Pandemic Influenza Response Plan. Cerro Gordo County Department of Public Health ANNEX J. Pandemic Influenza Preparedness & Response Plan

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1 Cerro Gordo County Department of Public Health ANNEX J Pandemic Influenza Preparedness & Response Plan August 23,

2 TABLE OF CONTENTS Introduction....4 Purpose of the Plan....5 Scope of the Plan....6 Planning Assumptions...7 Authorities.. 8 Phases of a Pandemic Response Partners Needed to Implement Plan Roles and Responsibilities...11 Concept of Operations Interpandemic Period (Phases 1 & 2) Direction and Control..12 Communication/Public Education...13 Surveillance..13 Antiviral Medication Distribution 13 Vaccine Distribution 13 Isolation and Quarantine..14 Social Distancing Strategies 14 Pandemic Alert Period (Phases 3, 4, & 5) Direction and Control..15 Communication/Public Education...15 Surveillance..16 Antiviral Medication Distribution 16 Vaccine Distribution 16 Isolation and Quarantine..17 Social Distancing Strategies 17 Pandemic Period (Phase 6A-6D) Direction and Control..18 Communication/Public Education...18 Surveillance..19 Antiviral Medication Distribution 20 Vaccine Distribution 20 Isolation and Quarantine..23 Social Distancing Strategies 23 Health and Medical Response Interpandemic & Early Alert Period- Phases 1, 2, & 3 25 Late Alert & Pandemic Period- Phases 4, 5, & 6.26 Infection Control Principles Maintenance of Essential Services Interpandemic & Early Alert Period- Phases 1, 2, & 3.29 Late Alert & Pandemic Period- Phases 4, 5, &

3 Mortuary Services...29 Psychosocial Support...29 Special Population Considerations. 30 Recovery APPENDIXES Appendix A- Healthcare System Surge Capacity.. 32 Appendix B- Priority Group for Receiving Influenza Vaccine Appendix C- Priority Group for Antiviral Medication..34 Appendix D- Cerro Gordo County Age Population..35 Appendix E- Social Distancing Strategies. 36 Appendix F- Mercy Health Network, Rural Hospitals, Clinics & County Stats TOOLS Tool 1- Isolation & Quarantine Patient Care Support Supplies Tool 2- Early Recognition, Isolation, & Reporting of Possible AI Cases Tool 3- Active Surveillance for School Absenteeism Tool 4- Active Surveillance for Long Term Care Facility Tool 5- Testing for Patients with Suspected Avian/Pandemic Strain Influenza..53 Tool 6- Hospital or Clinic ILI Surveillance Tool 7- MMC-NI Daily Pandemic Influenza Activities.. 56 Tool 8- Enhanced Travel Surveillance Tool 9- Isolation or Quarantine Patient Log Tool 10- Home Isolation Contact Form Tool 11- Home Quarantine Contact Form.63 Tool 12- Infection Control for Medical Workers.64 Tool 13- Infection Control for Emergency Medical Services (EMS) Tool 14- Infection Control for Public Health & Outreach Workers..69 Tool 15- Infection Control in Community Isolation Facilities..70 Tool 16- Infection Control & Isolation in the Home. 70 Tool 17- Infection Control for Postmortem Handling of Human Remains...74 Tool 18- Infection Control for Farm Workers/Animal Handlers

4 INTRODUCTION Severe influenza pandemics represent one of the greatest potential threats to the public s health. Pandemics are distinct from seasonal influenza epidemics that happen nearly every year, causing an average of 36,000 deaths annually in the United States. Seasonal influenza epidemics are caused by influenza viruses which circulate around the world. Over time, people develop some degree of immunity to these viruses, and vaccines are developed annually to protect people from serious illness. Pandemic influenza refers to a worldwide epidemic due to a new, dramatically different strain of influenza virus. A pandemic virus strain can pass rapidly from person to person and, if severe, can cause high levels of disease and death around the world. Pandemic viruses develop in two ways. First, wild birds are the reservoir for all influenza viruses. Most avian influenza viruses do not infect or cause significant disease in humans. However, new pandemic influenza viruses can arise when avian influenza viruses acquire the ability to infect and cause disease in humans, and then spread rapidly from person to person. Second, all influenza viruses experience frequent, slight changes to their genetic structure over time. This necessitates a change in annual vaccines to protect against seasonal influenza. Occasionally, however, influenza viruses undergo a major change in genetic composition through the combination of an avian and human virus. The creation of a novel virus means that most, if not all, people in the world will have never been exposed to the new strain and have no immunity to the disease. It also means that new vaccines must be developed and therefore are not likely to be available for months, during which time many people could become infected and seriously ill. During the 20 th century, three pandemics occurred that spread worldwide within a year. The influenza pandemic of 1918 was especially virulent, killing a large number of young, otherwise healthy adults. It is now known that an avian influenza virus that suddenly developed the ability to infect humans and was easily spread from person to person caused this pandemic. The pandemic caused more than 500,000 deaths in the United States and more than 40 million deaths around the world. Subsequent pandemics in and caused far fewer fatalities in the U.S.(70,000 and 34,000 deaths respectively), but caused significant morbidity and mortality around the world. These two pandemics were caused by an influenza virus that arose from genetic reassortment between human and avian viruses. The Centers for Disease Control and Prevention (CDC) estimates that in the U.S. alone, an influenza pandemic could infect up to 200 million people and cause between 200,000 and 1,900,000 deaths. The worldwide public health and scientific community is increasingly concerned about the potential for a pandemic to arise from the widespread and growing avian influenza A (H5N1). Although many officials believe it is inevitable that future influenza pandemics will occur, it is impossible to predict the exact timing of these outbreaks. 4

5 TABLE 1- Total Potential Impact of an Influenza Pandemic* Potential Impacts of a Pandemic on the U.S., Iowa, & Cerro Gordo County (1918-Like Virus- 30% Attack Rate) Site Illness Outpatient Hospitalized ICU Care Mechanical Deaths Care Ventilation U.S. 90 million 45 million 9.9 million 1.5 million 750, million Iowa* 889, ,950 97,889 14,683 7,386 18,777 Regional (includes the 14 counties MMC-NI serves**) Cerro Gordo County 82,318 49,390 9,055 1, ,737 13,934 6,967 1, (Cerro Gordo) 81 (Worth) * Based on past pandemic history, 50% of illness and death can be expected to take place in a 4-month period, during the heightened period of the outbreak. The remaining 50% of projected needs will need to be met during the remaining pandemic period. (Projected population impact in Iowa as a whole based on National trend numbers) ** Refer to Appendix F: Mercy Health Network, Rural Hospitals, Clinics, and County Statistics Post-mortem proceedings for the deceased in Worth County will be completed in Cerro Gordo County There are several characteristics of influenza pandemic that differentiate it from other public health emergencies. First, it has the potential to suddenly cause illness in a very large number of people, who could easily overwhelm the health care system throughout the nation. A pandemic outbreak could also jeopardize essential community services by causing high levels of absenteeism in critical positions in every workforce. It is likely that vaccines against the new virus will not be available for six to eight months following the emergence of the virus. Basic services, such as healthcare, law enforcement, fire, emergency response, communications, transportation, and utilities could be disrupted during a pandemic. Finally, the pandemic, unlike many other emergency events, could last for several weeks, months, or years. PURPOSE OF THE PLAN The Pandemic Influenza Response Plan for Cerro Gordo County provides guidance to Public Health and regional partners regarding detection, response, and recovery from an influenza pandemic. The Plan describes the unique challenges posed by a pandemic that may necessitate immediate and specific leadership decisions, response actions, and communication mechanisms. Specifically, the purpose of the plan is to: Define preparedness activities that should be undertaken before a pandemic occurs that will enhance the effectiveness of response measures. Describe the response, coordination, and decision making structure that will incorporate Cerro Gordo County Department of Public Health (CGCDPH), the 5

6 healthcare system in Cerro Gordo County, other local response agencies, and state and federal agencies during a pandemic. Define roles and responsibilities for CGCDPH, local healthcare partners, and local response agencies during all phases of a pandemic. Describe public health interventions in a pandemic response and the timing of such interventions. Serve as a guide for local healthcare system partners, response agencies, schools, and businesses in the development of pandemic influenza response plans. During an influenza pandemic, CGCDPH and regional partners will utilize the plan to achieve the following goals: Limit the number of illnesses and deaths Preserve continuity of essential government functions Minimize social disruption Minimize economic losses The plan will be coordinated with other CGCDPH preparedness plans activities and will be coordinated with the plans of community, regional, state, and federal partners. SCOPE OF THE PLAN The plan is an annex to the Cerro Gordo County Department of Public Health s Emergency Response Plan. It provides a broad description of the responsibilities, authorities, and actions associated with public health emergencies. The Plan primarily focuses on the roles, responsibilities, and activities of CGCDPH. However, specific responsibilities for key response partners are included to highlight points of coordination between agencies during a pandemic. It is expected that healthcare facilities and healthcare professionals, essential service providers, local government officials, and business leaders will develop and incorporate procedures and protocols addressing influenza preparedness and response activities into their own emergency response plans. This plan does not address measures that would be taken to contain an outbreak of the avian influenza virus in birds or other animal populations occurring in Cerro Gordo County. Federal and state departments of agriculture are primarily responsible for surveillance and control of influenza outbreaks in domestic animals, although agricultural control measures interface with public health actions to prevent transmission into humans. 6

7 PLANNING ASSUMPTIONS An influenza pandemic will result in the rapid spread of the infection with outbreaks throughout the world. Communities across the state and the country may be impacted simultaneously. There will be a need for heightened global, national, state, regional, and local surveillance. Birds with an avian influenza strain may arrive and cause avian outbreaks in Cerro Gordo County prior to the onset of a pandemic, significantly impacting domestic poultry, wild and exotic birds, and other species. Cerro Gordo County will not be able to rely on mutual aid resources or state and federal assistance to support local response efforts. Antiviral medications will be in extremely short supply. Local supplies of antiviral medications may be prioritized by CGCDPH for use in hospitalized influenza patients, healthcare workers providing for patients, and other priority groups based on recommended national guidelines and the assessed local need of the population. A vaccine for the pandemic influenza strain will likely not be available for 6 to 8 months following the emergence of a novel virus. In addition, initial vaccine shipments are expected to be in very limited supply forcing communities to prioritize how the vaccine will be distributed throughout the population. As vaccine becomes available, it will be distributed and administered by CGCDPH based on current guidelines and the assessed local need of the population. A novel influenza virus will require each person to receive two immunizations to achieve maximum protection from the vaccine. Insufficient supplies of vaccines and antiviral medication will place greater emphasis on social distancing strategies and public education to control the spread of the disease in the county. The number of ill requiring outpatient medical care and hospitalization could overwhelm the local health care system. Hospitals and clinics will have to modify their operational structure to respond to high patient volumes and maintain functionality of critical systems. The healthcare system may have to respond to increased demands for service while the medical workforce experiences significant absenteeism due to illness. Demand for inpatient beds and assisted ventilators will dramatically increase and prioritization criteria for access to limited services and resources may be needed. There will be tremendous demand for urgent medical care services. Infection control measures specific to management of influenza patients will need to be developed and implemented at healthcare facilities, outpatient care settings, and long-term care centers. The healthcare system, with the assistance from public health, may need to develop alternative care sites to relieve demand on hospital emergency 7

8 rooms and care for persons not ill enough to merit hospitalization but who cannot be cared for at home. Emergency Medical Service (EMS) responders will face extremely high call volumes for several weeks, and may face a significant reduction in available staff. The number of fatalities experienced during the heighten stages of a pandemic could overwhelm the resources of the Medical Examiner s Office, hospital morgues, and funeral homes. The demand for home care and social services will increase dramatically. There could be significant disruption of public and privately owned critical infrastructure including transportation, commerce, utilities, public safety, agriculture, and communications. Social distancing strategies may be aimed at reducing the spread of infection such as closing schools, community centers, and other public gathering points. Canceling public events may be required during a pandemic. Some persons will be unable or unwilling to comply with isolation directives. For others, social distancing strategies may be less feasible (for example, persons living in a congregate setting). It will be important to develop and disseminate strategies for infection control appropriate for these environments and populations. The general public, healthcare system, response agencies, and elected leaders will need continuous updates on the status of the pandemic, impacts on critical services, the steps CGCDPH is taking to address the incident, and steps response partners and the public can take to protect themselves. AUTHORITIES A critical function of the CGCDPH is its ability to invoke its legal authority to implement actions to limit the spread of disease. During pandemic influenza, the CGCDPH may need to invoke such authority. While numerous federal, state, and local statutes authorize public health actions to address pandemic influenza, cooperation with local law enforcement and the legal system will also be critical. Refer to: Code of Iowa, Chapter 137-Local Board of Health, Additional Powers of Local Boards, Subsection 2 states, Make and enforce such reasonable rules and regulations not inconsistent with law or with the rules of the state board as may be necessary for the protection and improvement of the public health. Code of Iowa, Chapter General Powers and Limitations, Subsection 1 states, A county may, except as expressly limited by the Constitution, and if not inconsistent with the laws of the general assembly, exercise any power and perform any function it deems appropriate to protect and preserve the rights, privileges, and property of the county or of its residents, and to preserve and improve peace, safety, health, welfare, comfort, and convenience of its residents. This grant of home rule powers does not include the power to enact private or civil law governing civil relationships, except as incident to an exercise of an independent county power. Code of Iowa, Chapter 135- Department of Public Health, Section Information Sharing states, When the department of public safety or other 8

9 federal, state, or local law enforcement agency learns of a case of a reportable disease or health condition, unusual cluster, or a suspicious event that may be the cause of a public health disaster, the department of agency shall immediately notify the department, the administrator of the homeland security and emergency management division of the department of public defense, the department of agriculture and land stewardship, and the department of natural resources as appropriate. Sharing of information on reportable diseases, health conditions, unusual clusters, or suspicious events between the department and public safety authorities and other governmental agencies shall be restricted to sharing of only the information necessary for the prevention, control, and investigation of a public health disaster. Release of information pursuant to this section shall be consistent with the federal Health Insurance Portability and Accountability Act of 1996, Pub. L. No Code of Iowa, Chapter 139A- Communicable and Infectious Diseases and Poisoning 9

10 PHASES OF A PANDEMIC The World Health Organization (WHO) has developed a global influenza preparedness plan that includes a classification system for guiding planning and response activities for an influenza pandemic. This classification system is comprised of six phases of increasing public health risk associated with the emergence and spread of a new influenza virus subtype that may lead to a pandemic. For each phase, the global influenza preparedness plan identifies response measures WHO will take, and recommends actions that countries around the world should implement. Pandemic Phases Interpandemic Period Phase 1- No new influenza virus subtypes detected in humans. An influenza virus subtype that has caused human infection may be present in animals. If present in animals, the risk of human infection or disease is considered low. Phase 2- No new influenza virus subtypes detected in humans. However, a circulating animal influenza virus subtype poses substantial risk of human disease. Public Health Goals Strengthen influenza pandemic preparedness at all levels. Closely monitor human and animal surveillance. Minimize the risk of transmission of animal influenza virus to humans; detect and report such transmission rapidly if it occurs. Pandemic Alert Period Phase 3- Human infection(s) are occurring with a new subtype, but no human-to-human spread, or at most rare instances of spread to a close contact. Phase 4- Small cluster(s) of human infection with limited human-to-human transmission but spread is highly localized suggesting that the virus is not well adapted to humans. Phase 5- Larger cluster(s) of human infection but human-to-human spread is localized; suggesting that the virus is becoming increasingly better adapted to humans, but may not yet be fully transmissible (substantial pandemic risk). Ensure rapid characterization of the new virus subtype and early detection, notification and response to additional cases. Contain the new virus within limited foci or delay spread to gain time to implement preparedness measures, including vaccine development. Maximize efforts to contain or delay spread to possibly avert a pandemic, and to gain time to implement response measures. Pandemic Period Phase 6- Pandemic is declared. Increased and sustained transmission in the general population. A. Pandemic strain is circulating in the world but is not yet in the U.S. B. Pandemic strain is circulating in the U.S. but not yet in Iowa. C. Pandemic strain is circulating in Iowa but not yet in Cerro Gordo County. D. Pandemic strain is circulating in Cerro Gordo County. Implement response measures including social distancing to minimize pandemic impacts. 10

11 RESPONSE PARTNERS NEEDED TO IMPLEMENT PLAN Local elected officials Local public health Local emergency management State public health Local health-care providers/hospital Local veterinarians Emergency medical services Law enforcement Fire department Schools Representatives from business organizations Representatives from civic and volunteer organizations Local media ROLES AND RESPONSIBILITIES The threat or actual occurrence of a pandemic influenza outbreak requires prompt notification of those individuals and agencies that may play a role in an effective community response. Responsibilities of Local Public Health CGCDPH is the lead local agency for responding to a pandemic influenza outbreak in Cerro Gordo County. The director of the agency, or designee, is responsible for implementing the provisions of this plan. Responsibilities of State Public Health Iowa Department of Public Health (IDPH) is the lead state agency for response to a pandemic influenza outbreak. IDPH will consult with and disseminate information concerning a pandemic influenza outbreak to Cerro Gordo County Department of Public Health, including information on prevention and control. 11

12 CONCEPT OF OPERATIONS Existing departmental command systems should be applied to pandemic influenza planning and response. These structures should delineate operational priorities and identify who is responsible for: making decisions related to public health response to a pandemic carrying out response activities before, during and after a pandemic preparing and maintaining the pandemic response plan. Interpandemic Period- Phases 1 & 2 Direction and Control CGCDPH, in cooperative coordination with the Emergency Management Administrator (EMA), will take the lead in planning the public health response to pandemic influenza for Cerro Gordo County. CGCDPH will coordinate with Mercy Medical Center- North Iowa (MMC-NI), local law enforcement, local EMS providers, and elected officials to ensure planning and response activities are organized within the county. CGCDPH will define and quantify priority population groups to receive vaccine and antiviral medications during the pandemic based on recommended national guidelines and the assessed local need of the population. Refer to Appendix B: Cerro Gordo County Priority Groups for Receiving Influenza Vaccination During a Pandemic. CGCDPH will coordinate planning for the procurement of antiviral medication, and supplies. Logistical processes to consider: transportation of the vaccines/medications/supplies from the node to the site of dispensing, storage of the items, ensuring the proper vaccine cold-chain is maintained and the development inventory logs for tracking purposes. CGCDPH will coordinate planning for the distribution of vaccines, antiviral medication and supplies. Refer to Annex D: Mass Dispensing/Vaccination Plan. CGCDPH will assess and maintain information about the capacity of MMC-NI s inpatient healthcare center. Refer to Appendix A: Cerro Gordo County Healthcare System Surge Capacity. CGCDPH will assess and maintain information about the outpatient healthcare centers capacity throughout the county. Refer to Appendix A: Cerro Gordo County Healthcare System Surge Capacity. CGCDPH will review and update the Pandemic Response Plan on an annual basis. CGCDPH will work with community partners via the Pandemic Influenza Planning Team (PIPT) to enhance community capacity for responding to pandemic influenza. CGCDPH will provide the Pandemic Influenza Response Plan to key policymakers and other stakeholders. 12

13 (Continued Phases 1 & 2) Communication/Public Education EMA will activate the Joint Information Center (JIC) and assign CGCDPH as the lead agency for risk communications messaging and public education regarding pandemic influenza. CGCDPH will assess the information needs/requests of health care providers via a knowledge assessment survey developed by the Health Department CGCDPH will assess the information needs/requests of the general public via an Ask A Question submission located on the CGCDPH website. CGCDPH will develop and update a list of local media contact names and numbers to assist in quickly disseminating information to the public. Refer to Emergency Response Plan, Annex B- Page 12B. Surveillance CGCDPH will assess current surveillance activities and determine the need for enhancement of those activities. Antiviral Medication Distribution CGCDPH will review federal guidance defining priority populations to receive antiviral medication during a pandemic. Refer to Appendix C: Cerro Gordo County Priority Groups for Receiving Antiviral Medications During a Pandemic. CGCDPH will review and update the methodology with its Mass Dispensing/ Vaccination Plan: Annex D for dispensing antiviral medication during a pandemic on an annual basis. CGCDPH will identify and maintain information about local resources and supplies needed for administering antiviral medication. Refer to Emergency Response Plan- Annex D, Attachments D2-D7. Vaccine Distribution CGCDPH will initiate and/or continue activities to enhance annual influenza vaccination coverage levels in traditional high-risk groups. CGCDPH will initiate and/or continue activities to enhance pneumococcal vaccination coverage levels in traditional high-risk groups to reduce the incidence and severity of secondary bacterial pneumonia. Pneumococcal conjugate vaccine (PCV 7) is routinely recommended for all children. Primary doses should be given at 2, 4, and 6 months of age, followed with a booster dose at months of age. Pneumococcal polysaccharide vaccine (Pneumovax) is approved for persons 2 years of age and older. It is recommended for routine usage for person > 65 years of age. It is also recommended for children and adults >2 years of age with one of the following risk factors: Chronic cardiovascular disease, chronic pulmonary diseases other than asthma, diabetes, alcoholism, chronic liver disease Functional or anatomic asplenia, including sickle cell disease 13

14 (Continued Phases 1 & 2) Immunocompromising conditions: HIV, Hodgkin s disease, lymphoma, leukemia, multiple myeloma, certain cancer drugs, organ transplant, chronic renal failure, long term steroid use CGCDPH will review federal guidance defining priority populations to receive vaccine for prophylaxis during a pandemic before vaccine is widely available to all citizens. Refer to Appendix B: Cerro Gordo County Priority Groups for Receiving Influenza Vaccination During a Pandemic. CGCDPH will determine and maintain local estimates of the number of persons within each priority population, revising the estimates on an annual basis. Refer to Appendix B: Cerro Gordo County Priority Groups for Receiving Influenza Vaccination During a Pandemic & Appendix D: Cerro Gordo County Age Population. CGCDPH will review and update the methodology within its Mass Vaccination Plan for providing vaccination during a pandemic on an annual basis. CGCDPH will identify and maintain information about local resources and supplies needed for administering vaccine. Refer to Emergency Response Plan- Annex D, Attachments D2-D7. Isolation and Quarantine CGCDPH will review current Isolation and Quarantine Ordinance for adequacy based on the current pandemic influenza threat. CGCDPH will ensure that legal authorities and procedures remain in place to implement isolation and quarantine procedure in the case of an influenza pandemic. Social Distancing Strategies CGCDPH will develop social distancing measures to reduce interactions of specific groups during a pandemic, thereby reducing the transmission risk within the groups. 14

15 Pandemic Alert Period- Phases 3-5 Direction and Control Continue ongoing activities from previous phases as appropriate. CGCDPH Health Director will initiate communication with local, regional, state, and national counterparts. A PIPT will evolve with individuals from various community response partners. CGCDPH will monitor the Health Alert Network (HAN) and other channels of information and will provide ongoing assessments of the situation to relevant response partners. CGCDPH will ensure local surveillance and, if applicable, case tracking activities are ongoing. CGCDPH will ensure Memorandum of Understandings (MOU) are currently in place with identified mass dispensing sites and staffing agencies. CGCDPH will develop and disseminate appropriate information to public about current pandemic influenza situation. CGCDPH will assess whether to activate the Pandemic Influenza Response Plan (PIRP) to coordinate the health care system response. Communication/Public Education Continue ongoing activities from previous phases as appropriate. CGCDPH will identify any logistical constraints to effective communications, such as communication staffing/equipment needs and public health information call center staffing and capacity. Refer to Emergency Response Plan, Annex B: Risk Communication Plan. CGCDPH will develop key messages for printed material, public presentations, or for news media. Key messages will address Pubic Health departmental activities, including planning efforts, as well as avian influenza education, pandemic influenza education, and general preparations. CGCDPH will intensify public education efforts about influenza pandemics and steps that can be taken to reduce exposure to infection. Information may be distributed via the CGCDPH web site, newspaper editorials, public forums, flyers and billboards, television and radio broadcasts. CGCDPH will intensify educational efforts for healthcare providers, public officials, businesses, faith-based communities, and emergency responders about influenza pandemic and the steps they should take to plan for pandemic outbreaks. CGCDPH will develop an internal plan on how to distribute public health information specific to the pandemic. CGCDPH will develop a method to post current public information on the website. CGCDPH will identify and train spokespersons on specific pandemic influenza risk communications. 15

16 (Continued Phases 3, 4, & 5) Surveillance Continue ongoing activities from previous phases as appropriate. CGCDPH will develop partnerships with key employers to track absenteeism in the event of a flu pandemic (i.e.; large factories & private businesses). CGCDPH will conduct weekly influenza tracking activities from identified county schools. CGCDPH will support state Influenza Like Illness (ILI) surveillance activities including Sentinel Clinician Surveillance, Laboratory Surveillance, and any enhanced surveillance activities as requested. CGCDPH and MMC-NI will monitor overall ILI activity among outpatient patients, hospitalized patients, and influenza deaths. CGCDPH will work in coordination with MMC-NI to develop laboratorytesting procedures related to personnel needs, testing proficiency, and safe specimen collection and testing. [To Be Developed] Cerro Gordo County health practitioners will use rapid antigen tests to make treatment decisions of ILI. Practitioners are requested to send cultures to UHL for confirmatory testing and isolate determination. Procedures for transporting specimens to the University Of Iowa Hygienic Lab (UHL) will be determined and set into place. CGCDPH will coordinate with local veterinarians to develop a system to routinely share animal and human influenza surveillance findings within the Cerro Gordo County. [To Be Developed] MMC-NI will immediately report all suspected or laboratory confirmed cases of pandemic influenza to CGCDPH. Antiviral Medication Distribution Continue ongoing activities from previous phases as appropriate. CGCDPH will establish and distribute guidelines for medical providers regarding the use of antiviral medications. CGCDPH will review and modify its Mass Dispensing/Vaccination: Annex D as needed to account for updates received in regards to the novel virus. Such updates may include recommended target groups, current antiviral sensitivity to the novel virus, and projected antiviral medication supply. CGCDPH will assess its human resources and logistics capabilities to ensure that appropriate staff and supplies are available to begin mass antiviral medication dispensing activities if necessary. Vaccine Distribution Continue ongoing activities from previous phases as appropriate. CGCDPH will review and modify its Mass Vaccination Annex D as needed to account for updates received in regards to the novel virus. Such updates may include recommended target groups and projected vaccine supply. 16

17 (Continued Phases 3, 4, & 5) CGCDPH will assess its human resources and logistics capabilities to ensure that appropriate staff and supplies are available to begin vaccination activities if necessary. CGCDPH will develop a vaccine distribution tracking system. [To Be Developed] Isolation and Quarantine Continue ongoing activities from previous phases as appropriate. CGCDPH will identify alternative care sites (Influenza Care Centers) for isolation of individuals who have no substantial healthcare requirements and/or persons for whom home isolation is indicated but who do not have access to an appropriate home setting such as travelers and homeless populations. CGCDPH will educate multi-disciplinary partners via the PIPT about the implementation and enforcement of the isolation and quarantine plan. CGCDPH will engage and educate local law enforcement and other partners within the county regarding isolation and quarantine. CGCDPH will provide information to educate response partners on the process, expected actions, and implementation of isolation and quarantine. CGCDPH will provide information via the CGCDPH website to educate the public about what containment procedures will be used in the community during an influenza pandemic. CGCDPH will develop a database structure to be used for collecting and monitoring individuals in isolation or quarantine for pandemic influenza. CGCDPH will develop a procedure to ensure distribution of support supplies to individuals in home isolation or quarantine is obtained. Refer to Tool 1: Isolation & Quarantine Patient Care Support Supplies. Social Distancing Strategies Continue ongoing activities from previous phases as appropriate. CGCDPH will educate elected officials, government leaders, school officials, response partners, businesses, media, and the public regarding the consequences of pandemics, the use of social distancing strategies, the associated impacts they cause, and the process for implementing the measures. 17

18 Pandemic Period- Phases 6A-6D Direction and Control Continue ongoing activities from previous phases as appropriate. The CGCDPH response will be managed per the guidance and protocols included in this plan and the Emergency Response Plan. The CGCDPH and all response partners will operate under the National Incident Management System and the Federal Emergency Support Function 8, listed in the Emergency Response Plan- Annex A, throughout the duration of the pandemic response. The CGCDPH will provide regular briefings to local elected officials, Board of Health (BOH), and regional response partners. Briefings will address: Nature of the disease Communicability and virulence of the disease Availability of vaccines and antiviral medication Actions that are being taken to minimize the impact of the pandemic Actions that response partners should implement to protect critical functions Health information being shared with the public and health care providers CGCDPH will assess the viability of social distancing measures in the county. If vaccine or antiviral medication are available, CGCDPH will carry out mass dispensing/vaccination activities per the CGCDPH Emergency Response Plan- Annex D. CGCDPH will coordinate the delivery of vaccine and/or antiviral with EMA and IDPH. CGCDPH will coordinate surveillance and epidemiological investigation activities, to include: Implementing ongoing influenza surveillance Planning for epidemiological investigation Coordinating specimen with testing UHL. CGCDPH, under the advisement of EMA, will activate the Public Health EOC to coordinate a countywide public health and medical response during a pandemic. Communication/Public Education Continue ongoing activities from previous phases as appropriate. CGCDPH will evaluate the need for and advise EMA of the necessity to establish a JIC in conjunction with appropriate health systems and response partners. A JIC will be activated when CGCDPH deems it necessary based on specific characteristics of the pandemic. CGCDPH will evaluate the need to establish a public information call center to respond to public inquiries. Refer to Emergency Response Plan, Annex D- Page 5B-6B. CGCDPH will develop key messages about the pandemic situation that will be updated and disseminated to the general public, response partners, and key 18

19 (Continued Phases 6A-6D) stakeholders as needed. Materials will be posted on the website as they are developed. CGCDPH, in cooperation with EMA, will provide news briefings with local media via designated spokespersons and/or community leaders to relay new information to the public as needed. CGCDPH will initiate daily communication briefings with hospital emergency rooms, infection control practitioners, infectious disease specialists, and community providers. CGCDPH will regularly communicate with IDPH regarding communication briefings with hospital emergency rooms, infection control practitioners, infectious disease specialists, and community providers. Designated CGCDPH staff will conduct regular briefings with key response partners to inform EOC staff, business leaders, community based organizations, first response agencies and critical infrastructure agencies on the status of the pandemic and the local response actions. Surveillance Continue ongoing activities from previous phases as appropriate. CGCDPH will work with clinicians, MMC-NI, and infectious disease specialists to enhance case detection, according to CDC screening criteria, among persons who have recently traveled to outbreak areas and present with illnesses meeting the clinical criteria for influenza. Refer to Tool 2: Early Recognition, Isolation, & Reporting of Possible AI Cases. CGCDPH will enhance surveillance efforts by conducting daily influenza tracking activities from all county schools. Refer to Tool 3: Active Surveillance for School Absenteeism. CGCDPH will enhance surveillance efforts by conducting daily influenza tracking activities from all county long-term care centers. Refer to Tool 4: Active Surveillance for Long Term Care Facility. CGCDPH will provide health alerts to inform community healthcare providers about recommendations for influenza laboratory testing based on the consultation with the CDC, IDPH and UHL. CGCDPH will require health care providers to send ILI test specimens to UHL for virus identification. Rapid detection of a suspected case is critical and needs to be readily confirmed or ruled out. Refer to Tool 5: Testing for Patients with Suspected Avian/Pandemic Strain Influenza. CGCDPH will coordinate surveillance activities with the disease control activities of the CDC, IDPH, and adjacent health department jurisdictions. CGCDPH will comply with CDC and IDPH guidelines to facilitate monitoring of the influenza pandemic strain for antiviral resistance. CGCDPH will gather relevant available clinical data (i.e. chief complaints, hospital admissions and discharge diagnosis) from MMC-NI and other selected medical group practices. Refer to Tool 6: Hospital or Clinic ILI Surveillance. 19

20 (Continued Phases 6A-6D) CGCDPH will gather relevant daily clinical data from MMC-NI regarding ILI and pneumonia admissions. Refer to Tool 7: MMC-NI Daily Pandemic Influenza Activities. CGCDPH will institute enhanced border surveillance. Major ports of entry within Cerro Gordo County would be the Mason City Municipal Airport and Jefferson Bus Lines. Screening for fever and other ILI signs and symptoms will take place. Refer to Tool 8: Enhanced Travel Surveillance. CGCDPH will enhance surveillance to individual health care providers by sending provider alerts to all physicians detailing the clinical presentation and exposure history of interest. Physicians will be asked to report to the Disease Prevention and Investigation Service Section Manger if they evaluate a patient with suspected infection with any novel influenza virus. Antiviral Medication Distribution Continue ongoing activities from previous phases as appropriate. CGCDPH will communicate with EMA regarding the availability and delivery of antiviral medication. CGCDPH will communicate with community healthcare providers regarding the availability of antiviral medication and how they will be distributed during an influenza pandemic. CGCDPH will distribute antiviral medications according to local needs and IDPH priority guidelines, via the activation of the Mass Dispensing Annex D as appropriate. Vaccine Distribution Continue ongoing activities from previous phases as appropriate. CGCDPH will communicate with EMA regarding the availability and delivery of vaccine. CGCDPH will prepare to receive, store, and transport vaccine. CGCDPH will administer vaccine as soon as possible after receipt of vaccine according to local needs and CDC priority guidelines, via the activation of the Mass Vaccination Plan as appropriate. Prior to widespread vaccine availability, CGCDPH will provide vaccine as it is available to priority groups. Refer to Appendix B: Cerro Gordo County Priority Groups for Receiving Influenza Vaccination During a Pandemic and Influenza Preparedness and Response Ordinance #38A. Upon widespread vaccine availability, CGCDPH will fully activate mass vaccination activities according to the Mass Vaccination Plan. CGCDPH will track and monitor adverse vaccine reactions. CGCDPH will provide persons receiving vaccine with information about reporting such reactions to the Health Department. CGCDPH will then report any reactions to the CDC Vaccine Adverse Event Reporting System (VAERS). 20

21 Investigational New Drugs and Emergency Use Authorization Purpose: The purpose of this section is to discuss the process and procedures for the utilization of investigational new drugs (IND) and/or emergency use authorization (EUA) for pharmaceuticals that may be supplied as federal assets. Procedure: All pharmaceuticals contained as federal assets are approved for use in humans. They have undergone rigorous testing as mandated by the Food and Drug Administration (FDA) to ensure their safety and efficacy in humans to treat certain diseases. However, some of the pharmaceuticals have not been widely studied for the treatment or prophylaxis of certain diseases (e.g. organisms causing anthrax, plague, tularemia, etc.). When pharmaceuticals are used for purposes that have not been specifically approved by the FDA, their use is referred to as off-label use and patients must be informed of and consent to their use in that manner. In addition to patient informed consent, protocol will require monitoring of all patients. Off-label use of any pharmaceutical will need to follow either the IND or EUA process as directed by the CDC and FDA. Investigational New Drug There are currently 3 types of IND applications that can be applied for approval from the FDA. The three types include: Investigator IND submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population. Emergency Use IND allows the FDA to authorize the use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with Code of Federal Regulations (CFR) Chapter 21, or It is also used for patients who do not meet the criteria of an existing protocol, or if an approved study protocol does not exist. Treatment IND submitted for experimental drugs showing promise in clinical testing for serious or immediate life-threatening conditions while the final clinical work is conducted and the FDA review of the study takes place. Each event and/or situation will dictate which IND application will need to be applied for. Regardless of which type of IND utilized, strict adherence to a product specific FDA approved protocol must be followed. In regards to pharmaceutical agents supplied through federal supplies, if an IND is required for use of any of the pharmaceuticals, the CDC will obtain the approval from the FDA. The CDC will also provide any needed forms and/or protocols. Because these forms are constantly being revised and updated, they are not supplied ahead of time. 21

22 Emergency Use Authorization After the 2001 anthrax events and the large-scale smallpox operational planning efforts, the Department of Health and Human Services (DHHS) concluded that the IND informed-consent process limits the public health community s ability to respond to and contain such events. Rather, DHHS deemed the IND process was not practical during a rapidly progressing public health emergency. In July 2004, Congress passed the Project BioShield Act of BioShield allowed for the FDA to have policies in place for authorizing the emergency use of medical products (Section 564 of the Federal Food, Drug, and Cosmetic Act). BioShield permits the FDA Commissioner to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces. For an EUA to be activated, the Secretary of DHHS must proclaim a public health emergency under Section 319 of the Public Health Service Act that affects, or has the significant potential to affect, national security and that involves a specific biological, chemical, radiological, or nuclear agent or agents or a specified disease or condition that may be attributable to such agent or agents. After the declaration of a public health emergency the Secretary of DHHS will consult with the EUA Work Group comprised of technical experts from the FDA, National Institute of Health (NIH), CDC, and other agencies and private entities where appropriate. The EUA Work Group will work to (1) identify medical product(s) that may be eligible for an EUA in light of the circumstances of the public health emergency and (2) facilitate timely submission of the EUA request by an appropriate entity. The FDA Commissioner will make the final decision on issuing the request EUA. An EUA can be issued for up to a one-year time period. Once medical products meet EUA eligibility, the FDA, CDC, or sponsor company will work to produce an EUA protocol for the intended emergency use of the medical product. This protocol will be specific to the medical product and will address such items as patient selection, patient informed consent, dosage, routes of administration, and patient follow-up requirements. Strict adherence to this issued protocol will be mandatory. EUA protocols will not be issued until the medical product(s) have met all requirements/recommendations of the FDA, CDC, and sponsor Company. Therefore, EUA protocols can not be supplied ahead of time. As IND and EUA protocols and expectations will not be available prior to an incident that will likely require the use of these guidelines Cerro Gordo County will follow/use all protocols, directives and forms supplied by the CDC through the IDPH during an incident once they are supplied. 22

23 (Continued Phases 6A-6D) Isolation and Quarantine Continue ongoing activities from previous phases as appropriate. CGCDPH will asses the need for and implement the Isolation and Quarantine Ordinance for residents of Cerro Gordo County as appropriate. Refer to Cerro Gordo County Ordinance #47 and Emergency Response Plan: Annex C, Forms C-4 through C-7 for official Isolation and Quarantine Orders. CGCDPH will monitor contacts in isolation at least once a day, by phone or in person, to assess individual basic needs and compliance of the isolation order. Refer to Tool 10: Home Isolation Contact Form. CGCDPH will monitor contacts in quarantine at least once a day, by phone or in person, to assess individual basic needs, possible symptoms of influenza, and compliance of the quarantine order. Refer to Emergency Response Plan Forms C-3 for Contact Tracing Form and Tool 11: Home Quarantine Contact Form. Physicians will be instructed to submit case reports by fax or to CGCDPH on each patient ordered to home isolation or quarantine. Refer to Tool 9: Isolation of Quarantine Patient Log. Influenza Care Centers (ICC) will be instructed to submit by fax or to CGCDPH on each patient isolated within the ICC. Refer to Tool 9: Isolation & Quarantine Patient Log. Persons who meet the case definition of pandemic influenza and who do not require hospitalization for medical reasons will be isolated in their homes. Refer to Tool 1: Isolation & Quarantine Patient Care Support Supplies. EMA will activate the appropriate support providers for the home isolated and quarantined population. Neighborhood distribution sites will be recommended when the number of cases in the county exceeds the capacity of the appointed support service providers for all individuals who are in home isolated or quarantined. The media will be used to provide instructions on how to access supplies through the neighborhood distribution sites. Social Distancing Strategies Continue ongoing activities from previous phases as appropriate. Specific county-wide strategies that may be identified include. Refer to Appendix E: Social Distancing Strategies Encourage government agencies and the private sector to implement emergency staffing plans to maintain critical business functions while maximizing the use of telecommunications, flex schedules, and alternate work site options. Encourage/recommend that the public use public transit only for essential travel. Advise Cerro Gordo County residents to defer non-essential travel to other areas of the country and the world affected by pandemic influenza outbreaks. 23