HCAD 635 University of Phoenix Long Term Healthcare Presentation

Applymanagement theory, concepts, and models to examine ethical best practices in long-term care administration and to foster performance excellence.

Develop and refine students’ ethical problem solving and analytical skills when confronted with complex challenges, decision making, and strategic planning in long-term care administration.

Background:Preparing for a regulatory survey is essential in long term care and complying with these regulations is critical for the success an organization. Over the past several weeks, we have learned a tremendous amount of information on different departments as well as various administrative areas. Now, we will apply your knowledge to creating a proactive plan that assists your team in being prepared should regulatory bodies arrive to conduct a survey or inspection. While we do not have the time to implement and discuss a full mock survey, we will have the time for you to work on a few of the processes for a survey readiness plan.

Your Scenario (Option A, B, or C): Your instructor will assign you one of the scenarios provided below. This communication for your assigned scenario will be provided from your instructor no later than Week 2 of the course.

Option B: South Carolina Home Health Agencies and ServiceI be HHA Option 3: Primsa Health Home Health located in Greenville South Carolina HHA Regulation Option 2: Federal CMS HHA Regulatory Condition: Quality assessment/performance improvement (484.65) o Regulatory Reference and Standard: 484.65 Participate in the HHA’sQAPI program o Regulatory Tag: G640 o Regulatory Information: Page 3 of the CMS 2018 HHA G TagInformation and Page 40 of the CMS State Operations Manual Appendix B for HHAs.Resources for this Scenario:How to locate the specific regulations for this scenario: You can you the Control F function on your PC or Command F function on your Mac to search for a specific regulatory reference/tag/rule. Type in the information that you want to search for in the specific document that you are reviewing, using this search function, to locate your information:CMS State Operations Manual Appendix B for HHAs PDFE-Tags Emergency Preparedness CMS State Operations Manual Appendix Z for All Certified Federal Level Providers PDFWebsite link to CMS Provider Compare– Main Page: CMS Provider Compare Search PageWebsite link to CMS – Emergency Preparedness Rule Page: CMS Emergency Preparedness Rule Landing PageResources for this Scenario:How to locate the specific regulations for this scenario: You can you the Control F function on your PC or Command F function on your Mac to search for a specific regulatory reference/tag/rule. Type in the information that you want to search for in the specific document that you are reviewing, using this search function, to locate your information:CMS SNF F Tags June 2021 PDFCMS State Operations Manual Appendix PP for LTC Facilities PDFE-Tags Emergency Preparedness CMS State Operations Manual Appendix Z for All Certified Federal Level Providers PDFWebsite link to CMS Provider Compare– Main Page: CMS Provider Compare Search PageWebsite link to CMS – Emergency Preparedness Rule Page: CMS Emergency Preparedness Rule Landing Page

Creating the PowerPoint Presentation:

• Survey Readiness PowerPoint:Must be 10-12 slides, excluding the introduction slide(s) and reference page slide(s).
• Presenter Notes:Every slide must have presenter notes except for the reference page(s).Your presenter notes will be the information that you will be sharing with your team.Your notes should be detailed and contain APA in-text citations.
• References:Minimum of five scholarly references, professional publications, and/or academic journals from the last five years.Include any references from your assigned LTC facility or setting such as the website, company information, facility website, service-level website, etc.Every reference must have a correlating in-text citation(s).
• APA 7th Edition Style:PowerPoint slides, cover page, and reference page.

The PowerPoint Must Contain the Following Content Aspects for Your Assigned Scenario:

Aspect A: Introduction Slide(s)

• APA Cover Page – Include the title of the presentation, your name, your instructor’s name, course name, your assigned LTC facility or setting, your assigned regulation, and date submitted.
• Provide bulleted points to identify each Content Aspect that will be presented in the presentation.

Aspect B: Regulatory Survey Readiness Analysis Slide(s)

• Provide an analysis of the regulatory survey process that includes the importance of survey readiness; a mock survey overview; and an assessment of being survey ready, as a means for creating successful survey outcomes.

Aspect C: Stakeholders Evaluation and Leadership Selection Analyses Slide(s)

• Include an evaluation of at least three stakeholders for the regulatory survey process.You must include the internal stakeholders of the patients and/or residents.The other stakeholders that you present, as part of your evaluation, may be internal or external.Include at least two of the applicable items from this list in your evaluation of the stakeholders: (a.) survey awareness; (b.) survey process understanding; (c.) survey engagement; (d.) stakeholder contribution; (e.) stakeholder justification; and/or (f.) importance of the stakeholder.
• Identify at least three specific leadership roles that will be involved in the mock survey process and provide an analysis of the assigned facility-level or service-level leaders involved in the mock survey.You must include the Administrator, Executive Director, or a top leader of the LTC facility or service in your analysis.The other two leadership roles may be any manager or director-level position at your assigned LTC facility or service for your analysis.

Aspect D: Regulation Assessment Slide(s)

• State the regulation that you assigned from your scenario and provide an assessment of this regulation to your assigned LTC facility or setting.You must include the regulatory standard, condition, rule, and/or tag in the assessment.Include an evaluation of the mock survey process for the assigned regulation, applying this information to your assigned LTC facility or setting.Apply your assigned specific regulation for one mock survey step, as this will act as an introduction for your LTC employees to understand the entire mock survey process. (Note - Remember you are only introducing the mock survey process to your staff, so this should be an overview of the potential regulatory mock survey steps.)

Aspect E: Conclusion Slide(s)

• Highlight the key takeaways of your presentation and include an explanation to why the information presented in the PowerPoint is essential for the staff to know.
• Include one call to action and share with your team any next steps for the upcoming mock survey.

Aspect F: APA Reference Page Slide(s)

• Provide the list of all references presented in the PowerPoint, formatted in APA 7th Edition.

Resources for Creating PowerPoints: https://cft.vanderbilt.edu/guides-sub-pages/making-better-powerpoint-presentations/ https://writingcenter.uagc.edu/how-make-powerpoint-presentation https://alum.mit.edu/best-practices-powerpoint-presentations Resources for Mock Surveys: Mock Survey Process Example PDF Home Health Mock Survey Example Guide PDF

State Operations Manual Appendix Z- Emergency Preparedness for All Provider and Certified Supplier Types Interpretive Guidance Table of Contents (Rev. 204, Issued: 04-16-21) Transmittals for Appendix Z §403.748, Condition of Participation for Religious Nonmedical Health Care Institutions (RNHCIs) §416.54, Condition for Coverage for Ambulatory Surgical Centers (ASCs) §418.113, Condition of Participation for Hospices §441.184, Requirement for Psychiatric Residential Treatment Facilities (PRTFs) §460.84, Requirement for Programs of All-Inclusive Care for the Elderly (PACE) §482.15, Condition of Participation for Hospitals §482.78, Requirement for Transplant Programs §483.73, Requirement for Long-Term Care (LTC) Facilities §483.475, Condition of Participation for Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) §484.102, Condition of Participation for Home Health Agencies (HHAs) §485.68, Condition of Participation for Comprehensive Outpatient Rehabilitation Facilities (CORFs) §485.625, Condition of Participation for Critical Access Hospitals (CAHs) §485.727, Conditions of Participation for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services §485.920, Condition of Participation for Community Mental Health Centers (CMHCs) §486.360, Condition of Participation for Organ Procurement Organizations (OPOs) §491.12, Conditions for Certification for Rural Health Clinics (RHCs) and Conditions for Coverage for Federally Qualified Health Centers (FQHCs) §494.62, Condition for Coverage for End-Stage Renal Disease (ESRD) Facilities Introduction (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) The “Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers” Final Rule (81 FR 63860, Sept. 16, 2016) (“Final Rule”) establishes national emergency preparedness requirements for participating providers and certified suppliers to plan adequately for both natural and man-made disasters, and coordinate with Federal, state, tribal, regional and local emergency preparedness systems. The Final Rule also assists providers and suppliers to adequately prepare to meet the needs of patients, clients, residents, and participants during disasters and emergency situations, striving to provide consistent requirements across provider and supplier-types, with some variations. The emergency preparedness Final Rule is based primarily off of the hospital emergency preparedness Condition of Participation (CoP) as a general guide for the remaining providers and suppliers, then tailored based to address the differences and or unique needs of the other providers and suppliers (e.g. inpatient versus out-patient providers). The requirements are focused on three key essentials necessary for maintaining access to healthcare during disasters or emergencies: safeguarding human resources, maintaining business continuity, and protecting physical resources. The interpretive guidelines and survey procedures in this appendix have been developed to support the adoption of a standard all- hazards emergency preparedness program for all certified providers and suppliers while similarly including appropriate adjustments to address the unique differences of the other providers and suppliers and their patients. Successful adoption of these emergency preparedness requirements will enable all providers and suppliers wherever they are located to better anticipate and plan for needs, rapidly respond as a facility, as well as integrate with local public health and emergency management agencies and healthcare coalitions’ response activities and rapidly recover following the disaster. While the use of healthcare coalitions are encouraged, this may not always be feasible for all providers and suppliers. For facilities participating in coalitions, the “level” of participation is not specified. However, if facilities use healthcare coalitions to conduct exercises or assist in their efforts for compliance, this should be documented and in writing. The 2016 Emergency Preparedness Final Rule emphasized that healthcare facilities should continue to engage their healthcare coalitions and state hospital preparedness program (HPP) coordinators for training and guidance. We encourage healthcare facilities, particularly those in neighboring geographic areas, to collaborate and build relationships that will allow facilities to share and leverage resources. For additional information, please visit https://www.cms.gov/About-CMS/AgencyInformation/Emergency/EPRO/Resources/State-resources. Applicability and Format of this Appendix Because the individual regulations for each specific provider and supplier share a majority of standard provisions, we have developed this Appendix Z to provide consistent interpretive guidance and survey procedures located in a single document Unless otherwise indicated, the general use of the terms “facility” or “facilities” in this Appendix refers to all 17 provider and suppliers, specifically Ambulatory Surgical Centers (ASCs); Critical Access Hospitals (CAHs); Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech Language Pathology Services (OPT/OSP); Community Mental Health Centers (CMHCs); Comprehensive Outpatient Rehabilitation Facilities (CORFs); End-Stage Renal Disease (ESRD) Facilities; Home Health Agencies (HHAs); Hospices; Hospitals; Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID); Long-Term Care (LTC) Facilities; Organ Procurement Organizations (OPOs); Psychiatric Residential Treatment Facilities (PRTFs);Programs of All-Inclusive Care for the Elderly (PACE); Religious Nonmedical Health Care Institutions (RNHCIs); Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs); and, Transplant Programs. Additionally, the term “patient(s)” within this appendix includes patients, residents and clients unless otherwise stated. Finally, as some specific citations between providers vary, we have specified changes in regulatory language with an asterisks and the specific language, for example: * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. Resources Facilities can consider using the checklists developed by Assistant Secretary for Preparedness and Response’s (ASPR’s) Technical Resources and Assistance Center and Information Exchange (TRACIE) and identify the location for each of their requirements. ASPR TRACIE developed resources and checklists created from our guidance, under https://asprtracie.s3.amazonaws.com/documents/aspr-tracie-cms-ep-rule-long-termcare.pdf, or see all checklists under Facility-Specific Requirement Overviews at https://asprtracie.hhs.gov/cmsrule. These checklists can be used by providers and suppliers, as well as the surveyors in order to have a provider-specific checklist. Survey Protocol These Conditions of Participation (CoP), Conditions for Coverage (CfC), Conditions for Certification and Requirements follow the standard survey protocols currently in place for each facility type and will be assessed during initial, revalidation, recertification and complaint surveys as appropriate. Compliance with the Emergency Preparedness (EP) requirements will be determined in conjunction with the existing survey process for health and safety compliance surveys or Life Safety Code (LSC) surveys for each provider and supplier type. Surveyors should also be using the same survey guidance (Appendix Q) in determining Immediate Jeopardy for Emergency Preparedness, as they would when surveying any other CoPs, CfCs or requirements. Additionally, Hospitals, CAHs, LTC Facilities, Inpatient Hospices, ASCs, ICF-IIDs, RNHCIs, and ESRD facilities all have life safety from fire protection regulations that require compliance with the LSC. The LSC typically requires an emergency power system/generator to provide limited emergency power in Hospitals, CAHs, LTC Facilities, Inpatient Hospice facilities, ESRD facilities and ASCs. Therefore, Therefore, for surveys in these facility types, a determination has to be made on whether a finding or potential deficiency related to emergency power is the result of the LSC or the EP requirement, which exceeds the LSC on this issue. It is recommended that health surveyors consult with their LSC survey team to make this determination. Surveyors must also closely review the guidance under tags E-0015 (requirements on alternate source power) and E-0041(requirements for emergency standby power systems). Please note, there may be instances in which the facility chooses, as part of their risk assessment and program, to install an emergency standby power systems with a generator that is not subject to LSC or Physical Environment regulations under their provider/supplier type. In this instance, the facility should consider the requirements under standard (e) (tag E-0041) of the EP regulations related to testing, inspection, fuel and generator location. Surveyors should also consider the volume of documentation provided by the facility and working with the facility when reviewing the Emergency Preparedness Program as facilities have the flexibility to determine how to format the documentation of their program. It is critical to understand that responses to emergency incidents may be the same process for multiple hazards or risks. For instance, the evacuation response to flooding and to fire emergencies may be the same. Therefore, facilities are not required to have a policy and procedure for each hazard, however, the facility should clearly identify within their policies and procedures under which circumstance the facility would evacuate, shelter, etc. and any potential considerations that may be different based on a particular hazards (e.g. is PPE required to evacuate during a biological threat); and should also include documentation on who would initiate the emergency preparedness response. Facilities must address each type of hazard within the emergency preparedness program, but can consolidate these policies and procedures based on the designated response without duplication within their program. While the documentation formatting is left to the discretion of the facility, the facility should be prepared to provide CMS with written evidence of its emergency preparedness program at the time of the survey. We also note there is no particular method in which the facility must document its review and updates (refer to more information under E-0013). We would recommend the surveyor review the program with the responsible facility representative and ask this representative to facilitate this review by referring the surveyor to the specific documentation asked for. IMPORTANT NOTE: Unless otherwise indicated, the general use of the terms “facility” or “facilities” in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well. This Appendix annotates under the Interpretive Guidelines sections for which providers or suppliers the specific standard does not apply to, unless the standard only applies to one provider or supplier type. Definitions All-Hazards Approach: An all-hazards approach is an integrated approach to emergency preparedness that focuses on identifying hazards and developing emergency preparedness capacities and capabilities that can address those as well as a wide spectrum of emergencies or disasters. This approach includes preparedness for natural, man-made, and or facility emergencies that may include but is not limited to: care-related emergencies; equipment and power failures; interruptions in communications, including cyber-attacks; loss of a portion or all of a facility; and, interruptions in the normal supply of essentials, such as water and food. Planning for using an all-hazards approach should also include emerging infectious disease (EID) threats. Examples of EIDs include Influenza, Ebola, Zika Virus and others. All facilities must develop an all-hazards emergency preparedness program and plan. Community Partners: Community partners are considered any emergency management officials (fire, police, emergency medical services, etc.) for full-scale and communitybased exercises, however can also mean community partners that assist in an emergency, such as surrounding providers and suppliers. Disaster: A hazard impact causing adverse physical, social, psychological, economic or political effects that challenges the ability to respond rapidly and effectively. Despite a stepped-up capacity and capability (call-back procedures, mutual aid, etc.) and change from routine management methods to an incident command/management process, the outcome is lower than expected compared with a smaller scale or lower magnitude impact (see “emergency” for important contrast between the two terms). Reference: Assistant Secretary for Preparedness and Response (ASPR) 2017-2022 Health Care Preparedness and Response Capabilities Document (ICDRM/GWU Emergency Management Glossary of Terms) (November 2016). Emergency/Disaster: An event that can affect the facility internally as well as the overall target population or the community at large or community or a geographic area. Emergency: A hazard impact causing adverse physical, social, psychological, economic or political effects that challenges the ability to respond rapidly and effectively. It requires a stepped-up capacity and capability (call-back procedures, mutual aid, etc.) to meet the expected outcome, and commonly requires change from routine management methods to an incident command process to achieve the expected outcome (see “disaster” for important contrast between the two terms). Reference: Assistant Secretary for Preparedness and Response (ASPR) 2017-2022 Health Care Preparedness and Response Capabilities Document (ICDRM/GWU Emergency Management Glossary of Terms) (November 2016). Emergency Preparedness Program: The Emergency Preparedness Program describes a facility’s comprehensive approach to meeting the health, safety and security needs of the facility, its staff, their patient population and community prior to, during and after an emergency or disaster. The program encompasses four core elements: an Emergency Plan that is based on a Risk Assessment and incorporates an all hazards approach; Policies and Procedures; Communication Plan; and the Training and Testing Program. Emergency Plan: An emergency plan provides the framework for the emergency preparedness program. The emergency plan is developed based on facility- and community-based risk assessments that assist a facility in anticipating and addressing facility, patient, staff and community needs and support continuity of business operations. Facility-Based: We consider the term “facility-based” to mean the emergency preparedness program is specific to the facility. It includes but is not limited to hazards specific to a facility based on its geographic location; dependent patient/resident/client and community population; facility type and potential surrounding community assets- i.e. rural area versus a large metropolitan area. Full-Scale Exercise: A full scale exercise is an operations-based exercise that typically involves multiple agencies, jurisdictions, and disciplines performing functional (for example, joint field office, emergency operation centers, etc.) and integration of operational elements involved in the response to a disaster event, i.e. ‘‘boots on the ground’’ response activities (for example, hospital staff treating mock patients). Though there is no specific number of entities required to participate in a full-scale communitybased exercise, it is recommended that it be a collaborative exercise which involves at a minimum local or state emergency officials and is robust to develop community-based responses to potential threats. Functional Exercise (FE): The Department of Homeland Security’s (DHS’s) Homeland Security Exercise and Evaluation Program (HSEEP) explains that FEs are an operations-based exercise that is designed to validate and evaluate capabilities, multiple functions and/or sub-functions, or interdependent groups of functions. FEs are typically focused on exercising plans, policies, procedures, and staff members involved in management, direction, command, and control functions. For additional details, please visit HSEEP guidelines located at: https://preptoolkit.fema.gov/documents/1269813/1269861/HSEEP_Revision_Apr13_Fina l.pdf/65bc7843-1d10-47b7-bc0d-45118a4d21da Mock Disaster Drill: A mock disaster drill is a coordinated, supervised activity usually employed to validate a specific function or capability in a single agency or organization. Mock disaster drills are commonly used to provide training on new equipment, validate procedures, or practice and maintain current skills. For example, mock disaster drills may be appropriate for establishing a community-designated disaster receiving center or shelter. Mock disaster drills can also be used to determine if plans can be executed as designed, to assess whether more training is required, or to reinforce best practices. A mock disaster drill is useful as a stand-alone tool, but a series of drills can be used to prepare several organizations to collaborate in an FSE. Risk Assessment: The term risk assessment describes a process facilities use to assess and document potential hazards that are likely to impact their geographical region, community, facility and patient population and identify gaps and challenges that should be considered and addressed in developing the emergency preparedness program. The term risk assessment is meant to be comprehensive, and may include a variety of methods to assess and document potential hazards and their impacts. The healthcare industry has also referred to risk assessments as a Hazard Vulnerability Assessments or Analysis (HVA) as a type of risk assessment commonly used in the healthcare industry. Staff: The term "staff" refers to all individuals that are employed directly by a facility. The phrase "individuals providing services under arrangement" means services furnished under arrangement that are subject to a written contract conforming with the requirements specified in section 1861(w) of the Act. Table-top Exercise (TTX): A tabletop exercise involves key personnel discussing simulated scenarios in an informal setting. TTXs can be used to assess plans, policies, and procedures. A tabletop exercise is a discussion-based exercise that involves senior staff, elected or appointed officials, and other key decision making personnel in a group discussion centered on a hypothetical scenario. TTXs can be used to assess plans, policies, and procedures without deploying resources. Workshop: A workshop, for the purposes of this guidance, is a planning meeting, seminar or practice session, which establishes the strategy and structure for an exercise program. We are aligning our definitions with the HSEEP guidelines. For additional details, see HSEEP guidelines at: https://preptoolkit.fema.gov/documents/1269813/1269861/HSEEP_Revision_Apr13_Fina l.pdf/65bc7843-1d10-47b7-bc0d-45118a4d21da. E-0001 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms “facility” or “facilities” in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an allhazards approach. The emergency preparedness program must include, but not be limited to, the following elements: Interpretive Guidelines applies to: §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920, §486.360, §491.12. NOTE: This does not apply to Transplant Programs. NOTE: The word comprehensive is not used in the language for ASCs. NOTE: The emergency preparedness program and its elements must be reviewed and updated annually for LTC facilities at §483.73(a). We’ve identified the differences in regulatory text for LTC facilities. Under this condition/requirement, facilities are required to develop an emergency preparedness program that meets all of the standards specified within the condition/requirement. The emergency preparedness program must describe a facility's comprehensive approach to meeting the health, safety, and security needs of their staff and patient population during an emergency or disaster situation. The program must also address how the facility would coordinate with other healthcare facilities, as well as the whole community during an emergency or disaster (natural, man-made, facility). The emergency preparedness program must be reviewed every two years for all providers and suppliers, with the exception of LTC providers who must review their emergency program annually. All facilities are expected to make the appropriate changes to their emergency program in the event changes are required more frequently outside of their update cycles. (“Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care” Final Rule, 84 FR 51732, 51735, Sept. 30, 2019) (“Burden Reduction Rule”). A comprehensive approach to meeting the health and safety needs of a patient population should encompass the elements for emergency preparedness planning based on the “allhazards” definition and specific to the location of the facility. For instance, a facility in a large flood zone, or tornado prone region, should have included these elements in their overall planning in order to meet the health, safety, and security needs of the staff and of the patient population. Additionally, if the patient population has limited mobility, facilities should have an approach to address these challenges during emergency events. The term “comprehensive” in this requirement is to ensure that facilities do not only choose one potential emergency that may occur in their area, but rather consider a multitude of events and be able to demonstrate that they have considered this during their development of the emergency preparedness plan. As emerging infectious disease outbreaks may affect any facility in any location across the country, a comprehensive emergency preparedness program should include emerging infectious diseases and pandemics during a public health emergency (PHE). The comprehensive emergency preparedness program emerging infectious disease planning should encompass how facilities will plan, coordinate and respond to a localized and widespread pandemic, similar to what is occurring with the 2019 Novel Coronavirus (COVID-19) PHE. Facilities should ensure their emergency preparedness programs are aligned with their State and local emergency plans/pandemic plans. Documentation and Requirements The emergency preparedness program must be in writing. The requirements under the emergency preparedness Final Rule allow for documentation flexibility. While facilities are required to meet all of the provisions applicable to their provider/supplier type, how they document their efforts is subject to their discretion. We are not requiring a hard copy/paper, electronic or any particular system for meeting the requirements. It is up to each individual facility to be able to demonstrate in writing their emergency preparedness program. We would also recommend, but are not requiring, facilities to develop a crosswalk as applicable for where their documents are located. For instance, if their emergency plan is located in a binder, specify this for surveyors. If there are policies and procedures to specific standards/requirements, identify where these are located. Providers and suppliers are encouraged to keep documentation and their written emergency preparedness program for a period of at least 2 years for inpatient providers and at least 4 years for outpatient providers. We are recommending this process due to the requirements related to training and testing exercises. Inpatient providers are required to have 2 exercises per year, therefore surveyors will review the current year and the previous year to determine compliance. For outpatient providers, testing exercises are required annually, however require full-scale exercises every other year, with the opposite years allowing for the exercise of choice. In order to determine compliance, surveyors will be required to review at least the past 2 cycles (generally 4 years) of emergency testing exercises. Additionally, we are not requiring approval of the Emergency Program or official “signoff,” however, we do recommend facilities check with their State Agencies and local emergency planning coordinators (LEPCs) as some states require approval of the emergency preparedness plans as part of state licensure. Survey Procedures • Interview the facility leadership and ask him/her/them to describe the facility’s emergency preparedness program. • Ask to see the facility’s written policy and documentation on the emergency preparedness program. • For hospitals and CAHs only: Verify the hospital’s or CAH’s program was developed based on an all-hazards approach by asking their leadership to describe how the facility used an all-hazards approach when developing its program. E-0002 (Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20) §482.78 Condition of participation: Emergency preparedness for transplant programs. A transplant program must be included in the emergency preparedness planning and the emergency preparedness program as set forth in § 482.15 for the hospital in which it is located. However, a transplant program is not individually responsible for the emergency preparedness requirements set forth in § 482.15. Interpretive Guidelines for §482.78. A representative from each transplant program must be actively involved in the development and maintenance of the hospital’s emergency preparedness program, as required under §482.15(g)(1). Transplant programs would still be required to have their own emergency preparedness policies and procedures as required under §482.78(a), as well as participate in mutuallyagreed upon protocols that address the transplant program, hospital, and OPO’s duties and responsibilities during an emergency. Survey Procedures • Verify that a representative from the transplant program was included in the planning of the emergency preparedness program of the hospital in which the transplant program is located. E-0003 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §494.62 Condition for Coverage: The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: Interpretive Guidelines for §494.62. Under this condition, the ESRD facility is required to develop and update an emergency preparedness program that meets all of the standards contained within the condition. The emergency preparedness program must describe a facility's comprehensive approach to meeting the health and safety needs of their patient population during an emergency; as well as the whole community during and surrounding an emergency event (natural or man-made). Survey Procedures • Ask to see written or electronic documentation of the program. • Verify that the ESRD facility emergency preparedness program measures plan for emergencies including,, but not limited to, emergencies of fire, equipment, or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. E-0004 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. Interpretive Guidelines applies to: §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). NOTE: This does not apply to Transplant Programs. Emergency Plan- General Facilities are required to develop and maintain an emergency preparedness plan. The plan must include all of the required elements under the standard. The plan must be reviewed and updated at least every 2 years, with the exception for LTC facilities which must review and update their plan on an annual basis. This periodic review must be documented to include the date of the review and any updates made to the emergency plan based on the review. The format of the emergency preparedness plan that a facility uses is at its discretion. While this 2-year review process (except for LTC facilities) provides more flexibilities for providers to update their program as they see fit, facilities are encouraged to continue to review and update their emergency preparedness plans and train their staff accordingly as the plan may change on a more frequent basis (84 FR at 51756). An emergency plan is one part of a facility's emergency preparedness program. The plan provides the framework, which includes conducting facility-based and community-based risk assessments that will assist a facility in addressing the needs of their patient populations, along with identifying the continuity of business operations which will provide support during an actual emergency. Elements of the Emergency Plan In addition, the emergency plan supports, guides, and ensures a facility's ability to collaborate with local emergency preparedness officials. This approach is specific to the location of the facility and considers particular hazards most likely to occur in the surrounding area. These include, but are not limited to: • Natural disasters • Man-made disasters, • Facility-based disasters that include but are not limited to: o Care-related emergencies; o Equipment and utility failures, including but not limited to power, water, gas, etc.; o Interruptions in communication, including cyber-attacks; o Loss of all or portion of a facility; and o Interruptions to the normal supply of essential resources, such as water, food, fuel (heating, cooking, and generators), and in some cases, medications and medical supplies (including medical gases, if applicable). • Emerging infectious diseases (EIDs) such as Influenza, Ebola, Zika Virus and others. o These EIDs may require modifications to facility protocols to protect the health and safety of patients, such as isolation and personal protective equipment (PPE) measures. Emerging Infectious Diseases (EIDs) As facilities develop or make revisions to their emergency preparedness plans, EID’s are a potential threat which can impact the operations and continuity of care within a healthcare setting and should be considered. The type of infectious diseases to consider or the care-related emergencies that are a result of infectious diseases are not specified. Adding EID’s within a facility’s risk assessment ensures that facilities consider having infection prevention personnel involved in the planning, development and revisions to the emergency preparedness program, as these individuals would likely be coordinating activities within the facility during a potential surge of patients. Some examples of EID’s may include, but are not limited to: o Hazardous Waste o Bioterrorism o Pandemic Flu o Highly Communicable Diseases (such as Ebola, Zika Virus, SARS, or novel COVID-19 or SARS-CoV-2) EID’s may be localized to a certain community or be widespread (as seen with the COVID-19 PHE) and therefore plans for coordination with local, state, and federal officials are essential. Facilities should engage and coordinate with their local healthcare systems and healthcare coalitions, and their state and local health departments when deciding on ways to meet surge needs in their community. Understanding the Terminology CMS recognizes that there are differences in terminology used within the emergency preparedness industry pertaining to “continuity of operations” and “business continuity.” We consider “continuity of business” to incorporate all continuity operations and business continuity, which involves planning to ensure business operations will continue even during a disaster. The concept of continuity is the facility’s ability to continue operations or services related to patient care and to ensure patient safety and quality of care is continued in an emergency event. The emergency plan provides the framework, which includes conducting facility-based and community-based risk assessments that will assist a facility in addressing the needs of their patient populations, along with identifying the continuity of business operations which will provide support to services that are necessary during an actual emergency (81 FR 63875-63876). For additional information related to continuity of operations, please visit the Federal Emergency Management Agency’s (FEMA’s) Continuity Guidance Circular at https://www.fema.gov/sites/default/files/2020-07/Continuity-GuidanceCircular_031218.pdf. Essential Services and Continuity of Care When evaluating potential interruptions to the normal supply of essential services, the facility should take into account the likely durations of such interruptions. Arrangements or contracts to re-establish essential utility services during an emergency should describe the timeframe within which the contractor is required to initiate services after the start of the emergency, how they will be procured and delivered in the facility’s local area, and that the contractor will continue to supply the essential items throughout and to the end of emergencies of varying duration. However, we recognize that contracts may be subject to some issues in itself as there are no guarantees in the event of a disaster that the contractor would be able to fulfill contract terms. Facilities should also be prepared to continue to provide care in a safe setting in the event that a contract is not able to be fulfilled during the event. The emergency plan should take into account contingency planning, such as evacuation triggers in the event essential resources provided by the contractor cannot be fulfilled. Finally, facilities should also include in their planning and revisions of existing plans, contracts and inventory of supply needs; availability of personal protective equipment (PPE); critical care equipment; and transportation options/needs to be prepared for surge events. NOTE: This is also further elaborated under the facility policies and procedures required by facilities under the emergency preparedness program. Survey Procedures • Verify the facility has an emergency preparedness plan by asking to see a copy of the plan. • Ask facility leadership to identify the hazards (e.g. natural, man-made, facility, geographic, etc.) that were identified in the facility’s risk assessment and how the risk assessment was conducted. • Review the plan to verify it contains all of the required elements. • Verify that the plan is reviewed and updated every 2 years (annually for LTC facilities) by looking for documentation of the date of the review and updates that were made to the plan based on the review E-0005 (Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20) §482.78(a) Standard: Policies and procedures. A transplant program must have policies and procedures that address emergency preparedness. These policies and procedures must be included in the hospital’s emergency preparedness program. Interpretive Guidelines for §482.78(a). Transplant programs must be actively involved in their hospital’s emergency planning and programming under §482.15(g). The transplant program’s emergency preparedness plans must be included in the hospital’s emergency plans. All of the Medicare-approved transplant programs are located within certified hospitals and, as part of the hospital, must be included in the hospital’s emergency preparedness plans. The transplant program needs to be involved in the hospital’s risk assessment because there may be risks to the transplant program that others in the hospital may not be aware of or appreciate. However, most of the risk assessment of the hospital and transplant program would be the same since the transplant program is located within the hospital. Therefore a separate risk assessment would be unnecessary and overly burdensome. Survey Procedures • Verify the transplant program has emergency preparedness policies and procedures. • Verify that the transplant program’s emergency preparedness policies and procedures are included in the hospital’s emergency preparedness program. E-0006 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. Interpretive Guidelines applies to: §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2). NOTE: This does not apply to Transplant Programs. Risk Assessments Using All-Hazards Approach Facilities are expected to develop an emergency preparedness plan that is based on the facility-based and community-based risk assessment using an “all-hazards” approach. Though a format is not specified, facilities must document the risk assessment. An example consideration may include, but is not limited to, natural disasters prevalent in a facility’s geographic region such as wildfires, tornados, flooding, etc. An all-hazards approach is an integrated approach to emergency preparedness planning that focuses on capacities and capabilities that are critical to preparedness for a full spectrum of emergencies or disasters, including pandemics and EIDs as noted under E-0004. This approach is specific to the location of the facility considering the types of hazards most likely to occur in the area, but should also include unforeseen widespread communicable diseases. Thus, all-hazards planning does not specifically address every possible threat or risk but ensures the facility will have the capacity to address a broad range of related emergencies. Also, a risk assessment is facility-based, which, among other things, considers a facility’s patient population and vulnerabilities. Facility-based and community-based risk assessments are intended to assist a facility in addressing the needs of their patient populations, along with identifying the continuity of business operations which will provide support during an actual emergency (81 FR 63876). For instance, if a facility has a population which is primarily dependent on medical equipment and is not located near a nuclear power plant, the risk assessment would identify a higher risk for emergencies due to power failures than a potential for a nuclear disaster. Facilities are encouraged to utilize the concepts outlined in the National Preparedness System, published by the United States Department of Homeland Security’s Federal Emergency Management Agency (FEMA), as well as guidance provided by the Agency for Healthcare Research and Quality (AHRQ). Understanding Community-Based “Community” is not defined in order to afford facilities the flexibility in deciding which healthcare facilities and agencies it considers to be part of its community for emergency planning purposes. However, the term could mean entities within a state or multi-state region. The goal of the provision is to ensure that healthcare providers collaborate with other entities within a given community to promote an integrated response. Conducting integrated planning with state and local entities could identify potential gaps in state and local capabilities that can then be addressed in advance of an emergency. Facilities may rely on a community-based risk assessment developed by other entities, such as public health agencies, emergency management agencies, and regional health care coalitions or in conjunction with conducting its own facility-based assessment. If this approach is used, facilities are expected to have a copy of the community-based risk assessment and to work with the entity that developed it to ensure that the facility’s emergency plan is in alignment. Development of Risk Assessments based on the Plan When developing an emergency preparedness plan, facilities are expected to consider, among other things, the following: • Identification of all business functions essential to the facility’s operations that should be continued during an emergency; • Identification of all risks or emergencies that the facility may reasonably expect to confront; • Identification of all contingencies for which the facility should plan; • Consideration of the facility’s location; • Assessment of the extent to which natural or man-made emergencies may cause the facility to cease or limit operations; and, • Determination of what arrangements may be necessary with other health care facilities, or other entities that might be needed to ensure that essential services could be provided during an emergency. Risk Assessment Considerations: Based on the community threat and hazard identification process, facilities should select a comprehensive risk assessment tool that evaluates their risk and potential for hazards.. The comprehensive risk assessment should include all risks that could disrupt the facility’s operations and necessitate emergency response planning to address the risk mitigation requirements and ensure continuity of care. Using an all-hazards approach helps facilities consider and prepare for a variety of risks which may impact their healthcare settings. Facilities should categorize the various probable risks and hazards identified by likelihood of occurrence and further create supplemental risk assessments based on the disaster or public health emergency. For example: • For power loss and potential disruptions of services: Facilities can consider using a heat index or heat risk assessment to identify situations which present concerns related to patient care and safety. Facilities are required to maintain safe temperatures under (b) policies and procedures (see Tag E-0015), therefore a heat risk assessment can be considered as an additional risk assessment, but is not required. Facilities may find it helpful to refer to ASPR TRACIE for the Natural Disasters Topic Collection at https://asprtracie.hhs.gov/technicalresources/36/natural-disasters/27. NOTE: In situations where the facility does not own the structure(s) where care is provided, it is the facility’s responsibility to discuss emergency preparedness concerns with the landlord to ensure continuation of care if the structure of the building and its utilities are impacted. • For public health emergencies, such as EIDs or pandemics: Facilities should consider risk assessments to include the needs of the patient population they serve in relation to a communicable or emerging infectious disease outbreak. Planning should include a process to evaluate the facility’s needs based on the specific characteristics of an EID that includes, but is not limited to: o Influx in need for PPE; o Considerations for screening patients and visitors; which may also include testing considerations for staff, visitors and patients for infectious diseases; o Transfers and discharges of patients; o Home-based healthcare settings; o Physical Environment, including but not limited to changes needed for distancing, isolation, or capacity/surge. Planning for Staffing in Emergencies: Facilities must develop strategies for addressing emergency events that were identified during the development of the facility- and community-based risk assessments. Examples of these strategies may include, but are not limited to, developing a staffing strategy if staff shortages were identified during the risk assessment or developing a surge capacity strategy if the facility has identified it would likely be requested to accept additional patients during an emergency. Facilities will also want to consider evacuation plans. For example, a facility in a large metropolitan city may plan to utilize the support of other large community facilities as alternate care sites for its patients if the facility needs to be evacuated. The facility is also expected to have a backup evacuation plan for instances in which nearby facilities are also affected by the emergency and are unable to receive patients. Additional Specific Requirements for LTC, ICF/IIDs and Hospice: • • For LTC facilities and ICF/IIDs, written plans and the procedures are required to also include missing residents and clients, respectively, within their emergency plans. Hospices must include contingencies for managing the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. Survey Procedures • Ask to see the written documentation of the facility’s risk assessments and associated strategies. • Interview the facility leadership and ask which hazards (e.g. natural, man-made, facility, geographic) were included in the facility’s risk assessment, why they were included and how the risk assessment was conducted. • Verify the risk-assessment is facility-based and community-based, and based on an all-hazards approach specific to the geographic location of the facility and encompasses potential hazards, such as EIDs. NOTE: Surveyors are not expected to analyze a facility’s risk assessment to determine whether the identified risks are appropriate. Surveyors may take into consideration the geographic location and review the remaining standards to determine that the facility has addressed the hazards within their risk assessment through their policies and procedures. However, the intent is that surveyors review the risk assessments to determine if the facility has a risk assessment which is facility-based and also community-based. The facility’s risk assessment should describe a process facilities use to assess and document potential hazards that are likely to impact their geographical region, community, facility and patient population. The ranking of priority of the hazards and the format of the risk assessment is at the discretion and expertise of the facility. E-0007 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §403.748(a)(3), §416.54(a)(3), §418.113(a)(3), §441.184(a)(3), §460.84(a)(3), §482.15(a)(3), §483.73(a)(3), §483.475(a)(3), §484.102(a)(3), §485.68(a)(3), §485.625(a)(3), §485.727(a)(3), §485.920(a)(3), §491.12(a)(3), §494.62(a)(3). [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (3) Address [patient/client] population, including, but not limited to, persons at-risk; the type of services the [facility] has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.** *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following: (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. *NOTE: [“Persons at risk” does not apply to: ASC, hospice, PACE, HHA, CORF, CMCH, RHC/FQHC, or ESRD facilities.] Interpretive Guidelines applies to: §403.748(a)(3), §416.54(a)(3), §418.113(a)(3), §441.184(a)(3), §460.84(a)(3), §482.15(a)(3), §483.73(a)(3), §483.475(a)(3), §484.102(a)(3), §485.68(a)(3), §485.625(a)(3), §485.727(a)(3), §485.920(a)(3), §491.12(a)(3), §494.62(a)(3). NOTE: This does not apply to Transplant Programs and OPOs. Patient Population: The emergency plan must specify the population served within the facility, such as inpatients and/or outpatients, and their unique vulnerabilities in the event of an emergency or disaster. A facility’s emergency plan must also address persons at-risk, except for plans of ASCs, hospices, PACE organizations, HHAs, CORFs, CMHCs, RHCs/FQHCs and ESRD facilities. As defined by the Pandemic and All-Hazards Preparedness Act (PAHPA) of 2006, members of at-risk populations may have additional needs in one or more of the following functional areas: maintaining independence, communication, transportation, supervision, and medical care. In addition to those individuals specifically recognized as at-risk in the PAHPA (children, senior citizens, and pregnant women), “at-risk populations” are also individuals who may need additional response assistance including those who have disabilities, live in institutionalized settings, are from diverse cultures and racial and ethnic backgrounds, have limited English proficiency or are non-English speaking, lack transportation, have chronic medical disorders, or have pharmacological dependency. At-risk populations would also include, but are not limited to, the elderly, persons in hospitals and nursing homes, people with physical and mental disabilities as well as others with access and functional needs, and infants and children. At-risk populations, in the event of emerging infectious diseases and communicable diseases, may also include older adults and people of any age with underlying medical conditions or who are immunocompromised, in which exposure may place them to be at higher risk for severe illnesses. Mobility & Transfers: Mobility is an important part in effective and timely evacuations, and therefore facilities are expected to properly plan to identify patients who would require additional assistance, ensure that means for transport are accessible and available and that those involved in transport, as well as the patients and residents are made aware of the procedures to evacuate. For outpatient facilities, such as Home Health Agencies (HHAs), the emergency plan is required to ensure that patients with limited mobility are addressed within the plan. The plan should also address ways the facility will address identified patient needs that can’t be addressed by in house services in an emergency, such as just in time contracts or emergency transfers. Ultimately, the delegations of authority and succession plans need to include plans on how the facility ensures patient safety is protected and patients will receive care at the facility or if transferred, under what circumstances transfers will occur. Surge & Staffing The emergency plan must also address the types of services that the facility would be able to provide in an emergency. The emergency plan must identify which staff would assume specific roles in another’s absence through succession planning and delegations of authority. Succession planning is a process for identifying and developing internal people with the potential to fill key business leadership positions in the company. Succession planning increases the availability of experienced and capable employees that are prepared to assume these roles as they become available. During times of emergency, facilities must have employees who are capable of assuming various critical roles in the event that current staff and leadership are not available. At a minimum, there should be a qualified person who "is authorized in writing to act in the absence of the administrator or person legally responsible for the operations of the facility." This does not mean that the facility must have documentation which lists each role and the designee for those roles within the same policy. Facilities may have a general plan which outlines the roles and responsibilities of the different individuals (e.g. incident commander, public information officer, patient liaison, etc.) and refers to those individuals by their titles. For example, a Facility Incident Commander may be the Facility Administrator. Also, an Emergency Department Charge Nurse of the Day may be the facility’s identified person as the Safety Officer. However, if the facility chooses to follow this process without individual name identification, the individual serving in the role during the time of the survey should be able to adequately describe their role and responsibility during an emergency. The emergency plan should also include ways the facility will respond to identified patient needs that cannot be addressed by in-house services in an emergency, such as use of just-in-time contracts or emergency transfers. As discussed under E-0001, CMS recognizes the variability in terminology in continuity of operations, business continuity, and other terms used by the emergency management industry. The intent behind this requirement is to ensure continuity of operations, including emergency preparedness succession planning, ultimately to ensure the facility has plans in place to continue functioning during an emergency and provide care in a safe setting, which may require some/all evacuations. Ultimately, the delegations of authority and succession plans, which are different from the “continuity” plans, are documented plans which outline the specific individuals and alternate/successors who can activate the facilities emergency plans to ensure patient safety is protected and patients will receive care at the facility or if transferred, under what circumstances transfers will occur. General Considerations In addition to the facility- and community-based risk assessment, continuity of operations planning generally considers elements such as: essential personnel, essential functions, critical resources, vital records and IT data protection, alternate facility identification and location, and financial resources. Facilities are encouraged to refer to and utilize resources from various agencies such as FEMA and Assistant Secretary for Preparedness and Response (ASPR) when developing strategies for ensuring continuity of operations. NOTE: This standard to the emergency preparedness plan must be reviewed and updated annually for LTC facilities only. Survey Procedures Interview leadership and ask them to describe the following: • The facility’s patient populations that would be at risk during an emergency event; • Strategies the facility (except for an ASC, hospice, PACE organization, HHA, CORF, CMHC, RHC/FQHC and ESRD facility) has put in place to address the needs of atrisk or vulnerable patient populations; • Services that the facility would be able to provide during an emergency and any plans to address services needed that cannot be provided by the facility during an emergency as part of continuity of operations and services. • How the facility plans to continue operations during an emergency; • Delegations of authority and succession plans. Verify that all of the above are included in the written emergency plan. • If the facility has delegations and succession plans which identifies roles and responsibilities over individual facility staff names (e.g. Safety Officer = Emergency Department Charge Nurse or Pharmacy Department Lead), identify the individual who would be designated in one of the roles and interview the individual asking them to describe their role based on the facility’s emergency program. E-0008 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §486.360(a)(3) Condition for Participation: [(a) Emergency Plan. The OPO must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (3) Address the type of hospitals with which the OPO has agreements; the type of services the OPO has the capacity to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. Interpretive Guidelines for §486.360(a)(3). The emergency plan must address the type of hospitals with which the OPO has agreements and the types of services that the OPO would be able to provide in an emergency. The OPO’s emergency preparedness plan must address/include the type of hospitals in which the OPO has an agreement. However, the emergency preparedness plan is not required to be included as a part of each agreement that the OPO has with their hospitals. The emergency plan must also identify which staff would assume specific roles in another’s absence through succession planning and delegations of authority. Succession planning is a process for identifying and developing staff with the potential to fill key business leadership positions in the company. Succession planning increases the availability of experienced and capable employees that are prepared to assume these roles as they become necessary. During times of emergency, facilities must have internal employees who are capable of assuming various critical roles in the event that current staff and leaders are not available. At a minimum, facilities should designate a qualified person who is authorized in writing to act in the absence of the administrator or person legally responsible for the operations of the facility. In addition to the facility- and community-based risk assessment, continuity of operations planning generally considers elements such as: essential personnel, essential functions, critical resources, vital records and IT data protection, alternate facility identification and location, and financial resources. Facilities are encouraged to refer to and utilize resources from various agencies such as FEMA and ASPR when developing strategies for ensuring continuity of operations. Survey Procedures Interview leadership and ask them to describe the following: • Services the OPO would be able to provide during an emergency; • How the OPO plans to continue operations during an emergency; • Delegations of authority and succession plans. • How the OPO has included/addressed all of the hospitals with which it has agreements into its emergency plan. Verify that all of the above are included in the written emergency plan. E-0009 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. Interpretive Guidelines applies to: §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4). NOTE: This does not apply to Transplant Programs. Cooperation and Collaboration While the responsibility for ensuring a coordinated disaster preparedness response lies upon the state and local emergency planning authorities, the facility must have a process to engage in collaborative planning for an integrated emergency response. The facility must include this integrated response process in its emergency plan. Facilities are encouraged to participate in a healthcare coalition as it may provide assistance in planning and addressing broader community needs that may also be supported by local health department and emergency management resources. While every detail of the cooperation and collaboration process is not required to be documented in writing, it is expected that the facility has documented sufficient details to support verification of the process. When deciding on ways to meet public health emergency needs in their community, facilities are expected to engage and coordinate with their local healthcare systems (including any emergency-related Alternate Care Sites), and their local and state health departments, and federal agency staff and also encouraged to engage with their healthcare coalitions, as applicable. Facility awareness of the state’s emergency preparedness programs and pandemic plan ensures coordination occurs with the community. Coordination and communications between facilities and their public health emergency officials is instrumental in ensuring a collaborative environment during a disaster. Coordination should be pre-planned and facility management should know the state and local emergency contacts (further defined within a facilities communication plan). We also note that under state licensure or their accreditation requirements, facilities may still be required to document their collaboration with local, tribal, regional, State, and Federal emergency preparedness officials. We recommend facilities contact their State Survey Agency (SA) and/or accrediting organizations (AO) to determine if any additional requirements exist. Additional Requirement for ESRD For ESRD facilities, §494.120(c)(2) of the ESRD Conditions for Coverage on Special Purpose Dialysis Facilities describes the requirements for ESRD facilities that are set up in an emergency (i.e., an emergency circumstance facility) which are issued a unique CMS Certification Number (CCN). ESRD facilities must incorporate these specific provisions into the coordination requirements under this standard. NOTE: This standard to the emergency preparedness plan must be reviewed and updated annually for LTC facilities only. Survey Procedures • Interview facility leadership and ask them to describe their process for ensuring cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation. • For ESRD facilities, ask facility leadership to describe their process for contacting the local public health and emergency management agency public official at least to confirm that the agency is aware of the ESRD facility’s needs in the event of an emergency and know how to contact the agencies in the event of an emergency. E-0010 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §485.727(a)(4) Condition for Participation: [(a) Emergency Plan. The Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (“Organizations”) must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (4) Address the location and use of alarm systems and signals; and methods of containing fire. Interpretive Guidelines for §485.727(a)(4). The Organizations’ emergency plan must address the location and use of alarm systems and signals. The plan must also include the methods used for containing fires, such as fire extinguishers, sprinkler systems and other current methods used. The National Fire Protection Association (NFPA) at section A.20.1.1.1.6, recognizes that certain functions necessary for the life safety of building occupants, such as the closing of corridor doors, the operation of manual fire alarm devices, and the removal of patients from the room of fire origin, require the intervention of facility staff. Therefore, the plan should follow guidelines set forth by the NFPA. Survey Procedures • Ask facility leadership to show the section of the plan which addresses location(s) and use of fire alarms. • Ask facility staff to describe the facility’s current procedure for containing fires. E-0011 (Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20) §485.68(a)(5) Condition for Participation: [(a) Emergency Plan. The Comprehensive Outpatient Rehabilitation Facility (CORF) must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (a)(5) Be developed and maintained with assistance from fire, safety, and other appropriate experts. §485.727(a)(6) Condition for Participation: [(a) Emergency Plan. The Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (“Organizations”) must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (a)(6) Be developed and maintained with assistance from fire, safety, and other appropriate experts. Interpretive Guidelines applies to: §485.68(a)(5), §485.727(a)(6). The CORF and Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services must collaborate with fire, safety and other appropriate experts to develop and maintain its emergency plan. They must document their collaboration with these experts and include them in the 2-year review of the plan. Survey Procedures • Ask for a list of/documentation for which experts were collaborated with to develop and maintain its plan. E-0012 (Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20) § 482.78 Condition of participation: Emergency preparedness for transplant programs. A transplant program must be included in the emergency preparedness planning and the emergency preparedness program as set forth in § 482.15 for the hospital in which it is located. However, a transplant program is not individually responsible for the emergency preparedness requirements set forth in § 482.15. (a) Standard: Policies and procedures. A transplant program must have policies and procedures that address emergency preparedness. These policies and procedures must be included in the hospital’s emergency preparedness program. (b) Standard: Protocols with hospital and OPO. A transplant program must develop and maintain mutually agreed upon protocols that address the duties and responsibilities of the transplant program, the hospital in which the transplant program is operated, and the OPO designated by the Secretary, unless the hospital has an approved waiver to work with another OPO, during an emergency. Interpretive Guidelines applies to: §482.78(a), and §482.78(b). Hospitals which have transplant programs must include within their emergency planning and preparedness process one representative, at minimum, from the transplant program. If a hospital has multiple transplant programs, each program must have at least one representative who is involved in the development and maintenance of the hospital’s emergency preparedness process. The hospital must include the transplant programs in its emergency preparedness plan policies and procedures, communication plans, as well is the training and testing programs. Both the hospital and the transplant programs are required to demonstrate during a survey that they have coordinated in planning and the development of the emergency program. Both are required to have written documentation of the emergency preparedness plans. However, the transplant programs is not individually responsible for the emergency preparedness requirements under §482.15. Survey Procedures • Verify the hospital has written documentation to demonstrate that a representative of each transplant programs participated in the development of the emergency program. • Ask to see documentation of emergency protocols that address transplant protocols that include the hospital, the transplant programs and the associated OPOs. E-0013 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. Interpretive Guidelines applies to: §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). NOTE: This does not apply to Transplant Programs. Facilities must develop and implement policies and procedures per the requirements of this standard. The policies and procedures are expected to align with the identified hazards within the facility’s risk assessment and the facility’s overall emergency preparedness program. We also recommend that facilities include strategies and succession planning as well as contingencies which support their response to any disaster or public health emergency (also see requirements at E-0024). Facilities should also consider updates to their emergency preparedness policies and procedures during a disaster, including planning for an emergency event with a duration longer than expected. For instance, during public health emergencies such as pandemics, the Centers for Disease Control and Prevention (CDC) and other public health agencies may issue event-specific guidance and recommendations to healthcare workers. Facilities should ensure their programs have policies in place to update or provide additional emergency preparedness procedures to staff. This may include a policy delegating an individual to monitor guidance by public health agencies and issuing directives and recommendations to staff such as use of PPE when entering the building; isolation of patients under investigation (PUIs); and, any other applicable guidance in a public health emergency. We are not specifying where the facility must have the emergency preparedness policies and procedures. A facility may choose whether to incorporate the emergency policies and procedures within their emergency plan or to be part of the facility’s Standard Operating Procedures or Operating Manual. We are also not specifying the type of documentation- i.e. hard copy, electronic or other system-based emergency plans. However, the facility must be able to demonstrate compliance upon survey, therefore we recommend that facilities have a central place to house the emergency preparedness program documents (to include all policies and procedures) to facilitate review. Furthermore, since the format of the documentation is at the discretion of the facility, surveyors can identify a facility’s reviews and updates of the emergency program through meeting minutes ( facilities need to be clear if the entire program or any specific policy was reviewed and updated); through electronic or hard copy signatures on the table of contents of the emergency program documentation; or another manner. Facilities should clearly document the date of review and update and what the update entailed. For ESRD and PACE Organizations, the policies and procedures must align with the risk assessment and also include specific policies related to fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. Care related emergencies may be specific to the patient population served within these healthcare entities; as a result, the facility should ensure that in the event of any EID, there are policies and procedures in place which protect the health and safety of patients, to include but not limited to disinfection of patient stations for ESRDs and notification of transportation considerations with local government and community providers. We would expect ESRD and PACE Organizations to encompass care related emergencies within their policies and procedures. NOTE: This policy and procedure is required to be reviewed and updated annually for LTC facilities only. Survey Procedures Review the written policies and procedures which address the facility’s emergency plan and verify the following: • Policies and procedures were developed based on the facility- and community-based risk assessment and communication plan, utilizing an all-hazards approach. • Ask to see documentation that verifies the policies and procedures have been reviewed and updated at least every 2 years (annually for LTC facilities). Format is at the discretion of the facility. E-0014 (Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20) §482.78(b) Standard: Protocols with hospital and OPO. A transplant program must develop and maintain mutually agreed upon protocols that address the duties and responsibilities of the transplant program, the hospital in which the transplant program is operated, and the OPO designated by the Secretary, unless the hospital has an approved waiver to work with another OPO, during an emergency. Interpretive Guidelines for §482.78(b). Transplant programs must be involved in the development of mutually agreed upon protocols that address the duties and responsibilities of the hospital, transplant program and the designated OPO during emergencies. All transplant programs are located within Medicare participating hospitals. Any hospital that furnishes organ transplants and other medical and surgical specialty services for the care of transplant patients is defined as a transplant hospital (42 CFR 482.70). Therefore, transplant programs must meet all hospital CoPs at §§482.1 through 482.57 (as set forth at §482.68(b)), and the hospitals in which they are located must meet the provisions of § 482.15, however, a transplant program is not individually responsible for the emergency preparedness requirements in §482.15. The hospital in which a transplant program is located (i.e., a transplant hospital) would be responsible for ensuring that the transplant program is involved in the development of an emergency preparedness program. This requirement does not oblige a transplant program that agrees to care for another transplant program’s patients during an emergency to put those patients on its waiting lists. We anticipate that most emergencies would be of short duration and that the transplant program that is affected by an emergency will resume its normal operations within a short period of time. However, if a transplant program does arrange for its patients to be transferred to another transplant program during an emergency, both transplant program would need to determine what care would be provided to the transferring patients, including whether and under what circumstances the patients from the transferring transplant program would be added to the receiving transplant program’s waiting lists. Survey Procedures • • Verify the transplant program has developed mutually agreed upon protocols that address the duties and responsibilities of the transplant program, the hospital in which the transplant program is operated, and the designated OPO. Ask to see documentation of the protocols. E-0015 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §403.748(b)(1), §418.113(b)(6)(iii), §441.184(b)(1), §460.84(b)(1), §482.15(b)(1), §483.73(b)(1), §483.475(b)(1), §485.625(b)(1) [(b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following: (1) The provision of subsistence needs for staff and patients whether they evacuate or shelter in place, include, but are not limited to the following: (i) Food, water, medical and pharmaceutical supplies (ii) Alternate sources of energy to maintain the following: (A) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions. (B) Emergency lighting. (C) Fire detection, extinguishing, and alarm systems. (D) Sewage and waste disposal. *[For Inpatient Hospice at §418.113(b)(6)(iii):] Policies and procedures. (6) The following are additional requirements for hospice-operated inpatient care facilities only. The policies and procedures must address the following: (iii) The provision of subsistence needs for hospice employees and patients, whether they evacuate or shelter in place, include, but are not limited to the following: (A) Food, water, medical, and pharmaceutical supplies. (B) Alternate sources of energy to maintain the following: (1) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions. (2) Emergency lighting. (3) Fire detection, extinguishing, and alarm systems. (C) Sewage and waste disposal. Interpretive Guidelines applies to: §403.748(b)(1), §418.113(b)(6)(iii), §441.184(b)(1), §460.84(b)(1), §482.15(b)(1), §483.73(b)(1), §483.475(b)(1), §485.625(b)(1). NOTE: This does not apply to ASCs, Outpatient Hospice Providers [applies to inpatient hospices], Transplant Programs, HHA, CORFs, CMHCs, RHCs/FQHCs, ESRD facilities. Facilities must be able to provide for adequate subsistence for all patients and staff for the duration of an emergency or until all its patients have been evacuated and its operations cease. Facilities have flexibility in identifying their individual subsistence needs that would be required during an emergency. Provisions There are no requirements or standards establishing a set amount of provisions to be provided in facilities, for example ensuring availability of 72 hours’ worth of supplies. However, some states laws or accrediting organization requirements do specify a set amount or duration of subsistence items to have on hand, therefore facilities should check with their state agencies and accrediting organizations to determine if any additional requirements exist. Facilities also are required to continue to meet existing health and safety standards, such as physical environment at §482.41(a)(1) for hospitals, which address requirements like the emergency power and lighting in at least the operating, recovery, intensive care, and emergency rooms, and stairwells. In all other areas not serviced by the emergency supply source, battery lamps and flashlights must be available.. Provisions include, but are not limited to, food, pharmaceuticals and medical supplies. Provisions should be stored in an area which is less likely to be affected by disaster, such as storing these resources above ground-level to protect from possible flooding. Additionally, when inpatient facilities determine their supply needs, they are expected to consider the possibility that volunteers, visitors, and individuals from the community may arrive at the facility to offer assistance or seek shelter. This standard does not apply to outpatient facilities such as ASCs, Outpatient Hospice providers, transplant programs, HHAs, CORFs, CMHCs, RHCs/FQHCs, and ESRD facilities as it is expected that such outpatient providers would close and evacuate their patients to a safer setting during the emergency. However, per subsection (b)(1), inpatient providers must ensure that they have policies and procedures that address food, water, medical/pharmaceutical needs for both staff and patients during an emergency, regardless of whether they evacuate or not. Evacuation efforts may be delayed, therefore facilities affected by this provision should account for patient and staff needs leading up to or during an evacuation. NOTE: Facilities should also consider subsistence needs of volunteers, visitors and other individuals who are sheltering in the facility during an event. See subsection (b)(4). Alternate Energy Sources & Temperatures It is up to each individual facility, based on its risk assessment, to determine the most appropriate alternate energy sources to maintain temperatures to protect patient health and safety and for the safe and sanitary storage of provisions, emergency lighting, fire detection, extinguishing, and alarm systems, and sewage and waste disposal and continuity of treatments. Facilities are not required to upgrade their alternate energy source or electrical systems, but after review of their risk assessment may find it prudent to make modifications. Regardless of the alternate sources of energy a facility chooses to utilize, it must be in accordance with local and state laws, manufacturer requirements, as well as applicable LSC requirements (for example, hospitals are required to have an essential electric system with a generator that complies with NFPA 99 – Health Care Facilities Code and associate reference documents). Facilities must establish policies and procedures that determine how required heating and cooling of their facility will be maintained during an emergency situation, as necessary, if there were a loss of the primary power source. Facilities are not required to heat and cool the entire building evenly, but must ensure safe temperatures are maintained in those areas deemed necessary to protect patients, other people who are in the facility, and for provisions stored in the facility during the course of an emergency, as determined by the facility risk assessment. If unable to meet the temperature needs, a facility should have a relocation/evacuation plan (that may include internal relocation, relocation to other buildings on the campus or full evacuation). The relocation/evacuation should take place in a timely manner so as not to expose patients and residents to unsafe temperatures. NOTE: For LTC facilities under 483.10(i)(6), there are additional requirements for facilities who were initially certified after October 1, 1990 who must maintain a temperature range of 71 (min) to 81 °F (max). Facilities should include their Medicare [and Medicaid, as applicable] certification date[s] in the front of their plan. If used, portable generators should be connected to a facility’s electrical circuits via a power transfer system as recommended by the generators’ manufacturer. A power transfer system typically consists of a transfer switch, generator power cord and power inlet box In accordance with manufacturer instructions and NFPA 70, Article 400.8, individual extension cords should not to be run from portable generator outlet receptacles to electrical appliances. If a facility’s risk assessment determines the best way to maintain temperatures, emergency lighting, fire detection and extinguishing systems and sewage and waste disposal would be through the use of a portable and mobile generator, rather than a permanent generator, then the LSC provisions such as generator testing, maintenance, etc. outlined under the NFPA guidelines requirements would not be applicable, except for NFPA 70 - National Electrical Code. Per NFPA 70, portable and mobile generators should: • Have all wiring to each unit installed in accordance with the requirements of any of the wiring methods in Chapter 3. • Be designed and located to minimize the hazards that might cause complete failure due to flooding, fires, icing, and vandalism. • Be located so that adequate ventilation is provided. Typically, this may be accomplished by locating a portable or mobile generator outside of the building. • • Be located or protected so that sparks cannot reach adjacent combustible material. Be operated, tested and maintained in accordance with manufacturer, local and/or State requirements. For requirements regarding permanently installed generators, please refer to applicable NFPA Codes and Standards. If a health surveyor is unclear whether the facility is complying with the alternate sources of energy and temperature requirements, the health surveyor must consult with their LSC surveyors. Extension cords or other temporary wiring devices may not be used to connect electrical equipment in the facility to a portable and mobile generator due to the potential for shock, fire, and tripping hazards when using such devices. For portable generators, they must be connected and provide emergency power to a facility’s electrical system circuits via a power transfer system as recommended by the generator manufacturer. A power transfer system typically consists of a generator power supply cord, power inlet box mounted outside, and transfer switch connected to the facility electrical panel. The type of protection needed for the fuel stored by the facility for use by the portable and mobile generator will depend on the amount of fuel stored and the location of the storage, as per the appropriate NFPA standard. If a facility has a permanent generator to maintain emergency power, LSC and NFPA 110 provisions such as generator location, testing, fuel storage and maintenance, etc. will apply and the facility may be subject to LSC surveys to ensure compliance is met. Please also refer to Tag E0041 Emergency and Standby Power Systems for additional requirements for LTC facilities, CAHs and Hospitals. As an example, some facilities have contracted services with companies who maintain portable emergency generators for the facilities off-site. In the event of an emergency where the facility is unable to reschedule patients or evacuate, the generators are brought to the location in advance to assist in the event of loss of power. Facilities which are not specifically required by the EP Final Rule to have a generator, but are required to meet the provision for alternate sources of energy, may consider this approach for their facility. Sewage & Waste Disposal Facilities are not required to provide onsite treatment of sewage or waste, but must make provisions for maintaining necessary services. In addition, we are not specifying necessary services for sewage or waste management; however, facilities are required to follow their current facility-type requirements (e.g., CoPs/CfCs) which may address these areas. For example, LTC facilities are already required to meet Food Receiving and Storage provisions at §483.35(i) Sanitary Conditions, which contain requirements for keeping food off the floor and clear of ceiling sprinklers, sewer/waste disposal pipes, and vents can also help maintain food quality and prevent contamination. Additionally, ESRD facilities under current CfCs at §494.40(a)(4) are also required to have policies and procedures for handling, storage and disposal of potentially infectious waste. Additionally, we would expect facilities under this requirement to ensure current practices are followed, such as those outlined by the Environmental Protection Agency (EPA) and under State-specific laws. Maintaining necessary services may include, but are not limited to, access to medical gases; treatment of soiled linens; disposal of biohazard materials for different infectious diseases; and may require additional assistance from transportation companies for safe and appropriate disposal in accordance with nationally accepted industry guidelines for emergency preparedness. Additional General Guidance As part of the cooperation and collaboration with emergency preparedness officials required under subsection (a) (for example, §482.15(a)(4), facilities should also confer with health department and emergency management officials to determine the types and duration of energy sources that could be available to assist them in providing care to their patient population during an emergency. As part of the risk assessment planning, facilities should determine the feasibility of relying on these sources and plan accordingly. NOTE: This policy and procedure is required to be reviewed and updated annually for LTC facilities only. Survey Procedures • Verify the emergency plan includes policies and procedures for the provision of subsistence needs including, but not limited to, food, water and pharmaceutical supplies for patients and staff. • Verify the emergency plan includes policies and procedures to ensure adequate alternate energy sources, including emergency power necessary to maintain: o Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions; o Emergency lighting; and, o Fire detection, extinguishing, and alarm systems. • Verify the emergency plan includes policies and procedures to provide for sewage and waste disposal. E-0016 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §418.113(b)(1): Condition for Participation: [(b) Policies and procedures. The hospice must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following: (1) Procedures to follow up with on duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The hospice must inform State and local officials of any on-duty staff or patients that they are unable to contact. Interpretive Guidelines for §418.113(b)(1). Hospices have the flexibility to determine how best to develop these policies and procedures. For administrative purposes, all hospices should already have some mechanism in place to keep track of patients and staff contact information. However, the information regarding patient services that are needed during or after an interruption in their services and on-duty staff and patients that were not able to be contacted must be readily available, accurate, and shareable among officials within and across the emergency response system, as needed, in the interest of the patient. Hospices must develop policies and procedures that address the use of hospice employees in an emergency and the hospices’ potential surge needs; accordingly, hospices should give consideration to their roles during a natural disasters and emerging infectious diseases outbreaks or pandemics. Depending on the type of emergency, hospice staff must develop policies and procedures to maintain the continuity of services to hospice patients and should account for variability in the services which they provide- including plannin...