Ensuring Continuity of Care in Health Emergencies, Study notes of Public Health

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2017-2022 Health Care

Preparedness and Response

Capabilities

Office of the Assistant Secretary for Preparedness and Response

November 2016

Activity 4. Assess Community Planning for Children, Pregnant Women, Seniors, Individuals with Access and Functional Needs, Including People with Disabilities, and Others with Unique Needs

• Introduction Table of Contents
  • Purpose of the 2017-2022 Health Care Preparedness and Response Capabilities
  • The Four Capabilities.............................................................................................................................
  • The Value of Health Care Coalitions in Preparedness and Response
  • Using the Capabilities Document
• Capability 1. Foundation for Health Care and Medical Readiness
  • Objective 1: Establish and Operationalize a Health Care Coalition
    • Activity 1. Define Health Care Coalition Boundaries
    • Activity 2. Identify Health Care Coalition Members
    • Activity 3. Establish Health Care Coalition Governance..................................................................
  • Objective 2: Identify Risk and Needs
    • Activity 1. Assess Hazard Vulnerabilities and Risks
    • Activity 2. Assess Regional Health Care Resources
    • Activity 3. Prioritize Resource Gaps and Mitigation Strategies
    • Activity 5. Assess and Identify Regulatory Compliance Requirements...........................................
  • Objective 3: Develop a Health Care Coalition Preparedness Plan
  • Objective 4: Train and Prepare the Health Care and Medical Workforce
    • Activity 1. Promote Role-Appropriate National Incident Management System Implementation
    • Activity 2. Educate and Train on Identified Preparedness and Response Gaps
    • Other Response Organizations Activity 3. Plan and Conduct Coordinated Exercises with Health Care Coalition Members and
    • Requirements Activity 4. Align Exercises with Federal Standards and Facility Regulatory and Accreditation
    • Activity 5. Evaluate Exercises and Responses to Emergencies
    • Activity 6. Share Leading Practices and Lessons Learned
  • Objective 5: Ensure Preparedness is Sustainable
    • Activity 1. Promote the Value of Health Care and Medical Readiness
    • Activity 2. Engage Health Care Executives
    • Activity 3. Engage Clinicians
    • Activity 4. Engage Community Leaders...........................................................................................
    • Activity 5. Promote Sustainability of Health Care Coalitions
• Capability 2. Health Care and Medical Response Coordination
  • Plans Objective 1: Develop and Coordinate Health Care Organization and Health Care Coalition Response
    • Activity 1. Develop a Health Care Organization Emergency Operations Plan
    • Activity 2. Develop a Health Care Coalition Response Plan
  • Objective 2: Utilize Information Sharing Procedures and Platforms
    • Activity 1. Develop Information Sharing Procedures
    • Activity 2. Identify Information Access and Data Protection Procedures.......................................
    • Activity 3. Utilize Communications Systems and Platforms
  • Objective 3: Coordinate Response Strategy, Resources, and Communications
    • Activity 1. Identify and Coordinate Resource Needs during an Emergency
    • Activity 2. Coordinate Incident Action Planning During an Emergency
    • during an Emergency Activity 3. Communicate with Health Care Providers, Non-Clinical Staff, Patients, and Visitors
    • Activity 4. Communicate with the Public during an Emergency
• Capability 3. Continuity of Health Care Service Delivery
  • Objective 1: Identify Essential Functions for Health Care Delivery
  • Objective 2: Plan for Continuity of Operations
    • Activity 1. Develop a Health Care Organization Continuity of Operations Plan
    • Activity 2. Develop a Health Care Coalition Continuity of Operations Plan
    • Activity 3. Continue Administrative and Finance Functions
    • Activity 4. Plan for Health Care Organization Sheltering-in-Place
  • Objective 3: Maintain Access to Non-Personnel Resources during an Emergency
    • Activity 1. Assess Supply Chain Integrity.........................................................................................
    • Activity 2. Assess and Address Equipment, Supply, and Pharmaceutical Requirements
  • Objective 4: Develop Strategies to Protect Health Care Information Systems and Networks
  • Objective 5: Protect Responders’ Safety and Health
    • Activity 1. Distribute Resources Required to Protect the Health Care Workforce
    • Activity 2. Train and Exercise to Promote Responders’ Safety and Health
    • Activity 3. Develop Health Care Worker Resilience
  • Objective 6: Plan for and Coordinate Health Care Evacuation and Relocation
    • Activity 1: Develop and Implement Evacuation and Relocation Plans
    • Activity 2. Develop and Implement Evacuation Transportation Plans
  • Objective 7: Coordinate Health Care Delivery System Recovery
    • Activity 1. Plan for Health Care Delivery System Recovery
    • Activity 2. Assess Health Care Delivery System Recovery after an Emergency
    • Activity 3. Facilitate Recovery Assistance and Implementation
• Capability 4. Medical Surge.....................................................................................................................
  • Objective 1: Plan for a Medical Surge
    • Operations Plan............................................................................................................................... Activity 1. Incorporate Medical Surge Planning into a Health Care Organization Emergency
    • Plan.................................................................................................................................................. Activity 2. Incorporate Medical Surge into an Emergency Medical Services Emergency Operations
    • Activity 3. Incorporate Medical Surge into a Health Care Coalition Response Plan
  • Objective 2: Respond to a Medical Surge
    • Activity 1. Implement Emergency Department and Inpatient Medical Surge Response
    • Activity 2. Implement Out-of-Hospital Medical Surge Response
    • Activity 3. Develop an Alternate Care System
    • Activity 4. Provide Pediatric Care during a Medical Surge Response
    • Activity 5. Provide Surge Management during a Chemical or Radiation Emergency Event
    • Activity 6. Provide Burn Care during a Medical Surge Response
    • Activity 7. Provide Trauma Care during a Medical Surge Response
    • Activity 8. Respond to Behavioral Health Needs during a Medical Surge Response
    • Activity 9. Enhance Infectious Disease Preparedness and Surge Response
    • Activity 10. Distribute Medical Countermeasures during Medical Surge Response
    • Activity 11. Manage Mass Fatalities................................................................................................
• Glossary
• Appendix 1: The 2017-2022 Health Care Preparedness and Response Capabilities Revision Process
• Capabilities Areas for Alignment Appendix 2: Health Care Preparedness and Response Capabilities and Public Health Preparedness

Introduction 5

Introduction

The U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) leads the country in preparing for, responding to, and recovering from the adverse health effects of emergencies and disasters. This is accomplished by supporting the nation’s ability to withstand adversity, strengthening health and emergency response systems, and enhancing national health security. ASPR’s Hospital Preparedness Program (HPP) enables the health care delivery system to save lives during emergencies and disaster events that exceed the day-to-day capacity and capability of existing health and emergency response systems. HPP is the only source of federal funding for health care delivery system readiness, intended to improve patient outcomes, minimize the need for federal and supplemental state resources during emergencies, and enable rapid recovery. HPP prepares the health care delivery system to save lives through the development of health care coalitions (HCCs) that incentivize diverse and often competitive health care organizations with differing priorities and objectives to work together.

ASPR developed the 2017-2022 Health Care Preparedness and Response Capabilities guidance to describe what the health care delivery system, including HCCs, hospitals, and emergency medical services (EMS), have to do to effectively prepare for and respond to emergencies that impact the public’s health. Each jurisdiction, including emergency management organizations and public health agencies, provides key support to the health care delivery system.

Individual health care organizations, HCCs, jurisdictions, and other stakeholders that develop the capabilities outlined in the 2017-2022 Health Care Preparedness and Response Capabilities document will:

• Help patients receive the care they need at the right place, at the right time, and with the right resources, during emergencies
• Decrease deaths, injuries, and illnesses resulting from emergencies
• Promote health care delivery system resilience in the aftermath of emergencies
• Behavioral health services and organizations
• Child care providers (e.g., daycare centers)
• Community Emergency

The intended audience for this document is any health care delivery system organization, HCC, or state or local agency that supports the provision of care during emergencies, including but not limited to:

Response Teams (CERT)^1

(^1) “Community Emergency Response Teams.” FEMA , 31 Aug. 2016. Web. Accessed 7 Sept. 2016.

www.fema.gov/community-emergency-response-teams.

and Medical Reserve Corps (MRC)^2

(^2) “Medical Reserve Corps.” MRC, 22 Sept. 2016. Web. Accessed 26 Sept. 2016. https://mrc.hhs.gov.

• Dialysis centers and regional Centers for Medicare & Medicaid Services (CMS)-funded end-stage renal disease (ESRD) networks^3

(^3) “ESRD Networks.” KCER , 2016. Web. Accessed 7 Sept. 2016. http://kcercoalition.com/en/esrd-networks/.

• EMS (including inter-facility and other non-EMS patient transport systems)
• Emergency management organizations
• Faith-based organizations
• Federal facilities (e.g., U.S. Department of Veterans Affairs (VA) Medical Centers, Indian Health Service facilities, military treatment facilities)
• Home health agencies, including home and community-based services

Introduction 7

awardees’ and sub-awardees’ progress toward building the capabilities, in the HPP funding opportunity announcement for the five-year project period that begins in July 2017.

The Four Capabilities

The four Health Care Preparedness and Response Capabilities are:

Capability 1: Foundation for Health Care and Medical Readiness

Goal of Capability 1: The community’s^5

(^5) As the HCC defines in Capability 1, Objective 1, Activity 1 – Define HCC Boundaries

health care organizations and other stakeholders—coordinated through a sustainable HCC—have strong relationships, identify hazards and risks, and prioritize and address gaps through planning, training, exercising, and managing resources.

Capability 2: Health Care and Medical Response Coordination

Goal of Capability 2: Health care organizations, the HCC, their jurisdiction(s), and the ESF-8 lead agency plan and collaborate to share and analyze information, manage and share resources, and coordinate strategies to deliver medical care to all populations during emergencies and planned events.

Capability 3: Continuity of Health Care Service Delivery

Goal of Capability 3: Health care organizations, with support from the HCC and the ESF-8 lead agency, provide uninterrupted, optimal medical care to all populations in the face of damaged or disabled health care infrastructure. Health care workers are well-trained, well-educated, and well-equipped to care for patients during emergencies. Simultaneous response and recovery operations result in a return to normal or, ideally, improved operations.

Capability 4: Medical Surge

Goal of Capability 4: Health care organizations—including hospitals, EMS, and out-of-hospital providers—deliver timely and efficient care to their patients even when the demand for health care services exceeds available supply. The HCC, in collaboration with the ESF-8 lead agency, coordinates information and available resources for its members to maintain conventional surge response. When an emergency overwhelms the HCC’s collective resources, the HCC supports the health care delivery system’s transition to contingency and crisis surge response^6

(^6) Altevogt, Bruce M., et al. “Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations.” The

National Academies Press, 2009. Web. Accessed 26 Oct. 2016. www.nap.edu/read/12749/chapter/1.

and promotes a timely return to conventional standards of care as soon as possible.

These four capabilities were developed based on guidance provided in the 2012 Healthcare Preparedness Capabilities: National Guidance for Healthcare System Preparedness document. They support and cascade from guidance documented in the National Response Framework ,^7

(^7) “National Response Framework.” FEMA , ed. 3, Jun. 2016. PDF. Accessed 24 Aug. 2016. www.fema.gov/media-

library-data/1466014682982-9bcf8245ba4c60c120aa915abe74e15d/National_Response_Framework3rd.pdf. (^8) “National Preparedness Goal.” FEMA , ed. 2. 5 Jul. 2016. PDF. Accessed 26 Oct. 2016.

https://www.fema.gov/media-library-data/1443799615171- 2aae90be55041740f97e8532fc680d40/National_Preparedness_Goal_2nd_Edition.pdf (^9) “National Health Security Strategy and Implementation Plan.” ASPR, HHS, 2015-2018. PDF. Accessed 26 Oct.

2016. http://www.phe.gov/Preparedness/planning/authority/nhss/Documents/nhss-ip.pdf

National Preparedness Goal ,^8 and the National Health Security Strategy^9 to build community health resilience and

Introduction 8

integrate health care organizations, emergency management organizations, and public health agencies. See Appendix 1 for more details on the process ASPR followed to revise the capabilities.

The Value of Health Care Coalitions in Preparedness and Response

HCCs—groups of individual health care and response organizations (e.g., hospitals, EMS, emergency management organizations, public health agencies, etc.) in a defined geographic location—play a critical role in developing health care delivery system preparedness and response capabilities. HCCs serve as multiagency coordination groups that support and integrate with ESF-8 activities in the context of incident command system (ICS) responsibilities. HCCs coordinate activities among health care organizations and other stakeholders in their communities; these entities comprise HCC members that actively contribute to HCC strategic planning, operational planning and response, information sharing, and resource coordination and management. As a result, HCCs collaborate to ensure each member has what it needs to respond to emergencies and planned events, including medical equipment and supplies, real-time information, communication systems, and educated and trained health care personnel.

The value of participating in an HCC is not limited to emergency preparedness and response. Day-to-day benefits^10

(^10) Priest, Chad and Benoit Stryckman. “Identifying Indirect Benefits of Federal Health Care Emergency

Preparedness Grant Funding to Coalitions: A Content Analysis.” Disaster Medicine and Public Health Preparedness , vol. 9, no. 6, 2015.

may include:

• Meeting regulatory and accreditation requirements
• Enhancing purchasing power (e.g., bulk purchasing agreements)
• Accessing clinical and non-clinical expertise
• Networking among peers
• Sharing leading practices
• Developing interdependent relationships
• Reducing risk
• Addressing other community needs, including meeting requirements for tax exemption through community benefit^11

(^11) “Instructions for Schedule H (Form 990).” IRS , 2015. Web. Accessed 18 Jul. 2016. https://www.irs.gov/pub/irs-

pdf/i990sh.pdf.

Using the Capabilities Document

The 2017-2022 Health Care Preparedness and Response Capabilities document is organized into four sections—one for each capability. Each capability has a goal and a set of objectives with associated activities. Definitions of capability goal, objective, and activity are defined below.

• Goal: The outcome of developing the capability
• Objective: Overarching component of the capability that, when completed, helps achieve the goal
• Activity: A task critical for achieving an objective

The capabilities are a high-level overview of the objectives and activities that the nation’s health care delivery system, including HCCs and individual health care organizations, should undertake to prepare for, respond to, and recover from emergencies. ASPR encourages HCCs, health care organizations, and

Foundation for Health Care and Medical Readiness 10

Capability 1. Foundation for Health Care and Medical

Readiness

The foundation for health care and medical readiness enables the health care delivery system and other organizations that contribute to responses to coordinate efforts before, during, and after emergencies; continue operations; and appropriately surge as necessary. This is primarily accomplished through health care coalitions (HCCs) that incentivize diverse and often competitive health care organizations with differing priorities and objectives to work together. HCCs should collaborate with a variety of stakeholders to ensure the community has the necessary medical equipment and supplies, real-time information, communication systems, and trained and educated health care personnel to respond to an emergency. These stakeholders include core HCC members—hospitals, emergency medical services (EMS), emergency management organizations, and public health agencies—additional HCC members, and the Emergency Support Function-8 (ESF-8, Public Health and Medical Services) lead agency. (For more information, see Capability 1, Objective 1, Activity 2 – Identify Health Care Coalition Members.)

Goal for Capability 1: Foundation for Health Care and Medical Readiness

The community’s^13

(^13) As the HCC defines in Capability 1, Objective 1, Activity 1 – Define HCC Boundaries

health care organizations and other stakeholders—coordinated through a sustainable HCC—have strong relationships, identify hazards and risks, and prioritize and address gaps through planning, training, exercising, and managing resources.

e

Objective 1: Establish and Operationalize a Health Care Coalition

HCCs should coordinate with their members to facilitate:

• Strategic planning
• Identification of gaps and mitigation strategies
• Operational planning and response
• Information sharing for improved situational awareness
• Resource coordination and management

HCCs serve as multiagency coordination groups that support and integrate with other ESF-8 activities. Coordination between the HCC and the ESF-8 lead agency can occur in a number of ways. Some HCCs serve as the ESF-8 lead agency for their jurisdiction(s). Others integrate with their ESF-8 lead agency through an identified designee at the jurisdiction’s Emergency Operations Center (EOC) who represents HCC issues and needs and provides timely, efficient, and bi-directional information flow to support situational awareness. (Se Capability 2 – Health Care and Medical Response Coordination for details on ESF-8 and situational awareness.)

HCCs serve as a public-private partnership. As stated in the National Response Framework :

“…private sector organizations contribute to response efforts through partnerships with each level of government….During an incident, key private sector partners should have a direct link to

Foundation for Health Care and Medical Readiness 11

emergency managers and, in some cases, be involved in the decision making process….Private sector entities can assist in delivering the response core capabilities by collaborating with emergency management personnel before an incident occurs to determine what assistance may be necessary and how they can support local emergency management organizations during response operations….”^14

(^14) “National Response Framework.” FEMA , ed. 3, Jun. 2016, pp. 10, 29. PDF. Accessed 24 Aug. 2016.

https://www.fema.gov/media-library-data/1466014682982- 9bcf8245ba4c60c120aa915abe74e15d/National_Response_Framework3rd.pdf.

Activity 1. Define Health Care Coalition Boundaries

The HCC should define its boundaries based on daily health care delivery patterns—including those established by corporate health systems—and organizations within a defined geographic region, such as independent organizations and federal health care facilities. Additionally, the HCC may consider boundaries based on defined catchment areas, such as regional EMS councils, trauma regions, accountable care organizations, emergency management regions, etc. Defined boundaries should encompass more than one of each member type (e.g., hospitals, EMS) to enable coordination and enhance the HCC’s ability to share the load during an emergency. HCC boundaries may span several jurisdictional or political boundaries, and the HCC should coordinate with all ESF-8 lead agencies within its defined boundaries.

The HCC should:

• Include enough members to ensure adequate resources; however, at the same time, having too many members may make the HCC unmanageable
• Consider existing regional service areas, as they define common and known health care delivery patterns and emergency response activities
• Consider HCC boundaries that cross state borders where appropriate
• Engage the jurisdiction’s public health agency to ensure all health care facilities, including independent facilities, belong to an HCC and that there are no geographic gaps in HCC coverage

Activity 2. Identify Health Care Coalition Members

An HCC member is defined as an entity within the HCC’s defined boundaries that actively contributes to HCC strategic planning, identification of gaps and mitigation strategies, operational planning and response, information sharing, and resource coordination and management. In cases where there are multiple entities of an HCC member type, there may be a subcommittee structure that establishes a lead entity to communicate common interests to the HCC (e.g., multiple dialysis centers forming a subcommittee). HCC membership does not begin or end with attending meetings.

The HCC should include a diverse membership to ensure a successful whole community response. If segments of the community are unprepared or not engaged, there is greater risk that the health care delivery system will be overwhelmed. As such, the HCC should liaise with the broader response community on a regular basis (see Introduction for a list of stakeholders). The list is recreated below, delineating core and additional HCC members.

• Core HCC members should include, at a minimum, the following:  Hospitals  EMS (including inter-facility and other non-EMS patient transport systems)

Foundation for Health Care and Medical Readiness 13

Activity 3. Establish Health Care Coalition Governance

The HCC should define and implement a structure and processes to execute activities related to health care delivery system readiness and coordination. The elements of governance include organizational structures, roles and responsibilities, mechanisms to provide guidance and direction, and processes to ensure integration with the ESF-8 lead agency. The HCC should specify how structure, processes, and policies may shift during a response, as opposed to a steady state. HCC members should adopt these elements and be part of regular reviews.

The HCC should document the following information related to its governance:

• HCC membership
• An organizational structure to support HCC activities, including executive and general committees, election or appointment processes, and any necessary administrative rules and operational functions (e.g., bylaws)
• Member guidelines for participation and engagement that consider each member and region’s geography, resources, and other factors
• Policies and procedures, including processes for making changes, orders of succession, and delegations of authority
• HCC integration within existing state, local, and member-specific incident management structures and specified roles—such as a primary point of contact who serves as the liaison to the ESF-8 lead agency and EOCs during an emergency

Objective 2: Identify Risk and Needs

The HCC should identify and plan for risks, in collaboration with the ESF-8 lead agency, by conducting assessments or using and modifying data from existing assessments for health care readiness purposes. These assessments can determine resource needs and gaps, identify individuals who may require additional assistance before, during, and after an emergency, and highlight applicable regulatory and compliance issues. The HCC and its members may use the information about these risks and needs to inform training and exercises and prioritize strategies to address preparedness and response gaps in the region.

Activity 1. Assess Hazard Vulnerabilities and Risks

A hazard vulnerability analysis (HVA) is a systematic approach to identifying hazards or risks that are most likely to have an impact on the demand for health care services or the health care delivery system’s ability to provide these services. This assessment may also include estimates of potential injured or ill survivors, fatalities, and post-emergency community needs based on the identified risks.

General principles for the HVA process include but are not limited to the following:

• HCC members should participate in the HVA process, using a variety of HVA tools^19

(^19) “ASPR TRACIE Evaluation of Hazard Vulnerability Assessment Tools.” ASPR TRACIE, 19 Jul. 2016. PDF. Accessed 24

Aug. 2016. asprtracie.hhs.gov/documents/tracie-evaluation-of-HVA-tools.pdf.

• The HVA process should be coordinated with state and local emergency management organization assessments (e.g., Threat and Hazard Identification and Risk Assessment [THIRA] 20 )

(^20) “Threat and Hazard Identification and Risk Assessment.” FEMA , Mar. 2015. Web. Accessed 19 Jul. 2016.

www.fema.gov/threat-and-hazard-identification-and-risk-assessment.

Foundation for Health Care and Medical Readiness 14

and any public health hazard assessments (e.g., jurisdictional risk assessment). The intent is to ensure completion, share risk assessment results, and minimize duplication of effort

• Health care facilities, EMS, and other health care organizations should provide input into the development of the regional HVA based on their facilities’ or organizations’ HVAs
• The assessment components should include regional characteristics, such as risks for natural or man-made disasters, geography, and critical infrastructure
• The assessment components should address population characteristics (including demographics), and consider those individuals who might require additional help in an emergency, such as children; pregnant women; seniors; individuals with access and functional needs, including people with disabilities; and others with unique needs
• The HCC should regularly review and share the HVA with all members

Activity 2. Assess Regional Health Care Resources

HCC members should perform an assessment to identify the health care resources and services that are vital for continuity of health care delivery during and after an emergency. The HCC should then use this information to identify resources that could be coordinated and shared. This information is critical to uncovering resource vulnerabilities relative to the HVA that could impede the delivery of medical care and health care services during an emergency.

The resource assessment will be different for various HCC member types, but should address resources required to care for all populations during an emergency. The resource assessment should include but is not limited to the following:

• Clinical services – inpatient hospitals, outpatient clinics, emergency departments, private practices, skilled nursing facilities, long-term care facilities, behavioral health services, and support services (see Capability 4 – Medical Surge)
• Critical infrastructure supporting health care (e.g., utilities, water, power, fuel, information technology [IT] services, communications, transportation networks)
• Caches (e.g., pharmaceuticals and durable medical equipment)
• Hospital building integrity
• Health care facility, EMS, corporate health system, and HCC information and communications systems and platforms (e.g., electronic health records [EHRs], bed and patient tracking systems) and communication modalities (e.g., telephone, 800 MHz radio, satellite telephone)
• Alternate care sites
• Home health agencies (including home and community-based services)
• Health care workforce
• Health care supply chain
• Food supply
• Medical and non-medical transportation system
• Private sector assets that can support emergency operations

Activity 3. Prioritize Resource Gaps and Mitigation Strategies

A comparison between available resources and current HVA(s) will identify gaps and help prioritize HCC and HCC member activities. Gaps may include a lack of, or inadequate, plans or procedures, staff, equipment and supplies, skills and expertise, services, or any other resources required to respond to an emergency. Just as the resource assessment will be different for different member types, so will efforts to prioritize identified gaps. HCC members should prioritize gaps based on consensus and determine

Foundation for Health Care and Medical Readiness 16

Activity 5. Assess and Identify Regulatory Compliance Requirements

The HCC, in collaboration with the ESF-8 lead agency and state authorities, should assess and identify regulatory compliance requirements that are applicable to day-to-day operations and may play a role in planning for, responding to, and recovering from emergencies.

The HCC should:

• Understand federal statutory, regulatory, or national accreditation requirements that impact emergency medical care, including:

 Centers for Medicare & Medicaid Services (CMS) conditions of participation, (including CMS-3178-F Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers)^23

(^23) See “Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers.” 81 Fed. Reg. 63859_._ (16 Sept. 2016.) Federal Register: The Daily Journal of the United States. Web. Accessed 26 Oct. 2016.

 Clinical Laboratory Improvement Amendments (CLIA)^24

(^24) See “Clinical Laboratory Improvement Amendments (CLIA).” CMS , May 2016. Web. Accessed 18 Aug. 2016. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html.

 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule requirements^25

(^25) See “Emergency Situations: Preparedness, Planning, and Response.” HHS , 2016. Web. Accessed 19 Jul. 2016. www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/index.html.

and circumstances when covered entities can disclose protected health information (PHI) without individual authorization including to public health authorities and as directed by laws (e.g., state law)^26

(^26) “HIPAA and Disasters: What Emergency Professionals Need to Know.” ASPR TRACIE , 31 Aug. 2016. PDF. Accessed 21 Oct. 2016. https://asprtracie.hhs.gov/documents/aspr-tracie-hipaa-emergency-fact-sheet.pdf

 Emergency Medical Treatment & Labor Act (EMTALA) requirements^27

(^27) See “Emergency Medical Treatment & Labor Act (EMTALA).” CMS. 2012. Web. Accessed 19 Jul. 2016. https://www.cms.gov/Regulations-and-Guidance/Legislation/EMTALA/.

 Licensing and accrediting agencies for hospitals, clinics, laboratories, and blood banks (e.g., Joint Commission,^28

(^28) “Emergency Management Resources

DNV GL – Healthcare^29

(^29) “DNV GL Healthcare

 Federal disaster declaration processes^30

(^30) See “The Disaster Declaration Process.” FEMA , 3 Jun. 2016. Web. Accessed 19 Jul. 2016. www.fema.gov/disaster- declaration-process.

, 31

(^31) See “Legal Authority of the Secretary.” ASPR , 2016. Web. Accessed 19 Jul. 2016. www.phe.gov/preparedness/support/secauthority/Pages/default.aspx.

and public health authorities  Available federal liability protections for responders (e.g., Public Readiness and Emergency Preparedness (PREP) Act^32

(^32) See “Public Readiness and Emergency Preparedness Act.” ASPR, Dec. 2015. Web. Accessed 14 Aug. 2016. http://www.phe.gov/preparedness/legal/prepact/pages/default.aspx.

 Environmental Protection Agency (EPA) requirements^33

(^33) See “EPA Laws and Regulations.” EPA , Jun. 2016. Web. Accessed 19 Jul. 2016. www.epa.gov/laws-regulations.

 Occupational Safety and Health Administration (OSHA) requirements^34

(^34) See “OSHA laws and regulations.” OSHA , 2016. Web. 19 Jul. 2016. www.osha.gov/law-regs.html.

(e.g., general duty clause, blood-borne pathogen standard)

.” The Joint Commission , 24 Aug. 2016. Web. Accessed 24 Aug. 2016. www.jointcommission.org/emergency_management.aspx.

.” DNV GL Healthcare, 2016. Web. Accessed 19 Jul. 2016. dnvglhealthcare.com/.

Foundation for Health Care and Medical Readiness 17

• Understand state or local regulations or programs that impact emergency medical care, including:

 Scope and breadth of emergency declarations  Regulations for health care practitioner licensure, practice standards, reciprocity, scope of practice limitations, and staff-to-patient ratios  Legal authorization to allocate personnel, resources, equipment, and supplies among health care organizations  Laws governing the conditions under which an individual can be isolated or quarantined  Available state liability protections for responders

• Understand the process and information required to request necessary waivers and suspension of regulations, including:  Processes for emergency resource acquisition (this may require coordination with the federal, state, and/or local government)  Special waiver processes (e.g., section 1135 of the Social Security Act waivers^35

(^35) See “1135 Waivers.” ASPR, 2 May 2013. Web. Accessed 12 Sept. 2016.

http://www.phe.gov/Preparedness/legal/Pages/1135-waivers.aspx.

) of key regulatory requirements pursuant to emergency declarations  Process and implications for Food and Drug Administration (FDA) issuance of emergency use authorizations for use of non-approved drugs or devices or use of approved drugs or devices for unapproved uses  Legal resources^36

(^36) “Hospital Legal Preparedness: Relevant Resources.” CDC , 20 Apr. 2015. Web. Accessed 19 Jul. 2016.

www.cdc.gov/phlp/publications/topic/hospital.html.

related to hospital legal preparedness, such as the deployment and use of volunteer health practitioners  Legal and regulatory issues related to alternate care sites and practices  Legal issues regarding population-based interventions, such as mass prophylaxis and vaccination  Processes for emergency decision making from state or local legislature

• Support crisis standards of care planning,^37

(^37) Altevogt, Bruce M., et al. “Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations.” The

National Academies Press, 2009. Web. Accessed 26 Oct. 2016. www.nap.edu/read/12749/chapter/1.

including the identification of appropriate legal authorities and protections necessary when crisis standards of care are implemented (see Capability 4 – Medical Surge)

• Maintain awareness of standing contracts for resource support during emergencies

Objective 3: Develop a Health Care Coalition Preparedness Plan

The HCC preparedness plan enhances preparedness and risk mitigation through cooperative activities based on common priorities and objectives. In collaboration with the ESF-8 lead agency, the HCC should develop a preparedness plan that includes information collected on hazard vulnerabilities and risks, resources, gaps, needs, and legal and regulatory considerations (as collected in Capability 1, Objective 2, Activities 1-5 above). The HCC preparedness plan should emphasize strategies and tactics that promote communications, information sharing, resource coordination, and operational response planning with HCC members and other stakeholders. The HCC should develop its preparedness plan to include core HCC members and additional HCC members so that, at a minimum, hospitals, EMS, emergency

Foundation for Health Care and Medical Readiness 19

Activity 1. Promote Role-Appropriate National Incident Management System

Implementation

The HCC should assist its health care organization members and other HCC members with National Incident Management System (NIMS)^38

(^38) “NIMS Implementation for Healthcare Organizations Guidance.” ASPR HPP, Jan. 2015. PDF. Accessed 7 Sept.

2016. www.phe.gov/Preparedness/planning/hpp/reports/Documents/nims-implementation-guide-jan2015.pdf.

implementation.

The HCC should:

• Ensure HCC leadership receives NIMS training
• Promote NIMS implementation, including training and exercises, among HCC members to facilitate operational coordination with public safety and emergency management organizations during an emergency using an incident command system (ICS)
• Assist HCC members with incorporating NIMS components into their EOPs
• For those members not bound by NIMS implementation, the HCC should consider training on response planning techniques, organizational structure, and other incident management practices that will prepare members for their roles during a response

Activity 2. Educate and Train on Identified Preparedness and Response Gaps

HCC members should support education and training to address health care preparedness and response gaps identified through strategic planning, development of the HCC preparedness and response plans, or other assessments. Whenever possible, training should be standardized at the HCC level to ensure efficiency and consistency.

The HCC should:

• Promote understanding of every HCC member’s specific roles and responsibilities in the health care delivery system’s emergency response
• Base training on specific gaps and needs identified by HCC members
• Promote and support training for health care providers, laboratorians, non-clinical staff, and ancillary workforce in:

 Clinical management (e.g., chemical, biological, radiological, nuclear and explosives [CBRNE]39,

(^39) “Decontamination Guidance for Chemical Incidents.” HHS, 2016. Web. Accessed 11 Oct. 2016.

https://www.medicalcountermeasures.gov/barda/cbrn/decontamination-guidance-for-chemical-incidents/.

40

(^40) Cibulsky, Susan M., et al. “Patient Decontamination in a Mass Chemical Exposure Incident: National Planning

Guidance for Communities.” HHS, DHS, Dec. 2014. PDF. Accessed 11 Oct. 2016. http://www.phe.gov/Preparedness/responders/Documents/patient-decon-natl-plng-guide.pdf.

, burn, trauma, and other recognized hazards) for all populations  Responder safety and health requirements (see Capability 3, Objective 5 – Protect Responders’ Safety and Health)  Management of patients in a resource-scarce environment, including the implementation of crisis standards of care

• Ensure health care organization leadership is aware of and engaged in HCC activities^41

(^41) Browning, Henry W., et al. “Collaborative Healthcare Leadership: A Six-Part Model for Adapting and Thriving

during a Time of Transformative Change.” Center for Creative Leadership , Mar. 2016. PDF. Accessed 7 Sept. 2016. insights.ccl.org/wp-content/uploads/2015/04/CollaborativeHealthcareLeadership.pdf.

(see Capability 1, Objective 5, Activity 2 – Engage Health Care Executives below)

Foundation for Health Care and Medical Readiness 20

• Develop and implement training plans, including those that support appropriate health care providers and first responders. Training plans may include but are not limited to, initial education, continuing education, appropriate certifications, and just-in-time training
• Employ a variety of modalities (e.g., online, classroom, etc.)

Activity 3. Plan and Conduct Coordinated Exercises with Health Care Coalition

Members and Other Response Organizations

The HCC, in collaboration with its members, should plan and conduct coordinated exercises to assess the health care delivery system’s readiness. The HCC should focus exercises on the outcomes of HVAs and other assessments that identify resource needs and gaps, identify individuals who may require additional assistance before, during, and after an emergency, and highlight applicable regulatory and compliance issues.

The HCC should:

• Plan and conduct health care delivery system-wide exercises that incorporate hospitals, EMS, emergency management organizations, public health agencies, and additional HCC member participation
• Base exercises on specific gaps and needs identified by HCC members, including emerging infectious diseases and CBRNE threats
• Update an exercise schedule annually or in accordance with jurisdictional needs
• Provide opportunities for clinical laboratory participation
• Assess readiness to support emergencies involving children across the age and developmental trajectory; children represent nearly 25 percent of the population^42

(^42) Lofquist, Daphne, et al. “Households ad Families: 2010.” 2010 Census Briefs, Apr. 2012. PDF. Accessed 26 Aug.

2016. www.census.gov/prod/cen2010/briefs/c2010br-14.pdf.

and have unique response needs during emergencies, including special medical equipment and treatment needs and family reunification considerations

• Assess readiness to support other individuals who have special health needs and may require additional assistance before, during, and after an emergency (e.g., pregnant women, seniors, individuals who depend on electricity-dependent medical and assistive equipment, etc.)
• Exercise Continuity of Operations (COOP) plans (see Capability 3, Objective 2, Activity 1 – Develop a Health Care Organization Continuity of Operations Plan and Capability 3, Objective 2, Activity 2 – Develop a Health Care Coalition Continuity of Operations Plan)
• Exercise medical surge capacity and capability,^43

(^43) “Health Care Coalition Surge Evaluation Tool.” ASPR, Jun. 2016. Web. Accessed 19 Jul. 2016.

www.phe.gov/Preparedness/planning/hpp/Pages/coaltion-tool.aspx.

including decisions leading to the implementation of crisis standards of care (see Capability 4 – Medical Surge)

 Assess the mobilization of beds, personnel, and key resources, including equipment, supplies, and pharmaceuticals

• Coordinate exercises with other response organizations (e.g., Federal Emergency Management Agency [FEMA], National Guard, etc.)
• When appropriate, include federal, state, and local response resources in exercises (e.g., National Disaster Medical System [NDMS] Disaster Medical Assistance Teams [DMAT],^44

(^44) “Disaster Medical Assistance Team.” ASPR, 25 Sept. 2015. Web. Accessed 15 Sept. 2016.

www.phe.gov/preparedness/responders/ndms/teams/pages/dmat.aspx.

NDMS