Every finding on record at 1st Option Adult Day Services and Home Health LLC

The Indiana Department of Health conducted an Emergency Preparedness survey, conducted in accordance with 42 CFR §484.102, for a Home Health Provider and Suppliers. Survey Dates: August 12, 13, 14, 15, 18 and 19, 2025 Census: 18 During this Emergency Preparedness survey, 1St Option Adult Day Services and Home Health Inc. was found to be out of compliance with Conditions of Participation at 42 CFR §484.102: Emergency Preparedness.

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to evidence a plan which was updated at least every two years (Tag E0004); failed to include a process for cooperation and collaboration with local, state and federal emergency preparedness officials that included documented attempts to contact officials in an effort of collaboration and cooperative planning (Tag E0009); failed to evidence updated policies and procedures at least every two years (Tag E0013); failed to evidence they developed procedures for the use of volunteers and other emergency staffing strategies to address surge needs during an emergency situation (Tag E0024); and failed to evidence the agency conducted exercises to test the emergency preparedness plan at least annually, at least one full scale community based exercise and either a second community based exercise, facility based exercise or tabletop exercise (Tag E0039). Findings include: During an interview, on 08/18/2025, beginning at 1:00 PM, the Clinical Manager indicated the agency did not have documentation the emergency preparedness plan was reviewed every 2 years, and did not have documentation of attempt to contact local/state/federal emergency preparedness officials. During an interview, on 08/18/2025, beginning at 1:00 PM, the Administrator indicated the agency had conducted an in-office fire drill in January 2023, but did not conduct an agency tabletop exercise or participate in a community-based emergency preparedness exercise. The Administrator indicated the agency had an agreement with another home health agency to provide emergency staffing during an emergency. The Administrator failed to provide documentation of emergency staffing, with another home health agency, upon exit on 08/19/2025. 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 at 42 CFR 484.102 Emergency Preparedness, with the likelihood to affect all 18 current patients receiving Home Health services from this provider.

This visit was for a Federal Recertification and State Re-Licensure survey of a home health provider. Survey Dates: 08/12/2025, 08/14/2025, 08/15/2025, 08/18/2025, and 08/19/2025 Unduplicated 12-month skilled admissions: 1 A partially extended survey was announced to the Administrator on 08/14/2025 at 3:10 PM. A fully extended survey was announced to the Administrator on 08/15/2025 at 10:30 AM. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. During this Federal Recertification Survey, 1st Option Adult Day Services & Home Health, Inc. was found to be out of compliance with Conditions of Participation 42 CFR 484.45 Reporting OASIS Information, 42 CFR 484.65 Quality Assessment/Performance Improvement, 42 CFR 484.80 Home Health Aide Services, and 42 CFR 484.105 Organization and Administration of Services. Based on the Condition-level deficiencies during the 08/19/2025 survey, your agency was subject to an extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 08/15/2025. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating a home health aide training, skills competency and/or competency evaluation programs for a period of two years beginning 08/19/2025 and continuing through 08/18/2027. Abbreviations used in report: Home Health Aide (HHA), Clinical Manager (CM), Registered Nurse (RN), Plan of Care (POC), Start of Care (SOC), and Skilled Nurse (SN). QR: 08/27/25, A1

Reporting OASIS information CFR(s): 484.45 Condition of participation: HHAs must electronically report all OASIS data collected in accordance with §484.55. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the OASIS (Outcome and Assessment Information Set, a comprehensive assessment data collection tool) information was electronically reported. (Per tag G0372). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42 CFR 484.45 Reporting OASIS Information. A deficient practice citation was also evidenced at this standard as follows: Based on record review and interview, the agency failed to encode and electronically transmit a completed OASIS assessment to the CMS (Centers for Medicare and Medicaid Services) system in 1 of 1 active clinical record reviewed of a skilled patient in a census of 1 active skilled patient in last 12 months. (Patient #1) The findings include: An undated policy titled “Comprehensive Client Assessment” indicated all skilled patients, excluding pregnant and pediatric patients, would have a comprehensive assessment with OASIS data sets specific to mandated time points. A clinical record review for Patient #1, SOC 11/27/2024 and over the age of 18 years old and not pregnant, evidenced a POC for recertification period 07/25/2025 -09/22/2025 which indicated the agency provided a skilled nurse 1 time a month to administer an injectable medication. The record evidenced a comprehensive assessment for the SOC dated 11/27/2024, recertification assessments to include the assessment dated 07/21/2025, the transfer assessment dated 06/06/2025, and the resumption of care assessment dated 06/13/2025; the agency failed to evidence the encoding and transmission of the OASIS information to CMS. On 08/14/2025 at 10:53 AM, the CM indicated the agency had never submitted OASIS information in the 15 years she had owned the agency. The CM indicated their electronic medical record program did not allow for OASIS submissions, so they don’t submit.

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the administrator’s name was provided in writing in 2 of 2 home visits conducted with an agency folder present. (Patient #1, 2) The findings include: 1. A review of the agency’s admission folder failed to evidence the administrator’s name for who to contact in order to receive complaints. 2. During a home observation for Patient #1 on 08/14/2025 from 12:20 PM to 12:57 PM, the agency folder was reviewed and failed to evidence the administrator’s name. No other document was found to evidence the agency provided the administrator’s name in writing. 3. During a home observation for Patient #2 on 08/14/2025 from 11:42 AM to 11:58 PM, the agency folder was reviewed and failed to evidence the administrator’s name. No other document was found to evidence the agency provided the administrator’s name in writing. 4. During the entrance conference on 08/12/2025 beginning at 11:08 AM, the CM indicated most of the patient complaints the agency receives were regarding the HHA not showing up. The CM indicated the agency did not file a grievance for that reason but only would for a complaint of mistreatment or abuse. 5. On 08/15/2025 at 10:01 AM, the Administrator indicated the agency folder did not contain the written administrator’s name in writing and indicated they would add a document to the agency folder containing the administrator’s name.

Transfer and discharge CFR(s): 484.50(d) Standard: Transfer and discharge. The patient and representative (if any), have a right to be informed of the HHA's policies for transfer and discharge. The HHA may only transfer or discharge the patient from the HHA if: This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient and representative were informed of the agency’s transfer/discharge policy in 2 of 2 home visits conducted with an agency folder present. (Patient #1, 2) The findings include: 1. A review of the agency’s admission folder failed to evidence the agency’s transfer/discharge policy. 2. During a home observation for Patient #1 on 08/14/2025 from 12:20 PM to 12:57 PM, the agency folder was reviewed and failed to evidence the agency’s transfer/discharge policy. No other document was found to evidence the agency’s transfer/discharge policy in the Patient’s home. 3. During a home observation for Patient #2 on 08/14/2025 from 11:42 AM to 11:58 PM, the agency folder was reviewed and failed to evidence the agency’s transfer/discharge policy. No other document was found to evidence the agency transfer/discharge policy in the Patient’s home. 4. On 08/15/2025 at 10:01 AM, the Administrator indicated the agency folder did not contain the transfer/discharge policy and was not aware the agency was supposed to provide it to the patients.

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 observation, record review, and interview, the agency failed to ensure the comprehensive assessment included a review of all the medications to identify medication interactions and duplicative drug therapy in 1 of 1 active skilled record review in a total sample of 1 active skilled patient. (Patient #1) The findings include: During an observation of care at the home for Patient #1 on 08/14/2025, at 12:20 PM, the following medications were observed on the table: sertraline (antidepressant) 50 milligrams (mg) at bedtime, and famotidine (to treat acid reflux) 40 mg daily. On 08/14/2025 at 12:30 PM, the Patient indicated there had been no medication changes or new medications in the last 2 months and indicated they took the medications on the table every day. A clinical record review evidenced a POC for the recertification period of 07/25/2025-09/22/2025 which indicated the Patient’s medications included haloperidol (brand name for Haldol, a medication to treat hallucinations) decanoate 100 milligrams (mg)/1 milliliter (ml) monthly intramuscular, Haldol decanoate 150 mg/ml monthly intramuscular, sertraline 100 mg daily, and sertraline 100 mg daily. The POC failed to indicate the Patient’s medications included famotidine. The record failed to evidence all of the Patient’s medications were reviewed to include the discrepancies in dosage for the Haldol decanoate and sertraline were reviewed. On 08/14/2025 at 3:22 PM, the CM indicated the comprehensive assessment did not evidence the medications not on the POC and indicated she did not review the medications that were not on the POC. The CM indicated she was unsure why there were discrepancies in the dosage of sertraline and Haldol. 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 services were provided as directed in the POC in 3 of 5 active clinical records reviewed. (Patient #1, 4, 5) The findings include: 1. A clinical record review for Patient #1 evidenced a POC for recertification period 05/26/2025-07/24/2025 indicated the agency would provide HHA services 5 hours a day Monday through Friday. The record failed to evidence the agency provided HHA services on Friday, 07/04/2025, Monday, 07/14/2025, Tuesday, 07/15/2025, and Wednesday, 07/16/2025. On 08/19/2025 at 1:42 PM, the CM indicated the agency does not provide services on holidays, so no services were provided on 07/04/2025. On 08/19/2025 at 1:53 PM, the Administrative Assistant indicated the HHA requested to be off 07/14/2025, 07/15/2025, and 07/16/2025, and there was no back-up HHA to provide the services. 2. A clinical record review for Patient #4 evidenced a POC for the initial certification period 03/29/2024-05/27/2024 signed by the physician on 04/02/2024 which indicated the agency was to provide HHA services 6 hours a day 5 days a week. The record failed to evidence the agency provided HHA services prior to 04/12/2024. On 08/19/2025 at 1:18 PM, the CM indicated there was a delay in the HHA services, because the agency was awaiting prior authorization and indicated there was no other physician order to related to the start of HHA services. 3. A clinical record review for Patient #5 evidenced a POC for initial certification period 06/13/2025-08/11/2025 signed by the nurse practitioner on 06/25/2025 which indicated the agency was to provide HHA services 5 hours a day 5 days a week. The record failed to evidence the agency provided HHA services prior to 07/09/2025. On 08/18/2025 at 4:20 PM, the CM indicated HHA services were delayed until the agency received approval for the prior authorization. The CM indicated there was not any other physician orders related to the start of HHA services. 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 evidence coordination of care with all other agencies providing services to the patients in the home in 1 of 1 active skilled record reviewed in a total census of 1 active skilled patient and in 1 of 1 active clinical record reviewed with personal services provided by the agency in a total census of 1 patient with personal services provided by the agency (Patient #1) in a total sample of 5 active clinical records reviewed. The findings include: 1. A clinical record review for Patient #1 comprehensive assessment for recertification completed by the CM and dated 07/21/2025 indicated the Patient complained of pain to the lower back 8/10 at its worst, pain to the right knee 10/10 at its worst, and pain to the right hip 9/10 at its worst. The comprehensive assessment indicated The POC for the recertification period 07/25/2025-09/22/2025 failed to evidence interventions and goals related to pain. The POC indicated the primary diagnosis was schizophrenia (a chronic mental health disorder leading to hallucinations and delusions) and indicated the SN administered Haldol (a medication to treat hallucinations) monthly via injection. The POC also indicated the Patient’s medications included Haldol 3 times daily. The record evidenced documents from Entity 3 which indicated the Patient was admitted to Entity 3 from 06/06/2025-06/13/2025 for suicidal ideations, hallucinations, schizophrenia, and major depressive disorder. The POC failed to evidence interventions and goals related to the Patient’s behaviors and mental disorder. On 08/15/2025 at 3:25 PM, the CM indicated there were no other interventions on the POC besides the Patient was to take their pain medications. The CM indicated the Patient’s goal for pain was 3-4/10 but it was not included in the POC. The CM indicated there were no interventions or goals related to the Patient’s mental disorder other than to ensure the Patient was taking their medication and reporting any hallucinations to the doctor. 2. A clinical record review for Patient #4 evidenced a visit schedule for August 2025 which indicated the agency provided attendant care services 2 times a week and homemaker services 1 time weekly. The POC for recertification period 07/22/2025-09/19/2025 failed to evidence the housemaker and attendant care services provided by the agency. On 08/19/2025 at 12:46 PM, the CM indicated the homemaker and attendant care services were not included in the POC. On 08/19/2025 at 12:46 PM, the Administrative Assistant indicated the agency started homemaker and attendant care services for the Patient in March 2025. 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 the agency provided services only as ordered by a physician in 1 of 5 active clinical records reviewed. (Patient #3) The findings include: The clinical record review for Patient #3 evidenced a POC for recertification period 07/01/2025- 08/29/2025 which failed to be signed by the physician. The record indicated the agency provided 39 visits by a HHA from 07/01/2025-08/09/2025 for personal care and activities of daily living. No other physician orders for home care services were found since the POC for the previous certification period ended on 06/30/2025. On 08/14/2025 at 3:10 PM, the CM indicated the POC effective 07/01/2025 was not yet signed by the physician and indicated there was no documentation the agency followed up with the physician regarding the need to sign the POC since 07/02/2025 when the POC was faxed to the physician. 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 notify the physician of drug interactions and continued behaviors in 1 of 1 skilled clinical record reviewed in a total sample of 1 active skilled patient. (Patient #1) The findings include: A clinical record review for Patient #1 evidenced a POC for the recertification period of 07/25/2025- 09/22/2025 which indicated the Patient’s medications included Haldol (a medication to treat hallucinations) 5 milligrams (mg) twice a day, 10 mg nightly, Haldol Decanoate (an injectable, long-acting medication to treat schizophrenia) injected monthly, and hydroxyzine (to treat itching) 25 mg nightly. The undated medication interactions list indicated severe interactions between Haldol and hydroxyzine and Haldol Decanoate and hydroxyzine. The record failed to evidence the agency notified the physician of the severe drug interactions. The comprehensive assessment indicated the Patient was not having any hallucinations or paranoia and was feeling better at the time of assessment. The HHA visit notes completed by HHA 3 indicated the Patient was having “episodes” all day on 07/25/2025, “episodes” all day and screaming and hollering on 07/30/2025, “episodes” the entire shift on 08/06/2025 and 08/14/2025. The record failed to evidence the agency notified the physician of the reoccurring behaviors. On 08/15/2025 at 2:45 PM, the CM indicated she could not find any documentation the agency notified the physician of the severe interactions. On 08/19/2025 at 11:59 AM, HHA 3 indicated the “episodes” were Patient’s behavior issues and hallucinations On 08/19/2025 at 1:42 PM, the CM indicated HHA 3 notified her every time the Patient experienced behaviors. The CM indicated Patient was admitted to the hospital in June 2025 for increased behavior issues, and Patient’s behaviors were getting worse lately. The CM indicated the physician was already aware of the behaviors when Patient was hospitalized and she had not notified the physician of the increased behaviors. 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 evidence coordination of care with all other agencies providing services to the patients in the home in 1 of 1 active skilled record reviewed in a total active census of 1 skilled patient. (Patient #1) The findings include: The clinical record for Patient #1 included a comprehensive assessment for a recertification, completed by the CM and dated 07/21/2025, which indicated Patient received homemaker services from Entity 1 in the mornings; the record failed to evidence care coordination with Entity 1. On 08/15/2025 at 3:25 PM, the CM indicated there was no care coordination since January 2023 and indicated she was sure of how often Entity 1 provided services. On 08/18/2025 at 2:25 PM, Person 2 at Entity 1 indicated Entity 1 provided the Patient attendant care services 3 hours in the morning 7 days a week. 410 IAC 17-12-2(h)

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 failed to evidence they had a QAPI program that measured, analyzed, and tracked quality indicators (G0642); utilized data to identify opportunities for improvement (G0644); improvement activities focused on high risk or problem prone areas (G0646); performance improvement activities analyze patient adverse events and implement preventative actions (G0654); performance improvement project had documented reason and measured progress (G0655); and that the Governing Body approved the data detail and frequency of collection (G0660). 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. Findings include: An undated, Quality Assurance and Performance Improvement Agency Program Form indicated the QAPI team would decide what data to monitor routinely and areas to be considered may include but not limited to falls and repeated hospital admissions, and would include tracking, investigating and monitoring adverse events every time they occurred, and actions plans would be implemented through the plan. 2. An undated Patient Fall Risk Assessment Form indicated the agency identified four patients with fall risks and gathered information about the four patients, indicated there was an insignificant number of patients with fall risk factors and the agency data collection would be completed by observing, questioning patients about their mobility. 3. A Board of Directors QAPI Meeting, dated 02/19/2025, indicated the meeting involved how to collect, analyze data, identify areas of improvement, develop action plans and monitor progress; and indicated data was collected, analyzed and completed on patients’ fall risk; and failed to evidence documentation of frequency nor details of data collection. 4. During an interview on 08/15/2025, beginning at 1:00 PM, the Clinical Manager indicated the agency was tracking falls due to one patient fall, Patient #8 had a fall on 06/09/2025, and the home health aide would provide fall interventions. The Clinical Manager indicated there had been one patient fall since 2022. 5. An Implement High Risk Fall Prevention Intervention Form, dated 06/09/2025, indicated Patient #8 interventions would include but not limited to use of bedside commode, toilet patient every two hours or as needed, bedside table, tv remote, and cellphone would be within patient’s reach at all times, family/patient would be educated to install handrails in patient’s bathroom and hallway, proper bed height adjustment, remove clutter and tripping hazards and ensure adequate lights in room and hallway at all times. A Home Health Aide Care Plan, dated 05/09/2025, indicated secure oxygen tubing and help client to minimize fall and failed to evidence home health aide was to toilet patient every two hours, ensure tv remote and cellphone was in patient’s reach, tripping hazards were to be removed, and bedside commode was to be used. During an interview on 08/18/2025, beginning at 1:00 PM, the Clinical Manager indicated there was no documentation of Patient #8’s fall, nor an adverse event report completed. 6. An Agency Hospitalization Log indicated 5 patient hospitalizations documented from 07/19/2024 to 06/09/2025. During an interview on 08/15/2025, beginning at 1:00 PM, the Clinical Manager indicated patient hospitalizations were not analyzed nor were there interventions in place to prevent hospitalizations. 7. An Infection Control Log indicated there was three urinary tract infections from 07/18/2024 to 10/2024. During an interview on 08/15/2025, beginning at 1:00 PM, the Clinical Manager indicated the agency was not analyzing nor were inventions in place to prevent infections due to one of their patient’s with a foley catheter was monitored by another home health agency. 8. During an interview on 08/18/2025, beginning at 1:15 PM, the Clinical Manager indicated the average quarterly census for the agency for the last quarter of 2024 was 13, during the first quarter of 2025 was 12 and during the second quarter of 2025 was 13. 410 IAC 17-12-2(a)

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure: the home health aide was evaluated for competency before providing patient care (see tag G0768); the home health aide was assigned with appropriate written instructions (see tag G0798); the home health aide provide services that were included in the plan of care (see tag G0800); HHA supervision was provided every 14 days for skilled patients (see tag G0808); and the home health aide supervision ensured the care provided followed the plan of care (see tag G0818). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the Condition of Participation 42 CFR 484.80 Home Health Aide Services.

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure that prior to patient contact, the home health aide would successfully have completed a competency skills evaluation with a pseudo-patient or a live patient in 4 of 4 home health aides with a hire date between 02/26/2025 and 07/02/2025 (Home Health Aide 1, 5, 7, 10); in 1 of 1 staff members identified as a home health aide without a certification nor on the Indiana aide registry, (Home Health Aide 3); and in 5 of 5 home health aides with a hire date between 01/16/2023 and 09/23/2024 (Home Health Aide 6, 8, 9, 11, 12). Findings include: 1. The Personnel Record for HHA 1, with date of hire [DOH] 07/02/2025, first patient contact of 07/09/2025, failed to evidence a competency skills evaluation was completed. 2. The Personnel Record for HHA 3, identified as a home health aide without a certification nor on the Indiana aide registry, with DOH 02/26/2025 and first patient contact 03/07/2025, failed to evidence a competency skills evaluation was completed prior to first patient contact. 3. The Personnel Record for HHA 5, DOH 06/10/2025 and first patient contact 07/16/2025, failed to evidence a competency skills evaluation was completed. 4. The Personnel Record for HHA 7, DOH 03/04/2025, evidenced a competency skills evaluation was completed on 06/11/2025; the record failed to evidence the skills evaluation was completed with a pseudo-patient or a patient. 5. The Personnel Record for HHA 10, DOH 03/27/2025, evidenced a competency skills evaluation was completed on 06/11/2025, and failed to evidence skills evaluation was completed with a pseudo-patient or a patient. 6. During an interview on 08/15/2025, beginning at 3:00 PM, the Clinical Manager indicated HHA 5 first patient contact was providing care for Patient #9 and Patient #10 on 07/16/2025, and HHA 3's first patient contact was providing care for Patient #1 on 03/07/2025. 7. The Personnel file for HHA 6, DOH 09/16/2024, included a Home Health Aide Skills Competency/ Evaluation dated 06/11/2025; the record failed to evidence the skills evaluation was completed with a pseudo-patient or a patient. 8. The Personnel file for HHA 8, DOH 10/24/2023, included a Home Health Aide Skills Competency/Evaluation dated 06/11/2025 which failed to evidence the skills evaluation was completed with a pseudo-patient or a patient. 9. The Personnel file for HHA 9, DOH 04/22/2024, included a Home Health Aide Skills Competency/Evaluation dated 06/11/2025, and failed to evidence skills evaluation was completed with a pseudo-patient or a patient. 10. The Personnel file for HHA 11, DOH 01/16/2023, included a Home Health Aide Skills Competency/Evaluation dated 06/11/2025, and failed to evidence skills evaluation was completed with a pseudo-patient or a patient. 11. The Personnel file for HHA 12, DOH 09/23/2024, included a Home Health Aide Skills Competency/Evaluation dated 06/11/2025, and failed to evidence skills evaluation was completed with a pseudo-patient or patient. 12. During a follow up interview on 08/18/2025, beginning at 1:15 PM, the Clinical Manager indicated home health aide skills competencies were completed by the home health aide would watch a training video and she did not observe skills of the home health aide with a pseudo patient or a live patient. The Clinical Manager indicated the skills competency document that indicated demonstrated did not refer to a home health aide being observed providing care. During a follow up interview on 08/18/2025, beginning at 2:00 PM, the Clinical Manager indicated home health aide skills competencies were completed by the home health aide, who would watch a training video and then the home health aides would demonstrate skills on each other. 410 IAC 17-14-1(l)(1)(A)

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the RN assigned written tasks to the HHA in 3 of 5 active clinical records reviewed. (Patient #1, 2, 4) The findings include: 1. A clinical record review for Patient #1 evidenced a HHA Care Plan reviewed by the RN on 03/22/2025 which indicated the HHA was to provide assistance with a tub bath and a shower based on client choice. On 08/19/2025 at 1:32 PM, the CM indicated the Patient needs a shower and not a bath, because getting into and out of the bath tub is a safety issue for the Patient and HHA. 2. During an observation of care at the home of Patient #2 on 08/14/2025 at 11:42 AM, Patient was observed with a plastic tube from under their pants draining yellow liquid into a bag attached to the walker. A clinical record review for Patient #2 evidenced a POC for recertification period 07/01/2025- 08/29/2025 which indicated Patient had a suprapubic catheter (a plastic tube surgically inserted into the bladder from the abdomen to drain urine) and indicated the HHA interventions included obtaining vital signs and empty urine from the catheter bag every shift. The HHA CP, last reviewed 04/28/2025, failed to evidence the HHA was directed to obtain vital signs and provide catheter care. On 08/19/2025 at 1:56 PM, the CM indicated the HHA should have been directed to obtain vital signs, it was not included on the HHA Care Plan. The CM indicated catheter care was not included in the HHA care plan. 3. A clinical record review for Patient #4 includeed a POC for recertification period 07/22/2025- 09/19/2025 which indicated Patient was on a blood thinner (a medication to treat or prevent blood clots) and had safety measures to include bleeding precautions. The HHA Care Plan, last reviewed 03/24/2025, indicated the CM directed the aide to shave the Patient with either an electric or straight razor per Patient’s request and failed to evidence the bleeding precautions. The schedule for the Patient for the month of August 2025 indicated Patient received HHA services every Thursday, Friday, and Saturday. The HHA Care Plan indicated the HHA was to complete bathing and personal care at every visit Monday through Friday. On 08/29/2025 at 1:03 PM, the CM indicated using a straight razor for shaving the Patient should not have been included on the HHA Care Plan, because of the Patient’s bleeding precautions. The CM indicated the HHA Care Plan had not been updated to reflect the changes in the visit schedule since Patient began receiving homemaker and attendant care services in March of 2025 which changed the HHA visit schedule. 410 IAC 17-14-1(m)

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the HHA provided the tasks as directed in the HHA Care Plan in 4 of 5 active clinical records reviewed. (Patient #1, 2, 4, 5) The findings include: 1. A clinical record review for Patient #1 included the HHA Care Plan, last reviewed and signed by the RN on 03/22/2025, indicated Patient was to have either a tub bath or a shower, per Patient’s choice, at every visit. HHA visit notes completed by HHA 3 indicated she assisted Patient with: a bed bath and a shower on 07/25/2025; a bed bath on 07/28/2025, 07/30/2025; and a bed bath, shower, and chair bath on 07/29/2025, 08/01/2025, 08/04/2025, 08/05/2025, 08/07/2025, and 08/11/2025. The HHA Care Plan indicated the HHA should ambulate the Patient with the walker at every visit; the HHA visit notes failed to evidence the HHA ambulated Patient with the walker on 10 visits from 07/25/2025 to 08/11/2025. The HHA Care Plan indicated the HHA was to provide hair care at every visit; the HHA visit notes failed to evidence hair care was provided on 5 visits from 07/25/2025 to 08/13/2025. The HHA Care Plan indicated the HHA was to provide oral care at every visit; the HHA visit notes failed to evidence oral care was provided during 4 visits from 07/25/2025 to 08/11/2025. The HHA Care Plan evidenced the HHA was to provide medication reminders, skin care, and perineal (private area) care at every visit; the HHA visit notes failed to evidence the HHA provided medication reminders, skin care, and perineal care on 11 visits from 07/25/2025 to 08/11/2025. The HHA visit notes completed by HHA 3 indicated the HHA completed foot care on 07/07/2025, 07/22/2025, and 08/04/2025; the HHA Care Plan failed to evidence foot care was an assigned task for the HHA to complete. On 08/19/2025 beginning at 1:33 PM, the CM indicated the HHA did not follow the care plan, and only 1 method of bathing the Patient should be documented; the CM indicated the tasks not documented were not done. 2. On 08/14/2025 at 11:50 AM, HHA 4 indicated she checked the blood sugars for Patient #2 three times daily with an accucheck (a medical device used to check blood sugar). HHA 3 indicated Patient’s blood sugar that morning was 162. A clinical record review evidenced a HHA Care Plan, last reviewed 04/28/2025, which failed to evidence the HHA was directed to test Patient’s blood sugars. The HHA Care Plan indicated the HHA was to assist the Patient at every visit with a tub bath or shower per Patient’s choice. The HHA visit notes completed by HHA 4 indicated the HHA provided a bed bath, chair bath, and shower on 42 visits from 07/01/2025 to 08/16/2025. The HHA visit notes evidenced the HHA provided assistance with the commode, bed pan, dressing, foot care, and medication on 42 visits from 07/01/2025 to 08/16/2025; the HHA Care Plan failed to evidence the HHA was directed to provide assistance with the commode, bed pan, dressing, foot care, and medication. The POC for recertification period 07/01/2025- 08/29/2025 indicated the agency was to provide HHA services for 6 hours 5 days a week Monday through Friday; the HHA visit notes from 07/01/2025 to 08/16/2025 indicated the HHA provided 7 hours of care each visit Monday through Friday. On 08/19/2025 beginning at 2:01 PM, the CM indicated the HHA should never provide medication assistance and should only do the care assigned on the care plan. The CM indicated the HHA should have been providing 6 hours of care daily Monday through Friday. The CM indicated the HHA was not to test the Patient’s blood sugar and was unaware the HHA was doing so. 3. A clinical record review for Patient #4 evidenced a HHA Care Plan last reviewed on 03/24/2025 indicated the HHA was to assist Patient with hair care, oral care, and dressing at every visit. Eleven HHA visit notes completed by HHA 12 from 07/24/2025 to 8/15/2025 failed to evidence the HHA assisted with hair care, oral care, and dressing per the Care Plan. On 08/19/2025 at 12:47 PM, the CM indicated the care listed on the HHA Care Plan was not documented by the HHA. 4. A clinical record review for Patient #5 evidenced HHA visit notes completed by HHA 1 which indicated the HHA obtained vital signs (temperature, pulse, and respirations) on 07/09/2025, 07/11/2025, 07/17/2025, 07/24/2025, 07/25/2025, and 07/28/2025. The HHA Care Plan dated 07/08/2025 failed to indicate the HHA was directed to obtain vital signs. The HHA Care Plan indicated the HHA was directed to assist with feeding, hair care, oral care, shaving, dressing and showering, and provide a medication reminder. Twenty-two HHA visit notes from 07/09/2025 to 08/09/2025 completed by HHA 1 failed to evidence the HHA assisted with feeding, hair care, oral care, shaving, dressing, and showering and failed to provide a medication reminder. On 08/19/2025 at 2:33 PM, the CM indicated the HHA was not directed to obtain vital signs. The CM indicated the agency was still working with HHA 1 on documentation since she was newly hired.

Aides are members of interdisciplinary team CFR(s): 484.80(g)(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient's condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA's policies and procedures. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the HHA reported changes in the patient’s status in 1 of 1 active clinical record review of a patient receiving HHA services only with a hospitalization in a total sample of 5 active clinical records with HHA services. (Patient #5) The findings include: A clinical record review for Patient #5 evidenced an HHA visit note completed by HHA 1 and dated 08/11/2025 which indicated Patient was in the hospital. On 08/18/2025 at 2:45 PM, Patient’s caregiver indicated Patient was hospitalized after falling on 08/09/2025 and was discharged home on 08/11/2025. On 08/19/2025 at 2:50 PM, the CM indicated HHA 1 did not inform the agency of the Patient’s hospitalization. 410 IAC 17-14-1(n)

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the RN made an on-site supervisory visit to the patient’s home where both skilled and HHA services were provided in 1 of 1 skilled record review in a total active census of 1 skilled patient. (Patient #1) The findings include: The clinical record review for Patient #1 evidenced POCs for recertification periods 05/26/2025-07/24/2025 and 07/25/2025-09/22/2025 which indicated the agency provided SN and HHA services. The record failed to evidence HHA supervisory visits every 14 days between supervisory visits dated 05/21/2025 and 07/21/2025. On 08/15/2025 at 2:30 PM, the CM indicated she did not know Patients receiving skilled services were supposed to get HHA supervisory visits every 14 days and had been conducting them every 60 days.

HH aide supervision elements CFR(s): 484.80(h)(4)(i-vi) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements: (i) Following the patient's plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional; (ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family; (iii) Demonstrating competency with assigned tasks; (iv) Complying with infection prevention and control policies and procedures; (v) Reporting changes in the patient's condition; and (vi) Honoring patient rights. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the RN provided supervision of the HHA to ensure the tasks were provided as directed in 4 of 5 active clinical records reviewed. (Patient #1, 2, 4, 5) The findings include: 1. A clinical record review for Patient #1 indicated the HHA Care Plan reviewed and signed by the RN on 03/22/2025 indicated the HHA was to give either a tub bath or a shower per the Patient’s choice at every visit. HHA visit notes completed by HHA 3 indicated she assisted the Patient with a bed bath on 07/07/2025,07/08/2025, 07/09/2025, 07/10/2025, 07/11/2025, and 07/18/2025. The HHA Care Plan indicated the HHA should ambulate the Patient with the walker at every visit, and the HHA visit notes failed to evidence the HHA ambulated the Patient with the walker on 06/20/2025, 07/07/2025, 07/08/2025, 07/09/2025, 07/10/2025, 07/11/2025, 07/17/2025, and 07/18/2025. The HHA Care Plan evidenced the HHA was to provide medication reminders, skin care, and perineal (private area) care at every visit, and the HHA visit notes failed to evidence the HHA provided medication reminders, skin care, and perineal care on 06/20/2025, 07/07/2025, 07/08/2025, 07/09/2025, 07/10/2025, 07/11/2025, 07/17/2025, and 07/18/2025. The HHA Supervisory note signed and dated by the CM on 07/21/2025 indicated the HHA followed the care plan and failed to evidence the RN provided supervision to ensure the HHA followed the aide care plan as directed. On 08/19/2025 at 1:49 PM, the CM indicated the HHA notes had not been reviewed and there was no identification of the HHA not following the care plan, so the HHA was not re-directed to follow the care plan. 2. A clinical record review for Patient #2 evidenced a HHA Care Plan reviewed 04/28/2025 which indicated the HHA was to assist the Patient at every visit with a tub bath or shower per Patient’s choice. The HHA visit notes completed by HHA 4 indicated the HHA provided a bed bath, chair bath, and shower on 4 visits from 06/23/2025 to 06/26/2025. The HHA visit notes evidenced the HHA provided assistance with the commode, bed pan, dressing, foot care, and medication on 4 visits from 06/23/2025 to 06/26/2025, and the HHA Care Plan failed to evidence the HHA was directed to provide assistance with the commode, bed pan, dressing, foot care, and medication. The HHA Supervisory note signed and dated by the CM on 06/27/2025 indicated the HHA followed the care plan and failed to evidence the RN provided supervision to ensure the HHA followed the aide care plan as directed. On 08/19/2025 at 2:08 PM, the CM indicated the HHA visit notes were not reviewed and the HHA and not been re-directed to follow the care plan. 3. A clinical record review for Patient #4 evidenced a HHA CP last reviewed on 03/24/2025 indicated the HHA was to assist the Patient with hair care, oral care, and dressing at every visit. Eight HHA visit notes completed by HHA 12 from 07/03/2025-07/19/2025 failed to evidence the HHA assisted with hair care, oral care, and dressing per the HHA Care Plan. The HHA Supervisory note signed and dated by the CM on 07/21/2025 indicated the HHA followed the care plan and failed to evidence the RN provided supervision to ensure the HHA followed the aide care plan as directed. On 08/19/2025 at 12:52 PM, the CM indicated the supervision of the HHA was only done during an in-person supervision visit and the HHA visits notes were not reviewed to ensure care was provided per the HHA Care Plan. The CM indicated no re-direction for the HHA had yet occurred. 4. A clinical record review for Patient #5 evidenced HHA visit notes completed by HHA 1 which indicated the HHA obtained vital signs (temperature, pulse, and respirations) on 07/09/2025, 07/11/2025, 07/17/2025, 07/24/2025, 07/25/2025, and 07/28/2025. The HHA Care Plan dated 07/08/2025 failed to indicate the HHA was directed to obtain vital signs. The HHA Care Plan indicated the HHA was directed to assist with feeding, hair care, oral care, shaving, dressing and showering, and provide a medication reminder. Twenty-one HHA visit notes from 07/09/2025 to 08/07/2025 completed by HHA 1 failed to evidence the HHA assisted with feeding, hair care, oral care, shaving, dressing, and showering and failed to provide a medication reminder. . The HHA Supervisory note signed and dated by the CM on 08/07/2025 indicated the HHA followed the care plan and failed to evidence the RN provided supervision to ensure the HHA followed the aide care plan as directed. On 08/19/2025 at 2:33 PM, the CM indicated the HHA was not following the HHA Care Plan but had not yet been re-directed. 410 IAC 17-14-1(n)

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 and interview, the home health agency failed to ensure the organization and management of the home health agency as follows: the services provided were set forth in writing (see tag G0940); the governing body failed to develop and review the budget (see tag G0942); the employment of qualified personnel (see tag G0952); the clinical manager provided oversight of the patient/personnel schedule (see tag G0960); and the clinical manager coordinated referrals (see tag G0964). 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 42CFR 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 agency failed to ensure the organization structure was set forth in writing to include the services furnished. The findings include: A review of the agency’s organizational chart indicated “agency staff” and failed to indicate what services were provided to the patients and indicated a medical director and professional advisory board. During the entrance conference on 08/12/2025 beginning at 11:08 AM, the CM indicated the agency provided skilled nursing, HHA, attendant care, and homemaker services. On 08/15/2025 at 10:23 AM, the Administrator indicated the services provided by the agency were not listed on the organizational chart and indicated the agency did not have a medical director or professional advisory board. 410 IAC 17-12-1(b)

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 failed to ensure the governing body reviewed the annual budget. The findings include: The Governing Body Meeting Minutes dated 12/29/2023 indicated the budget for 2024 was reviewed. No other documents were provided in regard to the review of the 2025 budget; no 2025 budget was provided. On 08/15/2025 at 12:34 PM, the Administrator indicated the Administrator and the CM were the governing body members and indicated there was no 2025 budget available. The Administrator indicated the accountant did the budget and the Administrator did not have a copy of it. 410 IAC 17-12-1(b)(1)

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 agency failed to ensure the administrator provided oversight of the day-to-day operations of the agency to include notifying the Indiana Department of Health of changes in the administrative staff. The findings include: The review of the agency information reported to CMS and the Indiana Department of Health indicated RN 1 was the alternate clinical manager. Review of the personnel list indicated the last day of employment for RN 1 was 11/20/2024 and the first day of employment for RN 2 was 04/15/2025. During the entrance conference on 08/12/2025 at 11:08 AM, the Administrator indicated RN 1 was no longer employed with the agency; and RN 2 was then the Alternate Clinical Manager. The Administrator indicated the agency did not inform the Indiana Department of Health of the administrative change until RN 2 had been employed 90 days. 410 IAC 17-12-1(c)(1)

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on record review and interview, the administrator failed to ensure the employment of qualified personnel to ensure certification of the HHA. The findings include: A review of the agency’s personnel list indicated HHA 3 was hired on 02/26/2025 and was currently providing care for Patient #1. A personnel record review for HHA 3 failed to evidence HHA 3 held a certification or was on the Indiana aide registry. On 08/15/2025 at 2:54 PM, the Administrative Assistant indicated HHA 3 did not have a HHA certification, because HHA 3 started with the agency providing attendant care and not HHA services. The Administrative Assistant indicated HHA 3 began providing HHA services for Patient #1 on 03/07/2025. On 08/15/2025 at 3:02 PM, the Administrator indicated he was not aware HHA did not have a HHA certification nor on the Indiana aide registry. 410 IAC 17-12-1(d)(8)

Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical manager provided clinical oversight of the patient and personnel assignments. The findings include: 1. A clinical record review for Patient #2 evidenced a POC for recertification period 07/01/2025-08/29/2025 which indicated the agency was to provide HHA services for 6 hours 5 days a week Monday through Friday. The visit schedule for July 2025 The HHA visit notes from 07/01/2025 to 08/16/2025 indicated the HHA provided 7 hours of care each visit Monday through Friday. On 08/19/2025 at 2;01 PM, the CM indicated the Administrative Assistant did not change the HHA visit schedule from 4:00 AM to 11:00 AM to 4:00 AM to 10:00 AM to ensure the number of authorized hours were scheduled. The CM indicated the Administrative Assistant provided oversight of the HHA visit schedule and indicated the CM did not review it. 2. A clinical record review for Patient #4 evidenced a POC for recertification period 07/22/2025-09/19/2025 which indicated the agency was to provide HHA services for 6 hours a day 5 days a week. The HHA visit schedule for July 2025 indicated the HHA was scheduled 5 hours a day. On 08/18/2025 at 1:10 PM, the CM indicated the visit schedule made by the Administrative Assistant was incorrect, and the HHA should have been scheduled 6 hours a day.

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 agency failed to ensure the CM followed the agency’s policies regarding referrals. The findings include: An undated agency policy titled “Client Admission Process” indicated an intake form would be completed for a new referral to include the patient’s name, address, date of birth, referral source, and diagnosis. The policy indicated a record of all persons referred for service would be maintained. On 08/15/2025 at 10:38 AM, the CM indicated she “might write them down” when queried how coordination of referrals was provided. A review of a folder titled “New Referrals” contained printed emails from referral sources with patients’ names and contact information. On 08/15/2025 at 1:26 PM, the CM indicated there were no additional referrals documents and was unsure how the agency tracked referrals to ensure they were reviewed and coordinated for an initial assessment or denial.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the transfer summary was sent to the facility responsible for providing care within 2 business days of becoming aware of an unplanned transfer in 1 of 2 closed records reviewed. (Patient #6) The findings include: A clinical record review for Patient #6 evidenced a transfer comprehensive assessment completed by the CM and dated 07/12/2025 which indicated the Patient was transferred and admitted to the hospital on 07/12/2025. The record failed to evidence a transfer summary was sent to the receiving facility. On 08/19/2025 at 3:09 PM, the CM indicated the agency had not sent a transfer summary to the receiving facility. 410 IAC 17-15-1(a)(7)

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the HHA documented the visit note accurately and timely in 4 of 5 active clinical records reviewed. (Patients #1, 2, 4, 5) The findings include: 1. An undated policy titled “Flow Sheets” indicated all documentation must be completed on the day the service is rendered. 2. A clinical record review for Patient #1 evidenced POC for recertification periods 05/26/2025-07/24/2025 and 07/25/2025-09/22/2025 which indicated the agency was to provide HHA services 5 hours a day 5 days a week. The HHA visit notes for 06/20/2025 and 08/14/2025 failed to evidence the amount of time the HHA provided services, and only 4 visits were provided the weeks of 06/22/2025, 07/27/2025, and 08/13/2025. On 08/19/2025 at 1:48 PM, the Administrative Assistant indicated the HHA did not document the number of hours on the visit notes for 06/20/2025 and 08/14/2025 and indicated the HHA provided 5 hours of services on 06/26/2025, 07/31/2025, and 08/12/2025 but had not yet documented a visit note. 3. During an observation of care at the home of Patient #2 on 08/14/2025 from 11:42 AM to 11:58 AM, HHA 3 was observed assisting the Patient to ambulate with the walker from the front porch inside to the living room and into the chair. On 08/14/2025 at 11:50 AM, HHA 4 indicated she arrived to the Patient’s home that morning to begin care at 7:30 AM. A clinical record review evidenced a HHA visit note dated 08/14/2025 completed by HHA 4 which indicated the HHA provided care from 7:00 AM to 11:00 AM. On 08/19/2025 at 11:55 AM, HHA 4 indicated she did arrive at the Patient’s home at 4:00 AM on 08/14/2025, but the Patient was sleeping so she left and returned at 7:30 AM. 4. A clinical record review for Patient #4 evidenced a visit schedule for August 2025 which indicated the agency provided attendant care services 2 times a week, homemaker services 1 time weekly, and HHA services three times weekly. The visit notes from 07/22/2025 to 08/18/2025 completed by HHA 12 indicated the level of care was a HHA and failed to evidence the homemaker and attendant level of care. On 08/19/2025 at 12:47 PM, the CM indicated HHA 12 did not correctly document the service type when providing attendant services 2 times weekly and homemaker services once weekly. 5. A clinical record review for Patient #5 evidenced a POC for initial certification period 06/13/2025-08/11/2025 which indicated the agency was to provide HHA services 5 hours a day 5 days a week Monday through Friday. The HHA visit notes completed by HHA 1 indicated the HHA provided services on a Saturday, 08/09/2025, provided 17 hours on 07/14/2025 and 08/11/2025, and 12 hours on 07/24/2025. On 08/19/2025 at 2:30 PM, the Administrative Assistant indicated HHA 1 documented the wrong date on 08/09/2025, and it should have been 08/08/2025. The Administrative Assistant indicated the HHA documented the end time incorrectly on the visit notes for 07/14/2025, 07/24/2025, and 08/11/2025. 410 IAC 17-15-1(b)

HH aide supervision elements CFR(s): 484.80(h)(4)(i-vi) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements: (i) Following the patient's plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional; (ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family; (iii) Demonstrating competency with assigned tasks; (iv) Complying with infection prevention and control policies and procedures; (v) Reporting changes in the patient's condition; and (vi) Honoring patient rights. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure home health aides provided care which was ordered on the plan of care in 4 of 4 clinical records reviewed. (Patient #1, 2, 3, 4) The findings include: 1. Record review evidenced an agency policy revised 10/26/2011, titled "Home Health Aide Supervision" which stated, "... The aide visit record is reviewed by the supervising nurse/therapist to assure services are being provided according to the care plan ...." 2. Clinical record review for Patient #1 was completed on 7/11/2023. Record review evidenced a plan of care for certification period 5/12/2023 - 7/10/2023, which indicated the patient was to receive 6 hours of home health aide services 5 days per week, Monday through Friday. The plan of care indicated the home health aide would assist/prepare daily meals and set up, assist the patient with feeding, assist patient with dressing, change bed linens, empty catheter bag, and remind patient to take their medications. The home health aide plan of care indicated the home health aide was to perform housekeeping, vacuuming, washing dishes, dusting, laundry, and wiping down of surfaces, which were not covered services under the IHCP benefit. The plan of care indicated the home health aide was not to perform catheter care. Record review evidenced home health aide visit notes dated 6/30/2023, 7/2/2023, 7/3/2023, 7/5/2023, 7/6/2023, and 7/7/2023, which all indicated the aide performed the following tasks, which were not covered services under the IHCP benefit: laundry, cleaned the bathroom, bedroom, and kitchen, washed dishes, and went grocery shopping. These visit notes also indicated the home health aides performed the following tasks which were not included on the plan of care: catheter care, mouth care, shave, nail care, and foot care. Record review evidenced a home health aide visit note dated 7/1/2023, which indicated the home health aide failed to assist with meals, assist with feeding, assist with dressing, change bed linens, and remind the patient to take their medications. Record review evidenced a home health aide supervisory visit note dated 6/23/2023, which indicated the home health aide followed and implemented the plan of care. During an interview on 7/11/2023, at 1:40 PM, the Clinical Manager indicated home health aide supervisory visits were conducted every 30 days, by observing the home health aide provide care. The Clinical Manager indicated they did not review the home health aides previous documentation to ensure they were following the plan of care. 3. Clinical record review for Patient #2 was completed on 7/11/2023. Record review evidenced a plan of care for certification period 5/13/2023 - 7/11/2023, which indicated the home health aide was to take vital signs during visits, ensure the patient had a brief on prior to getting on the bus, assist patient with bathing, and give verbal medication reminders each visit. The plan of care indicated the home health aide was to call the office if the temperature was below 96 degrees. Record review evidenced home health aide visit notes dated 6/30/2023, 7/3/2023, and 7/5/2023, which all indicated the home health aide cleaned the bathroom, bedroom, kitchen, and did dishes, which was not covered services under the IHCP benefit, or ordered on the plan of care. Record review evidenced home health aide visit notes dated 6/30/2023, 7/3/2023, and 7/5/2023, which all failed to evidence the home health aide ensured the patient had a brief on prior to getting on the bus, assisted with bathing, and gave verbal medication reminders. These visit notes all had the following vital signs: pulse - 80, blood pressure -123/80, and temperature - 95. Record review failed to evidence any communication notes or documentation which indicated the home health aide called the office to notify of the temperature of 95 degrees as ordered on the plan of care. Record review evidenced a home health aide supervisory visit dated 6/16/2023, which indicated the home health aide was following and implementing the plan of care. During an interview on 7/11/2023, at 11:34 AM, the Clinical Manager indicated the home health aides should have been performing tasks as were ordered on the plan of care. The Clinical Manager indicated the home health aide was probably not checking the vital signs during visits, and copied the vitals from their assessment. 4. Clinical record review for Patient #3 was completed on 7/11/2023. Record review evidenced a plan of care for certification period 7/1/2023 - 8/29/2023, which indicated the home health aide was to assist the patient to turn every 2 hours, assist with meals and feeding, perform grooming assistance, change bed linens, wash dishes, and give verbal medication reminders. Record review evidenced a home health aide visit note dated 7/1/2023, which failed to evidence the home health aide turned the patient every 2 hours, assisted with meals and feeding, performed grooming assistance, changed bed linens, washed dishes, and gave verbal medication reminders as ordered on the plan of care. Record review evidenced a home health aide supervisory visit dated 7/3/2023, which indicated the home health aide was following and implementing the plan of care. During an interview on 7/11/2023, at 1:19 PM, the Clinical Manager indicated if the home health aide did not perform the tasks on the plan of care they would be blank on the visit note. The Clinical Manager indicated maybe the patient did not want the home health aide to perform these tasks. The Clinical Manager indicated they did not review the visit notes during supervisory visits. 5. Clinical record review for Patient #4 was completed on 7/11/2023. Record review evidenced a plan of care for certification period 5/27/2023 - 7/25/2023, which indicated the home health aide was to assist with dinner, encourage use of cane, assist with bath/shower, dressing, shampoo hair, comb hair, take vital signs and give verbal medication reminders. Record review evidenced home health aide visit notes dated 6/30/2023, and 7/3/2023, which failed to evidence the home health aide performed a temperature, bath/shower, dressing, shampooed hair, combed hair, gave verbal medication reminders, encouraged the use of cane, and assisted with dinner. Record review evidenced a home health aide supervisory visit dated 6/23/2023, which indicated the home health aide was implementing and following the plan of care. During an interview on 7/11/2023, at 1:30 PM, the Clinical Manager indicated the home health aide should have been performing all the tasks on the plan of care. 410 IAC 17-14-1(n)

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, the Registered Nurse (RN) failed to provide a patient-specific Home Health Aide (HHA) care plan in 7 of 7 clinical records reviewed (#1, 2, 3, 4, 5, 6, 7). The findings include: 1. Record review evidenced an undated agency policy obtained 2/14/2023, titled “Home Health Aide Plan of Care” which stated, “… The home health aide cannot be responsible for performing any procedure that is not assigned to him/her inwriting by the registered nurse/therapist or that is beyond his/her ability … The home health aide tasks must be related to the physical care needs of the client ….” 6. Clinical record review for Patient #5 was completed on 2/14/2023. Record review evidenced a plan of care for certification period 1/13/2023 – 3/13/2023. The document evidenced the patient received HHA services. The document stated, "... Aide: Monitor patient at all times ... encourage use of assistive devices whenever possible ... ensure well-lit, clutter free walkway such as keeping cords secure ... removing throw rugs ... assist/prepare daily meals and set up ... assist with feeding whenever possible ... assist with bathing, dressing, personal care such as grooming, hair care, shampoo, oral care ... assist patient with light housekeeping ... such as ... vacuuming, changing bedding/linens, dishes, wiping down of surfaces, laundry, etc. ...." The plan of care/Aide care plan failed to evidence patient specific instructions/tasks for how often or what the HHA was to monitor for; what assistive devices or when the HHA should encourage the patient to use them; which meals to prepare, how often, or what type of assistance was needed; patient specific personal care tasks, or how often to provide them; or patient specific household tasks, or how often to perform them. Clinical record review evidenced a comprehensive reassessment (recertification of services) dated 1/9/2023. The document evidenced the patient was dependent for toileting, grooming, and showering. The plan of care/Aide care plan failed to evidence patient specific instructions/tasks for provision of toileting, grooming, or showering needs. 7. Clinical record review for Patient #6 was completed on 2/14/2023. Record review evidenced a plan of care for certification period 2/5/2023 – 4/5/2023. The document evidenced the patient received HHA services. The document stated, "... Aide: Monitor patient at all times ... encourage use of assistive devices whenever possible ... ensure well-lit, clutter free walkway such as keeping cords secure ... removing throw rugs ... assist/prepare daily meals and set up ... assist with feeding whenever possible ... assist with bathing, dressing, personal care such as grooming, hair care, shampoo, oral care ... assist patient with light housekeeping ... such as ... vacuuming, changing bedding/linens, dishes, wiping down of surfaces, laundry, etc. ...." The plan of care/Aide care plan failed to evidence patient specific instructions/tasks for how often or what the HHA was to monitor for; what assistive devices or when the HHA should encourage the patient to use them; which meals to prepare, how often, or what type of assistance was needed; patient specific personal care tasks, or how often to provide them; or patient specific household tasks, or how often to perform them. Clinical record review evidenced a comprehensive reassessment (recertification of services) dated 1/31/2023. The document evidenced the patient was independent for toileting, grooming, and showering. The plan of care/Aide care plan failed to identify which tasks the patient required assistance with. 8. Clinical record review for Patient #7 was completed on 2/14/2023. Record review evidenced a plan of care for certification period 1/13/2023 – 3/13/2023. The document evidenced the patient received HHA services. The document stated, "... Aide: Monitor patient at all times ... encourage use of assistive devices whenever possible ... ensure well-lit, clutter free walkway such as keeping cords secure ... removing throw rugs ... assist/prepare daily meals and set up ... assist with feeding whenever possible ... assist with bathing, dressing, personal care such as grooming, hair care, shampoo, oral care ... assist patient with light housekeeping ... such as ... vacuuming, changing bedding/linens, dishes, wiping down of surfaces, laundry, etc. ...." The plan of care/Aide care plan failed to evidence patient specific instructions/tasks for how often or what the HHA was to monitor for; what assistive devices or when the HHA should encourage the patient to use them; which meals to prepare, how often, or what type of assistance was needed; patient specific personal care tasks, or how often to provide them; or patient specific household tasks, or how often to perform them. Clinical record review evidenced a resumption of care comprehensive assessment dated 1/26/2023. The document evidenced the patient was dependent for showering, but independent with feeding, grooming, and toileting. The plan of care/Aide care plan failed to evidence patient specific instructions/tasks for provision of showering. 410 IAC 17-14-1(m) 2. Clinical record review for Patient #1 was completed on 2/14/2023. Record review evidenced a plan of care for certification period 1/13/2023 – 3/13/2023. The document evidenced the patient received HHA services, diagnoses included diabetes, and nutritional requirements stated, "... No Problem ...." The document also stated, "... Aide: Monitor patient at all times ... encourage use of assistive devices whenever possible ... ensure well-lit, clutter free walkway such as keeping cords secure ... removing throw rugs ... prepare meals and assist with set up/feed ... assist with bathing, dressing, personal care such as grooming, hair care, shampoo, oral care ... assist patient with light housekeeping ... such as ... vacuuming, changing bedding/linens, dishes, wiping down of surfaces, laundry, etc. ...." The plan of care/Aide care plan failed to evidence patient specific instructions/tasks for how often or what the HHA was to monitor for; what diet the patient required due to diabetes, how often, or what type of assistance was needed; patient specific personal care tasks, or how often to provide them; or patient specific household tasks, or how often to perform them. Clinical record review evidenced a comprehensive assessment (start of care) dated 1/12/2023. The document evidenced the patient was incontinent of bowel and bladder. The plan of care failed to evidence HHA orders for incontinence care. During an interview on 2/14/2023 at 3:30 PM, the Clinical Manager stated, "... It’s not a skilled patient, so the plan of care is generic for all of them ... The patients tell them [aides] what they need ...." 3. Clinical record review for Patient #2 was completed on 2/14/2023. Record review evidenced a plan of care for certification period 1/13/2023 – 3/13/2023. The document evidenced the patient received HHA services. The document stated, "... Aide: Monitor patient at all times ... encourage use of assistive devices whenever possible ... ensure well-lit, clutter free walkway such as keeping cords secure ... removing throw rugs ... assist/prepare daily meals and set up ... assist with feeding whenever possible ... assist with bathing, dressing, personal care such as grooming, hair care, shampoo, oral care ... assist patient with light housekeeping ... such as ... vacuuming, changing bedding/linens, dishes, wiping down of surfaces, laundry, etc. ...." The plan of care/Aide care plan failed to evidence patient specific instructions/tasks for how often or what the HHA was to monitor for; what assistive devices or when the HHA should encourage the patient to use them; which meals to prepare, how often, or what type of assistance was needed; patient specific personal care tasks, or how often to provide them; or patient specific household tasks, or how often to perform them. Clinical record review evidenced a comprehensive reassessment (recertification of services) dated 1/04/2023. The document evidenced the patient was dependent for toileting needs (ability to maintain personal hygiene, adjust clothes before and after using the toilet), and use of a shower chair to prevent falls. The plan of care/Aide care plan failed to evidence patient specific instructions/tasks for provision of toileting needs, or use of a shower chair during personal care. During an interview on 2/14/2023 at 2:04 PM, the Clinical Manager indicated the patient's plan of care and the Aide Care Plan were the same thing (one document). During an interview on 2/14/2023 at 3:20 PM, the Clinical Manager stated, "... like I said, all plans of care are the same because it’s just ADLs [activities of daily living] ...." 4. Clinical record review for Patient #3 was completed on 2/14/2023. Record review evidenced a plan of care for certification period 2/07/2023 – 4/07/2023. The document evidenced the patient received HHA services. The document stated, "... Home Health Aide Care Plan: ... Patient recently diagnoses with disorientation ... Redirect client [patient] appropriately such as bathroom door, kitchen entrance, food choices, etc. ... constantly remind patient to slowly rise from chair/bed to minimize fall risk ... encourage use of assistive device, whenever possible ... ensure well-lit, clutter free walkway such as keeping cords secure ... removing throw rugs ... assist/prepare daily meals and assist with set up ... assist with bathing, dressing, personal care such as grooming, hair care, shampoo, oral care ... assist patient with light housekeeping ... such as ... vacuuming, changing bedding/linens, dishes, wiping down of surfaces, laundry, etc. ... [patient] is on 1500 cc [cubic centimeters] fluid restriction ... [patient] self-monitors ...." The plan of care/Aide care plan failed to evidence patient specific instructions/tasks for when it was appropriate for the HHA to redirect the patient; if the patient needed contact assistance or an assistive device when transferring from sitting to standing; what assistive device or when the HHA should encourage the patient to use it; which meals to prepare, how often, or what type of assistance was needed; patient specific personal care tasks, or how often to provide them; patient specific household tasks, or how often to perform them; or HHA to monitor fluid intake due to recent diagnosis of disorientation. Clinical record review evidenced a comprehensive reassessment (recertification of services) dated 2/02/2023. The document evidenced the patient lived alone, had tooth or mouth problems that made it hard to eat, ate fewer than 2 meals per day, ate few fruits, vegetables, or milk products, ate alone most of the time, and was a high nutritional risk. The plan of care/Aide care plan evidenced HHA provided services for 4 hours on Mondays, 8 hours on Tuesdays/Thursdays, and 6 hours on Wednesdays/Fridays; but failed to evidence patient specific instructions/tasks to encourage the patient to increase nutritional intake, encourage a well balanced diet to include fruits, vegetables and dairy products, or if the patient required a mechanically altered diet (chopped, pureed) due to tooth or mouth problems that made it hard to eat. During an interview on 2/14/2023 at 3:35 PM, the Clinical Manager indicated the plan of care/Aide care plan was not patient specific. 5. Clinical record review for Patient #4 was completed on 2/14/2023. Record review evidenced a plan of care for certification period 2/07/2023 – 4/07/2023. The document evidenced the patient received HHA services. The document stated, "... Home Health Aide Care Plan: ... Encourage [patient] to participate in his care at all times ... encourage use of assistive device, whenever possible ... ensure well-lit, clutter free walkway such as keeping cords secure ... removing throw rugs ... assist/prepare daily meals and set up ... assist with bathing, dressing, personal care such as grooming, hair care, shampoo, oral care ... assist patient with light housekeeping ... such as ... vacuuming, changing bedding/linens, dishes, wiping down of surfaces, laundry, etc. ...." The plan of care/Aide care plan failed to evidence patient specific instructions/tasks for what specific care the HHA was to encourage the patient to participate; what assistive device or when the HHA should encourage the patient to use it; which meals to prepare, how often, or what type of assistance was needed; patient specific personal care tasks, or how often to provide them; or patient specific household tasks, or how often to perform them. Clinical record review evidenced a comprehensive reassessment (recertification of services) dated 2/06/2023. The document evidenced the patient lived alone, ate fewer than 2 meals per day, ate few fruits, vegetables, or milk products, ate alone most of the time, and was a high nutritional risk. The plan of care/Aide care plan evidenced HHA provided services for 3 hours per day, 5 days per week; but failed to evidence patient specific instructions/tasks to encourage the patient to increase nutritional intake, or encourage a well balanced diet to include fruits, vegetables and dairy products. During an interview on 2/14/2023 at 2:44 PM, the Clinical Manager indicated all the patients' plans of care looked the same because all the patients wanted basic ADL’s (activities of daily living). The Clinical Manager confirmed "such as" meant it was an example, not an actual order specific to the patient. When queried if each patient's plan of care included patient-specific interventions, the Clinical Manager stated, "... Probably not ....", and indicated the plans of care were generic because they were all HHA only patients.

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: 9/13/2022, 9/14/2022, 9/15/2022, 9/16/2022, 9/19/2022, and 9/20/2022. Facility ID: 012812

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 observation, record review, and interview, the home health agency failed to: ensure the emergency preparedness plan included an all-hazards, community-based risk assessment, and/or strategies for addressing emergency events identified by the risk assessment (see tag E0006); ensure the emergency preparedness plan included a process for cooperation and collaboration with regional, state, and/or federal emergency preparedness officials’ efforts to maintain an integrated response during an emergency (see tag E0009); ensure patients had individual emergency preparedness plans as a part of the comprehensive assessment (see tag E0017); ensure the emergency preparedness policies and procedures included procedures to inform state and/or local officials of on duty staff or patients they were unable to contact (see tag E0021); ensure the emergency preparedness communication plan was updated at least every 2 years (see tag E0029); ensure the emergency preparedness communication plan included names and contact information for staff and patients’ physicians (see tag E0030); ensure the emergency preparedness communication plan which included contact information for federal, state, regional and local emergency preparedness staff (see tag E0031); ensure the emergency preparedness communication plan included a primary and alternate means of communicating with federal, state, regional, and local emergency management agencies and facility staff (see tag E0032); provide and maintain documentation of emergency preparedness training at least every 2 years (see tag E0037); and conduct any exercises to test the emergency plan annually (see tag E0039). 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 resulted in the agency being found out of compliance with the condition 42 CFR 484.102 Emergency preparedness.

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 ensure the emergency preparedness plan included an all-hazards, community-based risk assessment, and/or strategies for addressing emergency events identified by the risk assessment. The findings include: Review of the agency’s emergency preparedness plan on 9/16/2022, evidenced an undated document obtained 9/15/2022, titled “The Home Health Agency Emergency Preparedness Plan” which stated, “… The home health agency preparedness plan is detailed, all hazard, plan designed to guide for agencies when developing their emergency preparedness policies and procedures … This plan uses the term ‘all hazard’ to address all types of incidents … Examples of incidents include: … Fire … Weather related emergencies … Hazardous materials accidents … Power outages … Transit and worker strikes … Natural disasters … Terrorist/WMD events … Incidents of naturally occurring disease outbreak … Planned Public Events ….” Review of the agency’s emergency preparedness plan on 9/16/2022, evidenced an agency document updated 9/3/2020, titled “Staffing Strategy/Use of Volunteers Emergency Planning Policy” which stated, “… This policy includes disasters such as … hurricane … earthquake, wildfire, erosion ….” Review of the emergency preparedness plan on 9/16/2022, failed to include strategies to address the events identified in the risk assessment such as fire, hazardous materials accidents, power outages, transit and worker strikes, terrorist events, disease outbreak, and planned public events. During an interview on 9/16/2022, at 11:04 AM, administrator #1 indicated the biggest risks based on the community the agency served would be COVID-19 and monkey pox. Clinical manager #2 indicated the agency usually saw storms and blizzards. Administrator #1 indicated hurricanes were included in the plan because a hurricane could happen, even if a hurricane hasn’t happened in the past. Administrator #1 indicated the emergency plan included all the possibilities.

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 ensure the emergency preparedness plan included a process for cooperation and collaboration with regional, state, and/or federal emergency preparedness officials’ efforts to maintain an integrated response during an emergency. The findings include: Review on 9/16/2022, of the emergency preparedness plan evidenced a document revised 9/3/2020, titled “Staffing Strategy/Use of Volunteers Emergency Planning Policy” which stated, “… 1st Option Adult Day Services will partner/contact with local or state emergency management agencies to find out what is happening, request for specific help or rescue, and keep updated as the situation unfolds … Local emergency management agencies to collaborate with includes EMS [emergency medical services], Fire, police, local and state health departments, hospitals and other home health agencies ….” The emergency preparedness plan failed to include the process for collaboration with regional and federal emergency preparedness officials. During an interview on 9/16/2022, at 11:07 AM, administrator #1 stated, “… We deal with local emergency management agencies, not directly with federal or state ….”

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 observation, record review, and interview, the home health agency failed to ensure patients had individual emergency preparedness plans as a part of the comprehensive assessment in 2 of 3 home visits conducted. (#1, 2) The findings include: 1. Observation of a home visit for patient #1 was conducted on 9/14/2022, at 8:00 AM, to observe a routine home health aide visit. During the visit, a home folder was reviewed, which contained an individual emergency preparedness plan. This plan failed to include an evacuation location or emergency classification level. Patient #1’s emergency contact was person #4, who was deceased according to patient #1. During an interview on 9/16/2022, at 11:09 AM, clinical manager #2 indicated the individual emergency preparedness plans do not include evacuation locations. Administrator #1 indicated the agency instructed patients to go anywhere safe in case of emergency but did not designate specific areas. Clinical manager #2 indicated patient #1’s emergency contact had not been updated with a new emergency contact yet. 2. Observation of a home visit for patient #2 was conducted on 9/14/2022, at 12:30 PM, to observe a routine home health aide visit. During the visit, a home folder was reviewed, which contained an individual emergency preparedness plan. This plan failed to include an evacuation location. During an interview on 9/16/2022, at 11:12 AM, clinical manager #2 indicated evacuation locations were not discussed with the patients as part of their emergency plans. Administrator #1 indicated the patients should just go outside or somewhere safe and then call for help.

HHA- Procedures for Follow up Staff/Pts. CFR(s): 484.102(b)(3) §484.102(b)(3) Condition of 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:] (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure the emergency preparedness policies and procedures included procedures to inform state and/or local officials of on duty staff or patients they were unable to contact. The findings include: Record review evidenced an undated agency policy obtained 9/15/2022, titled “Emergency Preparedness Policy” which stated, “… The Red Cross and local authorities will be notified by the Director of high-risk clients … Upon arrival, every 5 minutes, secretary will try those employees not found with the first call attempt and notify the disaster supervisors of any other employees available to be on standby ….” The emergency preparedness policies and procedures failed to include notification of local and state officials of staff who they are unable to contact, and failed to include notification of state officials for patients who they are unable to contact. During an interview on 9/16/2022, at 11:07 AM, administrator #1 stated, “… We deal with local emergency management agencies, not directly with federal or state ….” At 11:16 AM, clinical manager #2 stated, “… if I can’t get the employees, I will call the emergency contact, and if I still can’t get ahold of them, I would go to their house, and check and if I’m not able to reach them, I would call the police ….”

Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (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]. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness communication plan was updated at least every 2 years. The findings include: Review on 9/16/2022, of the emergency preparedness communication plan evidenced an undated patient call list and an undated employee call list, which included 7 employees who were no longer employed by the agency and failed to include 6 home health aides who were currently employed. The patient call list failed to include 10 of 13 active patients on the communication call list. During an interview on 9/16/2022, at 11:25 AM, administrator #1 indicated the communication plan had not been updated since the beginning of 2020.

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 and interview, the home health agency failed to ensure the emergency preparedness communication plan included names and contact information for staff and patients’ physicians. The findings include: Review on 9/16/2022, of the agency’s emergency preparedness communication plan evidenced an undated employee call list, which included 7 employees who were no longer employed by the agency and failed to include 6 home health aides who were currently employed. The communication plan failed to include names and contact information for patients’ physicians. During an interview on 9/16/2022, at 11:25 AM, administrator #1 indicated the call list did not include all active employees because it had not been updated since the beginning of 2020. Administrator #1 indicated the call list did not include physician’s names or contact information.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(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: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness communication plan which included contact information for federal, state, regional and local emergency preparedness staff. The findings include: Review on 9/16/2022 of the emergency preparedness communication plan failed to evidence any contact information for local, federal, state, or regional emergency preparedness staff. During an interview on 9/16/2022, at 11:20 AM, clinical manager #2 stated, “… I would call 911 … I don’t have other numbers … I would call 911 and they would direct us ….”

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 ensure the emergency preparedness communication plan included a primary and alternate means of communicating with federal, state, regional, and local emergency management agencies and facility staff. The findings include: Review on 9/16/2022 of the emergency preparedness communication plan failed to evidence any contact information for local, federal, state, or regional emergency preparedness staff. Review of the agency’s emergency preparedness communication plan evidenced an undated employee call list, which failed to include 6 home health aides who were currently employed and any primary or alternate means of communication with them. During an interview on 9/16/2022, at 11:20 AM, clinical manager #2 stated, “… I would call 911 … I don’t have other numbers … I would call 911 and they would direct us ….” Administrator #1 indicated the communication plan had not been updated, so it didn’t include 6 of the home health aides.

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 interview, the agency failed to provide and maintain documentation of emergency preparedness training at least every 2 years. The findings include: Record review evidenced an undated agency policy obtained 9/15/2022, titled “Emergency Preparedness Policy” which stated, “… All staff members will be oriented to the emergency preparedness plan and their associated responsibilities … Reviews will be held at least annually ….” Record review on 9/15/2022, evidenced an employee in-service dated 11/23/2021, but failed to evidence documentation that emergency preparedness training was completed at this in-service. Review failed to evidence any additional employee emergency preparedness training. During an interview on 9/15/2022, at 3:07 PM, administrator #1 indicated emergency preparedness training was completed at every in-service, at least yearly. Administrator #1 indicated this would be documented on the in-service sheet.

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 agency failed to conduct any exercises to test the emergency plan annually. The findings include: Record review evidenced an undated agency policy obtained 9/15/2022, titled “Emergency Preparedness Policy” which stated, “… Agency staff members will participate in an annual desktop drill to determine the effectiveness and efficiency of the current plan and any forms developed for use in disaster ….” Record review on 9/16/2022, of the agency’s emergency preparedness plan, failed to evidence any testing exercises were completed. During an interview on 9/16/2022, at 3:45 PM, administrator #1 indicated the only drills or testing of an emergency preparedness plan the agency participated in, was for the office building they resided in. Administrator #1 indicated no testing was documented or completed for the agency specific emergency preparedness plan. Administrator #1 indicated the agency could not participate in a drill for emergencies which had not yet happened.

This visit was for a Federal Recertification and State Re-licensure survey. Facility ID: 012812 Survey Dates: 9/13/2022, 9/14/2022, 9/15/2022, 9/16/2022, 9/19/2022, and 9/20/2022. Census: 13 1st Option Adult Day Services and Home Health INC., is precluded from providing its own home health aide training and competency evaluation for a period of two years from 9/20/2022 – 09/19/2024, due to being found out of compliance with Conditions of Participation: 42 CFR 484.102 Emergency preparedness, 42 CFR 484.55 Comprehensive assessment of patients, 42 CFR 484.60 Care Planning, Coordination of Care and Quality of Care, 42 CFR 484.65 Quality Assessment and Performance Improvement, 42 CFR 484.80 Home health aide services, and 42 CFR 484.105 Organization and administration of services. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Quality Review Completed 10/05/2022

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to provide patients with contact information for the administrator, including name, address, and/or phone number in 3 of 3 home visits conducted. (#1, 2, 3) The findings include: 1. Record review on 9/13/2022, evidenced a home folder which contained an undated document titled “Client Bill of Rights and Responsibilities” which stated, “… Clients of 1st Option Home Health have the right to: … Receive complete written information on the plan of care, including the name of the home aide and supervisor responsible for the services and the agency phone number …..” 2. Observation of a home visit for patient #1 was conducted on 9/14/2022, at 8:00 AM, to observe a routine home health aide visit. During the visit, a home health folder was reviewed, which failed to include the administrator’s name. During an interview on 9/19/2022, at 1:41 PM, clinical manager #2 indicated patients should have the administrator’s name and phone number in their home folder. 3. Observation of a home visit for patient #2 was conducted on 9/14/2022, at 12:30 PM, to observe a routine home health aide visit. During the visit, a home health folder was reviewed, which failed to include the administrator’s name. 4. Observation of a home visit for patient #3 was conducted on 9/19/2022, at 9:00 AM, to observe a routine skilled nurse visit. During the visit, a home health folder was reviewed, which failed to include the administrator’s name.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure patients were informed about the completion of all assessment and the care to be furnished in 1 of 3 home visits conducted. (#2) The findings include: Record review evidenced an undated agency policy obtained 9/20/2022, titled “Service Agreement” which stated, “… The client has the right to be informed, in advance, about the care to be furnished and of anticipated changes in the care to be furnished ….” Clinical record review for patient #2 was completed on 9/19/2022. Record review evidenced a plan of care for certification period 8/15/2022 – 10/13/2022, which indicated the patient was to receive home health aide services 6 hours per day/5 days per week. Record review evidenced a comprehensive assessment dated 8/15/2022, which indicated the start of care date was 8/15/2022. Record review indicated the patient failed to receive any home health aide services until 9/6/2022 (21 days after start of care). Record review failed to evidence any patient or physician communication regarding delay in services. During an interview on 9/14/2022, at 12:35 PM, patient #1 indicated the home health aide services had just started recently. He did not know why he hadn’t received home health aide services beginning 8/15/2022. He indicated he thought it was because the home health agency was waiting on the physician for something. During an interview on 9/19/2022, at 2:33 PM, clinical manager #2 indicated patient #2 did not receive any home health aide visits for 3 weeks following the start of care because the agency was waiting for insurance approval. 410 IAC 17-12-3(b)(2)(D)(ii)(BB)

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to document complaints and the resolution of complaints. The findings include: Record review evidenced an undated agency policy obtained 9/20/2022, titled “Home Care Bill of Rights/Grievance Procedure” which stated, “… If a complaint regarding services provided is received by an agency staff professional providing care, the complaint will be documented and communicated to the Director/Clinical Supervisor. The Director of Nursing/Designee will contact the client, caregiver, and/or interested parties, and attempt to reconcile the situation … The complaint shall be documented on the Client Grievance/Complaint Form ….” Review of a complaint log on 9/14/2022, failed to evidence documentation of any complaints. Personnel record review on 9/15/2022, evidenced a personnel file for home health aide #3. This personnel file contained an incident report dated 8/17/2022, which stated, “… home health aide #3 took it upon herself to wash her underwear while at work, and dry them with the box fan that was in [patient #8’s] household … [person #1/patient #8’s power of attorney] felt it was inappropriate to do so inside of their home. So, she requested for [home health aide #3] to leave and not return to their home ….” This complaint failed to be documented in the complaint log. During an interview on 9/13/2022, at 11:58 AM, clinical manager #2 stated, “… since COVID, we haven’t had any severe complaints which need to be documented … person #4 [patient care coordinator/non-clinical] handles complaints with scheduling like the aide running late … we just fix it ….” During an interview on 9/20/2022, at 11:45 PM, clinical manager #2 indicated the complaint log was blank, because the agency had not received any complaints. Clinical manager #2 indicated most of the issues were patients who called the agency if the home health aide was running late, or not at the visit at the expected time. Clinical manager #2 indicated these patient calls were not documented in the complaint log because they were resolved with the patient during the call. Clinical manager #2 indicated these were not considered complaints. Clinical manager #2 indicated they considered it a complaint if the home health aide did not show up for a visit, or the patient did not want an aide to come back to their home. Clinical manager #2 indicated the incident involving patient #8 and home health aide #3 was not documented in the complaint log because an incident report was completed instead. 410 IAC 17-2-3(c)(2)

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to: ensure the initial assessment visit was held within 48 hours of referral, the patient’s return home, or on the physician ordered start of care date (see tag G514); ensure the comprehensive assessment accurately reflected the patient’s status (see tag G526); ensure the comprehensive assessments included the patient’s current health, psychosocial, functional, and/or cognitive status (see tag G528); and complete a review of all medications the patient was currently using in order to identify potential drug interactions, duplicative drug therapy, and/or noncompliance with drug therapy (see tag G536). 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 resulted in the agency being found out of compliance with the condition of participation: 42 CFR 484.55 Comprehensive assessment of patients. A standard citation was also evidenced at this level as follows: Based on record review and interview, the home health agency failed to ensure comprehensive assessments were updated, and assessment visits were made to the patient's home to assess the patient in 5 of 7 clinical records reviewed. (1, 4, 5, 6, 7) The findings include: 1.Record review evidenced an undated agency policy obtained 9/20/2022, titled "Comprehensive Client Assessment" which stated, "... In addition to general health status/system assessment, the agency comprehensive assessment assessment tool with OASIS will include: ... respiratory status ... sensory status ... integumentary status ... medications ... nutritional status ... functional status ... Assessment and doucmentation are made regarding whether the home environment is suitable for providing home care ...." 2. Record review evidenced an undated agency policy obtained 9/20/2022, titled "Client Reassessment/Update of Comprehensive Assessment" which stated, "... Clients are reassessed to determine their response to care ... Each professional discipline will be responsible for reassessing care/services at lease every 56-60 days ... the initial and ongoing assessments inclcue consideration of the following: ... Description of any appliclable strength the client has including physican, psychosocial, and or spiritual ... Condition of the home and surrounding environment ...." 3. Clinical record review for patient #1 was completed on 9/19/2022, for certification period 8/13/2022 - 10/11/2022. Record review evidenced a comprehensive recertification assessment dated 8/8/2022, which failed to be signed by patient #1. Record review failed to evidence the recertification visit was completed in person. During an interview on 9/14/2022, at 8:00 AM, patient #1 indicated the home health nurse came to do an assessment visit about every 4 months. During an interview on 9/19/2022, at 2:03 PM, clinical manager #2 indicated the home health agency verified visits were made by obtaining the patient's signature every visit. Clinical manager #2 indicated sometimes patients wouldn't let her in to do comprehensive assessments, so she would complete the comprehensive assessment over the phone. Clinical manager #2 indicated re-assessment visits should have been made every 60 days in the patient's home. 4. Clinical record review for patient #4 was completed on 9/19/2022, for certification period 9/11/2022 - 11/9/2022. Record review evidenced a recertification comprehensive assessment dated 9/6/2022, which failed to include the patient's signature. Record review failed to evidence the assessment visit was conducted in the patient's home. 5. Clinical record review for patient #5 was completed on 9/19/2022, for certification period 7/28/2022 - 9/25/2022. Record review evidenced a recertification comprehensive assessment dated 7/25/2022, which failed to include vital signs, documentation of a wound assessment for patient's pressure ulcer, or a patient signature. Record review failed to evidence the assessment visit was conducted in person in the patient's home. During an interview on 9/19/2022, at 3:53 PM, clinical manager #2 indicated she was unsure of the location of the wound because she did not assess it during the visit. Clinical manager #2 indicated no vital signs were completed during the comprehensive assessment due to patient shaking. 6. Clinical record review for patient #6 was completed on 9/20/2022, for certification period 2/15/2022 - 4/15/2022. Record review evidenced a recertification comprehensive assessment dated 2/10/2022, which failed to include a wound assessment for patient's wound, vitals, or a patient signature. Record review failed to evidence this comprehensive assessment visit was conducted in person at the patient's home. During an interview on 9/20/2022, at 10:50 AM, clinical manager #2 indicated the wound was not assessed during the assessment. Clinical manager #2 indicated vital signs were not completed during the assessment visit maybe because the patient refused. 7. Clinical record review for patient #7 was completed on 9/20/2022, for certification period 7/6/2022 - 9/3/2022. Record review evidenced a recertification comprehensive assessment dated 7/1/2022, which failed to include the patient's signature. During an interview on 9/20/2022, at 11:00 AM, clinical manager #2 indicated the recertification comprehensive assessment for patient #7 was completed over the phone since the patient was not home when she arrived for the visit.

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 home health agency failed to ensure the initial assessment visit was held within 48 hours of referral, upon the patient’s return home, or on the physician ordered start of care date in 1 of 3 home visits conducted. (#2) The findings include: Record review evidenced an undated agency policy obtained 9/20/2022, titled “Client Admission Process” which stated, “… Upon referral, each client shall be evaluated by a Registered Nurse/Therapist to determine the immediate care and support needs of the client; … The initial assessment visit will be completed within 48 hours of referral or within 48 hours of the client’s return home, or on the physician ordered start of care date ….” Clinical record review for patient #2 was completed on 9/19/2022, for certification period 8/15/2022 – 10/13/2022. Record review evidenced a referral order dated 8/10/2022 which indicated the patient required home health aide services. Record review evidenced an initial assessment visit was conducted on 8/15/2022 (5 days after referral). Record review failed to evidence the physician had ordered a start of care date of 8/15/2022. During an interview on 9/14/2022, at 12:40 PM, patient #2 indicated he didn't receive home health services immediately because the agency indicated they were waiting for the doctor. During an interview on 9/19/2022, at 2:30 PM, clinical manager #2 indicated the agency based the initial assessment visit timeline on patients’ requests. Clinical manager #2 indicated the agency completed the initial assessment visit after speaking with the patient to see when the visit could be made. 410 IAC 17-14-1(a)(1)(A)

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the comprehensive assessment accurately reflected the patient’s status in 4 of 5 active clinical records reviewed. (#1, 3, 4, 5) The findings include: 1. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Comprehensive Client Assessment” which stated, “… Purpose: … To accurately reflect the current health status of the client and need for home care services ….” 2. Observation of a home visit for patient #1 was conducted on 9/14/2022, at 8:00 AM, to observe a routine home health aide visit. During the visit, the patient was observed to be alert and oriented, and was not wearing any oxygen. Patient #1 indicated he hadn’t worn oxygen since he got out of the hospital for colitis (inflammation of the bowels). Clinical record review for patient #1 was completed on 9/19/2022, for certification period 8/13/2022 – 10/11/2022. Record review evidenced a recertification assessment dated 8/8/2022, which indicated the patient wore oxygen at 3 liters per minute through a nasal cannula continuously. During an interview on 9/19/2022, at 11:45 AM, clinical manager #2 indicated they did not know the patient was not wearing oxygen and they only knew what the patient told them during the assessment. 3. Observation of a home visit for patient #3 was conducted on 9/20/2022, at 9:00 AM, to observe a routine skilled nurse visit. During the visit, the patient was observed not wearing oxygen. The patient indicated she wore 2 liters of oxygen via a nasal cannula, as needed. Clinical record review for patient #3 was completed on 9/20/2022, for certification period 8/18/2022 – 10/16/2022. Record review evidenced a comprehensive assessment dated 8/15/2022, which indicated the patient did not wear oxygen. During an interview on 9/20/2022, at 2:55 PM, clinical manager #2 indicated the patient had been non-compliant with oxygen use, and only wore it sometimes. Clinical manager #2 indicated the assessment should have included oxygen use. 4. Clinical record review for patient #4 was completed on 9/20/2022, for certification period 9/11/2022 – 11/9/2022. Record review evidenced a comprehensive assessment dated 9/6/2022, which indicated the patient had 2 pressure wounds, the patient had no pressure wounds, and the patient had a healing wound to the left lower extremity, being treated by home health agency #7. This document indicated the patient had a foley catheter (tube inserted into the urethra to drain urine from the bladder). This document failed to include any wound assessment, or frequency of dressing changes. This document failed to include a site assessment of foley catheter, or care instructions, including date changed. Clinical record review evidenced a plan of care from home health agency #7, for certification period 8/29/2022 – 10/27/2022, which was faxed to surveyor on 9/20/2022. This document indicated the patient had the following 3 wounds: right top of foot (diabetic wound), right great toe (pressure wound), and sacral wound (pressure wound). This document indicated home health agency #7 was providing wound care 3 times per week to these wounds. The plan of care from home health agency #7 indicated the patient had a suprapubic catheter (tube inserted through the skin into the bladder to drain urine), which was changed monthly by the skilled nurse. During an interview on 9/19/2022, at 3:38 PM, clinical manager #2 indicated patient #4 previously had wounds, but they were all healed, but she left them on the comprehensive assessment in case they opened again. Clinical manager #2 did not know when patient #4’s catheter was last changed. Clinical manager #2 did not know any wound care was being performed by home health agency #7. Clinical manager #2 indicated the comprehensive assessment should include an accurate wound assessment, and assessment of catheter site. Clinical manager #2 did not know why the comprehensive assessment indicated foley catheter if the patient had a suprapubic catheter. 5. Clinical record review for patient #5 was completed on 9/19/2022, for certification period 7/28/2022 – 9/25/2022. Record review evidenced a comprehensive assessment dated 7/25/2022, which indicated the patient had no wounds, and indicated the patient had a pressure wound, but failed to specify any additional information. This document indicated the patient was NPO (nothing by mouth) and also indicated the patient was on a cardiac, renal, diabetic diet. During an interview on 9/19/2022, at 3:53 PM, clinical manager #2 indicated the patient had a wound, but was unsure of it’s location since it was not assessed on the comprehensive assessment. Clinical manager #2 indicated the patient had a jejunostomy (tube inserted through the skin into the small intestine to provide nutrition) tube, and was receiving tube feedings previously. Clinical manager #2 indicated she thought the caregiver had been educated on the administration of tube feedings, and maybe the patient was also eating regular food now. Clinical manager #2 was unsure of what diet the patient was on. Clinical manager #2 did not know why the comprehensive assessment indicated the patient had a wound and also did not have any wounds. 410 IAC 17-15-1(a)

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the comprehensive assessments included the patient’s current health, psychosocial, functional, and/or cognitive status in 5 of 5 active clinical records reviewed. (#1, 2, 3, 4, 5) The findings include: 1. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Comprehensive Client Assessment” which stated, “… In addition to a general health status/system assessment, the agency comprehensive assessment tool with OASIS will include: … Demographics and client history … Sensory status … Respiratory status … Equipment management ….” 2. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Pain Assessment/Management” which stated, “… All clients admitted to the Agency will receive a comprehensive assessment that includes identification of pain and its impact on function as well as the treatment and efficacy of treatment … The assessment includes a measure of pain intensity and quality [character, frequency, location, and duration] …. The nurse/therapist will use a standardized agency accepted pain assessment tool that evaluates the location, duration, severity [rating scale], alleviating factors, exacerbating factors, current treatment and response to treatment ….” 3. Observation of a home visit for patient #1 was conducted on 9/14/2022, at 8:00 AM, to observe a routine home health aide visit. During the visit, the patient was observed to be alert and oriented. Patient #1 indicated he wore a CPAP machine (machine which provides air through a mask, while sleeping) nightly. Patient #1 indicated he was hospitalized for colitis (inflammation of colon) a while ago but could not remember exactly when. Patient #1 also indicated he had a pacemaker placed due to a very low heart rate. Patient #1 indicated he used pain medication for pain in his back. Clinical record review for patient #1 was completed on 9/19/2022, for certification period 8/13/2022 – 10/11/2022. Record review evidenced a recertification assessment dated 8/8/2022, which failed to include information regarding the patient wearing a CPAP machine nightly, history of colitis, or pacemaker. This document indicated the patient was taking pain medication 2 – 3 times per day, and experienced pain on a daily basis, but failed to include a full pain assessment, including location, severity rating, or descriptors of pain. During an interview on 9/19/2022, at 2:23 PM, clinical manager #2 indicated a complete pain assessment should have included location, rating, and quality of pain. Clinical manager #2 indicated the CPAP should have been included in the assessment. Clinical manager #2 indicated they had no way of knowing any other medical history unless the patient told them about it. 4. Clinical record review for patient #2 was completed on 9/19/2022, for certification period 8/15/2022 – 10/13/2022. Record review evidenced a comprehensive assessment dated 8/15/2022, which indicated patient used breakthrough pain medication 2 – 3 times per day but failed to include an assessment of pain including rating, location, or quality. 5. Clinical record review for patient #3 was completed on 9/20/2022, for certification period 8/18/2022 – 10/16/2022. Record review evidenced a comprehensive assessment dated 8/15/2022, which indicated the patient utilized pain medication, but failed to include an assessment of pain including rating, location, frequency, and quality. The assessment indicated the patient had edema (swelling), but failed to include location of swelling or any other assessment. During an interview on 9/20/2022, at 2:55 PM, clinical manager #2 indicated the comprehensive assessment should have included the location of edema and how much edema the patient had. 6. Clinical record review for patient #4 was completed on 9/20/2022, for certification period 9/11/2022 – 11/9/2022. Record review evidenced a comprehensive assessment dated 9/6/2022, which indicated the patient had 2 wounds, but failed to include a wound assessment, including location, measurements, drainage, or other characteristics. This document indicated the patient had a foley catheter (tube inserted into the urethra to drain urine from the bladder) but failed to include an assessment of the catheter site. This document indicated the patient had pain but failed to include any assessment of pain including location, duration, intensity, or quality. Clinical record review evidenced a plan of care for certification period 8/29/2022 – 10/27/2022, from home health agency #7, which was faxed to surveyor on 9/20/2022. This document included the following diagnoses and medical history, which were not included in the comprehensive assessment: diabetes (problem regulating blood sugar) with foot ulcer (wound to foot), and the following diagnoses, non-pressure ulcer of right foot, pressure ulcer of sacral region, pressure ulcer of other site, urethral stricture (narrowing of urethra), hypertensive heart disease (high blood pressure causing heart disease), heart failure, chronic kidney disease, and chronic obstructive pulmonary disease (lung disease which makes it increasingly difficult to breathe). During an interview on 9/19/2022, at 3:59 PM, clinical manager #2 indicated the comprehensive assessment wound assessment should include location, measurements, site assessment, and drainage. Clinical manager #2 indicated the comprehensive catheter assessment should have included if there was any redness or signs of infection. Clinical manager #2 indicated the only diagnoses included in the comprehensive assessment, are the diagnoses the patient tells her about. 7. Clinical record review for patient #5 was completed on 9/19/2022. Record review evidenced a plan of care for certification period 7/28/2022 – 9/25/2022, which indicated the patient was a dialysis (artificial kidney filtration) patient, and had a fistula. Record review evidenced a comprehensive assessment dated 7/25/2022, which indicated the patient had pain, but failed to include a complete assessment of pain including rating, location, severity, frequency, or quality. This document indicated the patient had a stage 2 (pressure wound rating characterized by loss of the surface of skin) pressure wound, but failed to include a full assessment including, location, measurements, appearance, drainage, or odor. This document failed to include the patient’s jejunostomy (tube inserted through the skin into the small intestine for nutrition) assessment or tube feeding status. This document failed to include vital signs. This document failed to include an assessment of patient’s arteriovenous fistula (a connection made between a vein and an artery, to allow blood to be pulled out and pushed back into patient’s body during dialysis. Record review evidenced a plan of care for certification period 8/14/2022 – 10/12/2022, from home health agency #8, which was faxed to the surveyor on 9/21/2022. This document indicated the patient was receiving tube feedings through a jejunostomy tube. During an interview on 9/19/2022, at 3:53 PM, clinical manager #2 indicated she was unsure of the location of the wound because she did not assess it during the visit. Clinical manager #2 indicated the comprehensive assessment should include pain rating, location, and quality, and wound measurements and assessment. Clinical manager #2 indicated the patient had a jejunostomy tube, and the comprehensive assessment should have included a site assessment. Clinical manager #2 indicated maybe the patient was eating regular food now, but was unsure. Clinical manager #2 indicated no vital signs were completed during the comprehensive assessment due to patient shaking. Clinical manager #2 indicated the comprehensive assessment should have included an assessment of the patient’s fistula, its appearance, and blood flow. 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 observation, record review, and interview, the home health agency failed to complete a review of all medications the patient was currently using in order to identify potential drug interactions, duplicative drug therapy, and/or noncompliance with drug therapy in 4 of 5 active clinical records reviewed. (#1, 3, 4, 5) The findings include: 1. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Comprehensive Client Assessment” which stated, “… The comprehensive assessment will include a review of all medications the client is using. This assessment will identify potential adverse effects and drug reactions, including ineffective therapy, significant side effects, significant drug interactions, duplicative drug therapy, and non-compliance with therapy ….” 2. Observation of a home visit for patient #1 was conducted on 9/14/2022, at 8:00 AM, to observe a routine home health aide visit. During the visit, the patient’s medication bottles were reviewed. The following medication were observed which were not included in the patient’s home health medication list: mesalamine (anti-inflammatory to treat colitis), omeprazole (for stomach acid), duloxetine (anti-depressant), metoprolol (to control heart rate and blood pressure), buspirone (anti-anxiety), topiramate (anti-seizure), oxybutynin (for overactive bladder), atorvastatin (to lower cholesterol), and multivitamin. Sertraline (anti-depressant) and aspirin (to prevent blood clots and heart attack) were also observed. The home health aide indicated the patient was also taking klonopin (anti-anxiety) and Norco (pain medication), which was not on the patient’s medication list. Review on 9/20/2022, of the following web-based source, https://www.drugs.com/interactions-check.php, included 6 major drug interactions between the following medications observed in the patient’s home: sertraline and duloxetine – can cause seizures, dizziness, confusion, changes in blood pressure and heart rate; buspirone and duloxetine – can cause seizures, dizziness, confusion, changes in blood pressure and heart rate; buspirone and sertraline – can cause seizures, dizziness, confusion, changes in blood pressure and heart rate; oxybutynin and topiramate – can cause decreased sweating and increased body temperature; buspirone and Norco – can cause respiratory depression, coma, or death; and klonopin and Norco – can cause respiratory depression, coma, or death. This source also included the following 4 duplicative drug therapies: central nervous system medications – sertraline, Klonopin, duloxetine, buspirone and topiramate - the recommended maximum number of drugs in this category was 3; psychotropics – sertraline, Klonopin, duloxetine, and buspirone – recommended maximum number of drugs in this category was 3; antidepressants – sertraline and duloxetine – recommended maximum number of drugs in this category was 1; and tranquilizers – Klonopin and buspirone – recommended maximum number of drugs in this category was 1. Clinical record review for patient #1 was completed on 9/19/2022, for certification period 8/13/2022 – 10/11/2022. Review evidenced a comprehensive assessment dated 8/8/2022, which failed to evidence a medication review had been completed and drug interactions or duplicative drug therapy had been identified. Record review evidenced a medication profile dated 8/8/2022, which included the following medications the patient was not taking: acetaminophen-codeine (pain medication), isosorbide mononitrate (to prevent chest pain), cyclobenzaprine (muscle relaxant), Butalb-Acetaminophen-Caff-Codeine (to treat migraines), Flexeril (muscle relaxer), megestrol acetate (to increase appetite), nortriptyline (anti-depressant), prednisone (steroid), and questran light (to lower cholesterol). During an interview on 9/20/2022, at 2:12 PM, clinical manager #2 indicated the agency only knew what medications the patient was taking by what patients told them. Clinical manager #2 indicated the agency did not do anything with the patients’ medications unless the patient was receiving skilled nursing services. Clinical manager #2 indicated they did not review the patients’ medication bottles. Clinical manager #2 indicated the agency did not perform a medication review for drug interactions or duplicative drug therapy for patients receiving only home health aide services. 3. Observation of a home visit for patient #3 was conducted on 9/20/2022, at 9:00 AM, to observe a routine skilled nurse visit. During the visit the patient’s medications were reviewed. The observed medications included: baclofen (muscle relaxer), potassium chloride (supplement), gabapentin (for nerve pain), Reglan (for upset stomach or constipation), folic acid (supplement), oxycarbazapine (anti-seizure), magnesium (supplement), Keppra (anti-seizure), furosemide (to pull water off body), omeprazole (to decrease stomach acid), lacosamide (anti-seizure), iron (supplement), vitamin B12, aspirin (to prevent stroke or heart attack), Singulair (to help with breathing), Plavix (to prevent blood clots), clonazepam (anti-anxiety), Lipitor (to lower cholesterol), and ergocalciferol (vitamin D). Clinical record review for patient #3 was completed on 9/20/2022, for certification period 8/18/2022 – 10/16/2022. Record review evidenced a comprehensive assessment dated 8/15/2022, which failed to evidence a medication regimen review was completed. Record review evidenced a medication profile dated 8/15/2022, which included the following medications the patient was not taking: methenamine Hippurate (antibiotic), acetaminophen (for pain), mycophenolate mofetil (immunosuppressive), oxycodone (for pain), phenytoin (anti-seizure), Vimpat (anti-seizure), lactulose (for constipation), bumetanide (to pull water off the body), and sodium chloride (supplement). The medication profile failed to include the following medications the patient was taking: magnesium, iron, aspirin, and ergocalciferol. Review on 9/20/2022, of the following web-based source, https://www.drugs.com/interactions-check.php, included the following 3 categories of duplicative drug therapy: central nervous system drugs – Keppra, gabapentin, lacosamide, oxycarbazapine, and clonazepam – usually only 3 drugs in this category are prescribed; nutritionals – magnesium, potassium, folic acid, iron, vitamin B12, and ergocalciferol – usually only 3 drugs in this category are prescribed; and anticonvulsants – oxycarbazapine, Keppra, lacosamide, clonazepam, and gabapentin – usually only 3 drugs in this category are prescribed. During an interview on 9/20/2022, at 3:18 PM, clinical manager #2 indicated the medication list was not updated with all the patient’s medications. Clinical manager #2 indicated if drug duplication was identified, it would have been documented in the notes, and physician would have been notified. Clinical manager #2 indicated there was no duplicative drug therapy identified. 4. Clinical record review for patient #4 was completed on 9/20/2022, for certification period 9/11/2022 – 11/9/2022. Record review evidenced a comprehensive assessment dated 9/6/2022, which failed to evidence a drug regimen review had been completed. Record review failed to evidence the home health agency identified any drug-drug interactions or duplicative drug therapy. Review on 9/20/2022, of the following web-based source, https://www.drugs.com/interactions-check.php, included 2 major drug-drug interactions: aspirin (to prevent stroke and heart attack) and Xarelto (blood thinner), and Plavix (anti-platelet, to prevent blood clots) and Xarelto – both interactions increased risk for bleeding and potentially fatal hemorrhage. This source also included duplicative drug therapy between Plavix, aspirin, and Xarelto – increasing risk for bleeding. Record review evidenced a plan of care from home health agency #7, which was faxed to surveyor on 9/20/2022, for certification period 8/29/2022 – 10/27/2022. This document indicated home health agency #7 was providing skilled nursing to fill patient’s medication planner weekly. This document included the following 11 medication orders, which were not included in the home health agency’s medication list: Lexapro (anti-depressant), Floranex (probiotic), glipizide (to lower blood sugar), Lantus (insulin/to lower blood sugar) 40 units nightly, Rexulti (antipsychotic), trazodone (antipsychotic), calcium alginate (wound dressing), Nuedexta (to treat uncontrollable laughing or crying), Ramipril (to lower blood pressure), Tylenol (for pain or fever), and Gabapentin (for nerve pain) 300 milligrams three times daily. During an interview on 9/19/2022, at 2:12 PM, clinical manager #2 indicated no drug regimen review had been completed, because the agency was only providing home health aide services for patient #4. 5. Clinical record review for patient #5 was completed on 9/19/2022, for certification period 7/28/2022 – 9/25/2022. Record review evidenced a comprehensive assessment dated 7/25/2022, which failed to evidence a review of all medications the patient was taking was completed. Record review failed to evidence any drug-drug interactions or duplicative drug therapy was identified. Record review evidenced a medication list for certification period 7/28/2022 – 9/25/2022, which included duplications of the following medications: Allegra (allergy medicine), atorvastatin (to lower cholesterol), glyburide (to lower blood sugar), aspirin (to prevent stroke and heart attack), pantoprazole (to reduce stomach acid), clonidine (to lower blood pressure), acetaminophen (for pain or fever), metoprolol (to lower blood pressure), and quetiapine (antipsychotic). Review on 9/20/2022, of the following web-based source, https://www.drugs.com/interactions-check.php, included the following 3 major drug-drug interactions between medication on patient #5’s medication list: clonidine (to lower blood pressure) and metoprolol (to lower blood pressure and heart rate) – can cause slow heart beat, headaches, or dizziness; aspirin (to prevent stroke and heart attack) and Eliquis (blood thinner) – can cause bleeding or hemorrhage; and quetiapine (antipsychotic) and escitalopram (anti-anxiety) – can cause irregular heart beat which can be life threatening. Record review evidenced a plan of care from home health agency #8, for certification period 8/14/2022 – 10/12/2022, which was faxed to surveyor on 9/21/2022. This document included the following medications which were not include in the home health agency’s plan of care: clonazepam (anti-anxiety), and ferrous sulfate (iron supplement). This document indicated the following medications were discontinued, which were on patient #5’s medication list: glyburide, and midodrine. During an interview on 9/19/2022, at 3:50 PM, clinical manager #2 indicated a medication review was not completed for patient #5 because she was only receiving home health aide services. 410 IAC 17-14-1(a)(1)(B)

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 transfer/discharge summaries containing all necessary medical information pertaining the the current course of illness and treatment, post-discharge goals of care, and treatment preferences to the receiving facility or health care practitioner in 2 of 2 transfer records reviewed (#5, 6) and 1 of 2 discharged clinical records reviewed. (#7) The findings include: 1. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Client Transfer” which stated, “… A transfer summary shall be completed by the registered nurse/therapist. This summary will be based on data collected on the last visit and shall include documentation of services received, reason for transfer, the client’s physical and psychosocial status, current medications, continuing symptom management needs, instruction and referrals provided to the client, summary of care, any existing advance directives, and any relevant changes in caregiver support or lab results … The original transfer summary form shall be sent to the new provider or facility, and a copy shall be retained for the client’s chart ….” 2. Clinical record review for patient #5 was completed on 9/20/2022, for certification period 5/29/2022 – 7/27/2022, and 7/28/2022 – 9/25/2022. Record review indicated the patient was hospitalized and returned from the hospital on 6/15/2022. Record review failed to evidence a transfer summary was completed or sent to the hospital upon patient transfer. During an interview on 9/19/2022, at 3:52 PM, clinical manager #2 indicated the agency does not send transfer summaries, they instead call the doctor’s office and let them know the patient was in the hospital. 3. Clinical record review for patient #6 was completed on 9/20/2022, for certification period 2/15/2022 – 4/15/2022. Record review indicated the patient was transferred to the hospital on 3/7/2022. Review failed to evidence a transfer summary had been sent to the hospital. During an interview on 9/20/2022, at 10:35 AM, clinical manager #2 indicated she did not send transfer summaries, because she called the patient’s physician. Clinical manager #2 indicated the agency didn’t send transfer summaries to the hospital if the patient was admitted. 4. Clinical record review for patient #7 was completed on 9/20/2022, for certification period 7/6/2022 – 9/3/2022. Record review evidenced the patient was discharged on 8/29/2022, but failed to evidence a discharge summary was completed or sent to the patient’s physician. During an interview on 9/20/2022, at 10:55 AM, clinical manager #2 indicated she did not send a discharge summary for patient #7 because she called his physician.

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 patients received the home health services which were written in an individualized plan of care (see tag G572); ensure the plan of care included, all pertinent diagnoses, types of supplies and equipment required, nutritional requirements, all medications and treatments, patient and caregiver education and training, and/or measurable outcomes and goals (see tag G574); ensure services were provided, only as ordered by the physician (see tag G580); review and revise the plan of care (see tag G586); ensure the physician was promptly notified of any changes in patients’ condition which suggested goals were not being achieved (see tag G590); provide patients with written visit schedules (see tag G614); ensure patients received written medication schedule/instructions including medication name, dose and frequency of medications to be taken (see tag G616); provide patients with written instructions outlining treatments to be administered by home health personnel or personnel acting on behalf of the home health agency (see tag G618); and ensure patients received written name and contact information for the clinical manager (see tag G622). The cumulative effect of these systemic problems has resulted 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 Services, and Quality of Care.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure patients received the home health services which were written in an individualized plan of care in 5 of 5 active clinical records reviewed. (#1, 2, 3, 4, 5) The findings include: 1. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Plan of Treatment” which stated, “… The Plan of Care is based on a comprehensive assessment and information provided by the client/family and health team members … An individualized Plan of Care/485 signed by a physician shall be required for each client receiving home health and personal care services ….” 2. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Client Admission Process” which stated, “… Services will be initiated within 24 hours after the assessment, unless documentation supports alternate plan based on client needs and wishes and caregiver availability ….” 3. Clinical record review for patient #1 was completed on 9/19/2022. Record review evidenced a plan of care for certification period 8/13/2022 – 10/11/2022, which indicated the patient was to receive home health aide visits 3 days per week. Record review evidenced the patient only received 1 home health aide visit the week of 8/28/2022, and 2 home health aide visits the week of 9/4/2022. Review failed to evidence a missed visit note or documentation of why the visits were not completed. The plan of care included the following goals: able to understand medication regime and care related to diagnosis, medical condition stabilizes, when maximum functional potential reached, discharge at the end of the episode if the patient was hospitalized. During an interview on 9/19/2022, at 1:46 PM, clinical manager #2 indicated she did not know why patient #1 did not receive 3 home health aide visits the weeks of 8/28/2022 and 9/4/2022. Clinical manager #2 indicated the patient would have to call the agency and request a missed visit be rescheduled if a visit was missed. Clinical manager #2 did not know why the reason the visit was missed was not documented. At 2:39 PM, clinical manager #2 indicated the goals were the exact same on every patients’ plan of care because it was a generic template used when completing the plan of care. 4. Clinical record review for patient #2 was completed on 9/19/2022. Record review evidenced a plan of care for certification period 8/15/2022 – 10/13/2022, which indicated the patient was to receive home health aide services 6 hours per day/5 days per week. Record review evidenced a comprehensive assessment dated 8/15/2022, which indicated the start of care date was 8/15/2022. Record review indicated the patient failed to receive any home health aide services until 9/6/2022 (21 days after start of care). Record review failed to evidence any patient or physician communication regarding delay in services. The plan of care included the following goals: able to understand medication regime and care related to diagnosis, medical condition stabilizes, when maximum functional potential reached, discharge at the end of the episode if the patient is hospitalized. During an interview on 9/19/2022, at 2:33 PM, clinical manager #2 indicated patient #2 did not receive any home health aide visits for 3 weeks following the start of care because the agency was waiting for insurance approval. Clinical manager #2 indicated the physician should have been aware of the delay in services because they signed the plan of care. 5. Observation of a home visit for patient #3 was conducted on 9/19/2022, at 9:00 AM, to observe a routine skilled nurse visit. The patient was observed to be alert and oriented, sitting in a recliner. The patient indicated she could not walk, and was only able to stand with a walker, while the aides bathe her or clean up her bottom. The patient indicated she was incontinent of urine, and previously had an open wound to her bottom from the moisture. The patient indicated she used a cream on her bottom to prevent any more open areas. The nurse failed to complete a skin assessment during the visit or complete any education. Clinical record review for patient #3 was completed on 9/20/2022. Record review evidenced a plan of care for certification period 8/18/2022 – 10/16/2022, which indicated the primary diagnosis was chronic obstructive pulmonary disease (a chronic disease which blocks airflow and makes it hard to breathe). The plan of care indicated the patient had an oxygen concentrator. This document also included but was not limited to the following diagnoses: diabetes (problem regulating blood sugar), muscle weakness, hemiplegia affecting right side (weakness or paralysis of one side of body), sarcoidosis (inflammatory disease), and seizures. The plan of care included the following skilled nursing interventions: teach disease process, signs and symptoms of infections, and fall prevention. The plan of care failed to be individualized to include any specific interventions or education regarding relevant diagnoses, such as respiratory assessment, monitoring pulse oximetry, keeping head of bed elevated, instructions on oxygen use and safety, educating on assistive devices, education on energy conservation, medication education, or dietary compliance education. The plan of care failed to be individualized to include any interventions for preventing skin breakdown or maintaining skin integrity such as head-to-toe skin assessment, repositioning, or preventative creams. The plan of care included the following goals: able to understand medication regime and care related to diagnosis, medical condition stabilizes, when maximum functional potential reached, discharge at the end of the episode if the patient was hospitalized. The plan of care indicated the skilled nurse was to administer insulin, but insulin was not ordered. This document failed to be individualized to reflect that the patient did not take insulin. The plan of care indicated the patient was to receive home health aide services 7 hours per day/5 days per week. Record review evidenced the patient only received 4 home health aide visits the week of 9/4/2022. During an interview on 9/20/2022, at 2:50 PM, clinical manager #2 indicated the plan of care should be individualized for each patient, and patient #3 should have had education about raising her recliner, wearing oxygen, seizure prevention, and taking all medications as prescribed. At 2:53 PM, clinical manager #2 indicated the agency was closed on 9/5/2022, so no visits were made that day. Clinical manager #2 indicated visits were only rescheduled if the patient called and requested the visit to be rescheduled. Clinical manager #2 indicated she only performed skin assessments every 2 weeks. Clinical manager #2 indicated the patient no longer used insulin, and the plan of care should have reflected that. 6. Clinical record review for patient #4 was completed on 9/20/2022. Record review evidenced a plan of care for certification period 9/11/2022 – 11/9/2022, which included the following goals: able to understand medication regime and care related to diagnosis, medical condition stabilizes, when maximum functional potential reached, discharge at the end of the episode if the patient is hospitalized. This document failed to include any patient-specific and measurable outcomes or goals. 7. Clinical record review for patient #5 was completed on 9/20/2022. Record review evidenced a plan of care for certification period 7/28/2022 – 9/25/2022, which included the following goals: able to understand medication regime and care related to diagnosis, medical condition stabilizes, when maximum functional potential reached, discharge at the end of the episode if the patient is hospitalized. This document failed to include any patient-specific and measurable outcomes or goals. 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 observation, record review, and interview, the home health agency failed to ensure the plan of care included, all pertinent diagnoses, types of supplies and equipment required, nutritional requirements, all medications and treatments, patient and caregiver education and training, and/or measurable outcomes and goals in 5 of 5 active clinical records reviewed. (#1, 2, 3, 4, 5) The findings include: 1. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Plan of Treatment” which stated, “… An individualized Plan of Care/485 signed by a physician shall be required for each client receiving home health and personal care services … The Plan of Care shall be completed in full to include: … All pertinent diagnoses … Surgical procedures … Specific dietary or nutritional requirements or restrictions … Medications, treatments, and procedures … Medical supplies and equipment required … Any safety measures to protect against injury … Instructions to client/caregiver … Treatment goals … Name and address of client’s physician ….” 2. Observation of a home visit for patient #1 was conducted on 9/14/2022, at 8:00 AM, to observe a routine home health aide visit. During the visit, the patient was observed to be alert and oriented, and using a cane. He indicated he had a history of colitis (inflammation of the colon), liver cancer, and a pacemaker. He indicated he used a CPAP (machine which provides air through a mask, while sleeping) nightly. Clinical record review for patient #1 was completed on 9/19/2022. Record review evidenced a plan of care for certification period 8/13/2022 – 10/11/2022, which failed to include diagnoses of colitis, liver cancer, and pacemaker. This document failed to include a cane or CPAP. This plan of care failed to include any education or training. Record review evidenced a plan of care from home health agency #3, which was faxed to surveyor on 9/14/2022. This document included a primary diagnosis of hypertensive chronic kidney disease, which was not included in the 1st Option Adult Day Services plan of care. This document also included the following diagnoses which were not included in the 1st Option Adult Day Services's plan of care: peripheral vascular disease (circulation problem to legs), chronic pain syndrome, gastro-esophageal reflux disease with esophagitis (inflammation of the esophagus due to stomach acid reflux), and repeated falls. During an interview on 9/19/2022, at 1:55 PM, clinical manager #2 indicated the agency only included diagnoses on the plan of care which were verbalized to them by the patient. Clinical manager #2 indicated all durable medical equipment in use should be included in the plan of care. Clinical manager #2 indicated education was not included on plans of care for home health aide only patients because the home health aides do not educate patients. At 2:41 PM, clinical manager #2 indicated the patients should receive education at every recertification assessment. 3. Observation of a home visit for patient #2 was conducted on 9/14/2022, at 12:30 PM, to observe a routine home health aide visit. The patient was observed sitting in a recliner. The patient’s right side was weak from a stroke in 2013. During the visit an electric wheelchair, cane, and hemi walker were observed. Patient #2 indicated he used the wheelchair, cane, and walker depending on the activity. Clinical record review for patient #2 was completed on 9/19/2022. Record review evidenced a plan of care for certification period 8/15/2022 – 10/13/2022, which failed to include any durable medical equipment. The plan of care failed to include any education or training. Clinical record review evidenced a comprehensive assessment dated 8/15/2022, which indicated the patient was taking a CBD (cannabidiol, medication used for pain, anxiety, and inflammation) prescription, which was not included on the plan of care. During an interview on 9/19/2022, at 2:41 PM, clinical manager #2 indicated home health aide only patients do not receive any education or training. During an interview on 9/19/2022, at 2:45 PM, clinical manager #2 indicated the CBD medication should have been included in the plan of care. 4. Observation of a home visit for patient #3 was conducted on 9/20/2022, to observe a routine skilled nurse visit. During the visit, the following durable medical equipment was observed: walker, commode, and wheelchair. Patient #3 indicated she had broken her right ankle, and as a result, was unable to walk. Patient #3 indicated she was applying a cream to her bottom to prevent skin breakdown. Clinical record review for patient #3 was completed on 9/20/2022. Record review evidenced a plan of care for certification period 8/18/2022 – 10/16/2022, which only included an oxygen concentrator for durable medical equipment. This document failed to include a walker, commode, or wheelchair under durable medical equipment. This document failed to include diagnosis of broken right ankle. This document failed to include the medication Triamcinolone, which had been prescribed. During an interview on 9/20/2022, at 3:22 PM, clinical manager #2 indicated the physician had prescribed Triamcinolone for patient #3. Clinical manager #2 indicated all medications should be included on the plan of care. 5. Clinical record review for patient #4 was completed on 9/20/2022, for certification period 9/11/2022 – 11/9/2022. Record review evidenced a comprehensive assessment dated 9/6/2022, which indicated the patient used a wheelchair and walker. Record review evidenced a plan of care for certification period 9/11/2022 – 11/9/2022, which failed to include a wheelchair and walker under durable medical equipment. This document failed to include any education or training for patient. Clinical record review evidenced a plan of care from home health agency #7, for certification period 8/29/2022 – 10/27/2022, faxed to surveyor on 9/20/2022, which included the following diagnoses, which were not included in patient #4’s plan of care: diabetes (problem regulating blood sugar) with foot ulcer (wound to foot), non-pressure ulcer of right foot, pressure ulcer of sacral region, pressure ulcer of other site, urethral stricture (narrowing of urethra), hypertensive heart disease (high blood pressure causing heart disease), heart failure, chronic kidney disease, and chronic obstructive pulmonary disease (lung disease which makes it increasingly difficult to breathe). 6. Clinical record review for patient #5 was completed on 9/20/2022, for certification period 7/28/2022 - 9/25/2022. Record review evidenced a plan of care from home health agency #8, for certification period 8/14/2022 – 10/12/2022, which indicated the patient received tube feedings. Record review evidenced a plan of care for certification period 7/28/2022 – 9/25/2022, which failed to include tube feedings. During an interview on 9/19/2022, at 3:50 PM, clinical manager #2 indicated the plan of care should have been updated to include tube feedings. 410 IAC 17-13-1(a)(1)(B) 410 IAC 17-13-1(a)(1)(C) 410 IAC 17-13-1(a)(1)(D)(ii, iii, viii, ix, xi)

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 home health agency failed to ensure services were provided, only as ordered by the physician in 1 of 5 active clinical records reviewed. (#5) The findings include: Record review evidenced an undated agency policy obtained 9/20/2022, titled “Home Health Aide Assignment” which stated, “… Any changes in the assignment will be communicated to the home health aide and will be documented on a new care plan. Changes must reflect physician orders and be documented on the care plan and in the client’s chart (signed physician orders) ….” Clinical record review for patient #5 was completed on 9/20/2022. Record review evidenced a plan of care for certification period 7/27/2022 – 9/25/2022, which indicated the patient went to dialysis (artificial kidney filtration) on Monday, Wednesday, and Friday. This document failed to include any orders for home health aides to assist patient in transferring to dialysis, or to go with the patient to dialysis. During an interview on 9/19/2022, at 3:46 PM, clinical manager #2 indicated the home health aides accompanied patient #5 to dialysis on Mondays, Wednesdays, and Fridays, and stay for the duration of the treatment. Clinical manager #2 indicated the home health aides know which services to provide by the plan of care. Clinical manager #2 indicated the orders for treatment should all be on the plan of care. 410 IAC 17-13-1(a)

Review and revision of the plan of care CFR(s): 484.60(c) Standard: Review and revision of the plan of care. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to review and revise the plan of care in 5 of 5 active clinical records reviewed. (#1, 2, 3, 4, 5) The findings include: 1. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Plan of Treatment” which stated, “… the Plan of Care shall be completed in full to include: … Type, frequency, and duration of all visits/services … Professional staff shall promptly alert the physician to any changes that suggest a need to alter the Plan of Care ….” 2. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Coordination of Client Services” which stated, “… The primary care Nurse or Therapist will assume responsibility for updating/changing the Care Plan and communicating changes to caregivers within 24 hours following the conference or changes. The physician will be contacted when his/her approval for that change is necessary and to alert physician to changes in client condition ….” 3. Clinical record review for patient #1 was completed on 9/19/2022. Record review evidenced a plan of care for certification period 8/13/2022 – 10/11/2022, which indicated the patient was to receive home health aide services 5 hours per day/3 days per week. Review of visit notes evidenced the patient was receiving home health aide services 2 hours per day/3 days a week. Record review evidenced a prior authorization document dated 3/17/2022, which indicated the patient had only been approved for 6 hours of home health aide services per week. Record review failed to evidence the plan of care was revised to include accurate frequency and duration of home health aide visits. During an interview on 9/19/2022, at 1:43 PM, clinical manager #2 indicated the duration and frequency of aide visits was determined by the insurance authorization approval. Clinical manager #2 indicated patients’ plans of care should be revised to match the current insurance authorizations. 4. Clinical record review for patient #2 was completed on 9/19/2022. Record review evidenced a plan of care for certification period 8/15/2022 – 10/13/2022, which indicated the patient was to receive home health aide services 6 hours per day/5 days per week. Review of visit notes evidenced the patient was receiving 3 hours per day/5 days per week. Record review evidenced a prior authorization document dated 9/1/2022, which indicated the patient had only been approved for 18 hours of home health aide services per week. Record review failed to evidence the plan of care was revised to include an accurate frequency and duration of home health aide visits. During an interview on 9/19/2022, at 2:29 PM, clinical manager #2 indicated they only revised the plan of care during recertification assessments. 5. Clinical record review for patient #3 was completed on 9/20/2022. Record review evidenced a plan of care for certification period 8/18/2022 – 10/16/2022, which indicated the patient was to receive home health aide services 7 hours per day/5 days per week. Record review evidenced the patient was only receiving home health aide services 6 hours per day/5 days per week. Record review evidenced a prior authorization dated 8/24/2022, which indicated the patient was only approved for 30 hours of home health aide services per week. Record review failed to evidence the plan of care was revised to include the accurate frequency and duration of home health aide visits being performed. 6. Clinical record review for patient #4 was completed on 9/20/2022. Record review evidenced a plan of care for certification period 9/11/2022 – 11/9/2022, which indicated the patient was to receive home health aide services 9 hours per day/5 days per week. Record review evidenced the patient was receiving home health aide services 7 days per week, about 6 hours per visit. Record review failed to evidence the plan of care was revised to reflect the actual frequency and duration of home health aide visits being performed. 7. Clinical record review for patient #5 was completed on 9/20/2022. Record review evidenced a plan of care for certification period 7/28/2022 – 9/25/2022, which indicated the patient was to receive home health aide services 10 hours per day/7 days per week. Record review evidenced the patient was receiving home health aide services 6 hours per day/6 days per week. Record review failed to evidence the plan of care was revised to reflect the actual frequency and duration of home health aide visits being performed. During an interview on 9/19/2022, at 3:41 PM, clinical manager #2 indicated the patient was only approved through her insurance for 6 hours per day/6 days per week.

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 home health agency failed to ensure the physician was promptly notified of any changes in patients’ condition which suggested goals were not being achieved or the plan of care should be altered in 2 of 5 active clinical records reviewed. (#1, 3) The findings include: 1. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Plan of Treatment” which stated, “… the Plan of Care shall be completed in full to include: … Type, frequency, and duration of all visits/services … Professional staff shall promptly alert the physician to any changes that suggest a need to alter the Plan of Care ….” 2. Clinical record review for patient #1 was completed on 9/19/2022, for certification period 8/13/2022 – 10/11/2022. Record review evidenced a comprehensive recertification assessment dated 8/8/2022, which indicated the patient had 2 or more falls within the last 12 months. Record review evidenced a plan of care from home health agency #3 which was faxed on 9/14/2022, which indicated the patient fell on 8/3/2022, while trying to get out of bed, and had some bruising to his right side. Record review failed to evidence any documentation from 1st Option Adult Day Services regarding this fall. Record review failed to evidence the primary care physician was notified of patient’s fall or another comprehensive assessment completed. During an interview on 9/19/2022, at 2:21 PM, clinical manager #2 indicated the physician should be notified if the patient fell and another comprehensive assessment completed. 3. Observation of a home visit for patient #3 was conducted on 9/20/2022, at 9:00 AM, to observe a routine skilled nurse visit. The patient was observed to be alert and oriented, sitting in a recliner. The patient indicated she lived alone. The patient indicated she had broken her right ankle and had been unable to walk since then. She indicated she wanted to be able to walk again, and indicated she was chairbound and only able to stand up long enough for the home health aide to wipe her bottom. The patient indicated she would like to receive physical therapy to meet her goal of walking. Clinical record review for patient #3 was completed on 9/20/2022, for certification period 8/18/2022 – 10/16/2022. Record review failed to evidence the patient received physical therapy or had been referred for physical therapy. Record review failed to evidence any communication with the physician regarding patient’s therapy need. During an interview on 9/20/2022, at 2:58 PM, clinical manager #2 indicated the patient received physical therapy a long time ago. Clinical manager #2 indicated the physician was not notified of patient’s need for therapy because the home health agency did not offer therapy services. 410 IAC 17-13-2(a)(2)

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits 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 patients with written visit schedules in 3 of 3 home visits conducted. (#1, 2, 3) The findings include: 1. Record review evidenced an undated agency policy obtained 9/13/2022, titled “Client Bill of Rights and Responsibilities” which stated, “… Clients of 1st Option Home Health have the right to: … Receive complete written information on the plan of care, including the name of the home aide and supervisor responsible for the services ….” 2. Observation of a home visit for patient #1 was conducted on 9/14/2022, at 8:00 AM, to observe a routine home health aide visit. During the visit, a home folder was reviewed, which failed to evidence a written visit schedule was provided to the patient. During an interview on 9/19/2022, at 2:01 PM, clinical manager #2 indicated the agency verbally reviewed visit schedules with patients and encouraged them to put it in their phones. Clinical manager #2 indicated the agency did not provide a written visit schedule to patients. 3. Observation of a home visit for patient #2 was conducted on 9/14/2022, at 12:30 PM, to observe a routine home health aide visit. During the visit, a home folder was reviewed, which failed to evidence a written visit schedule was provided to the patient. 4. Observation of a home visit for patient #3 was conducted on 9/19/2022, at 9:00 AM, to observe a routine skilled nurse visit. During the visit, a home folder was reviewed, which failed to evidence a written visit schedule was provided to the patient.

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 ensure patients received written medication schedule/instructions including medication name, dose and frequency of medications to be taken in 2 of 3 home visits conducted. (#1, 3) The findings include: 1. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Medication Profile” which stated, “… The original Medication Profile shall be filed in the clinical record. A copy shall be retained by the Registered Nurse or staff member or placed in the client’s home chart when extended hours of service are being provided ….” 2. Observation of a home visit for patient #1 was conducted on 9/14/2022, at 8:00 AM, to observe a routine home health aide visit. During the visit, a home health folder was reviewed, which failed to include written medication schedule/instructions. During an interview on 9/19/2022, at 1:40 PM, clinical manager #2 indicated the written medication schedule/instructions would be provided to patients on their plan of care which would be provided to them during comprehensive assessments. 3. Observation of a home visit for patient #3 was conducted on 9/19/2022, at 9:00 AM, to observe a routine skilled nurse visit. During the visit, the patient’s medication bottles were reviewed. The medications included but were not limited to: baclofen (muscle relaxer) 10 milligrams three times daily, as needed, oxycarbazepine (anti-seizure medication) 600 milligrams twice daily, gabapentin (to help nerve pain) 300 milligrams three times daily, and magnesium oxide 400 milligrams twice daily. During the visit, a home folder was reviewed, which contained a plan of care. This plan of care contained a list of medications which included but was not limited to: oxycarbazepine 300 milligrams twice daily, gabapentin 200 milligrams three times daily, and baclofen 10 milligrams three times daily. This medication list failed to include magnesium oxide. This medication list included the following medications the patient was not taking: lactulose (for constipation) and sodium chloride tablet. During an interview on 9/20/2022, at 3:11 PM, clinical manager #2 indicated the patient’s gabapentin order must have been changed. Clinical manager #2 indicated the medication list provided to the patient had the incorrect dosage of gabapentin and oxycarbazepine. Clinical manager #2 indicated all the medications the patient was taking should have been on her written medication list.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to provide patients with written instructions outlining treatments to be administered by home health personnel or personnel acting on behalf of the home health agency in 1 of 3 home visits conducted. (#1) The findings include: Record review evidenced an undated agency policy obtained 9/13/2022, titled “Client Bill of Rights and Responsibilities” which stated, “… Clients of 1st Option Home Health have the right to: … Receive complete written information on the plan of care, including the name of the home aide and supervisor responsible for the services ….” Record review evidenced an undated agency policy obtained on 9/20/2022, titled “Home Health Aide Plan of Care” which stated, “… A copy of the Care Plan shall be placed in the client’s home ….” Observation of a home visit for patient #1 was conducted on 9/14/2022, at 8:00 AM, to observe a routine home health aide visit. During the visit, a home folder was reviewed, which failed to include a current plan of care outlining treatments to be administered by home health agency staff. During an interview on 9/19/2022, at 2:02 PM, clinical manager #2 indicated the agency provided patients with a copy of the plan of care.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure patients received written name and contact information for the clinical manager in 3 of 3 home visits conducted. (#1, 2, 3) The findings include: 1. Record review on 9/13/2022, evidenced a home folder which contained an undated document titled “Client Bill of Rights and Responsibilities” which stated, “… Clients of 1st Option Home Health have the right to: … Receive complete written information on the plan of care, including the name of the home aide and supervisor responsible for the services and the agency phone number ….” 2. Observation of a home visit for patient #1 was conducted on 9/14/2022, at 8:00 AM, to observe a routine home health aide visit. During the visit, a home folder was reviewed, which failed to include the name and contact information for the clinical manager. During an interview on 9/19/2022, at 1:41 PM, clinical manager #2 indicated the patients should have home folders with the clinical manager’s name and contact information written on them. 3. Observation of a home visit for patient #2 was conducted on 9/14/2022, at 12:30 PM, to observe a routine home health aide visit. During the visit, a home folder was reviewed, which failed to include the name and contact information for the clinical manager. 4. Observation of a home visit for patient #3 was conducted on 9/19/2022, at 9:00 AM, to observe a routine skilled nurse visit. During the visit, a home folder was reviewed, which failed to include the name and contact information for the clinical manager.

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 failed to: to ensure the QAPI program demonstrated measurable improvement in indicators which would improve health outcomes, patient safety, and quality of care, and failed to measure, analyze, and track these indicators (see tag G642); collect and utilize quality indicator data in the QAPI program to monitor the effectiveness and safety of services and quality of care and identify opportunities for improvement (see tag G644); ensure performance improvement activities considered incidence, prevalence, and severity or problems (see tag G650); ensure performance improvement activities tracked adverse patient events, analyze their causes, and implement preventative actions (see tag G654); and conduct and document performance improvement projects (see tag G658). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42 CFR 484.65 Quality assessment and performance improvement (QAPI).

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 the QAPI program demonstrated measurable improvement in indicators which would improve health outcomes, patient safety, and quality of care, and failed to measure, analyze, and track these indicators. The findings include: Record review evidenced an undated agency policy obtained on 9/15/2022, titled “Quality Assurance/Performance Improvement” which stated, “… Agency shall establish a performance improvement plan to continuously measure, assess, and improve the performance of clinical and other processes … Objectives of the program … To identify, address, track, and resolve problems in client care services and satisfaction to insure resolution and/or improvement ….” Review on 9/16/2022, of the agency’s QAPI (quality assurance and performance improvement) program, indicated the agency would reduce the rate of falls with injury from 7% to 3% by December 2021, and would increase the percentage of patients who received flu and pneumonia vaccines from 61% to 90% by December 2023. Review failed to evidence any measurement, analysis, or tracking of falls or vaccination rates. Review of the QAPI program failed to evidence any baseline data, or measurable improvement in falls or vaccination rates. During an interview on 9/16/2022, at 11:36 AM, administrator #1 indicated the agency was tracking fall risk assessments but did not have any documentation of the tracking of fall risk assessments. Clinical manager #2 indicated they were tracking general improvements in patient care, and would call the physician if the patient was improving or declining. 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 collect and utilize quality indicator data in the QAPI program to monitor the effectiveness and safety of services and quality of care and identify opportunities for improvement. The findings include: Record review evidenced an undated agency policy obtained 9/15/2022, titled “Quality Assurance/Performance Improvement” which stated, “… Data will be collected to allow the agency to monitor its performance … Data will be systematically collected to measure process and outcome ….” Review of the QAPI (quality assurance performance improvement) program on 9/16/2022, indicated the agency’s goal was to reduce the rate of falls with injury from 7% to 3% by December 2021, and increase flu and pneumonia vaccination rate from 61% to 90% by December 2023, but failed to evidence collection or utilization of any quality indicator data regarding falls or vaccinations. Clinical record review completed on 9/20/2022, evidenced 3 patients with wounds (#3, 4, 5) and 1 patient hospitalized (#5) out of 5 active clinical records reviewed. Record review evidenced 1 patient was hospitalized (#7) and 1 patient fell (#7) out of 2 discharged clinical records reviewed. During an interview on 9/16/2022, at 11:39 AM, administrator #1 indicated if the patient population was too insignificant, there was no data to collect. Clinical manager #2 indicated the QAPI program should collect and measure data from OASIS (outcome and assessment information set). At 11:41 AM, administrator #1 indicated the agency didn’t have any data to collect. 410 IAC 17-12-2(a)

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 performance improvement activities considered incidence, prevalence, and severity or problems. The findings include: Record review evidenced an undated agency policy obtained 9/15/2022, titled “Quality Assurance/Performance Improvement” which stated, “… Objectives of the program … to identify, address, track and resolve problems in client care services and satisfaction to insure resolution and/or improvement ….” Review of the QAPI (quality assurance performance improvement) program on 9/16/2022, indicated the agency’s goal was to reduce the rate of falls with injury from 7% to 3% by December 2021, and increase flu and pneumonia vaccination rate from 61% to 90% by December 2023. Review failed to evidence consideration of incidence, prevalence, or severity of issues such as wounds, hospitalizations, or infections. Clinical record review completed on 9/20/2022, evidenced 3 patients with wounds (#3, 4, 5) and 1 patient hospitalized (#5) out of 5 active clinical records reviewed. Record review evidenced 1 patient was hospitalized (#7) and 1 patient fell (#7) out of 2 discharged clinical records reviewed. Record review on 9/15/2022, evidenced a blank fall log and infection log. Record review failed to evidence any tracking of hospitalizations or wounds. During an interview on 9/16/2022, at 11:42 AM, clinical manager #2 indicated the most prevalent areas of concern would be immobile patients who were at a higher risk for infections and pressure ulcers, and patients with dementia who would be at higher risk for falls. Administrator #1 indicated the agency did not look at patient hospitalizations or wound tracking. Administrator #1 did not know why patient #7’s fall was not recorded in the fall log.

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 tracked adverse patient events, analyzed their causes, and implemented preventative actions. The findings include: Record review evidenced an undated agency policy obtained 9/15/2022, titled “Quality Assurance/Performance Improvement” which stated, “… Objectives of the program … to identify, address, track and resolve problems in client care services and satisfaction to insure resolution and/or improvement ….” Review of the QAPI (quality assurance performance improvement) program on 9/16/2022, indicated the agency’s goal was to reduce the rate of falls with injury from 7% to 3% by December 2021, and increase flu and pneumonia vaccination rate from 61% to 90% by December 2023. Clinical record review completed on 9/20/2022, evidenced 3 patients with wounds (#3, 4, 5) and 1 patient hospitalized (#5) out of 5 active clinical records reviewed. Record review evidenced 1 patient was hospitalized (#7) and 1 patient fell (#7) out of 2 discharged clinical records reviewed. Record review on 9/15/2022, evidenced a blank fall log and infection log. Record review failed to evidence any tracking of hospitalizations or wounds. Record review failed to evidence any analysis or implementation of preventative actions regarding adverse events such as falls, hospitalizations, wounds, or infections. During an interview on 9/16/2022, at 11:42 AM, administrator #1 indicated the agency did not look at patient hospitalizations or wound tracking. Administrator #1 did not know why patient #7’s fall was not recorded in the fall log. Clinical manager #2 indicated the performance improvement activities were assessing the patient’s home environment for supplies needed. 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 conduct and document performance improvement projects. The findings include: Record review evidenced an undated agency policy obtained 9/15/2022, titled “Quality Assurance/Performance Improvement” which stated, “… The development of a performance improvement plan will be guided by the mission, vision and strategic goals of the organization. Additional activities for performance improvement will be prioritized by the agency’s management team … The plan will target the performance of existing processes and outcomes and identify/design new processes based on priorities, standards, and resources ….” Review on 9/16/2022, of the agency’s QAPI (quality assurance and performance improvement) plan failed to evidence any performance improvement projects. During an interview on 9/16/2022, at 11:45 AM, clinical manager #2 indicated the agency’s performance improvement project was to assess patients’ home environments for any unmet needs. Clinical manger #2 indicated the performance improvement activities were only discussed verbally, not documented.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure clinical notes were prepared accurately in 2 of 3 home visits conducted. (#2, 3) The findings include: 1. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Clinical Documentation” which stated, “… Purpose … To ensure that there is an accurate record of the services provided … To document conformance with the plan of care ….” 2. Observation of a home visit for patient #2 was conducted on 9/14/2022, at 12:30 PM, to observe a routine home health aide visit. During the visit, a home health folder was reviewed, which contained an individual emergency preparedness plan, which indicated the patient was allergic to seafood, fish, and heparin. Clinical record review for patient #2 was completed on 9/19/2022. Record review evidenced a plan of care for certification period 8/15/2022 – 10/13/2022, which indicated the patient was allergic to aspirin and sulfa. During an interview on 9/19/2022, at 2:43 PM, clinical manager #2 indicated the plan of care probably defaulted when they clicked on allergies. Clinical manager #2 indicated the plan of care was probably inaccurate, and the patient was probably allergic to heparin and seafood. 3. Clinical record review for patient #3 was completed on 9/20/2022, for certification period 8/18/2022 – 10/16/2022. Record review evidenced a comprehensive assessment dated 8/15/2022, which indicated the patient had both a mild and severe cognitive impairment. This document indicated physical therapy was working with the patient. During an interview on 9/20/2022, at 3:02 PM, clinical manager #2 indicated the assessment was documented in error, and the accurate assessment should have only included mild cognitive impairment. Clinical manager #2 indicated the patient was not currently receiving physical therapy, and it was probably carried over documentation from a previous certification period. 410 IAC 17-14-1(a)(2)(E)

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure skilled professionals communicated with all physicians involved in the plan of care regarding the plan of care in 4 of 5 active clinical records reviewed. (#2, 3, 4, 5) The findings include: 1. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Medical Supervision” which stated, “… Physician will be contacted when any of the following occurs: … Condition changes … Expected response to treatment or medication changes … Any change in client condition or agency services ….” 2. Clinical record review for patient #2 was completed on 9/20/2022. Record review evidenced a plan of care for certification period 8/15/2022 – 10/13/2022, which indicated the patient was to receive home health aide services 6 hours per day/5 days per week. Review of visit notes indicated the patient was receiving home health aide services 3 hours per day/5 days per week. Record review evidenced a prior authorization document dated 9/1/2022, which indicated the patient was only approved for 18 hours of home health aide services per week. Record review failed to evidence the physician was notified of the change in the amount of home health aide services provided. During an interview on 9/19/2022, at 2:29 PM, clinical manager #2 indicated the physician should be notified if the services change, or hours are adjusted. 3. Clinical record review for patient #3 was completed on 9/20/2022. Record review evidenced a plan of care for certification period 8/18/2022 – 10/16/2022, which indicated the patient was to receive home health aide services 7 hours per day/5 days per week. Record review evidenced the patient was only receiving home health aide services 6 hours per day/5 days per week. Record review evidenced a prior authorization dated 8/24/2022, which indicated the patient was only approved for 30 hours of home health aide services per week. Record review failed to evidence the physician was notified of the change in the amount of home health aide services provided. 4. Clinical record review for patient #4 was completed on 9/20/2022. Record review evidenced a plan of care for certification period 9/11/2022 – 11/9/2022, which indicated the patient was to receive home health aide services 9 hours per day/5 days per week. Record review evidenced the patient was receiving home health aide services 7 days per week, about 6 hours per visit. Record review failed to evidence the physician was notified of the change in the amount of home health aide services provided. 5. Clinical record review for patient #5 was completed on 9/20/2022. Record review evidenced a plan of care for certification period 7/28/2022 – 9/25/2022, which indicated the patient was to receive home health aide services 10 hours per day/7 days per week. Record review evidenced the patient was receiving home health aide services 6 hours per day/6 days per week. Record review failed to evidence the physician was notified of the change in frequency and duration of home health aide visit. Record review evidenced a comprehensive assessment dated 7/25/20222, which failed to include an assessment of the wound the patient had. Record review failed to evidence the physician was notified the wound could not be assessed. During an interview on 9/19/2022, at 3:41 PM, clinical manager #2 indicated the patient was only approved through her insurance for 6 hours per day/6 days per week. At 3:53 PM, clinical manager #2 indicated the patient was too “… feisty …” and she was unable to turn the patient to assess the wound. Clinical manager #2 indicated the wound was not assessed during the recertification assessment. Clinical manager #2 indicated it was the other home health agency providing skilled nursing to the patient, so they should have notified the physician of any wound care needs. 410 IAC 17-14-1(a)(1)(G)

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, agency failed to: ensure home health aides received competency training (see tag G768); ensure home health aide services were provided appropriately and as ordered on the plan of care, and allowed by state law (see tag G800); and ensure home health aides were directly supervised every 60 days for home health aide only patients (see tag G814). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42 CFR 484.80 Home health aide services.

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure home health aides completed competency evaluations prior to providing patient care in 6 of 7 home health aide personnel records reviewed. (#3, 6, 7, 8, 9, 10) The findings include: 1. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Competency Evaluation of Home Care Staff” which stated, “… A home health aide will not be permitted to provide home health aide services until evidence of adequate training and/or competency has been determined by the designated professional in the agency … Documentation of individual Home Health Aide training and/or competency shall be maintained in the Home health aide’s personnel file ….” 2. Personnel record review for home health aide #3, start date 11/20/2019, first patient contact date 1/21/2020, failed to evidence a skills competency evaluation was completed prior to performing patient care. 3. Personnel record review for home health aide #6, start date 8/22/2022, first patient contact date 9/7/2022, failed to evidence a skills competency evaluation was completed prior to performing patient care. 4. Personnel record review for home health aide #7, start date12/2/2021, first patient contact date 12/6/2021, failed to evidence a skills competency evaluation was completed prior to performing patient care. 5. Personnel record review for home health aide #8, start date 5/18/2022, first patient contact date 8/25/2022, failed to evidence a skills competency evaluation was completed prior to performing patient care. 6. Personnel record review for home health aide #9, start date 10/18/2018, first patient contact date 10/29/2018, failed to evidence a skills competency evaluation was completed prior to performing patient care. 7. Personnel record review for home health aide #10, start date 7/22/2016, first patient contact date 8/7/2016, failed to evidence a skills competency evaluation was completed prior to performing patient care. 8. During an interview on 9/16/2022, at 11:52 AM, clinical manger #2 indicated upon hire, the home health aides were brought to the patient’s home who they would be taking care of to shadow the other home health aide for about 2 – 3 hours. Clinical manager #2 indicated this was done so the new home health aide knew what to do with the specific patient. Clinical manager #2 indicated the next day after shadowing, the new hire home health aide would go see the patient alone.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure home health aides provided services which were included in the plan of care, permitted to be performed under state law, and consistent with home health aide training in 1 of 3 home visits conducted. (#1) The findings include: Record review evidenced an undated agency policy obtained 9/20/2022, titled “Home Health Aide Plan of Care” which stated, “… The home health aide cannot be responsible for performing any procedure that is not assigned to him/her inwriting by the registered nurse/therapist or that is beyond his/her ability … The home health aide tasks must be related to the physical care needs of the client ….” Record review evidenced an undated agency policy obtained 9/20/2022, titled “Medication Administration by Home Health Aides” which stated, “… Home Health aides can not administer medication to the client it is against the state law … State laws allow home health aid to only remind patients … Home health aide shall not act in the following capacities: … Become or act as a power of attorney ….” Observation of a home visit for patient #1 was conducted on 9/14/2022, at 8:00 AM, to observe a routine home health aide visit. During the visit, patient's medications were observed to be in a locked box for which home health aide #5 had the key. This box failed to include Norco (pain medicine) and Klonopin (anti-anxiety medication). Clinical record review for patient #1 was completed on 9/19/2022. Record review evidenced a plan of care for certification period 8/13/2022 – 10/11/2022, which indicated the patient was to receive home health aide services 3 times weekly for bathing, housekeeping, picking up prescriptions and groceries, and activities of daily living. This document indicated the home health aide was to verbally remind patient to take medications, not physically prepare or administer medications. The plan of care indicated the home health aide should report refusal to the skilled nurse. Record review evidenced an agency document signed by home health aide #5 on 12/15/2021, titled “Medication Distribution” which stated, “… I [home health aide #5] understand that I will not and cannot dispense, distribute, or administer medication in any form i.e. pill, liquid, cream, shot, that have been prescribed by the doctor or purchased over the counter ….” During an interview on 9/14/2022, at 8:15 AM, home health aide #5 indicated they kept patient #1’s Klonopin (anti-anxiety medication) and Norco (narcotic pain medication) in a locked box in their car due to patient’s history of overdose. Home health aide #5 indicated they had the Klonopin and Norco in their car currently. During an interview on 9/14/2022, at 1:57 PM, person #2 (registered nurse caring for patient #1 from home health agency #3) indicated home health aide #5 was filling patient #1’s medication planner and administering all the medications. During an interview on 9/14/2022, at 3:19 PM, clinical manager #2 indicated they did not know anything about home health aide #5 administering medications, keeping medications in their personal car, or filling the patient’s medication planner. Clinical manager #2 indicated it was home health agency #3’s responsibility to let her know the aide was filling the medication planner. Clinical manager #2 indicated the home health aide should not have been filling a medication planner, keeping medications in the car, or administering medication as this was out of the scope of practice for home health aides. Clinical manager #2 indicated the agency doesn’t do anything with the patient’s medications, and home health agency #3 should be the ones responsible. During an interview on 9/15/2022, at 9:45 AM, home health aide #5 indicated they only touch patient #1’s medication when they were off the clock. Home health aide #5 indicated they went on their off days and hours to patient #1’s home to assist them with medication administration.

Non-skilled direct observation every 60 days CFR(s): 484.80(h)(2) If home health aide services are provided to a patient who is not receiving skilled nursing care, physical or occupational therapy, or speech-language pathology services, the registered nurse must make an on-site visit to the location where the patient is receiving care no less frequently than every 60 days in order to observe and assess each aide while he or she is performing care. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure the registered nurse made an on-site visit every 60 days to observe and assess the home health aide performing care in 3 of 7 clinical records reviewed. (#1, 5, 7) The findings include: 1. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Clinical Supervision” which stated, “… On-site supervision of clients receiving services will be performed by a Registered Nurse/Therapist to direct, demonstrate, and evaluate the implementation of the Plan of Care and the delivery of services … The frequency and method of supervision will be based on the amount and type of care provided, client complaints, and changes in client condition ….” 2. Record review evidenced an undated agency policy obtained 9/20/2022, titled “Home Health Aide Supervision” which stated, “… Supervisory visits are to be documented in the client’s chart on the home health aide supervision form ….” 3. Clinical record review for patient #1 was completed on 9/19/2022. Record review evidenced a plan of care for certification period 8/13/2022 – 10/11/2022, which indicated the patient was to receive home health aide services 3 times weekly for bathing, housekeeping, picking up prescriptions and groceries, and activities of daily living. Clinical record review failed to evidence a home health aide supervisory visit was completed during the recertification assessment on 8/8/2022. During an interview on 9/14/2022, at 8:15 AM, patient #1 indicated the skilled nurse from 1st Option Adult Day Services and Home Health came to his home for a supervisory visit maybe every 4 months. During an interview on 9/14/2022, at 3:19 PM, clinical manager #2 indicated home health aide supervisory visits should be conducted with the home health aide every 60 days, but sometimes, they are done over the phone instead. 4. Clinical record review for patient #5 was completed on 9/20/2022. Record review evidenced a plan of care for certification period 9/11/2022 – 11/9/2022, which indicated the patient was receiving home health aide services 9 hours per day/5 days per week for activities of daily living, bathing, and housekeeping. Record review evidenced a comprehensive recertification assessment completed 9/6/2022, which failed to include a supervisory visit. Record review failed to evidence documentation of supervisory visits were completed every 60 days for home health aide only patients. 5. Clinical record review for patient #7 was completed on 9/20/2022. Record review evidenced a plan of care for certification period 7/6/2022 – 9/3/2022, which indicated the patient was receiving home health aide services 6 hours per day/5 days per week for activities of daily living, bathing, and housekeeping. Record review evidenced a comprehensive recertification assessment dated 7/1/2022, which failed to be signed by the patient. Record review failed to evidence a supervisory visit had been conducted every 60 days to observe the home health aide providing care. During an interview on 9/20/2022, at 11:00 AM, clinical manager #2 indicated the recertification assessment was not signed by the patient because when she arrived to complete the assessment and supervisory visit, the patient was not home. Clinical manager #2 indicated the only in-person visits conducted for home health aide patients were comprehensive assessments at recertification every 60 days. Clinical manager #2 indicated patient #7’s recertification and supervisory visit was completed over the phone.

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 observation, record review, and interview, the home health agency failed to: ensure the administrator was appointed by the governing body (see tag G946); ensure the administrator was responsible for all day-to-day operations of the home health agency (see tag G948); ensure the clinical manager provided oversight of all patient care services and personnel (see tag G958); ensure the clinical manager coordinated patient care with other home health agencies and the physician (see tag G962); and ensure the clinical manager assured the implementation of the individualized plan of care (see tag G968). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42 CFR 484.105 Organization and administration of services.

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) (i) Be appointed by and report to the governing body; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the administrator was appointed by the governing body. The findings include: Record review evidenced an undated agency policy obtained 9/15/2022, titled “Governing Body” which stated, “… The duties and responsibilities of the Governing Body shall include: … Appoint a qualified administrator ….” Record review on 9/15/2022, evidenced a personnel record for administrator #1. This record failed to evidence the administrator was appointed by the governing body. During an interview on 9/20/2022 at 11:46 AM, administrator #1 indicated there was no documentation that the administrator was appointed by the governing body. 410 IAC 17-12-1(b)(1)

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 be responsible for all day-to-day operations of the home health agency. The findings include: Record review evidenced a signed job description for administrator dated and signed by administrator #1 on 11/28/2019, which stated, “… the administrator oversees all aspects of the agency including planning, staffing and salary … Responsibilities: … Coordinate with doctors, nurses and other healthcare professionals to identify their issues and needs … Ensure patient medical records are kept up to date … Ensure all departments comply with the current healthcare laws and regulations ….” During an interview at the entrance conference on 9/13/2022, at 11:20 AM, administrator #1 indicated he would like to wait for the clinical manager to arrive to answer questions because he did not want to answer incorrectly. Administrator #1 did not know what the agency’s process was for making corrections in the clinical record. Administrator #1 indicated they did not know what services the agency’s patients were currently receiving. Administrator #1 did not know if any patients were shared with another agency or how care was coordinated with other agencies. Administrator #1 did not know how medication review was completed. 410 IAC 17-12-1(b)(3) 410 IAC 17-12-1(c)(1)

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the clinical manager provided oversight of all patient care services and personnel. The findings include: Record review on 9/15/2022, evidenced a director of nursing job description signed by clinical manager #2 on 8/18/2011, which stated, “… the primary function is for the overall administration of the clinical departments and monitoring of appropriate staffing and productivity in the agency … Directs and coordinates clinical departments; assumes responsibility for continuity, quality, and safety of services delivered in compliance with State and Federal regulations … Supervises and provides direction to subordinates, in an effort to ensure quality, compliance with Plan of care and assessment and reassessment of patient’s needs and continuity of services by appropriate health care personnel ….” Observation of a home visit for patient #1 was conducted on 9/14/2022, at 8:00 AM, to observe a routine home health aide visit. The patient was observed to be alert and oriented. During the visit, home health aide #5 indicated she kept the patient’s Klonopin (anti-anxiety medication) and Norco (pain medication), in a locked box in her car to administer to the patient because the patient had a history of drug overdose. During an interview on 9/14/2022, at 1:57 PM, person #2 (patient #1’s registered nurse from home health agency #3) indicated they did not administer or fill a medication planner box for patient #1 because home health aide #5 was filling the patient’s medication planner. During an interview on 9/14/2022, at 3:19 PM, clinical manager #2 indicated they did not know anything about home health aide #5 keeping medications in a lock box or filling patient #1’s medication planner. Clinical manager indicated this was out of the home health aide’s scope of practice. Clinical manager #2 indicated it was home health agency #3’s responsibility to let them know home health aide #5 was filling the medication planner. Clinical manager #2 indicated there was no way for them to know the home health aide was filling the medication planner or keeping medications in a lock box in their car. During an interview on 9/19/2022, at 2:06 PM, clinical manager #2 indicated they perform in person supervisory visits every 60 days to monitor the home health aides. Clinical manager #2 indicated sometimes supervisory visits were completed over the phone if the patient refused to let them in. 410 IAC 17-12-1(d)

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the clinical manager coordinated patient care with other home health agencies and the physician in 3 of 5 active clinical records reviewed. (#1, 4, 5) The findings include: 1. Record review evidenced an undated agency policy obtained on 9/20/2022, titled “Coordination of Client Services” which stated, “… All personnel providing services shall maintain a liaison to assure that their efforts are coordinated effectively and support the objectives outlined in the Plan of Care … This may be done through formal care conferences; maintaining completed, current Care Plans; and written and verbal interaction ….” 2. Record review on 9/15/2022, evidenced an agency document signed by clinical manager #2 on 8/11/2011, titled “Job Description for Director of Nursing” which stated, “… The director of nursing coordinates care with the interdisciplinary team, patient/family and referring agency … Directs and coordinates clinical departments; assumes responsibility for continuity, quality, and safety of services delivered in compliance with State and Federal regulations ….” 3. Observation of a home visit for patient #1 was conducted on 9/14/2022, at 8:00 AM, to observe a routine home health aide visit. During the visit, the patient indicated he received home health care from home health agency #3. The patient indicated the nurse from home health agency #3 came one time per week to do vitals. The patient indicated he did not wear oxygen, and had liver cancer and surgery to remove it. Patient #1 indicated he also had colitis (inflammation of colon) and a pacemaker. Patient #1 indicated he wore a CPAP (machine which provides air through a mask, while sleeping) nightly, which was not included in the plan of care. Clinical record review for patient #1 was completed on 9/19/2022, for certification period 8/13/2022 – 10/11/2022. Record review failed to evidence any care coordination with home health agency #3. Review evidenced a plan of care for certification period 8/13/2022 – 10/11/2022, which indicated the patient wore 3 liters of oxygen continuously, and failed to include history of liver cancer, pacemaker placement, or colitis. This document indicated the patient’s primary diagnosis was chronic obstructive pulmonary disease (damage to the lungs, which causes progressive worsening in ability to breathe). This document indicated the patient’s physician was physician #6. Clinical record review on 9/14/2022, evidenced a faxed plan of care from home health agency #3 for certification period 8/9/2022 – 10/7/2022, which indicated the patient’s primary diagnosis was hypertensive chronic kidney disease (high blood pressure which causes kidney disease), and also included the following diagnoses which were not included in the home health agency’s plan of care: peripheral vascular disease (problem with circulation, decreasing blood flow to legs), chronic pain syndrome, gastro-esophageal reflux disease with esophagitis (inflammation of esophagus due to stomach acid), liver cancer, repeated falls, and presence of cardiac pacemaker. This document indicated the patient fell on 8/3/2022, while getting out of bed, and had bruising to his right arm as a result. This document indicated the patient’s physician was physician #5. This document included the following medications which were not included in 1st Option Adult Day Services and Home Health’s plan of care: Nurtec (for migraines), furosemide (to pull water off the body), tramadol (for pain), Narcan (to reverse opiate overdose), cholestyramine (to lower cholesterol), lomotil (to stop diarrhea), gabapentin (for nerve pain), norco (for pain), Ativan (for anxiety), metoprolol (to lower blood pressure and heart rate), flonase (for stuffy nose), oxybutynin (for overactive bladder), psyllium husk (probiotic), albuterol (to open airways), and delysm (for cough). During an interview on 9/19/2022, at 1:52 PM, clinical manager #2 indicated home health agency #3 was responsible for skilled nursing services, so they were not doing anything with his oxygen. Clinical manager #2 indicated the plan of care included oxygen because the other home health agency was providing skilled nursing. Clinical manager #2 indicated the plan of care was not altered, and the physician was not notified that the patient was not wearing oxygen, was using a CPAP, or that the patient had colitis, liver cancer, peripheral vascular disease, chronic kidney disease, and a pacemaker because the other home health agency managed all that. Clinical manager #2 did not know patient #1 fell and indicated the agency providing skilled nursing services was responsible for notifying the physician of this. Clinical manager #2 indicated they did not review patient’s medications because this was the responsibility of home health agency #3. Clinical manager #2 indicated the agency coordinated care with home health agency #3 by calling and making sure they were still seeing the patient. Clinical manager #2 indicated care coordination was not documented anywhere. 4. Clinical record review for patient #4 was completed on 9/20/2022, for certification period 9/11/2022 – 11/9/2022. Record review evidenced a comprehensive assessment dated 9/6/2022, which indicated the patient was also receiving care from home health agency #7 for skilled nursing services, but failed to include what interventions were being provided, or what frequency of visits was. The comprehensive assessment indicated the patient had 2 pressure ulcers, and also indicated the patient had no pressure ulcers. This document failed to include an assessment of any wounds. The comprehensive assessment indicated the patient had a foley catheter (tube inserted in the urethra to drain urine from the bladder), but failed to include an assessment of the catheter, and indicate when it was changed, or how frequently it should have been changed. Record review failed to evidence any documented care coordination with home health agency #7. Record review evidenced a plan of care from home health agency #7, which was faxed to surveyor on 9/20/2022, for certification period 8/29/2022 – 10/27/2022. This document indicated the patient was receiving skilled nursing visits 3 times weekly for 8 weeks, and a physical therapy evaluation. This document included a primary diagnoses of diabetes (problem regulating blood sugar) with foot ulcer (wound to foot), and the following diagnoses, non-pressure ulcer of right foot, pressure ulcer of sacral region, pressure ulcer of other site, urethral stricture (narrowing of urethra), hypertensive heart disease (high blood pressure causing heart disease), heart failure, chronic kidney disease, and chronic obstructive pulmonary disease (lung disease which makes it increasingly difficult to breathe), which were all not included in the home health agency’s plan of care or comprehensive assessment. This document included the following 11 medication orders, which were not included the home health agency’s plan of care: Lexapro (anti-depressant), Floranex (probiotic), glipizide (to lower blood sugar), Lantus (insulin/to lower blood sugar) 40 units nightly, Rexulti (antipsychotic), trazodone (antipsychotic), calcium alginate (wound dressing), Nuedexta (to treat uncontrollable laughing or crying), Ramipril (to lower blood pressure), Tylenol (for pain or fever), and Gabapentin (for nerve pain) 300 milligrams three times daily. This document indicated the patient had 3 wounds, to the right top of foot (diabetic wound), right great toe (pressure wound), and sacral area (pressure wound). This document indicated the patient was to be turned by the caregiver every 2 hours for pressure wound prevention and patient’s heels were to be floated to prevent pressure sores. This document indicated the patient had a suprapubic catheter (tube inserted through the skin, directly into the bladder to drain urine), which was to be changed monthly by the skilled nurse. This document did not indicate home health agency #7 was performing catheter care. Record review evidenced a plan of care for certification period 9/11/2022 – 11/9/2022, which indicated the patient was to receive home health aide services 9 hours per day/5 days per week. This document failed to include orders for turning the patient every 2 hours or floating patient’s heels to prevent further pressure wounds. This document failed to include any orders for catheter care such as cleaning the site to prevent urinary tract infection. This document failed to include any information regarding services provided by home health agency #7. During an interview on 9/19/2022, at 3:32 PM, clinical manager #2 indicated home health agency #7 was providing skilled nursing for patient #4. Clinical manager #2 indicated home health agency #7 was doing skilled nursing for foley catheter care. Clinical manager #2 indicated home health agency #7 provided skilled nursing visits once or twice per week. Clinical manager #2 indicated the patient did not have any wounds. Clinical manager #2 indicated care was coordinated through a phone call with home health agency #7. Clinical manager #2 indicated care coordination was not documented. Clinical manager #2 indicated the home health aides only empty the catheter, because the other home health agency was performing catheter care. Clinical manager #2 did not know exactly what interventions home health agency #7 was performing for patient #4. Clinical manager #2 indicated the patient’s caregiver did not live with him, but would visit him before and after work. 5. Clinical record review for patient #5 was completed on 9/19/2022, for certification period 7/28/2022 – 9/25/2022. Record review evidenced a resumption of care assessment dated 6/22/2022, which indicated the patient was receiving services from home health agency #8 for skilled nursing services. Record review evidenced a comprehensive assessment dated 7/25/2022, which indicated the patient had 1 pressure wound, a jejunostomy, was a dialysis patient, and incontinent. This document failed to include an assessment or location of wound, type of tube feedings provided to patient, or type of dialysis access. Record review failed to evidence any care coordination with home health agency #8. Record review evidenced a plan of care from home health agency #8, for certification period 8/14/2022 – 10/12/2022, which was faxed to surveyor on 9/21/2022. This document indicated home health agency #8 provided skilled nursing 2 times per week. Home health agency #8’s plan of care included the following diagnoses, which were not included in the home health agency’s plan of care: pressure ulcer of sacral region (wound caused by pressure on the area at the base of the spine), end stage renal disease (kidney failure, requiring artificial kidney filtration), aphasia (loss of ability to understand or express speech), hepatitis C (virus which attacks the liver), Alzheimer’s disease (progressive disease which destroys memory and mental functions), bipolar disorder (a disorder with mood swings), open wound of left breast, and hypertension (high blood pressure). This document also included the following medications which were not include in the home health agency’s plan of care: clonazepam (anti-anxiety), and ferrous sulfate (iron supplement). This document indicated the patient received Novasource tube feedings, 3 cans per day with a 75 milliliter water flush. This document indicated the patient had a sacral wound which measured 3 centimeters (cm) x 3 cm x 0.1 cm, and a wound under left breast which measured 1cm x 2 cm. During an interview on 9/19/2022, at 3:56 PM, clinical manager #2 indicated home health agency #8 provided skilled nursing 2 times per week to check patient’s wound. Clinical manager #2 did not know what dressing was being applied, or how large the wounds were. Clinical manager #2 indicated care coordination was a phone call in which she confirmed that the other agency was still seeing the patient. Clinical manager #2 indicated she only added diagnoses which the patient told her about to the plan of care. Clinical manager #2 indicated the medication for home health aide only patients is completely managed by the other home health agency, so no medication review on her part is completed. Clinical manager #2 indicated they don’t request a copy of they other home health agency’s care plan.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the clinical manager assured the implementation of the individualized plan of care in 1 of 3 home visits conducted. (#1) The findings include: Record review on 9/15/2022, evidenced a document signed by clinical manager #2 on 8/18/2011, titled “Job Description for Director of Nursing” which stated, “… Supervises and provides direction to subordinates, in an effort to ensure quality, compliance with Plan of care and assessment and reassessment of patient’s needs and continuity of services by appropriate health care personnel ….” Clinical record review for patient #1 was completed on 9/19/2022. Record review evidenced a plan of care for certification period 8/13/2022 – 10/11/2022, which indicated the patient was to receive home health aide visits 3 days per week. Record review evidenced the patient only received 1 home health aide visit the week of 8/28/2022, and 2 home health aide visits the week of 9/4/2022. Review failed to evidence a missed visit note or documentation of why the visits were not completed. During an interview on 9/19/2022, at 1:46 PM, clinical manager #2 indicated she did not know why patient #1 did not receive 3 home health aide visits the weeks of 8/28/2022 and 9/4/2022. Clinical manager #2 indicated the agency would only reschedule the missed visits if the patient called and requested it to be rescheduled. Clinical manager #2 did not know why the reason for the visit was missed was not documented. 410 IAC 17-14-1(a)(1)(C)