Every finding on record at Amore Home Health Care Services, Inc

An Emergency Preparedness Survey was conducted by the Indiana State Department of Health in accordance with 42 CFR 494.62 Survey Dates: 12/02/2025-12/05/2025 12-month unduplicated skilled admissions: 64 At this Emergency Preparedness Survey, Lasik HHC Inc was found to be in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 494.62.

This visit was for a Federal Recertification and State Re-Licensure survey of a home health provider. Survey Dates: 12/02/2025 – 12/05/2025 Unduplicated 12-month skilled admissions: 64 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. The Administrator was notified of the partially extended survey on 12/04/2025 at 11:27 AM. Abbreviations used in report: Registered Nurse (RN), Plan of Care (POC), Physical Therapy (PT), Start of Care (SOC), and Clinical Manager (CM).

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 record review and interview, the agency failed to ensure the initial assessment was completed within 48 hours of the referral in 1 of 2 active clinical records with only SN services in a total sample of 7 clinical records reviewed. (Patient #2) The findings include: A clinical record review for Patient #2 evidenced a referral document with a faxed date to the agency on 11/07/2025, and the record failed to evidence an initial assessment prior to the comprehensive assessment for the SOC on 11/13/2025. On 12/04/2025 at 12:40 PM, the CM indicated she would look for any additional documentation/information, but none was provided prior to survey exit on 12/05/2025. 410 IAC 17-14-1(a)(1)(A)

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included the patient’s nursing needs in 1 of 2 active clinical records reviewed with SN services only in 7 clinical records reviewed. (Patient #2) The findings include: A clinical record review for Patient #2 evidenced a POC for the initial certification period of 11/13/2025-01/11/2026 which indicated the primary diagnosis was hypertension (high blood pressure), and the agency would provide SN services 1 time a week for 9 weeks for education of disease management and treatment. The comprehensive assessment for the SOC dated 11/13/2025 indicated the Patient’s blood pressure has been well-controlled. The assessment failed to include the assessment of the nursing needs for home care. On 12/04/2025 at 1:20 PM, the CM indicated she was unsure what the nursing need was. 410 IAC 17-14-1(a)(1)(B)

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included a review of the medication to include drug interactions in 1 of 1 active clinical record review with therapy only services in a total sample of 7 clinical records reviewed. (Patient #3) The findings include: A clinical record review for Patient #3 evidenced a POC for the recertification period 09/27/2025-11/25/2025 which indicated the medications included levothyroxine (to treat underacting thyroid), metoprolol (for high blood pressure), milk of magnesia (for constipation), omeprazole (for gastric reflux), and vitamin D with calcium (mineral supplement). The undated drug interactions indicated 5 drug interactions to include 4 moderate interactions between levothyroxine and metoprolol, levothyroxine and milk of magnesia, levothyroxine and vitamin D with calcium, and omeprazole and vitamin D with calcium. The comprehensive assessment for the recertification completed by PT 1 on 11/21/2025 failed to include the assessment of the drug interactions. On 12/04/2025 at 12:04 PM, the CM indicated the PT did not include the review of the medications for drug interactions in the comprehensive assessment. 410 IAC 17-14-1(a)(1)(B)

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 record review and interview, the agency failed to ensure the POC was developed in conjunction with the physician in 1 of 2 active clinical records reviewed with a SOC date after 11/01/2025 in a total sample of 7 clinical records reviewed. (Patient #4) The findings include: A clinical record review for Patient #4 evidenced a physician order dated 11/20/2025 which indicated Patient was admitted for SN services 1 time a week for 9 weeks to include wound care. The record failed to evidence a POC and failed to evidence the POC was reviewed with the physician. On 12/04/2025 at 5:07 PM, the CM indicated the SOC was 11/20/2025, and the POC was not yet developed. The CM indicated the agency had left a message with the physician responsible for the POC but had not yet received a return call from the physician’s office. 410 IAC 17-13-1(a)

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 record review and interview, the agency failed to ensure the POC included all measurable goals, medical equipment, and treatments for 4 of 4 active clinical records reviewed with a POC in a total sample of 7 clinical records reviewed. (Patient #1, 2, 3, 5) The findings include: 1. A clinical record review for Patient #1 evidenced a comprehensive assessment for the SOC dated 08/30/2025 which indicated Patient had frequent pain affecting sleep and day-to-day activities rated 4/10. The assessment indicated the Patient used a bipap/cpap (medical devices used to assist in breathing for sleep apnea) and had a wound to the right leg. The record evidenced wound assessment notes from Entity 1 (wound clinic) dated 08/12/2025 and 09/15/2025 which indicated Patient was recommended to increase protein intake and take a multivitamin to assist wound healing. The POC failed to include the wound care provided by Entity 1 and the recommendations for increased protein and multivitamin. The POC for the initial certification period 08/30/2025-10/28/2025 indicated Patient would have optimal effectiveness of pain and failed to include what was Patient’s optimal level of pain. The POC failed to include the use of the bipap/cpap. On 12/04/2025 beginning at 12:18 PM, the CM indicated the optimal level of pain was not clear and measurable. The CM indicated Patient used a cpap which was not included on the POC. The CM indicated the wound care provided by Entity 1 and their recommendations were not included in the POC. 2. A clinical record review for Patient #2 evidenced a POC for the initial certification period of 11/13/2025-01/11/2026 which indicated the goals included having optimal bowel management and optimal pain management. The POC failed to evidence what was Patient’s optimal bowel and pain management. The POC indicated the caregiver was to demonstrate strategies for symptom management of anemia (low red blood cells) and failed to evidence a diagnosis of anemia. On 12/04/2025 at 1:20 PM, the CM indicated she was unsure how the goals for optimal bowel and pain management were measurable. The CM indicated she was not sure why the POC included the demonstration of anemia symptom management. 3. A clinical record review for Patient #3 evidenced physician orders from Entity 2 (ALF) dated 12/03/2025 which indicated Patient had a wanderguard (an alarming device for patients at risk for elopement) in place. The POC failed to evidence the wanderguard use at Entity 2 and failed to include the delineation of care provided by Entity 2. On 12/04/2025 at 11:10 AM, the CM indicated the wanderguard and the delineation of care at the ALF were not included on the POC. 4. A clinical record review for Patient #5 evidenced a POC for the recertification period 10/14/2025-12/12/2025 which indicated a goal for optimal bowel evacuation and effectiveness of pian management. The POC failed to evidence what was Patient’s optimal bowel and pain management. On 12/05/2025 at 2:04 PM, the CM indicated the goals for bowel evacuation and pain management were not patient specific. 410 IAC 17-13-1(a)(1)(D)(xiii)

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 record review and interview, the agency failed to ensure services were provided only as ordered by a physician in 2 of 2 active clinical records reviewed in a total sample of 2 active patients with wounds. (Patient #1, 4) The findings include: 1. A clinical record review for Patient #1 evidenced a comprehensive assessment for the SOC dated 08/30/2025 completed by the CM which indicated the CM completed wound care to include applying a foam dressing to the wound on the right leg. SN visit notes completed by the CM dated 09/02/2025, 09/11/2025, 09/17/2025, 09/25/2025, 10/01/2025, and 10/06/2025 indicated the CM performed wound care to include applying a foam dressing to the right leg. The record failed to evidence a wound care order to include the foam dressing prior to the POC for the initial certification period 08/30/2025-10/28/2025 was signed by the physician on 10/23/2025. On 12/04/2025 at 12:10 PM, the CM indicated she performed the wound care based on what the wound treatment was in place on Patient upon discharge from the hospital. 2. A clinical record review for Patient #4 evidenced a physician order dated 11/20/2025 which indicated the agency was to provide SN services 1 time a week to include wound care. On 12/04/2025 at 5:07 PM, the CM indicated she completed wound care to surgical wounds to the top of the head and the nose to include applying mupirocin (antibiotic ointment) to a gauze and inserting into the surgical wound and covering with a non-stick dry dressing on the SOC on 11/20/2025 and on 11/26/2025. The review failed to evidence a wound care order to include the mupirocin and non-stick dressing. On 12/04/2025 at 5:07 PM, the CM indicated there was not a physician order for specific wound care. 410 IAC 17-13-1(a)

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physician was notified of changes potentially requiring a change in the POC in 1 of 2 active clinical records reviewed with a hospitalization in a total sample of 7 clinical records reviewed. (Patient #3) The findings include: At an observation of care at Entity 2 on 12/03/2025 at 4:54 PM for Patient #3, a clinical record review evidenced a Discharge Summary from Entity 3 dated 11/05/2025 which indicated physician orders from a physician other than the physician responsible for the POC to begin losartan (for high blood pressure) and discontinue amlodipine (for high blood pressure), clonazepam (for anxiety), and metoprolol (for high blood pressure). The record failed to evidence the agency notified the physician of the change in medication orders upon discharge from the hospital and as administered by Entity 2. On 12/04/2025 at 11:28 AM, the C indicated the physician responsible for the POC was not notified of the change in medication orders. 410 IAC 17-13-1(a)(2)

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure care was coordinated with all healthcare providers providing services to the patient in 1 of 1 active clinical record reviewed receiving services from a wound clinic (Patient #1) in a total sample of 2 active patients with wounds and in 1 of 1 active clinical record reviewed residing in an Assisted Living Facility (ALF) in a total sample of 7 clinical records reviewed (Patient #3) The findings include: 1. A clinical record review for Patient #1 evidenced wound assessment notes from Entity 1 (wound clinic) dated 08/12/2025 which indicated the wound care included a foam dressing covered by an ABD (absorbent dressing) pad three times a day. The POC for the initial certification period 08/30/2025-10/28/2025 failed to include the ABD pad in the wound care and indicated wound care was every 3-4 days. The record failed to evidence care coordination with Entity 1 to clarify the wound treatment and frequency. On 12/04/2025 at 12:10 PM, the CM indicated there was no care coordination with Entity 1. 2. A clinical record review for Patient #3 evidenced physician orders from Entity 2 (ALF) dated 12/03/2025 which indicated Patient’s medications included gabapentin (for nerve pain), pantoprazole (for gastric reflux), and losartan (for high blood pressure) which were not included in the POC for the recertification period 11/26/2025-01/24/2026. The record failed to evidence care coordination with the ALF to clarify the medication discrepancy. On 12/04/2025 at 11:15 AM, the CM indicated there was no care coordination with the ALF regarding the medication discrepancy. 410 IAC 17-12-2(h)

Program activities CFR(s): 484.65(c) (1) The HHA's performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the performance improvement activities focused on high risk and problem-prone areas. The findings include: A review of the Discharge Patient List dated 06/03/2025-12/03/2025 indicated 4 patients that were discharged due to being admitted to the hospital. A review of the agency’s Quality Assurance and Performance Improvement (QAPI) Program failed to include performance improvement activities related to the high risk area of patient hospitalizations. On 12/05/2025 at 3:04 PM, the CM indicated Patients #3, #5, and #8 had hospitalizations but the agency did not have any tracking information or data such as length of hospitalization and admitting diagnosis related to the hospitalizations. The CM indicated the QAPI program did not review data and include performance improvement activities related to the patient hospitalizations.

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 record review and interview, the agency failed to ensure a program was developed for the surveillance, identification, prevention, and control of infectious and communicable diseases specific to care and services provided in the home setting and was included in the agency’s Quality Assurance and Performance Improvement (QAPI) program. The findings include: A review of Patient Infection Reports for 2025 indicated 12 patient infections to include 8 urinary tract infections, 2 wound infections, and 2 respiratory infections. The agency failed to evidence an infection control program to include the surveillance of infections to include the aggregations of data to track and trend the patient infections. A review of the QAPI program failed to evidence the data related to the patient infections. On 12/05/2025 at 2:37 PM, the CM indicated there was no surveillance of patient infections, and the infections were not included in the QAPI program.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the RN completed the clinical documentation at the time services were provided in 2 of 5 active clinical records reviewed. (Patient #1, 4) The findings include: 1. A clinical record review for Patient #1 evidenced a POC for the recertification period of 10/29/2025-12/27/2025 which indicated the agency was to provide SN services 1 time a week. The record failed to evidence a SN visit since 11/20/2025. On 12/04/2025 at 12:28 PM, the CM indicated she completed a SN visit on 11/26/2025 but had not documented the visit yet. 2. A clinical record review for Patient #4 evidenced a SOC date of 11/20/2025 but failed to evidence a comprehensive assessment for the SOC. The clinical record failed to evidence a SN visit. On 12/04/2025 at 5:05 PM, the CM indicated she performed the comprehensive assessment on 11/20/2025 and a SN visit on 11/26/2026 but had not yet documented them. 410 IAC 17-14-1(a)(1)(E)

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure care was coordinated with outside healthcare entities who services agency patients for 2 of 2 active clinical records reviewed of patients living in an assisted living facility. (patient #1, #2). The findings include: 1. An agency policy dated April 2012, titled “Coordination Of Services With Other Providers:”, stated “… Purpose To ensure the coordination of services provided by the organization and by other service providers. Policy A Case Manager will be assigned to be responsible for coordinating services provided to the patient by the organization, including services provided directly and through contract. The Case Manager will act as liaison with other organizations or individuals also providing care to the patient to assure effective coordination of related services. … The Case Manager will be responsible for the coordination between service providers, which will include, but not be limited to: A. Organization personnel’s understanding of each organization’s/individual’s responsibility in providing care. … Ongoing communication regarding issues and concerns with the organizations or individuals providing care will be the responsibility of Amore Home Health Care Services, Inc. management team.” 2. Observation of a home visit was conducted on 2/3/2023, for patient #1 and with physical therapist (PT) #3. Observation evidenced the patient was dependent and required assistance with activities of daily living (ADLs) including but not limited to ambulation, toileting, and feeding. Clinical record review on 2/9/2023, for patient #1, start of care 12/21/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 12/21/2022 – 2/18/2023. This document indicated the patient lived at entity #6. This document failed to indicate what treatments and services were provided by entity #6’s nursing staff. During an interview on 2/3/2023, at 10:17 AM, person #7 indicated the family of patient #1 had to choose a home health agency that could come to entity #6, who also recommended Amore. During an interview on 2/8/2023, at 8:40 AM, person #8 indicated that home health aides and private duty caregivers were not allowed at entity #6. During an interview on 2/9/2023, at 11:52 AM, when queried if the patient/caregivers were offered home health aide services for assistance with ADL’s, the administrator indicated the patient’s family was always there to help and did not remember if they refused services. 3. Clinical record review on 2/9/2023, for patient #2, start of care 1/20/2023, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 12/21/2022 – 2/18/2023. This document indicated the patient lived at entity #6. This document failed to evidence what treatments and services were provided by entity #6’s nursing staff. During an interview on 2/9/2023, at 1:24 PM, when queried what level of care the nursing staff at entity #6 provided to the patient, administrator #1 indicated the patient was located on the memory care unit which mostly had bed alarms and nurse aides to assist.

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR §484.102 for Home Health Providers and Suppliers. Survey Dates: 12/07/2022-12/14/2022 Census: 15 At this Emergency Preparedness survey, Amore Home Health Care Services Inc. was found to be out of compliance with Conditions of Participation 42 CFR §484.102: Emergency Requirements for Medicare and Medicaid Participating Providers and Suppliers. QR Completed on 1/4/2023 A1

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, §485.625, §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: Based on record review and interview, the home health agency failed to: maintain an emergency preparedness plan that was reviewed and updated at least every 2 years (see tag E0004); maintain an emergency plan that included a facility-based and community-based risk assessment utilizing an all-hazards approach (see tag E0006); maintain a process for cooperation and collaboration with local tribal, regional, state and federal emergency preparedness officials (see tag E0009); document the policies and procedures were reviewed and updated every 2 years (see tag E0013); include an individualized plan for each patient during a natural or man-made disaster (see tag E0017); maintain an emergency preparedness communication plan which included names and contact information for staff (see tag E0030); maintain an emergency preparedness communication plan that include primary and alternate means for communication with the facility, staff, state, tribal, regional, and local emergency management (see tag E0032); to provide emergency preparedness training to staff every 2 years (see tag E0037); and failed to conduct exercises to test the emergency plan annually (see tag E0039). Findings include: The cumulative effect of these systemic problems resulted in the home health agency’s inability to ensure the provision of quality health care in a safe environment and results in the agency being out of compliance with condition 42 CFR §484.102 Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers.

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), §485.625(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 record review and interview, the home health agency failed to maintain an emergency preparedness plan that was reviewed and updated at least every 2 years. Findings include: Record review on 12/13/2022, evidenced an agency policy dated April 2012, titled, “Emergency Management Plan,” which stated, “… an annual evaluation of the organization’s hazard vulnerability analysis and emergency management plan, including its objectives, scope, functionality, and effectiveness will be conducted. The annual evaluation may be based on the drill evaluation or actual implementation of the emergency management plan ….” Record review on 12/08/2022, evidenced an agency document dated 01/18/2021, titled, “Board of Directors Meeting, Meeting Minutes,” which indicated the board of directors discussed plan for emergency preparedness for COVID-19. Review of the emergency preparedness binder on 12/08/2022, failed to evidence documentation the emergency preparedness plan was reviewed or updated every 2 years. During an interview on 12/08/2022, at 12:25 PM, administrative staff #5 indicated the last emergency preparedness plan was reviewed on January 2021 board of directors meeting regarding COVID-19. Administrative staff #5 indicated they thought the agency was going to close so did not update the emergency plan.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to maintain an emergency preparedness plan that included a facility-based and community-based risk assessment, utilizing an all-hazards approach that was updated every 2 years. Findings include: Record review on 12/13/2022, evidenced an undated agency policy titled, “Hazard Vulnerability Analysis,” which stated, “… this all-hazards approach to our emergency preparedness plan must be reviewed and updated at least annually in order to help identify gaps and challenges to be considered and addressed ….” Record review on 12/08/2022, evidenced an agency document dated 12/12/2019, titled, “Hazard Vulnerability Assessment.” This document failed to evidence an updated hazard vulnerability assessment. During an interview on 12/08/2022, at 12:25 PM, administrative staff #5 indicated the emergency preparedness plan has not been updated or reviewed due to they thought the agency was going to close.

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), §485.625(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 record review and interview, the home health agency failed to maintain a process for cooperation and collaboration with local, tribal, regional, state, and federal emergency preparedness officials. Findings include: Record review on 12/13/2022, evidenced an undated agency policy titled, “Emergency Preparedness Rule:” which indicated the communication plan will be well-coordinated within the facility, across health care providers, and with state and local public health departments and emergency management agencies. Review of the emergency preparedness binder on 12/08/2022, failed to evidence a process for collaboration with local, tribal, regional, state, and federal emergency preparedness officials. During an interview on 12/08/2022, at 12:30 PM, the administrator indicated they had meetings for area updates with local officials and have the phone number for local officials for emergencies, but no federal information.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to document the policies and procedures had been reviewed and updated at least every 2 years. Findings include: Record review on 12/13/2022, evidenced an agency policy dated April 2012, titled, “Emergency Management Plan,” which indicated an annual evaluation of the organization’s emergency management plan will be conducted. Review of the emergency preparedness binder on 12/08/2022, failed to evidence documentation the policies and procedures have been reviewed and updated every 2 years. During an interview on 12/08/2022, at 12:25 PM, administrative staff #5 indicated the last discussion of emergency preparedness was at the board of directors meeting in January of 2022, and they discussed COVID only.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure an individualized plan for each patient during a natural or man-made disaster was included in the patient’s comprehensive assessment in 7 of 7 clinical records reviewed. (#1, #2, #3, #4, #5, #6, #7) Findings include: 1. Clinical record review on 12/9/2022, for Patient #5, start of care 8/19/2022, “OASIS-D1 [Outcome and Assessment Information Set] Start of Care” dated 8/19/2022. Review indicated emergency preparedness was performed. Review failed to evidence an individualized emergency plan. 2. Clinical record review on 12/12/2022, for Patient #6, start of care 11/30/2022, evidenced an agency document titled “OASIS-D1 Start of Care (PT) [Physical Therapy]” dated 11/30/2022. Review indicated emergency preparedness was performed. Review failed to evidence an individualized emergency plan. 3. Clinical record review on 12/7/2022, for Patient #7, start of care 5/3/2022, evidenced an agency document titled “OASIS-D1 Start of Care (PT)” dated 5/3/2022. Review indicated emergency preparedness was performed. Review failed to evidence an individualized emergency plan. 3. During an interview on 12/9/2022, at 11:19 AM, the administrator indicated the extent of the agency’s emergency preparedness plans for their patients was the patients were instructed to call 911 in the event of an emergency. 1. Record review on 12/13/2022, evidenced an agency policy dated April 2012, titled, “Natural Disasters/Emergencies,” which stated, “… upon admission the patient and family/caregiver will be assessed regarding their emergency management plan for the home, and any special needs will be noted ….” 2. Record review on 12/13/2022, evidenced an agency policy dated April 2012, titled, “Emergency Management Plan, which stated, “…detailed written instructions will be given to patients and/or family members to ensure an appropriate and timely response in the event of an emergent event that may cause interruptions of service ….” 3. Record review on 12/13/2022, evidenced an agency policy dated April 2012, titled, “Initial and Comprehensive Assessment,” which stated, “… during the initial and comprehensive patient assessment … will be documented in the patient’s clinical record, including at least the following information … an evaluation of the home environment and assessment of emergency preparedness of the patient ….” 4. Record review on 12/08/2022, for patient #1, start of care 09/28/2022, evidenced an agency document titled, “OASIS [outcome and assessment information set] -D1 Recertification,” for certification period 11/27/2022-01/25/2023 which stated, “… emergency care plan review: instructed patient/caregiver on the purpose of an emergency care plan ….” This comprehensive assessment failed to include an individualized emergency plan. 5. Record review on 12/08/2022, for patient #2, start of care 11/10/2022, evidenced an agency document titled, “OASIS [outcome and assessment information set]-D1 Start of Care,” for certification period 11/10/2022-01/08/2023. This comprehensive assessment did not include an emergency care plan review. This document failed to evidence an individualized emergency plan. 6. Record review on 12/08/2022, for patient #3, start of care 04/28/2022, evidenced an agency document titled, “OASIS [outcome and assessment information set]-D1 Recertification,” for certification period 06/27/2022-08/25/2022, which stated, “… emergency care plan review instructed patient/caregiver on the purpose of an emergency care plan ….” This comprehensive assessment failed to evidence an individualized emergency plan. 7. Record review on 12/12/2022, for patient #4, start of care 11/10/2022, evidenced an agency document titled, “OASIS [outcome and assessment information set]-D1 Start of Care,” for certification period 11/10/2022-01/08/2023. This comprehensive assessment did not include an emergency care plan review. This document failed to evidence an individualized emergency plan. 8. During an interview on 12/09/2022, at 11:17 AM, the clinical manager indicated there is not an individualized emergency plan on the comprehensive assessment, the patients are informed to call 911 for emergency.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(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:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review the home health agency failed to maintain an emergency preparedness communication plan which included names and contact information for staff. Findings include: Clinical record review on 12/13/2022, evidenced an undated agency policy titled, “Communication During An Emergency,” which stated, “… during an emergency, the emergency incident commander is responsible for contacting staff to inform of the emergency … emergency incident commander calls-succession incident commander … Operations Manager … finance manager … utility companies, nurses and all other disciplines ….” Review of the emergency preparedness binder on 12/08/2022, evidenced an agency document revised 12/2015, titled, “Disaster Preparedness Phone Tree,” which stated, “In the event of a natural disaster, the following personnel will be responsible in contacting … personnel and agency clients ….” The personnel list included the administrator, the alternate administrator and the alternate clinical manager names and phone numbers. This list failed to include a communication plan for all staff with names and phone numbers. Review of the emergency preparedness binder on 12/08/2022, evidenced the last staff phone tree was dated 09/2019. During an interview on 12/08/2022, at 12:35 PM, the administrator was informed there was not an updated emergency preparedness staff phone tree in the emergency preparedness binder. The administrator remained silent.

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), §485.625(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 record review and interview, the home health agency failed to develop and maintain an emergency preparedness communication plan that included primary and alternate means for communication with the facility, staff, federal, state, tribal, regional, and local emergency management. Findings include: Record review evidenced an undated agency policy received 12/13/2022, titled, “Communications During An Emergency,” which stated, “… when the telephone lines are down or cellular phones are not functioning, the Emergency Incident Commander should utilize the runner messenger system (when safe) as alternate communications and back-up ….” Review of the emergency preparedness binder on 12/08/2022, failed to evidence the runner messenger system instructions/plan. During an interview on 12/08/2022, at 12:40 PM, the administrator indicated they will have a runner messenger system for alternate means of communication and asked administrative staff #5 who the runner was. The administrator indicated the messenger system was not set up.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on record review and interviewx, the home health agency failed to provide emergency preparedness training at least every 2 years, and failed to maintain documentation of all emergency preparedness training. Findings include: Record review on 12/13/2022, evidenced an agency policy dated April 2012, titled, “Emergency Management Plan,” which stated, “… organization leadership will provide for orientation and education of all personnel regarding participation in the emergency plan. Education will be provided during orientation and annually ….” Review of the emergency preparedness binder on 12/08/2022, evidenced documentation of the last staff training was on COVID-19 in June 2020. During an interview on 12/08/2022, at 12:50 PM, the administrator indicated there has been no emergency preparedness training done with the staff since the pandemic started and no new hires since the pandemic. The administrator indicated there was not any formal training and no documentation of staff training since 2020.

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), §485.625(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, 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 record review and interview, the home health agency failed to conduct or participate in a full scale community based drill, a facility based exercise or a tabletop exercises to test the emergency plan annually. Findings include: Record review on 12/03/2022, evidenced an agency policy titled, “Training and Testing of the Emergency Preparedness Plan,” which stated, “… two tests of the emergency preparedness plan need to be conducted annually … home health will participate in a full-scale exercise that is community based … a full-scale exercise … agency will document the date, personnel, and any agency or healthcare coalition they contact. Agency will resource participation and ensure all documentation is developed and available to demonstrate compliance … if … unable to participate in a full-scale, community based event, the Agency will maintain documentation of the attempts to participate, but then MUST conduct a facility based event … the second drill should be full-scale community based or facility-based, OR if unable to participate in either of theses drills, then a tabletop exercise can be conducted ….” Review of the emergency preparedness binder on 12/08/2022, evidenced a real event on 06/01/2020, 02/25/2020, and 01/24/2019; an emergency drill on 12/12/2019; a tabletop exercise on 09/18/2019 and 01/14/2018; and a full scale exercise on 11/07/2018. This binder failed to evidence a training and testing program annually. During an interview on 12/08/2022, at 12:00 PM, the administrator indicated the last real event was June of 2020. There were no recent drills, or tabletop exercises.

This survey was a Recertification and Emergency Preparedness survey for a home health agency. Survey dates:12/07/2022-12/14/2022 Facility ID 012121 Census: 15 During this Federal Recertification Survey, Amore Home Health Care Services Inc., was found to be out of compliance with Conditions of Participation 42 CFR §484.60 Care Planning, Coordination, Quality of Care; 42 CFR §484.65 Quality Assessment/Performance Improvement; 42 CFR §484.70 Infection Prevention and Control; 42 CFR §484.102 Emergency Preparedness; and 42 CFR §484.105 Organization and Administration of Services. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Based on the condition-level deficiencies during the 12/13/2022 survey, Amore Home Health Care Services Inc. is precluded from providing its own home health aide training and competency evaluation for a period for two years which began on 12/14/2022 through 12/14/2024.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the comprehensive assessment failed to be completed to include the assessment of the wounds within 30 days of the start of care in 1 of 2 clinical records reviewed with wounds. (#5) The findings include: Review of an agency policy obtained 12/14/2022, and dated April 2012, titled “Initial and Comprehensive Assessment” stated, “… A comprehensive patient assessment will be completed within five (5) calendar days of the patient’s start of care. … The assessment will be patient-specific and comprehensive to include the patient’s need for home care … The comprehensive assessment should determine … Baseline information to be used to measure the patient’s progress toward achievement of desired outcomes ….” Review of an undated agency policy obtained 12/14/2022, titled “Wound Care Management” stated, “… Documentation of wounds must include type of wound, measurements including length, depth, and width, description of the wound bed, surrounding area, undermining, staging, color, odor and estimated amount of drainage….” Clinical record review on 12/9/2022, for Patient #5, start of care 8/19/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 8/19/2022-10/17/2022, which indicated the patient was to receive skilled nursing services, to include but not limited to, wound care. Review indicated the patient’s goals included, but were not limited to, maintaining skin integrity. Review of an agency document titled “OASIS-D1 [Outcome and Assessment Information Set] Start of Care” completed by the clinical manager and dated 8/19/2022, indicated the patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (a type of open pressure ulcer with partial thickness loss of skin) to the right buttocks. Review failed to evidence the comprehensive assessment included the depth of the wound and the appearance of the wound base. Review indicated the patient had a pressure ulcer stage I (a type of pressure ulcer with reddened, nonblanching, intact skin) to the right buttock and failed to evidence comprehensive assessment included the measurements and appearance of the wound. During an interview on 12/12/2022, at 10:52 AM, the clinical manager indicated the assessment of the wound base should be included in the comprehensive assessment. The clinical manager indicated she was told that a stage I pressure ulcer did not need to be measured.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure all medications were reviewed as part of the comprehensive assessment the patient was currently using, to identify any potential adverse effects, drug reactions, significant side effects, significant drug interactions and duplicate medications in 4 of 7 clinical records reviewed. (#1, #5, #6, #7) Findings include: 1. Clinical record review on 12/9/2022, for Patient #5, start of care 8/19/2022, evidenced an agency document titled “Medication Profile”, which was signed by the clinical manager on 8/19/2022. Review indicated the patient’s medications included, but were not limited to, Tramadol (a medication used to treat pain), ondansetron (a medication used to treat nausea), hydrocodone-acetaminophen (a medication used to treat pain), gabapentin (a medication used to treat seizures and nerve pain), mirtazapine (a medication used to treat depression), and Soma (a medication also known as carisoprodol used to treat musculoskeletal pain). Review of an agency document titled “Drug-Drug Interactions” dated 12/12/2022, indicated 8 major drug interactions. Review indicated a major drug interaction between acetaminophen-hydrocodone and Tramadol, Tramadol and mirtazapine, ondansetron and Tramadol, ondansetron and mirtazapine, carisoprodol and acetaminophen-hydrocodone, gabapentin and acetaminophen-hydrocodone, and gabapentin and Tramadol. Review of an agency document titled “OASIS-D1 [Outcome and Assessment Information Set] Start of Care” completed by the clinical manager and dated 8/19/2022, failed to evidenced medication interactions were identified. During an interview on 12/12/2022, at 10:40 AM, the clinical manager indicated the medication interactions should have been identified during the medication review at the start of care. Review of an agency document titled “Communication Note” electronically signed by the clinical manager and dated 10/19/2022, indicated the patient was to start Nitrofurantoin (an antibiotic) and Fluconazole (a medication used to treat fungal infections). Review failed to evidence the medication profile was updated to include a review of the new medications for potential drug interactions. During an interview on 12/12/2022, at 11:35 AM, the clinical manager indicated the medication profile should be reviewed when a new medication is added. The clinical manager indicated the new medications were not reviewed for potential drug interactions. 2. Clinical record review on 12/12/2022, for Patient #6, start of care 11/30/2022, evidenced an unsigned, undated agency document titled “Medication Profile”, which indicated the patient’s medications included, but were not limited to Tramadol (a medication used to treat pain), Keppra (a medication used to treat seizures), aspirin (a medication used to treat pain/fever, and/or to thin the blood to prevent blood clots), and losartan (a medication used to treat high blood pressure). The medication profile stated, “… I have reviewed all the listed medications for potential … significant drug interactions ….” Review failed to evidence the drug profile was signed to verify the medications were reviewed since the start of care on 11/30/2022. Review of an agency document titled “Drug-Drug Interactions” dated 12/12/2022, indicated there were 5 moderate drug interactions, to include, but not limited to: tramadol and Keppra and aspirin and losartan. Review of an agency document titled “OASIS-D1 Start of Care (PT) [Physical Therapy]” completed by the PT and dated 11/30/2022, failed to evidenced medication interactions were identified. During an interview on 12/12/2022, at 3:43 PM, the administrator indicated the PT should have reviewed the medications to identify the drug interactions. The administrator indicated the PT should have signed the medication profile after reviewing the medications. 3. Clinical record review on 12/7/2022, for Patient #7, start of care 5/3/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 5/3/2022-7/1/2022, which indicated the patient’s medications included, but were not limited to, aspirin (a medication used to treat pain/fever and/or to thin the blood to prevent blood clots) and Lexapro (a medication used to treat depression). Review indicated an increased risk in bleeding with the use of both aspirin and Lexapro. Review of an agency document titled “OASIS-D1 Start of Care (PT)” dated 5/3/2022. Review evidenced no issues were found during the drug review and failed to evidence the increased risk of bleeding between aspirin and Lexapro. During an interview on 12/9/2022, at 11:42 AM, the clinical manager indicated the PT should have identified the interaction of increased risk of bleeding during the drug review. 1. Record review evidenced an agency policy dated April 2012, received 12/13/2022 titled, “Initial and Comprehensive Assessment,” which stated “…the comprehensive patient assessment … including at least the following information … review of medication history … and current medication use … identifying drug interactions, duplicate drug therapy, and noncompliance with therapy ….” 2. Clinical record review for patient #1 on 12/08/2022, start of care 09/28/2022, evidenced an agency document titled, “Oasis [outcome and assessment information set]-D1 Recertification” for certification period 11/27/2022-01/25/2023 that indicated the medications were reconciled. This comprehensive assessment failed to evidence the medications were reviewed for drug interactions. Review evidenced an agency document titled, “Drug-Drug Interaction” dated 12/12/2022, indicated major drug interactions noted between fluoxetine (antidepressant) and ondansetron (prevent nausea and vomiting), fluoxetine and mirtazapine (antidepressant), and ondansetron and mirtazapine. This document failed to evidence the physician was notified of the major drug interactions. During an interview on 12/12/2022, at 12:06 PM, the clinical manager indicated drug interactions are noted in Axxess (electronic medical record system) and should be noted on the comprehensive assessment that medications were reviewed, and the physician was notified of drug interactions. The clinical manager indicated there is no documentation of physician notification. 410 IAC 17-14-1(a)(1)(B)

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 record review and interview, the agency failed to update the comprehensive assessment after significant decline in the patient’s health status in 1 of 1 clinical record reviewed with an injury sustained from a fall. (#7) The findings include: Review of an agency policy obtained 12/14/2022, and dated April 2012, titled “Reassessment/Recertification” stated, “… Each patient will be reassessed using a comprehensive OASIS [Outcome and Assessment Information Set] assessment tool for the review and revision of the plan of care when: … There is a significant change in the patient’s condition ….” Clinical record review on 12/7/2022, for Patient #7, start of care 5/3/2022, evidenced agency documents titled “Communication Note”, which indicated the patient had falls on 5/15/2022, 5/29/2022, 6/11/2022, 6/20/2022, and 6/28/2022. Review indicated the patient hit their head, which required staples to the wound, during the fall on 6/11/2022. Review failed to evidence an updated comprehensive assessment was completed after the start of care assessment on 5/3/2022 and prior to the recertification assessment on 6/30/2022. Review failed to evidence an assessment of the head wound. During an interview on 12/9/2022, at 11:33 AM, the administrator indicated the agency should complete a comprehensive assessment after a patient had a fall.

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on record review and interview, the comprehensive assessment failed to be completed to include the assessment of the wounds within 48 hours of the patient’s return home from a hospital admission in 1 of 1 active clinical record reviewed with a hospitalization. (#5) The findings include: Review of an agency policy obtained 12/14/2022, and dated April 2012, titled “Reassessment/Recertification” stated, “… Each patient will be reassessed using a comprehensive OASIS [Outcome and Assessment Information Set] assessment tool for the review and revision of the plan of care when: … The patient returns home after an inpatient admission lasting 24 hours or longer ….” Review of an undated agency policy obtained 12/14/2022, titled “Wound Care Management” stated, “… Documentation of wounds must include type of wound, measurements including length, depth, and width, description of the wound bed, surrounding area, undermining, staging, color, odor and estimated amount of drainage….” Clinical record review on 12/9/2022, for Patient #5, start of care 8/19/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 10/18/2022-12/16/2022, which indicated the patient was to receive skilled nursing services, to include but not limited to, wound care. Review indicated the patient’s goals included, but were not limited to, maintaining skin integrity. Review of an agency document titled “OASIS-D1 [Outcome and Assessment Information Set] Resumption of Care” completed by the clinical manager and dated 12/2/2022, indicated the patient was hospitalized from 11/25/2022 – 12/1/2022, for a urinary tract infection. Review indicated the patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage I (a type of pressure ulcer with reddened, nonblanching, intact skin) to the sacrum (lower back, above the buttocks). Review failed to evidence comprehensive assessment included the measurements and appearance of the wound. During an interview on 12/12/2022, at 10:52 AM, the clinical manager indicated the assessment of the wound base should be included in the comprehensive assessment. The clinical manager indicated she was told that a stage I pressure ulcer did not need to be measured.

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 record review and interview, the home health agency failed to send all necessary medical information to the receiving facility or health care practitioner of a discharged or transferred patient to ensure the safe and effective transition of care in 3 of 3 discharged or transferred patients. (#3, #5, #7) Findings include: 1. Clinical record review on 12/9/2022, for Patient #5, start of care 8/19/2022, evidenced an agency document titled “Transfer Summary” dated 11/25/2022, which indicated the patient was transferred to the hospital. Review failed to evidence the agency provided the receiving hospital with the transfer summary. During an interview on 12/12/2022, at 11:18 AM, the administrator indicated the agency did not send the transfer summary to the hospital. 2. Clinical record review on 12/7/2022, for Patient #7, start of care 5/3/2022, evidenced an agency document titled “Transfer Summary” dated 7/22/2022. Review failed to evidence to which facility the patient was transferred, the patient’s condition, significant health history, and transfer orders and instructions. During an interview on 12/9/2022, at 10:49 AM, the administrator indicated the patient transferred to Hospital A for seizures and to rule out a stroke. The administrator indicated the transfer summary was not sent because it was not completed to include the facility to which the patient transferred and transfer orders/instructions. Review of an agency document titled “Physician Order” dated 8/5/2022, indicated the patient was discharged from the agency and being admitted to hospice. Review of an agency document titled “PT [physical therapy] Discharge Summary” dated 8/5/2022, failed to evidence discharge instructions and failed to evidence to which hospice agency the patient was discharged to. Review failed to evidence the discharge summary was provided to the hospice agency and the physician responsible for the plan of care. During an interview on 12/9/2022, at 10:49 AM, the administrator indicated the agency should include in the discharge summary the summary of the patient’s care to include the diet, activities, upcoming physician appointments, safety precautions, and necessary equipment/supplies. 1. Record review evidenced an agency policy dated April 2012, received 12/13/2022 titled, “Discharge Planning,” which stated “… clinicians will assist patients regarding their discharge by … sending a post discharge letter to the patient’s physician ….” 2. Record review evidenced an agency policy dated April 2012, received 12/13/2022 titled, “Discharge Summary,” which stated “… a complete discharge summary … 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 [home health agency] within 5 business days of the patient’s discharge ….” 3. Clinical record review of patient #3 on 12/08/2022, start of care 04/28/2022, evidenced an agency document titled, “PT [physical therapy] Discharge Summary” for discharge date 08/25/2022. This document failed to reveal the discharge summary was sent to the patient’s physician or the receiving facility. During an interview on 12/12/2022, at 3:03 PM, the clinical manager indicated the discharge plan was not sent to the physician or facility upon patient’s discharge.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the patient’s services that are written in an individualized plan of care identifies patient specific measurable outcomes and goals (see tag G572); the plan of care included all required information for the treatment of the patient (see tag G574); the patient care orders including verbal orders in the plan of care (see tag G576); a revised plan of care by physician every 60 days (see tag G588); physician notification of changes (see tag G590); revisions to the plan of care due to a change in patient's health status must be communicated to the patient and all physicians (see tag 596); integrate services that could affect patient safety and treatment (see tag G606); each patient receive ongoing education and training identified in the plan of care (see tag G610); failed to include written instructions to the patient to include a visit schedule (see tag G612); and failed to include patient medication instructions written in plan language (see tag 616). The cumulative effect of these systemic problems has results in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42 CFR §484.60 Care Planning, Coordination of Care and Quality of Care. A deficient practice citation was also evidenced at this standard as follows: Based on record review and interview, the home health agency failed to ensure the patient's medical and social needs were met in (3 of 7) clinical records reviewed. (#3, #5, #7) Findings include: 1. Clinical record review on 12/9/2022, for Patient #5, start of care 8/19/2022, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set] Start of Care” completed by the clinical manager and dated 8/19/2022. Review indicated the patient was at risk for falls, required assistance for dressing, bathing, toileting, and ambulation. Review indicated the patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (a type of open pressure ulcer with partial thickness loss of skin) to the right buttocks and a pressure ulcer stage I (a type of pressure ulcer with reddened, nonblanching, intact skin) to the right buttock. Review indicated the patient was at risk for skin breakdown and indicated the patient required 24 hour supervision. Review evidenced the patient lived with her daughter, who was the primary caregiver. Review failed to evidence the agency offered home health aide services to assist the patient with personal care and activities of daily living. During an interview on 10/14/2022, at 9:02 AM, the patient’s caregiver indicated she has had to quit her job to care for her mother and indicated the patient is bedridden. The caregiver indicated she could use assistance from a home health aide to help with the patient’s bathing and personal care and indicated she was not offered home health aide services from the agency. During an interview on 12/12/2022, at 11:51 AM, the administrator indicated home health aide services were not offered to the patient because the agency did not provide home health aide services. 2. Clinical record review on 12/7/2022, for Patient #7, start of care 5/3/2022, evidenced an agency document titled “OASIS-D1 Start of Care (PT) [Physical Therapy]” dated 5/3/2022. Review indicated the patient was at risk for falls; was dependent for grooming and dressing; required assistance with toileting, bathing, transferring; and was chairfast. Review indicated the patient required a 2 person moderate to maximum assistance due to severe neurological and cognitive dysfunction. Review indicated the patient lived in an assisted living facility. Review failed to evidence the patient was offered home health aide services to assist with patient care. Review failed to evidence if the assisted living provided dependent care to meet the patient’s needs. Review of agency documents titled “Communication Note” indicated the patient had falls on 5/15/2022, 5/29/2022, 6/11/2022, 6/20/2022, 6/28/2022, 7/14/2022, 7/19/2022, and 7/21/2022. Review failed to evidence the agency offered home health aide services to assist with patient transfers and activities of daily living. Review of an agency document titled “Recertification (PT)” dated 6/30/2022, indicated the patient was dependent for grooming and dressing and needed assistance for bathing, toileting, and transfers. Review indicated occupational therapy was recommended. Review failed to evidence occupational therapy was offered to the patient. During an interview at the entrance conference on 12/7/2022, at 10:44 AM, the administrator indicated the agency did not offer home health aide services and did not contract with another agency for home health aide services. The administrator indicated if the patient was assessed to need home health aide services, the agency would inform the physician so the patient could go to another agency that offered home health aide services. During an interview on 12/9/2022, at 11:04 AM, the administrator indicated the agency did not offer home health aide services to assist with personal care because the agency did not provide home health aide services. The administrator indicated she was unsure if the assisted living facility provided dependent care. The administrator indicated if another discipline was recommended, the physician should be contacted for the order for that discipline to evaluate. The cumulative effect of these systemic problems has results in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42 CFR §484.60 Care Planning, Coordination of Care and Quality of Care. A deficient practice citation was also evidenced at this standard as follows: Based on record review and interview, the home health agency failed to ensure the patient's medical and social needs were meet in (# of #) clinical records reviewed. (#3) 1. Record review evidenced an agency policy revised 02/09/2020, received 12/13/2022 titled, “Coordination of Services,” which stated, “… the following are essential components of professional coordination and supervision of services to assigned patients for the ongoing evaluation of the patient’s needs: … maintaining efficient communication with patient, family, physician, and all care providers to ensure prompt transmission of significant information which may require immediate action or decision-making. Coordinating with patient, family, caregivers, and all involved services to unify and maximize their contributions to ensure patient safety, comfort, and benefits of services ….” 2. Record review evidenced an agency policy dated April 2012, received 12/13/2022, titled, "Admission Criteria and Process," which stated,"... A patient will be accepted for care based on consideration. Consideration will be given to the adequacy and suitability of organization personnel, resources to provide the required services, and the reasonable expectation that the patient's medical, nursing, rehabilitative, and social needs can be adequately met in the patient's place of residence ...." 3. Clinical record review on 12/08/2022 for patient #3, start of care 04/28/2022, evidenced an agency document titled, “Oasis [outcome and assessment information set]-D1, Recertification (PT) [physical therapy]” for certification period 06/27/2022-08/25/2022. This comprehensive assessment identified needs for self-care deficits related to dressing and to consider need for OT (occupation therapy) and HHA (home health aide), and for cognition consider need for OT, ST (speech therapy), MSW (social worker). This comprehensive assessment indicated OT for other disciplines recommended. This document failed to evidence OT, HHA, ST, or MSW was recommended to physician. During an interview on 12/02022, at 10:45 AM, the administrator indicated their agency does not currently employ home health aides. During an interview on 12/12/2022, at 2:54 PM, the clinical manager indicated the care coordination regarding recommendations on the comprehensive assessment would require contacting the physician’s office to get approval and then notifying the assisted living facility nurse. The clinical manager indicated she would have to check with the physical therapist to see what happened with the OT and HHA considerations/recommendations. During an interview on 12/14/2022, at 11:15 AM, the clinical manager indicated she had contacted PT #2 and PT #2 indicated he had spoken to the occupational therapist and the occupational therapist indicated the patient had reach the max potential during occupational therapy prior. The clinical manager indicated there was no documentation of PT discussion with the OT. The clinical manager indicated she doesn’t remember if she was notified regarding recommendations provided by the PT or OT. 410 IAC 17-13-1(a)

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 record review and interview, the agency failed to provide the services as directed in the plan of care in 1 of 2 clinical records reviewed with wounds. (#5) The findings include: Review of an undated agency policy on 12/14/2022, titled “Physician’s Plan of Care” stated, “… Skilled nursing and other home health services should be provided in accordance with a plan of care based on the patient’s diagnosis and assessment ….” Clinical record review on 12/9/2022, for Patient #5, start of care 8/19/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 10/18/2022-12/16/2022, which indicated the skilled nurse was to reconcile the patient’s medications at every visit and educate on the risk of anticoagulant (a type of medication that thins the blood to prevent blood clots and increasing the risk of bleeding) use. Review of agency documents titled “Skilled Nurse Visit” completed by the clinical manager and dated 11/3/2022, 11/9/2022, 11/16/20221, and 11/21/2022 failed to evidence the nurse reconciled the patient’s medications as directed in the plan of care. Review failed to evidence the patient was educated on the risk of bleeding as directed in the plan of care. During an interview on 12/12/2022, at 11:40 AM, the clinical manager indicated the medications should have been reconciled at every visit. At 11:43 AM, the clinical manager indicated she did not see education on the risk of bleeding was provided to the patient.

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 observation, record review, and interview, the home health agency failed to ensure the mental, psychosocial, cognitive status, types of services, supplies, equipment required, frequency and duration of visits, all medications, treatments and safety measures to protect again injury were in the patients individualized plan of care in 6 of 7 clinical records reviewed. (#1,#2, #3, #5, #6, #7) Findings include: 1. Clinical record review on 12/9/2022, for Patient #5, start of care 8/19/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 10/18/2022-12/16/2022, which indicated the patient’s medications included, but were not limited to, Nystatin (a medication used to treat fungal infections) to affected areas and Lidocaine patches (a medication used to relieve pain) to affected areas. Review failed to evidence the plan of care included to what areas of the body were the affected areas for the application of Nystatin and Lidocaine. Review indicated a blank for what emphasis the skilled nurse was to focus the physical assessment on and what comorbidities the skilled nurse was to assess. During an interview on 12/12/2022, the administrator indicated the Nystatin was to be applied to the groin and the Lidocaine patches were to be applied to the knees and back. The administrator indicated she leaves the blanks on the plan of care to double-check what goes in the blanks. 2. Clinical record review on 12/12/2022, for Patient #6, start of care 11/30/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/30/2022-1/28/2023. Review indicated the patient’s diagnoses included, but were not limited to, epilepsy (a brain disorder that causes seizures), and indicated the patient’s medications included, but were not limited to, Keppra (a medication used to treat/prevent seizures). Review failed to evidence the plan of care included safety measures of seizure precautions. During an interview on 12/12/2022, at 3:35 PM, the clinical manager indicated seizure precautions should be included in the plan of care. 3. Clinical record review on 12/7/2022, for Patient #7, start of care 5/3/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 5/3/2022-7/1/2022, which indicated the patient’s medications included, but were not limited to, aspirin (a medication used to treat pain/fever and/or to thin the blood to prevent blood clots) and Lexapro (a medication used to treat depression). Review indicated an increased risk in bleeding with the use of both aspirin and Lexapro and failed to evidence the plan of care included bleeding precautions as a safety measure. During an interview on 12/9/2022, at 11:42 AM, the administrator indicated bleeding risk should have been included in the plan of care. 1. Record review evidenced an undated agency policy received 12/13/2022 titled “Physician’s Plan of Care,” which stated, “… the plan of care should include: medications … treatments … mental status … types of services, frequency of visits, equipment/supplies required, and safety measures to protection against injury ….” 2. Clinical record review of patient #1 on 12/08/2022, start of care 09/28/2022, evidenced an agency document titled, “Home Health Certification and Plan of Care” for certification period 11/27/2022-01/25/2023, which stated, “… medications glucose (for low blood sugar), oxygen, atorvastatin (cholesterol lowering medication), carvedilol (heart medication), furosemide (diuretic), metolazone (diuretic), Norco (pain medication), and NovoLog (insulin) ….” Record review on 12/08/2022 evidenced assisted living facility B document, received 12/08/2022, titled, “Physician’s Orders for 12/08/2022 which indicated medication Glimepiride (blood sugar lowering medication) 1milligram daily for order date 11/08/2022. The plan of care failed to evidence the medication Glimepiride. During an interview on 12/12/2022, at 12:16 PM, the clinical manager indicated the physical therapist should get a medication list from the assisted living facility and give to the nurse to check and verify medications are current and clarify with physician if any new medications noted. The clinical manager was notified of glimepiride medication was not on the plan of care but on assisted living facility’s medication list. The clinical manager did not respond. Observation on 12/08/2022, at 11:05 AM, evidenced physical therapy use of a gait belt on patient for sitting to standing from wheelchair. The plan of care failed to evidence the gait belt under DME (durable medical equipment) and supplies. 3. Clinical record review of patient #3, start of care 04/28/2022, evidenced an agency document titled, Home Health Certification and Plan of Care,” for certification period 06/27/2022-08/25/2022 which stated, “DME [durable medical equipment] and Supplies… tub/shower bench, grab bars, wheelchair ….” Record review on 12/08/2022, evidenced an agency document dated 08/13/2022, titled, “PT [physical therapy] Visit,” which stated, “…continue walking the patient using a gait belt for safety ….” The plan of care failed to evidence the gait belt under DME and supplies. During an interview on 12/12/2022, at 12:22 PM, the clinical manager indicated the gait belt should be on the plan of care. 4. Clinical record review on 12/08/2022, for patient #2, start of care 11/10/2022, evidenced an agency document titled, “Home Health Certification and Plan of Care” for certification period 11/10/2022-01/08/2023, which stated, “…DME [durable medical equipment] walker, wheelchair, cane, oxygen, nebulizer, tub/shower bench ….” Observation on 12/08/2022, at 9:00 AM, evidenced use of bilateral lower extremity compression stockings. The plan of care failed to include compression stockings under DME and supplies. During an interview on 12/12/2022, at 3:10 PM, the clinical manager indicated the compression stockings should be included on the plan of care. 410 IAC 17-13-1(a)(1)(c)

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to include all patient care orders, including verbal orders in the plan of care in 1 of 3 patients receiving skilled nursing care. (#4) Findings include: Record review evidenced an agency policy dated April 2012, received 12/13/2022, titled, “Verification of Physician Orders,” which stated “… orders will be documented on a form provided by Amore Home Health Care Services, Inc., dated and signed by the professional receiving the order. A copy of the physician’s order will be kept in the clinical record ….” Record review evidenced an undated agency policy received on 12/13/2022, titled, “Physician’s Plan of Care,” which stated, “… the plan of care should include … medications, and treatments ….” Clinical record review of patient #4 on 12/08/2022, evidenced an assisted living facility B document dated 12/13/2022, titled, “Physician’s Orders for 12/13/2022,” which stated, “… treatment: Eucerin cream apply to bilateral lower extremities every day ….” Review evidenced an agency document titled, “Home Health Certification and Plan of Care” for certification period 11/10/2022-01/08/2023, which stated, “… wound care to open wounds on left lower extremity every skilled nurse visit. Cleanse wound with NS [normal saline], pat dry, apply silver alginate dressing and wrap with kerlix ….” The home health agency plan of care failed to evidence Eucerin cream to lower extremities. Observation of a home visit on 12/13/2022, at 10:30 AM, evidenced the clinical manager applied Eucerin cream to bilateral lower extremities. During an interview on 12/13/2022, at 1:08 PM, the clinical manager indicated the Eucerin cream was ordered by the nurse practitioner at assisted living facility B based on the clinical manager’s discussion with the nurse practitioner, and the order was on the assisted living facility's B treatment order. The clinical manager indicated the Eucerin cream was not a prescription medication so an order does not need to be written.

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to revise the plan of care as frequently as the patient’s care required in 2 of 2 clinical records reviewed with hospitalizations. (#5, 7) The findings include: 1. Review of an undated agency policy obtained 12/14/2022, titled “Physician’s Plan of Care” stated, “… The plan should be reviewed and updated as necessary by the home health services team every sixty (60) days or more often should the patient’s condition warrant….” 2. Clinical record review on 12/9/2022, for Patient #5, start of care 8/19/2022, evidenced agency documents titled “Home Health Certification and Plan of Care” for certification period 8/19/2022-10/17/2022 and 10/18/2022-12/16/2022, which indicated the patient’s goals included, but were not limited to, the patient would remain free from falls/injury and would remain free of signs and symptoms of urinary tract infection. Review of an agency document titled “60-Day Summary/Case Conference” dated 10/14/2022, indicated the patient had a fall and a urinary tract infection during the certification period. Review failed to evidence the plan of care was revised to reflect a change in the patient’s goals related to the falls and urinary tract infection. Review of an agency document titled “OASIS-D1 [Outcome and Assessment Information Set] Resumption of Care” completed by the clinical manager and dated 12/2/2022, indicated the patient was hospitalized from 11/25/2022 – 12/1/2022 for a urinary tract infection. Review failed to evidence the plan of care was revised to reflect a change in the patient’s goals related to urinary tract infections. During an interview on 12/12/2022, at 11:07 AM, the administrator indicated the agency did not change the goals but should have made them something different since the patient did have a fall and a urinary tract infection. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 10/18/2022-12/16/2022, indicated the patient’s primary diagnosis was a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (a type of open pressure ulcer with partial thickness loss of skin) to the left buttock. Review of an agency document titled “Skilled Nurse Visit”, dated 11/21/2022, indicated the wound to the patient’s left buttock was healed. Review failed to evidence the plan of care was revised to reflect the change in the patient’s primary diagnosis before 12/2/2022. During an interview on 12/12/2022, at 11:21 AM, the administrator indicated the plan of care was not revised until 12/2/2022. 3. Clinical record review on 12/7/2022, for Patient #7, start of care 5/3/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/2/2022-8/20/2022, which indicated physical therapy (PT) services were to be provided 1 time a week for 8 weeks. Review indicated the PT goals included, but were not limited to, the patient would remain free from falls/injury. Review of agency documents titled “Communication Note” indicated the patient had falls on 7/14/2022, 7/19/2022, and 7/21/2022. Review failed to evidence the plan of care was revised to reflect a change in the PT goals related to the patient’s falls. Review of an agency document titled “Physician Order” dated 7/28/2022, indicated the PT services were changed to 1 time a week for 3 weeks for range of motion exercise to decrease the risk of contractures. Review failed to evidence the plan of care was revised to reflect a goal related to the risk of contractures. During an interview on 12/9/2022, at 11:31 AM, the administrator indicated the plan of care should have been revised to reflect the risk of contractures and the patient’s repeated falls.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to notify the physician of changes in the patient’s condition in 3 of 7 clinical records reviewed. (#5, 6, 7) The findings include: 1. Review of an agency policy obtained 12/14/2022, and revised 2/9/2020, titled “Coordination of Services” stated, “… The following are essential components of professional coordination … maintaining efficient communication with patient, family, physician … to ensure prompt transmission of significant information which may require immediate action or decision-making….” 2. Clinical record review on 12/9/2022, for Patient #5, start of care 8/19/2022, evidenced an agency document titled “SN [skilled nurse] Wound Care Visit” completed by the registered nurse (RN) and dated 11/3/2022. Review indicated the patient’s wound to the left buttock had purulent drainage and failed to evidence the physician was notified of the change in wound care status. During an interview on 12/12/2022, at 11:13 AM, the clinical manager indicated the physician should be notified with any deterioration of the wound. 3. Clinical record review on 12/12/2022, for Patient #6, start of care 11/30/2022, evidenced an agency document titled “Occupational Therapy Assessment/Evaluation” completed by the occupational therapist and dated 12/1/2022. Review indicated the patient complained of having diarrhea throughout the night before due to the nurse from the assisted living giving her a laxative that was not a normal medication for the patient. Review failed to evidence the occupational therapist notified the physician of the patient’s diarrhea. During an interview on 12/12/2022, at 3:45 PM, the clinical manager indicated the occupational therapist should have called the physician. 4. Clinical record review on 12/7/2022, for Patient #7, start of care 5/3/2022, evidenced an agency document titled “Communication Note” dated 6/30/2022, which indicated the patient had falls on 6/20/2022 and 6/28/2022. Review failed to evidence the physician was notified of the patient’s falls. During an interview on 12/9/2022, at 11:33 AM, the administrator indicated the agency should have notified the physician of the falls.

Revisions communicated to patient and MDs CFR(s): 484.60(c)(3)(i) (i) Any revision to the plan of care due to a change in patient health status must be communicated to the patient, representative (if any), caregiver, and all physicians or allowed practitioner's issuing orders for the HHA plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to communicate change in discharge plans to the physician in 1 of 2 closed records reviewed. (#7) The findings include: Review of an agency policy dated April 2012, and obtained 12/14/2022, titled “Discharge Planning” stated, “… Provide information regarding the patient discharge potential at case conferences with other team members … All communication and information regarding discharge planning will be documented in the clinical record….” Clinical record review on 12/7/2022, for Patient #7, start of care 5/3/2022, evidenced agency documents titled “Physician Order”, which indicated the PT was to provide services 1 time a week for 3 weeks per the order signed by the PT and dated 7/29/2022. Review of document dated 8/5/2022, and with a fax date to the physician of 8/25/2022, indicated the patient was discharged from the agency and was to be admitted to hospice. Review failed to evidence the physician was notified of the change in discharge plans prior to the order being faxed to the physician for signature on 8/25/2022. During an interview on 12/9/2022, at 12:16 PM, the administrator indicated there was no documentation of communication to the physician regarding the change in discharge plans.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on observation record review and interview, the home health agency failed to integrate services to assure the identification of patient needs that could affect patient safety and treatment effectiveness and failed to ensure the coordination of care was provided by all disciplines, in 4 of 7 clinical records reviewed. (#1, #5, #6, #7) Findings include: 1. Clinical record review on 12/9/2022, for Patient #5, start of care 8/19/2022, evidenced an agency document titled “PT [Physical Therapy] Discharge” completed by the PT and dated 10/12/2022, indicated the patient refused the PT visit due to the patient complaining of being in a lot of pain. Review failed to evidence the PT reported to the case manager to patient’s refusal of the PT visit and the patient’s complaint of pain. During an interview on 12/12/2022, at 11:36 AM, the clinical manager indicated she did not see any documentation that the patient’s report of pain and refusal of the PT was visit was communicated to the case manager. The clinical manager indicated the PT should have called her to coordinate care. 2. Clinical record review on 12/12/2022, for Patient #6, start of care 11/30/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/30/2022-1/28/2022, which indicated the agency was providing physical therapy and occupational therapy services. Review failed to evidence the patient’s medications included a laxative (a type of medication used to treat constipation). Review of an agency document titled “Occupational Therapy Assessment/Evaluation” completed by the occupational therapist and dated 12/1/2022, indicated the patient complained of having diarrhea throughout the night before due to the nurse from the assisted living giving her a laxative that was not a normal medication for the patient. Review failed to evidence the occupational therapist notified the physical therapist and failed to evidenced coordination of care with the assisted living to determine what laxative was administered to the patient. During an interview on 12/12/2022, at 3:45 PM, the clinical manager indicated she did not see any coordination of care with the assisted living facility and the physical therapist. The clinical manager indicated she was not sure what laxative was administered to the patient and indicated the patient did not have an order for a laxative. The clinical manager indicated the occupational therapist should have reported the patient’s complaint of diarrhea to the clinical manager. 3. Clinical record review on 12/7/2022, for Patient #7, start of care 5/3/2022, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set] Start of Care (PT)” dated 5/3/2022. Review indicated the patient lived in an assisted living facility and indicated the patient was assessed to have a memory deficit with constant confusion. Review of an agency document titled “OT [occupational therapy] Discharge” dated 6/10/2022, indicated the patient had severely impaired short and long term memory and indicated the patient was assessed to require assistance with toilet transfer, feeding, and transfers. Review indicated the occupational therapist provided discharge instructions to the patient and failed to evidence the coordination of care was provided to the assisted living to include discharge instructions. During an interview on 12/9/2022, at 11:13 AM, the administrator indicated the agency should coordinate care with the assisted living regarding the OT discharge instructions. 1. Record review evidenced an agency policy revised 02/09/2020, received 12/13/2022 titled, “Coordination of Services,” which stated, “… the following are essential components of professional coordination and supervision of services to assigned patients for the ongoing evaluation of the patient’s needs: … maintaining efficient communication with patient, family, physician, and all care providers to ensure prompt transmission of significant information which may require immediate action or decision-making. Coordinating with patient, family, caregivers, and all involved services to unify and maximize their contributions to ensure patient safety, comfort, and benefits of services ….” 2. Observation of patient #1, start of care 09/28/2022, on 12/08/2022, at 10:55 AM, evidenced patient requiring frequent rest periods due to shortness of breath and fatigue. On 12/08/2022, at 11:10 AM, the patient indicated she felt nervous. Interview regarding patient #1 on 12/08/2022 at 11:30 AM, start of care 09/28/2022, with assisted living facility B, nurse C. This interview was conducted after the patient physical therapy visit. Nurse C indicated the patient had an incident that morning of being anxious and short of breath, nurse C indicated wheezing was noted, nurse C stated she contacted the physician and ordered a chest xray that would be done on 12/08/2022. During an interview with PT (physical therapist) #1 on 12/08/2022, at 10:45 AM the PT indicated he coordinated care with assisted living facility B by giving update to nurse after PT care visit completed. During an interview on 12/12/2022, at 12:18 PM, the clinical manager indicated the PT should have talked to the nurse prior to the start of physical therapy and should have contacted the physician to see if should continue the physical therapy. 410 IAC 17-12-2(h)

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide patient/caregiver education in 1 of 2 clinical records reviewed with an infection. (#5) The findings include: Review of an agency document on 12/14/2022, and dated April 2012, titled “Medication Profile” stated, “… Each patient will receive appropriate written material for specific medications he/she is receiving. The material will contain information on actions of the medication, potential side effects, contraindications the patient should be aware of, and any special instructions when taking the specific medication...." Clinical record review on 12/9/2022, for Patient #5, start of care 8/19/2022, evidenced an agency document titled “SN [skilled nurse] Wound Care Visit” completed by the registered nurse (RN) and dated 10/27/2022. Review indicated the patient received new medications for a urinary tract infection, nitrofurantoin (an antibiotic) and fluconazole (a medication used to treat fungal infections). Review failed to evidence the RN provided education related to the new medications to the patient and/or caregiver. During an interview on 12/12/2022, at 11:11 AM, the clinical manager indicated the agency should have printed out a drug information sheet to give to the patient and reviewed medication side effects and indications for use. The clinical manager indicated she did not see that education was provided to the patient on the new medication.

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD is not met as evidenced by: Based on observation, record review, and interview the home health agency failed to include written instructions to the patient regarding visit schedule in 1 of 2 skilled nurse assisted living facility visits. (#4) Findings include: Record review evidenced an agency policy dated April 2012, received on 12/13/2022, titled, "Admission Criteria and Process," stated, "... upon acceptance into service, the patient will be provided with an organization brochure and various educational materials providing the patient and family/caregiver with sufficient information on: ... hours during which care and service is available ...." Observation during a home visit for patient #4, on 12/13/2022, at 10:30 AM, evidenced a home health patient folder in which the visit schedule calendar was blank. During an interview on 12/13/2022, at 10:40 AM, the clinical manager indicated the patient visit schedule was verbalized with the nurse at the assisted living facility.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to provide the patient with written medication instructions written in plain language in 1 of 1 physical therapy home health visits observed. (#1) Findings include: Record review evidenced an agency policy dated April 2012 received 12/13/2022, titled, “Medication Profile,” which stated “…the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver as well as other clinicians understand the medication regimen. This includes … using the medication profile to evaluate the use of medications in the home setting … using the medication profile to teach purpose of medication, dosages, routes, administration times, side effects, and contraindications ….” 2. Observation of a home visit on 12/08/2022, at 10:50 AM, of patient #1, evidenced a patient’s home health folder with a medication list which stated, “… glucose [blood sugar] prn [as needed], acetaminophen [pain reliever] 500mg [milligrams] q [every] 6 hours prn, choleciferol [vitamin D] 2 caps one PO [by mouth], fluoxetine [depression] 20mg one cap, Remeron [depression] 15mg 1x, senna [for constipation] 8.6mg 2 tabs 1x, thera-fe plus [vitamin], miralax [laxative] 17g 1x, omeprazole [acid reflux] 20mg 1x, zofran [treat nausea and vomiting] 4mg q8 hours prn, potassium chloride [vitamin supplement] 10meq 1x, unker salve [muscle pain] 1 4 hours prn, novolog insulin bid [twice per day] ss [sliding scale], norco [pain reliever] 5 1x, atorvastatin [cholesterol medication] 20 1x, carvedilol [heart medication] 6.25mg 2x, furosemide [diuretic] 20mg 2x, metolazone [diuretic] 2.5mg M [Monday]/Wednesday ….” This document failed to evidence medication list for a patient in plain language. During an interview on 12/12/2022, at 12:00 PM, the clinical manager indicated the medications for the patient should be in a language the patient can understand.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency’s QAPI (quality assessment performance improvement) program failed to evidence measurable improvement in indicators (see tag G642); utilize quality indicator data to identify opportunities for improvement (see tag G644); the QAPI data focused on high risk, high volume or problem prone areas (see tag G648); the QAPI data considered incidence, prevalence, and severity of problems in the high risk or high volume areas (see tag G650); the QAPI data led to an immediate correction of any identified problems that directly or potentially threaten the health and safety of patients (see tag G652); performance improvement activities tracked adverse patient events, analyzed their causes, and implemented preventive actions (see tag G654); the agency took action aimed at performance improvement and measured its success and tracked performance to ensure that improvements are sustained (see tag G656); conducted a performance improvement project annually (see tag G658); and failed to ensure the governing body was responsible for the implementation and maintenance of the QAPI program (see tag 660). The cumulative effect of these systemic problems resulted in the home health agency’s inability to ensure the provision of quality health care in a safe environment for the condition of participation 42 CFR §484.65 Condition: Quality Assessment/Performance Improvement.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure measurable improvements indicators were implemented to improve health outcomes and quality of care for the agency's QAPI (quality assessment performance improvement) program. Findings include: Record review evidenced an agency policy received 12/14/2022, dated April 2012, titled, “Improving Organizational Performance,” which stated, “…senior management will … identify and set specific outcomes for measurable improvement and acceptable limits for findings ….” Review of the agency’s QAPI program on 12/09/2022, failed to evidence data showing the measurable improvements in indicators related to the patient health outcomes and quality of care. During an interview on 12/09/2022, at 10:40 AM, the administrator indicated there was no QAPI information, and that there wasn't enough staff to maintain QAPI. 410 IAC 17-12-2(a)

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the QAPI (quality assessment performance improvement) program utilized data from the measures derived from OASIS (outcome and assessment information set) to identify opportunities for improvement and monitor the quality of care. The findings include: Record review evidenced an agency policy received 12/14/2022, dated April 2012, titled, “Improving Organizational Performance,” which stated, “… at least one important aspect related to care must be monitored through use of OASIS [outcome and assessment information set]data ….” Record review evidenced an agency document received 12/13/2022, revised 01/28/2020, titled, “Performance Improvement Study Infection,” which stated, “… indicators patients who develop an infection … studies will be performed monthly ….” Review of the agency’s QAPI program on 12/09/2022, failed to evidence OASIS data was utilized to identify opportunities for improvement. Review of agency's documents titled, "Infections," for January, March, April, May, June, September, October and November 2022, received on 12/09/2022, evidenced 21 patients' names with physician, treatment, type of infection, and infection date. These documents failed to evidence OASIS data was utilized by the home health agency to identify opportunities for improvement. Review on 12/08/2022 of patient #2, start of care 11/10/2022, evidenced an agency document titled, “OASIS-D1 Start of Care,” for certification period 11/10/2022-01/08/2023, which indicated the patient was treated for a urinary tract infection in the past 14 days. During an interview on 12/09/2022, at 10:40 AM, the administrator indicated there was no QAPI information, and that there wasn't enough staff to maintain QAPI. 410 IAC 17-12-2(a)

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure performance improvement activities focused on areas of high risk and high volume. The findings include: 1. record review on 12/9/2022, for Patient #5, start of care 8/19/2022, evidenced an agency document titled “SN [skilled nurse] Wound Care Visit” dated 10/27/2022, which indicated the physician ordered antibiotics for a urinary tract infection. Review of an agency document titled “SN Foley [a type of catheter, a tube inserted into the bladder to drain urine from the body] Change Visit” dated 11/9/2022, indicated the patient complained of burning and pain at the catheter insertion site and was assessed to have cloudy, found smelling urine with sediment. The patient indicated the symptoms had been persistent for the pasts few days. Review indicated the physician prescribed antibiotics for a urinary tract infection. Review of an agency document titled “OASIS-D1 [Outcome and Assessment Information Set] Resumption of Care” completed by the clinical manager and dated 12/2/2022, indicated the patient was hospitalized from 11/25/2022 – 12/1/2022 for a urinary tract infection. 2. Clinical record review on 12/7/2022, for Patient #7, start of care 5/3/2022, evidenced agency documents titled “Communication Note”, which indicated the patient had falls on 5/15/2022, 5/29/2022, 6/11/2022, 6/20/2022, 6/28/2022, 7/14/2022, 7/19/2022, and 7/21/2022. 1. Record review evidenced an agency policy received 12/14/2022, dated April 2012, titled, “Improving Organizational Performance,” which stated, “… the problem solving approach will stress the interrelationship of quality services provided, management activities, and sound business practices as applicable to the organization’s …activities related to patient care and patient safety focusing on high risk, high volume, and problem prone areas … at least one important aspect related to care must be monitored …. 2. Record review evidenced an agency document received 12/13/2022, revised 01/28/2020, titled, “Performance Improvement Study Infection,” which stated, “…indicators patients who develop an infection … studies will be performed monthly … the director of nursing shall be responsible for evaluating all infection log data monthly ….” 3. Review on 12/08/2022 of patient #1, start of care 09/28/2022, evidenced an agency document dated 12/08/2022, titled, “Communication Note,” which stated, “… the patient was lowered to the floor …while trying to transfer her to the bathroom ….” 4. Review on 12/08/2022 of patient #2, start of care 11/10/2022, evidenced an agency document titled, “OASIS [outcome and assessment information set]-D1 Start of Care,” for certification period 11/10/2022-01/09/2023, indicated the patient was treated for a urinary tract infection in the past 14 days. 5. Review on 12/08/2022 of patient #3, start of care 04/28/2022, evidenced an agency document dated 05/31/2022, titled, “Incident Log,” which stated, “…fall with injury ….” 6. Review of agency's documents titled, "Infections," for January, March, April, May, June, September, October and November 2022, received on 12/09/2022, evidenced 21 patients' names with physician, treatment, type of infection, and infection date. These documents failed to evidence performance improvement activities focused on areas of high risk and high volume. 7. Review of agency's documents titled, "Incidents," for January, February, March, April May, June, September, October and November evidenced 24 patient incidents. These documents failed to evidence performance improvement activities focused on areas of high risk and high volume. 8. Review of the QAPI program on 12/08/2022, failed to evidence a focus on infections or incidents. 9. During an interview on 12/09/2022, at 10:40 AM, the administrator indicated there is no QAPI (quality assessment performance improvement) information, and that there isn’t enough staff to maintain QAPI.

Incidence, prevalence, severity of problems CFR(s): 484.65(c)(1)(ii) (ii) Consider incidence, prevalence, and severity of problems in those areas; and This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the QAPI (quality assessment performance improvement) data considered incidence, prevalence, and severity of problems in the high risk or high volume areas. Findings include: Record review evidenced an agency policy received 12/14/2022, dated April 2012, titled, “Improving Organizational Performance,” which stated, “… identify and set specific outcomes for measurable improvement and acceptable limits for findings ...." Review of agency's documents titled, "Incidents," for January, February, March, April May, June, September, October and November evidenced 24 patient incidents. These documents failed to evidence data considered in high risk or high volume areas was included in the agency's QAPI program. Review of agency's documents titled, "Infections," for January, March, April, May, June, September, October and November 2022, received on 12/09/2022, evidenced 21 patients' names with physician, treatment, type of infection, and infection date. These documents failed to evidence agency data was considered in high risk or high volume areas and was included in the agency's QAPI program. Review of the agency’s QAPI program on 12/09/2022, failed to evidence home health agency data was considered regarding incidence, prevalence, and severity of problems in the high risk or high volume areas. During an interview on 12/09/2022, at 10:40 AM, the administrator indicated there was no QAPI information, and there wasn't enough staff to maintain QAPI.

Activities lead to an immediate correction CFR(s): 484.65(c)(1)(iii) (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This ELEMENT is not met as evidenced by: Based on record review and interview the home health agency failed to evidence the QAPI (quality assessment performance improvement) data led to an immediate correction of any identified problems that directly or potentially threaten the health and safety of patients. Findings include: 1. Record review evidenced an agency policy received 12/14/2022, dated April 2012, titled, “Improving Organizational Performance,” which stated, “… that each performance improvement activity contains … follow-up plans if findings fail to meet acceptable limits including plan of correction ….” 2. Review of agency's documents titled, "Incidents," for January, February, March, April May, June, September, October and November evidenced 24 patient incidents. These documents failed to evidence the data led to a correction of any identified problems. 3. Review of agency's documents titled, "Infections," for January, March, April, May, June, September, October and November 2022, received on 12/09/2022, evidenced 21 patients' names with physician, treatment, type of infection, and infection date. These documents failed to evidence the data led to a correction of any identified problems. 4. Review of the agency’s QAPI (quality assessment performance improvement) program on 12/09/2022, failed to evidence data led to an immediate correction of any identified problems that directly or potentially threaten the health and safety of patients. 5. During an interview on 12/09/2022, at 10:40 AM, the administrator indicated there is not any QAPI information, and that there isn’t enough staff to maintain QAPI.

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure performance improvement activities were utilized to track adverse patient events, analyze their causes, and implement preventative actions. The findings include: Record review evidenced an agency policy received 12/14/2022, dated April 2012, titled, "Improving Organizational Performance," which stated, "... that each performance improvement activity contains ... follow-up plans if findings fail to meet acceptable limits including plan of correction ...." Record review evidenced an agency document received 12/14/2022, revised 01/28/2020, titled, "Performance Improvement Study Infection," which stated, "... indicators patient who develop an infection ... studies will be performed monthly ...." Review of the agency's QAPI (quality assessment performance improvement) program on 12/09/2022, failed to evidence performance improvement activities that tracked adverse patient events, analyzed their causes, and implemented preventative actions. During an interview on 12/09/2022, at 10:40 AM, the administrator indicated there was no QAPI information, and that there wasn't enough staff to maintain QAPI. 410 IAC 17-12-2(a)

Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the agency took measures aimed at performance improvement, to measure its success and track performance to ensure that improvements were sustained. Findings include: Record review evidenced an agency policy received 12/14/2022, dated April 2012, titled, “Improving Organizational Performance,” which stated, “… assure that each performance improvement activity contains … follow-up plans if findings fail to meet acceptable limits including plan of correction ….” Review on 12/09/2022, of the QAPI (quality assessment performance improvement) program failed to evidence the agency had taken action to measure and track the performance of the performance improvement activities. During an interview on 12/09/2022, at 10:40 AM, the administrator indicated there was no QAPI information, and there wasn't enough staff to maintain QAPI. 410 IAC 17-12-2(a)

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure there was at least one performance improvement project either in development, ongoing or completed each calendar year. The findings include: Record review evidenced an agency policy received 12/14/2022, dated April 2012, titled, “Improving Organizational Performance,” which stated, “… the governing body is responsible for ensuring that the performance improvement program is defined, implemented and maintained, and is evaluated annually ….” Review of an agency document revised 01/28/2020, received on 12/13/2022, titled, "Performance Improvement Study Infection," failed to evidence a performance improvement study was maintained and evaluated annually. Review of the agency’s QAPI (quality assessment performance improvement) program on 12/09/2022, failed to evidence a performance improvement project. During an interview on 12/09/2022, at 10:40 AM, the administrator indicated there was no QAPI information, and there wasn’t enough staff to maintain QAPI.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the governing body was responsible for implementing and maintaining an ongoing program for quality improvement and patient safety. The findings include: Record reviewed evidenced an agency policy received 12/14/2022, dated April 2012, titled, “Improving Organizational Performance,” which stated, “… the governing body is responsible for ensuring that the performance improvement program is defined, implemented, and maintained, and is evaluated annually ….” Record review of a revised agency document dated 01/28/2020, received on 12/12/2022, titled, “Performance Improvement Study Infection,” indicated the director of nursing would be responsible for evaluating all infection log data monthly, and the QAPI (quality assessment performance improvement) team would summarize monthly findings into a quarterly report, including trends and recommendations which would then be submitted to the administrator. The administrator would report QAPI findings to the board of directors. This document failed to evidence the governing body maintained and evaluated a performance improvement program annually. Review of the agency’s QAPI program on 12/09/2022, failed to evidence performance improvement activities by the governing body. Review of an agency document titled “Board of Directors Meeting,” dated 01/17/2022, failed to evidence QAPI was discussed in the meeting minutes. During an interview on 12/09/2022, at 10:40 AM, the administrator indicated there was no QAPI information, and there wasn’t enough staff to maintain QAPI.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on record review and interview the home health agency failed to maintain an infection control program (see tag G684); and provide infection control education to staff (see tag G686). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality healthcare in a safe environment for Condition of Participation 42 GFR §484.70: Infection Prevention and Control.

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 record review and interview the home health agency failed to maintain a coordinated agency-wide program for the surveillance, identification, prevention, and investigation of infectious and communicable diseases that is an integral part of the agency’s quality assessment and performance improvement program. Findings include: Clinical record review on 12/9/2022, for Patient #5, start of care 8/19/2022, evidenced an agency document titled “SN [skilled nurse] Wound Care Visit” dated 10/27/2022, which indicated the physician ordered antibiotics for a urinary tract infection. Review of an agency document titled “SN Foley [a type of catheter, a tube inserted into the bladder to drain urine from the body] Change Visit” dated 11/9/2022, indicated the patient complained of burning and pain at the catheter insertion site and was assessed to have cloudy, found smelling urine with sediment. The patient indicated the symptoms had been persistent for the pasts few days. Review indicated the physician prescribed antibiotics for a urinary tract infection. Review of an agency document titled “OASIS-D1 [Outcome and Assessment Information Set] Resumption of Care” completed by the clinical manager and dated 12/2/2022, indicated the patient was hospitalized from 11/25/2022 – 12/1/2022 for a urinary tract infection. Review failed to evidence the agency provided infection surveillance to include data on the tracking and trending of the infections. 1. Record review evidenced an agency policy dated April 2012, received 12/13/2022, titled, “Infection Control Plan,” which stated, “… establish the mechanism by which the organization will address surveillance, prevention, identification, control, and reporting of infections … educate organization personnel … in the prevention and control of infections … provide for surveillance system to track the occurrence and transmission of infections ….” 2. Record review evidenced a revised agency document dated 01/28/2020, received 12/13/2022, titled, “Performance Improvement Study Infection,” which stated, “… indicators patients who develop an infection while receiving … services … studies will be performed monthly; summaries will be conducted quarterly and annually … the director of nursing shall be responsible for evaluating all infection log data monthly, the QAPI [quality assessment performance improvement] team shall summarize monthly findings into a quarterly reporting, including trends identified … which will then be submitted to the administrator ….” 3. Record review evidenced an agency policy dated April 2012, received 12/13/2022, titled, “Risk Management: Infection and Safety Control.” Which stated, “… the organization will utilize its safety and performance improvement process to identify risks for the acquisition and transmission of infectious agents on an ongoing basis. The infection control plan will be monitored and evaluated in the annual program evaluation …with the review of the organization’s safety and performance improvement activities … success or failure of interventions for preventing and controlling infection will be addressed … the performance improvement coordinator will be responsible for managing and coordinating infection control activities and reporting of infection control activities to the Performance Improvement Committee ….” 4. Record review on 12/08/2022, for patient #2, start of care 11/10/2022, evidenced an agency document dated 11/10/2022, titled, “Infection Log,” which stated, “… patient went to the hospital on 11/01/2022 … urine culture showed enterococcus faecalis, patient was started on antibiotics ….” This document failed to evidence the infection log data was coordinated with an agency wide surveillance program. 5. Review of the agency’s incident/infection control log on 12/09/2022 evidenced the last date patient specific data was entered is 12/21/2021. 6. Review of agency's document titled, "Infections," for January, March, April, May, June, September, October and November 2022, received on 12/09/2022, evidenced patients' names with physician, treatment, type of infection, and infection date. This document failed to evidence surveillance, identified sources of infection, tracking of patterns and trends of infections or establishment of a corrective plan for infection control and monitoring of the corrective plan. During an interview on 12/07/2022, at 2:45 PM, the clinical manager indicated the infection control plan log is not finished and is still being put together.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on record review and interview the home health agency failed to provide infection control education to staff. Findings include: 1. Record review evidenced an agency policy dated April 2012, received 12/13/2022, titled, “Risk Management: Infection and Safety Control,” which stated, “… Amore Home Health Care Services will educate all personnel on infection control policies, procedures … personnel will be provided training on the basics of transmission of pathogens to patients and personnel … infection control inservices will be scheduled no less than annually … attendance will be mandatory and will be documented … records of inservice attendance will be maintained in the personnel file ….” Review of the infection control log on 12/07/2022, evidenced the last documented agency infection control training as 03/2020. During an interview on 12/07/2022, at 2:45 PM, the clinical manager indicated the infection control plan log is not finished, still putting together. At 5:10 PM, the clinical manager indicated there is no further information regarding the infection control plan.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review, interview, and observation the home health agency failed to prepare clinical notes in 4 of 7 clinical records reviewed. (#2, #5, #6, #7) Findings include: 1. Clinical record review on 12/9/2022, for Patient #5, start of care 8/19/2022, evidenced an agency document titled “Medication Profile”, which was signed by the clinical manager on 8/19/2022. Review indicated the patient’s medications included, but were not limited to, Eliquis (a type of anticoagulant medication used to thin the blood to treat and/or prevent blood clots). Review of an agency document titled “OASIS-D1 [Outcome and Assessment Information Set] Start of Care” completed by the clinical manager and dated 8/19/2022, failed to evidence the patient was on anticoagulant medication. During an interview 12/12/2022, at 10:40 AM, the clinical manager indicated the box for anticoagulant medication should have been checked. Review of an agency document titled “SN [skilled nurse] Wound Care Visit” dated 11/3/2022, and signed by the registered nurse, indicated the nurse administered the flu vaccination to the patient in the right arm via injection. Review failed to evidence the box indicating the sharps were disposed of per biohazard policy was checked. During an interview on 12/12/2022, at 10:40 AM, the administrator indicated she gave the patient the injection and did dispose of the sharp in the biohazard container but forgot to mark the box. Review of an agency document titled “Skilled Nurse Visit”, completed by the clinical manager and dated 10/19/2022, 10/27/2022, 11/3/2022, 11/9/2022, 11/16/2022, and 11/21/2022 failed to evidence the patient was using an anticoagulant. During an interview on 12/12/2022, at 11:41 AM, the clinical manager indicated she should have marked the box indicating the patient used an anticoagulant because she assessed the patient for bruising during visits. 2. Clinical record review on 12/12/2022, for Patient #6, start of care 11/30/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/30/2022-1/28/2023, which indicated the agency was to provide physical therapy (PT) services 2 times a week for 3 weeks and then 1 time a week for 6 weeks. Review failed to evidence a PT visit since 12/2/2022. Review indicated the patient’s diagnoses included, but were not limited to, epilepsy (a brain disorder that causes seizures), and indicated the patient’s medications included, but were not limited to, Keppra (a medication used to treat/prevent seizures). During an interview on 12/12/2022, at 3:37 PM, the administrator indicated the PT provided services to the patient on 12/6/2022 and 12/8/2022 and indicated the PT had not yet started the visit notes. The administrator indicated the agency encouraged staff to complete their notes the same day as the visit. Review of an agency document titled “OASIS-D1 Start of Care (PT)” completed by the PT and dated 11/30/2022, failed to evidence seizure precautions were included in the patient’s safety measures. During an interview on 12/12/2022, at 3:39 PM, the administrator indicated the PT should have documented seizure precautions in the safety measures in the comprehensive assessment. 3. Clinical record review on 12/7/2022, for Patient #7, start of care 5/3/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 5/3/2022-7/1/2022, which indicated the patient’s medications included, but were not limited to, aspirin (a medication used to treat pain/fever and/or to thin the blood to prevent blood clots) and Lexapro (a medication used to treat depression). Review indicated an increased risk in bleeding with the use of both aspirin and Lexapro. Review of an agency document titled “OASIS-D1 [Outcome and Assessment Information Set] Start of Care (PT) [Physical Therapy]” completed by the PT and dated 5/3/2022. Review failed to evidence the patient’s safety measures included bleeding precautions. During an interview on 12/9/2022, at 11:42 AM, the administrator indicated the PT should have included bleeding precautions in the safety measures. 1. Record review evidenced an undated agency policy received on 12/13/2022 titled, “Nursing Services,” which stated, “…the nursing care will include … assessing, noting and reporting the patient’s physical condition ….” 2. Record review evidenced an undated agency policy received on 12/13/2022 titled, “Clinical Records,” which stated, “… all entries recorded in the record must be … accurate ….” 3. Record review evidenced an agency policy dated April 2012 received 12/13/2022 titled, “Ongoing Assessments,” which stated, “… during each home visit the appropriate clinician will re-evaluate the patient according to the problems identified during the initial visit … the clinician will reassess the patient for weight [once each week, if indicated by disease process] ….” 4. Clinical record review for patient #2 on 12/08/2022, start of care 11/10/2022, evidenced an agency document dated 12/08/2022 titled, “Skilled Nurse Visit,” which stated, “… Weight 202 pounds ….” Review evidenced an agency document dated 12/08/2022 titled, “Skilled Nurse Visit,” which stated, “… Skilled nurse to instruct the patient to log weight daily and inform skilled nurse/medical doctor if weight is >2 lbs. [pounds]/day or >5 lbs./week ….” Review evidenced an agency document dated 11/22/2022 titled, “Skilled Nurse Visit,” which evidenced the weight was not recorded on that day. Review evidenced an agency document dated 12/01/2022 titled, “Skilled Nurse Visit,” which stated, “… weight at 202 lbs. ….” During an observation on 12/08/2022, at 9:00 AM, patient’s spouse indicated patient was weighed on 12/08/2022 and his weight was at 220 pounds. Observation on 12/08/2022, at 9:55 AM, evidenced upon exit from the home visit the patient was not weighed during skilled nurse home visit. The skilled nurse visits failed to evidence patient’s weight was accurately documented on the nurse visit note. During an interview on 12/12/2022, at 3:05 PM, the clinical manager indicated the patient’s weight is done daily by the patient and the patient’s weight is not 220lbs because he doesn’t have edema to his lower extremities and stated weight is 202 lbs. The clinical manager indicated education to the patient was to call if weight >2 lbs. in one day or >5lbs in one week. 410 IAC 14-1(a)(1)(E)-RN

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: Based on record review, interview, and observation the home health agency failed to ensure the organization and management of the home health agency as follows: the governing body failed to assume responsibility of the agency’s budget and quality assessment and performance improvement program (see tag G942); the administrator failed to maintain the day to day operations of the agency (see tag G948); the clinical manager failed to coordinate referrals (see tag 964); and the clinical manager failed to ensure the home health agency services are provided in accordance with current clinical practice guidelines regarding medication storage (see tag G984). The cumulative effect of these systemic problems has resulted in the home health agency’s inability to ensure provision of quality health care in a safe environment for the condition of participation 42 CFR §484.105 Organization and Administration of Services. A deficient practice citation was also evidenced at this standard as follows: Based on record review and interview the home health agency failed to set forth, in writing, its organizational structure, including lines of authority. Findings include: 1. Record review on 12/13/2022, of an undated agency policy titled, “Use of Organizational Chart,” which stated, “… organizational charts will be used to define relationships and lines of authority within the organization … organizational charts will be reviewed, revised and dated as changes occur….” Record review on 12/12/2022, evidenced an agency document revised 05/04/2020, titled, “Organizational Chart,” which included PTA (physical therapy assistant) and COTA(certified occupational therapy assistant). During an interview on 12/12/2022, at 4:30 PM, the clinical manager indicated the agency does not use PTA and COTA in its facility. 410 IAC 17-12-1(a)(2)

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 record review and interview the agency’s governing body failed to assume responsibility for the agency’s review of the agency’s budget and the quality assessment and performance improvement program. Findings include: 1. Clinical record review of an agency policy revised 05/03/2020, received on 12/13/2022, titled, “Organizational Plan,” which stated, “… the agency’s operating and capital expense budget is prepared … and approved by the Board of Directors annually….” During an interview on 12/09/2022, at 2:45 PM, administration staff #4 indicated the only budget she has is from 2021 doesn’t have the budget from 2022. 2. Clinical record review of an agency policy dated April 2012, received on 12/14/2022, titled, “Improving Organizational Performance” which stated, “… senior management will have the responsibility … define expectations of the performance improvement activities … performance improvement results will be utilized to address problem issues … the governing body is responsible for ensuring the performance improvement program is defined, implemented and maintained, and is evaluated annually ….” During an interview on 12/09/2022, at 10:40 AM, the clinical manager indicated there is no QAPI (quality assessment performance improvement) information, there is not enough staff to maintain QAPI. 410 IAC 17-12-1(b)

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview the administrator failed to ensure responsibility for all day-to-day operations of the home health agency. Findings include: 1. Record review evidenced a revised agency policy dated 05/04/2020, received on 12/14/2022, titled, “Organizational Plan,” which stated, “… responsibilities of the administrator … maintains current organizational charts … ensures the completion, maintenance and submission of reports and records required … maintains … administrative records and all policies and procedures of the agency ….” 2. Record review evidenced an agency policy dated April 2012, received 1213/2022, titled, Improving Organizational Performance,” which stated, “… senior management will have the responsibility: to guide the organization’s efforts in improving organizational performance; to define expectations of the performance improvement activities … performance improvement results will be utilized to address problem issues ….” 3. Record review evidenced a revised agency policy dated 01/28/2022, received on 12/13/2022, titled, “Performance Improvement Study Infection,” which stated “… the QAPI [quality assessment performance improvement] team shall summarize monthly findings … which will then be submitted to the administrator … the administrator shall report to BOD [board of directors] all QAPI findings ….” 4. The administrator failed to ensure the agency policy was followed for the review of medications. Please see tag G536. 5. The administrator failed to ensure the plan of care was individualized and included all required documentation. Please see tag G574. 6. The administrator failed to ensure there was coordination of care with all disciplines servicing the patients. Please see tag G606. 7. The administrator failed to ensure there was an infection control program documented and maintained. Please see tag G684. 8. The administrator failed to ensure there was a Quality Assessment and Performance Improvement program maintained at the home health agency. Please see tag G942. 9. The administrator failed to maintain the emergency preparedness program. Please see tag E0004. 10. The administrator failed to ensure the individualized plan of care specified the care and services necessary to meet the patient-specific needs identified in the comprehensive assessment. Please see tag G570. During an interview on 12/07/2022, at 2:45 PM, the administrator indicated the infection log is not finished. During an interview on 12/08/2022, at 12:35 PM, administration staff #5 indicated they thought the agency was going to close, so did not update the emergency preparedness program. During an interview on 12/09/2022, at 10:40 AM, the administrator indicated there is no QAPI information because she doesn’t have the staff to maintain. 410 IAC 17-12-1(b)(3) 410 IAC 17-12-1(c)(1)

Coordinate referrals; CFR(s): 484.105(c)(3) Coordinating referrals, This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to provide clinical oversight of referrals for therapy in 2 of 4 clinical records reviewed with physical therapy services. (#3, 7) The findings include: 1. Review of an agency policy on 12/14/2022, titled “Organizational Plan” revised 5/4/2020, stated, “… Responsibilities of the Director of Nursing: … Responsible for the quality and coordination of home health services ….” 2. Clinical record review on 12/08/2022 for patient #3, start of care 04/28/2022, evidenced an agency document titled, “OASIS [Outcome and Assessment Information Set]-D1 Recertification (PT) [physical therapy]” for certification period 06/27/2022-08/25/2022. Review indicated the PT recommended occupational therapy (OT) for the patient based on assessment. Review failed to evidence OT services were provided. During an interview on 12/14/2022, at 11:15 AM, the clinical manager indicated she does not remember if she was notified regarding recommendation for OT services. 3. Clinical record review on 12/7/2022, for Patient #7, start of care 5/3/2022, evidenced an agency document “Recertification (PT)” dated 6/30/2022. Review indicated PT recommended OT services for the patient. Review failed to evidence occupational therapy was provided to the patient. 4. During an interview on 12/9/2022, at 11:04 AM, the clinical manager indicated if another discipline was recommended, the physician should be contacted for the order for that discipline to evaluate.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the administrator failed to ensure medications were stored properly. The findings include: Review of an undated agency policy obtained 12/14/2022, titled “Vaccinations” stated, “… A working thermometer should be placed centrally in the unit….” During an interview on 12/9/2022, at 10:45 AM, the administrator indicated the agency provided patients with flu vaccines if requested and stored the vaccines on site. During an observation on 12/9/2022, at 10:45 AM, an unlabeled refrigerator was observed in the office. Inside of the refrigerator was a box labeled “Flucelvax Quadrivalent” (a medication used to administer the influenza vaccine) was observed on the shelf with 6 single dose, pre-filled syringes observed inside of the box. Observed on the box were storage guidelines from the manufacturer which indicated the medication should be stored between 36-46 degrees Fahrenheit. There was not a thermometer observed inside of the refrigerator. During an interview on 12/9/2022, at 10:45 AM, the administrator indicated the agency does not check the temperature of the refrigerator containing the vaccines. 410 IAC 17-12-1(d)