Every finding on record at Harmony Heights Home Health Services LLC

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR §484.102. Survey Dates: 12/10/25, 12/11/25, 12/12/25, 12/15/25, and 12/16/25 Active Census: 10 At this Emergency Preparedness survey, Harmony Heights Home Health Services LLC was found to be in compliance with Emergency Preparedness Requirements for Medicaid Participating Providers and Suppliers, 42 CFR §484.102. QR completed by Area 3 on 12/23/2025.

This visit was for an Initial Federal Medicaid survey for a Home Health provider. Survey Dates: 12/10/25, 12/11/25, 12/12/25, 12/15/25, and 12/16/25 12 Month Unduplicated Admissions: 10 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. Harmony Heights Home Health Services LLC is precluded from providing its own home health aide training and competency evaluation program for a period of 2 years beginning 12/16/2025 for being found out of compliance with the Conditions of Participation 42 CFR 484.60 Care Planning, coordination, quality of care and 484.105 Organization and administration of services. Abbreviations: HHA Home Health Aide SN Skilled Nursing RN Registered Nurse CM Clinical Manager POC Plan of Care SOC Start of care QR completed by Area 3 on 12/24/2025.

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the comprehensive assessment was updated after a change in condition with 1 of 1 patient with outpatient surgical procedure (Patient #2). Findings include: 1. A review of a policy titled ‘Assessments Policy Number C:7’ stated, “… Update of the comprehensive assessment: will be performed: …significant change in condition …” 2. On 12/11/2025 at 2:30 PM, during a home visit to observe HHA 1 provide HHA services for Patient #2, HHA 1 indicated they were not sure how to care for Patient #2 since they could not get in the shower and called the Administrator/Clinical Manager, indicated Patient #2 could not get in the shower, asked if it was fine to conduct a chair bath. HHA 1 indicated they were instructed it would be acceptable. HHA 1 placed a gait belt around Patient #2, assisted them into the bathroom onto the bath bench in front of the bathroom sink, bathed, rinsed, and dried Patient #2. HHA 1 placed a robe around Patient #2, with gait belt in place, assisted Patient #2 back to their bed. 3. On 12/11/2025 at 3:30 PM, a home observation visit was conducted to observe RN 1 provide care and a medication set-up for Patient #2. RN 1 assessed Patient #2’s vital signs, assessed lung sounds anteriorly and posteriorly, assessed bowel sounds, and checked bilateral lower extremities for edema. RN 1 set pill box up for Patient #2 for 1 week. The RN failed to ensure an updated comprehensive assessment was completed with the change in condition. 4. A review of the clinical record of Patient #2 contained a document titled, ‘OASIS Assessment’ completed and signed on 12/09/2025 by RN 1 for the recertification period of 12/14/2025 through 02/11/2026 which indicated Patient #2 lived alone, had a family member that was able to transport Patient #2 to medical appointments. Functional Assessment indicated Grooming utensils must be placed within reach before able to complete grooming activities. Able to dress upper body without assistance if clothing is laid out or handed to the patient. Bathing indicated able to bathe in shower or tub with the assistance of another person. The clinical summary indicated the following: Assessment completed prior to knee surgery, demonstrated functional limitations related to endurance and the need of bilateral knee replacements, ambulates with walker. Endurance remains limited, benefits from rest periods during activity, having knee surgery and will be staying with (family member) post-surgery. 5. On 12/15/2025 at 2:30 PM, when queried of the timeline for comprehensive assessments to be conducted following a change in condition, the Administrator/CM indicated patients would be seen within 48 hours of returning home and had not thought of the surgery being a change in condition. 6. On 12/16/2025 at 12:35 PM, when queried what would qualify for a change in condition, RN 1 indicated a surgery would be a change in condition, and normally would go out within 24 hours after returning home from surgery or any hospital stay and they should had moved their patients around so they could have seen Patient #2 the day after surgery, checked her surgery incision site, should have conducted a functional/cognition assessment, and did not realize it was difficult for the aide to provide care for Patient #2. 410 IAC 17-14-1(a)(1)(B)

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 record review and interview, the agency failed to ensure the ordering physician was notified of missed SN visits (see G0572), failed to obtain verbal orders prior to providing services (see G0580), and failed to ensure all verbal orders included the time the verbal order was obtained with the clinician’s signature with the date the order received (see G0584) The cumulative effects 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 of 42 CFR 484.60, Care Planning, Coordination of Care, and Quality of Care. Findings include: * 410 IAC 17-13-1(a)

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the ordering physician was notified of missed SN visits with 2 of 5 patients receiving only SN services for medication set-up every 14 days. (Patients #4 and 10) Findings include: 1. A review of a policy titled ‘Interruption in Services/Missed Visits Policy Number C:36’ stated, “… Agency must notify the responsible medical provided of the missed visit … all documentation will be filed in the patient chart.” 2. A review of the clinical record of Patient #4 contained a POC signed by RN with a SOC 08/19/2025 for the recertification period of 10/18/2025 through 12/16/2025, evidenced SN services to perform a medication set-up every 14 days. Further review of the clinical record failed to evidence a SN visit on 11/04/2025 and failed to evidence MD notification of the missed visit. 3. A review of the clinical record of Patient #10 contained two POCs signed by the Administrator/CM with a SOC 07/31/2025 for the recertification period of 09/29/2025 to 11/27/2025 and for the recertification period of 11/28/2025 to 01/26/2026 evidenced SN services to perform a medication set-up every 14 days. Further review of the clinical record failed to evidence SN visits on 10/06/2025, 11/03/2025, and 12/03/2025 and failed to evidence MD notification of missed visits. 4. On 12/15/2025 at 2:30 PM, the Administrator/CM indicated there should be MD notification of all missed visits, the MD notification of missed visit should be documented in the record, and they were not for Patients #4 and #10. 5. On 12/16/2025 at 12:35 PM, RN 1 indicated they had not realized MD notification would be required of missed visits. 410 IAC 17-13-1(a)

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 obtain verbal orders prior to providing services with 8 of 10 SN services (Patients #1, 2, 4, 6, 7, 8, 9, and 10), failed to obtain orders to administer injections to 3 of 3 patients receiving injections (Patients #4, 7, and 8), failed to obtain orders to administer a glucose monitoring system to 3 of 3 patients (Patients #4, 7, and 8). Findings include: 1. A review of a policy titled ‘Plan of Care (POC) Policy Number C:48’ stated “… the medical provider’s verbal orders will be documented and will constitute the POC until 485 is completed, signed by the medical provider, and returned to the agency. The original verbal orders may be transcribed onto the initial plan, including date received …” 2. A review of the clinical record of Patient #1 contained a POC signed by the Administrator/CM for the recertification 09/28/2025 through 11/26/2025 which indicated SN services were to be provided every 14 days for a medication set-up, which had been returned and signed by the ordering physician on 10/22/2025. A SN visit note signed by the Administrator/CM on 10/08/2025 evidenced a medication set-up was provided. A POC signed by the Administrator/CM for the recertification 11/27/2025 through 01/25/2025 which indicated SN services were to be provided every 14 days for a medication set-up and had not been signed by the ordering physician. A SN visit note signed by the Administrator/CM on 12/03/2025 evidenced a medication set-up was provided. The record failed to evidence communication notes or a verbal order was obtained from the ordering physician prior to the SN visit on 10/08/2025 and on 12/03/2025. 3. A review of the clinical record of Patient #2 contained a POC signed by RN 1 for the recertification period of 10/15/2025 through 12/13/2025 which indicated SN services were to be provided every 7 days for a medication set-up, HHA services for personal care 2 times a week, which was returned, signed by the ordering physician on 11/22/2025. SN visit notes signed by RN 1 for 10/21/2025, 10/28/2025, 11/04/2025, 11/11/2025, and 11/18/2025 evidenced medication set-up was provided during those visits. HHA visit notes signed by HHA 1for 10/21/2025, 10/18/2025, 10/31/2025, 11/04/2025, 11/07/2025, 11/14/2025, 11/18/2025 and 11/21/2025 evidenced personal care was performed during those visits. The clinical record failed to evidence communication notes in regard for verbal orders or verbal orders failed to be obtained prior to the SN and HHA visits which occurred between 10/21/2025 through 11/21/2025. 4. A review of the clinical record of Patient #4 contained a POC signed by RN 1 for the initial certification period of 08/19/2025 through 10/17/2025 which indicated Medications were but not limited to Ozempic (a GLP-1 prescription-only medication used to treat type 2 diabetes and reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes) subcutaneous solution Pen-injector 2 MG/1.5ML 1 time weekly subcutaneous (under the skin into the fatty tissue) injection. DME supplies listed but not limited to: Dexcom (often called G-7, a small, all-in-one wearable device for continuous glucose monitoring, which tracks glucose without finger sticks by sending data to your phone/pump; it's changed 10 days)SN services were to be provided every 7 days for a medication set-up, was returned, signed by the ordering physician on 12/02/2025. The record evidenced an order written by RN 1 on 09/02/2025 effective 08/23/2025 stated, “skilled nurse to treat patient, after initial home health assessment” signed and returned by the ordering physician on 09/15/2025. SN visit notes signed by RN 1 evidenced the following: 08/19/2025 indicated medication set-up and Ozempic was administered, 08/26/2025 indicated medication was set-up, Ozempic administered, and replaced the G-7 sensor, 09/02/2025 indicated medication set-up and Ozempic was administered, 09/09/2025 indicated medication set-up and Ozempic was administered, 09/16/2025 indicated Ozempic was administered, 09/23/2025 indicated Ozempic was administered, 09/30/2025 indicated medication set-up, 10/07/2025 indicated medication set-up and Ozempic, and 10/14/2025 indicated medication set-up and Ozempic was administered. A review of the clinical record of Patient #4 evidenced a POC signed by RN 1 for the recertification period of 10/18/2025 through 12/16/ which indicated medications were not limited to Ozempic subcutaneous solution Pen-injector 2 MG/1.5ML 1 time weekly subcutaneous injection. DME supplies listed but not limited to: Dexcom. SN services were to be provided every 7 days for a medication set-up, which was returned, signed by the ordering physician on 12/02/2025. SN visit notes signed by RN 1 evidenced the following: 10/21/2025 provided medication set-up and administered Ozempic, 10/28/2025 provided medication set-up, administered Ozempic, and replaced the G-7 sensor, 11/04/2025 provided medication set-up and administered Ozempic, 11/11/2025 provided medication set-up and administered Ozempic, 11/18/2025 administered Ozempic, and 11/25/2025 administered Ozempic. The clinical record failed to evidence communication notes or failed to obtain verbal orders for medication set-up, Ozempic administration, and the replacement of Dexcom sensor device prior to the SN visits which occurred between the initial certification period 08/19/2025 through 10/17/2025 and the recertification period 10/18/2025 through 12/16/2025. The record failed to evidence orders on the POC for both certification periods for the SN to administer the Ozempic and change the Dexcom G-7 sensor. 5. A review of the clinical record of Patient #6 contained a POC signed by the Administrator/CM for the initial certification period of 08/19/2025 through 10/17/2025 which indicated SN services were to be provided every 7 days for a medication set-up, which had been returned and signed by the ordering physician on 09/05/2025. The clinical record evidenced an order written and signed by the Administrator/CM on 08/19/2025 stated, “consent for skilled nurse to treat following initial assessment” returned dated 09/05/2025 and signed by the ordering physician . SN visit notes for the initial certification period included: 08/26/2025 and 09/02/2025 which evidenced a medication setup was provided by the Administrator/CM. A review of the clinical record of Patient #6 evidenced an POC signed by the Administrator/CM for the recertification period of 10/18/2025 through 12/16/2025 which indicated SN services were to be provided every 7 days for a medication set-up, which had been returned and signed by the ordering physician on 11/04/2025. SN visit notes for the recertification period included 10//29/2025 evidenced a medication setup was provided by the Administrator/CM. The record failed to evidence communication notes in regard for verbal orders and failed to obtain verbal orders for the medication set-up conducted during the initial certification period 08/19/2025 through 10/17/2025, for the SN visits on 08/26/2025 and 09/02/2025, and for the recertification period 10/18/2025 through 12/16/2025 for the SN visit on 10//29/2025. 6. A review of the clinical record of Patient #7 contained a POC signed by RN 1 for the initial certification period of 08/15/2025 through 10/13/2025 indicated medications were but not limited to Ozempic subcutaneous solution Pen-injector 2 MG/1.5ML 1 time weekly subcutaneous injection. DME supplies listed but not limited to: G-7 for blood sugar monitoring. SN services were to be provided every 7 days for a medication set-up, which had been returned and signed by the ordering physician on 11/26/2025. SN visit notes signed by RN 1 for the initial certification period evidenced: 08/21/2025 evidenced the G-7 sensor was replaced, 08/28/2025 a medication set-up was conducted, 09/04/2025 Ozempic was administered and a medication set-up was conducted, 09/11/2025 a medication set-up was conducted, 09/18/2025 a medication set-up was conducted, Ozempic was administered, and the G7 sensor was replaced; 09/25/2025 Ozempic was administered and medication set-up was conducted, 10/02/2025 Ozempic was administered, and 10/09/2025 Ozempic was administered and medication set-up was conducted. A review of the clinical record of Patient #7 evidenced a POC signed by RN 1 for the initial certification period of 10/14/2025 through 12/12/2025 indicated medications were but not limited to Ozempic subcutaneous solution Pen-injector 2 MG/1.5ML 1 time weekly subcutaneous injection. DME supplies listed but not limited to: G-7 for blood sugar monitoring. SN services were to be provided every 7 days for a medication set-up, which had been returned and signed by the ordering physician on 11/26/2025. SN visit notes signed by RN 1 for the recertification period evidenced: 10/16/2025 Ozempic was administered, 10/23/2025 Ozempic was administered, 10/30/2025 Ozempic was administered, 11/06/2025 Ozempic was administered, 11/13/2025 Ozempic was administered, 11/20/2025 Ozempic was administered, 11/27/2025 Ozempic was administered, and 12/04/2025 Ozempic was administered and a medication set-up was conducted. The clinical record failed to evidence communication notes in regard for verbal orders and failed to obtain verbal orders for the medication set-up, Ozempic administration, and changing the Dexcom sensor device prior to all SN visits which occurred between the initial certification period 08/15/2025 through 10/13/2025 and the recertification period 10/14/2025 through 12/12/2025 for the SN visits on 10/16/2025, 10/23/2025, 10/30/2025, 11/06/2025, 11/13/2025, 11/20/2025, 11/27/2025, and 12/04/2025. The record failed to evidence orders on the POC for both certification periods for the SN to administer Ozempic and change the Dexcom G-7 sensor. 7. A review of the clinical record of Patient #8 contained a POC signed by RN 1 for the initial certification period of 08/15/2025 through 10/13/2025 indicated medications but not limited to Trulicity (works by mimicking a natural hormone to stimulate insulin release after eating, slow digestion, and reduce liver sugar production, approved for adults with type 2 diabetes who have established cardiovascular disease) Subcutaneous Solution Pen-injector 4.5 mg/0.5ML Inject 0.5 subcutaneous weekly and DME supplies were but not limited to Dexcom G-7 sensor device. SN services were to be provided for a medication set-up every 7 days which was signed and returned by the ordering physician on 11/24/2025. The clinical record evidenced an order dated 08/20/2025 and signed by RN 1 stated, “Skilled Nurse to treat after initial home health assessment” was returned, signed by the ordering physician on 10/08/2025. SN visit notes signed by RN 1 for the initial certification period evidenced: 08/21/2025 G-7 sensor device replaced and Trulicity administered, 09/04/2025 replaced G-7 sensor device and a medication set-up was conducted, 09/11/2025 replaced G-7 sensor device and administered Trulicity, 09/18/2025 a medication set-up was conducted, 10/02/2025 a medication set-up was conducted, and 10/09/2025 a medication set-up was conducted. A review of the clinical record of Patient #8 contained a POC signed by RN 1 for the recertification period of 10/14/2025 through 12/12/2025 indicated medications but not limited to Trulicity Subcutaneous Solution Pen-injector 4.5 mg/0.5ML Inject 0.5 subcutaneous weekly and DME supplies were but not limited to Dexcom G-7 sensor device. SN services were to be provided for a medication set-up every 7 days which was signed and returned by the ordering physician on 11/25/2025. SN visit notes signed by RN 1 for the recertification period evidenced: 10/16/2025 replaced G-7 sensor device and administered Trulicity, 10/23/2025 replaced G-7 sensor device and administered Trulicity, 10/30/2025 administered Trulicity, 11/06/2025 administered Trulicity and a medication set-up was conducted, 11/13/2025 administered Trulicity, 11/20/205 administered Trulicity and a medication set-up was conducted, 11/27/2025 The clinical record failed to evidence communication notes in regard to verbal orders and failed to obtain verbal orders for medication set-up, Trulicity administration, and changing the Dexcom sensor device prior to all SN visits which occurred between the initial certification period 08/15/2025 through 10/13/2025 and the recertification period 10/14/2025 through 12/12/2025 for the SN visits on 10/16/2025, 10/23/2025, 10/30/2025, 11/06/2025, 11/13/2025, and 11/20/2025. The record failed to evidence orders on the POC for both certification periods for the SN to administer Trulicity and change the Dexcom G-7 sensor. 8. A review of the clinical record of Patient #9 contained a POC signed by RN 1 for the initial certification period of 08/14/2025 through 10/12/2025 indicated SN services 1 time a week for medication set-up and added verbal order on 08/28/2025 SN to clean lower extremities with wound cleanser, pat dry, massage ammonium lactate lotion into skin, wrap with gauze roll, secure bandage with tape weekly. SN to assess for signs of infection and report to ordering physician, which was returned signed by the ordering physician on 11/24/2025. The clinical record evidenced an order dated 08/16/2025, effective 09/02/2025 and signed by RN 1 on 09/02/2025 stated, “Consent for Harmony Heights Skilled Nurse to treat after completion of assessment for homehealth services” was returned, signed by the ordering physician on 09/03/2025 A verbal order dated 10/02/2025, signed by RN 1 stated, “Effective now, Skilled Nurse or Caregiver to rub Aquaphor ointment on lower extremities affected areas daily to prevent mild irritation and skin breakdown”. SN visit notes signed by RN 1 for the initial certification period evidenced: 08/28/2025 wound care was provided, 09/01/2025 wound care was provided and medication set-up, 09/04/2025 wound care was provided and medication set-up, 09/08/2025 wound care was provided, 09/11/2025 wound care was provided, 09/15/2025 wound care was provided, 09/18/2025 wound care was provided, 09/18/2025 wound care was provided, 09/22/2025 wound care was provided, 09/25/2025 wound care and medication set-up was provided, 09/29/2025 wound care was provided, 10/02/2025 wound care and medication set-up was provided, 10/06/2025 wound care and medication set-up was provided, and10/09/2025 wound care and medication set-up was provided. A review of the clinical record of Patient #9 contained a POC signed by RN 1 for the recertification period of 10/13/2025 through 12/11/2025 indicated SN services 1 time a week for medication set-up. SN 2 times a week to rub Aquaphor ointment on lower extremities to prevent mild irritation and skin breakdown, returned signed by the ordering physician on 11/24/2025. The record contained an order dated 11/28/2025 SN visits every 14 days, SN/Caregiver to rub Aquaphor ointment daily. SN visit notes signed by RN 1 for the recertification period evidenced: 10/13/2025 wound care and medication set-up was provided, 10/16/2025 medication set-up was provided, 10/20/2025 wound care and medication set-up was provided, 10/23/2025 wound care and medication set-up was provided, 10/30/2025 wound care and medication set-up was provided, 11/03/2025 wound care and medication set-up was provided, 11/06/2025 wound care and medication set-up was provided, 11/10/2025 medication set-up was provided, 11/13/2025 medication set-up was provided, 11/20/2025 medication set up was provided, 11/24/2025 wound care and medication set-up was provided, 11/28/2025 wound care and mediation set-up was provided, 12/02/2025 wound care and medication set-up was provided. The clinical record failed to evidence communication notes in regard to verbal orders for the medication set-up and failed to obtain verbal orders for medication set-up for the initial certification period of 08/14/2025 through 10/12/2025 for SN visits which evidenced a medication set-up on 08/28/2025, 09/01/2025, 09/04/2025, 09/25/2025, 10/02/2025, 10/06/2025, and 10/09/2025; and the recertification period 10/13/2025 through 12/11/2025 for the SN visits which evidenced a medication set-up on 10/13/2025, 10/16/2025, 10/20/2025, 10/23/2025, 10/30/2025, 11/03/2025, 11/06/2025, 11/10/2025, 11/13/2025, and 11/20/2025. 9. A review of the clinical record of Patient #10 contained a POC signed by the Administrator/CM for the recertification period of 09/29/2025 through 11/27/2025 indicated SN services every 14 days for a medication set-up, returned signed by the ordering provided on 11/13/2025. SN visit notes signed by the Administrator/CM for the initial certification period evidenced medication set-up was provided on the following dates: 10/20/2025, 11/05/2025, 11/19/20/20/25, and 12/08/2025. The clinical record failed to evidence communication notes in regard to verbal orders for the medication set-up and failed to obtain verbal orders for medication set-up for the recertification period of 09/29/2025 through 11/27/2025. 10. On 12/15/2025 at 2:30 PM, after discussion of the above findings, this writer queried the Administrator/CM what happens after the initial assessments or recertification assessments were completed. They indicated they created the POC and sent it to the physician for their signature, when they realized this method was not accurate, they resorted to writing the orders to treat. When queried of the orders to treat, this writer asked if all the information was on the order to treat, to treat the patient, the Administrator/CM indicated the orders were inaccurate, and the clinician completing assessments should reach out to the ordering provider right after the assessment was completed to obtain their verbal orders for care. 410 IAC 17-13-1(a)

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure all verbal orders included the time the verbal order was obtained with the clinician’s signature and date the order received with 9 of 10 patients receiving SN services (Patients #1, 2, 3, 4, 5, 6, 8, 9, and 10) Findings include: 1. A review of a policy titled ‘Verbal Orders Policy Number C:63’ stated, “… Procedure … a. Who is going to do it (the discipline to render the services) b. how often the services is to be performed (the frequency of the services) … Date/time the verbal order is taken by agency professional … The orders must be signed and dated with the date of receipt by the nurse …” 2. A review of the clinical record of Patient #1 contained the following verbal orders (VO): a VO written 07/30/2025 for consent for skilled nurse to treat patient following initial assessment, signed and dated 09/16/2025 by the ordering provider, and signed and dated by the Administrator/CM on 07/30/2025, failed to evidence the time the VO was received; a VO written on 09/12/2025, for an addendum to the POC was signed and dated 09/12/2025 by the Administrator/CM and signed and dated by the ordering provided on 09/16/2025, failed to evidence the time the VO was received; a VO written on 08/14/2025 for an addendum to the POC was signed and dated by the Administrator/CM on 08/14/2025, signed by the ordering provider on 09/16/2025 failed to evidence a time the VO was received; a VO written on 11/02/2025 for an addendum to the POC was signed and dated by the Administrator/CM on 11/02/2025, signed by the ordering provider on 11/06/2025 failed to evidence the time the VO was received; a VO written on 11/06/2025 for Doxycycline Hyclate (an antibiotic) 100 mg capsule 1 capsule BID for 10 days (was prescribed on 10/26/2025, Patient #1 completed on 11/05/2025) signed and dated 11/22/2025 by the Administrator/CM and signed and dated by the ordering provided on 11/25/2025; a VO written on 12/01/2025 for Doxycycline Hyclate 100 mg 1 capsule by mouth two times a day for 10 days, signed and dated 12/02/2025 by the Administrator/CM, failed to evidence the time the VO was received. 3. A review of the clinical record of Patient #2 contained the following VO: a VO written 11/21/2025 for addendums to update the POC for the initial certification period 08/16/2025 through 10/14/2025 and the recertification period of 10/15/2025 through 12/13/2025, signed and dated 11/21/2025 by the Administrator/CM, signed by the ordering provider on 12/02/2025, failed to evidence a time the order was received; and a VO written on 11/25/2025 for Furosemide (known as a water pill, used to treat edema) 20mg tablet take 1 tablet by mouth daily was signed and dated 12/05/2025 by the Administrator/CM, failed to evidence the time the VO was received. 4. A review of the clinical record of Patient #3 contained the following VO: a VO written on 09/11/2025 for consent for skilled nursing to treat following evaluation, signed and dated 09/10/2025 by the Administrator/CM, signed by the ordering provided on 09/22/2025 failed to evidence the time the VO was received; a VO written on 10/04/2025 for Gabapentin (used to control seizures and relieve specific types of nerve pain) 300 mg 1 capsule by mouth 3 times daily for 14 days, signed and dated 10/10/2025 by the Administrator/CM, signed by the ordering provided on 10/17/2025, failed to evidence the time the VO was received; a VO written on 09/18/2025 for SN to apply 4 x 4 gauze with tape to incisions as needed for drainage, signed and dated 09/18/2025 by the Administrator/CM, signed by the ordering provider on 09/25/2025, failed to evidence the time the VO was received; and a VO written on 09/18/2025 for SN to wrap Patient #3 right leg, from the foot to knee with ace bandage as needed for calf swelling, signed and dated by the Administrator on 09/18/2025, signed by the ordering provided on 09/09/2025, failed to evidence the time the VO was received. 5. A review of the clinical record of Patient #4 contained the following VO: a VO written on 11/21/2025 for addendum to the initial certification period of 08/19/2025 through 10/17/2025 and the recertification period of 10/18/2025 through 12/16/2025, signed and dated 11/21/2025 by the Administrator/CM, signed by the ordering provider on 11/26/2025, failed to evidence the time the VO was received. 6. A review of the clinical record of Patient #5 contained the following VO: a VO written on 11/28/2025 for an addendum to the recertification period of 11/28/2025 through 01/26/2025, SN to set up medications biweekly was signed and dated 11/28/2025 by the Administrator/CM, signed by the ordering provided on 12/02/2025, failed to evidence the time the VO was received; a VO written on 11/02/2025 for an addendum to the POC for the recertification period of 09/29/2025 through 11/27/2025 for SN medication set-up biweekly, signed and dated 11/02/2025 by the Administrator/CM, signed by the ordering provider on 11/04/2025, failed to evidence the time the VO was received; and a VO written on 08/01/2025 for SN to treat patient following the initial evaluation was signed and dated 08/01/2025 by the Administrator/CM, signed by the ordering provider on 09/09/2025, failed to evidence a time the VO was received. 7. A review of the clinical record of Patient #6 contained the following VO: a VO written on 08/19/2025 for SN to treat patient following the initial assessment, signed and dated 08/19/2025 by the Administrator/CM on 08/19/2025, signed by the ordering provider on 09/05/2025, failed to evidence the time the VO was received. 8. A review of the clinical record of Patient #8 contained the following VO: a VO written on 11/21/2025 for addendums to the POC for the initial certification period of 08/14/2025 through 10/13/2025 and for the recertification period of 10/14/2025 through 12/12/2025 was signed and dated 11/22/2025 by the Administrator/CM, signed by the ordering provider on 11/24/2025, failed to have the time the VO was received, 9. A review of the clinical record of Patient #9 contained the following VO: a VO written on 11/28/2025 for addendum to the POC for the recertifcation period of 10/13/2025 through 12/11/2025 signed and dated 12/01/2025 by the Administrator/CM, failed to evidence the time the VO was received. 10. A review of the clincial record of Patient #10 contained the following VO: a VO written on 09/04/2025 for the SN to treat patietn following the initial assessment, signed and dated 07/31/2025 by the Administrator/CM, signed by the ordering provider on 09/22/2025, failed to evidence the time the VO was received; a VO written on 09/26/2025 for Lisinopril-HCTZ (used for blood pressure and to treat edema) 12.5-10mg 2 tables per day by mouth, check blood pressure 1 to 2 times a day, go to the emergency room if complaints of shortness of breath and/or chest pain, signed and dated 09/26/2025 by the Administrator/CM, signed by the ordering provider 11/19/2025, failed to evidence the time the VO was received; and a VO written on 12/08/2025 for ciprodex (ear drops to treat bacterial infections) 4 drops 2 times a day for 10 days signed and dated 12/08/2024 by the Administrator/CM, failed to evidence the time the VO was received. 11. On 12/15/2025 at 2:50 PM, after the discussion of the above findings, the Administrator/CM indicated all verbal orders should be read back to the ordering provider, should have the date and time received, the clinician who received the order should sign the day the order was received. 410 IAC 17-14-1(a)(1)(H)

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 Agency failed to ensure the Governing Body approved the frequency and detail of the Quality Assurance Performance Improvement (QAPI) program. Findings include: 1. A review of a policy titled ‘Governing Body Policy Number CO: 7 stated “… Responsible for the establishment, oversight & active participation in the Agency the Quality Assurance Performance Improvement program ...” 2. A review of the Governing Body meeting and minutes on 04/29/2024, 05/13/2024, 02/10/2025, 02/24/2025, 06/09/2025, 07/21/2025, and 10/28/2025 failed to evidence frequency and detail of the QAPI program. 3. On 12/15/2025 at 2:30 PM, when queried as to what the Governing Body was responsible for, the Administrator indicated policies, approving/appointing Administrative staff, fiscal responsibilities, and QAPI. When queried if the Governing Body had approved the frequency and detail of the QAPI program, the Administrator indicated they had talked about it but failed to document it. 410 IAC 17-12-2(a)

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure their clinicians adhered to standard precautions to prevent the transmission of infections and communicable diseases through proper hand hygiene, gloving, and bag technique during 2 of 2 RN home visit observations. (RN 1 and Administrator/CM) Findings Include: 1. A review of a policy titled ‘Bag Technique: Nursing Policy Number C: 8’ stated, “…never set the visit bag on …. Couch … Close the bag before performing patient care … wash your hands again if you need to re-enter the bag for additional supplies …” 2. A review of a policy titled ‘Hand Hygiene Policy Number C:30’ stated, “… clean hands before and after patient care and with each glove change. Clean hands prior to entering the clean section of the visit bag …” 3. On 12/11/2025 at 12:35 PM, during a home visit to observe the Administrator/CM provide wound care for Patient #3, the Administrator/CM was observed performing hand hygiene, donned gloves, placed barriers on an ottoman, placed nursing bag on the barrier, created 2 other barriers, placed supplies and wipes on 1 barrier. The Administrator/CM removed doffed gloves, donned gloves without performing hand hygiene. The Administrator/CM initiated the physical assessment on Patient #3, doffed gloves when completed, reached into their nursing bag, obtained a pair of clean gloves, donned gloves without performing hand hygiene, cleaned supplies, removed gloves, reached into their bag to obtain another pair of clean gloves, donned gloves without performing hand hygiene, then removed Patient #3’s socks assessed pedal pulse bilaterally, and used an elastic bandage to wrap Patient #3’s right lower extremity. After completion of visit, the Administrator/CM cleaned the area, pulling the barrier out under their nursing bag, placing the bag directly on ottoman. On 12/11/2025 at 1:25 PM, the Administrator/CM indicated hand hygiene should be performed between glove changes, hand hygiene prior to entering nurse bag, and nursing bag should always be on a barrier. When this writer discussed the above findings, the Administrator/CM indicated they had not performed appropriate hand hygiene during the visit. On 12/11/2025 at 3:32 PM, during a home visit to observe RN 1 provide a medication set-up for Patient #2, RN 1 began by washing hands at the kitchen sink, created a barrier, place their nursing bag on the barrier, placed the scale on the floor, a barrier on the bed, where supplies were placed, then without hand hygiene reached into their nursing bag to retrieve gloves. Vital signs taken, lung sounds bowel sounds, lower extremities assessed Equipment cleaned, placed on clean barrier to dry. Without hand hygiene, gloves were donned to set-up medications. All medications set-up on counter, containers filled, removed gloves, and without hand hygiene closed the pill containers. On 12/16/2025 at 12:35 PM, RN 1 indicated they should always perform hand hygiene after removing gloves. 410 IAC 17-12-1(m)

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 CM failed to ensure the HHA followed the HHA POC with 1 of 3 patients who received HHA services. (Patient #2) (HHA 1) Findings include: 1. A review of a policy titled “Supervision: Clinical Staff Policy Number P:37” stated, “… Supervision must ensure … Aides are furnishing care … following the established, written POC for completion of tasks …” 2. A review of the clinical record of Patient #2 contained a document titled ‘Aide Plan of Care’ signed by the Administrator/CM, effective 08/16/2025 indicated HHA visits were to be completed 2 times a week for the initial certification period of 08/16/2025 through 10/14/2025. The following tasks were to be completed at each HHA visit included: blood pressure to be taken, foot care, put socks on, light laundry, light housekeeping, meal preparation, shower, and medication reminder. HHA visit notes for the initial certification period indicated: 08/19/2025 failed to provide foot care, meal preparation, and to apply socks, indicated “feet good”; 08/22/2025 failed to provide foot, meal preparation, and to apply socks, indicated “feet good”; 08/26/2025 failed to provide foot care, meal preparation, and to apply socks; 08/29/2025 failed to provide foot care, meal preparation, and to apply socks; 09/02/2025 failed to provide foot care, meal preparation, and to apply socks; 09/05/2025 failed to provide foot care, meal preparation, and failed to apply socks; 09/09/2025 failed to provide foot care, to apply socks, and meal preparation,; 09/12/2025 failed to provide foot care, to apply socks, and meal preparation; 09/16/2025 failed to provide foot care, to apply socks, meal preparation, and failed to provide light housekeeping, 09/19/2025 failed to provide foot care, to apply socks, to provide meal preparation, and light housekeeping; 09/23/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 09/26/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 09/30/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 10/03/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 10/07/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 10/10/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; and 10/14/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry. A review of the clinical record of Patient #2 contained a document titled ‘Aide Plan of Care’ signed by the Administrator/CM, effective 10/15/2025 indicated HHA visits were to be completed 2 times a week for the recertification period of 10/15/2025 through 12/13/2025. The following tasks were to be completed at each HHA visit included: blood pressure to be obtained, foot care, put socks on, light laundry, light housekeeping, meal preparation, shower, and medication reminder. HHA visit notes for the recertification period indicated: 10/17/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 10/21/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 10/24/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 10/28/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 10/31/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 11/04/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 11/07/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 11/11/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 11/14/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 11/18/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 11/21/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 11/25/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 11/28/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry; 12/02/2025 failed to provide foot care, to apply socks, and to provide meal preparation; 12/05/2025 failed to provide foot care, to apply socks, to provide meal preparation, and laundry. On 12/15/2025 at 12:10 PM, HHA 1 indicated they hadn’t realized they need to address items marked on the HHA POC with each visit. On 12/15/2025 at 12:15 PM, after discussing the above findings with the Administrator/CM, they indicated the aide did not follow the HHA POC. 410 IAC 17-13-2(a)

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 Agency failed to ensure the Governing Body approved the Agency’s budget, and failed to provide establishment, oversight and active participation in the Agency’s Quality Assurance Performance Improvement (QAPI) program (see G0942), failed to ensure the Governing Body appointed and approved the acting Administrator, the acting Alternate Administrator (see G0946), failed to be responsible for the day-to-day operations (see G0948). 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 484.105 Condition of Participation: Organization and Administration of Services, with the potential to affect all 10 current patients receiving Home Health services from this provider. * 410 IAC 17-12-1(a)(1)(2)

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Governing Body approved the Agency’s budget, and failed to provide establishment, oversight and active participation in the Agency’s Quality Assurance Performance Improvement (QAPI) program with 1 of 1 Agency. Findings include: 1. A review of a policy titled ‘Governing Body Policy Number CO: 7’ stated, “… Responsibilities of the GB include … establishment, oversight and active participation in the Agency QA program … approval of budgets …" 2. A review of the Governing Body minute meetings on 04/25/2024, 05/13/2024, 02/10/2025, 02/24/2025, 06/09/2025, 07/21/2025, and 10/28/2025 failed to evidence QAPI was discussed and failed to approve a budget. 3. On 12/11/2025 at 10:35 AM, when queried for Governing Body approval for the budget and which meeting the Governing Body established or participated with the QAPI program, the Administrator indicated there were no meetings to reflect the above. 410 IAC 17-12-1(b)

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) Standard: Administrator. The administrator must: (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 Agency failed to ensure the Governing Body appointed and approved the acting Administrator, the acting Alternate Administrator with 1 of 1 Agency. Findings include: 1. A review of a policy titled ‘Governing Body Policy Number CO: 7’ stated, “… Responsibilities of the GB include … appoint a … Administer/Alternate to oversee all operations …” 2. A review of the Governing Body minute meetings on 04/25/2024, 05/13/2024, 02/10/2025, 02/24/2025, 06/09/2025, 07/21/2025, and 10/28/2025 evidence the acting Administrator and Alternate Administrator were approved and appointed. 3. On 12/11/2025 at 10:35 AM, when queried for Governing Body which meeting was conducted to approve the acting Administrator and Alternate Administrator, the Administrator indicated there was not a meeting to reflect the above. 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 the day-to-day operations of 1 of 1 home health agency. Findings include: In regard to the individualized care planning, coordination of services, and quality of care: 1. The Administrator failed to ensure they provided the ordering provider notification of missed SN visits patients receiving SN services for medication set-up (see G572), failed to obtain verbal orders prior to providing medication set-ups, failed to obtain orders to administer injections to patients, failed to obtain orders to administer a glucose monitoring system (see G580), and failed to ensure all verbal orders included the time the verbal order was obtained with the clinician’s signature with the date the order received (see G584). In regard to Home Health Aide Services: 1. The Administrator failed to ensure the aide had completed their skills competency with a patient (see G798) In regard to patient safety: 1. The Administrator failed to ensure the comprehensive assessment was updated after a change in condition (see G546) 2. The Administrator failed to ensure their clinicians adhered to standard precautions to prevent the transmission of infections and communicable diseases through proper hand hygiene, gloving, and bag technique (see G682). 410 IAC 17-12-1(c)(1)