populations. Indicators P.4.1 Surveillance systems in place for priority zoonotic diseases/pathogens 2016 Capacity Level: 3 P.4.2 Veterinary or animal health workforce 2016 Capacity Level: 4 P.4.3 Mechanisms for responding to infectious zoonoses and potential zoonoses are established and functional 2016 Capacity Level: 4 Summary of U.S. Self-Assessment Programs connecting human, animal, and environmental health exist (some of which are well coordinated for specific zoonoses). The overall federal approach to One Health currently remains informal. Surveillance and information systems across sectors are largely separate from one another. Departments and agencies involved in public health security need to formally share and align their priorities for zoonotic disease prevention, detection, and response. 2016 JEE Recommendations from the External Evaluators 1. Establish a national One Health approach that can formally delineate common goals, roles, and responsibilities for the various health and multidisciplinary sectors taking into account the steady state and emergency response. 2. Formalize interagency networks to address One Health issues through joint investigation, data sharing, communications, and funding of high priority projects and diseases using existing or new multidisciplinary tools. 3. Increase dedicated public health veterinarians to work on zoonotic diseases at the federal, state, and local levels. Summary of Action Items Efforts will focus on incorporating the One Health approach to addressing zoonotic diseases nationally and through collaboration across departments and agencies. The first priority is to create a shared vision and roadmap for a more formal approach to One Page 33 of 115 Health. Multiple federal departments and agencies will convene a multisectoral One Health Zoonotic Disease Prioritization workshop to: (a) prioritize the zoonotic diseases of greatest national concern for human, animal, and environmental health sectors that are responsible for federal zoonotic disease programs to address; and (b) develop plans for implementing and strengthening multisectoral approaches to address these diseases in the United States. This work will allow departments and agencies to develop jointly a list of necessary action items and next steps for strengthening One Health approaches to integrate surveillance systems, laboratory systems, joint outbreak response capacity, preparedness planning, and cross-sector prevention and control strategies. Action Items Table 8. JEE RECOMMENDATION 1 (JEE INDICATORS P.4.1 and P.4.3): Establish a national One Health approach that can formally delineate common goals, roles, and responsibilities for the various health and multidisciplinary sectors taking into account the steady state and emergency response. CY DEPARTMENTS ACTION ITEMS AGENCIES 2018 DOI, HHS, USDA DOI, CDC, USDA 2018 DOI, HHS, USDA 2018 DOI, HHS, USDA Formalize the collaboration among key stakeholders for development of a strategy to enhance One Health approaches in the United States. Conduct a One Health Zoonotic Disease Prioritization Workshop using tools developed by HHS/CDC and USDA with facilitators from the human, animal, and environmental health sectors. Publish prioritized list of diseases and key outcomes resulting from the One Health Zoonotic Disease Prioritization Workshop including plans and next steps from departments and agencies responsible for federal zoonotic disease programs to jointly address the diseases using a multisectoral One Health approach. 2018 2019 2019 2020 DOI, HHS, USDA DOI, HHS, USDA DOI, HHS, USDA DOI, HHS, USDA Draft a national framework for One Health. Finalize the national framework for One Health and disseminate it to federal government partners. Begin implementing the national framework for One Health in collaboration with federal government partners. Continue implementing the national framework for One Health in collaboration with federal government partners. Page 34 of 115 DOI, CDC, USDA DOI, CDC, USDA DOI, CDC, USDA DOI, CDC, USDA DOI, CDC, USDA DOI, CDC, USDA Table 9. JEE RECOMMENDATION 2 (JEE INDICATORS P.4.1 and P.4.3): Formalize interagency networks to address One Health issues through joint investigation, data sharing, communications, and funding of high priority projects and diseases using existing or new multidisciplinary tools. CY DEPARTMENTS 2018 DOI, HHS, USDA 2018 2019 2020 DOI, HHS, USDA DOI, HHS, USDA DOI, HHS, USDA ACTION ITEMS Use the outcomes from the One Health Zoonotic Disease Prioritization Workshop to develop a priority list of actions for individual departments and agencies and the interagency teams. Identify and launch up to three specific One Health implementation projects for the priority zoonoses. Identify and launch up to three additional One Health implementation projects identified during the One Health Zoonotic Disease Prioritization Workshop. Identify successes and challenges to strengthen future One Health projects building on 2018 and 2019 implementation projects. AGENCIES DOI, CDC, USDA DOI, CDC, USDA DOI, CDC, USDA DOI, CDC, USDA Table 10. JEE RECOMMENDATION 3 (JEE INDICATOR P.4.2): Increase dedicated public health veterinarians to work on zoonotic diseases at the national, state, and local levels. CY DEPARTMENTS ACTION ITEMS 2018 DOI, HHS, USDA Identify existing training programs for veterinarians and animal health professionals in the federal government. DOI, CDC, USDA 2018 DOI, HHS, USDA Conduct a field epidemiology course (co-presented by HHS/CDC and USDA) for federal veterinary epidemiologists. DOI, CDC, USDA 2018 DOI, HHS, USDA Conduct additional One Health courses for a multisectoral audience. DOI, CDC, USDA 2018 USDA 2019 HHS Identify state veterinarians who have not had training in transboundary and emerging diseases and One Health concepts and methods for multi-sector response. Increase the number of veterinarians trained in public health and applied epidemiology through existing programs such as the CDC-Hubert Global Health Fellowship, Epidemiology Elective Program for Senior Veterinary and Medical Students, HHS/CDC’s Epidemic Intelligence Service, and others. Page 35 of 115 AGENCIES USDA CDC CY DEPARTMENTS 2019 HHS Identify additional opportunities to integrate One Health training among relevant departments and agencies. CDC 2019 HHS, USDA Work with governmental and non-governmental partners to identify and integrate One Health core competencies into technical- and sector-specific trainings. CDC, USDA 2019 USDA Identify additional opportunities to integrate One Health training into USDA programs such as AgDiscovery, the Saul T. Wilson scholars program, and others. USDA 2019 USDA Recruit and select a current USDA employee for sponsored training in the HHS/CDC’s Epidemic Intelligence Service. USDA 2019 USDA 2019 USDA ACTION ITEMS Conduct a tabletop exercise, developed and led by the Veterinary Services Training and Exercise Program, for a team of state and federal animal and public health officials to manage response activities and infection risk for responders during a zoonotic disease outbreak. Courses: One Health Collaboration Methods and One Health: Applied Critical Thinking focused on Zoonotic Disease Outbreaks. Review evaluation data from joint training and exercises hosted by HHS/CDC and USDA/APHIS to strengthen future delivery of training events, as outlined in the Veterinary Services (VS) National Training and Exercise Program, ensuring that the training involves state counterparts. AGENCIES USDA APHIS Table 11. OTHER ACTIVITIES (JEE INDICATORS P.4.1 and P.4.3) CY DEPARTMENTS 2018 DOI, HHS, USDA 2018 DOI, HHS, USDA ACTION ITEMS Support federal and non-federal institutions and investigators in efforts to apply surveillance tools and strategies for the rapid detection and characterization of emerging and re-emerging pathogens at the animal-human interface and perform research to enhance understanding of the molecular, ecological, and/or environmental factors that influence pathogenesis, transmission, and evaluation of emerging and re-emerging pathogens. Support the global One Health Tripartite and other global human and animal health partners representing WHO, FAO, and OIE to advance the prevention, detection, and response to zoonotic diseases and related health threats. Page 36 of 115 AGENCIES USGS, CDC, NIH, APHIS, ARS, NIFA USGS, CDC, USDA CY DEPARTMENTS 2018 DOI, HHS, USDA ACTION ITEMS Support the OIE by leading multiple OIE Collaborating Centres and Reference Laboratories. Continue to support the Zoonoses and One Health Updates (ZOHU) Call for a U.S. audience to provide timely updates and continuing education on issues covering zoonoses and One Health topics. Support federal and non-federal institutions and investigators in efforts to characterize zoonotic pathogens to better understand replication and transmission in zoonotic reservoirs. AGENCIES USGS, CDC, APHIS, ARS 2018 HHS 2018 HHS 2018 HHS, USDA 2018 USDA 2018 USDA 2018 USDA 2018 USDA Continue to serve, through NVSL, as a FAO Reference Center for animal influenza, Newcastle disease, bovine tuberculosis, and paratuberculosis. APHIS DOI, HHS, USDA Continue to support federal and non-federal institutions and investigators in efforts to apply surveillance tools and strategies for the rapid detection and characterization of emerging and re-emerging pathogens at the animal-human interface and perform research to enhance understanding of the molecular, ecological, and/or environmental factors that influence pathogenesis, transmission, and evaluation of emerging and re-emerging pathogens. USGS, CDC, NIH, APHIS, ARS, NIFA 2019 Support the FAO by leading multiple Reference Centres for zoonoses. Continue to support OIE’s One Health objectives, including the timely reporting of all OIE-listed diseases through the National Animal Health Reporting System (NAHRS). Continue to serve, through the National Veterinary Services Laboratories (NVSL) and the Center for Veterinary Biologics (CVB), as an OIE Collaborating Center for the Diagnosis of Animal Diseases and Vaccine Evaluation in the Americas. Continue to serve, through NVSL, as an OIE reference laboratory for the following animal diseases: avian influenza; anthrax; bluetongue; contagious equine metritis; Eastern, Western, and Venezuelan encephalomyelitis; equine infectious anemia; foot-and-mouth disease; leptospirosis; Newcastle disease; pseudorabies; swine influenza; vesicular stomatitis; and West Nile fever. Page 37 of 115 CDC NIH CDC, APHIS APHIS APHIS APHIS CY DEPARTMENTS ACTION ITEMS AGENCIES 2019 DOI, HHS, USDA Continue to support the global One Health Tripartite and other global human and animal health partners representing WHO, FAO, and OIE to advance the prevention, detection, and response to zoonotic diseases and related health threats. USGS, CDC, USDA 2019 DOI, HHS, USDA 2019 HHS 2019 HHS 2019 HHS, USDA 2019 USDA 2020 DOI, HHS, USDA 2020 DOI, HHS, USDA 2020 DOI, HHS, USDA 2020 HHS 2020 HHS Continue to support the OIE, by leading multiple OIE Collaborating Centres and Reference Laboratories. Continue to support the Zoonoses and One Health Updates (ZOHU) Call for a U.S. audience to provide timely updates and continuing education on issues covering zoonoses and One Health topics. Continue to support federal and non-federal institutions and investigators in efforts to characterize zoonotic pathogens to better understand replication and transmission in zoonotic reservoirs. USGS, CDC, APHIS, ARS Continue to support the FAO by leading multiple Reference Centres for zoonoses. CDC, APHIS Continue to support the OIE’s One Health objectives, including the timely reporting of all OIE-listed diseases through the NAHRS. Continue to support federal and non-federal institutions and investigators in efforts to apply surveillance tools and strategies for the rapid detection and characterization of emerging and re-emerging pathogens at the animal-human interface and perform research to enhance understanding of the molecular, ecological, and/or environmental factors that influence pathogenesis, transmission, and evaluation of emerging and re-emerging pathogens. Continue to support the global One Health Tripartite and other global human and animal health partners representing WHO, FAO, and OIE to advance the prevention, detection, and response to zoonotic diseases and related health threats. Continue to support the OIE, by leading multiple OIE Collaborating Centres and Reference Laboratories. Continue to support the Zoonoses and One Health Updates (ZOHU) Call for a U.S. audience to provide timely updates and continuing education on issues covering zoonoses and One Health topics. Continue to support federal and non-federal institutions and investigators in efforts to characterize zoonotic pathogens to better understand replication and transmission in zoonotic reservoirs. Page 38 of 115 CDC NIH APHIS USGS, CDC, NIH, APHIS, ARS, NIFA USGS, CDC, USDA USGS, CDC, APHIS, ARS CDC NIH CY DEPARTMENTS 2020 HHS, USDA 2020 USDA ACTION ITEMS Continue to support the FAO by leading multiple Reference Centres for zoonoses. Continue to support the OIE’s One Health objectives, including the timely reporting of all OIE-listed diseases through the NAHRS. Page 39 of 115 AGENCIES CDC, APHIS APHIS PREVENT 5 — Food Safety JEE Target States Parties should have surveillance and response capacity for food and waterborne disease risk or events. It requires effective communication and collaboration among the sectors responsible for food safety and safe water and sanitation. Indicator P.5.1 Mechanisms are established and functioning for detecting and responding to foodborne disease and food contamination 2016 Capacity Level: 4 Summary of U.S. Self-Assessment Food safety programs are largely effective, but there are still challenges in detecting multistate outbreaks with lack of access to specialized laboratories at all local levels. 2016 JEE Recommendations from the External Evaluators 1. Continue to develop new epidemiological and environmental tools to enhance foodborne illness outbreak investigations. 2. Continue to develop next generation laboratory methods such as WGS for pathogen identification. 3. Reinforce the coordination and support for state and local governments by conducting more clinical, food and environmental testing and isolation characterization. Summary of Actions Items Efforts focus on enhancing detection and reporting of foodborne illness outbreaks and progressively developing additional, state-ofthe-art laboratory testing capabilities in state and local public health laboratories. These include next-generation WGS and related technologies, methods and platforms, and advanced computational and bioinformatic tools for enhanced pathogen identification. Page 40 of 115 Action Items Table 12. JEE RECOMMENDATION 1 (JEE INDICATOR P.5.1): Continue to develop new epidemiological and environmental tools to enhance foodborne illness outbreak investigations. CY DEPARTMENTS ACTION ITEMS AGENCIES 2018 HHS Enhance current System for Enteric Disease Response, Investigation, and Coordination capabilities to allow integration of new data sources (e.g., AMR data for bacteria isolated from food) and improve functionality (e.g., build an embedded outbreak detection algorithm). CDC 2018 HHS Continue to expand the National Environmental Assessment Reporting System (NEARS), in which 26 sites are participating as of 2017. CDC 2018 HHS Expand the Environmental Assessment Training Series (EATS) from one module to three modules. CDC 2019 HHS Update the NEARS Instruction Manual. CDC 2019 HHS Change the exercises in EATS. CDC 2019 HHS CDC 2020 HHS Merge NEARS and National Outbreak Reporting System into one system. Sequence and analyze more than 80% of all clinical Salmonella, STEC, and Listeria isolates received in state public health laboratories using core genome/whole genome Multilocus Sequence Typing (MLST) and AMR prediction in the United States. CDC Table 13. JEE RECOMMENDATION 2 (JEE INDICATOR P.5.1): Continue to develop next generation laboratory methods such as WGS for pathogen identification. CY DEPARTMENTS 2018 HHS 2018 HHS ACTION ITEMS Ensure that public health laboratory sequencing capability exists in 95% of states in the United States. Certify 70% of state public health laboratories for WGS in PulseNet. Page 41 of 115 AGENCIES CDC CDC CY DEPARTMENTS ACTION ITEMS Provide the public health community with capabilities in next-generation WGS and related technologies, methods and platforms, and advanced computational and bioinformatic tools for enhanced pathogen identification and for informing development of MCMs and subsequent technologies. Ensure that all pathogens recovered from USDA/FSIS sampling program are sequenced and uploaded to PulseNet and National Center for Biotechnology Information (NCBI) Pathogen Detector, including at least 60% of microbial indicators tested by USDA/FSIS. AGENCIES 2018 HHS 2018 USDA 2019 HHS Ensure that all 50 states have sequencing capacity in their public health laboratories. CDC 2019 HHS Certify 95% of state public health laboratories for WGS in PulseNet. CDC 2019 HHS 2019 USDA 2020 HHS 2020 HHS 2020 USDA Continue to provide the public health community with capabilities in next-generation WGS and related technologies, methods and platforms, and advanced computational and bioinformatic tools for enhanced pathogen identification and for informing development of MCMs and subsequent technologies. Ensure that all pathogens recovered from USDA/FSIS sampling program are sequenced and uploaded to PulseNet and NCBI Pathogen Detector including at least 60% of microbial indicators tested by USDA/FSIS as well as isolates from other USDA/AMS and state inspection programs. Sequence and analyze more than 80% of all clinical Salmonella, Shiga toxin producing E. coli, and Listeria isolates received in the state public health laboratories using core genome/whole genome MLST and AMR prediction in the United States. Continue to provide the public health community with capabilities in next-generation WGS and related technologies, methods and platforms, and advanced computational and bioinformatic tools for enhanced pathogen identification and for informing development of MCMs and subsequent technologies. Ensure that all pathogens recovered from USDA/FSIS sampling program are sequenced and uploaded to PulseNet and NCBI Pathogen Detector including at least 60% of microbial indicators tested by USDA/FSIS as well as isolates from other USDA/AMS and state inspection programs. Page 42 of 115 NIH FSIS NIH FSIS CDC NIH FSIS Table 14. JEE RECOMMENDATION 3 (JEE INDICATOR P.5.1): Reinforce the coordination and support for state and local governments by conducting more clinical, food and environmental testing and isolation characterization. CY DEPARTMENTS 2018 HHS 2018 HHS 2018 USDA 2018 USDA 2018 USDA 2019 2019 Ensure that public health laboratory sequencing capability exists in 95% of states in the United States. Certify 70% of state public health laboratories for WGS in PulseNet. Conduct surveillance in 19 states on FSIS-regulated commodities, where target effort is 5000 samples tested. Develop or validate three methods of detecting select/threat agents in food. AGENCIES CDC CDC FSIS FSIS Conduct at least one exercise to document capability and capacity to respond to emergencies caused by specific agents. FSIS HHS Ensure that all 50 states have sequencing capacity in their public health laboratories. CDC HHS Certify 95% of state public health laboratories for WGS in PulseNet. CDC Conduct characterization including AST and WGS on 100% of USDA/FSIS regulated pathogens, all Salmonella and Campylobacter from cecal NARMS program, isolates submitted by the USDA/AMS National School Lunch Program and states on behalf of the MPI program, and at least 60% of microbial indicators. FSIS Sequence and analyze more than 80% of all clinical Salmonella, SEC, and Listeria isolates received in the state public health laboratories using core genome/whole genome MLST and AMR prediction in the United States. CDC Conduct characterization including AST and WGS on 100% of USDA/FSIS regulated pathogens, all Salmonella and Campylobacter from NARMS Cecal Sampling Program, isolates submitted by the USDA/AMS National School Lunch Program and states on behalf of the MPI program, and at least 90% of microbial indicators. FSIS 2019 USDA 2020 HHS 2020 ACTION ITEMS USDA Page 43 of 115 Table 15. OTHER ACTIVITIES (JEE INDICATOR P.5.1) CY DEPARTMENTS ACTION ITEMS AGENCIES 2018 USDA FSIS 2019 USDA 2019 USDA 2019 USDA 2020 USDA Add isolates from newly developed programs to WGS characterization, including Siluriformes sampling. Add more isolates to WGS characterization from newer programs such as the “other parts” category for chicken products (e.g., necks, hearts, livers, gizzards) and highrisk products from beef sources (e.g., cheek, head meat, and weasand). Add more isolates to WGS characterization from newer programs including minor species such as sheep, goat, and ratites. Conduct characterization including AST and WGS on 100% of FSIS regulated pathogens submitted by the AMS School Lunch Program and from states on behalf of the MPI Program. Conduct characterization including AST and WGS on 100% of FSIS regulated pathogens submitted by the AMS School Lunch Program and from states on behalf of the MPI Program. Page 44 of 115 FSIS FSIS FSIS FSIS PREVENT 6 — Biosafety and Biosecurity JEE Target A whole-of-government national biosafety and biosecurity system is in place, ensuring that especially dangerous pathogens are identified, held, secured, and monitored in a minimal number of facilities according to best practices; biological risk management training and educational outreach are conducted to promote a shared culture of responsibility, reduce dual use risks, mitigate biological proliferation and deliberate use threats, and ensure safe transfer of biological agents; and, country-specific biosafety and biosecurity legislation, laboratory licensing, and pathogen control measures are in place, as appropriate. Indicators P.6.1 Whole-of-government biosafety and biosecurity system is in place for human, animal, and agriculture facilities 2016 Capacity Level: 4 P.6.2 Biosafety and biosecurity training and practices 2016 Capacity Level: 4 Summary of U.S. Self-Assessment Overall, systems for biosafety and biosecurity are strong, yet there are still areas for improvement with respect to federal oversight and training availability. 2016 JEE Recommendations from the External Evaluators 1. Continue to implement recommendations by the FESAP and Fast Track Action Committee on Select Agent Regulations (FTACSAR). 2. Enhance partnerships with the biomedical industry and scientific community to comprehensively evaluate gain-of-function research and develop federal policies and guidelines. 3. Finalize and implement recommendations on gain-of-function studies involving pathogens with pandemic potential. Summary of Actions Items The focus will be on implementing two sets of recommendations, one from the FESAP, which conducted an internal federal government review of biosafety and biosecurity practices, and another from the FTAC-SAR, which conducted an external review that Page 45 of 115 focused on the effects of the select agent regulations on researchers and laboratories. The recommendations made by both the FESAP and FTAC-SAR address the culture of responsibility, oversight, outreach, and education; applied biosafety research; incident reporting; material accountability; inspection processes; regulatory changes; and guidance to improve biosafety and biosecurity. Implementation of the FESAP and FTAC-SAR recommended actions is anticipated to strengthen biosafety and biosecurity practices and oversight activities. The United States is committed to fostering progress in the life sciences including peaceful research involving BSAT and non-BSAT, while at the same time ensuring that such work is being conducted in a safe and secure manner. The United States will also continue to implement policies regarding dual use research of concern. Action Items Table 16. JEE RECOMMENDATION 1 (JEE INDICATORS P.6.1 and P.6.2): Continue to implement recommendations by FESAP and FTAC-SAR. CY DEPARTMENTS 2018 Multiple 2019 Multiple 2020 Multiple ACTION ITEMS Implement regulatory changes, develop guidance, and expand outreach to improve biosafety and biosecurity (subject to availability of funds). Implement measures to optimize biosafety and biosecurity including actions to address the culture of responsibility, oversight, applied biosafety research, incident reporting, material accountability, and inspection processes, and continue to expand outreach and education (subject to availability of funds). Complete implementation of the FESAP and FTAC-SAR recommendations to address the culture of responsibility, oversight, outreach, and education; applied biosafety research; incident reporting; material accountability; inspection processes; and regulatory changes and guidance to improve biosafety and biosecurity (subject to availability of funds). Page 46 of 115 AGENCIES ASPR ASPR ASPR Table 17. JEE RECOMMENDATION 2 (JEE INDICATOR P.6.2): Enhance partnerships with the biomedical industry and scientific community to comprehensively evaluate gain-of-function research and develop federal policies and guidelines. CY DEPARTMENTS 2018 HHS 2019 HHS 2020 Multiple ACTION ITEMS Engage with stakeholders implementing the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC) 16 to educate stakeholders; collect feedback about resources needed to effectively implement the policy; and discuss stakeholder experiences, challenges, and innovative practices. Continue to engage with stakeholders regarding DURC and any policies or procedures regarding work involving the creation, transfer, or use of enhanced potential pandemic pathogens (PPP). Engage stakeholders to assess the impact that review mechanisms adopted pursuant to the Recommended Policy Guidance for Departmental Development of Review Mechanism for Potential Pandemic Pathogen Care and Oversight (P3CO) policy guidance have on work involving the creation, transfer, or use of enhanced PPPs; and provide transparency, public engagement, and continued dialogue about enhanced PPP research. AGENCIES NIH NIH ASPR Table 18. JEE RECOMMENDATION 3 (JEE INDICATOR P.6.2): Finalize and implement recommendations on gain-of-function studies involving pathogens with pandemic potential. 16 CY DEPARTMENTS 2018 Multiple 2018 Multiple 2019 HHS ACTION ITEMS Continue to implement federal government policies for the oversight of DURC. Implement standardized review procedures for multi-leveled and multidisciplinary reviews of research anticipated to create, transfer, and/or use enhanced PPP or gain-of-function research of concern. Develop public outreach and education programs to communicate updated information on DURC and gain-of-function research of concern regarding PPP. AGENCIES ASPR ASPR ASPR S3: Science Safety Security, “United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern” (last reviewed: November 13, 2015). Page 47 of 115 CY 2020 DEPARTMENTS Multiple ACTION ITEMS Consider findings from stakeholder engagement about multidisciplinary reviews of research anticipated to create, transfer, or use enhanced PPP or gain-of-function research of concern and coordinate a process to assess the impact of implementation of the P3CO policy guidance on research programs and institutions that considers how to provide transparency, public engagement, and continued dialogue about enhanced PPP research. AGENCIES Multiple Table 19. OTHER ACTIVITIES (JEE INDICATOR P.6.2) CY DEPARTMENTS 2018 EPA 2018 EPA 2018 HHS 2018 HHS 2018 HHS 2018 Multiple 2018 Multiple Departments ACTION ITEMS Establish the EPA Biosafety and Biosecurity Advisory Board to provide oversight of DURC, compliance with select agent regulations, and measures to enhance a culture of responsibility in life sciences research. Implement an EPA biosafety and biosecurity training program for life sciences researchers. (EPA) Develop a compendium of freely available biosafety and biosecurity training programs and other resources. Sponsor the 15th CDC International Biosafety Symposium to promote biosafety best practices, with a specific emphasis in 2018 on One Health, to enhance the understanding of laboratory biosafety practitioners of the One Health approach. Continue to support and refine the National Biosafety and Biocontainment Training Program to expand the pool of highly trained biosafety professionals to staff key positions and roles. Continue to engage with stakeholders to enhance the culture of biosafety, biosecurity, and responsible conduct in the life sciences and sharing of best practices. Continue to update the “S3: Science, Safety, Security” website to further biorisk management education across a range of stakeholders, promoting communication, transparency, and awareness about biosafety, biocontainment, and biosecurity issues and activities in laboratories. (HHS/ASPR to maintain website; multiple federal departments and agencies to contribute content). Page 48 of 115 AGENCIES EPA EPA CDC CDC NIH Multiple ASPR CY DEPARTMENTS ACTION ITEMS AGENCIES 2018 Multiple Departments ASPR, CDC, NIH 2018 USDA 2019 HHS 2019 HHS 2019 Multiple Departments 2019 USDA 2020 HHS 2020 HHS 2020 Multiple Departments Develop a draft Biosafety in Microbiological and Biomedical Laboratories, 6th edition. Assemble a steering committee to plan the scientific program for the USDA ARS 5th International Biosafety and Biocontainment symposium series in 2019 to promote the principles and practices of biosafety, biocontainment, and biosecurity focused on agricultural research, both in the controlled laboratory environment and field research and response applications. Continue development of a draft Biosafety in Microbiological and Biomedical Laboratories, 6th edition. Increase entity involvement for the National Biosafety and Biocontainment Training Program fellowship developmental assignments to diversify training and practical knowledge learning experiences. Continue to update the “S3: Science, Safety, Security” website to further biorisk management education across a range of stakeholders, promoting communication, transparency, and awareness about biosafety, biocontainment, and biosecurity issues and activities in laboratories. (HHS/ASPR to maintain website; multiple federal departments and agencies to contribute content). Hold the USDA ARS 5th International Biosafety and Biocontainment symposium series to promote the principles and practices of biosafety, biocontainment, and biosecurity focused on agricultural research, both in the controlled laboratory environment and field research and response applications. Release Biosafety in Microbiological and Biomedical Laboratories, 6th edition. Expand training courses and opportunities for learning for biosafety professionals outside of the National Biosafety and Biocontainment Training Program fellowship. Continue to update the “S3: Science, Safety, Security” website to further biorisk management education across a range of stakeholders, promoting communication, transparency, and awareness about biosafety, biocontainment, and biosecurity issues and activities in laboratories. (HHS/ASPR to maintain website; multiple federal departments and agencies to contribute content). Page 49 of 115 ARS ASPR, CDC, NIH NIH ASPR ARS CDC, NIH NIH ASPR PREVENT 7 — Immunization JEE Target A functioning national vaccine delivery system—with nationwide reach, effective distributions, access for marginalized populations, adequate cold chain, and ongoing quality control—that is able to respond to new disease threats. Indicators P.7.1 Vaccine coverage (measles) as part of the national program 2016 Capacity Level: 5 P.7.2 National vaccine access and delivery 2016 Capacity Level: 5 Summary of U.S. Self-Assessment The United States has successfully reached the global vaccination goal for measles and maintains a strong supply system for vaccines. However, vaccination rates among individual states vary for complex reasons and reaching vaccination goals for all jurisdictions requires additional efforts. 2016 JEE Recommendations from the External Evaluators 1. Improve vaccination coverage for the adult population. 2. Increase interoperability between state-based immunization information systems and provider level electronic health records. 3. Reduce disparities in vaccinations by increasing coverage among subpopulations. Summary of Action Items Efforts will focus on improving interoperability between state-based immunization information systems and reducing disparities in vaccinations. Coordination between HHS/CDC and HHS/CMS will leverage the existing networks of Medicaid providers to improve vaccination coverage in states and localities where rates continue to be persistently below the national targets. New standards for existing awards for state and local immunization programs will also help to increase access to and uptake of vaccines, which will be measured using the existing methods. Efforts include providing federal funds and technical assistance to state and local immunization programs to help address gaps in subpopulations at SLTT levels. Page 50 of 115 Action Items JEE RECOMMENDATION 1 (JEE INDICATOR P.7.2): Improve vaccination coverage for the adult population. NOTE: HHS/CDC and HHS/OASH/NVPO currently use the U.S. National Adult Immunization Plan 17 to facilitate coordinated action by federal and non-federal partners to protect public health and achieve optimal prevention of infectious diseases and their consequences through the vaccination of adults. HHS uses the U.S. Healthy People objectives for adult immunization (IID-12, 13, 14, 15) 18 to monitor progress towards improving vaccination coverage in this population, which adequately addresses this recommendation. Table 20. JEE RECOMMENDATION 2 (JEE INDICATOR P.7.2): Increase interoperability between state-based immunization information systems and provider level electronic health records. CY 17 18 DEPARTMENTS 2018 HHS 2019 HHS 2020 HHS ACTION ITEMS Measure state progress in meeting Immunization Information Systems (IIS) functional standards using the IIS Annual Report (IISAR) and through the American Immunization Registry Association assessment and certification efforts. (IISAR results for 2017 will be available during the fall of 2018). Measure state progress in meeting IIS functional standards using the IISAR and through the American Immunization Registry Association assessment and certification efforts. (IISAR results for 2018 will be available during the fall of 2019). Measure state progress in meeting IIS functional standards using the IISAR and through the American Immunization Registry Association assessment and certification efforts. (IISAR results for 2019 will be available during the fall of 2020). See HHS. “Adult Immunization Plans.” See Office of Disease Prevention and Health Promotion (ODPHP). “Immunization and Infectious Diseases.” Page 51 of 115 AGENCIES CDC CDC CDC Table 21. JEE RECOMMENDATION 3 (JEE INDICATOR P.7.2): Reduce disparities in vaccinations by increasing coverage among subpopulations. CY DEPARTMENTS 2018 HHS 2018 HHS 2018 HHS 2019 HHS 2019 HHS 2019 HHS 2020 HHS 2020 HHS 2020 HHS ACTION ITEMS Continue providing federal funds and technical assistance to state and local immunization programs to implement strategies to reduce disparities in vaccination coverage in their jurisdictions. Facilitate open communications with state Medicaid programs and identify and share best practices to increase immunization. Continue to measure national and local area estimates of vaccination coverage of children 19-35 months using the 2017 National Immunization Survey; estimates will be available during the fall of 2018. Continue providing federal funds and technical assistance to state and local immunization programs for immunization operations. A new five-year cooperative agreement will be awarded in 2019 that includes identifying disparities in the awardees’ jurisdictions and implementing strategies to reduce them. Continue to facilitate communications related to immunization priorities among Medicaid programs. Continue to measure national and local area estimates of vaccination coverage of children 19-35 months using the 2018 National Immunization Survey; estimates will be available during the fall of 2019. Continue providing federal funds and technical assistance to state and local immunization programs to implement strategies to reduce disparities in vaccination coverage in their jurisdictions. Continue to facilitate communications related to immunization priorities among Medicaid programs. Continue to measure national and local area estimates of vaccination coverage of children 19-35 months using the 2019 National Immunization Survey; estimates will be available during the fall of 2020. Page 52 of 115 AGENCIES CDC CDC CDC CDC CDC CDC CDC CDC CDC DETECT 1 — National Laboratory System JEE Target Real-time biosurveillance with a national laboratory system and effective modern point-of-care and laboratory-based diagnostics. Indicators D.1.1 Laboratory testing for detection of priority diseases 2016 Capacity Level: 5 D.1.2 Specimen referral and transport system 2016 Capacity Level: 4 D.1.3 Effective modern point-of-care and laboratory-based diagnostics 2016 Capacity Level: 5 D.1.4 Laboratory quality system 2016 Capacity Level: 5 Summary of U.S. Self-Assessment The United States has an extensive and high-quality public health laboratory system. However, capacities for surge testing and bioinformatics are limited in many places. 2016 JEE Recommendations from the External Evaluators 1. Institutionalize partnerships among collaborating federal agencies by jointly developing policies and programs to strengthen laboratory networks across health sectors and between federal and state laboratories. These will be in the areas of financing, harmonizing laboratory protocols, reporting chains, laboratory information systems, sample sharing, role of laboratory support in surveillance for outbreaks and emerging trends, and data sharing and confidentiality. 2. Develop an inventory of vulnerabilities in capacity and capability for all health sectors at the state level to improve testing service with surge requirements for a concerted whole-of-government plan. 3. Continue to enhance capabilities of all health sectors for emerging disease detection including strengthening and assuring bioinformatics to inform future metagenomic technologies, the use of culture-independent diagnostic tests for patient care; and, digitizing records in the human and veterinary laboratory networks to support real-time surveillance. 4. Explore the appropriate protocols for rapid and safe sample sharing in anticipation of or during a public health emergency. Page 53 of 115 5. Continue to engage in various global laboratory networks including sharing resources, experiences, data, and biological samples taking into consideration the global benefits. Summary of Action Items Building on existing frameworks and laboratory programs, efforts will include continuing to evaluate the roadblocks to effective laboratory response during emergencies, strengthening laboratory networks, growing capabilities in state and local public health laboratories, and facilitating the acquisition and transportation of biological samples that are critical for MCM development for novel pathogens. Action Items Table 22. JEE RECOMMENDATION 1 (JEE INDICATORS D.1.1 and D.1.2): Institutionalize partnerships among collaborating federal agencies by jointly developing policies and programs to strengthen laboratory networks across health sectors and between federal and state laboratories. These will be in the areas of financing, harmonizing laboratory protocols, reporting chains, laboratory information systems, sample sharing, role of laboratory support in surveillance for outbreaks and emerging trends, and data sharing and confidentiality. CY DEPARTMENTS 2018 HHS 2018 HHS 2018 HHS 2018 HHS ACTION ITEMS Finalize the “USG Framework for the Rapid Sharing of Biological Material Related to Non-influenza Pathogens with the Potential to Cause a Public Health Emergency of International Concern” (federal government Sample Sharing Framework) which provides a consensus-driven process for federal government departments and agencies to jointly identify, obtain, and coordinate national and/or international distribution of samples for preparedness and response purposes. Hold a Lab Preparedness Summit to share best practices focusing on the Laboratory Response Network. Participate in a functional exercise with relevant state and federal stakeholders that includes the National Animal Health Laboratory Network to identify potential gaps or challenges when responding to a national-level emergency. Continue to support the Integrated Consortium of Laboratory Networks (ICLN) for coordinating federally sponsored analytical laboratory services for chemical, biological, radiological, and nuclear incidents. Page 54 of 115 AGENCIES ASPR CDC APHIS USDA CY DEPARTMENTS 2019 HHS ACTION ITEMS Conduct national/international tabletop exercises with relevant stakeholders to test the federal government Sample Sharing Framework and identify additional challenges. AGENCIES ASPR, CDC Table 23. JEE RECOMMENDATION 2 (JEE INDICATOR D.1.1): Develop an inventory of vulnerabilities in capacity and capability for all health sectors at the state level to improve testing service with surge requirements for a concerted whole-of-government plan; and.JEE RECOMMENDATION 3 (JEE INDICATOR D.1.3): Continue to enhance capabilities of all health sectors for emerging disease detection including strengthening and assuring bioinformatics to inform future metagenomic technologies, the use of cultureindependent diagnostic tests for patient care; and, digitizing records in the human and veterinary laboratory networks to support realtime surveillance. CY 2018 DEPARTMENTS ACTION ITEMS AGENCIES DoD, HHS Hold biannual consultations among HHS/CDC, HHS/FDA, HHS/CMS, HHS/ASPR, DoD, and APHL on approval and distribution of diagnostic tests and reagents during emergency responses to improve process flows for: (a) Emergency Use Authorizations and laboratory developed tests, and (b) clinical specimens received for diagnostic testing, reporting, quality, biosafety, and interpretation. DoD, ASPR, CDC, CMS, FDA Page 55 of 115 CY DEPARTMENTS 2018 HHS 2018 HHS ACTION ITEMS Use the CDC Epidemiology and Laboratory Capacity for Infectious Diseases Cooperative Agreement mechanism to address high priority needs that are not disease-specific to:  Build and maintain an effective public health workforce for rapid response to infectious disease outbreaks. • Ensure health departments are well equipped with staff, surveillance systems, and other tools to identify, characterize, and provide rapid, effective, and flexible response to infectious disease threats.  Strengthen cross-cutting national surveillance systems. • Develop, execute, and evaluate public health interventions to promote early detection methods that will facilitate the timely implementation of control measures and minimize transmission of infectious diseases.  Boost laboratory infrastructure with the latest diagnostic technologies. • Develop modern and well-equipped public health laboratories, with well-trained staff, employing high quality laboratory processes and systems that foster communication and appropriate integration between laboratory and epidemiology functions.  Improve health information systems to efficiently transmit, receive, and analyze infectious disease-related data electronically. • Develop and enhance health information systems infrastructure in public health agencies including public health laboratories, focusing on standards-based electronic data exchange, information systems interoperability, and enhancing and sustaining integrated surveillance information systems. • Enhance the electronic exchange of data between public health agencies and clinical care entities, focusing on electronic laboratory reporting and electronic case reporting (eCR).  Increase informatics/information technology (IT) capacity in public health agencies through staff, contracts, and training. Provide the public health community with capabilities in next-generation WGS and related technologies, methods and platforms, and advanced computational and bioinformatic tools for enhanced pathogen identification and to inform development of MCMs and subsequent technologies. Page 56 of 115 AGENCIES CDC CDC, NIH CY DEPARTMENTS 2018 HHS 2019 HHS 2019 USDA 2020 HHS ACTION ITEMS Engage with AAVLD and National Animal Health Laboratory Network laboratories to develop standardized electronic messaging of AST data to support monitoring national-level AMR in real-time. (CARB 2.3.2) Continue to provide the public health community with capabilities in next-generation WGS and related technologies, methods and platforms, and advanced computational and bioinformatic tools for enhanced pathogen identification and to inform development of MCMs and subsequent technologies. Incorporate bioinformatics and metagenomics technologies into the current AAVLDAPHIS AMR surveillance pilot project to expand resistance monitoring in identified pathogens of importance to animal and public health. Continue to provide the public health community with capabilities in next-generation WGS and related technologies, methods and platforms, and advanced computational and informatics tools for enhanced pathogen identification and to inform development of MCMs and subsequent technologies. Page 57 of 115 AGENCIES APHIS CDC, NIH APHIS CDC, NIH Table 24. JEE RECOMMENDATION 4 (JEE INDICATOR D.1.2): Explore the appropriate protocols for rapid and safe sample sharing in anticipation of or during a public health emergency. CY DEPARTMENTS ACTION ITEMS Develop a white paper proposing actions that the federal government can take to support SLTT efforts to collect and transport specimens during a potential or actual public health emergency. Actions to explore include:  Determining contracting and funding capabilities to create a contract (multiple if needed) for sample collection and shipment during an emergency.  Identifying sources of existing programmatic or operational funding federal government departments and agencies could use to perform sample management functions (e.g., propagation and distribution) as part of federal government preparedness and response efforts.  Determining the feasibility of developing a generic protocol that SLTT health departments could use to collect a range of specimens (e.g., blood, urine, and saliva) that may be required for preparedness and response research during an emergency.  Identifying policy options for expediting institutional review board (IRB) review at the institutional level during an emergency such as establishing a policy of reliance on a central IRB for review.  Determining if guidance to SLTT officials on the implementation of federal policy and regulations relevant to specimen collection is adequate (e.g., human subject protections regulations and the application of the Health Insurance Portability and Accountability Act of 1996). Develop a generic specimen collection protocol to use as a model during a public health emergency. AGENCIES ASPR, CDC, NIH 2018 HHS 2019 HHS 2019 HHS Socialize, select, and implement policy options that expedite IRB reviews during a public health emergency. ASPR, CDC 2019 HHS Refine existing guidance, where needed, for SLTT that clarify implementation of federal policies and regulations related to protection of human research subjects when collecting specimens for research related to preparedness and response. ASPR, CDC Page 58 of 115 ASPR, CDC Table 25. JEE RECOMMENDATION 5 (JEE INDICATORS D.1.1 and D.1.2): Continue to engage in various global laboratory networks including sharing resources, experiences, data, and biological samples taking into consideration the global benefits. CY DEPARTMENTS 2018 HHS 2018 USDA 2018 USDA 2018 USDA 2018 USDA 2018 USDA 2019 HHS 2019 USDA 2020 USDA 2020 USDA 2020 USDA 2020 USDA ACTION ITEMS Work through forums such as the Global Health Security Initiative’s Risk Management and Communications Working Group and the Global Laboratory Network Working Group to support the development of international policies and agreements related to sharing specimens during emergencies, including by participating in the implementation of WHO’s Research and Development Blueprint and WHO’s Pandemic Influenza Preparedness Framework. Continue to support OIE’s One Health objectives including the timely reporting of all OIE-listed diseases through the NAHRS. Continue to serve, through NVSL and CVB, as an OIE Collaborating Center for the Diagnosis of Animal Diseases and Vaccine Evaluation in the Americas. Continue to serve, through NVSL, as an OIE reference laboratory for the following animal diseases: avian influenza; anthrax; bluetongue; contagious equine metritis; eastern, western, and Venezuelan equine encephalomyelitis; equine infectious anemia; foot-and-mouth disease; leptospirosis; Newcastle disease; pseudorabies; swine influenza; vesicular stomatitis; and West Nile fever. Continue to serve, through NVSL, as a FAO Reference Center for animal influenza and Newcastle disease, and bovine tuberculosis and paratuberculosis. Continue to serve as an OIE collaborating center for “Research on Emerging Avian Diseases.” Continue to engage in international fora to identify and develop global mechanisms to facilitate the rapid sharing of specimens during public health emergencies. Continue to serve as an OIE collaborating center for “Research on Emerging Avian Diseases.” Continue to serve as an OIE collaborating center for “Research on Emerging Avian Diseases.” Continue to participate in OIE/FAO global OIE/FAO Influenza Network (OFFLU) activities to reduce risks to animal and public health from animal influenza viruses. Continue to support OIE’s One Health objectives including the timely reporting of all OIE-listed diseases through the NAHRS. Continue to serve, through NVSL and CVB, as an OIE Collaborating Center for the Diagnosis of Animal Diseases and Vaccine Evaluation in the Americas. Page 59 of 115 AGENCIES ASPR APHIS APHIS APHIS APHIS ARS ASPR ARS ARS APHIS APHIS APHIS CY DEPARTMENTS 2020 USDA 2020 USDA 2020 USDA ACTION ITEMS Continue to serve, through NVSL, as an OIE reference laboratory for the following animal diseases: avian influenza; anthrax; bluetongue; contagious equine metritis; eastern, western, and Venezuelan equine encephalomyelitis; equine infectious anemia; foot-and-mouth disease; leptospirosis; Newcastle disease; pseudorabies; swine influenza; vesicular stomatitis; and West Nile fever. (USDA/APHIS) Continue to serve, through NVSL, as a FAO Reference Center for animal influenza and Newcastle disease, and bovine tuberculosis and paratuberculosis. (USDA/APHIS) Continue to serve as an OIE collaborating center for “Research on Emerging Avian Diseases.” Page 60 of 115 AGENCIES APHIS APHIS ARS DETECT 2 — Real-Time Surveillance JEE Target Strengthened foundational indicator- and event-based surveillance systems that are able to detect events of significance for public health, animal health, and health security; improved communication and collaboration across sectors and between sub-national (local and intermediate), national, and international levels of authority regarding surveillance of events of public health significance; and, improved country and intermediate level/regional capacity to analyze and link data from and between strengthened, real-time surveillance systems including interoperable, interconnected electronic reporting systems. This can include epidemiologic, clinical, laboratory, environmental testing, product safety and quality, and bioinformatics data; and, advancement in fulfilling the core capacity requirements for surveillance in accordance with IHR and the OIE standards. Indicators D2.1 Indicator and event based surveillance systems 2016 Capacity Level: 5 D2.2 Inter-operable, interconnected, electronic real-time reporting system 2016 Capacity Level: 3 D2.3 Analysis of surveillance data 2016 Capacity Level: 5 D2.4 Syndromic surveillance systems 2016 Capacity Level: 4 Summary of U.S. Self-Assessment The United States has an extensive system for public health surveillance that is capable of quickly detecting major outbreaks. However, there are inconsistent linkages between key aspects of the human and animal surveillance systems, and there could be significant improvements in the rapid acquisition, processing, and interpretation of electronic data. 2016 JEE Recommendations from the External Evaluators 1. Create opportunities for United States departments and agencies to exchange and integrate the results of their respective surveillance programs in a better manner. 2. Enhance strategies and partnerships to increase the use and interoperability of electronic health care records. 3. Increase the number of trained personnel at subnational levels who are capable of collecting and analyzing large volumes of diverse data and integrating that information with non-clinical information sources. Page 61 of 115 Summary of Action Items Efforts will focus on further integration and rapid exchange of surveillance information among departments and agencies, testing and improving interoperability of electronic health care records, and increasing trained personnel at the SLTT levels to strengthen surveillance systems. Activities will also include the development and promotion of indicator-based surveillance tools and strategies for the rapid detection and characterization of emerging and re-emerging pathogens at the animal-human interface. Action Items Table 26. JEE RECOMMENDATION 1 (JEE INDICATOR D.2.1): Create opportunities for United States departments and agencies to exchange and integrate the results of their respective surveillance programs in a better manner. CY DEPARTMENTS 2018 DHS, USDA 2019 DHS, DoD ACTION ITEMS Develop a plan for increasing interagency liaison activity between the National Biosurveillance Integration Center and 14 federal departments and agencies. Provide an information technology system designed to integrate and exchange surveillance information between departments and agencies as part of a national targeting capability. AGENCIES DHS, USDA DHS, DoD Table 27. JEE RECOMMENDATION 2 (JEE INDICATORS D.2.2 and D.2.4): Enhance strategies and partnerships to increase the use and interoperability of electronic health care records. CY DEPARTMENTS 2018 DHS, VA 2018 DoD 2018 HHS 2018 HHS 2019 DoD ACTION ITEMS Develop an IT system and CONOPS for interagency analysis of de-identified electronic health records. Implement upgrade of DoD’s Electronic Surveillance System for the Early Notification of Community-Based Epidemics (ESSENCE) to enable compatibility with interagency for comprehensive syndromic surveillance. Develop requirements and technical architecture for eCR. Pilot test technical specifications to demonstrate viability of eCR for public health and health care in six sites. Develop collaborative enhancements of ESSENCE to meet interagency and DoD requirements. Page 62 of 115 AGENCIES DHS, VHA DoD CDC CDC DoD CY DEPARTMENTS 2019 2019 HHS HHS 2019 VA 2020 2020 DoD HHS ACTION ITEMS Assess and evaluate pilot implementation of eCR. Continue national implementation of eCR through addition of participating sites. Create a Next-Generation Electronic Health Record that is fully interoperable with DoD and community partners and continues to promote clinician involvement and innovation. Create interagency partnerships for syndromic surveillance using ESSENCE. Continue national implementation of eCR through addition of participating sites. AGENCIES CDC CDC VHA DoD CDC Table 28. JEE RECOMMENDATION 3 (JEE INDICATOR D.2.3): Increase the number of trained personnel at subnational levels who are capable of collecting and analyzing large volumes of diverse data and integrating that information with non-clinical information sources. CY DEPARTMENTS 2018 DHS 2018 DoD 2018 HHS 2018 USDA 2019 DoD 2019 HHS 2019 HHS 2019 HHS ACTION ITEMS Pursue a third party platform that SLTT users can integrate and analyze emergency medical service (EMS) data with complementary data sources such as emergency 911 calls, law enforcement, or highway safety data. Begin online and in-person training of updated ESSENCE for users. Explore opportunities among interagency partners to support strengthening and expanding public health workforce capabilities at the SLTT level. Assess opportunities to strengthen and expand workforce capabilities at the state and local levels in the analysis and interpretation of animal health data. Ensure that two users per medical treatment facility are trained in ESSENCE, which is moving to the same code base/software version as the CDC and over half the states in the United States. Develop a strategy to engage department and agency programs to draft and pilot comprehensive workforce strengthening models based on identified gaps (potentially extending into 2020). Identify additional opportunities to strengthen and expand public health workforce capabilities at the SLTT level. Identify scenario-based threat activities and related workforce needs. Page 63 of 115 AGENCIES DHS DoD CDC USDA DoD CDC CDC CDC Table 29. OTHER ACTIVITIES (JEE INDICATOR D.2.1) CY DEPARTMENTS 2018 DOI, HHS, USDA 2018 USDA 2019 DOI, HHS, USDA 2020 DOI, HHS, USDA ACTION ITEMS Support federal and non-federal institutions and investigators in efforts to apply surveillance tools and strategies for the rapid detection and characterization of emerging and re-emerging pathogens at the animal-human interface and perform research to enhance understanding of the molecular, ecological, and/or environmental factors that influence pathogenesis, transmission, and evaluation of emerging and re-emerging pathogens. Pilot and evaluate indicator- and model-based tools for global monitoring and early detection and characterization of potentially emerging or re-emerging pathogens in domestic poultry, livestock, and aquaculture populations. Continue to support federal and non-federal institutions and investigators in efforts to apply surveillance tools and strategies for the rapid detection and characterization of emerging and re-emerging pathogens at the animal-human interface and perform research to enhance understanding of the molecular, ecological, and/or environmental factors that influence pathogenesis, transmission, and evaluation of emerging and re-emerging pathogens. Continue to support federal and non-federal institutions and investigators in efforts to apply surveillance tools and strategies for the rapid detection and characterization of emerging and re-emerging pathogens at the animal-human interface and perform research to enhance understanding of the molecular, ecological, and/or environmental factors that influence pathogenesis, transmission, and evaluation of emerging and re-emerging pathogens. Page 64 of 115 AGENCIES USGS, CDC, NIH, USDA USDA USGS, CDC, NIH, USDA USGS, CDC, NIH, USDA DETECT 3 — Reporting JEE Target Timely and accurate disease reporting according to WHO requirements and consistent coordination with FAO and OIE. Indicators D3.1 System for efficient reporting to WHO, FAO, and OIE 2016 Capacity Level: 5 D3.2 Reporting network and protocols in country 2016 Capacity Level: 4 Summary of U.S. Self-Assessment The United States has an effective system in place for assessing public health events at the federal level and notifying WHO of public health events. However, the protocols within federal departments and agencies and at SLTT levels require improvement to minimize inconsistency and reporting delays. 2016 JEE Recommendations from the External Evaluators 1. Improve understanding of FAO, OIE, and WHO requirements among federal, state, and local stakeholders through multisectoral discussions. 2. Work towards developing consistency in reporting on IHR requirements across all agencies and subnational health departments. 3. Improve overall coordination among all reporting entities by developing a policy on international event reporting. Summary of Action Items Efforts will focus on raising awareness and understanding at the federal and SLTT levels about the IHR and its requirements through trainings, dissemination of training tools, and development of an internal HHS policy framework to enhance ASPR’s coordination during an event at the national-international interface. Staff members who support the U.S. IHR NFP will collaborate with federal departments and agencies and national non-governmental actors (e.g., Council of State and Territorial Epidemiologists (CSTE), National Association of County and City Health Officials (NACCHO), and Association of State and Territorial Health Officials (ASTHO)) to refine existing policies and procedures that support IHR-related reporting and to reduce the lag in notifying WHO and Page 65 of 115 other international organizations of public health events. To improve regional and global reporting in the interest of protecting U.S. health security, the U.S. IHR NFP will participate in IHR NFP strengthening workshops outside of the United States. Action Items Table 30. JEE RECOMMENDATION 1 (JEE INDICATOR D.3.2): Improve understanding of FAO, OIE, and WHO requirements among federal, state, and local stakeholders through multisectoral discussions; JEE RECOMMENDATION 4 (JEE INDICATOR P.2.1): Enhance consistency among federal agencies to ensure that each has an internal IHR protocol that aligns with the IHR NFP processes; and JEE RECOMMENDATION 2 (JEE INDICATOR D.3.1): Work towards developing consistency in reporting on IHR requirements across all agencies and subnational health departments. CY DEPARTMENTS ACTION ITEMS AGENCIES 2018 Multiple Develop and implement the U.S. IHR NFP Strengthening Strategy, coordinating with federal partners to leverage existing SLTT partnerships in all sectors, including the national public health organizations, to further reduce/prevent reporting and WHO notification delays, streamline event risk assessments, and increase the value of the global NFP network to federal and SLTT partners. 2018 Multiple Coordinate with federal partners to help develop or revise IHR-related standard operating procedures (SOP) of the following departments and agencies: DHS, DoD, DOI, and HHS/CDC. ASPR, CDC 2018 Multiple Facilitate finalization of U.S. International Food Safety Authorities Network (INFOSAN)-IHR event communication protocol through HHS/FDA-HHS/CDC-USDA memorandum of understanding. ASPR, CDC 2019 HHS, USDA Finalize U.S. OIE-IHR event communication protocol. 2019 Multiple Based on the U.S. IHR NFP Strengthening Strategy, continue to conduct activities that further reduce/prevent reporting and WHO notification delays, streamline event risk assessments, and increase the value of the global NFP network to federal and SLTT partners. 2019 Multiple Coordinate with federal partners to help develop or revise IHR-related SOP of the following departments and agencies: HHS/FDA, USDA, and VA. Page 66 of 115 ASPR, CDC ASPR, USDA ASPR, CDC ASPR, CDC CY DEPARTMENTS 2020 Multiple 2020 Multiple ACTION ITEMS Based on the U.S. IHR NFP Strengthening Strategy, continue to conduct activities that further reduce/prevent reporting and WHO notification delays, streamline event risk assessments, and increase the value of the global NFP network to federal and SLTT partners. Coordinate with federal partners to help develop or revise IHR-related SOP of the following departments and agencies: DOC, DOJ, DOT, and U.S. Coast Guard (USCG). Page 67 of 115 AGENCIES ASPR, CDC ASPR, CDC DETECT 4 — Workforce Development JEE Target States Parties should have skilled and competent health personnel for sustainable and functional public health surveillance and response at all levels of the health system and the effective implementation of the IHR. A workforce includes physicians, animal health or veterinarians, biostatisticians, laboratory scientists, farming/livestock professionals, and an optimal target of one trained field epidemiologist (or equivalent) per 200,000 population, who can systematically cooperate to meet relevant IHR and the OIE Performance of Veterinary Services core competencies. Indicators D.4.1 Human resources are available to implement IHR core capacity requirements D.4.2 Applied epidemiology training program in place such as FETP D.4.3 Workforce strategy 2016 Capacity Level: 5 2016 Capacity Level: 5 2016 Capacity Level: 4 Summary of U.S. Self-Assessment The United States has a robust and highly skilled public health workforce, largely at the federal level. The workforces in some states remain under-resourced. 2016 JEE Recommendations from the External Evaluators 1. Use data sources to study the existing multidisciplinary public health workforce and anticipated gaps between human resource needs and staffing at state and local levels to: a. Supplement the current knowledge on staff enumeration and help in projection and planning; and, b. Inform the CDC plan to create a National Action Plan for public health workforce development. 2. Establish workforce staffing and incentives models in collaboration with existing agency programs to reduce human resources gaps through either current or new public support models. 3. Increase focus of existing programs towards human resource recruitment, development, and retention. Page 68 of 115 Summary of Action Items Efforts will focus on identifying and addressing gaps in the public health workforce at the SLTT level. This will include conducting evaluations of existing trainings and exercises and using this data to inform and strengthen existing workforce development efforts (e.g., trainings, exercises, and programs) aimed at increasing public health emergency preparedness. Action Items Table 31. JEE RECOMMENDATION 1 (JEE INDICATORS D.4.1 and D.4.3): Use data sources to study the existing multidisciplinary public health workforce and anticipated gaps between human resource needs and staffing at state and local levels to: (a) supplement the current knowledge on staff enumeration and help in projection and planning; and, (b) inform the CDC plan to create a National Action Plan for public health workforce development. CY DEPARTMENTS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 USDA 2018 USDA ACTION ITEMS Synthesize information about state and local health departments’ workforce ability to fully staff and operationalize distribution and dispensing of life saving MCMs in the event of a public health emergency. Finalize the list of MCM Critical Knowledge, Skills, and Abilities and report evaluations of state and local workforce training needs in partnership with ASTHO and NACCHO. Outline plans to inventory known gaps in data, information, and best practices related to state and local public health workforce needs. Inventory existing federal grants and other programs aimed at public health workforce development. Survey SLTT representatives regarding existing public health workforce requirements, barriers to hiring and retaining the workforce, resources to study the workforce, opportunities to leverage resources in collaboration with organizations and other departments and agencies to address workforce development, and best practices/lessons learned from SLTT representatives (potentially leading into 2019). Identify best practices and methods to strengthen multi-sector preparedness and response to review and strengthen existing training programs. Identify state veterinarians who have not had training in transboundary and emerging diseases and One Health concepts and methods for multi-sector response. Page 69 of 115 AGENCIES ASPR, CDC ASPR, CDC CDC HRSA HRSA APHIS APHIS CY DEPARTMENTS 2019 HHS 2019 HHS 2019 HHS 2019 HHS 2019 USDA 2019 USDA 2019 USDA 2020 HHS 2020 HHS 2020 HHS, USDA ACTION ITEMS Expand workforce evaluation of state and local health departments to core preparedness and response capability areas beyond MCMs (such as emergency management). Update strategy to address workforce development for public health emergency preparedness and response in state and local health departments (supported through PHEP). Inventory existing data, information, and best practices that provide evidence for improving the comprehensive understanding of the public health workforce development needs at the state and local level. Integrate assessment of state and local public health workforce needs that remain incompletely defined, where feasible, into planned data collection by governmental and non-governmental partners. Review evaluation data from joint training and exercises hosted by HHS/CDC and USDA/APHIS to strengthen future delivery of trainings, as outlined in the VS National Training and Exercise Program, and ensure training involves state counterparts. Conduct needs assessment of employees to determine training needs (on 3-year cycle). Work with governmental and non-governmental partners to identify and integrate One Health core competencies into technical- and sector-specific trainings. Outline plans to inventory known gaps in data, information, and best practices related to tribal and territorial public health workforce needs. Develop a strategy to integrate assessment findings into a public health workforce development plan. Collaborate to identify local and state personnel that need training, prioritize training gaps, and deliver targeted joint training. Page 70 of 115 AGENCIES ASPR, CDC ASPR, CDC CDC CDC APHIS APHIS APHIS CDC CDC CDC, APHIS Table 32. JEE RECOMMENDATION 2 (JEE INDICATOR D.4.1): Establish workforce staffing and incentives models in collaboration with existing agency programs to reduce human resources gaps through either current or new public support models. CY DEPARTMENTS 2018 HHS 2018 HHS 2018 USDA 2018 USDA 2018 USDA 2019 HHS 2019 HHS 2019 2019 HHS HHS 2019 USDA 2020 HHS 2020 HHS ACTION ITEMS Outline plans to inventory and identify existing workforce models that potentially address needs at the state and local level. Develop a plan to inventory state and local health departments staffing needs based on capabilities, threat, function, or a combination thereof. Review and assess the APHIS-VS Succession Plan and other workforce development planning materials for veterinary and animal health-specific competencies and multi-sectoral competencies. Update existing models and training frameworks to minimize gaps and provide employees with both technical and multisectoral competencies needed to work with other sectors to respond to complex health challenges. Train veterinary researchers to work on Biosafety Level (BSL)-4 zoonotic agents in preparation for the National Bio and Agro-defense Facility (NBAF). Develop a strategy to engage department and agency programs to draft and pilot comprehensive workforce strengthening models based on identified gaps (potentially extending into 2020). Outline plans to inventory and identify existing workforce models that potentially address needs at the tribal and territorial level. Seek resources to support department and agency strategy. Identify scenario-based threat activities and needs for supporting the workforce. Continue to train veterinary researchers to work on Biosafety Level (BSL)-4 zoonotic agents in preparation for the NBAF. Contingent on identification of sufficient resources, implement strategy to engage department and agency programs to draft and pilot comprehensive workforce strengthening models. Establish state/regional collaboratives to develop and implement human and resource staffing models that meet unique geographic requirements. Page 71 of 115 AGENCIES CDC CDC APHIS APHIS ARS CDC CDC CDC CDC ARS CDC HRSA Table 33. JEE RECOMMENDATION 3 (JEE INDICATOR D.4.1): Increase focus of existing programs towards human resource recruitment, development, and retention. CY 2018 2018 2018 2019 2019 2019 2020 2020 DEPARTMENTS ACTION ITEMS HHS Further implement and evaluate training in information management. Review outcomes from recruitment and retention programs and identify areas to USDA strengthen. Continue evaluation and delivery of existing technical training programs to ensure USDA employees have the skills they need to be successful. USDA Further evaluate and implement the Veterinary Medical Officer Career Program. Identify existing operational capacity to support multisectoral work and identify USDA opportunities to strengthen through training or other human resource programs. Create a framework to strengthen and focus outreach and education about existing USDA human resource recruitment tools including student pathways and scholarship programs. Continue to train veterinary researchers to work on Biosafety Level (BSL)-4 zoonotic USDA agents in preparation for the NBAF. Continue sponsoring VS employee training in HHS/CDC’s Epidemic Intelligence USDA Service and other applied field epidemiology training programs. Page 72 of 115 AGENCIES NIH APHIS APHIS APHIS APHIS APHIS ARS APHIS RESPOND 1 — Preparedness JEE Target Preparedness includes the development and maintenance of national, intermediate, and local or primary response level public health emergency response plans for relevant chemical, biological, radiological, and nuclear (CBRN) hazards. This covers mapping of potential hazards, identification and maintenance of available resources including national stockpiles, and the capacity to support operations at the intermediate and local or primary response levels during a public health emergency. Indicators R.1.1 Multi-hazard national public health emergency preparedness and response plan is developed and implemented R.1.2 Priority public health risks and resources are mapped and utilized 2016 Capacity Level: 5 2016 Capacity Level: 4 Summary of U.S. Self-Assessment The United States has complex federal and SLTT structures for public health emergency preparedness and response, which necessitate consistency and coordination in response plans and systems. 2016 JEE Recommendations from the External Evaluators 1. Incorporate emergency preparedness into technology platforms. 2. Assess the impact of corrective actions implemented as a result of lessons learned. 3. Address challenges in coordinating responses to complex incidents that do not receive Stafford Act declarations. 4. Develop exercises that involve state and other local partners including the private sector. Summary of Actions Items Efforts will focus on continuing to strengthen emergency preparedness through technology platforms; developing new—and enhancing existing—multi-platform tools and resources; coordinating planning for responding to complex incidents that do not receive Stafford Act declarations through such activities as exercises linked to the Biological Incident Annex to the Response and Page 73 of 115 Recovery Federal Interagency Operational Plans and the National Response Framework that include state and local partners in exercises (e.g., the Pandemic Influenza exercise, Gotham Shield nuclear/radiological response exercise, and recent past exercises linked to Zika Virus responses); developing formal guidance that standardizes post-event/exercise CAP and the after action review/reporting (AAR) processes used by federal and SLTT public health planners; and, collaborating among federal and SLTT partners to develop higher quality and more inclusive public health CONOPS, documents, and exercises. Action Items Table 34. JEE RECOMMENDATION 1 (JEE INDICATOR R.1.1): Incorporate emergency preparedness into technology platforms. CY DEPARTMENTS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 HHS ACTION ITEMS Work with Regional Emergency Coordinators to develop regional emergency preparedness profiles using capabilities of a dynamic geographic information system (GIS) application for regional preparedness to spatially layer data on a web-based, dynamic GIS application that would serve as a regional emergency preparedness tool. Incorporate public health and medical infrastructure and region-specific threats into the GIS regional emergencies preparedness tool. Develop demographic profiles and highlight vulnerable/at-risk populations in the GIS regional emergencies preparedness tool. Collaborate with SLTT partners to include points of contact and additional reference information in the GIS regional emergencies preparedness tool. Utilize existing technical assistance platforms, such as the ASPR Technical Resources, Assistance Center, and Information Exchange (TRACIE) technical resource database and web platform for health care emergency preparedness personnel and CDC’s Online Technical Resource and Assistance Center (On-TRAC) technical assistance platform, to store and make available resource material, after action reports, and lessons learned documents for emergency preparedness personnel. Page 74 of 115 AGENCIES ASPR, CDC ASPR ASPR ASPR ASPR, CDC CY DEPARTMENTS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 USDA 2019 HHS 2019 HHS 2019 HHS 2019 HHS ACTION ITEMS Utilize existing just-in-time response, clinical, and decision support platforms, such as ASPR and NIH’s Radiation Emergency Medical Management (REMM), ASPR and NIH’s Chemical Hazards Emergency Medical Management (CHEMM), Wireless Information System for Emergency Responders (WISER), Primary Response Incident Scene Management (PRISM), and the Dermal Exposure Risk Management and Logic for Emergency Preparedness and Response (DERMaL eToolkit) to inform responders, decision makers, and response operations. Maintain and enhance web-accessible data collection tools, resources, and health information to assist emergency response personnel in preparations for, and during response to, incidents. (See Disaster Research Response Data Collection Tools and Resources developed as part of the NIH Disaster Research Response Program and distributed through the Disaster Information Management Research Center website.) Continue to develop Virtual Incident Command System Training and HID Emergency Management training tools and continue Resilient Communications research programs. Initiate research and development to apply machine-learning techniques to disaster response tools and disaster preparedness training applications. Support research responsive to emergent situations, including gaps in knowledge, emerging transboundary and zoonotic diseases, and veterinary medical countermeasures in response to disease outbreaks through the Agriculture and Food Research Initiative Exploratory Program and other mechanisms as appropriate. Demonstrate the use of regional emergency preparedness profiles in the GIS regional emergencies preparedness tool. Assess strengths, gaps, and areas for improvement of the GIS regional emergencies preparedness tool. Explore available innovative data sources and integrate new data sets as appropriate into the GIS regional emergencies preparedness tool. Using machine learning, tailor the user experience and messaging capabilities of the ASPR TRACIE website to target messaging and resource recommendations to specific users, user types, and geographic locations. Page 75 of 115 AGENCIES ASPR, CDC, NIH NIH NIH NIH NIFA ASPR ASPR ASPR ASPR CY DEPARTMENTS 2019 HHS 2019 HHS 2019 HHS 2019 HHS 2019 HHS 2019 HHS 2019 USDA 2019 USDA 2020 HHS 2020 HHS ACTION ITEMS Continue to enhance web-accessible data collection tools, resources, and health information to assist emergency response personnel in preparations for, and during the response to, incidents. (See Disaster Research Response Data Collection Tools and Resources developed as part of the NIH Disaster Research Response Program and distributed through the Disaster Information Management Research Center website.) Continue to develop Virtual Incident Command System and HID Emergency Management training tools and continue Resilient Communications research programs (subject to availability of funds). Continue research and development to apply machine-learning techniques to disaster response tools and disaster preparedness training applications. Continue to support non-federal research scientists for projects related to the medical and public health aspects of disasters, public health emergencies, and emerging issues to help inform further enhancement of web-based tools and information resources. Collect, organize and disseminate technology platforms and resources to support disaster research, training, and information dissemination (existing platforms and those under development). Continue to maintain and update information and training resources for emergency preparedness and response. Continue emergency research to address gaps in knowledge and veterinary medical countermeasures in response to disease outbreaks. Continue to support research responsive to emergent situations including gaps in knowledge, emerging transboundary and zoonotic diseases, and veterinary medical countermeasures in response to disease outbreaks through the Agriculture and Food Research Initiative Exploratory Program and other mechanisms as appropriate. Work to incorporate data sets from other departments and agencies into the GIS regional emergencies preparedness tool to support predictive modeling of public health and medical concerns. Work with other departments and agencies to explore the potential for predictive modeling of certain natural disasters (e.g., mudslides and wildfires) in the GIS regional emergencies preparedness tool. Page 76 of 115 AGENCIES NIH NIH NIH NIH NIH NIH ARS NIFA ASPR ASPR CY DEPARTMENTS 2020 HHS 2020 HHS 2020 HHS 2020 HHS 2020 HHS 2020 USDA 2020 USDA ACTION ITEMS Continue to enhance web-accessible data collection tools, resources, and health information to assist emergency response personnel in preparations for, and during the response to, incidents. (See Disaster Research Response Data Collection Tools and Resources developed as part of the NIH Disaster Research Response Program and distributed through the Disaster Information Management Research Center website.) Continue to develop Virtual Incident and Command System and HID Emergency Management training tools and continue Resilient Communications research programs (subject to the availability of funds). Continue research and development to apply machine-learning techniques to disaster response tools and disaster preparedness training applications. Continue to support non-federal research scientists for projects related to the medical and public health aspects of disasters, public health emergencies, and emerging issues to help inform further enhancement of web-based tools and information resources. Continue to collect, organize and disseminate technology platforms and resources to support disaster research, training, and information dissemination (existing platforms and those under development). Continue emergency research to address gaps in knowledge and veterinary medical countermeasures in response to disease outbreaks. Continue to support research responsive to emergent situations including gaps in knowledge, emerging transboundary and zoonotic diseases, and veterinary medical countermeasures in response to disease outbreaks through the Agriculture and Food Research Initiative Exploratory Program and other mechanisms as appropriate. Page 77 of 115 AGENCIES NIH NIH NIH NIH NIH ARS NIFA Table 35. JEE RECOMMENDATION 2 (JEE INDICATOR R.1.2): Assess the impact of corrective actions implemented as a result of lessons learned. CY DEPARTMENTS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 USDA 2019 HHS 2020 HHS 2020 USDA ACTION ITEMS Submit reauthorization language for PAHPRA outlining more clearly the response coordination lines of authority and doctrine/frameworks to follow during all-hazards events. Develop and implement a formal CAP to use for all emergency responses and events. Establish a formal AAR process that identifies lessons learned and corrective actions. Adjust plans, operating procedures, and CONOPS using the AARs and CAP that correct the identified shortfalls and/or gaps or new practices/approaches or best practices identified. Review Interagency Agreements instituted in 2016 as a result of an AAR that provide mobilization of staff and resources from across USDA during large-scale emergency responses and events. Compile gaps and recommendations for improving the operationalization of the National Response Framework (NRF) during all-hazards events, both with and without Stafford Act declarations. Submit formal revisions for the NRF and associated and relevant response annexes to ensure effective U.S. Government responses to all-hazards events that could potentially threaten national health security. Update Interagency Agreements among agencies internal to USDA that provide for staff and resources for a critical response that requires a departmental response but has not received Stafford Act declaration. Page 78 of 115 AGENCIES ASPR ASPR ASPR ASPR USDA ASPR ASPR USDA Table 36. JEE RECOMMENDATION 3 (JEE INDICATOR R.1.1): Address challenges in coordinating responses to complex incidents that do not receive Stafford Act declarations. CY DEPARTMENTS 2018 DHS, HHS 2018 HHS 2018 HHS 2019 DHS, HHS 2019 HHS 2019 HHS 2020 DHS, HHS 2020 HHS 2020 HHS 2020 HHS 2020 USDA ACTION ITEMS Train and exercise on the 2017 Biological Incident Annex to the U.S. Response Federal Interagency Operations Plan to ensure collaboration, coordination and unity of effort to a biological incident. Support non-federal research scientists for projects related to the medical and public health aspects of disasters, public health emergencies, and emerging issues to help inform further enhancement of web-based tools and information resources. Convene key federal government stakeholders to address gaps in the NRF, both in the language of the NRF and in interagency practices surrounding the NRF’s usage. Continue to train and exercise on the 2017 Biological Incident Annex to the U.S. Response Federal Interagency Operations Plan to ensure collaboration, coordination and unity of effort to a biological incident. Assess changes made to plans, operating procedures, and CONOPS to institutionalize lessons learned. Provide leadership a “quick look” at the early onset of a response to help focus on gaps and lessons learned from past events using the CAP and lessons learned trends. Continue to train and exercise on the 2017 Biological Incident Annex to the U.S. Response Federal Interagency Operations Plan to ensure collaboration, coordination and unity of effort to a biological incident. Adjust exercises and organizational budgets to reflect process improvements and to test effectiveness of plans, policies, and procedures. Coordinate planning and exercises with consideration of complex incidents that do not receive Stafford Act declarations. Develop a crisis response funding option that minimizes challenges in coordinating response funding options for complex incidents that do not receive Stafford Act declarations. Update Interagency Agreements among agencies internal to USDA that provide for staff and resources for a critical response that requires a departmental response but has not received Stafford Act declaration. Page 79 of 115 AGENCIES FEMA, ASPR NIH ASPR FEMA, ASPR ASPR ASPR FEMA, ASPR ASPR ASPR, CDC ASPR, CDC USDA Table 37. JEE RECOMMENDATION 4 (JEE INDICATOR R.1.2): Develop exercises that involve state and other local partners including the private sector. CY DEPARTMENTS ACTION ITEMS AGENCIES 2018 HHS Support interagency discussions and planning (e.g., Biological Incident Annex – HHS; International Assistance CONOPs – DHS/FEMA) for coordinating public health emergencies when there is no active or imminent emergency declaration under Emergency Support Function (ESF) 19 No. 8 (Public Health and Medical Services) 20 . ASPR 2018 USDA Initiate emergency research to address gaps in knowledge and veterinary medical countermeasures in response to disease outbreaks. Work with Regional Emergency Coordinators and DHS/FEMA CBRN Coordinators to educate/inform state and local emergency managers on developing biological plans by using the Key Planning factors and Considerations for Response to a Biological Incident. ARS 2018 DHS 2018 DHS, HHS Hold a NLE to test CONOPS and inform further development/enhancements. DHS, ASPR 2018 DoD, HHS Continue to conduct regional tabletop exercises to engage major metropolitan areas to consider preparedness needs for a medical surge resulting from distant radiological disasters in partnership with private sector coalitions and organizations such as the National Marrow Donor Program’s (NMDP) Radiation Injury Treatment Network (RITN). DoD, AHRQ, ASPR 2018 EPA Participate in CBRN-related training and exercises with EPA regions and national special teams, federal partners (DHS, DHS/FEMA, USCG, etc.), and SLTT partners regarding response activities involving CBRN agents. EPA FEMA “Emergency Support Functions (ESF) are the grouping of governmental and certain private sector capabilities into an organizational structure to provide support, resources, program implementation, and services that are most likely needed to save lives, protect property and the environment, restore essential services and critical infrastructure, and help victims and communities return to normal following domestic incidents.” (HHS/ASPR. “Emergency Support Functions.”). 20 ESF No. 8 (Public Health and Medical Services) “provides the mechanism for coordinated federal assistance to supplement state, tribal, and local resources in response to the following: public health and medical care needs, veterinary and/or animal health issues in coordination with the USDA, potential or actual incidents of national significance, and a developing potential health and medical situation.” (HHS/ASPR. “ESF No. 8—Public Health and Medical Services”). 19 Page 80 of 115 CY DEPARTMENTS ACTION ITEMS 2018 HHS Conduct a series of exercises at the federal and SLTT levels to demonstrate the ability to transport patients with HID. ASPR 2018 HHS Continue to engage in both external and internal AARs after events and exercises at the national and regional level to develop corrective actions for identified needs and gaps. ASPR 2018 HHS Identify gaps in the current planning process for public health exercises. ASPR 2018 HHS Establish a national public health exercise calendar with respect to which participants from the states may volunteer. ASPR 2018 HHS Identify and enhance processes to include all U.S. Government sectors in NLE with a public health component. ASPR 2018 HHS Incorporate AARs from U.S. responses that activate ESF No. 8 into preparedness and response documents and activities. ASPR 2018 Multiple 2018 USDA Engage state and other local partners for representation in exercises used to validate response planning. Conduct at least one food safety exercise to document capability and capacity to respond to emergencies caused by specific agents. 2019 DHS Continue to work with Regional Emergency Coordinators and DHS/FEMA CBRN Coordinators to educate/inform state and local emergency managers on developing biological plans by using the Key Planning factors and Considerations for Response to a Biological Incident. 2019 DoD, HHS Test the hematologic lab surge plan through an exercise and publish a template plan for use by the preparedness community in partnership with private sector coalitions and organizations such as the NMDP’s RITN. Page 81 of 115 AGENCIES CDC in coordination with others FSIS FEMA DoD, AHRQ, ASPR CY DEPARTMENTS ACTION ITEMS 2019 EPA Participate in CBRN-related training and exercises with EPA regions and national special teams, federal partners (DHS, DHS/FEMA, USCG, etc.), and SLTT partners regarding response activities involving CBRN agents. 2019 HHS Continue to conduct HID transport exercises at the federal and SLTT levels. ASPR 2019 HHS Revise (and, as needed, create) a sub-national public health virtual tabletop exercise that includes actionable public health objectives for all sectors of government. ASPR 2019 HHS Revise, as needed, federal plans and procedures, and assist SLTT to revise their related plans. ASPR 2019 HHS Improve situational awareness among SLTT and federal partners during a radiological incident through exercises that focus on secure information exchange technology, predetermination of data needs, exercising the exchange of data in both directions, and working with all partners that will require data to ensure minimal impact on the provider of data. 2019 HHS Incorporate AARs from U.S. responses that activate ESF No. 8 into preparedness and response documents and activities. 2019 USDA 2020 DHS 2020 DoD, HHS 2020 EPA Review evaluation data from joint training and exercises hosted by HHS/CDC and USDA/APHIS to strengthen future delivery as outlined in the VS National Training and Exercise Program, ensure training involves state counterparts. Continue to work with Regional Emergency Coordinators and DHS/FEMA CBRN Coordinators to educate/inform state and local emergency managers on developing biological plans by using the Key Planning factors and Considerations for Response to a Biological Incident. Continue to conduct regional tabletop exercises to engage major metropolitan areas to consider preparedness needs for a medical surge resulting from distant radiological disasters in partnership with private sector coalitions and organizations such as the NMDP’s RITN. Participate in CBRN-related training and exercises with EPA regions and national special teams, federal partners (DHS, DHS/FEMA, USCG, etc.), and SLTT partners regarding response activities involving CBRN agents. Page 82 of 115 AGENCIES EPA ASPR, CDC ASPR APHIS FEMA DoD, AHRQ, ASPR EPA CY DEPARTMENTS 2020 HHS 2020 HHS 2020 HHS 2020 HHS 2020 HHS 2020 HHS in coordination with others ACTION ITEMS AGENCIES Conduct full-scale exercises that test rural and urban jurisdictions for complex and rare hazards. Revise sub-national exercises as needed to improve outcomes from SLTT exercises. Incorporate AARs from U.S. responses that activate ESF #8 into preparedness and response documents and activities. Conduct exercises or show through real health emergencies that communities are equal partners and that community engagement happens before, during, and after health emergencies. Coordinate with SLTT health departments to exercise plans for population radiation exposure/contamination monitoring consistent with the Nuclear/Radiological Incident Annex (NRIA) and state preparedness plans. Engage state and other local partners for representation in exercises used to validate response planning; revise sub-national exercises as needed to improve outcomes from SLTT exercises. ASPA, ASPR, CDC ASPR Page 83 of 115 ASPR CDC CDC CDC in coordination with others RESPOND 2 — Emergency Response Operations JEE Target Public health emergency operations centers (EOC) at all appropriate locations that are centrally coordinated, which have fully trained staff that meet core competencies for emergency management and systems in place to fully activate within two hours of an alert. Indicators 2016 Capacity Level: 5 R2.1 Capacity to activate emergency operations R2.2 Emergency Operations Center operating procedures and plans R2.3 Emergency operations program R2.4 Case management procedures are implemented for IHR relevant hazards 2016 Capacity Level: 4 2016 Capacity Level: 4 2016 Capacity Level: 3 Summary of U.S. Self-Assessment Most federal departments and agencies have well-established EOC capacities, and those centers are connected and coordinated centrally during a major public health emergency. However, not all of the centers perform as effectively or efficiently as possible, and many of the state-level EOCs do not consistently plan or exercise adequately for public health emergencies. 2016 JEE Recommendations from the External Evaluators 1. Standardize minimum acceptable performance criteria for federal emergency management programs and consider a formal policy for accreditation across all federal agencies. 2. Create a systematic One Health cross-agency approach in activation, EOC operational procedures, plans, and full-scale exercises. This should include after-action reviews, delineating agency role and responsibilities, and developing liaison officers and surge staff personnel exchange. 3. Consider actions to help states and local health authorities fully implement existing federal guidelines on IHR-relevant hazards. Page 84 of 115 Summary of Actions Items Efforts will focus on involving more federal and SLTT jurisdictions in NLE and ensuring that best practices and lessons learned are shared at all levels of government, in order to improve outcomes, internal and external communication, information sharing, and situational awareness, and to establish a common operating picture during events and exercises. Federal departments and agencies will also work to establish EOC standards and incident management systems for situational awareness, staffing, and staff education and training; provide federal support to SLTT programs to increase local capacities to identify, hold, treat, and transport patients with HID or physical contaminants or who are physically contaminated; and assist local medical networks to identify facilities capable of receiving such patients and coordinate with EMS providers. Action Items Table 38. JEE RECOMMENDATION 1 (JEE INDICATORS R.2.1 and R.2.3): Standardize minimum acceptable performance criteria for federal emergency management programs and consider a formal policy for accreditation across all federal agencies; and JEE RECOMMENDATION 3 (JEE INDICATOR R.2.1): Consider actions to help states and local health authorities to fully implement existing federal guidelines on IHR-relevant hazards. CY DEPARTMENTS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 HHS ACTION ITEMS Encourage the accreditation of federal and SLTT emergency management programs through nationally recognized accreditation or certification process; compile a list of those accreditations and certifications. Document/identify and share/distribute emergency management programs improvement processes used within SLTT and federal departments and agencies. Assess current improvement processes used within SLTT and federal departments and agencies. Encourage federal and SLTT authorities to establish written policies and procedures for EOC operations. Assist federal and SLTT authorities in developing a CAP that identifies process improvement and best practices for EOC operations. Continue to engage in both external and internal AARs after events and exercises at the national and regional levels to develop corrective actions for identified needs and gaps. Identify baseline EOC standards/practices common across federal and SLTT EOCs. Encourage federal and SLTT EOCs to document standards of practice and instruction. Page 85 of 115 AGENCIES ASPR, CDC ASPR, CDC ASPR, CDC ASPR, CDC ASPR, CDC ASPR, CDC ASPR, CDC ASPR, CDC CY DEPARTMENTS ACTION ITEMS AGENCIES 2018 HHS ASPR, CDC 2018 HHS 2018 HHS 2018 HHS 2019 HHS 2019 HHS 2019 HHS 2019 HHS 2019 HHS 2019 HHS 2020 HHS Establish credentialing standards for EOC operations and share with partner EOCs. Develop regional and facility HID plans that include safe transport from within and outside the region. Establish best practices and guidelines for EMS safe transport of patients with HID and the management/disposal of hazardous waste. Conduct a series of exercises at the federal and SLTT levels to demonstrate the ability to transport patients with HID. Establish a community of practice for EOC practitioners to foster information sharing. Establish national accreditation body and standards through the established community of EOC practitioners. Establish health-related training standards for EMS and air transport of patients with HID, in coordination with Federal Aviation Administration (FAA) and other DOT elements. Identify safe transport systems (e.g., patient isolation units) to transport HID patients and work with relevant regulatory agencies to obtain all necessary authorizations. Continue to conduct HID transport exercises at the federal and SLTT levels. Establish/publish federal level emergency management training standards for functional IMS/EOC level positions and fund implementation programs. Adjust regional and facility plans, using corrective action and lessons learned programs, to improve the safe transport of patients with HID. ASPR, CDC ASPR, CDC ASPR, CDC ASPR ASPR ASPR ASPR ASPR ASPR, CDC ASPR Table 39. JEE RECOMMENDATION 2 (JEE INDICATORS R.2.1, R.2.2, and R.2.3): Create a systematic One Health cross-agency approach in activation, EOC operational procedures, plans, and full-scale exercises. This should include after-action reviews, delineating agency role and responsibilities and developing liaison officers and surge staff personnel exchange. CY DEPARTMENTS ACTION ITEMS AGENCIES 2018 2018 HHS HHS ASPR ASPR 2018 HHS 2018 HHS Identify current public health exercises that involve all sectors of government. Identify gaps in current planning process for public health exercises. Establish a national public health exercise calendar with respect to which participants from the states may volunteer. Identify and enhance processes to include all federal government sectors in NLE with a public health component. Page 86 of 115 ASPR ASPR CY DEPARTMENTS 2018 USDA 2019 HHS 2019 HHS 2020 HHS ACTION ITEMS Maintain a roster of trained and certified individuals within USDA available to deploy from normal agency duties to provide service in their specific area of expertise during emergency events. Revise (and create as needed) a sub-national public health virtual tabletop exercise that includes actionable public health objectives for all sectors of government. Revise, as needed, federal plans and procedures and assist SLTT partners to revise their related plans. Revise sub-national exercises as needed to improve outcomes from SLTT exercises. Page 87 of 115 AGENCIES USDA ASPR ASPR ASPR RESPOND 3 — Linking Public Health and Security Authorities JEE Target In the event of a biological event of suspected or confirmed deliberate origin, a country will be able to conduct a rapid, multisectoral response including the capacity to link public health and law enforcement and to provide and/or request effective and timely international assistance including to investigate alleged use events. Indicator R3.1 Public health and security authorities (e.g., law enforcement, border control, and customs) are linked during a suspect or confirmed biological event 2016 Capacity Level: 5 Summary of U.S. Self-Assessment The U.S. Criminal-Epidemiological Investigation Model provides the foundation for the combined public health and law enforcement response to suspicious incidents, but the implementation of that model at the state level is inconsistent. 2016 JEE Recommendations from the External Evaluators 1. Determine the strategy and content for recurring basic and proposed advanced level Criminal-Epidemiological trainings at the national and subnational levels. 2. Develop FBI and subnational/SLTT public health department jurisdiction-specific written protocols for joint public health law enforcement investigations. Summary of Action Items Efforts will focus on expanding the number of individuals and SLTT agencies trained in the Criminal-Epidemiological Investigation Model including development of online learning tools and advanced training modules. Page 88 of 115 Action Items Table 40. JEE RECOMMENDATION 1 (JEE INDICATOR R.3.1): Determine the strategy and content for recurring basic and proposed advanced level Criminal-Epidemiological trainings at the national and subnational levels. CY DEPARTMENTS 2018 DOJ, HHS 2018 DOJ, HHS 2019 DOJ, HHS 2019 DOJ, HHS 2019 DOJ, HHS 2020 DOJ, HHS 2020 DOJ, HHS ACTION ITEMS Complete six Joint Criminal-Epidemiological Investigations Workshops at the subnational/jurisdictional level for public health, law enforcement, and multi-sectoral (e.g., military, agriculture/food safety, academic, and non-governmental organizations) personnel. Develop new curriculum for the Joint Criminal-Epidemiological Investigations Workshops. Complete six Joint Criminal-Epidemiological Investigations Workshops at the subnational/jurisdictional level for public health, law enforcement, and multi-sectoral (e.g., military, agriculture/food safety, academic, and non-governmental organizations) personnel. Develop an interactive, web-based capability to serve as the platform for the Advanced Criminal-Epidemiological Program. Develop a five-year strategy for the FBI/CDC Criminal-Epidemiological Investigations Program. Complete six Joint Criminal-Epidemiological Investigations Workshops at the subnational/jurisdictional level for public health, law enforcement, and multi-sectoral (e.g., military, agriculture/food safety, academic, and non-governmental organizations) personnel. Conduct pilot workshop for the Advanced Criminal-Epidemiological Program. AGENCIES FBI, CDC FBI, CDC FBI, CDC FBI, CDC FBI, CDC FBI, CDC FBI, CDC Table 41. JEE RECOMMENDATION 2 (JEE INDICATOR R.3.1): Develop FBI and subnational/SLTT public health department jurisdiction-specific written protocols for joint public health law enforcement investigations. CY DEPARTMENTS ACTION ITEMS AGENCIES 2019 DOJ, HHS Work with national, sub-national, and jurisdictional partners (e.g., NACCHO, ASTHO, and the National Governors Association) to identify SLTT public health authorities without a joint investigation protocol/memorandum of understanding (MOU). FBI, CDC Page 89 of 115 RESPOND 4 — Medical Countermeasures and Personnel Deployment JEE Target A national framework for transferring (sending and receiving) MCMs and public health and medical personnel among international partners during public health emergencies. Indicators R4.1 System is in place for sending and receiving MCMs during a public health emergency 2016 Capacity Level: 5 R4.2 System is in place for sending and receiving health personnel during a public health emergency 2016 Capacity Level: 4 Summary of U.S. Self-Assessment A system is in place to send MCMs internationally and a framework to develop a similar model for sending teams of medical personnel. However, there is a need for additional efforts to facilitate the receipt of MCMs and personnel from partner countries. 2016 JEE Recommendations from the External Evaluators 1. Develop a companion framework to the International Assistance System that will describe the roles, responsibilities, and processes that HHS will use to manage international offers of public health and medical assistance including medical teams. 2. Work with international partners to improve cross-border deployment capabilities by supporting the development of global emergency regulatory mechanisms and developing checklists, operational plans, and other tools to support the development of emergency medical teams, facilitating their deployment and improving coordination. Summary of Action Items Efforts will focus on improving the federal government’s ability to request, send, and receive MCMs and health personnel from international partners during a public health emergency. This will include developing a policy framework and corresponding operational plans to receive MCMs and public health and medical personnel from foreign countries during a major public health or medical emergency in the United States. The development of an internal policy framework to describe the roles, responsibilities, and processes within HHS during a public health emergency at the national-international interface will further support these efforts. In addition, there will be efforts to work bilaterally and multilaterally to develop and test new tools for addressing legal, regulatory, and Page 90 of 115 logistical challenges to cross-border deployments of public health and medical personnel and to support initiatives to standardize and further professionalize international public health and medical response practices such as the WHO Emergency Medical Teams Initiative and the regional efforts of Pan American Health Organization (PAHO). Action Items Table 42. JEE RECOMMENDATION 1 (JEE INDICATORS R.4.1 and R.4.2): Develop a companion framework to the International Assistance System that will describe the roles, responsibilities, and processes that HHS will use to manage international offers of public health and medical assistance including medical teams. CY DEPARTMENTS ACTION ITEMS AGENCIES 2018 DHS, HHS Finalize the internal HHS policy framework as a companion to the International Assistance System and corresponding operating procedures that describe how the Department will make requests for, or manage offers of, public health and medical assistance from foreign partners. 2018 DHS, HHS Circulate for interagency review and comment a draft internal policy framework to enhance ASPR’s coordination during an event at the national-international interface. ASPR 2019 DHS, HHS Exercise the internal HHS policy framework and corresponding operating procedures for how the Department will make requests for international assistance, or manage offers of, public health and medical assistance from foreign partners. FEMA, ASPR, CDC, FDA 2019 DHS, HHS Incorporate lessons learned from the exercise into the internal HHS framework that describes how the Department will make requests for, or manage offers of, public health and medical assistance from foreign partners. FEMA, ASPR, FDA 2019 HHS Finalize and obtain clearance from interagency and senior federal government leadership of the internal HHS policy framework to enhance ASPR’s coordination during an event at the national-international interface. Page 91 of 115 FEMA, ASPR, CDC, FDA, OGC ASPR Table 43. JEE RECOMMENDATION 2 (JEE INDICATORS R.4.1 and R.4.2): Work with international partners to improve crossborder deployment capabilities by supporting the development of global emergency regulatory mechanisms and developing checklists, operational plans, and other tools to support the development of emergency medical teams, facilitating their deployment and improving coordination. CY DEPARTMENTS 2018 HHS ACTION ITEMS Support PAHO efforts to implement the regional implementation of the WHO Emergency Medical Teams Initiative. AGENCIES ASPR Table 44. OTHER ACTIVITIES (JEE INDICATOR R.4.1) CY DEPARTMENTS 2019 DHS, HHS 2019 HHS 2020 DHS, HHS 2020 DHS, HHS ACTION ITEMS AGENCIES Plan and participate in an exercise that includes testing capabilities to send, and/or receive, MCMs across international borders in collaboration with federal government stakeholders. Identify the specific liability concerns, by stakeholder type, related to the transport, distribution, and dispensing/administration of unapproved MCMs imported from foreign sources to assess their impact on the rapid response to public health emergencies. Identify existing HHS/FDA medical product access mechanisms for transporting, distributing, and dispensing/administering unapproved medical products imported from foreign sources during a public health emergency. Review and revise the federal government policies and procedures, as needed, based on the results of the exercise that includes testing capabilities to send and/or receive MCMs across international borders. FEMA, ASPR, CDC, FDA, OGC Page 92 of 115 FEMA, ASPR, CDC, FDA, OGC FEMA, ASPR, CDC, FDA, OGC FEMA, ASPR, CDC, FDA, OGC RESPOND 5 — Risk Communication JEE Target States Parties should have a risk communication capacity that is multi-level and multi-faced; utilizes real time exchange of information; and employs advice and opinion between experts and officials or people who face a threat or hazard to their survival, health, economic, or social well-being so that they can make informed decisions that mitigate the effects of the threat or hazard and take protective and preventive action. It includes a mix of communication and engagement strategies such as media and social media communication, mass awareness campaigns, health promotion, social mobilization, and stakeholder and community engagement. Indicators R5.1 Risk communication systems (e.g., plans, mechanisms, etc.) 2016 Capacity Level: 4 R5.2 Internal and partner communication and coordination 2016 Capacity Level: 5 R5.3 Public communication 2016 Capacity Level: 4 R5.4 Communication engagement with affected communities 2016 Capacity Level: 3 R5.5 Dynamic listening and rumor management 2016 Capacity Level: 4 Summary of U.S. Self-Assessment The United States has an effective system for developing risk communications at the federal level that involves all of the key departments and agencies. However, during the earliest stages of a response, various departments and agencies may conduct communication operations more independently and less cohesively. There are not enough personnel trained in handling major emergencies, with too few who can surge where and when needed. 2016 JEE Recommendations from the External Evaluators 1. Strengthen risk communication in professional disciplines with the help of increased resources for training and encourage professional peer-review publishing on the topic by practitioners. 2. Ensure adequate numbers of risk communication specialists are trained for a possible radiological (or other rare) event. Page 93 of 115 3. Evaluate existing risk communication staffing models and develop options for surge capacity. 4. Increase resources for real-time population knowledge and beliefs to adjust behavior change messages. Summary of Action Items Efforts will focus on promoting community engagement and evaluating the current capacities and challenges among SLTT partners, and working with them to develop training and staffing plans to improve the number of qualified risk communicators. Action items will include training around complex situations and specific (rare) hazards; surveying national risk communication partners and media outlets to develop a plan to address existing gaps and shortfalls in community engagement and readiness; and conducting exercises to test those plans. Action Items Table 45. JEE RECOMMENDATION 1 (JEE INDICATORS R.5.1 and R.5.3): Strengthen risk communication in professional disciplines with the help of increased resources for training and encourage professional peer-review publishing on the topic by practitioners. CY DEPARTMENTS 2018 HHS 2019 HHS 2019 HHS 2019 HHS 2020 HHS 2020 HHS ACTION ITEMS Partner with local and non-government organizations to publish literature related to public health emergency community engagement and risk communication. Develop a plan to train public health communication professionals on emergency risk communication. Develop a plan to train SLTT and federal jurisdiction leaders who may be involved in complex public emergencies on crisis leadership and emergency risk communication. Develop a plan that improves the scope and consistency across SLTT and federal jurisdictions to offer plain language health advice across diverse media, as well as sector-specific health advice phrased in terminology appropriate to the sector. Implement plans to routinely assess and evaluate public communications for complex situations. Conduct full-scale exercises that test rural and urban jurisdictions for complex and rare hazards, including public communications and emergency risk communications aspects of same. Page 94 of 115 AGENCIES CDC ASPA, ASPR, CDC ASPA, ASPR, CDC ASPA, ASPR, CDC ASPA, ASPR, CDC ASPA, ASPR, CDC CY DEPARTMENTS 2020 HHS Train public health communication professionals on emergency risk communication. HHS Train SLTT and federal jurisdiction leaders who potentially may be involved in complex public emergencies on crisis leadership and emergency risk communication. 2020 ACTION ITEMS AGENCIES ASPA, ASPR, CDC ASPA, ASPR, CDC Table 46. JEE RECOMMENDATION 2 (JEE INDICATOR R.5.1): Ensure adequate numbers of risk communication specialists are trained for a possible radiological (or other rare) event. CY DEPARTMENTS 2018 DOE, EPA, NRC ACTION ITEMS Continue to lead the interagency Nuclear/Radiological Communications Working Group in charge of developing products and plans for radiological risk communications that might be helpful during an emergency. AGENCIES DOE, EPA, NRC Table 47. JEE RECOMMENDATION 3 (JEE INDICATOR R.5.1): Evaluate existing risk communication staffing models and develop options for surge capacity. CY DEPARTMENTS 2018 HHS 2018 HHS 2019 HHS 2019 HHS ACTION ITEMS Review current crisis and emergency risk communication personnel capacity across SLTT and federal jurisdictions and hazards for critical gaps. Consult with multiple jurisdictions on an approach for the risk communication personnel capacity needs assessment. Conduct a needs assessment for minimum required emergency risk communication capacity across SLTT and federal jurisdictions for complex situations including nuclear/radiological threats. Conduct and publish the results of a needs assessment for minimum required emergency risk communication capacity among leaders. Page 95 of 115 AGENCIES CDC CDC CDC CDC Table 48. JEE RECOMMENDATION 4 (JEE INDICATOR R.5.5): Increase resources for real-time population knowledge and beliefs to adjust behavior change messages. CY DEPARTMENTS 2018 HHS 2018 HHS 2019 HHS 2019 HHS 2019 HHS 2020 HHS 2020 HHS ACTION ITEMS Develop a survey with national public health partners and media to determine the level of collaboration in providing health advice and managing misinformation during events. Conduct a needs assessment on community engagement capacity in rural and urban settings. Develop a practitioner’s handbook on community engagement that focuses on local responses for all-hazards. Include community engagement best practices as a core module of crisis and emergency risk communication curriculum and training. Conduct pre- and post-conference workshops on risk communication and community engagement and standing public health and emergency response conferences and meetings. Survey community members to assess the extent to which they perceive themselves as equal partners in the risk communication process. Conduct exercises or show through real health emergencies that communities are equal partners and that community engagement happens before, during, and after health emergencies. AGENCIES CDC CDC CDC CDC CDC CDC CDC Table 49. OTHER ACTIVITIES (JEE INDICATORS R.5.1 and R.5.2) CY DEPARTMENTS 2018 HHS ACTION ITEMS Constitute an interagency group to oversee risk communication planning and evaluation. Page 96 of 115 AGENCIES ASPA, ASPR, CDC OTHER IHR HAZARDS — Points of Entry (PoE) JEE Target States Parties should designate and maintain the core capacities at international airports and ports (and where justified for public health reasons, a State Party may designate ground crossings), which implement specific public health measures required to manage a variety of public health risks. Indicators PoE.1 Routine capacities are established at PoE 2016 Capacity Level: 4 PoE.2 Effective public health response at PoE 2016 Capacity Level: 5 Summary of U.S. Self-Assessment The United States has strong systems in place at international points of entry (PoE) designated for IHR purposes, but there is a large variance in preparedness for public health emergencies at many other international ports (mostly airports). 2016 JEE Recommendations from the External Evaluators 1. Development of a comprehensive national aviation preparedness plan aimed at preventing and containing the spread of diseases, which would include PoE not already covered by the CDC. 2. Expansion of capacity to detect, assess, report, and respond at non-designated ports supported by exercise programs. 3. Provisioning of on-site access to specialized public health officers at non-designated ports (ground, sea, and air). Summary of Action Items Given the complexity of federal, state, and local government jurisdiction and authority over components of civil aviation (including public health and safety), and the responsibilities of SLTT authorities and private companies to maintain public health emergency plans, the federal government will develop guidelines for public health preparedness at international PoEs. The national guidelines will include a catalog of complementary resources and templates (where appropriate) to assist with planning. Ultimately, the efforts will evaluate the effectiveness of those guidelines through existing mechanisms at the federal level to determine the need for additional information, research, and resources. Page 97 of 115 Action Items Table 50. JEE RECOMMENDATION 1 (JEE INDICATOR PoE.2): Development of a comprehensive national aviation preparedness plan aimed at preventing and containing the spread of diseases, which would include PoE not already covered by the CDC; and JEE RECOMMENDATION 2 (JEE INDICATOR PoE.1): Expansion of capacity to detect, assess, report, and respond at non-designated ports supported by exercise programs; JEE RECOMMENDATION 3 (JEE INDICATOR PoE.1): Provisioning of on-site access to specialized public health officers at non-designated ports (ground, sea, and air). CY DEPARTMENTS 2018 DHS, DOT, HHS 2018 DHS, DOT, HHS 2018 DHS, DOT, HHS 2018 DHS, HHS 2019 DHS, DOT, HHS 2019 DHS, DOT, HHS 2019 DHS, HHS 2020 DHS, DOT, HHS 2020 DHS, DOT, HHS ACTION ITEMS Complete a white paper describing the functions of the HHS/CDC Quarantine Stations in covering the international PoE and the current federal government approach to public health emergency preparedness in civil aviation. Conduct a comprehensive review of the existing national and international guidelines and mechanisms for establishing aviation public health emergency plans. Update and draft, as needed, guidelines for communicable disease response plans and other public health emergency preparedness strategies for non-IHR-designated international airports. Develop and pilot a “public health preparedness dashboard” to facilitate awareness of overall preparedness at PoE, which can initially be used among the airports with quarantine stations. Finalize and publish guidelines and performance benchmarks for state and local officials (and others involved in the aviation industry) to use to increase public health emergency preparedness at international airports. Assist individual airport operators to devise and (if feasible) exercise their public health emergency plans. Determine the feasibility of expanding the public health preparedness dashboard to more airports. Assist individual airport operators to devise and (if feasible) exercise their public health emergency plans. Determine the feasibility of expanding the online public health preparedness dashboard to include all airports. Page 98 of 115 AGENCIES CBP, FAA, CDC CBP, FAA, CDC CBP, FAA, CDC CBP, CDC CBP, ASPR, CDC CBP, FAA, ASPR, CDC CBP, ASPR, CDC CBP, FAA, ASPR, CDC CBP, FAA, ASPR, CDC OTHER IHR HAZARDS — Chemical Events JEE Target States Parties should have surveillance and response capacity for chemical risk or events. This requires effective communication and collaboration among the sectors responsible for chemical safety, industries, transportation, and safe disposal. Indicators CE.1 Mechanisms are established and functioning for detecting and responding to chemical events or emergencies 2016 Capacity Level: 4 CE.2 Enabling environment is in place for management of chemical events 2016 Capacity Level: 5 Summary of U.S. Self-Assessment The United States has an adequate system in place to identify chemical events quickly. However, local laboratories and health departments require improvements in their capacity for rapid risk assessments and diagnostics. 2016 JEE Recommendations from the External Evaluators 1. Follow up and evaluate implementation of the Federal Interagency Working Group Action Plan issued in 2014. 2. Improve the capacity for recovery and resiliency with respect to chemical response by reducing variations between states’ capacities. 3. Expand the number of the trained personnel who can manage larger-scale emergencies. Summary of Action Items Efforts will focus on federal government departments and agencies developing additional guidance for preparedness at the SLTT level, and developing and stockpiling improved MCMs for chemical exposures; expanding the number of laboratories in the ERLN; evaluating the variations in SLTT capacities; and developing tools to assist them in reviewing and improving their local capacities to provide a medical response to a large-scale chemical event. Page 99 of 115 Action Items Table 51. JEE RECOMMENDATION 1 (JEE INDICATOR CE.2): Follow up and evaluate implementation of the Federal Interagency Working Group Action Plan issued in 2014. CY DEPARTMENTS 2018 EPA 2018 EPA 2018 EPA 2018 EPA 2018 EPA 2018 EPA 2018 EPA 2018 HHS 2019 EPA ACTION ITEMS Leverage improved communication and coordination with the federal and regional working group (EPA, DHS, DOL/OSHA, and DOJ/ATF) resulting from the successful implementation of the “Executive Order 13650: Actions to Improve Chemical Facility Safety and Security – A Shared Commitment Report for the President (May 2014),” which was developed and implemented as a result of Executive Order 13650: Improving Chemical Facility Safety and Security. Participate in CBRN-related training and exercises with EPA regions and national special teams, federal partners (DHS, DHS/FEMA, HHS/ASPR, HHS/CDC, USCG, etc.), and SLTT partners regarding response activities involving CBRN agents. Continue the open solicitation to public and private laboratories for membership in the ERLN. Develop methods for detection of chemical threats in environmental matrices to support the ERLN. Conduct decontamination studies for chemical agents on surfaces including material compatibility studies. Evaluate waste treatment technologies for Chemical Warfare Agents (CWA) contaminated building materials. Conduct demonstrations of decontaminating drinking water systems and household plumbing/appliances from contamination at the Water Security Test Bed at DOE’s Idaho National Laboratory. Continue to maintain and update information and training resources for emergency preparedness and response. Leverage improved communication and coordination with the federal and regional working group (EPA, DHS, DOL/OSHA, and DOJ/ATF) resulting from the successful implementation of the “Executive Order 13650: Actions to Improve Chemical Facility Safety and Security – A Shared Commitment Report for the President (May 2014),” which was developed and implemented as a result of Executive Order 13650: Improving Chemical Facility Safety and Security. Page 100 of 115 AGENCIES EPA EPA EPA EPA EPA EPA EPA NIH EPA CY DEPARTMENTS 2019 EPA 2019 EPA 2019 EPA 2019 EPA 2019 EPA 2019 EPA 2019 HHS 2020 EPA 2020 EPA 2020 EPA 2020 EPA 2020 EPA 2020 EPA ACTION ITEMS Participate in CBRN-related training and exercises with EPA regions and national special teams, federal partners (DHS, DHS/FEMA, HHS/ASPR, HHS/CDC, USCG, etc.), and SLTT partners regarding response activities involving CBRN agents. Continue the open solicitation to public and private laboratories for membership the ERLN. Continue to develop methods for detection of chemical threats in environmental matrices to support the ERLN. Continue to conduct decontamination studies for chemical agents on surfaces including material compatibility studies. Continue to evaluate waste treatment technologies for CWA contaminated building materials. Conduct demonstrations of decontaminating drinking water systems and household plumbing/appliances from contamination at the Water Security Test Bed at DOE’s Idaho National Laboratory. Continue to maintain and update information and training resources for emergency preparedness and response. Leverage improved communication and coordination with the federal and regional working group (EPA, DHS, DOL/OSHA, and DOJ/ATF) resulting from the successful implementation of the “Executive Order 13650: Actions to Improve Chemical Facility Safety and Security – A Shared Commitment Report for the President (May 2014),” which was developed and implemented as a result of Executive Order 13650: Improving Chemical Facility Safety and Security. Participate in CBRN-related training and exercises with EPA regions and national special teams, federal partners (DHS, DHS/FEMA, HHS/ASPR, HHS/CDC, USCG, etc.), and SLTT partners regarding response activities involving CBRN agents. Continue the open solicitation to public and private laboratories for membership in the ERLN. Continue to develop methods for detection of chemical threats in environmental matrices to support the ERLN. Continue to conduct decontamination studies for chemical agents on surfaces including material compatibility studies. Continue to evaluate waste treatment technologies for CWA contaminated building materials. Page 101 of 115 AGENCIES EPA EPA EPA EPA EPA EPA NIH EPA EPA EPA EPA EPA EPA CY DEPARTMENTS 2020 HHS ACTION ITEMS Continue to maintain and update information and training resources for emergency preparedness and response. AGENCIES NIH Table 52. JEE RECOMMENDATION 2 (JEE INDICATOR CE.1): Improve the capacity for recovery and resiliency with respect to chemical response by reducing variations between states’ capacities. CY DEPARTMENTS 2018 DHS, HHS 2018 EPA 2018 EPA 2018 EPA 2018 HHS 2018 HHS 2019 DHS, HHS ACTION ITEMS Publish implementation action steps for mass patient decontamination based on “Patient Decontamination in a Mass Chemical Exposure Incident: National Planning Guidance for Communities,” published in 2014. Leverage improved communication and coordination with the federal and regional working group (EPA, DHS, DOL/OSHA and DOJ/ Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF)) resulting from the successful implementation of the “Executive Order 13650: Actions to Improve Chemical Facility Safety and Security – A Shared Commitment Report for the President (May 2014),” which was developed and implemented as a result of Executive Order 13650: Improving Chemical Facility Safety and Security. Participate in CBRN-related training and exercises with EPA regions and national special teams, federal partners (DHS, DHS/FEMA, HHS/ASPR, HHS/CDC, USCG, etc.), and SLTT partners regarding response activities involving CBRN agents. Continue the open solicitation to public and private laboratories for membership in the ERLN. Research, develop, and stockpile new and improved MCMs for CWA, such as nerve agents, sulfur mustard, cyanide, chlorine, and toxic industrial chemicals. Refine, promote and continue training and integration into response novel responder guidance and decision support tools, such as CHEMM, WISER, PRISM, and DERMaL eToolkit. Develop guidance for local communities on MCM optimization and contingency MCM use during a mass casualty chemical incident. Page 102 of 115 AGENCIES DHS, ASPR EPA EPA EPA ASPR, CDC, FDA, NIH ASPR, CDC, NIH DHS, ASPR, CDC CY DEPARTMENTS 2019 EPA 2019 EPA 2019 EPA 2019 HHS 2019 HHS 2020 EPA 2020 EPA 2020 EPA 2020 HHS 2020 HHS ACTION ITEMS Leverage improved communication and coordination with the federal and regional working group (EPA, DHS, DOL/OSHA, and DOJ/ATF) resulting from the successful implementation of the “Executive Order 13650: Actions to Improve Chemical Facility Safety and Security – A Shared Commitment Report for the President (May 2014),” which was developed and implemented as a result of Executive Order 13650: Improving Chemical Facility Safety and Security. Participate in CBRN-related training and exercises with EPA regions and national special teams, federal partners (DHS, DHS/FEMA, HHS/ASPR, HHS/CDC, USCG, etc.), and SLTT partners regarding response activities involving CBRN agents. Continue the open solicitation to public and private laboratories for membership in the ERLN. Research, develop, and stockpile new and improved MCMs for CWA, such as nerve agents, sulfur mustard, cyanide, chlorine, and toxic industrial chemicals. Continue to refine, promote, train, and integrate into response novel responder guidance and decision support tools, such as CHEMM, WISER, PRISM, and DERMaL eToolkit. Leverage improved communication and coordination with the federal and regional working group (EPA, DHS, DOL/OSHA, and DOJ/ATF) resulting from the successful implementation of the Report for the President: Actions to Improve Chemical Facility Safety and Security – A Shared Commitment (May 2014),” which was developed and implemented as a result of Executive Order 13650: Improving Chemical Facility Safety and Security. Participate in CBRN-related training and exercises with EPA regions and national special teams, federal partners (DHS, DHS/FEMA, HHS/ASPR, HHS/CDC, USCG, etc.), and SLTT partners regarding response activities involving CBRN agents. Continue the open solicitation to public and private laboratories for membership in the ERLN. Research, develop, and stockpile new and improved MCMs for CWA, such as nerve agents, sulfur mustard, cyanide, chlorine, and toxic industrial chemicals. Continue to refine, promote, train, and integrate into response novel responder guidance and decision support tools, such as CHEMM, WISER, PRISM, and DERMaL eToolkit. Page 103 of 115 AGENCIES EPA EPA EPA ASPR, CDC, FDA, NIH ASPR, CDC, NIH EPA EPA EPA ASPR, CDC, FDA, NIH ASPR, CDC, NIH Table 53. JEE RECOMMENDATION 3 (JEE INDICATOR CE.2): Expand the number of the trained personnel who can manage larger-scale emergencies. CY DEPARTMENTS ACTION ITEMS 2018 DHS, HHS Update training curricula as new guidance on MCM optimization, contingency MCM use, patient decontamination, and others are available. 2018 DHS, HHS Train personnel on risk assessment, medical challenges, decision-making, and other critical issues during the first four hours of a response. 2018 HHS Publish research results and practical guidance from a pre-hospital mass patient decontamination research project. 2019 DHS, HHS Update training curricula as new guidance on MCM optimization, contingency MCM use, patient decontamination, and others are available. 2019 DHS, HHS Train personnel on risk assessment, medical challenges, decision-making, and other critical issues during the first four hours of a response. 2019 HHS Publish national planning guidance on decontaminating pediatric and pregnant patients. 2020 DHS, HHS Update training curricula as new guidance on MCM optimization, contingency MCM use, patient decontamination, and others are available. 2020 DHS, HHS Train personnel on risk assessment, medical challenges, decision-making, and other critical issues during the first four hours of a response. Page 104 of 115 AGENCIES FEMA, CMWD, ASPR, CDC, NIH FEMA, CWMD, ASPR, NIH ASPR FEMA, CWMD, ASPR, CDC, NIH FEMA, CWMD, ASPR, NIH ASPR FEMA, CWMD, ASPR, CDC, NIH FEMA, CWMD, ASPR, NIH OTHER IHR HAZARDS — Radiation Emergencies JEE Target States Parties should have surveillance and response capacity for radio-nuclear hazards/events/emergencies. This requires effective communication and collaboration among the sectors responsible for radio-nuclear management. Indicators RE.1 Mechanisms are established and functioning for detecting and responding to radiological and nuclear emergencies 2016 Capacity Level: 3 RE.2 Enabling environment is in place for management of radiation emergencies 2016 Capacity Level: 3 Summary of U.S. Self-Assessment While early radiation detection is generally available across the country, few locations have the ability to assess dose and conduct post-event risk assessments. 2016 JEE Recommendations from the External Evaluators 1. Establish mechanisms for systematic information exchange between authorities of the radiological competent and human health service surveillance unit. 2. Develop a long-term waste management repository following the cleanup of a radiological spill. 3. Research, develop, and implement systems to create novel, high-throughput systems that are capable of performing biodosimetry and bioassay in both mass casualty and large-scale radionuclide dispersion situations. 4. Implement the recommendations in the report “Where are the radiation professionals?” (Statement No. 12) issued by the National Council on Radiation Protection and Measurements in 2015. 5. Integrate triage systems and population monitoring guidance with the existing national public health and clinical systems in order to provide a national capacity for continuity of assessment, care, and treatment. Page 105 of 115 Summary of Action Items Efforts will focus on developing laboratory bioassays for the remaining priority radionuclides and disseminating the tests to designated labs across the country (funding dependent); increasing the overall capacity to conduct radiobiodosimetry testing including characterization and validation of new methods; collaborating with U.S. hospitals to identify locations that could potentially adopt standardized biodosimetry methods and coordinate to enable responses to larger-scale exposures; increase number of radiation professionals through education, work experience, and increasing awareness of the profession; and collaborating with SLTT health departments/PHEP grant awardees to raise awareness of their potential role in a radiation emergency response, to provide them with guidance on emergency response preparations, and to enhance situational awareness between partners in a radiological response. Action Items Table 54. JEE RECOMMENDATION 1 (JEE INDICATOR RE.1): Establish mechanisms for systematic information exchange between authorities of the radiological competent and human health service surveillance unit. CY DEPARTMENTS 2019 DHS, DOE, HHS 2019 DHS, HHS 2019 HHS ACTION ITEMS Improve situational awareness among SLTT and federal partners during a radiological incident through exercises that focus on secure information exchange technology, predetermination of data needs, exercising the exchange of data in both directions, and working with all partners that will require data to ensure minimal impact on the provider of data. Conduct a thorough capabilities analysis and develop specific guidance for the resources necessary to conduct large-scale triage, early patient assessment, screening, and decontamination prior to and during early evacuation phases for a major nuclear detonation requiring population movement and evacuation. Develop a framework and plans to incorporate mass casualty triage into an Integrated Clinical Diagnostics System (ICDS) for biodosimetry surge to assess radiation injury. The ICDS is a framework that includes massive surge for hematology (lymphocyte depletion kinetics via complete blood count and white blood cell differential analysis, DCA, radiobioassay, and novel point-of-care and highthroughput dosimetry currently under development). Page 106 of 115 AGENCIES DHS, DOE, CDC DHS, ASPR, CDC ASPR Table 55. JEE RECOMMENDATION 2 (JEE INDICATOR RE.2): Develop a long-term waste management repository following the cleanup of a radiological spill. CY DEPARTMENTS ACTION ITEMS AGENCIES 2018 DOE, EPA NNSA, EPA 2018 DOE, EPA 2018 DOE, EPA 2018 DOE, EPA 2018 2019 EPA DOE, EPA 2019 DOE, EPA 2019 DOE, EPA 2019 DOE, EPA 2019 DOE, EPA 2019 DOE, EPA 2019 DOE, EPA 2019 DOE, EPA 2019 DOE, EPA 2019 DOE, EPA 2020 DOE, EPA Develop methods for rapid survey of radiologically contaminated areas. Evaluate the fate and transport of radiological threats to inform environmental response and remediation and report the results. Develop methods for owner/occupant decontamination of radiological contaminated residences and businesses. Further develop decision-support tools for environmental response and remediation including transport of waste. Develop methods for management of contaminated water. Continue to develop methods for rapid survey of radiologically contaminated areas. Continue to develop methods for owner/occupant decontamination of radiological contaminated residences and businesses. Continue to develop methods for management of contaminated water. Continue to further develop decision-support tools for environmental response and remediation including transport of waste. Develop a comprehensive wide-area radiological response strategy with recommendations for radiological assessment, mitigation, and environmental cleanup. Waste management is a critical element of radiological cleanup. The strategy will include recommendations for management and disposal of radiologically contaminated soils and other wastes. Continue to develop methods for rapid survey of radiologically contaminated areas. Continue to develop methods for owner/occupant decontamination of radiological contaminated residences and businesses. Continue to develop methods for management of contaminated water. Continue to further develop decision-support tools for environmental response and remediation including transport of waste. Develop a comprehensive wide-area radiological response strategy with recommendations for radiological assessment, mitigation, and environmental cleanup. Waste management is a critical element of radiological cleanup. The strategy will include recommendations for management and disposal of radiologically contaminated soils and other wastes. Continue to develop methods for rapid survey of radiologically contaminated areas. Page 107 of 115 NNSA, EPA NNSA, EPA NNSA, EPA EPA NNSA, EPA NNSA, EPA NNSA, EPA NNSA, EPA NNSA, EPA NNSA, EPA NNSA, EPA NNSA, EPA NNSA, EPA NNSA, EPA NNSA, EPA CY DEPARTMENTS 2020 DOE, EPA 2020 DOE, EPA ACTION ITEMS Continue to develop methods for owner/occupant decontamination of radiological contaminated residences and businesses. Continue to further develop decision-support tools for environmental response and remediation including transport of waste. AGENCIES NNSA, EPA NNSA, EPA NOTE: Successful implementation of this recommendation is dependent on a significant number of activities performed in advance of an actual incident in order to be prepared for such an event. Table 56. JEE RECOMMENDATION 3 (JEE INDICATOR RE.1): Research, develop, and implement systems to create novel, highthroughput systems that are capable of performing biodosimetry and bioassay in both mass casualty and large-scale radionuclide dispersion situations. CY DEPARTMENTS 2018 DoD 2018 DoD 2018 DoD 2018 DoD 2018 DoD 2018 DOE ACTION ITEMS Validate the DoD requirement for biodosimetry support under the National Response Framework, Nuclear/Radiological Incident Annex. Brief DHA and/or ASDHA on reports prepared for the U.S. Army Public Health Command per Delivery Order Number 0750, CBRNIAC Task Number CB-12-0356, “DoD Biodosimetry Project: Recommendations for Advanced Biodosimetry Modalities” and “DoD Biodosimetry Project: Operational Aspects of a DoD Advanced Biodosimetry System;” and obtain decision as to whether to proceed with formally establishing a biodosimetry capability/network within the DoD and, if decision is to proceed, which presented course of action to pursue (further actions that are listed for this and the following years are dependent on an affirmative decision to proceed). Establish DoD Biodosimetry Center and Network with initial capabilities in executive, data management, logistics, laboratory, and regulatory functions, as resources allow, pending completion of funding authority. Establish and validate initial throughput capacity currently existing in DoD for three techniques: dicentric chromosome analysis (DCA), Whole Body Counting, and, when FDA-cleared/approved, Electron Paramagnetic Resonance (EPR). Validate emerging biodosimetry methods and establish initial DoD capacity. Fully automate metaphase scoring using the DCA in the Cytogenetic Biodosimetry Laboratory (CBL) at the Radiation Emergency Assistance Center/Training Site (REAC/TS) and revise the SOPs. Page 108 of 115 AGENCIES DoD DoD DoD DoD DoD DOE CY DEPARTMENTS 2018 DOE 2018 DOE 2018 DOE 2018 DOE 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2019 DoD ACTION ITEMS Identify and initiate preliminary contacts with all sites in the United States with an operating Metafer slide-scanning platform. Implement the revised REAC/TS SOP and common calibration curves for DCA and provide technical cross-training for an additional CBL. Fully characterize the pseudo-Pelger Huët Anomaly (PHA) as a new biodosimeter. Explore feasibility of leveraging Metafer slide-scanning platform located at U.S. hospitals and commercial laboratories for DCA. Continue support of advanced development of biodosimetry methods and devices (including high-throughput image assessment of cytogenetic changes and microRNA based point-of-care triage devices). Develop rapid bioassay methods for Ra-226, Po-210, Th-232, and Np-237. Develop a bioassay surge capacity deployment plan for the priority threat radionuclides. Develop a five-year spend plan for bioassay surge capacity. Identify all of the instrumentation and small equipment needs, validation requirements, proficiency testing needs, and data exchange criteria for a bioassay surge capacity. Facilitate the collaboration of HHS/CDC radiation health physics staff and HHS/CDC radiobioassay laboratory to ensure the capability to interpret laboratory data and rapidly produce dose estimates for large population groups. Fund early research and development of novel biodosimetry methods and biomarker identification through inter- and intra-agency agreements. Fund research for identification of biomarkers of radiation injury to use as the basis for triage and injury assessment. Provide funding and guidance to universities developing surge-capacity, cytogenetics assays, and devices capable of screening large numbers of potentially radiation-exposed individuals. Fund research for identifying biomarkers of acute radiation exposure that are predictive of organ-specific injuries and late effects, allowing for effective use of scarce medical management resources post-incident. Provide biological samples for validations of methods and biomarkers. Exercise DoD biodosimetry support to domestic incident response under the National Response Framework, Nuclear/Radiological Incident Annex. Page 109 of 115 AGENCIES DOE DOE DOE DOE ASPR, FDA, NIH CDC CDC CDC CDC CDC NIH NIH NIH NIH NIH DoD CY DEPARTMENTS 2019 DoD 2019 DOE 2019 DOE 2019 DOE 2019 DOE 2019 DOE 2019 HHS 2019 2019 HHS HHS 2019 HHS 2019 HHS 2019 HHS 2019 HHS 2019 HHS 2019 HHS 2019 HHS ACTION ITEMS Establish DoD Biodosimetry Center and Network interoperability with DOE network, as resources allow. Increase throughput at REAC/TS CBL through implementation of commercially available platforms for automated sample processing and use SOPs and common calibration curves with a U.S. CBL to reduce inter-laboratory variation. Validate accuracy of PHA versus DCA. Explore integration of DCA with EPR and radio bioassays using the National Analytical Management Program. Fully automate micronuclei assay. Develop MOUs with hospitals and commercial laboratories for Metafer use for meeting the surge capacity based on outcomes from FY 2018. Continue support of advanced development of biodosimetry methods and devices (including high-throughput image assessment of cytogenetic changes and microRNA based point-of-care triage devices). Develop rapid bioassay methods for Cm-244, I-131, and I-125. Automate the pre-analytical component of the Sr-90, Am-214 analytical methods. Develop a technology transfer program for bioassay surge capacity (funding dependent). Develop a performance testing program for the bioassay surge capacity (funding dependent). Demonstrate through exercise or drill HHS/CDC radiobioassay laboratory coordination with HHS/CDC radiation health physics staff to ensure capability of dose assessment. Continue funding early research and development of novel biodosimetry methods and biomarker identification through inter- and intra-agency agreements. Continue providing funding for identification of biomarkers of radiation injury to use as the basis for triage and injury assessment. Continue providing funding and guidance to universities developing surge-capacity, cytogenetics assays and devices capable of screening large numbers of potentiallyradiation exposed individuals. Continue providing funding for identifying biomarkers of acute radiation exposure that are predictive of organ-specific injuries and late effects, allowing for effective use of scarce medical management resources post-incident. Page 110 of 115 AGENCIES DoD DOE DOE DOE DOE DOE ASPR, CDC, NIH CDC CDC CDC CDC CDC NIH NIH NIH NIH CY DEPARTMENTS ACTION ITEMS AGENCIES 2019 HHS NIH 2020 HHS 2020 HHS 2020 HHS 2020 HHS 2020 HHS 2020 HHS 2020 HHS 2020 HHS 2020 HHS 2020 HHS Continue providing biological samples for validations of methods and biomarkers. Continue support of advanced development of biodosimetry methods and devices (including high-throughput image assessment of cytogenetic changes and microRNA based point-of-care triage devices). Develop rapid bioassay methods for Cf-252 and Se-75. Validate the laboratory test set for bioassay surge capacity, assessing analytical levels of detail, linear range validation, inter-instrument comparisons, sample receipt, analysis and reporting, and Clinical Laboratory Improvement Amendments compliance (funding dependent). Challenge the deployable bioassay surge capacity four times per year with performance testing samples (funding dependent). Demonstrate capacity of HHS/CDC radiobioassay laboratory (lead), HHS/CDC radiation health physics staff, and SLTT assets to coordinate laboratory samples, data, and dose estimates through exercise or drill. Continue funding early research and development of novel biodosimetry methods and biomarker identification through inter- and intra-agency agreements. Continue providing funding for identification of biomarkers of radiation injury to use as the basis for triage and injury assessment. Continue providing funding and guidance to universities developing surge-capacity, cytogenetics assays and devices capable of screening large numbers of potentiallyradiation exposed individuals. Continue providing funding for identifying biomarkers of acute radiation exposure that are predictive of organ-specific injuries and late effects, allowing for effective use of scarce medical management resources post-incident. Continue providing biological samples for validations of methods and biomarkers. Page 111 of 115 ASPR, CDC, NIH CDC CDC CDC CDC NIH NIH NIH NIH NIH Table 57. JEE RECOMMENDATION 4 (JEE INDICATOR RE.2): Implement the recommendations in the report “Where are the radiation professionals?” (Statement No. 12) issued by the National Council on Radiation Protection and Measurements in 2015. CY DEPARTMENTS 2018 HHS 2018 HHS 2018 HHS 2018 HHS 2018 HHS ACTION ITEMS Provide radiation-related training/mentoring to undergraduates, graduate students, and current public health workforce through collaboration with universities and cooperative agreements to build baseline expertise to support ongoing radiationrelated work and staff an IMS Structure to support a radiation-related response. Provide training and mentoring to undergraduates, graduate students, and postdoctoral fellows in the area of radiation biology to better prepare and staff a workforce with expertise in radiation injuries. Provide travel funding for undergraduates, graduate students, and post-doctoral fellows and training in radiation biology laboratories to attend both domestic and international meetings in order to present research findings. Make a valuable, free resource available to the wider scientific community through an online textbook, organized using HHS/NIH funding, and including chapter contributions from thought leaders in the fields of radiation biology, radiation chemistry, and radiation physics. Continue to maintain and update information and training resources for emergency preparedness and response. Page 112 of 115 AGENCIES CDC NIH NIH NIH NIH Table 58. JEE RECOMMENDATION 5 (JEE INDICATOR RE.1): Integrate triage systems and population monitoring guidance with the existing national public health and clinical systems in order to provide a national capacity for continuity of assessment, care, and treatment. CY DEPARTMENTS 2018 DoD, HHS 2018 DOE, HHS 2018 HHS 2018 HHS ACTION ITEMS In partnership with private sector coalitions and organizations such as the NDMP’s RITN:  Grow network of response hospitals to expand capacity to care for patients with acute radiation syndrome (ARS).  Continue to conduct regional tabletop exercises to engage major metropolitan areas to consider preparedness needs for the resulting medical surge from distant radiological disasters.  Continue to fund hospitals to conduct full-scale and functional exercises for radiological incidents.  Convene group of subject-matter experts to collate existing triage guidelines to produce a simple format to guide first receivers in their decisions for the care of ARS patients and administration of cytokines.  Create just-in-time training for first receivers handling ARS patients in austere conditions before transportation to a higher level of care.  Develop hematologic lab surge plan.  Coordinate with public health partners to review radiological preparedness efforts and identify existing gaps in priority order for correction.  Create training program (five courses) for public health preparedness staff that are inexperienced with radiological disasters Validate emerging molecular platforms to assess individual biological dose. Validate novel biomarkers of radiation injury to accurately assess radiation dose received and bridge from animals to humans. Provide funding for the development of devices and assays for potential incorporation into existing clinical laboratory testing programs. Page 113 of 115 AGENCIES DoD, AHRQ, ASPR DOE, ASPR NIH NIH CY DEPARTMENTS 2019 DoD, HHS 2020 DoD, HHS ACTION ITEMS In partnership with private sector coalitions and organizations such as the NDMP’s RITN:  Test through exercise the hematologic lab surge plan and publish template plan for use by preparedness community.  Produce and publish triage guidelines to help first receivers in their decisions for the care of ARS patients and administration of cytokines.  Fund the creation of a solution to one of the gaps identified by the public health radiological preparedness gap assessment.  Conduct national-level patient movement exercise with key stakeholders to evaluate current plans associated with the movement of ARS patients to definitive care facilities following a radiological incident.  Grow network of response hospitals to expand capacity to care for patients with ARS.  Continue to conduct regional tabletop exercises to engage major metropolitan areas to consider preparedness needs for the resulting medical surge from distant radiological disasters.  Continue to fund hospitals to conduct full-scale and functional exercises for radiological incidents. In partnership with private sector coalitions and organizations such as the NDMP’s RITN:  Fund the creation of a solution to one of the gaps identified by the public health radiological preparedness gap assessment.  Grow network of response hospitals to expand capacity to care for patients with ARS.  Continue to conduct regional tabletop exercises to engage major metropolitan areas to consider preparedness needs for the resulting medical surge from distant radiological disasters.  Continue to fund hospitals to conduct full-scale and functional exercises for radiological incidents.  Develop telemedicine consultation process for distant bone marrow transplant/hematology/oncology communities to provide treatment advice to medical staff closer to the disaster. Page 114 of 115 AGENCIES DoD, AHRQ, ASPR DoD, AHRQ, ASPR Table 59. OTHER ACTIVITIES (JEE INDICATOR RE.2) CY DEPARTMENTS 2018 DHS 2018 DHS, HHS 2018 HHS 2018 HHS 2018 HHS 2019 DHS 2019 HHS 2020 DHS 2020 HHS ACTION ITEMS Conduct analysis of radiological policies, regulations, and operational capabilities through the FRPCC. Hold NLE to test CONOPS at the national level and inform further development/enhancements. Complete initial drafts of CONOPS at the national level, informed by 2017 NLE findings. Raise awareness among PHEP grant awardees at the SLTT jurisdictions that they may be part of a receiving community for evacuees in a radiological emergency, and they should have some capability to monitor the population for radiation. Further develop the criteria for the chemical, biological, radiological, nuclear, or highyield explosive (CBRNE) Medical Operations Science Support Expert and their role by working with senior leadership for preparedness, planning, and response in collaboration with the Society of Disaster Medicine and Public Health. Continue to conduct analysis of radiological policies, regulations, and operational capabilities through the FRPCC. Improve SLTT radiation programs’ access to funding and HHS/CDC guidance to use in enhancing ability to assess risks from and reduce radiation-related exposure/contamination through appropriate selection and use of hand-held and portable monitoring instrumentation. Continue to conduct analysis of radiological policies, regulations, and operational capabilities through the FRPCC. Coordinate with SLTT health departments to exercise plans for population radiation exposure/contamination monitoring consistent with the NRIA and state preparedness plans. Page 115 of 115 AGENCIES FEMA DHS, ASPR ASPR ASPR, CDC ASPR, CDC, NIH FEMA CDC FEMA CDC