Care Essentials Home Health

“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 2023 and 2024 years reviewed, in a universe of 96 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 2023 and 2024 years reviewed, in a universe of 96 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 2023 and 2024 years reviewed, in a universe of 96 patients. (Refer to E 019) 4. Based on interview and record review, the agency failed to develop and implement a procedure to provide for emergency staffing during a disaster or emergency, for the 2023 and 2024 years reviewed, in a universe of 96 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 2023 and 2024 years reviewed, in a universe of 96 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 2023 and 2024 years reviewed, in a universe of 96 patients. (Refer to E 034) 7. 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 2023 and 2024 years reviewed, in a universe of 96 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, and problems within the Emergency Preparedness Plan had the potential to go unrecognized and unaddressed.”

“Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This Condition is not met as evidenced by: The agency failed to ensure the Condition of Participation: G 940 484.105 Organization and administration of services was in compliance when: 1. Based on interview, and record review, the agency failed to review and update its Emergency Preparedness Program (EPP) every two years, for the 2023 and 2024 years reviewed, in a universe of 96 patients. (Refer to G 942) 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 2023 and 2024 years reviewed, in a universe of 96 patients. (Refer to G 942) 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 2023 and 2024 years reviewed, in a universe of 96 patients. (Refer to G 942) 4. Based on interview, and record review, the agency failed to develop and implement a procedure to provide for emergency staffing during a disaster or emergency, for the 2023 and 2024 years reviewed, in a universe of 96 patients. (Refer to G 942) 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 2023 and 2024 years reviewed, in a universe of 96 patients. (Refer to G 942) 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 2023 and 2024 years reviewed, in a universe of 96 patients. (Refer to G 942) 7. 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 2023 and 2024 years reviewed, in a universe of 96 patients. (Refer to G 942) 8. Based on interview, and record review, the agency failed to transmit OASIS (Outcome and Assessment Information Set-patient-specific information used in Medicare to determine reimbursement and measure quality) data (facts collected together for analysis) from patient assessments was transmitted to CMS (Centers for Medicare and Medicaid Services) within 30 days of the completion date for one of seven sampled patients (Patient 6) when transfer and discharge OASIS assessments were not conducted or transmitted. (Refer to G 942) 9. 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 four of seven sampled patients (Patients 1, 2, 5, and 6). (Refer to G 942) 10. Based on observation, interview, and record review, the agency failed to ensure a Registered Nurse (RN) updated the comprehensive assessment for one of seven sampled patients (Patient 1) when Patient 1’s right ankle surgical wound had healed and the continued need for the protective orthopedic (the branch of medicine concerned with conditions involving bones and/or muscles) “boot” (a medical device that protects and stabilizes the foot or ankle after an injury) was not re-evaluated in consultation with the orthopedic physician. (Refer to G 942) 11. Based on interview, and record review, the agency failed to ensure upon transfer and/or discharge all necessary medical information pertaining to the patient’s current course of illness and treatment, was sent to the receiving healthcare facility and healthcare practitioner for two of seven sampled patients (Patients 6 and 7). (Refer to G 942) 12. Based on observation, interview, and record review, the agency failed to ensure each patient received home health services that were written in an individualized plan of care that identified patient-specific measurable outcomes and goals, for one of seven sampled patients (Patient 1) when Patient 1’s right ankle surgical wound was enclosed in a protective orthopedic “boot” and the “boot” was not in Patient 1’s plan of care. (Refer to G 942) 13. Based on interview, and record review, the agency failed to ensure the patients’ individualized plans of care contained all the required elements for two of seven sampled patients (Patients 3 and 5) when: a. For Patient 3: the Physical Therapy (PT) and Occupational Therapy (OT) visit frequencies were not in the plan of care and there were no physician’s orders with PT and OT visit frequencies to update the plan of care. (Refer to G 942) b. For Patient 5: the Skilled Nursing (SN) frequencies were not in the plan of care and there were no physician’s orders with SN visit frequencies to update the plan of care. (Refer to G 942) 14. Based on interview, and record review, the agency failed to obtain physician’s orders for one of seven sampled patients (Patient 1) when an RN removed surgical staples from Patient 1’s right ankle without a physician’s order. (Refer to G 942) 15. Based on interview, and record review, the agency failed to maintain an infection control program that was integrated into the agency’s Quality Assessment Performance Improvement (QAPI) program in order to: identify infection trends (analysis of a pattern), develop action plans and improve disease prevention, from January 3, 2024, to February 13, 2025, in a universe of 96 patients. (Refer to G 942) 16. Based on observation, interview, and record review, the agency failed to ensure an RN provided a Certified Home Health Aide (CHHA) written patient care instructions for one of seven sampled patients (Patient 1) when the CHHA’s care plan did not contain special instructions on how to care for Patient 1’s orthopedic “boot.” (Refer to G 942) 17. Based on interview, and record review, the agency failed to conduct an on-site CHHA supervisory visit every 14 days for two of seven sampled patients (Patients 1 and 4). (Refer to G 942) 18. Based on interview, and record review, the agency failed to ensure the clinical record contained a completed discharge summary sent to the primary care practitioner within five business days of the patient’s discharge and a completed transfer summary was sent within two business days of becoming aware of a planned transfer to a receiving health care facility, for two or seven sampled patients (Patients 6 and 7). (Refer to G 942) The cumulative effect of these systemic practices resulted in the potential: for the EPP to indicate ineffective procedures and outdated information, 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, 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, to cause patients to suffer an absence of care due to a staff shortage, 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, 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, to cause problems within the Emergency Preparedness Program to go unrecognized and unaddressed, to result in inaccurate reimbursement calculations and quality measurements, to cause a delay in the determination of Patients 1, 2, 5, and 6’s immediate care and support needs, to cause Patient 1 to suffer skin irritation and pressure sores from prolonged contact with the “boot,” to cause Patient 6 and 7 to suffer healthcare complications, including delayed diagnosis, incorrect treatment decisions, and adverse drug interactions, to cause Patient 1 to suffer improper use and maintenance of the boot, which was crucial for optimal healing of the injured area by providing the necessary stability and immobilization, while also preventing complications like skin irritation, infection, or improper weight distribution, to cause Patients 3 and 5 not to receive the care and services to meet their care planning goals, to cause Patient 1’s surgical wound to open before it was healed, to cause trends in infections to go unrecognized, unaddressed and patients to suffer repeated and prolonged infections, to cause Patient 1 to suffer skin irritation and breakdown when the CHHA did not clean the area under the “boot” and misalignment of the “boot,” potentially causing delayed healing and increased pain, and to cause inconsistent quality of care, missed opportunities to address changing patient needs, and compromising the well-being of the patient due to improper or inadequate care.”

“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 2023 and 2024 years reviewed, in a universe of 96 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, 2023, to February 27, 2025, 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, 2023, to February 27, 2025, was conducted. There was no documented evidence to show the Governing Body had reviewed the Emergency Preparedness Program. During an interview with the Administrator Designee (AD) and Administrator/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 1:19 PM, the Admin/DPCS stated she was responsible for the Emergency Preparedness Program (EPP). The AD stated he was a member of the Governing Body, and he could not show documented evidence the agency’s Emergency Preparedness Program had been reviewed by the Governing Body for the years 2023 or 2024. A review of the agency’s policy and procedure titled, “Emergency Management Plan,” dated November 2018 was conducted. There was no documented evidence to show a requirement to review and update the agency’s Emergency Preparedness Program every two years. A review of the agency’s policy and procedure titled, “Emergency Preparedness Plan,” undated, was conducted. There was no documented evidence to show a requirement to review and update the agency’s Emergency Preparedness Program every two years.”

“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 2023 and 2024 years reviewed, in a universe of 96 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, 2023, to February 27, 2025, 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/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 1:29 PM, the Admin/DPCS stated she was responsible for the Emergency Preparedness Program (EPP). The Admin/DPCS stated she had not reached out to their local Emergency Management Office. The Admin/DPCS stated she 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 Management Plan,” dated November 2018, indicated, “Staff will work with regional or county emergency management planning agencies, where available, in: A. Establishing priorities among the potential emergencies identified in the hazard vulnerability analysis. B. Defining organization’s role in relation to the community-wide emergency management program and the organization’s surge capacity. C. Developing an “all-hazards” command structure within the organization that links with the community command structure.””

“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 2023 and 2024 years reviewed, in a universe of 96 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, 2023, to February 27, 2025, 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/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 1:49 PM, the Admin/DPCS stated she was responsible for the Emergency Preparedness Program (EPP). The Admin/DPCS stated she 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 Management Plan,” dated November 2018, indicated, “The organization will maintain an emergency preparedness communication plan that complies with Federal, State, and local laws and is reviewed and updated annually. The plan includes the following: … 6. A means of informing state and local emergency preparedness officials before, during and after an emergency on the following: A. Patients that the organization has been unable to contact to determine service needs. B. Patients in need of evacuation due to their medical or behavioral health conditions of home environment.””

“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 develop and implement a procedure to provide for emergency staffing during a disaster or emergency, for the 2023 and 2024 years reviewed, in a universe of 96 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, 2023, to February 27, 2025, 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/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 1:49 PM, the Admin/DPCS stated she was responsible for the Emergency Preparedness Program (EPP). The Admin/DPCS stated she did not establish an emergency staffing agreement with another home health agency or business and should have. A review of the agency’s policy and procedure titled, “Emergency Management Plan,” dated November 2018, was conducted. There was no documented evidence to show a procedure had been developed to address emergency staffing.”

“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 2023 and 2024 years reviewed, in a universe of 96 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, 2023, to February 27, 2025, 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. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 1:59 PM, the Admin/DPCS stated she was responsible for the Emergency Preparedness Program (EPP). The Admin/DPCS stated she had not developed or implemented an alternate means for communicating with Federal, State, tribal, regional and/or local emergency management agencies. A review of the agency’s policy and procedure titled, “Emergency Management Plan,” dated November 2018, indicated, “The organization will maintain an emergency preparedness communication plan that complies with Federal, State, and local laws and is reviewed and updated annually. The plan includes the following: … 3. Primary and alternate means for communicating with the staff, federal, State, tribal, regional and local emergency management agencies.””

“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 2023 and 2024 years reviewed, in a universe of 96 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, 2023, to February 27, 2025, 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/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 1:39 PM, the Admin/DPCS stated she was responsible for the Emergency Preparedness Program (EPP). The Admin/DPCS stated she 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 Management Plan,” dated November 2018, indicated, “The organization will maintain an emergency preparedness communication plan that complies with Federal, State, and local laws and is reviewed and updated annually. The plan includes the following: … 7. A means of providing information about the organization’s needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.””

“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 2023 and 2024 years reviewed, in a universe of 96 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, 2023, to February 27, 2025, 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/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 2:20 PM, the Admin/DPCS stated she was responsible for the Emergency Preparedness Program (EPP). The Admin/DPCS stated she had not conducted a full-scale community based or tabletop emergency preparedness exercise in 2023 or 2024. A review of the agency’s policy and procedure titled, “Emergency Management Plan,” dated November 2018, indicated, “Testing: 1. [Name of agency] will test the emergency management plan, at each site included in the plan, at least annually, either in response to an actual emergency or in a planned exercise. 2. The agency participates in a full-scale exercise that is community-based or individual, facility-based if a community-based exercise is not accessible. A. In the event an actual natural or man-made emergency occurred, the agency will be exempt for 1 year following the onset of the actual event. 3. An additional exercise is conducted and may include, but not limited to: A. A second full-scale exercise that is community-based or individual facility-based, or B. A tabletop exercise led by a facilitator and includes a group discussion, emergency scenarios and prepared questions designed to challenge an emergency plan.””

“Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This Standard is not met as evidenced by: Based on interview and record review, the agency failed to transmit OASIS (Outcome and Assessment Information Set-patient-specific information used in Medicare to determine reimbursement and measure quality) data (facts collected together for analysis) from patient assessments was transmitted to CMS (Centers for Medicare and Medicaid Services) within 30 days of the completion date for one of seven sampled patients (Patient 6) when transfer and discharge OASIS assessments were not conducted or transmitted. This failure caused missing and delayed information to CMS with the potential to result in inaccurate reimbursement calculations and quality measurements. A review of Patient 6’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of November 16, 2024, with a certification period of November 16, 2024, to January 14, 2025. Patient 6 had diagnoses that included hypertension (high blood pressure). A review of Patient 6’s physician’s order dated November 22, 2024, indicated Patient 6 had been transferred to the hospital. A review of Patient 6’s physician’s order dated January 14, 2025, indicated Patient 6 had been discharged from the agency. A review of Patient 6’s OASIS assessments from November 16, 2024, to February 26, 2025, was conducted. There was no documented evidence to show the agency had conducted an OASIS transfer assessment or an OASIS discharge assessment. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 26, 2025, at 1:43 PM, the Admin/DPCS confirmed Patient 6 had not received OASIS transfer or discharge assessments and should have. The Admin/DPCS stated since the assessments had not been conducted, they were not transmitted to CMS. A review of the agency’s policy and procedure titled, “OASIS Data Transmission,” dated November 2018, indicated, “PURPOSE: To outline the OASIS data transmission requirements. POLICY: The organization will adhere to all OASIS data transmission requirements as outlined in the Medicare Conditions of Participation, … PROCEDURE: 1. The organization will encode and transmit completed OASIS data for each applicable patient within thirty (30) days of the … date assessment completed. A. OASIS data is collected and completed by the qualified clinician as part of the comprehensive assessment at the required time points (i.e. start of care, resumption of care, follow-up, transfer to inpatient facility with or without discharge, discharge to community, and death at home.) B. The organization may take up to thirty calendar days after the date of completion of the comprehensive assessment to enter the OASIS data into their computers using … or software that conforms to all CMS data transmission specifications available on the OASIS website. C. All OASIS data items must be complete, i.e. locked, in order to accurately compute the information necessary for billing Medicare patients under the prospective payment system.””

“Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient’s condition warrants due to a major decline or improvement in the patient’s health status, but not less frequently than- This Standard is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure a Registered Nurse (RN) updated the comprehensive assessment for one of seven sampled patients (Patient 1) when Patient 1’s right ankle surgical wound had healed and the continued need for the protective orthopedic (the branch of medicine concerned with conditions involving bones and/or muscles) “boot” (a medical device that protects and stabilizes the foot or ankle after an injury) was not re-evaluated in consultation with the orthopedic physician. This failure had the potential to cause Patient 1 to suffer skin irritation and pressure sores from prolonged contact with the “boot.” A review of Patient 1’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of March 13, 2023, with a recertification period of January 1, 2025, to March 1, 2025. Patient 1 had diagnoses that included infection or inflammation of internal orthopedic implants (a medical device that replaces or supports damaged bones or joints), or prosthetic device (a medical implant that replaces a damaged joint, such as the hip, knee, or ankle). A review of Patient 1’s acute care hospital’s discharge information dated December 30, 2024, indicated Patient 1 had surgery to her right ankle to remove buried hardware on December 19, 2024. Patient 1 was discharged December 28, 2024, with orthopedic “boot” in place. During Patient 1’s home visit observation and interview with a Certified Home Health Aide (CHHA 1) and Patient 1’s son on February 25, 2025, from 9:56 AM to 11:06 AM, Patient 1 was in a hospital bed in her room and an orthopedic “boot” was noted to Patient 1’s right lower leg and foot. CHHA 1 proceeded to give Patient 1 a bed bath (a wash given to someone who is unable to leave their bed) and washed Patient 1’s right leg up to the “boot” but no further. CHHA 1 stated Patient 1’s son had told her about a month ago not to remove the “boot” and she had reported this to the Administrator/Director of Patient Care Services (Admin/DPCS) who told her to follow the son’s direction. Patient 1’s son stated his mother had some infected hardware removed from her right ankle in December 2024 and the hospital had placed staples and the “boot” to her right ankle. Patient 1’s son stated at the end of last month (January 2025) he had asked the visiting nurse to take the “boot” off because the Admin/DPCS had removed the staples, and the wound had healed but the nurse told him he would have to take his mother to an orthopedic doctor’s appointment to receive orders to remove the “boot.” Patient 1’s son stated it was extremely difficult and painful to move his mother from her bed and transport her to a doctor’s appointment, so he “just left the ‘boot’ on.” Patient 1’s son stated he would have appreciated assistance from the home health agency to contact the orthopedic doctor to get permission to remove the “boot.” Patient 1’s son stated it was “Okay” with him if CHHA 1 removed the “boot” and cleaned the right lower leg because the visiting nurses removed and replaced the “boot” at each visit and the wound was healed. A review of Patient 1’s Skilled Nursing (SN) visit note by the Admin/DPCS, dated January 21, 2025, indicated, Wound one, Location: right, back of ankle, Type: surgical wound, Wound Status: closed, Surrounding Tissue: normal, Wound Bed Tissue: scabbing, Drainage Type: None, Drainage Amount: None, Drainage Odor: None.” During an interview with the Admin/DPCS on February 26, 2025, at 3:32 PM, the Admin/DPCS stated when she had reassessed Patient 1’s right ankle wound as closed and scabbed on January 21, 2025, she should have provided the orthopedic physician with Patient 1’s wound reassessment information and inquired about continuing with the orthopedic “boot” and had not. A review of the agency’s policy and procedure titled, “Ongoing Assessments,” dated November 2018, indicated, “PURPOSE: To provide guidelines for assessments of patients during ongoing care. POLICY: The scope and intensity of ongoing assessments will be determined by the patient’s diagnoses, condition, desire for care, response to previous care, and the care setting. PROCEDURE: 1. During each home visit, the clinician or other discipline will re-evaluate the patient according to the problems identified during the initial visit and subsequent visits. 2. Using the standards of care identified by the organization, the clinician will reassess the patient (as appropriate) for: … E. Skin integrity … L. Progress toward goals and patient needs and problems. … 3. Reassessments should focus on: A. Patient’s response to care. B. Changes in patient condition. C. Changes in patient diagnoses. … 5. Based on each reassessment, the plan of care-including problems, needs, goals, and outcomes-will be reviewed and revised by the clinician. 6. Based on the findings of the reassessment, additional orders will be generated and forwarded to the physician (or other authorized licensed independent practitioner) for signature(s).””

“Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This Standard is not met as evidenced by: Based on interview and record review, the agency failed to ensure upon transfer and/or discharge all necessary medical information pertaining to the patient’s current course of illness and treatment, was sent to the receiving healthcare facility and healthcare practitioner for two of seven sampled patients (Patients 6 and 7). This failure had the potential to cause Patient 6 and 7 to suffer healthcare complications, including delayed diagnosis, incorrect treatment decisions, and adverse drug interactions (a harmful and unintended reaction to a drug or combination of drugs). 1. A review of Patient 6’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of November 16, 2024, with a certification period of November 16, 2024, to January 14, 2025. Patient 6 had diagnoses that included hypertension (high blood pressure). A review of Patient 6’s physician’s order dated November 22, 2024, indicated Patient 6 had been transferred to the hospital. A review of Patient 6’s physician’s order dated January 14, 2025, indicated Patient 6 had been discharged from the agency. A review of Patient 6’s transfer summaries (a document that provides a concise overview of a patient’s current medical condition, including diagnosis, treatment plan, medications, and relevant medical history) and discharge summaries (a written document that details a patient’s medical condition upon leaving a healthcare facility, summarizing their admission details, diagnosis, treatment received, current medications, and any necessary follow-up care) from November 22, 2024, to January 14, 2025, was conducted. There was no documented evidence to show a transfer summary and/or discharge summary had been created and sent to the receiving healthcare facility and healthcare practitioner. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 26, 2025, at 1:43 PM, the Admin/DPCS verified a transfer summary and discharge summary had not been created for Patient 6 or sent to the receiving healthcare facility or healthcare practitioner. 2. 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 July 18, 2024, with a recertification period of September 16, 2024, to November 14, 2024. Patient 7 had diagnoses that included presence of an indwelling urinary catheter (a thin, flexible tube inserted into the bladder through the urinary duct to collect and drain urine). A review of Patient 7’s “Inter-Office Communication Note,” dated October 29, 2024, indicated, “PCG [Primary Caregiver) states that [Patient 7] is in [name of a California city] and does not know when he will be back but needs to be seen by [a Skilled Nurse] for [indwelling urinary catheter] care and needs supplies. [Agency’s Scheduler] told PCG that we do not service the [name of a California city] area, and we would have to redirect to another [Home Health Agency]. [Agency’s Scheduler] called [Patient 7’s medical insurance company] and spoke with [name of a medical insurance company’s representative], she will obtain [physician’s] orders and redirect [as soon as possible]. A review of Patient 7’s physician’s order dated October 29, 2024, indicated, “[Discharge from] home health services, [Patient 7] moved out of service area and will be transferred to another [Home Health Agency].” A review of Patient 7’s transfer summaries and discharge summaries from October 29, 2024, to February 26, 2025, was conducted. There was no documented evidence to show a transfer summary and/or discharge summary had been created and sent to the receiving healthcare facility and healthcare practitioner. During an interview with the Admin/DPCS on February 26, 2025, at 1:55 PM, the Admin/DPCS verified a transfer summary and discharge summary had not been created for Patient 7 or sent to the receiving healthcare facility or healthcare practitioner. A review of the agency’s policy and procedure titled “Transfer Summary,” dated November 2018, indicated, “PURPOSE: To define the requirements for documentation of a patient transfer to another service provider. POLICY: All patients transferred from the organization will have a transfer summary completed and filed in the clinical record. Definition: Service Provider: Another home health, hospice or health care facility. PROCEDURE: 1. Within 48 hours of transfer, the transferring clinician will complete a transfer summary that includes, as appropriate: A. The reason for transfer. B. The physical and psychosocial status at the time of transfer, including specific medical, psychosocial, or other problems requiring interventions or follow-up. C. Continuing symptom management needs. D. Medication profile. E. A summary of the care provided, and the progress toward achieving goals. F. Any instructions and/or referrals provided to the patient. G. The existence of any Advance Directives known to the organization. H. Date of face-to-face encounter, if during initial certification. I. The date of transfer, which is the date of the last visit made. 2. Completed transfer summaries will be given to a clinical records clerk, who will send a copy to the receiving organization, along with a copy of the clinical record, within two (2) business days of a planned transfer or within two (2) days of becoming aware of an unplanned transfer and will file the original in the clinical record. 3. A copy of the transfer summary will be sent to the physician within 48 hours of transfer.” A review of the agency’s policy and procedure titled “Discharge Summary,” dated November 2018, indicated, “PURPOSE: To define requirements for documentation of service discontinuation and when patients are discharged from the organization. POLICY: Each patient discharged from a service and from the organization will have a written discharge summary filed in the clinical record. PROCEDURE: 1. Each clinician who provides care will complete a discharge summary at the time his/her discipline is discharged, which may include, as appropriate: A. The date of discharge, including the date the physician and the patient were informed of discharge. B. The reason for discharge. C. The reason for discharge, including, as applicable, the name of the organization to which the patient is being transferred. D. The status of problems identified at admission and during the provision of care. E. The progress toward goals/desired outcomes. F. Medical status at discharge, including continuing symptom management needs. G. The overall status of the patient. H. A summary of care or services provided. 2. The discharge summary and other relevant clinical record documents will be completed and submitted within 72 hours of discharge from service. 3. A copy of the discharge summary will be provided to the patient’s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the organization within five (5) business days of the patient’s discharge. …””

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure each patient received home health services that were written in an individualized plan of care that identified patient-specific measurable outcomes and goals, for one of seven sampled patients (Patient 1) when Patient 1’s right ankle surgical wound was enclosed in a protective orthopedic (the branch of medicine concerned with conditions involving bones and/or muscles) “boot” (a medical device that protects and stabilizes the foot or ankle after an injury) and the “boot” was not in Patient 1’s plan of care. This failure had the potential to cause Patient 1 to suffer improper use and maintenance of the boot, which was crucial for optimal healing of the injured area by providing the necessary stability and immobilization, while also preventing complications like skin irritation, infection, or improper weight distribution. A review of Patient 1’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of March 13, 2023, with a recertification period of January 1, 2025, to March 1, 2025. Patient 1 had diagnoses that included infection or inflammation of internal orthopedic implants (a medical device that replaces or supports damaged bones or joints), or prosthetic device (a medical implant that replaces a damaged joint, such as the hip, knee, or ankle). A review of Patient 1’s acute care hospital’s discharge information dated December 30, 2024, indicated Patient 1 had surgery to her right ankle to remove buried hardware on December 19, 2024. Patient 1 was discharged December 28, 2024, with orthopedic “boot” in place. During Patient 1’s home visit observation and interview with a Certified Home Health Aide (CHHA 1) and Patient 1’s son on February 25, 2025, from 9:56 AM to 11:06 AM, Patient 1 was in a hospital bed in her room and an orthopedic “boot” was noted to Patient 1’s right lower leg and foot. CHHA 1 proceeded to give Patient 1 a bed bath (a wash given to someone who is unable to leave their bed) and washed Patient 1’s right leg up to the “boot” but no further. CHHA 1 stated Patient 1’s son had told her about a month ago not to remove the “boot” and she had reported this to the Administrator/Director of Patient Care Services (Admin/DPCS) who told her to follow the son’s direction. Patient 1’s son stated his mother had some infected hardware removed from her right ankle in December 2024 and the hospital had placed staples and the “boot” to her right ankle. Patient 1’s son stated at the end of last month (January 2025) he had asked the visiting nurse to take the “boot” off because the Admin/DPCS had removed the staples, and the wound had healed but the nurse told him he would have to take his mother to an orthopedic doctor’s appointment to receive orders to remove the “boot.” Patient 1’s son stated it was extremely difficult and painful to move his mother from her bed and transport her to a doctor’s appointment, so he “just left the ‘boot’ on.” Patient 1’s son stated he would have appreciated assistance from the home health agency to contact the orthopedic doctor to get permission to remove the “boot.” Patient 1’s son stated it was “Okay” with him if CHHA 1 removed the “boot” and cleaned the right lower leg because the visiting nurses removed and replaced the “boot” at each visit and the wound was healed. A review of Patient 1’s Resumption of Care Assessment, dated December 31, 2024, was conducted. There was no documented evidence to show the presence of Patient 1’s orthopedic “boot.” A review of Patient 1’s care plan for the certification period of January 1, 2025, to March 1, 2025, was conducted. There was no documented evidence to show Patient 1’s orthopedic “boot” had been care planned. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 26, 2025, at 3:32 PM, the Admin/DPCS stated she had conducted Patient 1’s Resumption of Care Assessment on December 31, 2024, and it was her responsibility to care plan Patient 1’s orthopedic “boot” and had not. A review of the agency’s policy and procedure titled, “Care Planning Process,” dated November 2018, indicated, “PURPOSE: To provide clinical direction to clinicians providing direct patient care. POLICY: A written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days, or as patient’s condition warrants. The patient plan of care will be developed or revised within five (5) working days of initiation of each service or of the reassessment of the patient. All clinicians including the physician involved in the patient’s care, either directly or indirectly, will contribute to the plan of care. The patient and family/caregiver will participate in decisions regarding the plan of care whenever possible. The care planning process will be documented on the plan of care, individualized discipline-specific care plans (if applicable), clinical notes, medication profiles, care conference/summary forms, and discharge/clinical summaries. Definitions 1. Individualized Plan of Care: The patient-specific clinical plan of care includes all pertinent diagnoses, mental status, types of services/equipment, frequency of visits, goals and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, treatments, safety measures, instructions, discharge plan. Documents include plan of treatment (485) and plans of care (all disciplines). … PROCEDURE: 1. At the time of the initial assessment, the clinician, along with the physician and other involved disciplines, will develop the patient plan of care based upon the patient’s identified needs and will review it with the patient and family/caregiver. 2. All clinicians will consider the conclusions of initial and ongoing assessments in their care planning process, including, but not limited to: A. Individualized patient needs, and resultant problems related to care, functional status, and family/caregiver support systems. B. Changes in patient’s condition. C. Clinical drug monitoring, as appropriate. D. Pain and symptom management, as appropriate. E. Psychosocial and spiritual needs of patient and family/caregiver, as appropriate. F. Patient treatment choices. G. Patient and caregiver education and training that the organization will provide specific to the patient’s care needs.””

“Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA’s quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This Standard is not met as evidenced by: Based on interview, and record review, the agency failed to maintain an infection control program that was integrated into the agency’s Quality Assessment Performance Improvement (QAPI) program in order to: identify infection trends (analysis of a pattern), develop action plans and improve disease prevention, from January 3, 2024, to February 13, 2025, in a universe of 96 patients. This failure had the potential to cause trends in infections to go unrecognized, unaddressed and patients to suffer repeated and prolonged infections. A review of the agency’s infection control logs from January 3, 2024, to February 13, 2025, was conducted. The infection control logs indicated the dates the infections were identified, the names of the patients, signs and symptoms of the infections, laboratory test results, and the treatments provided. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) and the Office Manager (OM) on February 27, 2025, at 12:45 PM, the Admin/DPCS stated she was responsible for the Infection Control Program and the QAPI Program and the OM stated she collected the patient infection information, filled out the infection control logs and provided the infection control log data to the QAPI Committee on a quarterly basis. A review of the QAPI committee meeting notes and QAPI Program binder from January 3, 2024, to February 13, 2025, was conducted. The QAPI committee meeting notes and QAPI Program binder did not contain documentation showing infection control data had been received, aggregated (gathered together) or analyzed by the QAPI Committee. In a continued interview with the Admin/DPCS and OM, the Admin/DPCS stated the patients’ infections were discussed at the QAPI committee meeting, but the discussions were not documented. The Admin/DPCS stated she was not aware the patients’ infection data needed to be analyzed in order to identify infection trends or develop action plans to improve disease prevention. A review of the agency’s policy and procedure titled “Infection Control Plan,” dated November 2018, indicated, “Introduction: The purpose of the infection control program is to reduce the risk of acquisition and transmission of health care associated infections (HAIs). The infection control program is an integral component of the organization’s safety and performance improvement programs. The organization performs an ongoing assessment of the risks for acquisition and transmission of infectious agents across all services and programs. The organization’s leaders actively participate in the design and implementation of the infection control program. The organization recognizes that infection prevention and control is a community-wide effort and integrates its efforts with other health care organizations where possible. An infection control program must include planning, surveillance, identification, prevention/control, and reporting. [name of the agency] is committed to the implementation of these policies and procedures to improve patient outcomes and reduce the risk of infection in patients and staff. … PROCEDURE: … 5. The infection control plan will be monitored and evaluated in the annual program evaluation and in conjunction with the review of the organization’s safety and performance improvement activities. Surveillance activities, including data collection and analysis, will be used to identify prevention and control risks. The evaluation of the infection control program includes a review of the plan, goals, and risk analysis across all services/programs. A review of the agency’s policy and procedure titled, “Improving Organizational Performance,” dated November 2018, indicated, “PURPOSE: To establish a performance improvement framework, which integrates activities to improve organization performance, manage change, improve patient safety, improve quality of care, treatment or services and reduce the risks for acquisition and transmission of infections. To improve organizational performance by focusing on high risk, high volume, and problem prone areas. … PROCEDURE: 1. Senior management with Governing Body oversight will: A. Participate in educational activities to increase their level of understanding and ability to implement performance improvement activities. The educational activities may include seminars, consultations, readings, periodicals, benchmarking, and review of available information from other organizations regarding the occurrence of sentinel events to reduce the risk of similar sentinel events within the organization. B. Set expectations for performance improvement, set priorities and frequency of data collection and manage processes to improve organization performance. C. Focus on high risk, high volume, and problem-prone areas. Consider incidence, prevalence, and severity of problems in those areas and lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. D. Adopt a scientific, problem-solving approach to performance improvement. The scientific, problem-solving approach will include, minimally:1. Planning for performance improvement with integration of information from other relevant activities … e. Infection control surveillance. …””

“Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This Standard is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure a Registered Nurse (RN) provided a Certified Home Health Aide (CHHA) written patient care instructions for one of seven sampled patients (Patient 1) when the CHHA’s care plan did not contain special instructions on how to care for Patient 1’s orthopedic (the branch of medicine concerned with conditions involving bones and/or muscles) “boot” (a medical device that protects and stabilizes the foot or ankle after an injury). This failure had the potential to cause Patient 1 to suffer skin irritation and breakdown when the CHHA did not clean the area under the “boot” and misalignment of the “boot,” potentially causing delayed healing and increased pain. A review of Patient 1’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of March 13, 2023, with a recertification period of January 1, 2025, to March 1, 2025. Patient 1 had diagnoses that included infection or inflammation of internal orthopedic implants (a medical device that replaces or supports damaged bones or joints), or prosthetic device (a medical implant that replaces a damaged joint, such as the hip, knee, or ankle). A review of Patient 1’s acute care hospital’s discharge information dated December 30, 2024, indicated Patient 1 had surgery to her right ankle to remove buried hardware on December 19, 2024. Patient 1 was discharged December 28, 2024, with orthopedic “boot” in place. During Patient 1’s home visit observation and interview with a Certified Home Health Aide (CHHA 1) and Patient 1’s son on February 25, 2025, from 9:56 AM to 11:06 AM, Patient 1 was in a hospital bed in her room and an orthopedic “boot” was noted to Patient 1’s right lower leg and foot. CHHA 1 proceeded to give Patient 1 a bed bath (a wash given to someone who is unable to leave their bed) and washed Patient 1’s right leg up to the “boot” but no further. CHHA 1 stated Patient 1’s son had told her about a month ago not to remove the “boot” and she had reported this to the Administrator/Director of Patient Care Services (Admin/DPCS) who told her to follow the son’s direction. Patient 1’s son stated his mother had some infected hardware removed from her right ankle in December 2024 and the hospital had placed staples and the “boot” to her right ankle. Patient 1’s son stated at the end of last month (January 2025) he had asked the visiting nurse to take the “boot” off because the Admin/DPCS had removed the staples, and the wound had healed but the nurse told him he would have to take his mother to an orthopedic doctor’s appointment to receive orders to remove the “boot.” Patient 1’s son stated it was extremely difficult and painful to move his mother from her bed and transport her to a doctor’s appointment, so he “just left the ‘boot’ on.” Patient 1’s son stated he would have appreciated assistance from the home health agency to contact the orthopedic doctor to get permission to remove the “boot.” Patient 1’s son stated it was “Okay” with him if CHHA 1 removed the “boot” and cleaned the right lower leg because the visiting nurses removed and replaced the “boot” at each visit and the wound was healed. A review of Patient 1’s CHHA plans of care dated December 31, 2024, and January 17, 2025, was conducted. There was no documented evidence to show special instructions for Patient 1’s orthopedic “boot.” During an interview with the Admin/DPCS on February 26, 2025, at 3:32 PM, the Admin/DPCS stated she had created Patient 1’s CHHA plans of care dated December 31, 2024, and January 17, 2025. The Admin/DPCS stated she should have included special instructions on how to care for Patient 1’s orthopedic “boot,” and had not. A review of the agency’s policy and procedure titled “Home Health Aide Plan of Care,” dated November 2018, indicated, “PURPOSE: To define the process for the development and use of the home health aide plan of care. POLICY: Each patient receiving home health aide services will have an individualized plan developed and utilized to direct care performed by the assigned aide. PROCEDURE: 1. The patient’s Case Manager or other appropriate skilled professional (physical therapist, speech-language pathologist, or occupational therapist), upon initialization of aide services, will develop the written home health aide plan of care, consistent with the comprehensive plan of care and physician (or other authorized licensed independent practitioner) orders. 2. The home health aide plan of care will be individualized to the specific patient and will include at least: … H. Specific procedure(s) to be performed, including amount, frequency, and duration. I. Safety measures, including use of specific equipment … The home health aide plan of care will be reviewed with the patient to ensure understanding of the aide’s role in the home.””

“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, 2023, to February 27, 2025, in a universe of 96 patients, when: 1. The agency failed to review and update its Emergency Preparedness Program (EPP) every two years, for the 2023 and 2024 years reviewed, in a universe of 96 patients. This failure had the potential to cause the EPP to indicate ineffective procedures and outdated information. 2. 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 2023 and 2024 years reviewed, in a universe of 96 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. 3. 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 2023 and 2024 years reviewed, in a universe of 96 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. 4. The agency failed to develop and implement a procedure to provide for emergency staffing during a disaster or emergency, for the 2023 and 2024 years reviewed, in a universe of 96 patients. This failure had the potential to cause patients to suffer an absence of care due to a staff shortage. 5. 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 2023 and 2024 years reviewed, in a universe of 96 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. 6. 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 2023 and 2024 years reviewed, in a universe of 96 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. 7. 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 2023 and 2024 years reviewed, in a universe of 96 patients. This failure had the potential to cause problems within the Emergency Preparedness Program to go unrecognized and unaddressed. 8. The agency failed to transmit OASIS (Outcome and Assessment Information Set-patient-specific information used in Medicare to determine reimbursement and measure quality) data (facts collected together for analysis) from patient assessments was transmitted to CMS (Centers for Medicare and Medicaid Services) within 30 days of the completion date for one of seven sampled patients (Patient 6) when transfer and discharge OASIS assessments were not conducted or transmitted. This failure caused missing and delayed information to CMS with the potential to result in inaccurate reimbursement calculations and quality measurements. 9. 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 four of seven sampled patients (Patients 1, 2, 5, and 6). This failure had the potential to cause a delay in the determination of Patients 1, 2, 5, and 6’s immediate care and support needs. 10. The agency failed to ensure a Registered Nurse (RN) updated the comprehensive assessment for one of seven sampled patients (Patient 1) when Patient 1’s right ankle surgical wound had healed and the continued need for the protective orthopedic (the branch of medicine concerned with conditions involving bones and/or muscles) “boot” (a medical device that protects and stabilizes the foot or ankle after an injury) was not re-evaluated in consultation with the orthopedic physician. This failure had the potential to cause Patient 1 to suffer skin irritation and pressure sores from prolonged contact with the “boot.” 11. The agency failed to ensure upon transfer and/or discharge all necessary medical information pertaining to the patient’s current course of illness and treatment, was sent to the receiving healthcare facility and healthcare practitioner for two of seven sampled patients (Patients 6 and 7). This failure had the potential to cause Patient 6 and 7 to suffer healthcare complications, including delayed diagnosis, incorrect treatment decisions, and adverse drug interactions (a harmful and unintended reaction to a drug or combination of drugs). 12. The agency failed to ensure each patient received home health services that were written in an individualized plan of care that identified patient-specific measurable outcomes and goals, for one of seven sampled patients (Patient 1) when Patient 1’s right ankle surgical wound was enclosed in a protective orthopedic “boot” and the “boot” was not in Patient 1’s plan of care. This failure had the potential to cause Patient 1 to suffer improper use and maintenance of the boot, which was crucial for optimal healing of the injured area by providing the necessary stability and immobilization, while also preventing complications like skin irritation, infection, or improper weight distribution. 13. The agency failed to ensure the patients’ individualized plans of care contained all the required elements for two of seven sampled patients (Patients 3 and 5) when: a. For Patient 3: the Physical Therapy (PT) and Occupational Therapy (OT) visit frequencies were not in the plan of care and there were no physician’s orders with PT and OT visit frequencies to update the plan of care. b. For Patient 5: the Skilled Nursing (SN) frequencies were not in the plan of care and there were no physician’s orders with SN visit frequencies to update the plan of care. This failure had the potential to cause Patients 3 and 5 not to receive the care and services to meet their care planning goals. 14. The agency failed to obtain physician’s orders for one of seven sampled patients (Patient 1) when an RN removed surgical staples from Patient 1’s right ankle without a physician’s order. This failure had the potential to cause Patient 1’s surgical wound to open before it was healed. 15. The agency failed to maintain an infection control program that was integrated into the agency’s Quality Assessment Performance Improvement (QAPI) program in order to: identify infection trends (analysis of a pattern), develop action plans and improve disease prevention, from January 3, 2024, to February 13, 2025, in a universe of 96 patients. This failure had the potential to cause trends in infections to go unrecognized, unaddressed and patients to suffer repeated and prolonged infections. 16. The agency failed to ensure an RN provided a Certified Home Health Aide (CHHA) written patient care instructions for one of seven sampled patients (Patient 1) when the CHHA’s care plan did not contain special instructions on how to care for Patient 1’s orthopedic “boot. “This failure had the potential to cause Patient 1 to suffer skin irritation and breakdown when the CHHA did not clean the area under the “boot” and misalignment of the “boot,” potentially causing delayed healing and increased pain. 17. The agency failed to conduct an on-site CHHA supervisory visit every 14 days for two of seven sampled patients (Patients 1 and 4). This failure had the potential to cause inconsistent quality of care, missed opportunities to address changing patient needs, and compromising the well-being of the patient due to improper or inadequate care. 18. The agency failed to ensure the clinical record contained a completed discharge summary sent to the primary care practitioner within five business days of the patient’s discharge and a completed transfer summary was sent within two business days of becoming aware of a planned transfer to a receiving health care facility, for two or seven sampled patients (Patients 6 and 7). This failure had the potential to cause Patient 6 and 7 to suffer healthcare complications, including delayed diagnosis, incorrect treatment decisions, and adverse drug interactions (a harmful and unintended reaction to a drug or combination of drugs). 1. A review of the agency’s Emergency Preparedness Binder, from January 1, 2023, to February 27, 2025, 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, 2023, to February 27, 2025, was conducted. There was no documented evidence to show the Governing Body had reviewed the Emergency Preparedness Program. During an interview with the Administrator Designee (AD) and Administrator/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 1:19 PM, the Admin/DPCS stated she was responsible for the Emergency Preparedness Program (EPP). The AD stated he was a member of the Governing Body, and he could not show documented evidence the agency’s Emergency Preparedness Program had been reviewed by the Governing Body for the years 2023 or 2024. A review of the agency’s policy and procedure titled, “Emergency Management Plan,” dated November 2018 was conducted. There was no documented evidence to show a requirement to review and update the agency’s Emergency Preparedness Program every two years. A review of the agency’s policy and procedure titled, “Emergency Preparedness Plan,” undated, was conducted. There was no documented evidence to show a requirement to review and update the agency’s Emergency Preparedness Program every two years. 2. A review of the agency’s Emergency Preparedness Binder, from January 1, 2023, to February 27, 2025, 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/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 1:29 PM, the Admin/DPCS stated she was responsible for the Emergency Preparedness Program (EPP). The Admin/DPCS stated she had not reached out to their local Emergency Management Office. The Admin/DPCS stated she 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 Management Plan,” dated November 2018, indicated, “Staff will work with regional or county emergency management planning agencies, where available, in: A. Establishing priorities among the potential emergencies identified in the hazard vulnerability analysis. B. Defining organization’s role in relation to the community-wide emergency management program and the organization’s surge capacity. C. Developing an “all-hazards” command structure within the organization that links with the community command structure.” 3. A review of the agency’s Emergency Preparedness Binder, from January 1, 2023, to February 27, 2025, 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/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 1:49 PM, the Admin/DPCS stated she was responsible for the Emergency Preparedness Program (EPP). The Admin/DPCS stated she 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 Management Plan,” dated November 2018, indicated, “The organization will maintain an emergency preparedness communication plan that complies with Federal, State, and local laws and is reviewed and updated annually. The plan includes the following: … 6. A means of informing state and local emergency preparedness officials before, during and after an emergency on the following: A. Patients that the organization has been unable to contact to determine service needs. B. Patients in need of evacuation due to their medical or behavioral health conditions of home environment.” 4. A review of the agency’s Emergency Preparedness Binder, from January 1, 2023, to February 27, 2025, 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/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 1:49 PM, the Admin/DPCS stated she was responsible for the Emergency Preparedness Program (EPP). The Admin/DPCS stated she did not establish an emergency staffing agreement with another home health agency or business and should have. A review of the agency’s policy and procedure titled, “Emergency Management Plan,” dated November 2018, was conducted. There was no documented evidence to show a procedure had been developed to address emergency staffing. 5. A review of the agency’s Emergency Preparedness Binder, from January 1, 2023, to February 27, 2025, 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. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 1:59 PM, the Admin/DPCS stated she was responsible for the Emergency Preparedness Program (EPP). The Admin/DPCS stated she had not developed or implemented an alternate means for communicating with Federal, State, tribal, regional and/or local emergency management agencies. A review of the agency’s policy and procedure titled, “Emergency Management Plan,” dated November 2018, indicated, “The organization will maintain an emergency preparedness communication plan that complies with Federal, State, and local laws and is reviewed and updated annually. The plan includes the following: … 3. Primary and alternate means for communicating with the staff, federal, State, tribal, regional and local emergency management agencies.” 6. A review of the agency’s Emergency Preparedness Binder, from January 1, 2023, to February 27, 2025, 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/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 1:39 PM, the Admin/DPCS stated she was responsible for the Emergency Preparedness Program (EPP). The Admin/DPCS stated she 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 Management Plan,” dated November 2018, indicated, “The organization will maintain an emergency preparedness communication plan that complies with Federal, State, and local laws and is reviewed and updated annually. The plan includes the following: … 7. A means of providing information about the organization’s needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.” 7. A review of the agency’s Emergency Preparedness Binder, from January 1, 2023, to February 27, 2025, 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/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 2:20 PM, the Admin/DPCS stated she was responsible for the Emergency Preparedness Program (EPP). The Admin/DPCS stated she had not conducted a full-scale community based or tabletop emergency preparedness exercise in 2023 or 2024. A review of the agency’s policy and procedure titled, “Emergency Management Plan,” dated November 2018, indicated, “Testing: 1. [Name of agency] will test the emergency management plan, at each site included in the plan, at least annually, either in response to an actual emergency or in a planned exercise. 2. The agency participates in a full-scale exercise that is community-based or individual, facility-based if a community-based exercise is not accessible. A. In the event an actual natural or man-made emergency occurred, the agency will be exempt for 1 year following the onset of the actual event. 3. An additional exercise is conducted and may include, but not limited to: A. A second full-scale exercise that is community-based or individual facility-based, or B. A tabletop exercise led by a facilitator and included a group discussion, emergency scenarios and prepared questions designed to challenge an emergency plan.” 8. A review of Patient 6’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of November 16, 2024, with a certification period of November 16, 2024, to January 14, 2025. Patient 6 had diagnoses that included hypertension (high blood pressure). A review of Patient 6’s physician’s order dated November 22, 2024, indicated Patient 6 had been transferred to the hospital. A review of Patient 6’s physician’s order dated January 14, 2025, indicated Patient 6 had been discharged from the agency. A review of Patient 6’s OASIS assessments from November 16, 2024, to February 26, 2025, was conducted. There was no documented evidence to show the agency had conducted an OASIS transfer assessment or an OASIS discharge assessment. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 26, 2025, at 1:43 PM, the Admin/DPCS confirmed Patient 6 had not received OASIS transfer or discharge assessments and should have. The Admin/DPCS stated since the assessments had not been conducted, they were not transmitted to CMS. A review of the agency’s policy and procedure titled, “OASIS Data Transmission,” dated November 2018, indicated, “PURPOSE: To outline the OASIS data transmission requirements. POLICY: The organization will adhere to all OASIS data transmission requirements as outlined in the Medicare Conditions of Participation, … PROCEDURE: 1. The organization will encode and transmit completed OASIS data for each applicable patient within thirty (30) days of the … date assessment completed. A. OASIS data is collected and completed by the qualified clinician as part of the comprehensive assessment at the required time points (i.e. start of care, resumption of care, follow-up, transfer to inpatient facility with or without discharge, discharge to community, and death at home.) B. The organization may take up to thirty calendar days after the date of completion of the comprehensive assessment to enter the OASIS data into their computers using … or software that conforms to all CMS data transmission specifications available on the OASIS website. C. All OASIS data items must be complete, i.e. locked, in order to accurately compute the information necessary for billing Medicare patients under the prospective payment system.” 9a. A review of Patient 1’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of March 13, 2023, with a certification period of March 13, 2023, to May 11, 2023. Patient 1 had diagnoses that included diabetes mellitus (a disease that causes high blood sugar levels). A review of Patient 1’s physician’s referral order dated March 9, 2023, indicated a request for home health services. A review of Patient 1’s initial assessment dated March 13, 2023, indicated the initial assessment had been conducted on March 13, 2023. (The initial assessment had been completed four days after the physician’s referral order) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 26, 2025, at 3:32 PM, the Admin/DPCS stated the referral order from the referring physician was dated March 9, 2023, and the agency needed to admit Patient 1 within 48 hours which would be no later than March 11, 2023, but had not. 9b. A review of Patient 2’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of February 1, 2025, with a certification period of February 1, 2025, to April 1, 2025. Patient 2 had diagnoses that included open wound of right upper arm. A review of Patient 2’s physician’s referral order dated January 27, 2025, indicated a request for home health services. A review of Patient 2’s initial assessment dated February 1, 2025, indicated the initial assessment had been conducted on February 1, 2025. (The initial assessment had been completed five days after the physician’s referral order) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 10:35 AM, the Admin/DPCS stated the referral order from the referring physician was dated January 27, 2025, and the agency needed to admit Patient 2 within 48 hours which would be no later than January 29, 2025, but had not. 9c. A review of Patient 5’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of January 6, 2025, with a certification period of January 6, 2025, to March 6, 2025. Patient 5 had diagnoses that included colon cancer. A review of Patient 5’s physician’s referral order dated January 3, 2025, indicated a request for home health services. A review of Patient 5’s initial assessment dated January 6, 2025, indicated the initial assessment had been conducted on January 6, 2025. (The initial assessment had been completed three days after the physician’s referral order) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 12:06 PM, the Admin/DPCS stated the referral order from the referring physician was dated January 3, 2025, and the agency needed to admit Patient 5 within 48 hours which would be no later than January 5, 2025, but had not. 9d. A review of Patient 6’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of November 16, 2024, with a certification period of November 16, 2024, to January 14, 2025. Patient 6 had diagnoses that included hypertension (high blood pressure). A review of Patient 6’s physician’s referral order dated November 11, 2024, indicated a request for home health services. A review of Patient 6’s initial assessment dated November 16, 2024, indicated the initial assessment had been conducted on November 16, 2024. (The initial assessment had been completed five days after the physician’s referral order) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 26, 2025, at 1:43 PM, the Admin/DPCS stated the referral order from the referring physician was dated November 11, 2024, and the agency needed to admit Patient 6 within 48 hours which would be no later than November 13, 2024, but had not. A review of the agency’s policy and procedure titled “Initial and Comprehensive Assessment,” dated November 2018, indicated, “PURPOSE: To provide guidelines for the initial assessments of patients admitted to service and for completing plans of care. POLICY: An initial patient assessment will be performed and documented in the patient’s clinical record by a registered nurse, physical therapist, or speech therapist on all patients referred. The initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of the patient’s return home, on the start of care date ordered by the physician (or other authorized licensed independent practitioner), or at the patient/family request with the approval of the physician (or other authorized licensed independent practitioner).” 10. A review of Patient 1’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of March 13, 2023, with a recertification period of January 1, 2025, to March 1, 2025. Patient 1 had diagnoses that included infection or inflammation of internal orthopedic implants (a medical device that replaces or supports damaged bones or joints), or prosthetic device (a medical implant that replaces a damaged joint, such as the hip, knee, or ankle). A review of Patient 1’s acute care hospital’s discharge information dated December 30, 2024, indicated Patient 1 had surgery to her right ankle to remove buried hardware on December 19, 2024. Patient 1 was discharged December 28, 2024, with orthopedic “boot” in place. During Patient 1’s home visit observation and interview with CHHA 1 and Patient 1’s son on February 25, 2025, from 9:56 AM to 11:06 AM, Patient 1 was in a hospital bed in her room and an orthopedic “boot” was noted to Patient 1’s right lower leg and foot. CHHA 1 proceeded to give Patient 1 a bed bath (a wash given to someone who is unable to leave their bed) and washed Patient 1’s right leg up to the “boot” but no further. CHHA 1 stated Patient 1’s son had told her about a month ago not to remove the “boot” and she had reported this to the Administrator/Director of Patient Care Services (Admin/DPCS) who told her to follow the son’s direction. Patient 1’s son stated his mother had some infected hardware removed from her right ankle in December 2024 and the hospital had placed staples and the “boot” to her right ankle. Patient 1’s son stated at the end of last month (January 2025) he had asked the visiting nurse to take the “boot” off because the Admin/DPCS had removed the staples, and the wound had healed but the nurse told him he would have to take his mother to an orthopedic doctor’s appointment to receive orders to remove the “boot.” Patient 1’s son stated it was extremely difficult and painful to move his mother from her bed and transport her to a doctor’s appointment, so he “just left the ‘boot’ on.” Patient 1’s son stated he would have appreciated assistance from the home health agency to contact the orthopedic doctor to get permission to remove the “boot.” Patient 1’s son stated it was “Okay” with him if CHHA 1 removed the “boot” and cleaned the right lower leg because the visiting nurses removed and replaced the “boot” at each visit and the wound was healed. A review of Patient 1’s SN visit note by the Admin/DPCS, dated January 21, 2025, indicated, Wound one, Location: right, back of ankle, Type: surgical wound, Wound Status: closed, Surrounding Tissue: normal, Wound Bed Tissue: scabbing, Drainage Type: None, Drainage Amount: None, Drainage Odor: None.” During an interview with the Admin/DPCS on February 26, 2025, at 3:32 PM, the Admin/DPCS stated when she had reassessed Patient 1’s right ankle wound as closed and scabbed on January 21, 2025, she should have provided the orthopedic physician with Patient 1’s wound reassessment information and inquired about continuing with the orthopedic “boot” and had not. A review of the agency’s policy and procedure titled, “Ongoing Assessments,” dated November 2018, indicated, “PURPOSE: To provide guidelines for assessments of patients during ongoing care. POLICY: The scope and intensity of ongoing assessments will be determined by the patient’s diagnoses, condition, desire for care, response to previous care, and the care setting. PROCEDURE: 1. During each home visit, the clinician or other discipline will re-evaluate the patient according to the problems identified during the initial visit and subsequent visits. 2. Using the standards of care identified by the organization, the clinician will reassess the patient (as appropriate) for: … E. Skin integrity … L. Progress toward goals and patient needs and problems. … 3. Reassessments should focus on: A. Patient’s response to care. B. Changes in patient condition. C. Changes in patient diagnoses. … 5. Based on each reassessment, the plan of care-including problems, needs, goals, and outcomes-will be reviewed and revised by the clinician. 6. Based on the findings of the reassessment, additional orders will be generated and forwarded to the physician (or other authorized licensed independent practitioner) for signature(s).” 11a. A review of Patient 6’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of November 16, 2024, with a certification period of November 16, 2024, to January 14, 2025. Patient 6 had diagnoses that included hypertension (high blood pressure). A review of Patient 6’s physician’s order dated November 22, 2024, indicated Patient 6 had been transferred to the hospital. A review of Patient 6’s physician’s order dated January 14, 2025, indicated Patient 6 had been discharged from the agency. A review of Patient 6’s transfer summaries (a document that provides a concise overview of a patient’s current medical condition, including diagnosis, treatment plan, medications, and relevant medical history) and discharge summaries (a written document that details a patient’s medical condition upon leaving a healthcare facility, summarizing their admission details, diagnosis, treatment received, current medications, and any necessary follow-up care) from November 22, 2024, to January 14, 2025, was conducted. There was no documented evidence to show a transfer summary and/or discharge summary had been created and sent to the receiving healthcare facility and healthcare practitioner. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 26, 2025, at 1:43 PM, the Admin/DPCS verified a transfer summary and discharge summary had not been created for Patient 6 or sent to the receiving healthcare facility or healthcare practitioner. 11b. 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 July 18, 2024, with a recertification period of September 16, 2024, to November 14, 2024. Patient 7 had diagnoses that included presence of an indwelling urinary catheter (a thin, flexible tube inserted into the bladder through the urinary duct to collect and drain urine). A review of Patient 7’s “Inter-Office Communication Note,” dated October 29, 2024, indicated, “PCG [Primary Caregiver) states that [Patient 7] is in [name of a California city] and does not know when he will be back but needs to be seen by [a Skilled Nurse] for [indwelling urinary catheter] care and needs supplies. [Agency’s Scheduler] told PCG that we do not service the [name of a California city] area, and we would have to redirect to another [Home Health Agency]. [Agency’s Scheduler] called [Patient 7’s medical insurance company] and spoke with [name of a medical insurance company’s representative], she will obtain [physician’s] orders and redirect [as soon as possible]. A review of Patient 7’s physician’s order dated October 29, 2024, indicated, “[Discharge from] home health services, [Patient 7] moved out of service area and will be transferred to another [Home Health Agency].” A review of Patient 7’s transfer summaries and discharge summaries from October 29, 2024, to February 26, 2025, was conducted. There was no documented evidence to show a transfer summary and/or discharge summary had been created and sent to the receiving healthcare facility and healthcare practitioner. During an interview with the Admin/DPCS on February 26, 2025, at 1:55 PM, the Admin/DPCS verified a transfer summary and discharge summary had not been created for Patient 7 or sent to the receiving healthcare facility or healthcare practitioner. A review of the agency’s policy and procedure titled “Transfer Summary,” dated November 2018, indicated, “PURPOSE: To define the requirements for documentation of a patient transfer to another service provider. POLICY: All patients transferred from the organization will have a transfer summary completed and filed in the clinical record. Definition: Service Provider: Another home health, hospice or health care facility. PROCEDURE: 1. Within 48 hours of transfer, the transferring clinician will complete a transfer summary that includes, as appropriate: A. The reason for transfer. B. The physical and psychosocial status at the time of transfer, including specific medical, psychosocial, or other problems requiring interventions or follow-up. C. Continuing symptom management needs. D. Medication profile. E. A summary of the care provided, and the progress toward achieving goals. F. Any instructions and/or referrals provided to the patient. G. The existence of any Advance Directives known to the organization. H. Date of face-to-face encounter, if during initial certification. I. The date of transfer, which is the date of the last visit made. 2. Completed transfer summaries will be given to a clinical records clerk, who will send a copy to the receiving organization, along with a copy of the clinical record, within two (2) business days of a planned transfer or within two (2) days of becoming aware of an unplanned transfer and will file the original in the clinical record. 3. A copy of the transfer summary will be sent to the physician within 48 hours of transfer.” A review of the agency’s policy and procedure titled “Discharge Summary,” dated November 2018, indicated, “PURPOSE: To define requirements for documentation of service discontinuation and when patients are discharged from the organization. POLICY: Each patient discharged from a service and from the organization will have a written discharge summary filed in the clinical record. PROCEDURE: 1. Each clinician who provides care will complete a discharge summary at the time his/her discipline is discharged, which may include, as appropriate: A. The date of discharge, including the date the physician and the patient were informed of discharge. B. The reason for discharge. C. The reason for discharge, including, as applicable, the name of the organization to which the patient is being transferred. D. The status of problems identified at admission and during the provision of care. E. The progress toward goals/desired outcomes. F. Medical status at discharge, including continuing symptom management needs. G. The overall status of the patient. H. A summary of care or services provided. 2. The discharge summary and other relevant clinical record documents will be completed and submitted within 72 hours of discharge from service. 3. A copy of the discharge summary will be provided to the patient’s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the organization within five (5) business days of the patient’s discharge. …” 12. A review of Patient 1’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of March 13, 2023, with a recertification period of January 1, 2025, to March 1, 2025. Patient 1 had diagnoses that included infection or inflammation of internal orthopedic implants (a medical device that replaces or supports damaged bones or joints), or prosthetic device (a medical implant that replaces a damaged joint, such as the hip, knee, or ankle). A review of Patient 1’s acute care hospital’s discharge information dated December 30, 2024, indicated Patient 1 had surgery to her right ankle to remove buried hardware on December 19, 2024. Patient 1 was discharged December 28, 2024, with orthopedic “boot” in place. During Patient 1’s home visit observation and interview with CHHA 1 and Patient 1’s son on February 25, 2025, from 9:56 AM to 11:06 AM, Patient 1 was in a hospital bed in her room and an orthopedic “boot” was noted to Patient 1’s right lower leg and foot. CHHA 1 proceeded to give Patient 1 a bed bath (a wash given to someone who is unable to leave their bed) and washed Patient 1’s right leg up to the “boot” but no further. CHHA 1 stated Patient 1’s son had told her about a month ago not to remove the “boot” and she had reported this to the Administrator/Director of Patient Care Services (Admin/DPCS) who told her to follow the son’s direction. Patient 1’s son stated his mother had some infected hardware removed from her right ankle in December 2024 and the hospital had placed staples and the “boot” to her right ankle. Patient 1’s son stated at the end of last month (January 2025) he had asked the visiting nurse to take the “boot” off because the Admin/DPCS had removed the staples, and the wound had healed but the nurse told him he would have to take his mother to an orthopedic doctor’s appointment to receive orders to remove the “boot.” Patient 1’s son stated it was extremely difficult and painful to move his mother from her bed and transport her to a doctor’s appointment, so he “just left the ‘boot’ on.” Patient 1’s son stated he would have appreciated assistance from the home health agency to contact the orthopedic doctor to get permission to remove the “boot.” Patient 1’s son stated it was “Okay” with him if CHHA 1 removed the “boot” and cleaned the right lower leg because the visiting nurses removed and replaced the “boot” at each visit and the wound was healed. A review of Patient 1’s Resumption of Care Assessment, dated December 31, 2024, was conducted. There was no documented evidence to show the presence of Patient 1’s orthopedic “boot.” A review of Patient 1’s care plan for the certification period of January 1, 2025, to March 1, 2025, was conducted. There was no documented evidence to show Patient 1’s orthopedic “boot” had been care planned. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 26, 2025, at 3:32 PM, the Admin/DPCS stated she had conducted Patient 1’s Resumption of Care Assessment on December 31, 2024, and it was her responsibility to care plan Patient 1’s orthopedic “boot” and had not. A review of the agency’s policy and procedure titled, “Care Planning Process,” dated November 2018, indicated, “PURPOSE: To provide clinical direction to clinicians providing direct patient care. POLICY: A written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days, or as patient’s condition warrants. The patient plan of care will be developed or revised within five (5) working days of initiation of each service or of the reassessment of the patient. All clinicians including the physician involved in the patient’s care, either directly or indirectly, will contribute to the plan of care. The patient and family/caregiver will participate in decisions regarding the plan of care whenever possible. The care planning process will be documented on the plan of care, individualized discipline-specific care plans (if applicable), clinical notes, medication profiles, care conference/summary forms, and discharge/clinical summaries. Definitions 1. Individualized Plan of Care: The patient-specific clinical plan of care includes all pertinent diagnoses, mental status, types of services/equipment, frequency of visits, goals and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, treatments, safety measures, instructions, discharge plan. Documents include plan of treatment (485) and plans of care (all disciplines). … PROCEDURE: 1. At the time of the initial assessment, the clinician, along with the physician and other involved disciplines, will develop the patient plan of care based upon the patient’s identified needs and will review it with the patient and family/caregiver. 2. All clinicians will consider the conclusions of initial and ongoing assessments in their care planning process, including, but not limited to: A. Individualized patient needs, and resultant problems related to care, functional status, and family/caregiver support systems. B. Changes in patient’s condition. C. Clinical drug monitoring, as appropriate. D. Pain and symptom management, as appropriate. E. Psychosocial and spiritual needs of patient and family/caregiver, as appropriate. F. Patient treatment choices. G. Patient and caregiver education and training that the organization will provide specific to the patient’s care needs.” 13a. 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 April 3, 2023, with a recertification period of January 22, 2025, to March 22, 2025. Patient 3 had diagnoses that included stiff-man syndrome (a rare chronic disorder that causes muscle stiffness and painful spasms). A review of Patient 3’s care plan dated January 22, 2025, to March 22, 2025, was conducted. There was no documented evidence to show PT or OT visit frequencies. A review of Patient 3’s physician’s orders from January 22, 2025, to February 13, 2025, was conducted. There was no documented evidence to show a physician’s order to update the plan of care for PT and OT visits as follows: A review of Patient 3’s PT visit notes indicated PT had visited Patient 3 on January 23, 28, and 30, 2025, and February 4, 11, and 13, 2025. A review of Patient 3’s OT visit notes indicated OT had visited Patient 3 on January 22, and 27, 2025. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 10:46 AM, the Admin/DPCS verified the PT and OT frequencies were not in Patient 3’s plan of care and there were no physician’s orders to update the plan of care for the PT and OT visits indicated above. 13b. A review of Patient 5’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of January 6, 2025, with a certification period of January 6, 2025, to March 6, 2025. Patient 5 had diagnoses that included colon cancer. A review of Patient 5’s care plan dated January 6, 2025, to March 6, 2025, was conducted. There was no documented evidence to show SN visit frequencies. A review of Patient 5’s physician’s orders from January 6, 2025, to March 6, 2025, was conducted. There was no documented evidence to show a physician’s order to update the plan of care for SN visits as follows: A review of Patient 5’s SN visit notes indicated the SN had visited Patient 5 on January 8, and 31, 2025, and February 9, and 22, 2025. During an interview with the Admin/DPCS on February 27, 2025, at 12:06 PM, the Admin/DPCS verified the SN frequencies were not in Patient 5’s plan of care and there were no physician’s orders to update the plan of care for the SN visits indicated above. A review of the agency’s policy and procedure titled, “Care Planning Process,” dated November 2018, indicated, “PURPOSE: To provide clinical direction to clinicians providing direct patient care. POLICY: A written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days, or as patient’s condition warrants. The patient plan of care will be developed or revised within five (5) working days of initiation of each service or of the reassessment of the patient. All clinicians including the physician involved in the patient’s care, either directly or indirectly, will contribute to the plan of care. The patient and family/caregiver will participate in decisions regarding the plan of care whenever possible. The care planning process will be documented on the plan of care, individualized discipline-specific care plans (if applicable), clinical notes, medication profiles, care conference/summary forms, and discharge/clinical summaries. Definitions 1. Individualized Plan of Care: The patient-specific clinical plan of care includes all pertinent diagnoses, mental status, types of services/equipment, frequency of visits, goals and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, treatments, safety measures, instructions, discharge plan. Documents include plan of treatment (485) and plans of care (all disciplines). … PROCEDURE: … 3. Based on the assessment and conclusions, the plan of care will include, but not be limited to: … Type, frequency, and duration of above actions. …” 14. A review of Patient 1’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of March 13, 2023, with a recertification period of January 1, 2025, to March 1, 2025. Patient 1 had diagnoses that included infection or inflammation of internal orthopedic implants (a medical device that replaces or supports damaged bones or joints), or prosthetic device (a medical implant that replaces a damaged joint, such as the hip, knee, or ankle). A review of Patient 1’s acute care hospital’s discharge information dated December 30, 2024, indicated Patient 1 had surgery to her right ankle to remove buried hardware on December 19, 2024. Patient 1 was discharged December 28, 2024, with orthopedic “boot” in place. During Patient 1’s home visit observation and interview with CHHA 1 and Patient 1’s son on February 25, 2025, from 9:56 AM to 11:06 AM, Patient 1 was in a hospital bed in her room and an orthopedic “boot” was noted to Patient 1’s right lower leg and foot. CHHA 1 proceeded to give Patient 1 a bed bath (a wash given to someone who is unable to leave their bed) and washed Patient 1’s right leg up to the “boot” but no further. CHHA 1 stated Patient 1’s son had told her about a month ago not to remove the “boot” and she had reported this to the Administrator/Director of Patient Care Services (Admin/DPCS) who told her to follow the son’s direction. Patient 1’s son stated his mother had some infected hardware removed from her right ankle in December 2024 and the hospital had placed staples and the “boot” to her right ankle. Patient 1’s son stated at the end of last month (January 2025) he had asked the visiting nurse to take the “boot” off because the Admin/DPCS had removed the staples. A review of Patient 1’s care plan and physician’s orders from January 1, 2025, to February 26, 2025, was conducted. There was no documented evidence to show a physician’s order to remove staples from Patient 1’s right ankle. During an interview with the Admin/DPCS on February 26, 2025, at 3:32 PM, the Admin/DPCS stated she had visited Patient 1 on January 21, 2025, and remove three staples from Patient 1’s right ankle. The Admin/DPCS stated she had not documented the staple removal on her visit note or obtained a physician’s order to remove the staples and should have. A review of the agency’s policy and procedure titled “Verification of Physician Orders,” dated November 2018, indicated, “PURPOSE: To ensure that accurate physician (or other authorized licensed independent practitioner) orders and prescriptions are obtained in accordance with state and federal law and regulation. POLICY: Orders will be obtained from a licensed physician (or other authorized licensed independent practitioner) for care and services to be provided to home health patients.” 15. A review of the agency’s infection control logs from January 3, 2024, to February 13, 2025, was conducted. The infection control logs indicated the dates the infections were identified, the names of the patients, signs and symptoms of the infections, laboratory test results, and the treatments provided. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) and the Office Manager (OM) on February 27, 2025, at 12:45 PM, the Admin/DPCS stated she was responsible for the Infection Control Program and the QAPI Program and the OM stated she collected the patient infection information, filled out the infection control logs and provided the infection control log data to the QAPI Committee on a quarterly basis. A review of the QAPI committee meeting notes and QAPI Program binder from January 3, 2024, to February 13, 2025, was conducted. The QAPI committee meeting notes and QAPI Program binder did not contain documentation showing infection control data had been received, aggregated (gathered together) or analyzed by the QAPI Committee. In a continued interview with the Admin/DPCS and OM, the Admin/DPCS stated the patients’ infections were discussed at the QAPI committee meeting, but the discussions were not documented. The Admin/DPCS stated she was not aware the patients’ infection data needed to be analyzed in order to identify infection trends or develop action plans to improve disease prevention. A review of the agency’s policy and procedure titled “Infection Control Plan,” dated November 2018, indicated, “Introduction: The purpose of the infection control program is to reduce the risk of acquisition and transmission of health care associated infections (HAIs). The infection control program is an integral component of the organization’s safety and performance improvement programs. The organization performs an ongoing assessment of the risks for acquisition and transmission of infectious agents across all services and programs. The organization’s leaders actively participate in the design and implementation of the infection control program. The organization recognizes that infection prevention and control is a community-wide effort and integrates its efforts with other health care organizations where possible. An infection control program must include planning, surveillance, identification, prevention/control, and reporting. [name of the agency] is committed to the implementation of these policies and procedures to improve patient outcomes and reduce the risk of infection in patients and staff. … PROCEDURE: … 5. The infection control plan will be monitored and evaluated in the annual program evaluation and in conjunction with the review of the organization’s safety and performance improvement activities. Surveillance activities, including data collection and analysis, will be used to identify prevention and control risks. The evaluation of the infection control program includes a review of the plan, goals, and risk analysis across all services/programs. A review of the agency’s policy and procedure titled, “Improving Organizational Performance,” dated November 2018, indicated, “PURPOSE: To establish a performance improvement framework, which integrates activities to improve organization performance, manage change, improve patient safety, improve quality of care, treatment or services and reduce the risks for acquisition and transmission of infections. To improve organizational performance by focusing on high risk, high volume, and problem prone areas. … PROCEDURE: 1. Senior management with Governing Body oversight will: A. Participate in educational activities to increase their level of understanding and ability to implement performance improvement activities. The educational activities may include seminars, consultations, readings, periodicals, benchmarking, and review of available information from other organizations regarding the occurrence of sentinel events to reduce the risk of similar sentinel events within the organization. B. Set expectations for performance improvement, set priorities and frequency of data collection and manage processes to improve organization performance. C. Focus on high risk, high volume, and problem-prone areas. Consider incidence, prevalence, and severity of problems in those areas and lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. D. Adopt a scientific, problem-solving approach to performance improvement. The scientific, problem-solving approach will include, minimally:1. Planning for performance improvement with integration of information from other relevant activities … e. Infection control surveillance. …” 16. A review of Patient 1’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of March 13, 2023, with a recertification period of January 1, 2025, to March 1, 2025. Patient 1 had diagnoses that included infection or inflammation of internal orthopedic implants (a medical device that replaces or supports damaged bones or joints), or prosthetic device (a medical implant that replaces a damaged joint, such as the hip, knee, or ankle). A review of Patient 1’s acute care hospital’s discharge information dated December 30, 2024, indicated Patient 1 had surgery to her right ankle to remove buried hardware on December 19, 2024. Patient 1 was discharged December 28, 2024, with orthopedic “boot” in place. During Patient 1’s home visit observation and interview with CHHA 1 and Patient 1’s son on February 25, 2025, from 9:56 AM to 11:06 AM, Patient 1 was in a hospital bed in her room and an orthopedic “boot” was noted to Patient 1’s right lower leg and foot. CHHA 1 proceeded to give Patient 1 a bed bath (a wash given to someone who is unable to leave their bed) and washed Patient 1’s right leg up to the “boot” but no further. CHHA 1 stated Patient 1’s son had told her about a month ago not to remove the “boot” and she had reported this to the Administrator/Director of Patient Care Services (Admin/DPCS) who told her to follow the son’s direction. Patient 1’s son stated his mother had some infected hardware removed from her right ankle in December 2024 and the hospital had placed staples and the “boot” to her right ankle. Patient 1’s son stated at the end of last month (January 2025) he had asked the visiting nurse to take the “boot” off because the Admin/DPCS had removed the staples, and the wound had healed but the nurse told him he would have to take his mother to an orthopedic doctor’s appointment to receive orders to remove the “boot.” Patient 1’s son stated it was extremely difficult and painful to move his mother from her bed and transport her to a doctor’s appointment, so he “just left the ‘boot’ on.” Patient 1’s son stated he would have appreciated assistance from the home health agency to contact the orthopedic doctor to get permission to remove the “boot.” Patient 1’s son stated it was “Okay” with him if CHHA 1 removed the “boot” and cleaned the right lower leg because the visiting nurses removed and replaced the “boot” at each visit and the wound was healed. A review of Patient 1’s CHHA plans of care dated December 31, 2024, and January 17, 2025, was conducted. There was no documented evidence to show special instructions for Patient 1’s orthopedic “boot.” During an interview with the Admin/DPCS on February 26, 2025, at 3:32 PM, the Admin/DPCS stated she had created Patient 1’s CHHA plans of care dated December 31, 2024, and January 17, 2025. The Admin/DPCS stated she should have included special instructions on how to care for Patient 1’s orthopedic “boot,” and had not. A review of the agency’s policy and procedure titled “Home Health Aide Plan of Care,” dated November 2018, indicated, “PURPOSE: To define the process for the development and use of the home health aide plan of care. POLICY: Each patient receiving home health aide services will have an individualized plan developed and utilized to direct care performed by the assigned aide. PROCEDURE: 1. The patient’s Case Manager or other appropriate skilled professional (physical therapist, speech-language pathologist, or occupational therapist), upon initialization of aide services, will develop the written home health aide plan of care, consistent with the comprehensive plan of care and physician (or other authorized licensed independent practitioner) orders. 2. The home health aide plan of care will be individualized to the specific patient and will include at least: … H. Specific procedure(s) to be performed, including amount, frequency, and duration. I. Safety measures, including use of specific equipment … The home health aide plan of care will be reviewed with the patient to ensure understanding of the aide’s role in the home.” 17a. A review of Patient 1’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of March 13, 2023, with a recertification period of January 1, 2025, to March 1, 2025. Patient 1 had diagnoses that included infection or inflammation of internal orthopedic implants (a medical device that replaces or supports damaged bones or joints), or prosthetic device (a medical implant that replaces a damaged joint, such as the hip, knee, or ankle). A review of Patient 1’s physician’s order dated January 19, 2025, indicated CHHA services three times a week for one week and two times a week for six weeks. A review of the CHHA’s visit notes from January 19, 2025, to February 17, 2025, indicated the CHHA visited Patient 1 on the following days: January 21, 23, 25, 28, and 30, 2025, and February 4, 6, and 11, 2025. A review of Skilled Nurse (SN) visit notes from January 19, 2025, to February 17, 2025, was conducted. There was no documented evidence to show a CHHA supervisory visit had been conducted every 14 days. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) February 26, 2025, at 4:22 PM, the Admin/DPCS verified the CHHA had not been supervised every 14 days during the time period of January 19, 2025, to February 17, 2025, and should have been. 17b. 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 January 1, 2025, with a certification period of January 1, 2025, to March 1, 2025. Patient 4 had diagnoses that included pressure ulcer at the base of the spine (a wound caused by prolonged pressure). A review of Patient 4’s physician’s order dated January 15, 2025, indicated CHHA services one time a week for one week and two times a week for six weeks. A review of the CHHA’s visit notes from January 15, 2025, to February 11, 2025, indicated the CHHA visited Patient 4 on the following days: January 17, 20, 24, 28, and 31, 2025, and February 3, 7, and 10, 2025. A review of Skilled Nurse (SN) visit notes from January 15, 2025, to February 11, 2025, was conducted. There was no documented evidence to show a CHHA supervisory visit had been conducted every 14 days. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) February 27, 2025, at 12:11 PM, the Admin/DPCS verified the CHHA had not been supervised every 14 days during the time period of January 15, 2025, to February 11, 2025, and should have been. A review of the agency’s policy and procedure titled “Responsibilities/Supervision of Clinical Services,” dated November 2018, indicated, “PROCEDURE: … 7. The Clinical Director will ensure that the following supervision is maintained within the organization: A. Home health aides: 1. Home health aide supervisory visits will be conducted on-site at least every fourteen (14) days by skilled personnel. Supervisory visits can be made in conjunction with the home health aide or in his/her absence. A direct observation supervisory visit will be made at least every six (6) months.” 18a. A review of Patient 6’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of November 16, 2024, with a certification period of November 16, 2024, to January 14, 2025. Patient 6 had diagnoses that included hypertension (high blood pressure). A review of Patient 6’s physician’s order dated November 22, 2024, indicated Patient 6 had been transferred to the hospital. A review of Patient 6’s physician’s order dated January 14, 2025, indicated Patient 6 had been discharged from the agency. A review of Patient 6’s transfer summaries (a document that provides a concise overview of a patient’s current medical condition, including diagnosis, treatment plan, medications, and relevant medical history) and discharge summaries (a written document that details a patient’s medical condition upon leaving a healthcare facility, summarizing their admission details, diagnosis, treatment received, current medications, and any necessary follow-up care) from November 22, 2024, to January 14, 2025, was conducted. There was no documented evidence to show a transfer summary and/or discharge summary had been created and sent to the receiving healthcare facility and healthcare practitioner. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 26, 2025, at 1:43 PM, the Admin/DPCS verified a transfer summary and discharge summary had not been created for Patient 6 or sent to the receiving healthcare facility or healthcare practitioner. 18b. 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 July 18, 2024, with a recertification period of September 16, 2024, to November 14, 2024. Patient 7 had diagnoses that included presence of an indwelling urinary catheter (a thin, flexible tube inserted into the bladder through the urinary duct to collect and drain urine). A review of Patient 7’s “Inter-Office Communication Note,” dated October 29, 2024, indicated, “PCG [Primary Caregiver) states that [Patient 7] is in [name of a California city] and does not know when he will be back but needs to be seen by [a Skilled Nurse] for [indwelling urinary catheter] care and needs supplies. [Agency’s Scheduler] told PCG that we do not service the [name of a California city] area, and we would have to redirect to another [Home Health Agency]. [Agency’s Scheduler] called [Patient 7’s medical insurance company] and spoke with [name of a medical insurance company’s representative], she will obtain [physician’s] orders and redirect [as soon as possible]. A review of Patient 7’s physician’s order dated October 29, 2024, indicated, “[Discharge from] home health services, [Patient 7] moved out of service area and will be transferred to another [Home Health Agency].” A review of Patient 7’s transfer summaries and discharge summaries from October 29, 2024, to February 26, 2025, was conducted. There was no documented evidence to show a transfer summary and/or discharge summary had been created and sent to the receiving healthcare facility and healthcare practitioner. During an interview with the Admin/DPCS on February 26, 2025, at 1:55 PM, the Admin/DPCS verified a transfer summary and discharge summary had not been created for Patient 7 or sent to the receiving healthcare facility or healthcare practitioner. A review of the agency’s policy and procedure titled “Transfer Summary,” dated November 2018, indicated, “PURPOSE: To define the requirements for documentation of a patient transfer to another service provider. POLICY: All patients transferred from the organization will have a transfer summary completed and filed in the clinical record. Definition: Service Provider: Another home health, hospice or health care facility. PROCEDURE: 1. Within 48 hours of transfer, the transferring clinician will complete a transfer summary that includes, as appropriate: A. The reason for transfer. B. The physical and psychosocial status at the time of transfer, including specific medical, psychosocial, or other problems requiring interventions or follow-up. C. Continuing symptom management needs. D. Medication profile. E. A summary of the care provided, and the progress toward achieving goals. F. Any instructions and/or referrals provided to the patient. G. The existence of any Advance Directives known to the organization. H. Date of face-to-face encounter, if during initial certification. I. The date of transfer, which is the date of the last visit made. 2. Completed transfer summaries will be given to a clinical records clerk, who will send a copy to the receiving organization, along with a copy of the clinical record, within two (2) business days of a planned transfer or within two (2) days of becoming aware of an unplanned transfer and will file the original in the clinical record. 3. A copy of the transfer summary will be sent to the physician within 48 hours of transfer.” A review of the agency’s policy and procedure titled “Discharge Summary,” dated November 2018, indicated, “PURPOSE: To define requirements for documentation of service discontinuation and when patients are discharged from the organization. POLICY: Each patient discharged from a service and from the organization will have a written discharge summary filed in the clinical record. PROCEDURE: 1. Each clinician who provides care will complete a discharge summary at the time his/her discipline is discharged, which may include, as appropriate: A. The date of discharge, including the date the physician and the patient were informed of discharge. B. The reason for discharge. C. The reason for discharge, including, as applicable, the name of the organization to which the patient is being transferred. D. The status of problems identified at admission and during the provision of care. E. The progress toward goals/desired outcomes. F. Medical status at discharge, including continuing symptom management needs. G. The overall status of the patient. H. A summary of care or services provided. 2. The discharge summary and other relevant clinical record documents will be completed and submitted within 72 hours of discharge from service. 3. A copy of the discharge summary will be provided to the patient’s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the organization within five (5) business days of the patient’s discharge. …” During an interview with the Administrator Designee (AD) on February 27, 2025, at 2:30 PM, The AD stated he was a member of the Governing Body (GB) and assumed full legal authority and responsibility for the operation of the agency, and for the quality of care and services provided. The AD stated the GB had not identified that: 1. The agency did not review and update its Emergency Preparedness Program (EPP) every two years, for the 2023 and 2024 years reviewed. 2. The agency had not collaborated 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 2023 and 2024 years reviewed. 3. The agency had not implemented 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 2023 and 2024 years reviewed. 4. The agency had not developed and implemented a procedure to provide for emergency staffing during a disaster or emergency, for the 2023 and 2024 years reviewed. 5. The agency had not developed a back-up communication plan with Federal, State, tribal, regional, and local emergency management agencies in the event of communications failure during a disaster or emergency, for the 2023 and 2024 years reviewed. 6. The agency had not implemented 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 2023 and 2024 years reviewed. 7. The agency had not conducted full-scale emergency preparedness exercises that were community based or tabletop emergency preparedness exercises for 2023 and 2024 years reviewed. 8. The agency had not transmitted OASIS data within 30 days of the completion date for Patient 6 when transfer and discharge OASIS assessments were not conducted or transmitted. 9. The agency did not 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 Patients 1, 2, 5, and 6. 10. The agency did not ensure an RN updated the comprehensive assessment for Patient 1 when Patient 1’s right ankle surgical wound had healed and the continued need for the protective orthopedic “boot” was not re-evaluated in consultation with the orthopedic physician. 11. The agency did not ensure upon transfer and/or discharge all necessary medical information pertaining to the patient’s current course of illness and treatment, was sent to the receiving healthcare facility and healthcare practitioner for Patients 6 and 7. 12. The agency did not ensure each patient received home health services that were written in an individualized plan of care that identified patient-specific measurable outcomes and goals, for Patient 1 when Patient 1’s right ankle surgical wound was enclosed in a protective orthopedic “boot” and the “boot” was not in Patient 1’s plan of care. 13. The agency did not ensure the patients’ individualized plans of care contained all the required elements when: a. For Patient 3: the PT and OT visit frequencies were not in the plan of care and there were no physician’s orders with PT and OT visit frequencies to update the plan of care. b. For Patient 5: the SN frequencies were not in the plan of care and there were no physician’s orders with SN visit frequencies to update the plan of care. 14. The agency did not obtain physician’s orders for Patient 1 when an RN removed surgical staples from Patient 1’s right ankle without a physician’s order. 15. The agency did not maintain an infection control program that was integrated into the agency’s QAPI program in order to: identify infection trends, develop action plans and improve disease prevention, from January 3, 2024, to February 13, 2025. 16. The agency did not ensure an RN provided a CHHA written patient care instructions for Patient 1 when the CHHA’s care plan did not contain special instructions on how to care for Patient 1’s orthopedic “boot.” 17. The agency did conduct an on-site CHHA supervisory visit every 14 days for Patients 1 and 4. 18. The agency did not ensure the clinical record contained a completed discharge summary sent to the primary care practitioner within five business days of the patient’s discharge and a completed transfer summary was sent within two business days of becoming aware of a planned transfer to a receiving health care facility, for Patients 6 and 7. A review of the agency’s policy and procedure titled “Governing Body,” dated November 2018, indicated, “PURPOSE: To outline the roles and responsibilities of the Governing Body. POLICY: The Governing Body will assume full legal authority and responsibility for the operation of [name of the agency]. The Governing Body of [name of the agency] will serve as the governing authority for the home health program, which will function according to [name of the agency] bylaws. PROCEDURE: … 4. The Governing Body will routinely evaluate to what extent the organization has met the needs of the community for home health, has provided adequate and appropriate care to patients, …””

“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 four of seven sampled patients (Patients 1, 2, 5, and 6). This failure had the potential to cause a delay in the determination of Patients 1, 2, 5, and 6’s immediate care and support needs. 1. A review of Patient 1’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of March 13, 2023, with a certification period of March 13, 2023, to May 11, 2023. Patient 1 had diagnoses that included diabetes mellitus (a disease that causes high blood sugar levels). A review of Patient 1’s physician’s referral order dated March 9, 2023, indicated a request for home health services. A review of Patient 1’s initial assessment dated March 13, 2023, indicated the initial assessment had been conducted on March 13, 2023. (The initial assessment had been completed four days after the physician’s referral order) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 26, 2025, at 3:32 PM, the Admin/DPCS stated the referral order from the referring physician was dated March 9, 2023, and the agency needed to admit Patient 1 within 48 hours which would be no later than March 11, 2023, but had not. 2. A review of Patient 2’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of February 1, 2025, with a certification period of February 1, 2025, to April 1, 2025. Patient 2 had diagnoses that included open wound of right upper arm. A review of Patient 2’s physician’s referral order dated January 27, 2025, indicated a request for home health services. A review of Patient 2’s initial assessment dated February 1, 2025, indicated the initial assessment had been conducted on February 1, 2025. (The initial assessment had been completed five days after the physician’s referral order) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 10:35 AM, the Admin/DPCS stated the referral order from the referring physician was dated January 27, 2025, and the agency needed to admit Patient 2 within 48 hours which would be no later than January 29, 2025, but had not. 3. A review of Patient 5’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of January 6, 2025, with a certification period of January 6, 2025, to March 6, 2025. Patient 5 had diagnoses that included colon cancer. A review of Patient 5’s physician’s referral order dated January 3, 2025, indicated a request for home health services. A review of Patient 5’s initial assessment dated January 6, 2025, indicated the initial assessment had been conducted on January 6, 2025. (The initial assessment had been completed three days after the physician’s referral order) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 12:06 PM, the Admin/DPCS stated the referral order from the referring physician was dated January 3, 2025, and the agency needed to admit Patient 5 within 48 hours which would be no later than January 5, 2025, but had not. 4. A review of Patient 6’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of November 16, 2024, with a certification period of November 16, 2024, to January 14, 2025. Patient 6 had diagnoses that included hypertension (high blood pressure). A review of Patient 6’s physician’s referral order dated November 11, 2024, indicated a request for home health services. A review of Patient 6’s initial assessment dated November 16, 2024, indicated the initial assessment had been conducted on November 16, 2024. (The initial assessment had been completed five days after the physician’s referral order) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 26, 2025, at 1:43 PM, the Admin/DPCS stated the referral order from the referring physician was dated November 11, 2024, and the agency needed to admit Patient 6 within 48 hours which would be no later than November 13, 2024, but had not. A review of the agency’s policy and procedure titled “Initial and Comprehensive Assessment,” dated November 2018, indicated, “PURPOSE: To provide guidelines for the initial assessments of patients admitted to service and for completing plans of care. POLICY: An initial patient assessment will be performed and documented in the patient’s clinical record by a registered nurse, physical therapist, or speech therapist on all patients referred. The initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of the patient’s return home, on the start of care date ordered by the physician (or other authorized licensed independent practitioner), or at the patient/family request with the approval of the physician (or other authorized licensed independent practitioner).””

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on interview, and record review, the agency failed to ensure the patients’ individualized plans of care contained all the required elements for two of seven sampled patients (Patients 3 and 5) when: 1. For Patient 3: the Physical Therapy (PT) and Occupational Therapy (OT) visit frequencies were not in the plan of care and there were no physician’s orders with PT and OT visit frequencies to update the plan of care. 2. For Patient 5: the Skilled Nursing (SN) frequencies were not in the plan of care and there were no physician’s orders with SN visit frequencies to update the plan of care. This failure had the potential to cause Patients 3 and 5 not to receive the care and services to meet their care planning goals. 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 April 3, 2023, with a recertification period of January 22, 2025, to March 22, 2025. Patient 3 had diagnoses that included stiff-man syndrome (a rare chronic disorder that causes muscle stiffness and painful spasms). A review of Patient 3’s care plan dated January 22, 2025, to March 22, 2025, was conducted. There was no documented evidence to show PT or OT visit frequencies. A review of Patient 3’s physician’s orders from January 22, 2025, to February 13, 2025, was conducted. There was no documented evidence to show a physician’s order to update the plan of care for PT and OT visits as follows: A review of Patient 3’s PT visit notes indicated PT had visited Patient 3 on January 23, 28, and 30, 2025, and February 4, 11, and 13, 2025. A review of Patient 3’s OT visit notes indicated OT had visited Patient 3 on January 22, and 27, 2025. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 27, 2025, at 10:46 AM, the Admin/DPCS verified the PT and OT frequencies were not in Patient 3’s plan of care and there were no physician’s orders to update the plan of care for the PT and OT visits indicated above. 2. A review of Patient 5’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of January 6, 2025, with a certification period of January 6, 2025, to March 6, 2025. Patient 5 had diagnoses that included colon cancer. A review of Patient 5’s care plan dated January 6, 2025, to March 6, 2025, was conducted. There was no documented evidence to show SN visit frequencies. A review of Patient 5’s physician’s orders from January 6, 2025, to March 6, 2025, was conducted. There was no documented evidence to show a physician’s order to update the plan of care for SN visits as follows: A review of Patient 5’s SN visit notes indicated the SN had visited Patient 5 on January 8, and 31, 2025, and February 9, and 22, 2025. During an interview with the Admin/DPCS on February 27, 2025, at 12:06 PM, the Admin/DPCS verified the SN frequencies were not in Patient 5’s plan of care and there were no physician’s orders to update the plan of care for the SN visits indicated above. A review of the agency’s policy and procedure titled, “Care Planning Process,” dated November 2018, indicated, “PURPOSE: To provide clinical direction to clinicians providing direct patient care. POLICY: A written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days, or as patient’s condition warrants. The patient plan of care will be developed or revised within five (5) working days of initiation of each service or of the reassessment of the patient. All clinicians including the physician involved in the patient’s care, either directly or indirectly, will contribute to the plan of care. The patient and family/caregiver will participate in decisions regarding the plan of care whenever possible. The care planning process will be documented on the plan of care, individualized discipline-specific care plans (if applicable), clinical notes, medication profiles, care conference/summary forms, and discharge/clinical summaries. Definitions 1. Individualized Plan of Care: The patient-specific clinical plan of care includes all pertinent diagnoses, mental status, types of services/equipment, frequency of visits, goals and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, treatments, safety measures, instructions, discharge plan. Documents include plan of treatment (485) and plans of care (all disciplines). … PROCEDURE: … 3. Based on the assessment and conclusions, the plan of care will include, but not be limited to: … Type, frequency, and duration of above actions. …””

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on interview and record review, the agency failed to obtain physician’s orders for one of seven sampled patients (Patient 1) when a Registered Nurse (RN) removed surgical staples from Patient 1’s right ankle without a physician’s order. This failure had the potential to cause Patient 1’s surgical wound to open before it was healed. A review of Patient 1’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of March 13, 2023, with a recertification period of January 1, 2025, to March 1, 2025. Patient 1 had diagnoses that included infection or inflammation of internal orthopedic implants (a medical device that replaces or supports damaged bones or joints), or prosthetic device (a medical implant that replaces a damaged joint, such as the hip, knee, or ankle). A review of Patient 1’s acute care hospital’s discharge information dated December 30, 2024, indicated Patient 1 had surgery to her right ankle to remove buried hardware on December 19, 2024. Patient 1 was discharged December 28, 2024, with orthopedic “boot” in place. During Patient 1’s home visit observation and interview with a Certified Home Health Aide (CHHA 1) and Patient 1’s son on February 25, 2025, from 9:56 AM to 11:06 AM, Patient 1 was in a hospital bed in her room and an orthopedic “boot” was noted to Patient 1’s right lower leg and foot. CHHA 1 proceeded to give Patient 1 a bed bath (a wash given to someone who is unable to leave their bed) and washed Patient 1’s right leg up to the “boot” but no further. CHHA 1 stated Patient 1’s son had told her about a month ago not to remove the “boot” and she had reported this to the Administrator/Director of Patient Care Services (Admin/DPCS) who told her to follow the son’s direction. Patient 1’s son stated his mother had some infected hardware removed from her right ankle in December 2024 and the hospital had placed staples and the “boot” to her right ankle. Patient 1’s son stated at the end of last month (January 2025) he had asked the visiting nurse to take the “boot” off because the Admin/DPCS had removed the staples. A review of Patient 1’s care plan and physician’s orders from January 1, 2025, to February 26, 2025, was conducted. There was no documented evidence to show a physician’s order to remove staples from Patient 1’s right ankle. During an interview with the Admin/DPCS on February 26, 2025, at 3:32 PM, the Admin/DPCS stated she had visited Patient 1 on January 21, 2025, and remove three staples from Patient 1’s right ankle. The Admin/DPCS stated she had not documented the staple removal on her visit note or obtained a physician’s order to remove the staples and should have. A review of the agency’s policy and procedure titled “Verification of Physician Orders,” dated November 2018, indicated, “PURPOSE: To ensure that accurate physician (or other authorized licensed independent practitioner) orders and prescriptions are obtained in accordance with state and federal law and regulation. POLICY: Orders will be obtained from a licensed physician (or other authorized licensed independent practitioner) for care and services to be provided to home health patients.””

“Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient’s plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This Element is not met as evidenced by: Based on interview and record review, the agency failed to conduct an on-site Certified Home Health Aide (CHHA) supervisory visit every 14 days for two of seven sampled patients (Patients 1 and 4). This failure had the potential to cause inconsistent quality of care, missed opportunities to address changing patient needs, and compromising the well-being of the patient due to improper or inadequate care. 1. A review of Patient 1’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of March 13, 2023, with a recertification period of January 1, 2025, to March 1, 2025. Patient 1 had diagnoses that included infection or inflammation of internal orthopedic implants (a medical device that replaces or supports damaged bones or joints), or prosthetic device (a medical implant that replaces a damaged joint, such as the hip, knee, or ankle). A review of Patient 1’s physician’s order dated January 19, 2025, indicated CHHA services three times a week for one week and two times a week for six weeks. A review of the CHHA’s visit notes from January 19, 2025, to February 17, 2025, indicated the CHHA visited Patient 1 on the following days: January 21, 23, 25, 28, and 30, 2025, and February 4, 6, and 11, 2025. A review of Skilled Nurse (SN) visit notes from January 19, 2025, to February 17, 2025, was conducted. There was no documented evidence to show a CHHA supervisory visit had been conducted every 14 days. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) February 26, 2025, at 4:22 PM, the Admin/DPCS verified the CHHA had not been supervised every 14 days during the time period of January 19, 2025, to February 17, 2025, and should have been. 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 January 1, 2025, with a certification period of January 1, 2025, to March 1, 2025. Patient 4 had diagnoses that included pressure ulcer at the base of the spine (a wound caused by prolonged pressure). A review of Patient 4’s physician’s order dated January 15, 2025, indicated CHHA services one time a week for one week and two times a week for six weeks. A review of the CHHA’s visit notes from January 15, 2025, to February 11, 2025, indicated the CHHA visited Patient 4 on the following days: January 17, 20, 24, 28, and 31, 2025, and February 3, 7, and 10, 2025. A review of Skilled Nurse (SN) visit notes from January 15, 2025, to February 11, 2025, was conducted. There was no documented evidence to show a CHHA supervisory visit had been conducted every 14 days. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) February 27, 2025, at 12:11 PM, the Admin/DPCS verified the CHHA had not been supervised every 14 days during the time period of January 15, 2025, to February 11, 2025, and should have been. A review of the agency’s policy and procedure titled “Responsibilities/Supervision of Clinical Services,” dated November 2018, indicated, “PROCEDURE: … 7. The Clinical Director will ensure that the following supervision is maintained within the organization: A. Home health aides: 1. Home health aide supervisory visits will be conducted on-site at least every fourteen (14) days by skilled personnel. Supervisory visits can be made in conjunction with the home health aide or in his/her absence. A direct observation supervisory visit will be made at least every six (6) months.””

“Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient’s discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This Element is not met as evidenced by: Based on interview, and record review, the agency failed to ensure the clinical record contained a completed discharge summary sent to the primary care practitioner within five business days of the patient’s discharge and a completed transfer summary was sent within two business days of becoming aware of a planned transfer to a receiving health care facility, for two or seven sampled patients (Patients 6 and 7). This failure had the potential to cause Patient 6 and 7 to suffer healthcare complications, including delayed diagnosis, incorrect treatment decisions, and adverse drug interactions (a harmful and unintended reaction to a drug or combination of drugs). 1. A review of Patient 6’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of November 16, 2024, with a certification period of November 16, 2024, to January 14, 2025. Patient 6 had diagnoses that included hypertension (high blood pressure). A review of Patient 6’s physician’s order dated November 22, 2024, indicated Patient 6 had been transferred to the hospital. A review of Patient 6’s physician’s order dated January 14, 2025, indicated Patient 6 had been discharged from the agency. A review of Patient 6’s transfer summaries (a document that provides a concise overview of a patient’s current medical condition, including diagnosis, treatment plan, medications, and relevant medical history) and discharge summaries (a written document that details a patient’s medical condition upon leaving a healthcare facility, summarizing their admission details, diagnosis, treatment received, current medications, and any necessary follow-up care) from November 22, 2024, to January 14, 2025, was conducted. There was no documented evidence to show a transfer summary and/or discharge summary had been created and sent to the receiving healthcare facility and healthcare practitioner. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 26, 2025, at 1:43 PM, the Admin/DPCS verified a transfer summary and discharge summary had not been created for Patient 6 or sent to the receiving healthcare facility or healthcare practitioner. 2. 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 July 18, 2024, with a recertification period of September 16, 2024, to November 14, 2024. Patient 7 had diagnoses that included presence of an indwelling urinary catheter (a thin, flexible tube inserted into the bladder through the urinary duct to collect and drain urine). A review of Patient 7’s “Inter-Office Communication Note,” dated October 29, 2024, indicated, “PCG [Primary Caregiver) states that [Patient 7] is in [name of a California city] and does not know when he will be back but needs to be seen by [a Skilled Nurse] for [indwelling urinary catheter] care and needs supplies. [Agency’s Scheduler] told PCG that we do not service the [name of a California city] area, and we would have to redirect to another [Home Health Agency]. [Agency’s Scheduler] called [Patient 7’s medical insurance company] and spoke with [name of a medical insurance company’s representative], she will obtain [physician’s] orders and redirect [as soon as possible]. A review of Patient 7’s physician’s order dated October 29, 2024, indicated, “[Discharge from] home health services, [Patient 7] moved out of service area and will be transferred to another [Home Health Agency].” A review of Patient 7’s transfer summaries and discharge summaries from October 29, 2024, to February 26, 2025, was conducted. There was no documented evidence to show a transfer summary and/or discharge summary had been created and sent to the receiving healthcare facility and healthcare practitioner. During an interview with the Admin/DPCS on February 26, 2025, at 1:55 PM, the Admin/DPCS verified a transfer summary and discharge summary had not been created for Patient 7 or sent to the receiving healthcare facility or healthcare practitioner. A review of the agency’s policy and procedure titled “Transfer Summary,” dated November 2018, indicated, “PURPOSE: To define the requirements for documentation of a patient transfer to another service provider. POLICY: All patients transferred from the organization will have a transfer summary completed and filed in the clinical record. Definition: Service Provider: Another home health, hospice or health care facility. PROCEDURE: 1. Within 48 hours of transfer, the transferring clinician will complete a transfer summary that includes, as appropriate: A. The reason for transfer. B. The physical and psychosocial status at the time of transfer, including specific medical, psychosocial, or other problems requiring interventions or follow-up. C. Continuing symptom management needs. D. Medication profile. E. A summary of the care provided, and the progress toward achieving goals. F. Any instructions and/or referrals provided to the patient. G. The existence of any Advance Directives known to the organization. H. Date of face-to-face encounter, if during initial certification. I. The date of transfer, which is the date of the last visit made. 2. Completed transfer summaries will be given to a clinical records clerk, who will send a copy to the receiving organization, along with a copy of the clinical record, within two (2) business days of a planned transfer or within two (2) days of becoming aware of an unplanned transfer and will file the original in the clinical record. 3. A copy of the transfer summary will be sent to the physician within 48 hours of transfer.” A review of the agency’s policy and procedure titled “Discharge Summary,” dated November 2018, indicated, “PURPOSE: To define requirements for documentation of service discontinuation and when patients are discharged from the organization. POLICY: Each patient discharged from a service and from the organization will have a written discharge summary filed in the clinical record. PROCEDURE: 1. Each clinician who provides care will complete a discharge summary at the time his/her discipline is discharged, which may include, as appropriate: A. The date of discharge, including the date the physician and the patient were informed of discharge. B. The reason for discharge. C. The reason for discharge, including, as applicable, the name of the organization to which the patient is being transferred. D. The status of problems identified at admission and during the provision of care. E. The progress toward goals/desired outcomes. F. Medical status at discharge, including continuing symptom management needs. G. The overall status of the patient. H. A summary of care or services provided. 2. The discharge summary and other relevant clinical record documents will be completed and submitted within 72 hours of discharge from service. 3. A copy of the discharge summary will be provided to the patient’s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the organization within five (5) business days of the patient’s discharge. …””