Caregivers, Inc.

“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 services were provided per the POC (See G0572); the services were provided only as ordered by physician (See G0580); notify the physician of not meeting the POC (See G0590); and coordination of care for all services provided to the patient (See G0606); and failed to provide patients/caregivers with a visit schedule (See G0614). 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, with the potential to affect all 191 current patients receiving Home Health services from this provider. Findings Include: 410 IAC 17-13-1(a) *”

“Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This Condition is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the clinical staff followed infection control guidelines in 4 of 4 home visits (See G0682); and failed to ensure they developed and maintained an agency-wide infection control program outlining surveillance, identification, prevention, control, and investigation of all infectious and communicable diseases. (See G 0684) The cumulative effects of these systemic problems resulted in the agency’s inability to ensure patients are protected from infectious diseases or improper infection control practices for the Condition of Participation of 42 CFR §484.70, Infection prevention and control, with the potential to affect all 191 current patients receiving Home Health services from this provider. Findings Include: *”

“Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to submit OASIS within 30 days of assessment completion for 3 of 7 active clinical records reviewed (Patients: #6, 7, and 11) and 5 of 5 inactive clinical records reviewed. (Patients: #8, 9, 10, 12, and 13) Findings Include: 1. A review of an undated agency policy titled “Encoding and Reporting OASIS Data” indicated, but was not limited to, “ … Caregivers, Inc. will electronically report all OASIS data collected in accordance with federal regulations … Caregivers, Inc. will encode individual patient assessment data within thirty (30) days of completing the comprehensive assessment … ” 2. During the entrance conference on 01/05/2026 at 9:30 AM, when queried regarding the submissions of OASIS, the Administrator/Clinical Manager reported Admin 8, the Quality Assurance (QA) Manager, submitted OASIS after review within 30 days of completion. 3. A review of an IQIES report titled “HHA Error Summary By Agency” dated 12/29/2025, report period 12/29/2024 to 12/29/2025, indicated but was not limited to, Caregivers, Inc. had the error number -3330, error description: Record submitted late: The submission date is more than 30 days after M00090 on this new record. # of assessments with error: 275 out of 915 records processed, a percentage of 30.5% with error. 4. A review of an agency document titled “OASIS (a comprehensive assessment designed to collect information related to a home care recipient’s demographic, clinical, functional, and service needs) Agency Final Validation.” The documents were for the reporting period of 12/29/2024 to 12/29/2025 the year to date, which indicated but was not limited to untimely submission errors reported to Caregivers, Inc, as the following: the active records for Patient #6 had a section titled “RFA” (Reason For Assessment) listed as 01, indicating SOC OASIS assessment had been submitted on 12/05/2025 and the M0090 date (date of completion) of 10/15/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record; Patient #7 had a section titled RFA listed as 01, indicating SOC OASIS assessment had been submitted on 12/23/2025 and the M0090 date of 11/17/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record; and Patient #11 had a section titled RFA listed as 01, indicating SOC OASIS assessment had been submitted on 11/14/2025 and the M0090 of 10/10/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record. The inactive records for Patient #8 had a section titled RFA listed as 09, indicating Discharge from Agency OASIS assessment had been submitted on 12/10/2025 and the M0090 date of 03/27/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record; Patient #9 had a section titled RFA listed as 09, indicating Discharge from Agency OASIS assessment had been submitted on 12/23/2025 and the M0090 date of 10/15/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record; Patient #10 had a section titled RFA listed as 09, indicating Discharge from Agency OASIS assessment had been submitted on 12/10/2025 and the M0090 date of 09/23/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record; Patient #12 had a section titled RFA listed as 09, indicating Discharge from Agency OASIS assessment had been submitted on 12/10/2025 and the M0090 date of 04/04/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record; and Patient #13 had a section titled RFA listed as 09, indicating Discharge from Agency OASIS assessment had been submitted on 12/10/2025 and the M0090 date of 06/20/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record. 5. A review of the active clinical record for Patient #6, SOC date 10/15/2025, contained a comprehensive assessment dated 10/15/2025, completed by PT 2. The OASIS Assessment reason was for SOC for the certification period 10/15/2025 to 12/13/2025. The agency failed to evidence the SOC OASIS Assessment had been submitted timely. 6. A review of the active clinical record for Patient #7, SOC date 11/17/2025, contained a comprehensive assessment dated 11/17/2025, completed by PT 1. The OASIS Assessment reason was for SOC for the certification period 11/17/2025 to 01/15/2026. The agency failed to evidence the SOC OASIS Assessment had been submitted timely. 7. A review of the inactive clinical record for Patient #8, discharge date 03/27/2025, contained a comprehensive assessment dated 03/27/2025, completed by PT 1. The OASIS Assessment reason was for discharge from the certification period 02/26/2025 to 04/26/2025. The agency failed to evidence the discharge OASIS Assessment had been submitted timely. 8. A review of the inactive clinical record for Patient #9, discharge date 03/27/2025, contained a comprehensive assessment dated 10/15/2025, completed by RN 1. The OASIS Assessment reason was for discharge from the certification period 08/19/2025 to 10/17/2025. The agency failed to evidence the discharge OASIS Assessment had been submitted timely. 9. A review of the inactive clinical record for Patient #10, discharge date 03/27/2025, contained a comprehensive assessment dated 03/27/2025, completed by RN 3. The OASIS Assessment reason was for discharge from the certification period 08/15/2025 to 10/13/2025. The agency failed to evidence the discharge OASIS Assessment had been submitted timely. 10. A focused review of the active clinical record for Patient #11, SOC date 10/10/2025, contained a comprehensive assessment dated 10/10/2025, completed by PT 1. The OASIS Assessment reason was for SOC for the certification period 10/10/2025 to 12/08/2025. The agency failed to evidence the SOC OASIS Assessment had been submitted timely. 11. A review of the inactive clinical record for Patient #12, discharge date 03/27/2025, contained a comprehensive assessment dated 04/04/2025, completed by PT 1. The OASIS Assessment reason was for discharge from the certification period 02/25/2025 to 04/25/2025. The agency failed to evidence the discharge OASIS Assessment had been submitted timely. 12. A review of the inactive clinical record for Patient #13, discharge date 03/27/2025, contained a comprehensive assessment dated 06/20/2025, completed by PT 2. The OASIS Assessment reason was for discharge from the certification period 04/29/2025 to 06/27/2025. The agency failed to evidence the discharge OASIS Assessment had been submitted timely. During an interview on 01/05/2026 at 11:55 AM, when asked about the OASIS submissions and timeline, the Administrator and Admin 8 confirmed that the OASIS should be submitted within 30 days of the comprehensive assessment M0090 date of completion. Admin 8 communicated they had issues with untimely submissions due to late clinician documentation and their move to their new office. Admin 8 further indicated they had untimely submissions in 2024 as well and had reported the issue to the Administrator. When asked for the 2024 process improvement plan for OASIS untimely submissions, the Administrator failed to provide evidence from the previous application the agency used to document QAPI and meetings.”

“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 patients were provided services as ordered in the POC for 3 of 6 active records reviewed. (Patients: #3, 4, and 5) and 2 of 2 inactive records reviewed. (Patient: #6, and 7) Findings Include: 1. A review of an undated agency policy titled “Medical Supervision” indicated, but was not limited to, “ … A Physician Plan of Care is developed for each Client … The physician’s orders shall outline the disciplines providing care and the type, frequency, and duration of services to be provided … ” 2. A review of the clinical record for Patient #3, SOC 04/29/2024, contained a POC for the certification period from 12/20/2025 to 02/17/2026. The POC indicated Patient #3 had a primary diagnosis of Quadriplegia (a condition caused by an injury to the spinal cord, causing paralysis affecting all four limbs). Patient #3 had orders for SN 3 times a week for cardiopulmonary assessments, wound care to wound #1, pubis area above suprapubic catheter (pressure ulcer), wound care to wound #2, coccyx wound care to wound #3 midline coccyx, and wound care to wound #4 right distal coccyx, bowel program, and catheter changes. A review of the SN visit notes for the week of 12/27/2025 to 01/02/2026 failed to evidence a SN visit had been made. During an interview on 01/08/2026 at 11:10 AM, with the Administrator/Alternate Clinical Manager, RN 2, the case manager for Patient #3, and LPN 2, when asked about the missed SN visits for the week of 12/29/2025 to 01/02/206 cancelled by the agency, LPN 2 communicated they had car issues and had notified the Administrator/Alternate Clinical Manager. 3. A review of the clinical record for Patient #4, SOC 12/08/2025, contained a POC for the certification period from 12/08/2025 to 02/05/2026. The POC indicated Patient #4 had a primary diagnosis of Alcoholic Polyneuropathy (a condition caused by prolonged and heavy consumption of alcohol, causing nerve damage to the peripheral nerves throughout the body to malfunction simultaneously). Patient #4 had orders for PT one time a week for one week, two times a week for two weeks, and one time a week for 5 weeks, for therapeutic exercise, endurance training, transfer training, balance training, gait training, and pain management. A review of the PT visit notes evidenced the following: the week of 12/8/2025 to 12/12/2025, PT 1 completed the SOC on 12/08/2025; the week of 12/13/2025 to 12/19/2025, no PT visits were made; the week of 12/20/2025 to 12/26/2025, no PT visits were made; the week of 01/03/2026 to 01/08/2026, PT completed a visit on 01/05/2026. During an interview on 01/08/2026 at 1:35 PM, when asked about the missing PT visits for Patient #4, PT 1 communicated they were waiting for the office to make them aware they had authorization from the insurance company. 4. A review of the clinical record for Patient #5, SOC 11/20/2025, contained a POC for the certification period from 11/20/2025 to 01/10/2026. The POC indicated Patient #5 had a primary diagnosis of Type 2 Diabetes Mellitus (a chronic condition affecting the body’s inability to regulate and process sugar in the bloodstream, causing high blood sugars). Patient #5 had orders for PT: one time per week for one week, then two times per week for 8 weeks, for therapeutic exercise, endurance training, transfer training, balance training, gait training, and pain management. Patient #5 had orders for a HHA 3 times a week for 7 weeks, starting 11/26/2025, for ADL and personal care assistance. A review of an agency document titled “Paraprofessional Assignment Sheet” signed and dated 11/26/2025 by PT 2, contained a care plan start date of 11/26/2025 for Patient #5 to receive HHA services with a frequency of 3 times a week for 8 weeks, two hours per service for assistance in ADLs of bathing, dressing, every Monday, Wednesday, and Friday. A review of the HHA visit notes evidenced the following: the week of 11/22/2025 to 11/28/2025, no HHA visits were completed, and the week of 11/29/2025 to 12/05/2025, no HHA visits were completed. During an interview on 01/08/2026 at 1:35 PM, when asked about the missing HHA visits for Patient #5, PT 2 communicated they were waiting for the office to make them aware they had authorization from the insurance company. 5. A review of the inactive clinical record for Patient #6, SOC 10/15/2025, and date of discharge 12/28/2025, contained a POC for the certification period from 10/15/2025 to 12/13/2025. The POC indicated Patient #6 had a primary diagnosis of Spastic Quadriplegic Cerebral Palsy (a condition causing increased muscle tone, causing muscle stiffness, and involuntary muscle movements). Patient #6 had orders for PT: one time a day for one day, one time a week for one week, and two times a week for 7 weeks, for balance training, transfer training, bed mobility training, and establishing a home exercise program. A review of the PT visit notes evidenced the following: the week of 10/15/2025 to 10/17/2025, PT 1 completed the SOC on 10/15/2025 and a visit on 10/17/2025; the week of 10/18/2025 to 10/24/2025, PT visits were completed 10/21/2025 and 10/23/2025; the week 10/25/2025 to 10/31/2025, no PT visits were completed; the week 11/01/2025 to 11/07/2025 no PT visits were completed; the week 11/08/2025 to 11/14/2025 no PT visits were completed; the week 11/22/2025 to 11/28/2025 a PT visit had been completed on 11/24/2025, and discharge visit completed 11/28/2025. During an interview on 01/08/2026 at 1:35 PM, when asked about the missing PT visits for Patient #7, PT 2 stated they were waiting for the office to notify them of authorization from the insurance company. When asked about notification to the MD regarding the POC PT frequency not being followed, PT 2 stated, “No, they did not notify the patient’s MD or obtain a hold services order regarding PT visits not being completed per the POC. 6. A review of the clinical record for Patient #7, SOC 11/17/2025, contained a POC for the certification period from 11/17/2025 to 01/15/2026. The POC indicated Patient #7 had a primary diagnosis of Type 2 Diabetes Mellitus with Diabetic Polyneuropathy (a chronic condition that occurs when the body fails to produce insulin to control blood sugar levels in the bloodstream, causing nerve damage due to prolonged high blood sugar levels). Patient #7 had orders for PT one time a week for 5 weeks for therapeutic exercise, endurance training, transfer training, balance training, gait training, and pain management. A review of the PT visit notes evidenced the following: for the week of 11/17/2025 to 11/21/2025, PT 1 completed the SOC on 11/17/2025; the clinical record failed to evidence any further visits had been completed. During an interview on 01/08/2026 at 3:00 PM, when asked about the missing PT visits for Patient #6, and the location of the hold order or notification to the patient’s MD regarding PT 1, it was communicated they were waiting for the office to make them aware they had authorization from the insurance company. 410 IAC 17-13-1(a)”

“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 agency failed to ensure the agency tracked and analyzed adverse patient events and implemented actions to prevent adverse events for 1 of 1 agency. Findings Include: 1. A review of an undated agency policy titled “Quality Assessment and Performance Improvement (QAPI)” indicated but was not limited to, “Agency shall establish a performance improvement plan to continuously measure, assess, and improve the performance of clinical and other processes … To monitor the effectiveness and safety of services and the quality of care; To identify opportunities for improvement in ... care, treatment, and services; … To reduce factors that contribute to unanticipated adverse events and/or outcomes … ” 2. A review of the of the agency’s IQIES report titled “Potentially Avoidable Event Report” dated for current period for10/2024 to 09/2025, indicated the agency had a potentially avoidable events with one patient having to seek emergent care for hypo/hyperglycemia (low/high blood sugar) and one patient had an increase in number of pressure ulcers. 3. A review of the agency’s IQIES report titled “Potentially Avoidable Event: Patient Listing Report” dated for the current period for10/2024 to 09/2025, indicated inactive Patient #14, SOC 11/11/2024, and transfer/discharge date 12/24/2024 had been treated for emergent care for Hypo/Hyperglycemia. The report further evidenced Patient #15 SOC 11/28/2023, and transfer/discharge date of 05/20/2025, with an increase in the number of pressure ulcers. During an interview on 01/08/2026 at 9:10 AM, when asked about tracking patient avoidable events or adverse events for the agency, the Administrator communicated they had not tracked adverse events and were unaware of the IQIES reports for monitoring agency information. When shown the IQIES report of the patient listing, it confirmed they were aware of Patient #14 with the blood sugar issues and Patient #15’s wounds. The Administrator further confirmed they had not reviewed the adverse events in the QAPI meeting and could not provide QAPI data for 2024. 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 the clinical staff followed the agency’s policies for infection control practices, performing wound care, the use of reusable medical equipment, hand hygiene, and gloving in 4 of 4 home visit observations. (Employees: Administrator/Alternate Clinical Manager, LPN 1, PT 1, and HHA 1) Findings include: 1. A review of an undated agency policy titled “Infection Prevention/Control” indicated, but was not limited to, “Policy: Caregivers, Inc. will observe the recommended precautions for home care as identified by the Centers for Disease Control and Prevention (CDC). ... Caregivers, Inc. will have an infection prevention and control component to the infection program. This program will evaluate which client populations are at risk and implement processes as needed. Purpose: ... To reduce the risk of transmission of microbes from both recognized and unrecognized sources of infection … 2. Hands are washed if contaminated with blood or body fluids, immediately after gloves are removed, between client contacts, and when indicated, to prevent the transfer of microorganisms between clients or the environment. 6. Equipment used for patient care is properly cleaned and reprocessed …” 2. A review of an undated agency policy titled “Wound Care Protocol for Home Healthcare Agency” indicated but was not limited to, “ ... Wound care dressing should be changed according to the wound care plan physician’s instructions, ensuring aseptic techniques are used during the process … Signs of infection, such as increased redness, warmth, or discharge, must be reported to the physician immediately. All supplies used in wound care must be disposed of properly to minimize contamination risks. 3. A review of an undated agency policy titled “Hand Washing” indicated, but was not limited to, “Purpose: To prevent the spread of infection by contaminated hands … CDC recommends routinely washing hands in the following situations: Before contact with clients … After handling contaminated equipment … ” 4. During a home visit at Patient #4’s residence on 01/05/2026 at 4:41 PM, PT 1 was observed in the bathroom washing their hands. After washing their hands, PT 1 turned off the faucet with their clean hands and placed their hands in their jacket pockets. PT 1 then gathered supplies from their bag and placed them on a clean barrier on the patient’s bed. PT 1 did not dry their hands with a paper towel, nor did they use a paper towel to turn off the dirty faucet. PT 1 also failed to perform hand hygiene after turning off the faucet and placing their hands in their jacket pockets before handling clean equipment. During an interview on 01/05/2026 at 5:19 PM, when asked about performing hand hygiene and touching clean and dirty items, PT 1 reported they had turned off the faucet with their bare hands, had dried their hands in their jacket pocket, and should not have touched the dirty faucet with clean hands. 5. During a home visit at Patient #1’s residence, observed the Administrator/Alternate Clinical Manager obtain their blood pressure cuff, thermometer, and container of cleaning wipes from their bag. The Administrator/Alternate Clinical Manager placed the items on Patient #1’s bed without using a clean barrier. RN 1 was observed cleaning the equipment, placing the items back on the bed, obtaining Patient #1’s temperature and blood pressure, and then placing the equipment back on Patient #1’s bed. The Administrator failed to clean the equipment after placing the equipment on Patient #1’s bed, prior to using the equipment on Patient #1, and after using the vital sign equipment. During an interview on 01/06/2026 at 12:00 PM, when asked about infection control and equipment placement during the home visit with Patient #1, the Administrator/Alternate Clinical Manager, stated they had not placed a barrier on the bed for their equipment, and the equipment should had been on a barrier. 6. During a home visit at Patient #3’s residence, on 01/06/2026, at 9:45 AM, observed HHA 1 providing Patient #3 assistance with dressing, transferring to their motorized wheelchair with a slide board. HHA 1 then removed the dirty bed linens and discarded them in the laundry hamper. HHA 1 obtained new bed linens from the bathroom with Patient #4 and proceeded in making Patient #3’s bed. HHA 1 failed to discard their gloves, perform hand hygiene, and don new gloves before obtaining clean linens from Patient #3 and making the bed. During an interview on 01/06/2026 at 10:55 AM, when asked if their gloves should had been removed and hand hygiene performed, HHA 1 communicated they had not changed gloves and performed hand hygiene, when they removed the dirty sheets from Patient #4’s bed and put on new clean sheets and should have done so. 7. During a home visit observation at Patient #2’s residence, on 01/06/2026 at 2:00 PM, observed LPN 1 performing wound care. LPN 1 sprayed wound cleanser on the wound dressing of Patient 2’s scalp wounds to remove the old non-adherent dressings. After removing the dressings and discarding them and their gloves into the trash receptacle. LPN 1 cleansed the 3 wounds with wound cleaner and 4x4 gauze, measured the wounds, then obtained Patient #3’s scissors off the chairside table, and cut the new non-adherent dressings. LPN 1 failed to clean the scissors prior to using them to cut the new non-adherent dressings. Observed LPN 1 opening the gentamicin ointment, dropping the cap on Patient #2’s floor. The LPN applied gentamicin ointment to the non-adherent dressings, then placed the dressings on the patient’s wounds, adhering the wounds to the scalp with steri-strip tape. Observed Patient #2 obtained their reacher, grabbed the cap for the gentamicin ointment, and placed the cap on the tube. LPN 1 failed to obtain the cap for the gentamicin tube, discarding the cap, and replacing it with another means of protective closure. During an interview on 01/06/2025 at 2:40 PM, when asked about using Patient #2’s scissors without cleaning them, and the gentamicin cap falling on the floor and the patient placing the cap back on the tube, LPN 1 stated, “No, the cap should have not been placed back on the gentamicin tube, it was dirty after falling on the floor. I should have used my own scissors. No, I did not clean the patient’s scissors prior to using them on a clean dressing.” 410 IAC 17-12-1(m)”

“Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA’s quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to have an agency wide infection control program for surveillance, identification, prevention, control, and investigation of infectious and communicable diseases, ongoing systematic collection, analysis, interpretation and evaluation for 1 of 1 agency. Findings Include: 1. A review of an undated agency policy titled “Infection Control Surveillance” indicated “Policy: Caregivers, Inc. will establish a continuous data monitoring and collecting system to detect infections or identify changes in infection trends ... Total Surveillance ... Targeted surveillance ... Outbreak surveillance ... The Agency will implement a process of identifying all infections in the client and/ or employee population and evaluate the effectiveness of current control measures, or identify an action plan to improve the incidence of infections. 2. A review of a binder titled “QAPI” contained an agency document dated 05/31/2025, titled “Meeting Minutes Quality Assessment/Quality Assurance” indicating the Administrator/Alternate Clinical Manger facilitated a staff meeting, and established agency specific Quality Assurance tools for chart reviews, incident reporting, falls, medication errors, tracking systems for hospitalization and infection control reporting by June 25, 2025. 3. A review of an agency document dated 12/22/2025, titled “ QAPI Annual Report” prepared by the Administrator/Alternate Clinical Manager with the Governing Body present for oversight, contained in the section titled “ V. Clinical Quality Indicators” subsection “B. Infection Control” that indicated “Infection tracing not formally implemented during 2025 and identified tracking identified as required to develop and implement formal tracking beginning 2026.” During an interview on 01/08/2026 at 9:10 AM, when asked for the infection control logs and QAPI reviews of infections, the Administrator/Alternate Clinical Manager stated the agency did not complete or monitor its infections for 2025 and could not provide the agency’s QAPI or infection control surveillance for 2024. The Administrator communicated they had found the 2018 QAPI review of infections. The Administrator further confirmed they had not been tracking patient or staff infections. 4. A review of an agency document dated 01/18/2018, titled “Performance Improvement Management Team,” noted a regular meeting of the Clinical Management Team reviewed Infectious Reports to include: 0 IV infections, 0 wound infections, 2 Urinary Tract Infections with patients on antibiotics, and one long-term Foley catheter and one with incontinence issues. 5. A review of the clinical record for Patient #1, SOC 01/04/2022, contained a Medication Profile that indicated, but was not limited to, Doxycycline Hyclate (an antibiotic) 100 milligrams (mg), twice a day, with a start date of 02/28/2023, and stop date 03/06/2023; Levaquin ( an antibiotic) 500 mg, 1 time every 48 hours, with a start date of 06/23/2023, and stop date 06/30/2023; Cirpfloxacin (an antibiotic) 500 mg once a day, with a start date of 09/23/2024, and a stop date of 09/25/2024. 6. A review of the clinical record for Patient #2, SOC 07/28/2025, contained a Medication Profile that indicated, but was not limited to, Gentamicin (an antibiotic cream) Sulfate External Cream 0.1%, apply one time a week for wound care scalp, with a start date of 11/24/2025, and Minoazole Nitrate ( an anitfungul powder) external powder 2%, use twice a day for fungal infection, with a start date of 07/28/2025. 7. A review of the clinical record for Patient #3, SOC 04/29/2024, contained a Medication Profile that indicated, but was not limited to, Cephalexin ( an antibiotic) 500 mg twice a day for 7 days, with a start date of 06/19/2024, and a stop date of 08/05/2024. The findings were reviewed with the Administrator/Alternate Clinical Manager and the Director of Clinical Services/Alternate Administrator on 01/08/26 from 3:10 PM to 3:55 PM, during which they had no further information or documentation to provide.”

“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 agency failed to ensure the HHA care plan was individualized and patient-specific for 1 of 1active records reviewed receiving SN and HHA services. (Patient: #3) Findings Include: 1. Review of an undated agency policy titled “Home Health Aide: Assignment” indicated but was not limited to “ ... To meet the Client’s needs for assistance with activities of daily living and personal care. To orient the aide to the Client and to the care plan. To provide direction … 1. The initial assessment for the need for health aide services shall be determined by the authorized nurse/therapist. The assignment of tasks will be identified in the home aide care plan/Assignment Sheet. 2. Factors to be considered shall include, but are not limited to: a. Specific medical and psychological needs of the Client … ” 2. A review of the clinical record for Patient #3, SOC 04/29/2024, contained a POC for the certification period from 12/20/2025 to 02/17/2026. The POC indicated Patient #3 had a primary diagnosis of Quadriplegia (a condition caused by an injury to the spinal cord causing paralysis affecting all four limbs), and other diagnoses included but are not limited to, Autonomic Dysreflexia (a potentially life threatening condition involving abnormal, overreaction of the autonomic nervous system (the network of nerves through your body that control unconscious processes such as breathing, heart beating, blood pressure, and digestion) to certain types of stimulation) leading to severe high blood pressure and other symptoms). Patient #3 had orders for HHA 6 hours daily 7 times weekly, for personal care services of bathing, grooming, dressing and safe transfers. A review of the agency document titled “Paraprofessional Assignment Sheet” electronically signed by RN 2 and dated 12/16/2025, indicated Patient #3 had a diagnosis of Quadriplegia, and HHA frequency of 7 times weekly, two times a day for 3 hours. Clinical findings indicated Patient #3 had paralysis and tired easily, safety precautions, catheter tubing/bag, electric cords, telephone within reach, adequate lighting, frequently used items in reach, clutter in pathways, and followed infection precautions and infection control, but failed to address safety precautions with Patient #4’s autonomic dysreflexia and precautions with preventative causes. During an interview on 01/08/2026 at 11:06 AM, during a conference with RN 2, LPN 2, and the Administrator, when asked about Patient #3’s HHA care plan having interventions for safety precautions HHAs should had provided Patient #3 for safety related to their diagnosis Autonomic Dysreflexia, communicated there were no safety plans or precautions documented for the HHAs to follow or orientation for HHAs who had provided care to Patient #3. When asked what about Patient #3’s episodes and increase in medication due to controlling high blood pressures, verbalized they were unaware, and were aware wrinkles in sheets or in clothes could manifest an episode.”

“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 observation, record review, and interview, the agency failed to ensure wound care treatments were provided only as ordered by a physician in 1 of 2 active clinical records reviewed, with patients receiving wound care treatments. (Patient: #2) Findings Include: 1. A review of an undated agency policy titled “Wound Care Protocol for Home Healthcare Agency” indicated, but was not limited to, “ ... Wound care dressing should be changed according to the wound care plan physician’s instructions, ensuring aseptic techniques are used during the process … 2. During a home visit observation at the residence for Patient #2, on 01/06/2026 at 2:00 PM, observed LPN 1, performing wound care. LPN 1 sprayed wound cleanser on the wound dressing of Patient #2’s scalp wounds to remove the old non-adherent dressings. After removing the dressings, cleansed the 3 wounds with wound cleaner and 4x4 gauze, and measured the wounds. LPN 1 removed their gloves, performed hand hygiene, donned new gloves, LPN 1 obtained the non-adherent dressings, cut the dressings to size, and applied gentamicin ointment (an antibiotic ointment) to the dressings, then placed the dressings on the patient’s wounds, adhering the wounds to the scalp with steri-strip tape. A review of the clinical record for Patient #2, SOC 07/28/2025, certification period 11/25/2025 to 01/23/2026, indicated but was not limited to primary diagnosis Encounter for Change or Removal of Surgical Wound Dressing, and other diagnosis included; Aftercare Following Surgery for Neoplasm (a new and abnormal growth of tissue in some part of the body that can be benign or cancerous), Squamous Cell Carcinoma (a type of skin cancer)of Skin of Scalp and Neck, and Type 2 Diabetes Mellitus(a chronic condition when the body cannot use insulin to regulate the amounts of sugar in the blood). Patient #2 had orders for SN 1 time a week to change and instruct caregiver/family, wound dressing as ordered: wound care #1 right frontal scalp as follows; cleanse/irrigate with (solution) soap and water apply duoderm or non stick dressing secure with duoderm/tape; wound care to wound #2 left parietal scalp as follows; cleanse/irrigate with (solution) soap and water apply duoderm or non stick dressing secure with duoderm/tape. During an interview on 01/07/2026 at 1:10 PM, when asked about where the documentation would be located for communication notifying the physician of Patient #2’s new wound, increased drainage, and changes in the wounds, RN 1 stated, “One or 2 weeks ago, the third wound showed up. The patient had a home visit from the patient’s nurse practitioner, who ordered gentamicin ointment for the wounds. No, there is not orders changing the wound care, and there needed to be updated orders. That is my fault.” 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 observation, record review, and interview, the agency failed to ensure the RN notified the physician of changes in the patient’s wounds for 1 of 2 (Patient: #2) active clinical records reviewed receiving wound care, and failed to ensure the physician had been notified of the agency’s inability to provide services in 2 of 3 (Patients: #4, and 7), active clinical records reviewed of patients receiving PT services, and 1 of 2 (Patient: #3) active clinical records reviewed receiving LPN services, and 1 of 2 inactive clinical records received PT services. (Patient: #6) Findings Include: 1. A review of an undated agency policy titled “Medical Supervision” indicated, but was not limited to, “ … A Physician Plan of Care is developed for each Client … The physician’s orders shall outline the disciplines providing care and the type, frequency, and duration of services to be provided … 4. Physician will be contacted when any of the following occurs: 1. Condition changes … e. Any change in Client condition or Caregivers, Inc., services …” 2. A review of an undated agency policy titled “Provision for 24-Hour RN Availability” indicated, but was not limited to, “ … The Registered Nurse will be available to make a home visit, if necessary … ” 3. A review of an undated agency policy titled “Wound Care Protocol for Home Healthcare Agency” indicated but was not limited to, “ ... Wound care dressing should be changed according to the wound care plan physician’s instructions, ensuring aseptic techniques are used during the process … Signs of infection, such as increased redness, warmth, or discharge, must be reported to the physician immediately. All supplies used in wound care must be disposed of properly to minimize contamination risks. 4. During a home visit observation for Patient #2, on 01/06/2026 at 2:00 PM, observed LPN 1 performing wound care. LPN 1 sprayed wound cleanser on the wound dressing of Patient #2’s scalp wounds to remove the old non-adherent dressings. After removing the dressings, LPN 1 informed Patient #2 that they had 3 scalp wounds, and Patient #2 requested a mirror to examine them. Patient #2 reported they did not like the way the wounds looked and needed to call the MD for follow-up. LPN 1 cleansed the 3 wounds with wound cleaner and 4x4 gauze, measured the wounds, removed their gloves, performed hand hygiene, and donned new gloves. The LPN obtained the non-adherent dressings, used scissors to cut the dressings to size, applied gentamicin (an antibiotic ointment) to the non-adherent dressings, and then placed the dressings on Patient #2’s three scalp wounds, adhering the dressings to the scalp with steri-strip tape. A review of the clinical record for Patient #2, SOC 07/28/2025, certification period 11/25/2025 to 01/23/2026, indicated but was not limited to primary diagnosis Encounter for Change or Removal of Surgical Wound Dressing, and other diagnosis included; Aftercare Following Surgery for Neoplasm (a new and abnormal growth of tissue in some part of the body that can be benign or cancerous), Squamous Cell Carcinoma (a type of skin cancer)of Skin of Scalp and Neck, and Type 2 Diabetes Mellitus(a chronic condition when the body cannot use insulin to regulate the amounts of sugar in the blood). Patient #2 had orders for SN 1 time a week to change and instruct caregiver/family, wound dressing as ordered: wound care #1 right frontal scalp as follows; cleanse/irrigate with (solution) soap and water apply duoderm or non stick dressing secure with duoderm/tape; wound care to wound #2 left parietal scalp as follows; cleanse/irrigate with (solution) soap and water apply duoderm or non stick dressing secure with duoderm/tape. During an interview on 01/07/2026 at 1:10 PM, when asked about where the documentation would be located for communication notifying the physician of Patient #2’s new wound, increased drainage, and changes in the wounds, RN 1 stated, “One or 2 weeks ago, the third wound showed up. The patient had a home visit from the patient’s nurse practitioner, who ordered gentamicin ointment for the wounds. No, no documentation of the physician being notified of changes in Patient #2’s wounds and the new wound. I didn’t do it.” 5. A review of the clinical record for Patient #3, SOC 04/29/2024, contained a POC for the certification period from 12/20/2025 to 02/17/2026. The POC indicated Patient #3 had a primary diagnosis of Quadriplegia (a condition caused by an injury to the spinal cord causing paralysis affecting all four limbs), and other diagnoses included but not limited to, Autonomic Dysreflexia (a potentially life threatening condition involving abnormal, overreaction of the autonomic nervous system (the network of nerves through your body that control unconscious processes such as breathing, heart beating, blood pressure, and digestion) to certain types of stimulation) leading to severe high blood pressure and other symptoms), Neurogenic bowel (loss of bowel function due to nerve damage), Encounter for Fitting Adjustment of Urinary Device, and Pressure Ulcer of Right Ankle, Stage 3 (full thickness skin loss that involves damage to the subcutaneous tissue). Patient #3 had orders for SN 3 times a week for cardiopulmonary assessments, wound care to wound #1, pubis area above suprapubic catheter (pressure ulcer), wound care to wound #2, coccyx wound care to wound #3 midline coccyx, and wound care to wound #4 right distal coccyx, bowel program, and catheter changes. A review of the SN notes for the week of 12/27/2025 to 01/02/2026 failed to evidence SN visits. A review of agency documents titled “Missed Visit Notes” evidenced the following: on 01/04/2026, LPN 2 documented missed visit notes for 12/29/2025, 12/31/2025, and 01/02/2026, noting missed visit reason cancelled by the agency, no agency staff available. During an interview on 01/08/2026 at 11:10 AM, with the Administrator/Alternate Clinical Manager, RN 2, the case manager for Patient #3, and LPN 2, when asked about the missed SN visits for the week of 12/29/2025 to 01/02/206 cancelled by the agency, LPN 2 communicated they had car issues and had notified the Administrator/Alternate Clinical Manager. The Administrator/Alternate Clinical Manager confirmed LPN 2 reported missed visits, and they had been the nurse on call. The Administrator/Alternate Clinical Manager further reported there were no other nurses available to see Patient #3, and the caregiver had provided care for Patient #3. When asked about the on-call nurse seeing patients, the Administrator/Alternate Clinical Manager indicated the on-call nurse should have seen Patient #3. RN 2 communicated they had not been notified of Patient #3 not being seen by the SN for a week and had not reported to the MD the inability to provide care per the POC. 6. A review of the clinical record for Patient #4, SOC 12/08/2025, contained a POC for the certification period from 12/08/2025 to 02/05/2026. The POC indicated Patient #4 had a primary diagnosis of Alcoholic Polyneuropathy (a condition caused by prolonged and heavy consumption of alcohol, causing nerve damage to the peripheral nerves throughout the body to malfunction simultaneously) and other diagnoses of Difficulty Walking. Patient #4 had orders for PT one time a week for one week, two times a week for two weeks, and one time a week for 5 weeks, for therapeutic exercise, endurance training, transfer training, balance training, gait training, and pain management. A review of the PT visit notes evidenced the following: the week of 12/8/2025 to 12/12/2025, PT 1 completed the SOC on 12/08/2025; the week of 12/13/2025 to 12/19/2025, no PT visits were made; the week of 12/20/2025 to 12/26/2025, no PT visits were made; the week of 01/03/2026 to 01/08/2026, PT 1 completed a visit on 01/05/2026. During an interview on 01/08/2026 at 1:35 PM, when asked about the missing PT visits for Patient #4, PT 1 stated they were waiting for the office to notify them of authorization from the insurance company. When asked about notification to the MD regarding the POC PT frequency not being followed, PT 1 stated, “No, they did not notify the patient’s MD and did not document the patient had been notified. I know if it isn’t documented, it isn’t done.” 7. A review of the inactive clinical record for Patient #6, SOC 10/15/2025, and date of discharge 12/28/2025, contained a POC for the certification period from 10/15/2025 to 12/13/2025. The POC indicated Patient #6 had a primary diagnosis of Spastic Quadriplegic Cerebral Palsy (a condition causing increased muscle tone, causing muscle stiffness and involuntary muscle movements), and other diagnoses Repeated Falls, Essential Hypertension (high blood pressure), Visual Disturbances, Idiopathic Epilepsy and Epileptic Syndrome ( a condition due to abnormal electrical activity I the brain causing unprovoked seizures). Patient #7 had orders for PT one time a day, one time a week for one week, and two times a week for 7 weeks, for balance training, transfer training, bed mobility training, and establishing a home exercise program. A review of the PT visit notes evidenced the following: the week of 10/15/2025 to 10/17/2025, PT 1 completed the SOC on 10/15/2025 and a visit on 10/17/2025; the week of 10/18/2025 to 10/24/2025, PT visits were completed 10/21/2025 and 10/23/2025; the week 10/25/2025 to 10/31/2025, no PT visits were completed; the week 11/01/2025 to 11/07/2025 no PT visits were completed; the week 11/08/2025 to 11/14/2025 no PT visits were completed; the week 11/22/2025 to 11/28/2025 a PT visit had been completed on 11/24/2025, and discharge visit completed 11/28/2025. During an interview on 01/08/2026 at 1:35 PM, when asked about the missing PT visits for Patient #7, PT 2 stated they were waiting for the office to notify them of authorization from the insurance company. When asked about notification to the MD regarding the POC PT frequency not being followed, PT 2 stated, “No, they did not notify the patient’s MD to obtain a hold services order or regarding PT visits not being completed per the POC.” PT 2 further communicated, if it isn’t documented, it isn’t done.” 8. A review of the clinical record for Patient #7, SOC 11/17/2025, contained a POC for the certification period from 11/17/2025 to 01/15/2026. The POC indicated Patient #7 had a primary diagnosis of Type 2 Diabetes Mellitus with Diabetic Polyneuropathy (a chronic condition that occurs when the body fails to produce insulin to control blood sugar levels in the bloodstream, causing nerve damage due to prolonged high blood sugar levels), and other diagnoses Low Back Pain, and Unsteadiness on Feet. Patient #7 had orders for PT one time a week for 5 weeks for therapeutic exercise, endurance training, transfer training, balance training, gait training, and pain management. A review of the PT visit notes evidenced the following: the week of 11/17/2025 to 11/21/2025, PT 1 completed the SOC on 11/17/2025; the clinical record failed to evidence any further visits had been completed. During an interview on 01/08/2026 at 3:00 PM, when asked about the missing PT visits for Patient #6, and the location of the hold order or notification to the patient’s MD regarding the missed visits, PT 1 communicated they were waiting for the office to make them aware they had authorization from the insurance company. When asked about notification to the MD regarding the POC PT frequency not being followed, PT 1 stated, “No, they did not notify the patient’s MD and did not document the patient had been notified. I know if it isn’t documented, it isn’t done.” 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 observation, record review, and interview, the agency failed to ensure the LPNs coordinated care, communicating patient concerns to the RN in 2 of 2 active patient records reviewed who received LPN services. (Patient #2 and 3) Findings Include: 1. A review of undated agency policy titled “Coordination of Client Services” indicated, but was not limited to, “ … To ensure services are coordinated between members of the interdisciplinary team. To ensure appropriate, quality care is being provided to Clients … 3. Interdisciplinary care conferences shall be conducted as often as necessary to respond to changes in the Client’s care needs, services, care, or goals … ” 2. During a home visit observation at the residence for Patient #2, on 01/06/2026 at 2:00 PM, observed LPN 1 performing wound care. LPN 1 sprayed wound cleanser on the wound dressing of Patient 2’s scalp wounds to remove the old non-adherent dressings. After removing the dressings, LPN 1 informed Patient #3 that there were now 3 scalp wounds, and Patient #3 requested the LPN to obtain their mirror to examine the wounds. Patient #2 reported they did not like the way the wounds looked and needed to call the MD for follow-up. LPN 1 cleansed the 3 wounds with wound cleaner and 4x4 gauze, and measured the wounds. LPN 1 removed their gloves, completed hand hygiene, donned new gloves, and obtained the non-adherent dressings. The LPN cut the dressings to size and applied gentamicin ointment (an antibiotic ointment) to the non-adherent dressings, then placed the dressings on the patient’s wounds, adhering the wounds to the scalp with steri-strip tape. A review of the clinical record for Patient #2, SOC date 07/28/2025, contained agency documents titled “Case Communication Notes.” A review of the communication notes dated 11/08/2025to 01/07/2026 failed to evidence LPN 1 had documented or reported to RN 1 changes in Patient #2’s wound drainage, appearance, number of wounds, and Patient #2’s concerns in the way the wounds appeared, to RN 1. During an interview on 01/07/2026 at 1:10 PM, RN 1 confirmed communication regarding the patient’s care needs between the care team should be documented in the communication notes. When asked if LPN 1 had called them and reported an increase in wounds and changes in Patient #2’s wounds, RN 1 stated, “No, the LPN did not contact me with changes in the wounds.” RN 1 further reviewed the notes in the EMR system for Patient #2 and reported there had been no documentation in LPN 1’s visit note dated 01/07/2026, and the communication notes of reporting Patient #2’s wound changes. 3. A review of the clinical record for Patient #3, SOC 04/29/2024, contained a POC for the certification period from 12/20/2025 to 02/17/2026. The POC indicated Patient #3 had a primary diagnosis of Quadriplegia (a condition caused by an injury to the spinal cord causing paralysis affecting all four limbs), and other diagnoses included but are not limited to, Autonomic Dysreflexia (a potentially life threatening condition involving abnormal, overreaction of the autonomic nervous system (the network of nerves through your body that control unconscious processes such as breathing, heart beating, blood pressure, and digestion) to certain types of stimulation) leading to severe high blood pressure and other symptoms), Neurogenic bowel (loss of bowel function due to nerve damage), Encounter for Fitting Adjustment of Urinary Device, and Pressure Ulcer of Right Ankle, Stage 3 (full thickness skin loss that involves damage to the subcutaneous tissue). Patient #3 had orders for SN 3 times a week for cardiopulmonary assessments, wound care to wound #1, pubis area above suprapubic catheter (pressure ulcer), wound care to wound #2, coccyx wound care to wound #3 midline coccyx, and wound care to wound #4 right distal coccyx, bowel program, and catheter changes. During a home visit at the residence of Patient #3, on 01/06/2026, at 9:45 AM, Patient #3 and the patient caregiver, provided a list of medications for review and communicated Patient #3 had an MD appoint two weeks ago and had the MD increased Labetalol (a medication used to treat to high blood pressure) from 100 milligrams (mg) to 150 mg twice daily. During an interview on 01/08/2026 at 11:00 AM, with LPN 2 and RN 2, when asked about the LPN reporting increased dosage of Labetalol, and missing visits for a week from 12/27/2025 through 01/02/2026 for wound care, and bowel program, RN 2 communicated they were not aware of Patient #3 not being seen for a week or the increase in Patient #3’s Labetalol. When asked LPN 2 about reporting to RN 2, LPN 2 indicated they had made the Administrator aware of their car issues that week, not being able to see Patient #3, and had not reported the medication changes to RN 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 record review and interview, the agency failed to provide patients and caregivers with a visit schedule for the frequency of visits by agency staff during 2 of 4 home visits conducted. (Patients: #2 and 4) Findings include: 1. During a home visit at Patient #2’s residence on 01/07/2026 at 4:35 PM, the admission booklet for Patient #2 was reviewed. No agency calendar was found in the patient’s booklet or at home. The agency failed to provide the patient and/or caregiver with an agency service calendar. When Patient #2 asked LPN 1 about a return visit, LPN 1 stated, “They did not know when the patient would have another visit.” 2. During a home visit at Patient #4’s residence on 01/06/2026 at 2:00 PM, the admission booklet for Patient #4 was reviewed. No agency calendar was found in the patient’s booklet or at home. The agency failed to provide the patient and/or caregiver with an agency service calendar. When Patient #4 asked PT 1 about when they would see them again, PT 1 stated, “They did not know when the patient would have another visit. They would give them a call.””

“Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This Element is not met as evidenced by: Based on record review and interview, the agency failed to measure and track performance improvement projects to determine if improvement occurred and was sustained from data derived from untimely OASIS assessments, and failed to implement a process improvement plan for the frequency and detail of data collection for 1 of 1 agency. Findings Include: 1. A review of an undated agency policy titled “Quality Assessment and Performance Improvement (QAPI)” indicated but was not limited to, “Agency shall establish a performance improvement plan to continuously measure, assess, and improve the performance of clinical and other processes … To monitor the effectiveness and safety of services and the quality of care; To identify opportunities for improvement in ... care, treatment, and services; To improve ... outcomes through a coordinated collaborative approach ... improving ... performance; To evaluate all areas of concern and implement plans to resolve the issues ... To support the organization’s process improvement through data collection and outcome measurement in compliance initiative and OASIS data Collection required by CMS … OASIS review and evaluation of accuracy and content. Staff performance assessment activities. Staff recruitment orientation and continuing education programs. Case Conferences. Clinical record and utilization review findings. Clinical staff competency evaluation programs. Satisfaction surveys of clients, referral sources, physicians, and staff. Risk management program. Sentinel events/ Adverse events. Incident reports, accidents, and worker compensation claims. Infection control activities and systems that support them. Annual program evaluation. ... Scope of Program: 1. The program will be capable of showing measurable improvement in indicators that will improve the health outcomes, client safety, and quality of care. 2. The agency will identify, measure, analyze, and track quality indicators that include client adverse events, and other relevant data to assess processes of care, services, and operations … 4. Data will be systematically collected to measure process and outcome … ” 2. A review of the 2024 and 2025 QAPI programs failed to evidence that a performance improvement project (PIP) was developed, ongoing, or completed for those years for an identified agency opportunity for improvement. 3. A review of an IQIES report titled “HHA Error Summary By Agency” dated 12/29/2025, report period 12/29/2024 to 12/29/2025, indicated but was not limited to, Caregivers, Inc. had the error number -3330, error description: Record submitted late: The submission date is more than 30 days after M00090 on this new record. # of assessments with error: 275 out of 915 records processed, a percentage of 30.5% with error. 4. A review of an agency document titled “OASIS (a comprehensive assessment designed to collect information related to a home care recipient’s demographic, clinical, functional, and service needs) Agency Final Validation.” The documents were for the reporting period of 12/29/2024 to 12/29/2025 the year to date, which indicated but was not limited to untimely submission errors reported to Caregivers, Inc, as the following: the active records for Patient #6 had a section titled “RFA” (Reason For Assessment) listed as 01, indicating SOC OASIS assessment had been submitted on 12/05/2025 and the M0090 date (date of completion) of 10/15/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record; Patient #7 had a section titled RFA listed as 01, indicating SOC OASIS assessment had been submitted on 12/23/2025 and the M0090 date of 11/17/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record; and Patient #11 had a section titled RFA listed as 01, indicating SOC OASIS assessment had been submitted on 11/14/2025 and the M0090 of 10/10/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record. The inactive records for Patient #8 had a section titled RFA listed as 09, indicating Discharge from Agency OASIS assessment had been submitted on 12/10/2025 and the M0090 date of 03/27/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record; Patient #9 had a section titled RFA listed as 09, indicating Discharge from Agency OASIS assessment had been submitted on 12/23/2025 and the M0090 date of 10/15/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record; Patient #10 had a section titled RFA listed as 09, indicating Discharge from Agency OASIS assessment had been submitted on 12/10/2025 and the M0090 date of 09/23/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record; Patient #12 had a section titled RFA listed as 09, indicating Discharge from Agency OASIS assessment had been submitted on 12/10/2025 and the M0090 date of 04/04/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record; and Patient #13 had a section titled RFA listed as 09, indicating Discharge from Agency OASIS assessment had been submitted on 12/10/2025 and the M0090 date of 06/20/2025 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record. 5. A review of the active clinical record for Patient #6, SOC date 10/15/2025, contained a comprehensive assessment dated 10/15/2025, completed by PT 2. The OASIS Assessment reason was for SOC for the certification period 10/15/2025 to 12/13/2025. The agency failed to evidence the SOC OASIS Assessment had been submitted timely. 6. A review of the active clinical record for Patient #7, SOC date 11/17/2025, contained a comprehensive assessment dated 11/17/2025, completed by PT 1. The OASIS Assessment reason was for SOC for the certification period 11/17/2025 to 01/15/2026. The agency failed to evidence the SOC OASIS Assessment had been submitted timely. 7. A review of the inactive clinical record for Patient #8, discharge date 03/27/2025, contained a comprehensive assessment dated 03/27/2025, completed by PT 1. The OASIS Assessment reason was for discharge from the certification period 02/26/2025 to 04/26/2025. The agency failed to evidence the discharge OASIS Assessment had been submitted timely. 8. A review of the inactive clinical record for Patient #9, discharge date 03/27/2025, contained a comprehensive assessment dated 10/15/2025, completed by RN 1. The OASIS Assessment reason was for discharge from the certification period 08/19/2025 to 10/17/2025. The agency failed to evidence the discharge OASIS Assessment had been submitted timely. 9. A review of the inactive clinical record for Patient #10, discharge date 03/27/2025, contained a comprehensive assessment dated 03/27/2025, completed by RN 3. The OASIS Assessment reason was for discharge from the certification period 08/15/2025 to 10/13/2025. The agency failed to evidence the discharge OASIS Assessment had been submitted timely. 10. A focused review of the active clinical record for Patient #11, SOC date 10/10/2025, contained a comprehensive assessment dated 10/10/2025, completed by PT 1. The OASIS Assessment reason was for SOC for the certification period 10/10/2025 to 12/08/2025. The agency failed to evidence the SOC OASIS Assessment had been submitted timely. 11. A review of the inactive clinical record for Patient #12, discharge date 03/27/2025, contained a comprehensive assessment dated 04/04/2025, completed by PT 1. The OASIS Assessment reason was for discharge from the certification period 02/25/2025 to 04/25/2025. The agency failed to evidence the discharge OASIS Assessment had been submitted timely. 12. A review of the inactive clinical record for Patient #13, discharge date 03/27/2025, contained a comprehensive assessment dated 06/20/2025, completed by PT 2. The OASIS Assessment reason was for discharge from the certification period 04/29/2025 to 06/27/2025. The agency failed to evidence the discharge OASIS Assessment had been submitted timely. During an interview on 01/07/2026 at 4:20 PM, when asked about the agency’s untimely OASIS submissions for 2024 and 2025 and a Process Improvement Plan (PIP) being implemented, Admin 8, the OASIS submissions Coordinator, and the Administrator stated they had been aware of the untimely submissions of OASIS and reviewed the OASIS submissions reports. When asked about the Process Improvement Plan (PIP) being implemented, the Administrator stated they had not implemented a PIP for OASIS this year and were starting from a blank slate. When asked about the 2024 PIP for untimely submissions, Admin 8 indicated they had reported the untimely OASIS submissions for 2024, provided the reports to the former Administrator, and there should had been a plan in place. The Administrator could not provide any 2024 PIPs. 410 IAC 17-12-2(a)”

“Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient/caregiver/family were instructed and demonstrated wound care dressing changes for 1 of 2 active clinical records review (Patient #2) with wound care orders. Findings Include: A review of the clinical record for Patient #2, SOC 07/28/2025, certification period 11/25/2025 to 01/23/2026, indicated but was not limited to primary diagnosis Encounter for Change or Removal of Surgical Wound Dressing, and other diagnosis included; Aftercare Following Surgery for Neoplasm (a new and abnormal growth of tissue in some part of the body that can be benign or cancerous), Squamous Cell Carcinoma (a type of skin cancer)of Skin of Scalp and Neck, and Type 2 Diabetes Mellitus(a chronic condition when the body cannot use insulin to regulate the amounts of sugar in the blood). Patient #3 had orders for SN 1 time a week to change and instruct caregiver/family, wound dressing as ordered: wound care #1 right frontal scalp as follows; cleanse/irrigate with (solution) soap and water apply duoderm or non stick dressing secure with duoderm/tape; wound care to wound #2 left parietal scalp as follows; cleanse/irrigate with (solution) soap and water apply duoderm or non stick dressing secure with duoderm/tape. During an interview on 01/07/2026 at 1:00 PM, when questioned regarding Patient #3’s wound care only being completed 1 time a week, RN 1 stated, “The caregiver/family member is to complete the dressing change the other time a week.” When asked if they had instructed or observed the caregiver/family member perform dressing changes, RN 1 stated, “No, I have not seen the daughter. No, I did not educate on the dressing changes. We honestly didn’t do that. I know it is my fault.” 410 IAC 17-14-1(a)(1)(G)”

“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 the record review and interview, the Administrator/Alternate Clinical Manager failed to ensure responsibility for the day-to-day operations, including 24-hour RN availability. Findings Include: 1. A review of an agency policy revision date November 2021, titled “Home Health Administrator” indicated but was not limited to, “ … The Executive Director/Administrator position will be responsible for the direction, coordination, and general supervision of all home health services … Responsibilities of the position will include, but not be limited to: A. Planning, organizing, directing, and evaluating operations to ensure the provision of adequate and appropriate care and services. B. Ensuring organizational compliance … D. Recruiting, employing, and retaining qualified personnel … G. Directing and monitoring performance improvement activities… Assuring that all clinical services are furnished under the supervision of a physician or registered nurse … L. Assuring that the Clinical Manager and other appropriate staff supervision are available … ” 2. A review of an undated agency policy titled “Provision for 24-Hour RN Availability” indicated, but was not limited to, “ … The Registered Nurse will be available to make a home visit, if necessary … ” 3. During an interview on 01/07/2025 at 6:30 AM, a call was placed to the agency’s phone number (317) 252-5958 to verify on-call. Received a voicemail indicating, had reached the agency outside business hours and reached the nurse on call by pressing option #1. Admin 7, the on-call agency nurse, communicated that they were the RN on call and answered the agency’s after-hours calls, directed calls to the appropriate staff. Admin 7 further indicated they lived in Florida and had not completed on-call visits for the agency. Admin 7 reported if a visit had been needed, they reported to the on-call nurse or case manager, who completed the needed visits. 4. A review of the clinical record for Patient #3, SOC 04/29/2024, contained a POC for the certification period from 12/20/2025 to 02/17/2026. The POC indicated Patient #3 had a primary diagnosis of Quadriplegia (a condition caused by an injury to the spinal cord causing paralysis affecting all four limbs), and other diagnoses included but are not limited to, Autonomic Dysreflexia (a potentially life threatening condition involving abnormal, overreaction of the autonomic nervous system (the network of nerves through your body that control unconscious processes such as breathing, heart beating, blood pressure, and digestion) to certain types of stimulation) leading to severe high blood pressure and other symptoms), Neurogenic bowel (loss of bowel function due to nerve damage), Encounter for Fitting Adjustment of Urinary Device, and Pressure Ulcer of Right Ankle, Stage 3 (full thickness skin loss that involves damage to the subcutaneous tissue). Patient #3 had orders for SN 3 times a week for cardiopulmonary assessments, wound care to wound #1, pubis area above suprapubic catheter (pressure ulcer), wound care to wound #2, coccyx wound care to wound #3 midline coccyx, and wound care to wound #4 right distal coccyx, bowel program, and catheter changes. A review of the SN notes for the week of 12/27/2025 to 01/02/2026 failed to evidence SN visits. A review of agency documents titled “Missed Visit Notes” evidenced the following: on 01/04/2026, LPN 2 documented missed visit notes for 12/29/2025, 12/31/2025, and 01/02/2026, noting the missed visit reason was cancelled by the agency, and no agency staff were available. During an interview on 01/08/2026 at 11:10 AM, with the Administrator/Alternate Clinical Manager, RN 2, the case manager for Patient #3, and LPN 2, when asked about the missed SN visits for the week of 12/29/2025 to 01/02/206 cancelled by the agency, LPN 2 communicated they had car issues and had notified the Administrator/Alternate Clinical Manager. The Administrator/Alternate Clinical Manager confirmed LPN 1 reported missed visits to the nurse on call, and no other nurses were available to see Patient #3. When asked about the on-call nurse seeing patients, the Administrator/Alternate Clinical Manager indicated they were the on-call nurse and should have seen the patient. 410 IAC 17-12-1(c)(1)”

“Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This Element is not met as evidenced by: Based on record review and interview, the Administrator failed to ensure the patients’ needs were continuously assessed and received services to meet their needs for 3 of 6 active records reviewed. (Patients: #3, 4, and 5) and 2 of 2 inactive records reviewed. (Patient: #6, and 7) Findings Include: 1. A review of an undated agency policy titled “Medical Supervision” indicated, but was not limited to, “ … A Physician Plan of Care is developed for each Client … The physician’s orders shall outline the disciplines providing care and the type, frequency, and duration of services to be provided … ” 2. A review of an agency policy revision date November 2021, titled “Home Health Administrator” indicated but was not limited to, “ … The Executive Director/Administrator position will be responsible for the direction, coordination, and general supervision of all home health services … Responsibilities of the position will include, but not be limited to: A. Planning, organizing, directing, and evaluating operations to ensure the provision of adequate and appropriate care and services. B. Ensuring organizational compliance … D. Recruiting, employing, and retaining qualified personnel … G. Directing and monitoring performance improvement activities… Assuring that all clinical services are furnished under the supervision of a physician or registered nurse … L. Assuring that the Clinical Manager and other appropriate staff supervision are available … ” 3. A review of an undated agency policy titled “Provision for 24-Hour RN Availability” indicated, but was not limited to, “ … The Registered Nurse will be available to make a home visit, if necessary … ” 4. A review of the clinical record for Patient #3, SOC 04/29/2024, contained a POC for the certification period from 12/20/2025 to 02/17/2026. The POC indicated Patient #3 had orders for SN 3 times a week for cardiopulmonary assessments, wound care to wound #1, pubis area above suprapubic catheter (pressure ulcer), wound care to wound #2, coccyx wound care to wound #3 midline coccyx, and wound care to wound #4 right distal coccyx, bowel program, and catheter changes. A review of the SN visit notes for the week of 12/27/2025 to 01/02/2026 failed to evidence a SN visit had been made. 5. A review of the clinical record for Patient #4, SOC 12/08/2025, contained a POC for the certification period from 12/08/2025 to 02/05/2026. The POC indicated Patient #4 had orders for PT one time a week for one week, two times a week for two weeks, and one time a week for 5 weeks, for therapeutic exercise, endurance training, transfer training, balance training, gait training, and pain management. A review of the PT visit notes evidenced the following: the week of 12/8/2025 to 12/12/2025, PT 1 completed the SOC on 12/08/2025; the week of 12/13/2025 to 12/19/2025, no PT visits were made; the week of 12/20/2025 to 12/26/2025, no PT visits were made; the week of 01/03/2026 to 01/08/2026, PT completed a visit on 01/05/2026. 6. A review of the clinical record for Patient #5, SOC 11/20/2025, contained a POC for the certification period from 11/20/2025 to 01/10/2026. The POC indicated Patient #5 had orders for PT: one time per week for one week, then two times per week for 8 weeks, for therapeutic exercise, endurance training, transfer training, balance training, gait training, and pain management. Patient #5 had orders for a HHA 3 times a week for 7 weeks, starting 11/26/2025, for ADL and personal care assistance. A review of an agency document titled “Paraprofessional Assignment Sheet” signed and dated 11/26/2025 by PT 2, contained a care plan start date of 11/26/2025 for Patient #5 to receive HHA frequency 3 times a week for 8 weeks, two hours per service for assistance in ADLs of bathing, dressing, every Monday, Wednesday, and Friday. A review of the HHA visit notes evidenced the following: the week of 11/22/2025 to 11/28/2025, no HHA visits were completed, and the week of 11/29/2025 to 12/05/2025, no HHA visits were completed. 7. A review of the inactive clinical record for Patient #6, SOC 10/15/2025, and date of discharge 12/28/2025, contained a POC for the certification period from 10/15/2025 to 12/13/2025. The POC indicated Patient #6 had orders for PT: one time a day for one day, one time a week for one week, and two times a week for 7 weeks, for balance training, transfer training, bed mobility training, and establishing a home exercise program. A review of the PT visit notes evidenced the following: the week of 10/15/2025 to 10/17/2025, PT 1 completed the SOC on 10/15/2025 and a visit on 10/17/2025; the week of 10/18/2025 to 10/24/2025, PT visits were completed 10/21/2025 and 10/23/2025; the week 10/25/2025 to 10/31/2025, no PT visits were completed; the week 11/01/2025 to 11/07/2025 no PT visits were completed; the week 11/08/2025 to 11/14/2025 no PT visits were completed; the week 11/22/2025 to 11/28/2025 a PT visit had been completed on 11/24/2025, and discharge visit completed 11/28/2025. 8. A review of the clinical record for Patient #7, SOC 11/17/2025, contained a POC for the certification period from 11/17/2025 to 01/15/2026. The POC indicated Patient #7 had orders for PT one time a week for 5 weeks for therapeutic exercise, endurance training, transfer training, balance training, gait training, and pain management. A review of the PT visit notes evidenced the following: for the week of 11/17/2025 to 11/21/2025, PT 1 completed the SOC on 11/17/2025; the clinical record failed to evidence any further visits had been completed. During an interview on 01/08/2026 at 11:10 AM, with the Administrator/Alternate Clinical Manager, RN 2, the case manager for Patient #3, and LPN 2, when asked about the missed SN visits for the week of 12/29/2025 to 01/02/206 cancelled by the agency, LPN 2 communicated they had car issues and had notified the Administrator/Alternate Clinical Manager. The Administrator/Alternate Clinical Manager confirmed the reported missed visits and had been the nurse on call, and there were no other nurses available to see Patient #3 and the caregiver had provided care for Patient #3. When asked about the on-call nurse seeing patients, the Administrator/Alternate Clinical Manager indicated they were the on-call nurse and should had seen the patient. When reviewing the clinical records for Patients #4, 5, 6, and 7, and asked about the clinical services not being provided as ordered per the POC, the Administrator indicated the agency had been waiting on insurance authorization.”