Excel Care Home Health Services Inc.

“Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §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 all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: The agency failed to ensure that the Condition of Participation: E 001 484.22 Establishment of the Emergency Program (EP) was in compliance as follows: 1. Based on interview and record review, the agency failed to review and update its Emergency Preparedness Program (EPP) every two years, for the 2022 and 2023 years reviewed, in a universe of 23 patients. (Refer to E 004) 2. Based on interview and record review, the agency failed to collaborate with local, regional, State, and Federal emergency preparedness officials to cooperate in the planning efforts and maintain an integrated response during a disaster or emergency for the 2022 and 2023 years reviewed, in a universe of 23 patients. (Refer to 009) 3. Based on interview and record review, the agency failed to implement policies and procedures to inform emergency preparedness officials about patients in need of evacuation and the needs the patients would require during the evacuation process, for the 2022 and 2023 years reviewed, in a universe of 23 patients. This failure had the potential to place the agency’s patients at risk when the agency was not prepared to inform emergency management officials about patients in need of evacuation and the needs the patients would require during the evacuation process. (Refer to E 019) 4. Based on interview and record review, the agency failed to implement a procedure to provide for emergency staffing during a disaster or emergency, for the 2022 and 2023 years reviewed, in a universe of 23 patients. (Refer to E 024) 5. Based on interview and record review, the agency failed to develop a back-up communication plan with Federal, State, tribal, regional, and local emergency management agencies in the event of communications (phone service, including cellular phone and Internet) failure during a disaster or emergency, for the 2022 and 2023 years reviewed, in a universe of 23 patients. (Refer to E 032) 6. Based on interview and record review, the agency failed to implement a policy and procedure to provide information about the agency’s occupancy, needs and staff available to help during an emergency or disaster to the authority having jurisdiction, for the 2022 and 2023 years reviewed, in a universe of 23 patients. (Refer to E 034) 7. Based on interview and record review, the agency failed to provide training to all staff, as well as contracted staff, on the agency’s Emergency Preparedness Program, for the 2022 and 2023 years reviewed, in a universe of 23 patients. (Refer to E 037) 8. Based on interview and record review, the agency failed to conduct full-scale emergency preparedness exercises that were community based (a full-scale exercise is a multi-agency, multi-jurisdictional, multi-discipline exercise involving functional [for example, joint field office, emergency operation centers, etc.] and “boots on the ground” response [for example, firefighters decontaminating mock victims]) or tabletop emergency preparedness exercises (an exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and set a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan), for 2022 and 2023 years reviewed, in a universe of 23 patients. (Refer to E 039) The cumulative effect of these systemic practices resulted in the potential to cause the Emergency Preparedness Program (EPP) to indicate ineffective procedures and outdated information. In addition, the potential to place the agency’s patients at risk when: the agency was not prepared to respond to the hazards most likely to occur in the community, the agency was not prepared to work with the emergency management office during an emergency or disaster, the agency did not have a back-up communication plan for governmental agencies able to provide assistance to the agency’s patients during an emergency or disaster, agency staff and contracted staff were not trained on what to do during an emergency or disaster and problems within the Emergency Preparedness Plan had the potential to go unrecognized and unaddressed.”

“Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA’s governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA’s performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This Condition is not met as evidenced by: The agency failed to ensure that the Condition of Participation: G 640 484.65 Quality assessment and performance improvement (QAPI) was in compliance as follows: 1. Based on interview, and record review, the agency failed to measure and analyze quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) to assess the agency’s processes of care, services, and operations, from January 1, 2022, to December 14, 2023, in a universe of 23 patients. (Refer to G 642) 2. Based on interview, and record review, the agency failed to use quality indicator (a measurable element of the agency’s practice that can be used to assess the quality of care provided) data from OASIS (Outcome and Assessment Information Set) to monitor the quality of the agency’s services. In addition, the agency’s Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program’s data collection, from January 1, 2022, to December 14, 2023, in a universe of 23 patients. (Refer to G 644) 3. Based on interview and record review, the agency failed to conduct and document performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the agency had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved, from January 1, 2022, to December 14, 2023, in a universe of 23 patients. (G 658) 4. Based on interview, and record review, the agency’s Governing Body (GB) failed to provide oversight for its Quality Assessment and Performance Improvement (QAPI) Program from January 1, 2022, to December 14, 2023, in a universe of 23 patients when: a. Based on interview, and record review, the agency failed to measure and analyze quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) to assess the agency’s processes of care, services, and operations, from January 1, 2022, to December 14, 2023, in a universe of 23 patients. (Refer to G 660) b. Based on interview, and record review, the agency failed to use quality indicator (a measurable element of the agency’s practice that can be used to assess the quality of care provided) data from OASIS (Outcome and Assessment Information Set) to monitor the quality of the agency’s services. In addition, the agency’s Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program’s data collection, from January 1, 2022, to December 14, 2023, in a universe of 23 patients. (Refer to (G 660) c. Based on interview and record review, the agency failed to conduct and document performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the agency had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved, from January 1, 2022, to December 14, 2023, in a universe of 23 patients. (Refer to G 660) The cumulative effect of these systemic practices resulted in the potential to cause problems in health outcomes, patient safety and quality of care, to go unrecognized and unaddressed. And the potential for the agency to provide inferior care and services to its patients.”

“Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §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), §485.542(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. . This Standard is not met as evidenced by: Based on interview and record review, the agency failed to review and update its Emergency Preparedness Program (EPP) every two years, for the 2022 and 2023 years reviewed, in a universe of 23 patients. This failure had the potential to cause the EPP to indicate ineffective procedures and outdated information. A review of the agency’s Emergency Preparedness Binder, from January 1, 2022, to December 14, 2023, was conducted. There was no documented evidence to show the Governing Body had reviewed its contents. A review of the agency’s policy and procedure titled, “Emergency Preparedness Plan,” undated, was conducted. There was no documented evidence to show a review had been conducted. A review of the agency’s Governing Body Meeting Minutes, from January 1, 2022, to December 14, 2023, was conducted. There was no documented evidence to show the Governing Body had reviewed the Emergency Preparedness Program. During an interview with the Administrator (Admin) and the Director of Patient Care Services (DPCS) on December 14, 2023, at 11:46 AM, the Admin and DPCS stated they were responsible for the Emergency Preparedness Program (EPP). The Admin stated she was a member of the Governing Body. The Admin stated she could not show documented evidence the agency’s Emergency Preparedness Program had been reviewed by the Governing Body for the years 2022 or 2023. A review of the agency’s policy and procedure titled, “Emergency Operations Plan (EOP),” dated December 1, 2017, indicated, “ANNUAL EVALUATION OF THE EMERGENCY OPERATIONS PLAN’S OBJECTIVES, SCOPE, PERFORMANCE AND EFFECTIVENESS: The annual evaluation of the Emergency Operations Plan shall include a review of the scope according to the current accrediting organization standards to evaluate the degree in which the program meets accreditation standards and the current risk assessment of the HHA [Home Health Agency]. A comparison of the expectations and actual results of the program shall be evaluated to determine if the goals and objectives of the program were met. The performance and effectiveness of the Emergency Operations Plan shall be reviewed by the Administration and Governing Body.””

“Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) §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), §485.542(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. This Standard is not met as evidenced by: Based on interview and record review, the agency failed to collaborate with local, regional, State, and Federal emergency preparedness officials to cooperate in the planning efforts and maintain an integrated response during a disaster or emergency for the 2022 and 2023 years reviewed, in a universe of 23 patients. This failure had the potential to place the agency’s patients at risk when the agency was not prepared to work with the emergency management office during an emergency or disaster. A review of the agency’s Emergency Preparedness Binder, from January 1, 2022, to December 14, 2023, was conducted. There was no documented evidence to show the agency had reached out to and collaborated with local, regional, State, and Federal emergency preparedness officials. During an interview with the Administrator (Admin) and the Director of Patient Care Services (DPCS) on December 14, 2023, at 12 PM, the Admin and DPCS stated they were responsible for the Emergency Preparedness Program (EPP). The Admin and DPCS stated they had not reached out to their local Emergency Management Office and were not a member of a healthcare coalition. The Admin and DPCS stated they had not collaborated with the local, regional, State, and Federal emergency preparedness officials and did not know who to report patients or staff they could not reach after an emergency or patients in need of evacuation. A review of the agency’s policy and procedure titled, “Emergency Preparedness Plan,” undated, indicated, “… While the responsibility for ensuring a coordinated disaster preparedness response lies upon the state, federal and local emergency planning authorities, the Agency will document its efforts to contact these officials to engage in collaborative planning for an integrated emergency response. The Agency will include this integrated response process in its emergency plan. The Agency will 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.””

“Homebound HHA/Hospice Inform EP Officials CFR(s): 484.102(b)(2) §418.113(b)(2), §460.84(b)(4), §484.102(b)(2) [(b) Policies and procedures. The [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. At a minimum, the policies and procedures must address the following:] *[For homebound Hospice at §418.113(b)(2), PACE at §460.84(b)(4), and HHAs at §484.102(b)(2):] The procedures to inform State and local emergency preparedness officials about [homebound Hospice, PACE or HHA] patients in need of evacuation from their residences at any time due to an emergency situation based on the patient’s medical and psychiatric condition and home environment. This Standard is not met as evidenced by: Based on interview and record review, the agency failed to implement policies and procedures to inform emergency preparedness officials about patients in need of evacuation and the needs the patients would require during the evacuation process, for the 2022 and 2023 years reviewed, in a universe of 23 patients. This failure had the potential to place the agency’s patients at risk when the agency was not prepared to inform emergency management officials about patients in need of evacuation and the needs the patients would require during the evacuation process. A review of the agency’s Emergency Preparedness Binder, from January 1, 2022, to December 14, 2023, was conducted. There was no documented evidence to show the agency had reached out to the local emergency management office to obtain contact information and directions on reporting to officials about patients in need of evacuation and the needs the patients would require during the evacuation process. During an interview with the Administrator (Admin) and the Director of Patient Care Services (DPCS) on December 14, 2023, at 12:33 PM, the Admin and DPCS stated they were responsible for the Emergency Preparedness Program (EPP). The Admin and DPCS stated they had not reached out to the local emergency management office and did not know the contact information or process to report to officials about patients in need of evacuation and the needs the patients would require during the evacuation process. A review of the agency’s policy and procedure titled, “Emergency Preparedness Plan,” undated, indicated, “Emergency Response Procedures: … B. The Administrator, Director of Clinical Services and/or Managers will inform both state and local emergency preparedness officials by telephone or in person about patients in need of evacuation from their homes at any time due to coronavirus pandemic based on the patient’s medical and/or psychiatric condition, home environment and relevant healthcare information assessed in the patient’s individual emergency plan. …””

“Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.542(b)(6), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(b) Policies and procedures. The [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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This Standard is not met as evidenced by: Based on interview and record review, the agency failed to implement a procedure to provide for emergency staffing during a disaster or emergency, for the 2022 and 2023 years reviewed, in a universe of 23 patients. This failure had the potential to cause patients to suffer an absence of care due to a staff shortage. A review of the agency’s Emergency Preparedness Binder, from January 1, 2022, to December 14, 2023, was conducted. There was no documented evidence to show the agency had developed an agreement with another agency or business to provide emergency staffing during an emergency or disaster. During an interview with the Administrator (Admin) and the Director of Patient Care Services (DPCS) on December 14, 2023, at 12:33 PM, the Admin and DPCS stated they were responsible for the Emergency Preparedness Program (EPP). The Admin stated it had been her intention to establish an emergency staffing agreement with another home health agency, but had not. A review of the agency’s policy and procedure titled, “Emergency Preparedness Plan,” undated, indicated, “The Agency will follow up by telephone with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services. Off-duty staff will be contacted by telephone as needed. In the event that staff are not able to report for duty, Agency may utilize staff from other facilities and state or federally designated health professionals.””

“Primary/Alternate Means for Communication CFR(s): 484.102(c)(3) §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.542(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID’s staff, Federal, State, tribal, regional, and local emergency management agencies. This Standard is not met as evidenced by: Based on interview and record review, the agency failed to develop a back-up communication plan with Federal, State, tribal, regional, and local emergency management agencies in the event of communications (phone service, including cellular phone and Internet) failure during a disaster or emergency, for the 2022 and 2023 years reviewed, in a universe of 23 patients. This failure had the potential to place the agency’s patients at risk when the agency could not communicate with Federal, State, tribal, regional, and local emergency management agencies in the event of a communications failure. A review of the agency’s Emergency Preparedness Binder, from January 1, 2022, to December 14, 2023, was conducted. There was no documented evidence to show the agency had reached out to the local emergency management office to obtain information on a back-up communication plan in the event of communications (phone service, including cellular phone and Internet) failure during a disaster or emergency. A review of the agency’s policy and procedure titled, “Emergency Preparedness Plan,” undated, indicated, “Primary and alternate means for communicating with the Agency’s staff, federal, state, tribal, regional and local emergency management agencies: … If telephones and cellular telephones cannot be used, alternate means of communication may include: radio and television announcements, pagers, walkie-talkies, Amateur Radio Operators (HAM Radio) Systems, satellite telephone, NOAA [National Oceanic and Atmospheric Administration] weather radios and in person coordination with applicable emergency management agencies by the Administrator or Director of Clinical Services.” During an interview with the Administrator (Admin) and the Director of Patient Care Services (DPCS) on December 14, 2023, at 12:48 PM, the Admin and DPCS stated they were responsible for the Emergency Preparedness Program (EPP). The Admin and DPCS stated radio and television announcements, pagers, walkie-talkies, and NOAA weather radios would not be effective ways to communicate with the emergency management office. The Admin and DPCS stated they had not reached out to the emergency management office to find out if they utilized HAM Radio systems, satellite telephones or allowed in person reporting in the event of a communications failure. The Admin and DPCS stated they had not activated or obtained a service agreement for a HAM Radio system and/or satellite telephone.”

“Information on Occupancy/Needs CFR(s): 484.102(c)(6) §403.748(c)(7), §416.54(c)(7), §418.113(c)(7) §441.184(c)(7), §482.15(c)(7), §460.84(c)(7), §483.73(c)(7), §483.475(c)(7), §484.102(c)(6), §485.68(c)(5), §485.68(c)(5), §485.727(c)(5), §485.542(c)(7), §485.625(c)(7), §485.920(c)(7), §491.12(c)(5), §494.62(c)(7). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (7) [(5) or (6)] A means of providing information about the [facility’s] occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For ASCs at 416.54(c)]: (7) A means of providing information about the ASC’s needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For Inpatient Hospice at §418.113(c):] (7) A means of providing information about the hospice’s inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This Standard is not met as evidenced by: Based on interview and record review, the agency failed to implement a policy and procedure to provide information about the agency’s occupancy, needs and staff available to help during an emergency or disaster to the authority having jurisdiction, for the 2022 and 2023 years reviewed, in a universe of 23 patients. This failure had the potential to cause the agency not to receive help and support from the authority having jurisdiction or provide staff available to help to the authority having jurisdiction. A review of the agency’s Emergency Preparedness Binder, from January 1, 2022, to December 14, 2023, was conducted. There was no documented evidence to show the agency had reached out to local emergency management office to obtain contact information and directions on reporting the agency’s occupancy, needs and staff available to help during an emergency or disaster. During an interview with the Administrator (Admin) and the Director of Patient Care Services (DPCS) on December 14, 2023, at 12:18 PM, the Admin and DPCS stated they were responsible for the Emergency Preparedness Program (EPP). The Admin and DPCS stated they had not reached out to the local emergency management office and did not know the contact information or process to report the agency’s occupancy, needs and availability of on-duty staff. A review of the agency’s policy and procedure titled, “Emergency Preparedness Plan,” undated, indicated, “Agency Communication Plan: A. The Agency has developed and maintains a communication plan that complies with federal, state, and local laws. … The communication plan includes the following: … Federal, state, tribal, regional or local emergency preparedness staff. … A means of providing information about the Agency needs, and its ability to provide assistance to the authority having jurisdiction (local and state emergency management agencies, local and state public health departments, Emergency Operations Center, the Incident Command Center or designee). The Administrator or Director of Clinical Services is responsible to provide information by telephone or in person about the Agency’s needs and ability to provide assistance.””

“EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, “Organizations” under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF’s emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This Standard is not met as evidenced by: Based on interview and record review, the agency failed to provide training to all staff, as well as contracted staff, on the agency’s Emergency Preparedness Program, for the 2022 and 2023 years reviewed, in a universe of 23 patients. This failure had the potential to place the agency’s patients at risk when agency staff and contracted staff were not trained on what to do during an emergency or disaster. During an interview with a Physical Therapist (PT 1) on December 12, 2023, at 12:41 PM, PT 1 stated she had not received an in service on the agency’s Emergency Preparedness Program. During an interview with a Licensed Vocational Nurse (LVN 1) on December 12, 2023, at 2:05 PM, LVN 1 stated he would go to an alternative meeting site if the telephone lines and cellular phone towers were down, but he did not know where the alternate site was. During an interview with a Licensed Vocational Nurse (LVN 2) on December 13, 2023, at 10:55 AM, LVN 2 stated he would use an application “app” on his phone to communicate with the agency if the telephone lines and cellular phone towers were down. LVN 2 stated the “app” may not work if the cellular phone towers were down and, in that case, he would not know what to do. A review of the agency’s in-service binder from January 1, 2022, to December 14, 2023, was conducted. There was no documented evidence to show a training on the agency’s Emergency Preparedness Program had been offered or attended. During an interview with the Administrator (Admin) and the Director of Patient Care Services (DPCS) on December 14, 2023, at 1:05 PM, the Admin and DPCS stated they were responsible for the Emergency Preparedness Program (EPP). The Admin stated she did not have documentation to show an in-service on the agency’s Emergency Preparedness Program had been provided to all staff including contracted staff. A review of the agency’s policy and procedure titled, “Emergency Operations Plan (EOP),” dated December 1, 2017, indicated, “GOALS: … Providing education to staff on the elements of the Emergency Operations Plan during orientation and annually thereafter. … ORIENTATION AND EDUCATION PROGRAM FOR THOSE WHO PARTICIPATE IN IMPLEMENTING THE PLAN: Staff shall attend orientation upon hire and an annual update of their specific roles and responsibilities and the skills they require to perform their duties during an emergency. Volunteers and individuals providing services under arrangement shall receive emergency preparedness training, consistent with their expected roles, during orientation and annually thereafter. In service education shall be given on the backup communication system and obtaining supplies/equipment in the event of an emergency. The Safety Director is responsible for the in-service of staff at the organization-wide Emergency Operations Plan. The Safety Director shall be responsible for reviewing, documenting, and updating the HHA’s emergency preparedness training and testing program annually and as needed.””

“EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: Based on interview and record review, the agency failed to conduct full-scale emergency preparedness exercises that were community based (a full-scale exercise is a multi-agency, multi-jurisdictional, multi-discipline exercise involving functional [for example, joint field office, emergency operation centers, etc.] and “boots on the ground” response [for example, firefighters decontaminating mock victims]) or tabletop emergency preparedness exercises (an exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and set a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan), for 2022 and 2023 years reviewed, in a universe of 23 patients. This failure had the potential to cause problems within the Emergency Preparedness Program to go unrecognized and unaddressed. A review of the agency’s Emergency Preparedness Binder, from January 1, 2022, to December 14, 2023, was conducted. There was no documented evidence to show a full-scale community based or tabletop emergency preparedness exercise had been conducted. During an interview with the Administrator (Admin) and the Director of Patient Care Services (DPCS) on December 14, 2023, at 1:17 PM, the Admin and DPCS stated they were responsible for the Emergency Preparedness Program (EPP). The Admin and DPCS stated they had not conducted a full-scale community based or tabletop emergency preparedness exercise in 2022 or 2023. A review of the agency’s policy and procedure titled, “Emergency Operations Plan (EOP),” dated December 1, 2017, indicated, “Implementation of the HHA’s [Home Health Agency] Emergency Operations Plan shall be conducted at least annually, either in response to an emergency or as a planned drill. If applicable, the HHA shall participate in at least one communitywide drill annually that is relevant to the priority of emergencies identified in the hazard vulnerability analysis. The HHA’s Emergency Operations Plan identifies who is in charge of specific activities and when they are to assume oversight responsibilities. This HHA cooperates with all local, county and state emergency management drills. The Safety Director is a member of the countywide emergency management system and coordinates with other agencies any large-scale drills. … In instances when the community partners are unable or unwilling to participate in the emergency planning efforts, the following shall be documented: Evidence of communication with the community partners in the form of letters, community meeting minutes and email correspondence. The Safety Director shall be responsible for documenting the HHA’s participation in collaborative and cooperative planning with community partners.””

“Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This Standard is not met as evidenced by: Based on interview, and record review, the agency failed to measure and analyze quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) to assess the agency’s processes of care, services, and operations, from January 1, 2022, to December 14, 2023, in a universe of 23 patients. This failure had the potential to cause problems in health outcomes, patient safety and quality of care, to go unrecognized and unaddressed. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2022, to December 14, 2023. The QAPI binder indicated the following quality indicators: a. Patient Infections b. Incident Reports c. Patient Hospitalizations The QAPI binder did not contain documented evidence to show data had been assembled and analyzed, from January 1, 2022, to December 14, 2023. There was no documented evidence to show statistical techniques such as controls charts (a graph used to study how a process changes over time), histograms (a graphical representation that organizes a group of data points into user-specified ranges), bar graphs (a chart that plots data using rectangular bars or columns) or pareto charts (a chart that contains both bars and a line graph, where individual values are represented in descending order by bars, and the cumulative total is represented by the line) had been used to analyze the collected data. The QAPI binder did not contain documented evidence to show the agency had developed mechanisms such as thresholds (a value), setting upper and lower control limits (identifies what value is acceptable), percentages (numbers that summarize data), ratios (the relationship in quantity, amount, or size between two or more things) or performance goals in order to identify levels, patterns or trends in the agency’s provision of care from January 1, 2022, to December 14, 2023. During a concurrent record review and interview, on December 14, 2023, at 10:47 AM, with the Administrator (Admin) and the Director of Patient Care Services (DPCS), the contents of the QAPI binder were reviewed. The Admin and DPCS stated they were responsible for the QAPI Program. The Admin and DPCS stated the QAPI Program had not been functioning from January 1, 2022, to December 14, 2023. A review of the agency’s policy and procedure titled, “Organizational Quality Assessment and Performance Improvement (QAPI) Program,” dated January 1, 2018, indicated, “PURPOSE: The HHA’s [Home Health Agency] Quality Assessment and Performance Improvement (QAPI) program shall be designed to: Delineate expectations and plan and manage processes to measure, assess and improve the HHA’s governance, management, clinical and support activities. … Identify, on an ongoing basis and in a coordinated and collaborative manner, areas for improvement in the quality of care, treatment and services. Evaluate, monitor, improve and resolve areas of concern. … POLICY: The Administration of [name of agency] shall be committed to and support a planned, systematic and data-driven organization-wide QAPI plan that encompasses well-designed processes and performance measurement, analysis and improvement. … The HHA shall maintain documentation of its QAPI program and related activities. GOALS: The primary goals of the organizational QAPI program shall be to continually and systematically plan, design, measure, assess and improve performance of organization­ wide key functions and processes relative to patient care, treatment, and services. To achieve this goal, the program strives to: …Provide for an organization-wide program that assures the HHA designs processes (with special emphasis on design of new or revisions in established services) well and systematically measures, assesses, and improves its performance to achieve optimal patient health outcomes in a collaborative, cross-departmental, interdisciplinary approach. These processes include mechanisms to assess the needs and expectations of patients and their families, staff, and others. Process design contains the following focus elements: … Utilizes collected data to: Monitor the effectiveness and safety of services and quality of care. Identify opportunities for improvement. … Information from departments/services and the findings of discrete OAPI activities shall be analyzed to detect trends, patterns of performance or potential problems that may impact more than one (1) department/service. … SCOPE OF ACTIVITIES: … Collaborative and specific indicators of both key processes and outcomes of care shall be designed, measured, and assessed by appropriate departments/services and disciplines in an effort to improve patient/staff safety and organizational performance. These indicators are objective, measurable, based on current knowledge and experience and are structured to produce statistically valid performance measures of care, treatment and services provided. This mechanism also provides for evaluation of improvements and the stability of the improvement over time. … Benchmarks or thresholds that trigger intensive assessment and evaluation shall be established. Undesirable patterns or trends in performance shall be analyzed for all of the above; however, an in-depth analysis is conducted for the following when the levels of performance, patterns or trends vary substantially from those expected …””

“Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA’s governing body. This Standard is not met as evidenced by: Based on interview, and record review, the agency failed to use quality indicator (a measurable element of the agency’s practice that can be used to assess the quality of care provided) data from OASIS (Outcome and Assessment Information Set) to monitor the quality of the agency’s services. In addition, the agency’s Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program’s data collection, from January 1, 2022, to December 14, 2023, in a universe of 23 patients. This failure had the potential for the agency to miss statistically significant data from OASIS reports and fail to identify patient population trends. In addition, the GB may miss an opportunity to correct ineffective data collection. 1. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2022, to December 14, 2023. The QAPI binder indicated the following quality indicators: a. Patient Infections b. Incident Reports c. Patient Hospitalizations The QAPI binder did not contain documented evidence to show a quality indicator had been chosen for the time period of: January 1, 2022, to December 14, 2023, from the following OASIS reports: a. Home Health Compare (a report on home health agency performance and patient satisfaction) b. Outcome-Bases Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing. (a report on incidence rates for 12 infrequently occurring untoward events. These potentially avoidable events reflect a serious health problem or decline in health status for an individual patient that potentially could have been avoided) c. Outcome-Based Quality Improvement (OBQI) Outcome Report (statistics from the agency’s OASIS reporting for use in the agency’s QAPI program) d. Patient/Agency Characteristics Report (presents a “snapshot” of agency patient characteristics) e. Submission Statistics by Agency Report (OASIS submissions made by or on behalf of an agency during a specified period of time) f. Error Summary Report by Home Health Agency (summarizes the errors an agency encountered in OASIS submissions during a specified period of time) During a concurrent record review and interview, on December 14, 2023, at 11:22 AM, with the Administrator (Admin) and Director of Patient Care Services (DPCS) the contents of the QAPI binder were reviewed. The Admin and DPCS stated they were responsible for the QAPI program. The Admin and DPCS verified a quality indicator had not been chosen from the OASIS reports. The Admin and DPCS stated they had been unaware of this requirement. A review of the agency’s policy and procedure titled, “Organizational Quality Assessment and Performance Improvement (QAPI) Program,” dated January 1, 2018, indicated, “GOALS: The primary goals of the organizational QAPI program shall be to continually and systematically plan, design, measure, assess and improve performance of organization-wide key functions and processes relative to patient care, treatment and services. To achieve this goal, the program strives to: … Utilizes reports generated from OASIS data, including the following OASIS reports: Outcome-Based Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing. Outcome-Based Quality Improvement (OBQI) Outcome Report. Patient/Agency Characteristics Report. Submission Statistics by Agency Report. Error Summary Report by HHA. …” 2. A review of the agency’s “Governing Body Minutes,” binder, undated, was conducted from January 1, 2022, to December 14, 2023. There was no documented evidence to show the Governing Body (GB) approved the frequency and detail of the QAPI program’s data collection. There was no documented evidence to show the QAPI Committee had provided the detail and frequency of data collection to the GB for review and approval. During an interview with the Administrator (Admin) on December 14, 2023, at 11:32 AM, the Admin stated she was a member of the Governing Body (GB) and the GB had not approved the frequency and detail of data collection for the QAPI program from January 1, 2022, to December 14, 2023. A review of the agency’s policy and procedure titled, “Organizational Quality Assessment and Performance Improvement (QAPI) Program,” dated January 1, 2018, indicated, “GOALS: The primary goals of the organizational QAPI program shall be to continually and systematically plan, design, measure, assess and improve performance of organization-wide key functions and processes relative to patient care, treatment and services. To achieve this goal, the program strives to: … The frequency and detail of the data collection as approved by the Governing Body. … REPORTING FORMAT: … The QAPI Committee shall provide the Governing Body with a report of the relevant findings from all QAPI activities performed throughout the organization at least on a quarterly basis.””

“Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA’s services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This Standard is not met as evidenced by: Based on interview and record review, the agency failed to conduct and document performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the agency had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved, from January 1, 2022, to December 14, 2023, in a universe of 23 patients. This failure had the potential to cause problems in health outcomes, patient safety and quality of care to go unaddressed and continue. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2022, to December 14, 2023. There was no documented evidence to show performance improvement projects had been initiated, were in process or had been completed for the 24 months (January 1, 2022, to December 14, 2023) reviewed. During a concurrent record review and interview, on December 14, 2023, at 11:45 AM, with the Administrator (Admin) and Director of Patient Care Services (DPCS) the contents of the QAPI binder were reviewed. The Admin and DPCS stated they were responsible for the QAPI Program. The Admin and DPCS stated a PIP had not been initiated or conducted from January 1, 2022, to December 14, 2023. A review of the agency’s policy and procedure titled, “Organizational Quality Assessment and Performance Improvement (QAPI) Program,” dated January 1, 2018, indicated, “PERFORMANCE IMPROVEMENT PROJECTS: The HHA [Home Health Agency] shall conduct Performance Improvement Projects as part of its organization-wide OAPI program. Performance Improvement Projects shall be conducted and documented at least annually. …””

“Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA’s governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This Standard is not met as evidenced by: Based on interview, and record review, the agency’s Governing Body (GB) failed to provide oversight for its Quality Assessment and Performance Improvement (QAPI) Program from January 1, 2022, to December 14, 2023, in a universe of 23 patients when: 1. Based on interview, and record review, the agency failed to measure and analyze quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) to assess the agency’s processes of care, services, and operations, from January 1, 2022, to December 14, 2023, in a universe of 23 patients. This failure had the potential to cause problems in health outcomes, patient safety and quality of care, to go unrecognized and unaddressed. 2. Based on interview, and record review, the agency failed to use quality indicator (a measurable element of the agency’s practice that can be used to assess the quality of care provided) data from OASIS (Outcome and Assessment Information Set) to monitor the quality of the agency’s services. In addition, the agency’s Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program’s data collection, from January 1, 2022, to December 14, 2023, in a universe of 23 patients. This failure had the potential for the agency to miss statistically significant data from OASIS reports and fail to identify patient population trends. In addition, the GB may miss an opportunity to correct ineffective data collection. 3. Based on interview and record review, the agency failed to conduct and document performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the agency had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved, from January 1, 2022, to December 14, 2023, in a universe of 23 patients. This failure had the potential to cause problems in health outcomes, patient safety and quality of care to go unaddressed and continue. This failure had the potential to cause the agency to provide inferior care and services to its patients. 1. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2022, to December 14, 2023. The QAPI binder indicated the following quality indicators: a. Patient Infections b. Incident Reports c. Patient Hospitalizations The QAPI binder did not contain documented evidence to show data had been assembled and analyzed, from January 1, 2022, to December 14, 2023. There was no documented evidence to show statistical techniques such as controls charts (a graph used to study how a process changes over time), histograms (a graphical representation that organizes a group of data points into user-specified ranges), bar graphs (a chart that plots data using rectangular bars or columns) or pareto charts (a chart that contains both bars and a line graph, where individual values are represented in descending order by bars, and the cumulative total is represented by the line) had been used to analyze the collected data. The QAPI binder did not contain documented evidence to show the agency had developed mechanisms such as thresholds (a value), setting upper and lower control limits (identifies what value is acceptable), percentages (numbers that summarize data), ratios (the relationship in quantity, amount, or size between two or more things) or performance goals in order to identify levels, patterns or trends in the agency’s provision of care from January 1, 2022, to December 14, 2023. During a concurrent record review and interview, on December 14, 2023, at 10:47 AM, with the Administrator (Admin) and the Director of Patient Care Services (DPCS), the contents of the QAPI binder were reviewed. The Admin and DPCS stated they were responsible for the QAPI Program. The Admin and DPCS stated the QAPI Program had not been functioning from January 1, 2022, to December 14, 2023. A review of the agency’s policy and procedure titled, “Organizational Quality Assessment and Performance Improvement (QAPI) Program,” dated January 1, 2018, indicated, “PURPOSE: The HHA’s [Home Health Agency] Quality Assessment and Performance Improvement (QAPI) program shall be designed to: Delineate expectations and plan and manage processes to measure, assess and improve the HHA’s governance, management, clinical and support activities. … Identify, on an ongoing basis and in a coordinated and collaborative manner, areas for improvement in the quality of care, treatment and services. Evaluate, monitor, improve and resolve areas of concern. … POLICY: The Administration of [name of agency] shall be committed to and support a planned, systematic and data-driven organization-wide QAPI plan that encompasses well-designed processes and performance measurement, analysis and improvement. … The HHA shall maintain documentation of its QAPI program and related activities. GOALS: The primary goals of the organizational QAPI program shall be to continually and systematically plan, design, measure, assess and improve performance of organization­ wide key functions and processes relative to patient care, treatment, and services. To achieve this goal, the program strives to: …Provide for an organization-wide program that assures the HHA designs processes (with special emphasis on design of new or revisions in established services) well and systematically measures, assesses, and improves its performance to achieve optimal patient health outcomes in a collaborative, cross-departmental, interdisciplinary approach. These processes include mechanisms to assess the needs and expectations of patients and their families, staff, and others. Process design contains the following focus elements: … Utilizes collected data to: Monitor the effectiveness and safety of services and quality of care. Identify opportunities for improvement. … Information from departments/services and the findings of discrete OAPI activities shall be analyzed to detect trends, patterns of performance or potential problems that may impact more than one (1) department/service. … SCOPE OF ACTIVITIES: … Collaborative and specific indicators of both key processes and outcomes of care shall be designed, measured, and assessed by appropriate departments/services and disciplines in an effort to improve patient/staff safety and organizational performance. These indicators are objective, measurable, based on current knowledge and experience and are structured to produce statistically valid performance measures of care, treatment and services provided. This mechanism also provides for evaluation of improvements and the stability of the improvement over time. … Benchmarks or thresholds that trigger intensive assessment and evaluation shall be established. Undesirable patterns or trends in performance shall be analyzed for all of the above; however, an in-depth analysis is conducted for the following when the levels of performance, patterns or trends vary substantially from those expected …” 2a. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2022, to December 14, 2023. The QAPI binder indicated the following quality indicators: a. Patient Infections b. Incident Reports c. Patient Hospitalizations The QAPI binder did not contain documented evidence to show a quality indicator had been chosen for the time period of: January 1, 2022, to December 14, 2023, from the following OASIS reports: a. Home Health Compare (a report on home health agency performance and patient satisfaction) b. Outcome-Bases Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing. (a report on incidence rates for 12 infrequently occurring untoward events. These potentially avoidable events reflect a serious health problem or decline in health status for an individual patient that potentially could have been avoided) c. Outcome-Based Quality Improvement (OBQI) Outcome Report (statistics from the agency’s OASIS reporting for use in the agency’s QAPI program) d. Patient/Agency Characteristics Report (presents a “snapshot” of agency patient characteristics) e. Submission Statistics by Agency Report (OASIS submissions made by or on behalf of an agency during a specified period of time) f. Error Summary Report by Home Health Agency (summarizes the errors an agency encountered in OASIS submissions during a specified period of time) During a concurrent record review and interview, on December 14, 2023, at 11:22 AM, with the Administrator (Admin) and Director of Patient Care Services (DPCS) the contents of the QAPI binder were reviewed. The Admin and DPCS stated they were responsible for the QAPI program. The Admin and DPCS verified a quality indicator had not been chosen from the OASIS reports. The Admin and DPCS stated they had been unaware of this requirement. A review of the agency’s policy and procedure titled, “Organizational Quality Assessment and Performance Improvement (QAPI) Program,” dated January 1, 2018, indicated, “GOALS: The primary goals of the organizational QAPI program shall be to continually and systematically plan, design, measure, assess and improve performance of organization-wide key functions and processes relative to patient care, treatment and services. To achieve this goal, the program strives to: … Utilizes reports generated from OASIS data, including the following OASIS reports: Outcome-Based Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing. Outcome-Based Quality Improvement (OBQI) Outcome Report. Patient/Agency Characteristics Report. Submission Statistics by Agency Report. Error Summary Report by HHA. …” 2b. A review of the agency’s “Governing Body Minutes,” binder, undated, was conducted from January 1, 2022, to December 14, 2023. There was no documented evidence to show the Governing Body (GB) approved the frequency and detail of the QAPI program’s data collection. There was no documented evidence to show the QAPI Committee had provided the detail and frequency of data collection to the GB for review and approval. During an interview with the Administrator (Admin) on December 14, 2023, at 11:32 AM, the Admin stated she was a member of the Governing Body (GB) and the GB had not approved the frequency and detail of data collection for the QAPI program from January 1, 2022, to December 14, 2023. A review of the agency’s policy and procedure titled, “Organizational Quality Assessment and Performance Improvement (QAPI) Program,” dated January 1, 2018, indicated, “GOALS: The primary goals of the organizational QAPI program shall be to continually and systematically plan, design, measure, assess and improve performance of organization-wide key functions and processes relative to patient care, treatment and services. To achieve this goal, the program strives to: … The frequency and detail of the data collection as approved by the Governing Body. … REPORTING FORMAT: … The QAPI Committee shall provide the Governing Body with a report of the relevant findings from all QAPI activities performed throughout the organization at least on a quarterly basis.” 3. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2022, to December 14, 2023. There was no documented evidence to show performance improvement projects had been initiated, were in process or had been completed for the 24 months (January 1, 2022, to December 14, 2023) reviewed. During a concurrent record review and interview, on December 14, 2023, at 11:45 AM, with the Administrator (Admin) and Director of Patient Care Services (DPCS) the contents of the QAPI binder were reviewed. The Admin and DPCS stated they were responsible for the QAPI Program. The Admin and DPCS stated a PIP had not been initiated or conducted from January 1, 2022, to December 14, 2023. A review of the agency’s policy and procedure titled, “Organizational Quality Assessment and Performance Improvement (QAPI) Program,” dated January 1, 2018, indicated, “PERFORMANCE IMPROVEMENT PROJECTS: The HHA [Home Health Agency] shall conduct Performance Improvement Projects as part of its organization-wide OAPI program. Performance Improvement Projects shall be conducted and documented at least annually. …” During an interview with the Administrator (Admin) on December 14, 2023, at 11:45 AM, the Admin stated she was a member of the Governing Body (GB). The Admin stated the GB had not identified the QAPI committee’s failure to measure and analyze data, choose a quality indicator from OASIS reports, or conduct performance improvement projects from January 1, 2022, to December 14, 2023. The Admin stated the GB had not approved the frequency and detail of the QAPI program’s data collection from January 1, 2022, to December 14, 2023. A review of the agency’s policy and procedure titled, “Organizational Quality Assessment and Performance Improvement (QAPI) Program,” dated January 1, 2018, indicated, “ORGANIZATION: To achieve fulfillment of the objectives, goals, and scope of the organizational QAPI plan, the organizational structure of the program shall be designed to facilitate an effective system of monitoring, assessment and evaluation of the care, treatment and services provided within the HHA [Home Health Agency]. The Governing Body shall ultimately be responsible for the quality of patient care, treatment and services provided. The Governing Body shall require staff, through the QAPI Committee and Administration, to implement and report on the activities and the mechanisms for monitoring, assessing, and evaluating patient safety practices and the quality of patient care, treatment and services, for identifying and resolving problems and for identifying opportunities to improve patient care, treatment and services or performance throughout the organization. This process addresses those departments/disciplines that have a direct or indirect effect on patient care, treatment, and services, including management and administrative functions. The Governing Body, through the HHA Administrator, shall provide for resources and support systems for the quality assessment and performance improvement functions and risk management functions related to patient care, treatment and services and safety. The Governing Body shall have a responsibility to evaluate the effectiveness of the QAPI activities performed throughout the HHA and the organizational QAPI program as a whole. …””

“Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency’s overall management and operation, the provision of all home health services, fiscal operations, review of the agency’s budget and its operational plans, and its quality assessment and performance improvement program. This Standard is not met as evidenced by: Based on interview, and record review, the Governing Body (GB) failed to operate and manage the agency from January 1, 2022, to December 11, 2023, in a universe of 23 patients when a current California Department of Public Health (CDPH) Laboratory Registration was not maintained. This failure caused the agency to perform waived laboratory testing without CDPH oversight for two years. During an agency tour on December 11, 2023, at 11:02 AM, the agency’s postings were reviewed. There was no posting of a California Department of Public Health (CDPH) Laboratory Registration, for the agency. During an interview with the Administrator (Admin) on December 11, 2023, at 11:02 AM, the Admin stated she was a member of the agency’s Governing Body (GB) and it was her responsibility to ensure the agency’s CDPH Laboratory Registration was kept current and active. The Admin stated she had been unaware of the requirement to obtain a CDPH Laboratory Registration. The Admin stated the agency had been conducting waived laboratory testing without a CDPH Laboratory Registration for two years. A review of the agency’s policy and procedure titled, “Governance-Governing Body/Management Company,” dated December 1, 2017, indicated, “PURPOSE: To ensure compliance with State and Federal rules and regulations, …. To delineate the authority and responsibilities of the Governing Body/Management Company. POLICY: [Name of Administrator-Admin] is the Governing Body for [name of agency] and as such possesses ultimate responsibility and legal authority for managing the organization, for the safety of HHA [Home Health Agency] staff and patients, and for the quality of care, treatment and services provided. … The Governing Body shall be responsible for (not all inclusive): Establishing the organization’s mission, vision and goals. Ensuring that appropriate licenses, certificates or permits, as required by applicable laws, regulations, and standards, are current and valid, and posted in a prominent location accessible to public view in accordance with applicable laws, standards and regulations. …””

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on interview, and record review, the agency failed to ensure the patients’ initial assessment was completed within 48 hours of the physician’s referral date or on the physician-ordered start of care date for three of seven sampled patients (Patients 3, 4, and 7). This failure had the potential to cause a delay in the determination of Patients 3, 4, and 7 immediate care and support needs. 1. A review of Patient 3’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of October 9, 2023, with a certification period of October 9, 2023, to December 7, 2023. Patient 3 had diagnoses that included dementia (a group of thinking and social symptoms that interferes with daily functioning) A review of Patient 3’s referral order dated October 6, 2023, indicated a request for home health services. A review of Patient 3’s initial assessment dated October 9, 2023, indicated the initial assessment had been conducted on October 9, 2023. (The initial assessment had been completed three days after the physician’s referral order) 2. A review of Patient 4’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of July 10, 2023, with a recertification period of November 7, 2023, to January 5, 2023. Patient 4 had diagnoses that included osteoporosis (a condition in which bones become weak and brittle). A review of Patient 4’s referral order dated July 7, 2023, indicated a request for home health services. A review of Patient 4’s initial assessment dated July 10, 2023, indicated the initial assessment had been conducted on July 10, 2023. (The initial assessment had been completed three days after the physician’s referral order) 3. A review of Patient 7’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of March 28, 2023, with a recertification period of September 24, 2023, to November 22, 2023. Patient 7 had diagnoses that included Parkinson’s disease (a disorder of the central nervous system that affects movement, often including tremors). A review of Patient 7’s referral order dated March 25, 2023, indicated a request for home health services. A review of Patient 7’s initial assessment dated March 28, 2023, indicated the initial assessment had been conducted on March 28, 2023. (The initial assessment had been completed three days after the physician’s referral order) During a concurrent interview and record review with the Administrator (Admin) and Director of Patient Care Services (DPCS) on October 13, 2023, at 3:07 PM, October 11, 2023, at 3 PM and October 14, 2023, at 9:28 AM, respectively, Patient 3, 4 and 7’s clinical record was reviewed, respectively. The Admin and DPCS verified Patient 3, 4, and 7, did not have an initial assessment within 48 hours of the referral to the agency and should have. A review of the agency’s policy and procedure titled “Initial Assessment,” dated December 1, 2017, indicated, “Initial Assessments shall be performed by a Registered Nurse (RN) or rehabilitation Skilled Therapist, as appropriate, within: 48 hours of referral, or 48 hours of the patient’s return home, or On the physician-ordered start of care date.””