Every finding on record at Help at Home Inc

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102 Survey Dates: 10-07-2024, 10-08-2024, 10-09-2024, and 10-10-2024 Active Census: 796 At this Emergency Preparedness survey, Help at Home Skilled Care was found to be in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.102. QR completed by Area 3 on 10-15-2024.

This visit was for a Federal Recertification and State Re-Licensure survey of Home Health Provider in conjunction with one (1) Complaint, IN00109676 Survey Dates: 10-07-2024, 10-08-2024, 10-09-2024, and 10-10-2024 12-month unduplicated skilled admissions: 17 This deficiency report reflects States findings in accordance with 410 IAC 17. QR completed by Area 3 on 10-17-2024,

Advise the patient of discharge for cause CFR(s): 484.50(d)(5)(i) (i) Advise the patient, representative (if any), the physician(s) or allowed practitioner(s), issuing orders for the home health plan of care, and the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) that a discharge for cause is being considered; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure discharge planning and documentation included involving the physician, patient, and patient family in 1 of 6 active record reviews. (Patient #1) Findings include: 1. A review of a policy titled 'Client Discharge Process' indicated "… 2. Client's needs for continuing care … clients are told in a timely manner of the need to plan for discharge or transfer … 3. The physician will be involved in the discharge plan … 4. The physician will order the discharge and/or transfer … 5. The agency will notify all clients, the client's legal representative … at least 15 calendar days before the services are stopped … f. The agency must … attempt to provide services … it's continuing attempts to provide the services must be documented … 11. To avoid charges of "abandonment" … documentation will include … a. Evidence that the decision was not made unilaterally. The client, family and physician participated in the decision to discharge …" 2. A review of the clinical record for Patient #1 evidenced a Home Care Certification/Recertification Plan of Care Order dated 08/05/2024 for the certification period 08/08/2024 through 10/06/2024 and signed by RN 3 revealed Patient #1 was to receive skilled nursing services 12 hours a day for 2 days a week and 8 hours a day for 2 days a week. A review of the clinical record for Patient #1 on 10/08/2024 evidenced as of 10/06/2024 there had not been a recertification completed, and the last skilled nursing visit conducted was 10/04/2024. The clinical record of Patient #1 failed to evidence communication notes as to why a recertification hadn't been completed, the disruption of care, or MD notification/orders for changes with care. 3. During an interview on 10/07/2024 at 2:18 PM with Person C, a family member to Patient #1, indicated Patient #1 wasn't currently being seen, the nursing staff that was to see Pt #1 was on medical leave, and wouldn't be back for 2 months, typically Patient #1 was seen on Monday, Tuesday, Thursday and Friday. Person C indicated the agency had known about the situation for some time, and hadn't bothered to find another nurse to care for Patient #1. 4. During an interview on 10/08/2024 at 2:05 PM with RN 3, they indicated they had discussed with Person C about the agency not being able to continue to care for Patient #1 but hadn't documented the conversation, and indicated they hadn't discussed the situation with the Administrator or the Physician. RN 3 indicated the plan was to discharge Patient #1, they just hadn't completed the paperwork or the documentation 5. During an interview on 10/08/2024 at 2:55 PM with Person H, a Registered Nurse from Entity G office, the ordering Physician for Patient #1 indicated they had not received notification of the agency discharging or placing Patient #1 on hold. 6. During an interview on 10/08/2024 at 4:53 PM with Person C, when queried if the agency had educated them on discharge, Person C asked this writer if the agency was discharging Patient #1. This writer told Person C they needed to speak with the agency. When queried if Person C was actively looking for another agency, Person C indicated they had made several calls to agencies, with some indicating they could not service Patient #1, and had yet to receive call back from others. When queried how Person C received information on the home care agencies, they indicated that RN 3 had provided them with a few agency names and phone numbers. 7. During an interview on 10/08/2024 at 1:05 PM with the Administrator, when queried if the agency had planned on discharging the patient, they indicated since recruitment efforts were unsuccessful, they didn't have a choice but to either place Patient #1 on hold for 2 months or discharge, but thought discharge would be the better option. The Administrator indicated there was no documentation of discussion of placing Patient #1 on hold or of pending discharge. 410 IAC 17-12-2(1)

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to document the existence of a patient's complaint, nor a resolution, for 1 of 1 known undocumented complaint investigated. Findings include: 1. A review of an agency policy revised 01-10-2024, titled 'Complaints and Grievances' stated, "… To establish a procedure for channeling complaints to the appropriate person for resolution and to respond to the client/family … A grievance is any formal or informal written or verbal expression of dissatisfaction that is not solved at that time by staff present … 4. Client complaints received by an employee will be documented under the client profile … 5. A grievance will be filed by the agency and forwarded to the appropriate parties by administrator/designee for investigations and evaluation of the complaint. 2. A review of an agency document titled 'Grievances [3rd quarter]' failed to evidence a complaint had been made by Patient #3. 3. A review of the clinical record for Patient #3 failed to evidence the patient's complaint/grievance had been documented or reported. 4. On 10-09-2024 when queried if they had spoken to the office about these concerns, Patient #3 indicated they had spoken to Administrative Staff 6, the office manager in the office about their concerns last month. 5. On 10-09-2024 at 12:41 PM, when queried as to whether the patient had expressed their dissatisfaction related to Home Health Aide services not being rendered, Registered Nurse (RN) 1 indicated recalled admitting Patient #3 recently, and recalled the patient being 'upset'. Indicated the patient had 'lots of concerns' they had expressed to the nurse. When queried as to what was done about this, RN 1 indicated had shown Patient #3 the number to call and told the patient to 'please feel free to call [administrative staff]'. When queried as to whether RN 1 had reported the patient's complaint themselves, indicated could not recall and 'would have to look at my notes'. When queried as to where such documentation might be found, indicated if they had documented the complaint it would appear in the patient's comprehensive assessment, and added, education notes would have been written within the visit note. Indicated had reported the patient's concerns to Administrative Staff 5, branch manager, either after the visit or the next day and had since had multiple conversations with Administrative Staff 5 about it. 6. On 10-09-2024 1:06 PM, Administrative Staff 5, indicated was well familiar with Patient #3 and their grievance related to not receiving Home Health Aide services as ordered. Indicated understood the issue was related to the patient's funding source having experienced recent changes which resulted in a delay in the patient's care. When queried as to whether the complaint had been documented, indicated since it was felt the issue laid with the funding source and was felt to be an 'external' issue, this was not documented as a complaint. Indicated normally would still try to help and might send follow-up email or text message. Indicated had this issue been considered a complaint, it would have been documented under activities/communication notes in the client or caregiver's file and provided no further documentation. 7. On 10-09-2024 at 3:05 PM, when queried as to what would constitute a complaint, the Administrator indicated any written or verbal complaints of abuse, neglect, theft, any dissatisfaction, an employee would be expected to report these to the branch manager and Administrator. Indicated further employees can document these in 'communications', under a tab in the agency's Electronic Medical Record (EMR) system, titled 'activities'. The Administrator indicated complaints can be documented in 'visit notes', and that she should be notified as well, as staff are expected to 'notify us [the Administrator and Alternate Administrator]'. The Alternate Administrator indicated Patient #3's complaint is a constant issue at the branch level, 'would assume a lot would be documented'. Indicated further, 'hours decrease is an issue across the board'. 8. On 10-10-2024 at 9:47 AM, Administrative Staff 6 indicated had spoken with Patient #3, who had been 'upset' after speaking with the patient's Case Manager with Entity A, as they had informed Patient #3 of changes initiated by the patient's funding source which meant their current caregiver could no longer provide the patient's waiver hours due to also being the patient's family member. Indicated the patient was offered an alternate caregiver for the waiver hours and the patient refused, stating only wanted same caregiver. Administrative Staff indicated offered to obtain Prior Authorization (PA) hours for the patient and was told 'no', only wanted their family member to care for them. When queried if this expression of dissatisfaction would be considered a complaint, indicated 'yes'. When queried as to where this would be documented, indicated normally would be documented under 'activities' in the patient's EMR and indicated 'everything should be there, everything that was documented'. When queried as to a resolution, indicated resolution was not documented. 410 IAC 17-12-(c)(2)

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 field staff followed appropriate infection control practices per agency policy while providing patient care in 2 of 3 home health aide (HHA) home visits conducted. (HHA 2 and HHA 3) Findings include: 1. A review of a policy with a revised date of 01/12/2024 titled 'Hand Hygiene' indicated, "… 1. The Center for Disease Control (CDC) recommends routinely washing hands in the following situations: … 15. Immediately after glove removal … Using soap and water … once hands are dry, use a clean paper towel to turn off the water …" 2. On 10/08/2024 a home visit was conducted to observe home health aide (HHA) 2 provide personal care to Patient #9. HHA 2 assisted Patient #9 into the bathroom, to the toilet, and without performing hand hygiene, donned gloves, assisted removing brief, threw the brief in trash, removed socks, gown, and removed t-shirt. At this time, Patient #9 indicated they preferred to not take a shower, so HHA 2 asked if they could wash Patient #9 while they sat on a chair next to the sink. Patient #9 was agreeable to this. HHA 2 brought the walker over to Patient #9, assisted Patient #9 to stand so HHA 2 could clean Patient #9 peri area, then doffed their gloves, and donned a clean pair of gloves before placing a towel on the chair, then assisted Patient #9 to sit on the chair. HHA 2 opened the cabinet to retrieve a towel and placed over Patient #9 lap, turned the water on at the sink to warm up, reached in the cabinet for a wash cloth, wet the cloth, applied a facial cleanser to face, and wiped off with cloth, then began washing arms, front and back. Once completed, took another towel from the cabinet to dry Patient #9 off, applied lotion to Patient #9 face, arms and legs. Went to bedroom to retrieve undergarments. HHA 2 then began to wash legs and feet, rinsed, dried, and applied lotion. HHA 2 doffed their gloves, then donned a clean pair of gloves. Once dressed, HHA 2 returned to the kitchen sink, washed their hands, and turned the water off with bare hand. HHA 2 failed to perform hand hygiene between glove changes and failed to use a dry paper towel to turn the water off. 3. On 10/08/2024 a home visit was conducted to observe HHA 3 provide personal care to Patient #2. HHA 3 without performing hand hygiene, donned a clean pair of gloves, began gathering clothes for Patient #2, made Patient's #2 bed, went to the bathroom, turned the water on in the shower to warm up, while Patient #2 was undressing. HHA 3 assisted Patient #2 into the shower, assisted with washing their back, and legs. HHA 3 doffed their gloves, and donned a clean pair of gloves, and assisted Patient #2 out of shower, assisted with drying patient, doffed their gloves, and donned a clean pair of gloves. HHA 3 applied lotion to Patient #2's face, then brushed their hair. HHA 3 assisted Patient #2 to their bedroom, and Patient #2 requested privacy to get dressed. HHA 3 went to the kitchen, doffed their gloves, went to the kitchen sink, washed their hands, then turned the water off with their bare hand. HHA 3 failed to perform hand hygiene between glove changes and failed to use a dry paper towel to turn the water off. 4. On 10/08/2024 at 8:43 AM when queried about when hand hygiene should be performed HHA 2 indicated they should perform hand hygiene between changing gloves. 5. On 10/08/2024at 10:39 AM when queried about when hand hygiene should be performed HHA 3 indicated they don't always wash their hands between glove changes because it hard for them to put gloves back on, and should have used a paper towel to turn the water off. 6. On 10/08/2024 at 4 PM the Administrator indicated the HHAs have been trained to wash their hands between glove changes, and to use paper towels to turn the water off. 410 IAC 17-12-1(m)

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484. 102. Survey Dates: 02/01/2024, 02/02/2024, 02/05/2024, 02/06/2024, and 02/07/2024. Active Census: 651 At this Emergency Preparedness survey, Help at Home was found in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.102. QR completed by Area 3 on 2/13/2024.

This visit was for a complaint survey of a Medicaid Home Health Provider. Complaint: 104303 Survey Dates: 02/01/2024, 02/02/2024, 02/05/2024, 02/06/2024, and 02/07/2024. 12 Month Unduplicated Skilled Census: 27 A fully extended survey was announced on 02/05/2024 at 12:49 PM. An immediate jeopardy concerning COP 484. 50 Patient Rights was identified on 02/02/2024 when it was determined the Agency had failed to protect a patient from neglect and failed to implement corrective action to ensure all patients were protected from neglect. The administrator was notified on 02/06/2024 at 10:25 AM of an Immediate Jeopardy at 484.50 Patient Rights. The Agency submitted an acceptable immediacy removal plan for 484.50 Patient Rights on 02/06/2024 at 4:10 PM. The Immediate Jeopardy for 484.50 Patients Rights was removed on 02/07/2024 at 4:19 PM, prior to exit, when it was determined the Agency had implemented corrective actions to prevent patients from neglect. Based on the Condition-level deficiencies during the Help at Home survey, your home health agency was subject to an extended survey pursuant to section 1891 (c)(2)(D) of the Social Security Act on 02/05/2024. Therefore, and pursuant to section 1891 (a)(3)(D)(iii) of the Act, your agency is precluded from operating a home health aide training program, skills competency and/or competency evaluation programs for a period of two years beginning February 7th, 2024 and continuing through February 6th, 2026. QR completed by Area 3 on 2/13/2024.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to protect the patient's right to be free of neglect while receiving care for 1 of 1 clinical record reviewed for a complaint of suspected neglect during home health services with the potential to impact all 651 active patients. (Patient #2). The cumulative effect of this systemic problem 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 484.50 Patient Rights. Findings include: 1. A review of agency policy "Incident Reporting," last revised March 20, 2023, indicated " ... Staff is expected to follow agency policies to prevent incidents ... Incidents to be reported include ... alleged, suspected, or actual neglect ... which includes but is not limited to failure to provide appropriate ... care ... " 2. A review of the comprehensive assessment for Patient #2, date of birth 03/17/1956, dated 11/17/23, indicated a primary diagnosis of contractures (shortening of the muscles and tendons) of the left lower leg muscles and secondary diagnoses including, but not limited to, pain in the left knee, and right and left foot drop (inability to lift the front of the foot). The patient was a full code (required full resuscitation measures such as Cardiopulmonary Resuscitation, or CPR, should the patient's heart stop), had a fair prognosis, was alert and oriented, and received HHA visits for 4 hours/day x 5 days/week for assistance with activities of daily living and instrumental activities of daily living, such as personal care, meal prep, and medication reminders. The comprehensive assessment indicated the patient's aide, Former Employee HHA D, was also the patient's daughter. A review of the plan of care for Patient #2, for certification 11/21/23 - 01/19/24, indicated HHA visits were ordered for 4 hours/day x 5 days/week, not to exceed 20 hours per week throughout the 60-day certification period, and indicated the patient had no advance directives and wanted to be a full code. A review of the daily visit note signed by HHA D, dated 01/02/24, evidenced the HHA's self-adjusted times of 5:30 PM - 9:30 PM and an actual clock out time of 10:26 PM, and indicated the patient received multiple care tasks such as bathing, laundry, hygiene, grooming, and nutrition. 3. A review of the agency's incident log evidenced an unsigned and untimed entry for Patient #2, dated 01/05/24, which indicated the caregiver was HHA D. The incident detail indicated "Daughter came home to find her mother had deceased. She did not specify how long she had been gone but patient had been sitting up eating and interacting appropriately. She does not know if an autopsy is being performed as the patient's sister has taken over in dealing with the situation." 4. The Administrator provided an undated, unsigned root cause analysis which indicated on 01/03/24, Person F, a relative of Patient #2, indicated receiving notification on 01/02/24 around 11 PM, that the patient had passed away. The Administrator indicated in the root cause investigation that HHA D, part of the preferred caregiver program where a family member cares for a patient as an employee of Help at Home, adjusted her clock in and clock out time for the 5:30 PM - 9:30 PM shift on 01/02/24 sometime between 10:16 PM and 10:26 PM. HHA D reported leaving the house during her shift, around 8 PM, to pick up her daughter from work, at which time the patient was sleeping. Upon her return home just before 10 PM, HHA D called out to Patient #2. HHA D found the patient in bed, not breathing, and called 911. The police report indicated HHA D initiated CPR but HHA D denied doing CPR when questioned for the root cause analysis. Person E, a relative of HHA D, was in the home and reported to HHA D that Patient #2 was awake at some point asking for water and a blanket. The root cause analysis indicated HHA D was educated to notify the office and the client she was leaving and had fraudulently adjusted her time to appear she was present for the entire shift. 5. A review of a police report, dated 01/02/24, indicated police were dispatched to Patient #2's home on 01/02/24 at 10:11 PM. They arrived at 10:13 PM and found the patient wasn't breathing and was cold. HHA D, identified on the police report as the patient's daughter, was present. Foul play was not suspected. 6. A review of the personnel file for HHA D evidenced an initial written statement, incorrectly dated 2/8/24, which indicated HHA D admitted leaving the home after 8 PM to pick a relative up from work and returning at 9:58 PM to find Patient #2 had expired. A second written statement, dated 01/11/24,was obtained as the inital statement was incorrect and indicated the same informaion. On 02/02/24, the Administrator indicated HHA D was asked to provide the second statement (01/11/24) because the initial date was incorrect on the first statement. 7. On 02/02/24 at 1:09 PM, the Administrator indicated she completed a root cause analysis and HHA D was terminated on 02/02/24, for failure to communicate with the office. When asked if there were other action steps taken by the Administrator regarding training/education, the Administrator indicated annual education is currently due and employees receive education regarding clocking in and out upon hire.

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure home health aide services were provided by qualified individuals who successfully completed an approved training and competency program and a competency evaluation, including 75 hours of qualified classroom and supervised practical training (G760), the required minimum number of hours for classroom and practical training (G762), failed to maintain documentation of the employee's successful completion of qualified training (G766), and failed to ensure all qualified Home Health Aides successfully completed a competency evaluation program in advance of providing patient care (G768), for 5 of 5 active Home Health Aide records reviewed for home health aide qualifications. (HHA 2, 3, 4, 5, 6) The cumulative effect of this systemic problem 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 484.80 Home Health Aide Services. *

Classroom and supervised practical training CFR(s): 484.80(b)(1) Home health aide training must include classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. Classroom and supervised practical training must total at least 75 hours. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all Home Health Aides (HHA) successfully completed 75-hours of classroom and supervised practical training in a setting or practicum laboratory where the HHA provided services to an individual under the direct supervision of a qualified nurse, for 4 of 5 active HHA records reviewed for HHA qualifications. (HHA 3, 4, 5, 6) Findings include: 6. A review of the personnel record for HHA 4, date of hire and first patient contact of 01/25/24, a skills competency evaluation dated 01/25/24, and a written competency test dated 01/24/24. HHA 4’s undated application indicated previous employment history as a host/server, effective 04/10/23 and HHA 4 had left that employer to take care of a parent. The record failed to evidence HHA 4 had received 75-hours of classroom and supervised practical training as a home health aide prior to first patient contact. 7. A review of the personnel record for HHA 5, date of hire and first patient contact 01/04/24, evidenced a skills competency evaluation dated 12/31/23, and a written competency evaluation dated 12/31/23. The record failed to evidence HHA 4 had received 75-hours of classroom and supervised practical training as a home health aide prior to first patient contact. 8. On 02/05/24 at 2:17 PM, the Administrator indicated all Home Health Aides complete a written test and a skills competency evaluation at the time of hire, using either a live or pseudo patient. When asked about verification of 75-hours of documented classroom and practical training, the Administrator indicated the regulation required either 75-hours of training or successful completion of the written and practical evaluation testing and indicated caring for a loved one or family member qualified as experience. If the individual had no experience, they could work for Entity F, a personal services agency. The Administrator indicated Entity F did not provide home health aide level of care to patients and was unable to indicate how the individuals received 75-hours of practical and classroom Home Health Aide training working in the capacity of a personal care attendant. 1. A policy titled “Competency Assessment” revised 03/20/2023 received from the Alternate Administrator on 02/07/2024 at 2:44 PM, indicated but was not limited to “ . . . A Home Health Aide must demonstrate evidence of: a. Successful completion of a training program totaling at least 75 hours. At least sixteen (16) of those hours must have been devoted to supervised practical training. The individual must complete 16 hours of classroom training before beginning the supervised practical training. OR B. Successful completion of a competency evaluation program . . . . “ 2. A review of the Personnel file for HHA 3 indicated a date of hire and first patient contact 07/19/2022. The file contained a Job description titled HHA/Home Health Aide dated 07/19/2022 and a competency assessment dated 08/24/2023 but failed to evidence 75 hours of classroom training and practical training as a home health aide prior to first patient contact. 3. During an interview with HHA 3 on 02/05/2024 at 1:20 PM, they reported this was their first HHA position and reported taking tests and some classroom training that occurred about a year and a half ago. 4. A review of the Personnel file for HHA 6 evidenced a date of hire and first patient contact 01/17/2024. The file contained a document titled “HHA Skills Competency Follow up” dated 01/17/2024 but failed to evidence 75 hours of classroom training and practical training as a home health aide prior to first patient contact. 5. During an interview on 02/07/2024 at 10:07 AM with HHA 6, they reported they were a rehire and left the agency sometime in 2022 or 2023 and did not work as a home health aide while away from the agency. They reported, “ . . . trained at Help at Home which demonstrated we are knowledgeable about baths, transfers, and stuff . . . . “

Minimum hours of training CFR(s): 484.80(b)(2) A minimum of 16 hours of classroom training must precede a minimum of l6 hours of supervised practical training as part of the 75 hours. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all qualified Home Health Aides (HHA) received a minimum of 16 hours of classroom training preceding 16 hours of supervised practical training as part of the 75-hours of Home Health Aide training, for 4 of 5 Home Health Aide files reviewed for HHA qualifications. (HHA 3, 4, 5, 6) Findings include: 5. A review of the Personnel file for HHA 3 indicated a hire date and first patient contact 07/19/2022. The file contained a Job description titled HHA/Home Health Aide dated 07/19/2022 and a competency assessment dated 08/24/2023 but failed to evidence 16 hours of classroom training which preceded 16 hours of practical training as a part of the 75 hours. 6. A review of the Personnel file for HHA 6 evidenced a date of hire and first patient contact. The file contained a document titled “HHA Skills Competency Follow up” dated 01/17/2024 and failed to evidence 16 hours of classroom training which preceded 16 hours of practical training as a part of 75 hours. 1. A review of agency policy “Competency Assessment,” last revised 03/20/2023, indicated “… The Home Health Aide must demonstrate evidence of a. Successful completion of a training program totaling at least seventy-five (75) hours. At least sixteen (16) of those hours must have been devoted to supervised practical training. The individual must complete at least sixteen (16) hours of classroom training before beginning the supervised practical training OR b. Successful completion of a competency evaluation program … if he/she demonstrates competency in a minimum of eleven (11) of the twelve (12) areas required by Federal guidelines.” 2. A review of the personnel record for HHA 4, date of hire 01/25/24, evidenced a skills competency evaluation dated 01/25/24, and a written competency test dated 01/24/24. The record failed to evidence HHA 4 had received 75-hours of classroom and supervised practical training as a home health aide, including a minimum of 16 hours of classroom training which preceded a minimum of 16 hours of supervised practical training as part of the 75 hours. 3. A review of the personnel record for HHA 5, date of hire 01/04/24, evidenced a skills competency evaluation dated 12/31/23, and a written competency evaluation dated 12/31/23. The record failed to evidence HHA 4 had received 75-hours of classroom and supervised practical training as a home health aide, including a minimum of 16 hours of classroom training which preceded a minimum of 16 hours of supervised practical training as part of the 75 hours. 4. On 02/05/24 at 2:17 PM, the Administrator indicated all Home Health Aides complete a written test and a skills competency evaluation at the time of hire, using either a live or pseudo patient. When asked about verification of 75-hours of documented classroom and practical training, the Administrator indicated the regulation required either 75-hours of training or successful completion of the written and practical evaluation testing and indicated caring for a loved one or family member qualified as experience and if the individual had no experience, they could work for Entity F, a personal services agency, then take the written and skills competency evaluations after they obtained experience at Entity F. The Administrator indicated Entity F was not licensed under this agency’s provider number and was not licensed to provide home health aide level of care to patients. The Administrator was unable to evidence Home Health Aide applicants were screened for classroom and practical training as a requirement for qualified Home Health Aide employment.

HHA maintains documentation of training CFR(s): 484.80(b)(4) The HHA must maintain documentation that demonstrates that the requirements of this standard have been met. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to maintain documentation of Home Health Aide (HHA) training for all home health aides including, but not limited to 75 hours of classroom and supervised practical training with a minimum of 16 hours of supervised practical training for 1 of 1 home health aide records reviewed for training documentation. (HHA 2) Findings Include: 1. A document titled “Competency Assessment” last revised on 03/20/2023 received from the Alternate Administrator on 02/07/24 at 2:44 PM indicated but was not limited to “ . . . vii. Documentation of individual Home Health Aide training and/or competency shall be maintained in the employee’s file. “ 2. A review of the personnel file for HHA 2 failed to evidence documentation for completion of a nurse aide training and competency evaluation program or completion of a State administered program that licenses or certifies home health aides. 3. During an interview on 02/05/2024 at 10:02 AM, HHA 2 reported they had been with the Agency since 2019 but had worked at a previous agency before working at Help at Home. 4. During an interview with the Administrator on 02/05/2024 at 2:17 PM in regards to how HHAs evidenced completion of a HHA training program, they reported if a HHA has experience with a family member or “loved one” it is counted as part of the training and they have passed the competency evaluation, the agency counts that as eligible for employment. 410 IAC 17-14-1 (I)(2)

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to evidence a written examination was completed in 1 of 5 active Home Health Aides (HHA) records reviewed. (HHA 3) Findings Include: 1. A review of the Personnel file for HHA 3 indicated a hire date of 07/19/2022 and a first patient contact of 07/19/2022. The file failed to contain evidence of a written examination. During an interview with the Alternate Administrator on 02/07/2024 at 2:10 PM they reported they could not find any documentation that HHA 3 had a written examination. 410 IAC 17-14-1(I)(A)

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 demonstrate incident reviews and personnel qualifications were maintained for 1 of 1 home health agency. Findings include: On 02/05/24 at 2:17 PM, the Administrator indicated there was no Personal Services Agency under the agency's license, however, if an applicant for a home health aide position had no experience, the applicant was hired by Entity F, a Personal Services Agency, to get experience. After receiving experience at Entity F, the individual could complete the written and skills competency evaluation for Home Health and become a Home Health Aide. The Administrator failed to evidence understanding of CoP 484.80 Home Health Aide Services concerning the requirement that all Home Health Aides must show evidence of 75 hours of training, with at least 16 hours of classroom training that precedes at least 16 hours of supervised practical training by a qualified nurse in advance of providing patient care. IAC 410 17-12-1(c)(1) 1. A policy titled “Organization and Services Administration” revised 03/20/2023 indicated but was not limited to “The agency provides supervision and administrative control of branches on a daily basis to the extent that the branch depends on the parent Agency’s supervision and administrative functions in order to meet Conditions of Participation . . . . ” 2. A review of the Agency’s incident log indicated “Date of Activity 01/02/2024 “ and evidenced Home Health Aide D had left a patient’s home during their shift without notifying the agency. When HHA D returned, the patient, a full code had expired. 3. During an interview with the Administrator on 02/02/2024 at 1:09 PM they reported they received notification on 01/03/2024, reviewed HHA D’s timecard, and determined the HHA had clocked in at the same time they had clocked out and the time stamp indicated this had occurred after the shift had ended. The HHA admitted to the falsification and was terminated, an incident was filed with the Indiana Department of Health . When queried if there were other interventions, the administrator reported there was no agency-wide follow-up and that all employees are trained on clocking in and out during orientation and annually. The administrator failed to take further action to review active employees’ time logs or prevent further employee abandonment of patients.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on record review and interview, the Administrator failed to ensure the agency hired qualified Home Health Aides, for 5 of 5 active Home Health Aide files reviewed for aide qualifications. (HHA 2, 3, 4, 5, 6) Findings include: 1. A review of agency policy “Competency Assessment,” last revised 03/20/2023, indicated “… The Home Health Aide must demonstrate evidence of a. Successful completion of a training program totaling at least seventy-five (75) hours. At least sixteen (16) of those hours must have been devoted to supervised practical training. The individual must complete at least sixteen (16) hours of classroom training before beginning the supervised practical training OR b. Successful completion of a competency evaluation program … if he/she demonstrates competency in a minimum of eleven (11) of the twelve (12) areas required by Federal guidelines.” 2. A review of the personnel record for HHA 2, date of hire 09/30/2020, failed to evidence HHA 2 had received 75-hours of classroom and supervised practical training as a home health aide, including a minimum of 16 hours of classroom training which preceded a minimum of 16 hours of supervised practical training as part of the 75 hours. 3. A review of the personnel record for HHA 3, date of hire 07/19/2022, failed to evidence HHA 3 had received 75-hours of classroom and supervised practical training as a home health aide, including a minimum of 16 hours of classroom training which preceded a minimum of 16 hours of supervised practical training as part of the 75 hours. 4. A review of the personnel record for HHA 4, date of hire 01/25/2024, failed to evidence HHA 4 had received 75-hours of classroom and supervised practical training as a home health aide, including a minimum of 16 hours of classroom training which preceded a minimum of 16 hours of supervised practical training as part of the 75 hours. 5. A review of the personnel record for HHA 5, date of hire 01/04/2024, failed to evidence HHA 5 had received 75-hours of classroom and supervised practical training as a home health aide, including a minimum of 16 hours of classroom training which preceded a minimum of 16 hours of supervised practical training as part of the 75 hours. 6. A review of the personnel record for HHA 6, date of hire 01/27/2024, failed to evidence HHA 6 had received 75-hours of classroom and supervised practical training as a home health aide, including a minimum of 16 hours of classroom training which preceded a minimum of 16 hours of supervised practical training as part of the 75 hours. 7. On 02/05/2024 at 2:17 PM, the Administrator indicated all Home Health Aides complete a written test and a skills competency evaluation at the time of hire, using either a live or pseudo patient. When asked about verification of 75-hours of documented classroom and practical training, the Administrator indicated the regulation required either 75-hours of training or successful completion of the written and practical evaluation testing and indicated caring for a loved one or family member qualified as experience and if the individual had no experience, they could work for Entity F, a personal services agency, then take the written and skills competency evaluations after they obtained experience at Entity F. The Administrator indicated Entity F was not licensed under this agency’s provider number and was not licensed to provide home health aide level of care to patients. The Administrator was unable to evidence Home Health Aide applicants were screened for classroom and practical training as a requirement for qualified Home Health Aide employment. IAC 410 17-12-1(d)(3)

This visit was for a Federal/State complaint survey of a Home Health Provider. Survey Dates: 07/05/23, 07/06/23, 07/07/23 Complaint # 99506 Related and unrelated deficiencies cited. 12-month Unduplicated Skilled Admissions: 960 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. QR complete by A3.

A qualified HH aide successfully completed: CFR(s): 484.80(a)(1)(i-iv) A qualified home health aide is a person who has successfully completed: (i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview the agency failed to ensure all home health aides successfully completed a training and competency evaluation program that included at least 75 hours of classroom and supervised practical training, a competency only program, based on previously completing the required training and competency, a nurse aide training and competency evaluation program approved by the state, or a competency or state licensure program, for 2 of 2 home health aides observed during orientation and competency classes. Findings include: 1. A review of agency policy "Competency Assessment," last revised 03/20/23, indicated “ii. Skills competency is evaluated by observing the aide with client and/or pseudo patient ... iv. The Home Health Aide must demonstrate evidence of: a. Successful completion of a training program totaling at least 75 hours ... OR b. Successful completion of a competency evaluation program. The Home Health Aide will have successfully completed the ... program if he/she demonstrates competency in a minimum of eleven (11) of the twelve areas required in federal guidelines. Skills with an asterisk must be evaluated using a client or pseudo patient …” 2. On 07/06/23 at 10:44 AM, Person C, a Registered Nurse (RN) and competency nurse, was observed conducting a Home Health Aide (HHA) Skills competency class. Person C provided skills training during the class, as observed by instruction on obtaining vital signs, using a gait belt, hand washing, use of a fracture pan (a type of bedpan), and use of a Hoyer lift (device used to transfer a person from bed to chair). During the competency class, HHA 5 and HHA 6 were questioned by Person C concerning their experience using a gait belt and Hoyer lift. HHA 5 and HHA 6 indicated they did not have any experience using the equipment and had never received classroom or supervised practical training to become a home health aide. Person C observed HHA 5 provide an incomplete bed bath to the lower extremities of Person F, the pseudo patient, and when questioned regarding the missing steps, HHA 5 indicated she did not miss any steps. During the bed bath provided by HHA 6, the aide indicated being confused and became anxious when required to demonstrate washing the breasts of Person F, who was fully clothed. Person C provided verbal cues and training to HHA 6 and HHA 6 continued the bed bath. Person C was asked about completing the shower/sink/tub bathing and shampooing and indicated she only assessed aide competency using a bed bath because that was what people were most nervous about. HHA 5 and HHA 6 required training throughout the competency, failed to demonstrate the required skills without verbal cuing and instruction, and failed to demonstrate all skills required to be performed using a client or pseudo patient . 3. On 07/06/23 at 2:44 PM, observations and findings were reviewed with the Administrator and Alternate Administrator, including the absence of documentation that HHA 5 and HHA 6 received 75 hours of classroom and supervised practical training, failure to demonstrate all required skills using a client or pseudo patient, and failure to demonstrate all required skills without training and verbal cuing. The Administrator indicated the date of hire for HHA 5 and HHA 6 was 07/06/23 and indicated the competency assessment forms for HHA 5 and HHA 6 were not accurate based on the observations in the competency class. 410 IAC 17-14-1(l)(1)(A)

HHA maintains documentation of training CFR(s): 484.80(b)(4) The HHA must maintain documentation that demonstrates that the requirements of this standard have been met. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure it maintained documentation of Home Health Aide (HHA or hha) training for all home health aides including, but not limited to, 75 hours of classroom and supervised practical training with a minimum of 16 hours classroom training and a minimum of 16 hours of supervised practical training, for 2 of 3 home health aide records reviewed for training documentation. (HHA 5, HHA 6) Findings include: 1. A review of agency policy "Competency Assessment," last revised 03/20/23, indicated, " ... vii. Documentation of individual Home Health Aide training and/or competency shall be maintained in the employee's file." 2. A review of the personnel file for HHA 5 failed to evidence documentation that HHA 5 successfully completed a training and competency program, successfully completed a competency evaluation program based on previous training received, successfully completed a nurse aide training and competency evaluation program and training and competency requirements for a home health aide, or successfully completed a State administered program that licenses or certifies home health aides. 3. A review of the personnel file for HHA 6 failed to evidence documentation that HHA 6 successfully completed a training and competency program offered by another home health agency, successfully completed a competency evaluation program only, based on home health aide training received previously, successfully completed a nurse aide training and competency evaluation program and training and competency requirements for an HHA, or successfully completed a State administered program that licenses or certifies home health aides. 4. On 07/06/23 at 2:44 PM, the Administrator indicated there was no further personnel file documentation for HHA 5 and HHA 6. 410 IAC 17-14-1)l)(2)

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview the agency failed to ensure it hired qualified home health aides who were competent to provide safe, effective, and efficient care, for 2 of 2 Home Health Aides observed during competency evaluations. (HHA 5, HHA 6) Findings include: 1. A review of agency policy "Competency Assessment," last revised 03/20/23, indicated “ii. Skills competency is evaluated by observing the aide with client and/or pseudo patient ... iv. The Home Health Aide must demonstrate evidence of: a. Successful completion of a training program totaling at least 75 hours ... OR b. Successful completion of a competency evaluation program. The Home Health Aide will have successfully completed the ... program if he/she demonstrates competency in a minimum of eleven (11) of the twelve areas required in federal guidelines. Skills with an asterisk must be evaluated using a client or pseudo patient …” 2. On 07/06/23 at 10:44 AM, Person C (a Registered Nurse [RN] and competency nurse) was observed conducting a Home Health Aide (HHA) Skills competency class. Person C provided skills training during the class as observed by instruction on obtaining vital signs, using a gait belt, hand washing, use of a fracture pan (a type of bedpan), and use of a Hoyer (device used to transfer a person from bed to chair) lift. During the competency class, HHA 5 and HHA 6 were questioned by Person C concerning their experience using a gait belt and Hoyer lift. HHA 5 and HHA 6 indicated they did not have any experience using the equipment and had never received classroom or supervised practical training to become a home health aide. Person C observed HHA 5 provide an incomplete bed bath to the lower extremities of Person F, the pseudo patient, and when questioned regarding the missing steps, HHA 5 indicated she did not miss any steps. During the bed bath provided by HHA 6, the aide indicated being confused and became tearful when required to demonstrate washing the breasts of Person F, who was fully clothed. Person C provided verbal cues and training to HHA 6 and HHA 6 continued the bed bath. Person C was asked about completing the shower/sink/tub bathing and shampooing and indicated she only assessed aide competency using a bed bath because that was what people were most nervous about. HHA 5 and HHA 6 required training throughout the competency and failed to demonstrate the required skills without verbal cuing and instruction. 3. A review of the self-assessment completed and signed by HHA 5, dated 07/05/23, indicated HHA 5 was experienced in all skills listed except documentation and following the aide plan of care, and had no experience in geriatrics or spinal cord injuries. HHA 5 was marked as “eligible for competency.” A review of the HHA competency assessment for HHA 6, dated 07/06/23 and signed by Person C, indicated HHA 6 successfully completed all the skills listed using a pseudo-patient. 4. A review of the self-assessment completed and signed by HHA 6, dated 07/05/23, indicated HHA 56was experienced in all skills listed except shaving and assisting with ambulation and indicated HHA 6 had no experience in pediatrics, geriatrics, autism, developmental disabilities, seizure disorders, cerebral palsy, spinal cord injuries, dementia, and Alzheimer's. HHA 6 was marked as "eligible for competency." A review of the “Competency Assessment – HHA,” for HHA 6, dated 07/06/23 and signed by Person C, indicated HHA 6 successfully completed all the skills listed using a pseudo-patient. 5. On 07/06/23 at 2:44 PM, observations and findings were reviewed with the Administrator and Alternate Administrator including, but not limited to, the absence of training and experience for HHA 5 and HHA 6, failure to use a client or pseudo patient to demonstrate the required skills, and failure to demonstrate all required skills, and failure to demonstrate all required skills without training and verbal cuing. The Administrator indicated the date of hire for HHA 5 and HHA 6 was 07/06/23 and indicated the competency assessment forms for HHA 5 and HHA 6 were not accurate based on the observations in the competency class. 410 IAC 17-12-1(d)(3)

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure a home health aide provided services according to the aide plan of care for 1 of 2 home health aide observations. (HHA 1) Findings include: A 2022 signed Home Health Aide job description was provided by the Administrator on 6/14/2022 at 12:10 p.m. The job description indicated, but was not limited to, "An individual that provides a broad range of non-medical ... and any other task appropriate according to the patient's plan of care. Responsibilities: Follows a client's written Plan of Care and carries out duties as assigned by the supervisor ... accurately follow written and oral instructions ...". The complete clinical record for patient 2 was reviewed on 6/14/2022, start of care date 4/22/2022, for the certification period 4/22/2022 to 6/20/2022, that included orders for "fluocinonide [medication for itchy skin] 0.05% topical solution, take 1 application 2 times a day (BID) for Psoriasis. Use for 2 weeks during flare ups, then stop. Dated 4/22/2022". Review of the Medication Report indicated medications were reconciled on 5/20/2022 by RN (registered nurse) 8. During a home visit on 6/14/2022 at 11:10 a.m., HHA (home health aide) 1 applied several drops of prescribed fluocinonide to patient 2's scalp. HHA 1 proceeded to gently rub medication into patient 2's scalp and allowed to soak in. HHA 1 indicated he/she would wash patient 2's hair. At that time, HHA 1 indicated the medication was used daily for itching. Patient 2 informed the HHA the medication was to be applied after showers. Review of the aide Plan of Care Service Plan dated 4/25/2022 indicated patient 2 received a tub/shower 3 times a week. The Plan of Care did not indicate a HHA was allowed to apply prescribed fluocinonide medication for patient 2 at any time. During an interview on 6/14/2022 at 2:10 p.m. the Administrator indicated HHA 1 should not administer prescribed medication and should follow the aide plan of care.

Duties of a HH aide CFR(s): 484.80(g)(3) The duties of a home health aide include: (i) The provision of hands-on personal care; (ii) The performance of simple procedures as an extension of therapy or nursing services; (iii) Assistance in ambulation or exercises; and (iv) Assistance in administering medications ordinarily self-administered. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the home health aide only applied non-prescription topical creams for 1 of 2 home health aide observations. (HHA 1) Findings include: 410 IAC 17-14-1(h)(1)-(14) A 2021 signed Home Health Aide job description was provided by the Administrator on 6/14/2022 at 12:10 p.m. The job description indicated, but was not limited to, "Follow a client's written Plan of Care and carries out duties as assigned by the supervisor." During a home visit observation on 6/14/2022 at 11:10 a.m. HHA 1 applied prescribed fluocinonide to patient 2's scalp. The agency failed to ensure the HHA only applied non-prescription topical medication. During an interview on 6/14/2022 at 2:10 p.m. the Administrator indicated HHA 1 should not apply prescribed topical medication. 410 IAC 17-14-1(h)(1)-(14)

This visit was for 2 federal/state complaints of a home health agency. The investigation began on 3/08/2022 and the facility was entered on 3/10/2022. A fully extended survey was announced on 3/11/2022 at 1:40 PM, and a recertification survey and state re-licensure survey were conducted. Complaint Intake: 62349-Substantiated with Findings Complaint Intake: 62350- Substantiated with Findings Survey Dates: 3/8, 3/9, 3/10, 3/11, 3/14, 3/15, 3/16, 3/17, 3/18, and 3/21 of 2022 An Immediate Jeopardy related to §484.70 (d) Infection Prevention and Control through vaccination of agency staff, or documentation of exemption, was identified and announced on 3/11/2022 at 1:40 p.m. The immediate jeopardy began on February 14th, 2022, when the agency failed to implement CMS-mandated tracking of the vaccination status of agency staff. The immediate jeopardy was unremoved at the survey exit date of 3/21/2022. The agency's 3/17/2022 removal plan was found to be unacceptable. The next Immediacy Removal plan (#2) was found unacceptable on 3/21/2022. Based on the Condition-level deficiencies identified during the 3/21/2022 survey, Help at Home Skilled was subject to a partial or extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act, on 3/11/2022 at 1:40 p.m. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, Help at Home Skilled Care is precluded from operating or being the site of a home health aide training and/or competency evaluation program for a period of 2 years beginning 3/21/2022, and continuing through 3/20/2024. QR by Area 3 on 4-2-2022

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patients had a written copy of their rights (See G412); failed to ensure all patients had the name & contact information of the agency administrator (See G414), failed to ensure patients had the right to make complaints to the agency and have them investigated by the agency (See G432 & G472); and failed to ensure all patients received services as ordered in their plan of care (See G436). The cumulative effect of these systemic problems resulted in the agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 484.50 Patient Rights.

Written notice of patient's rights CFR(s): 484.50(a)(1)(i) (i) Written notice of the patient's rights and responsibilities under this rule, and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to evidence patient consent was obtained prior to providing care, failed to have documentation evidencing the patients and/or power of attorneys received notice of their patient rights and responsibilities, and the agencies copies of the agencies discharge and transfer for policies for 9 of 22 Clinical Records Reviewed. (Patient 4, 5, 6, 8, 23, 24, 25, 26, and 27.) Findings include: The complete clinical record of patient #27 was reviewed on 3/15/2022. The record failed to evidence documentation of signed consents and failed to evidence receipt of patient rights, patient responsibilities, agency discharge policies, and agency transfer policies. On 3/17/2022 requested admission consents for patients on the patient roster from the alternate administrator. The agency failed to provide all admission consents requested, alternate administrator stated they may be PSA patients and she would continue to look for them. No additional consents were provided. The complete clinical record of patient 25 was reviewed on 3/15/2022. The record failed to evidence documentation of signed consents and failed to evidence receipt of patient rights, patient responsibilities, agency discharge policies, and agency transfer policies. The complete clinical record of patient 26 was reviewed on 3/15/2022. The record failed to evidence documentation of signed consents and failed to evidence receipt of patient rights, patient responsibilities, agency discharge policies, and agency transfer policies. An 8/26/2021 policy titled “Admission Criteria” was provided by RN B on 3/12/2022 at 12:35 p.m. The document indicated but was not limited to; “The following forms are signed, by the client or designated responsible party, healthcare proxy, or legal guardian during the admission process with a copy remaining in the client’s home chart and the original maintained in the office clinical record. a. Agreement/Consent for Home Care Services b. Home Safety Evaluation c. Handbook Acknowledgement … e. the consent/release of information form is to be signed by the client or responsible party, healthcare proxy, or legal guardian and placed in the medical record. The complete clinical record of patient #4 was reviewed on 3/17/2022. The record failed to evidence documentation of signed consents and failed to evidence receipt of patient rights, patient responsibilities, agency discharge policies, and agency transfer policies. The record contained receipt of consents for another agency, entity ?, patient 4’s previous home health agency. The complete clinical record of patient #5 was reviewed on 3/17/2022. The record failed to evidence documentation of signed consents and failed to evidence receipt of patient rights, patient responsibilities, agency discharge policies, and agency transfer policies. The complete clinical record of patient #6 was reviewed on 3/21/2022. The record failed to evidence documentation of signed consents and failed to evidence receipt of patient rights, patient responsibilities, agency discharge policies, and agency transfer policies. The complete clinical record of patient #8 was reviewed on 3/10/2022. The record failed to evidence documentation of signed consents and failed to evidence receipt of patient rights, patient responsibilities, agency discharge policies, and agency transfer policies. The complete clinical record of patient #23 was reviewed on 3/15/2022. The record failed to evidence documentation of signed consents and failed to evidence receipt of patient rights, patient responsibilities, agency discharge policies, and agency transfer policies. The complete clinical record of patient #24 was reviewed on 3/15/2022. The record failed to evidence documentation of signed consents and failed to evidence receipt of patient rights, patient responsibilities, agency discharge policies, and agency transfer policies.

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure patients had the correct contact information for the agency administrator in order to make complaints to the home health agency for 1 of 1 agency reviewed with the potential to affect all 1,931 patients. Findings include: 11. During a home visit on 3/15/2022 patient 11 did not have contact information for the agency's administrator and clinical manager in the home binder. A home observation visit with Patient #17 was conducted on 03/15/2022 at 10:00 AM, with Employee R, home health aide and patients’ family member present. Observed agency folder in home missing the name of Employee B, administrator. Administrator contact information missing in the home. Review of an agency document dated 04/2021, titled “Patient Orientation for Home Health Care” contained a section titled “Patient Rights and Responsibilities” missing the name of the current administrator. 1. A document titled “Patient Orientation for Home Health Aide Care” was provided by the Lafayette Branch Manager on 3/14/2022 at 10:50 a.m. when asked for the current admission packet. The document indicated but was not limited to; “Any concern or grievance may be made in writing or by a telephone to the Indianapolis Parent Office Administrator, [Former Administrator B 6 months prior] … Our offices hours are Monday through Friday from 9:00 a.m. to 5:00 p.m., except on the following holidays: Memorial Day, July Fourth, Labor Day, Thanksgiving, Christmas Day and New Year’s Day … After Hours Coverage: We provide 24-hour on-call services, 7 days per week to ensure that you receive necessary home care services.” 2. On 3/08/2022 a phone call was placed to the agency’s Bloomington branch at 3:15 p.m. during business hours. An answering system directed emergencies to call 911 or leave a voice mail and a call back would be received as soon as possible. 3. On 3/08/2022 a phone call was placed to the agency’s Bloomington branch at 3:20 p.m. during business hours. An answering system directed emergencies to call 911 or leave a voice mail and a call back would be received as soon as possible, the voice box mail was full and unable to accept messages. 4. On 3/15/2021 the agency’s after-hours phone number was called. The call was answered by a recording that directed patients to leave a voicemail to receive a callback. The voicemail then states the voicemail box is full and terminates the phone call. 5. On 3/08/2022 during an interview with patient 3’s power of attorney (POA), the POA stated they have made multiple attempts to reach the administrator and have been unsuccessful. They stated even during business hours they will not answer their phone. 6. During a home visit on 3/15/2022 patient 17's paperwork reviewed in the home had the incorrect name and contact information for the agency's administrator and clinical manager. 7. During a home visit on 3/15/2022 patient 15 did not have contact information for the agency's administrator and clinical manager. 8. During a home visit on 3/15/2022 patient 16's paperwork reviewed in the home had the incorrect name and contact information for the agency's administrator and clinical manager. 9. During an interview with HHA V, HHA V stated that ever since September of 2021 when Entity 3 took over the agency patient are unable to get a hold of someone at the agency. HHA V stated those that who do have to call repeatedly and occasionally during hours someone will answer but after-hours patients complain they do not receive a callback. 10. During an interview on 3/16/2022 at 10:45 a.m. when the administrator was informed the phones were not being answered and the voicemail box was full, they stated “Maybe there was a technical issue that day, I’ll have to look into it.” No further information was provided. 11. During an interview with the administrator on 3/21/2022 at 1:18 p.m., the administrator stated all complaints are placed into a program (Risk Management). The administrator stated they did not have access or oversight of the program and could only request specific information. The administrator stated he was not sure who had full oversight but that it was someone from the corporate-owned entity 1.

Patient's or legal representative's signature CFR(s): 484.50(a)(2) Obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to evidence patient consent was obtained prior to having furnished patient care, failed to have documentation evidencing the patients and/or power of attorneys received notice of their patient rights for 9 of 22 Clinical Records Reviewed. (Patients 4, 5, 6, 8, 23, 24, 25, 26, and 27.) Findings include: 17-12-3(a)(2) 1. An 8/26/2021 policy titled “Admission Criteria” was provided by RN B on 3/12/2022 at 12:35 p.m. The document indicated but was not limited to; “The following forms are signed, by the client or designated responsible party, healthcare proxy, or legal guardian during the admission process with a copy remaining in the client’s home chart and the original maintained in the office clinical record. a. Agreement/Consent for Home Care Services b. Home Safety Evaluation c. Handbook Acknowledgement … e. the consent/release of information form is to be signed by the client or responsible party, healthcare proxy, or legal guardian and placed in the medical record. 2. The complete clinical record of patient #4 was reviewed on 3/17/2022. The record failed to evidence documentation of signed consents, failed to evidence the receipt of patient rights, and responsibilities. The record contained receipt of consents for another agency, Entity 2, patient 4’s previous home health agency. 3. The complete clinical record of patient #5 was reviewed on 3/17/2022. The record failed to evidence documentation of signed consents, failed to evidence receipt of patient rights, and patient responsibilities. 4. The complete clinical record of patient #6 was reviewed on 3/21/2022. The record failed to evidence documentation of signed consents, failed to evidence receipt of patient rights, and patient responsibilities. 5. The complete clinical record of patient #8 was reviewed on 3/10/2022. The record failed to evidence documentation of signed consents, failed to evidence receipt of patient rights, and patient responsibilities. 6. The complete clinical record of patient #23 was reviewed on 3/15/2022. The record failed to evidence documentation of signed consents, failed to evidence receipt of patient rights, and patient responsibilities. 7. The complete clinical record of patient #24 was reviewed on 3/15/2022. The record failed to evidence documentation of signed consents, failed to evidence receipt of patient rights, and patient responsibilities. 8. The complete clinical record of patient #25 was reviewed on 3/15/2022. The record failed to evidence documentation of signed consents, failed to evidence receipt of patient rights, and patient responsibilities. 9. The complete clinical record of patient #26 was reviewed on 3/15/2022. The record failed to evidence documentation of signed consents, failed to evidence receipt of patient rights, and patient responsibilities. 10. The complete clinical record of patient #27 was reviewed on 3/15/2022.The record failed to evidence documentation of signed consents, failed to evidence receipt of patient rights, and patient responsibilities. 11. On 3/17/2022 requested admission consent for patients on the patient roster from the alternate administrator. The agency failed to provide all admission consents requested, alternate administrator stated they may be PSA (personal service agency) patients and she would continue to look for them. No additional consents were provided.

Make complaints to the HHA CFR(s): 484.50(c)(3) Make complaints to the HHA regarding treatment or care that is (or fails to be) furnished, and the lack of respect for property and/or person by anyone who is furnishing services on behalf of the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure patients had the ability to make complaints to the home health agency for 1 of 1 agency reviewed with the potential to affect all 1,931 patients. Findings include: 1. On 3/14/2022 at 10:50 AM, a document titled “Patient Orientation for Home Health Care,” was provided by Employee K. A review of the document indicated but was not limited to “...Policies...This book contains information regarding your rights...as a patient...The home health agency must protect and promote the exercise of these rights as follows … Make complaints to Help at Home..." 2. On 3/14/2022 the administrator provided meeting minutes for each branch for 2022. A review of the meeting minutes for the week ending 1/29/2022 ,for the Indianapolis branch of the agency stated "Additional Notes … HHA (Home Health Agency) reporting and grievances go to [name of State Quality & Compliance Lead out of Chicago Illinois.] 3. On 3/08/2022, a phone call was placed to the agency’s Bloomington branch at 3:15 p.m. during business hours. An answering system directed emergencies to call 911 or leave a voice mail and a call back would be received as soon as possible. 4. On 3/08/2022 a phone call was placed to the agency’s Bloomington branch at 3:20 p.m. during business hours. An answering system directed emergencies to call 911 or leave a voice mail and a call back would be received as soon as possible, the voice box mail was full and unable to accept messages. 5. On 3/08/2022 during an interview with Patient 3’s power of attorney (POA), the POA stated they have made multiple attempts to reach the administrator and have been unsuccessful. They stated even during business hours the agency would not answer their phone. 6. During an interview on 3/08/2022, with HHA V, HHA V stated ever since September of 2021, when Entity 3 took over the agency, patients are unable to get a hold of someone at the agency. HHA V stated those that do get a response must call repeatedly and occasionally during hours someone will answer, but after-hours patients complain they do not receive a callback. 7. On 3/15/2021, the agency’s after-hours phone number was called. The call was answered by a recording that directed patients to leave a voicemail to receive a callback. The voicemail then stated the voicemail box was full and terminated the phone call. 8. During an interview with the administrator on 3/21/2022 at 12:23 p.m., the administrator stated all complaints are placed into a program (RisKonnect.) The administrator stated no employee at this agency had access or oversight of the program and could only request specific information. The administrator stated he was not sure who had full oversight but that it was someone from the corporate-owned entity 1. 410 IAC 17-12-3(b)(2)(B)

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure patients received all services ordered in the plan of care for 4 of 12 active records reviewed. (Patients 2, 4, 8, and 10) The complete clinical record for patient #4 was reviewed on 03/11/2022 for the certification period of 01/07/2022 through 03/07/2022. Patient 4 had an admission/start of care date of 01/07/2022 with orders for home health aide services 6 hours per day 5 days per week. Patient #4's received 0 of the 270 home health hours ordered during the certification period. Patient #4 then received a recertification visit on 03/07/2022 by a registered nurse. During an interview with the administrator and alternate administrator on 3/21/2022, they stated they would have to look into why the patient did not receive visits. Upon return, they stated they were having issues obtaining preauthorization for the patient. The record failed to evidence any monitoring of the patient during the certification period and failed to evidence a new start of care date once preauthorization was obtained. The clinical record for patient #8 was reviewed on 3/10/2022 for the certification period 8/20/2021 through 10/18/2021 and indicated patient #8 received home health aide services 3-4 hours a day, 4-5 days per week and skilled nursing services 1 hr per week, 1 day a week. Patient #8 had 5 missed home health visits on 9/14/2021, 9/23/2021, 9/27/2021, 9/30/2021 and 10/1/2021. The clinical record for patient #10 was reviewed on 3/14/2022 for certification period 1/14/2022 through 3/14/2022 and indicated patient #10 received home health aide services 1 hour a day, 3 days a week. Patient # 10 had 2 missed visits on 2/5/2022 and 2/26/2022. On 3/14/22 at 10:50 AM, a document titled “Patient Orientation for Home Health Care” was provided by the Lafayette branch manager. The document indicated but was not limited to “...Policies...This book contains information regarding your rights...as a patient...Criteria for Admission...The services can be provided safely and effectively...clients are accepted for Home Health Services based on...that the clients’ health care needs can be met adequately...” The clinical record for patient #2 was reviewed on 3-21-22. The plan of care indicated the start of care was 2/10/22 with a certification period of 2/11/22 through 4/11/22, with orders for a home health aide to provide 3 hours a day for 5 days a week. A review of the record of the visit revealed that patient #2 received home health aide services 4 days a week. Patient #2 had one missed visit for the week of 2/13/22, one missed visit for the week of 2/20/22, one missed visit for the week of 2/28/22, one missed visit for the week of 3/6/22, and one missed visit for the week of 3/13/22. During an interview with the Alternate Administrator on 3/21/22 at 1:15 PM, she reported it was a scheduling issue and said, “we did not have a home health aide scheduled as we should have.”

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on observation and document review, the agency failed to ensure it provided all patients with the correct name, address and telephone number of the Quality Improvement Organization for 1 of 1 home visit records reviewed (Patient #17). Findings include: A home observation visit with Patient #17 was conducted on 03/15/2022 at 10:00 AM, with Employee R, home health aide and patients’ family member present. Observed agency folder in home which contained the incorrect name and contact information for the Quality Improvement Organization. Review of an agency document dated 04/2021, titled “Patient Orientation for Home Health Care,” contained a section titled “Patient Rights and Responsibilities” which indicated “… be advised of the names, address, and telephone numbers of the following federally-funded and state-funded entities … Quality Improvement Organization ….”

Investigate complaints made by patient CFR(s): 484.50(e)(1)(i) (i) Investigate complaints made by a patient, the patient's representative (if any), and the patient's caregivers and family, including, but not limited to, the following topics: This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to have all patient complaint's investigated with documented resolution and notification to the patient within the home health agency, for 1 of 1 complaints reviewed. Findings include: 1. On 3/14/2022 at 10:50 AM, a document titled “Patient Orientation for Home Health Care,” was provided by Employee K. A review of the document indicated but was not limited to “...Policies...This book contains information regarding your rights...as a patient...The home health agency must protect and promote the exercise of these rights as follows … Make complaints to Help at Home..." 2. On 3/14/2022 the administrator provided meeting minutes for each branch for 2022. A review of the meeting minutes for the week ending 1/29/2022 for the Indianapolis branch of the agency state "Additional Notes … HHA (Home Health Agency) reporting and grievances go to [name of State Quality & Compliance Lead out of Chicago Illinois.] 3. Meeting minute notes for quarter 3 of 2021, were provided by the administrator on 3/14/2021. A review of the document indicated but was not limited to; "Summary of findings … Indy East … patient missing 9/15. Last home visit 9/14. No other information." A family member of the missing patient called the agency to report their concern. 4. During an interview on 3/21/2022, at 1:30 PM, the administrator was asked about the outcome of the missing person notated in their QAPI (quality assurance & performance improvement) program. The administrator stated he/she would have to find out. He/she stated he did not have access to grievances once they are entered into the system. When queried on the "system" the administrator stated it is a program called RisKonnect that the staff input complaints and grievances into RisKonnect and then an outside entity takes over from there. The administrator stated he/she did not have oversight or access, but could request information from the outside entity and would find out more information about the missing patient. When asked about the investigation and resolution of the complaint from 9/15/2022, the administrator stated he/she was not sure who but someone from the corporate-owned entity 2 investigated complaints and grievances placed in the system, and if there were any questions the administrator was notified.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review, observation, and interview, the agency failed to maintain an updated list of all medications their patients were prescribed for 4 of 7 home visits. (Patient 10, 14, 15, and Patient 27) During a home visit on 3/14/2022 at 12:00 PM, Patient #16’s folder/binder contained medication instructions from the certification period of 6/16/21 through 8/10/21. During an interview on 3/14/2022 at 2:59 PM, with Employee L, Registered Nurse (RN) Clinical Manager, Lafayette, they confirmed that Patient #16 did not have updated information in a folder or binder. They reported, “we are behind a little … we are making new binders now.” During a home visit on 3/15/2022 at 10:00 AM, Patient #15 was unable to locate a folder/binder from Help at Home. Employee M, Home Health Aide, was not able to locate a current folder/binder in the patient’s home, containing updated medication instructions. During an interview on 3/15/2022 at 1:10 PM, with the Alternate Administrator, she confirmed the plan of care and information should be in the patient’s home binder and “they (referring to agency) usually replace them each recert. (recertification)…they are typically in a white binder, usually keep all plans of care, admission paperwork, handbook, and any medication changes. “ During a home visit on 3/17/2022, at 12:00 PM with Patient #27, certification period 2/11/22 to 4/11/22, Employee #UU, Home Health Aide, reported employee C, Registered Nurse, delivered an updated folder/binder this morning, that included an updated plan of care, medication instructions, patient’s care needs, and agency contact information. Patient # 27 confirmed just receiving a new binder this AM. IAC 1-17-14-1(a)(1)(B) During a home visit observation on 3/14/2022 at 1:00 p.m. patient #10's medications observed in the home were compared to the medications listed on the patient medication profile and plan of care. Three (3) medications were not listed on the medication profile, 2 medications had been discontinued and were on the medication profile, and 1medication indicated the wrong dosage. Patient #10's plan of care had orders for Vicodin (used to treat pain) 5 mg - 300 mg tablets 2 taken two times a day as needed for pain. The patient POA states they are no longer taking this medication. Patient #10's plan of care had orders for Cyclobenzaprine (used to treat pain) 10 mg tablets taken 1 tablet once a week for pain. The patient POA states they are no longer taking this medication. Patient #10's plan of care had orders for Simvastatin (used to treat high cholesterol) 40 mg tablets taken once daily. The correct dosage is 40 mg 1/2 tablet daily. Patient #10's plan of care was missing order for hydroxyzine (used to treat sleep disorder) 10 mg taken at bedtime as needed for sleep. This medication was in the home. Patient #10's plan of care was missing order for Vitamin C (used to treat low vitamin levels) 500 mg taken once daily. This medication was in the home. Patient #10's plan of care was missing order for Metformin (used to treat high blood sugar) 500 mg taken at twice daily. This medication was in the home. 1. A 01/04/2022 last revised document titled "Plan of Care" was provided by the administrator on 3/21/2022 at 10:15 a.m. The document indicated but was not limited to; "The plan of care/treatment shall … include the following … all medications and treatments." 2. During a home visit observation on 3/15/2022 at 3:00 p.m. patient #14's medications observed in the home were compared to the medications listed on the patient medication profile and plan of care. One (1) medication was not listed on the medication profile, 1 medication was listed inaccurately on the medication profile, 2 medications were not present in the patient's home that were listed on the medication profile, and 4 medications indicated the wrong dosage. Patient #14's plan of care had orders for Neurontin (used to treat diabetic nerve pain) 300 mg capsules 2 taken at bedtime and 1 taken in the morning. The patient takes 400 mg capsules, 2 at bedtime 1 in the morning. Patient #14's plan of care had orders for K-Dur (Potassium, an electrolyte) 20 (no unit of measure) twice a day. The correct dosage the patient takes is 10 MEq twice a day. Patient #14's plan of care had orders for Humalog (insulin) 10 units 3 times per day before meals. The correct dosage the patient takes is 15 units before meals 3 times a day. Patient #14's plan of care had orders for Lantus (long-acting insulin) 35 units at bedtime. The patient stated they came home from the Nursing Home with this but does not actually take it as they take Levemir (long-acting insulin) 40 units before bedtime. Patient #14's plan of care had orders for Metoprolol Succinate (used to treat high blood pressure) 50 mg 1 tablet twice a day but the medication is not listed on the patient's medication home profile. Patient # 14 takes 81 mg of Aspirin (suppresses normal functioning of platelets) every day which is not listed on the plan of care or the patient's medication profile. 3. During an interview on 3/15/2022 at 3:15 p.m. patient #14 stated the doctor takes care of their meds and the home health agency doesn't do anything with them.

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD is not met as evidenced by: Based on record review, observation, and interview, the agency failed to provide the patient and/or the caregiver written instructions outlining the visit schedule, including frequency of visits by the home health agency, medication schedule, and instructions, any treatments, and other pertinent instructions related to the patient’s care need, name, and contact number of the home health agency’s clinical manager for 7 of 7 home visit patients. (Patients 10, 11, 14, 15, 16, 17, and 27) During home visit patient #10’s home binder was without a home health aide visit schedule. Interview with Patient #10 during a home visit on 3/14/2022 during the home visit he stated he does not know when the aide is coming, they “just show up”. During a home visit on 3/15/2022 at 3:00 p.m., Patient #14's plan of care provided by the agency and the patient medication profile included in the home were compared to the medications observed in the home and what patient #14 stated they were currently prescribed. Patient #14 did not have a current plan of care in the home. On 3/14/22 at 10:50 AM, the admission packet titled, “Patient Orientation for Home Health Aide Care” was provided by Employee K. The document indicated but was not limited to; “Receive proper written notice, in advance of a specific service being furnished ….” A review of Patient # 16s clinical record evidenced a start of care 12/09/2021, certification period 2/07/2022 through 4/07/2022, diagnoses of rheumatoid arthritis (chronic inflammation of joints), hypertension (high blood pressure), depression, chronic edema (swelling), osteoporosis (new bone creation does not keep up with new bone growth), and history of transient ischemic attack, (temporary block of blood to the brain.) Orders include a home health aide for 7 hours a day on Tuesdays and Thursdays, 9 hours a day on Monday, Wednesdays, and Fridays, and 6 hours a day on Saturday and Sunday. A registered nurse is to perform supervisory visits every 30 days and a recertification visit every 56-60 days. During a home visit on 3/14/2022 at 12:00 PM, Patient #16’s folder/binder contained a plan of care for the certification period of 6/16/2021 through 8/10/2021. All information in the folder/binder contained information from another agency. During an interview on 3/14/2022 at 12:00 PM, Patient #16 reported this agency discussed the name change and new ownership, but he/she was not able to recall the administrator's name. During an interview on 3/14/2022 at 2:59 PM, with RN, Clinical Manager/Lafayette, they confirmed that Patient #16 did not have updated information in a folder or binder. They reported, “we are behind a little” … we are making new binders now. Review of Patient # 15’s clinical record evidenced a start of care of 10/16/2020, a certification period of 2/08/2022 to 4/08/2022, diagnoses of chronic kidney disease, osteoarthritis (breakdown of joint cartilage and underlying bone), hypertension high blood pressure), and gout (a type of arthritis that can cause pain and swelling). Orders included home health aide (HHA) 5 hours a day 6 days a week and registered nurse (RN) recertification visits every 56-60 days with a telehealth supervisory visit every 30 days. During a home visit on 3/15/2022 at 10:00 AM, Patient #15 was unable to locate a folder/binder from Help at Home. Employee M, Home Health Aide, was not able to locate a current folder/binder in the patient’s home. During an interview on 3/15/2022 at 1:10 PM, with the Alternate Administrator, she confirmed the plan of care and information should be in the patient’s home binder and “they (referring to agency) usually replace them each recert. (recertification)…they are typically in a white binder, usually keep all plans of care, admission paperwork, handbook, and any medication changes. “ During a home visit on 3/17/2022 at 12:00 PM with Patient #27, Employee #UU, Home Health Aide, reported employee C, Registered Nurse, delivered an updated folder/binder this morning, that included an updated plan of care, medication instructions, patient’s care needs, and agency contact information. Patient # 27 confirmed just receiving a new binder this AM.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation and interview, the agency failed to provide the patient written information regarding the frequency of visits by personnel of the home health agency for 7 of 7 home visit patients reviewed. (Patients 10, 11, 14, 15, 16, 17, and 27) During a home visit on 3/14/2022 at 1:00 PM with patient #10, start of care date 5/30/2019 and a certification period of 1/14/2022 through 3/14/2022, review of home binder evidenced without a current home health aide visit schedule. Interview with Patient #10 on 3/14/2022 during the home visit he stated he does not know when the aide is coming, they “just show up”. During a home visit on 3/14/2022 at 12:00 PM, Patient #16’s folder/binder contained a plan of care for the certification period of 6/16/2021 through 8/10/2021. All information in the folder/binder contained information from another agency. During an interview on 3/14/2022 at 2:59 PM, with RN Clinical Manager/Lafayette, they confirmed that Patient #16 did not have updated information in a folder or binder. They reported, “we are behind a little” … we are making new binders now. During a home visit on 3/15/2022 at 10:00 AM, Patient #15 was unable to locate a folder/binder from Help at Home. Employee M, Home Health Aide, was not able to locate a current folder/binder in the patient’s home During an interview on 3/15/2022 at 1:10 PM, with the Alternate Administrator, she confirmed the plan of care and information should be in the patient’s home binder and “they (referring to agency) usually replace them each recert. (recertification)…they are typically in a white binder, usually keep all plans of care, admission paperwork, handbook, and any medication changes. “ During a home visit on 3/17/2022, at 12:00 PM with Patient #27, certification period 2/11/2022 to 4/11/2022, Employee #UU, Home Health Aide, reported employee C, RN, delivered an updated folder/binder this morning, that included an updated plan of care, visit schedule, medication instructions, patient’s care needs, and agency contact information. Patient # 27 confirmed just receiving a new binder this AM. During a home visit on 3/15/2022 at 3:00 p.m., Patient #14's home information was reviewed. Patient 14 did not have a current or recent plan of care in the home. The clinical record for Patient #17, the start of care date 11/02/2020, was reviewed on 03/15/2022 and contained a plan of care for the certification period 02/25/2022-04/25/2022, with orders for Home Health Aide services 2 hours daily, 5 days a week. A home observation visit with Patient #17 was conducted on 03/15/2022 at 10:00 AM, with Employee R, home health aide and patients’ family member present. Copy of patient visit schedule not found in the home.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on record review, observation, and interview, the agency failed to provide written updated medication instructions to the patient and/or caregiver for 7 of 7 home visit patients reviewed. Patient #14's plan of care and medication profile had orders for Neurontin (used to treat diabetic nerve pain) 300 mg capsules 2 taken at bedtime and 1 taken in the morning. The patient takes 400 mg capsules, 2 at bedtime 1 in the morning. Patient #14's plan of care and medication profile had orders for K-Dur (Potassium, an electrolyte) 20 (no unit of measure) twice a day. The correct dosage the patient takes is 10 MEq twice a day. Patient #14's plan of care and medication profile had orders for Humalog (insulin) 10 units 3 times per day before meals. The correct dosage the patient takes is 15 units before meals 3 times a day. Patient #14's plan of care and medication profile had orders for Lantus (long-acting insulin) 35 units at bedtime. The patient stated they came home from the Nursing Home with this but does not actually take it as they take Levemir (long-acting insulin) 40 units before bedtime. Patient #14's plan of care had orders for Metoprolol Succinate (used to treat high blood pressure) 50 mg 1 tablet twice a day but the medication is not listed on the patient's medication home profile. Patient # 14 takes 81 mg of Aspirin (suppresses normal functioning of platelets) every day which is not listed on the plan of care or the patient's medication profile. During an interview on 3/15/2022 at 3:15 p.m. patient #14 stated the doctor takes care of their meds and the home health agency doesn't do anything with them. During a home visit on 3/14/2022 at 12:00 PM, Patient #16’s folder/binder contained medication instructions from the certification period of 6/16/2021 through 8/10/2021. During an interview on 3/14/2022 at 2:59 PM, with Employee L, Registered Nurse Clinical Manager, they confirmed that Patient #16 did not have updated information in a folder or binder. They reported, “we are behind a little” … we are making new binders now. During a home visit on 3/15/2022 at 10:00 AM, Patient #15 was unable to locate a folder/binder from Help at Home. Employee M, Home Health Aide, was not able to locate a current folder/binder in the patient’s home, containing updated medication instructions. During an interview on 3/15/2022 at 1:10 PM, with the Alternate Administrator, she confirmed the plan of care and information should be in the patient’s home binder and “they (referring to agency) usually replace them each recert. (recertification)…they are typically in a white binder, usually keep all plans of care, admission paperwork, handbook, and any medication changes. “ During a home visit on 3/17/2022, at 12:00 PM with Patient #27, certification period 2/11/2022 to 4/11/2022, Employee #UU, Home Health Aide, reported employee C, RN, delivered an updated folder/binder this morning, that included an updated plan of care, medication instructions, patient’s care needs, and agency contact information. Patient # 27 confirmed just receiving a new binder this AM. During a home visit on 3/14/2022 at 1:00 PM, Patient #10’s binder contained an incomplete medication list and had medications listed on it that had been discontinued. Patient’s POA stated he is no longer taking vicodin 5mg/300mg twice a day as needed for pain cyclobenzaprine 10 mg once weekly for pain and he is taking simvastatin 40mg ½ tablet daily. Medications not on the list provided by the POA hydroxyzine 10mg at bedtime as needed for sleep, metformin 500 mg twice a day, vitamin C 500 mg daily. The clinical record for Patient #17, the start of care date 11/02/2020, was reviewed on 03/15/2022 and contained a plan of care for the certification period 02/25/2022-04/25/2022. A home observation visit with Patient #17 was conducted on 03/15/2022 at 10:00 AM, with Employee R, home health aide and patients’ family member present. Copy of patients’ list of mediations not found in the home. Patients’ family member indicated the nurse does not leave a copy of medications.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on record review and observation, the home health agency failed to ensure all patients had the name and contact information of the clinical manager, and in 1 of 1 home visits observed (Patients 10, 11, 14, 15, 16, 17, and 27). Findings include: A home observation visit with Patient #17 was conducted on 03/15/2022 at 10:00 AM, with Employee R, home health aide and patients’ family member present. Observed agency folder in home missing the name and contact information of Employee D, clinical manager. Review of an agency document dated 04/2021, titled “Patient Orientation for Home Health Care” contained a cover page with space to write the name and phone number of the clinical manager. 3. During a home visit on 3/15/2022 patient 14's paperwork reviewed in the home had the incorrect name and contact information for the agency's administrator and clinical manager. 4. During a home visit on 3/15/2022 patient 17's paperwork reviewed in the home had the incorrect name and contact information for the agency's administrator and clinical manager. 5. During a home visit on 3/15/2022 patient 15 did not have contact information for the agency's administrator and clinical manager. 6. During a home visit on 3/15/2022 patient 16's paperwork reviewed in the home had the incorrect name and contact information for the agency's administrator and clinical manager. 7. During a home visit on 3/18/2022 patient 27 was provided the updated information the day of the visit. Prior to the home visit the patient did not have the updated information for the clinical manager. During the home visit on 3/15/2022 with patient #11 the home binder was missing contact information for clinical manager. During the home visit with patient #11, RN H had document titled “Patient Orientation for Home Health Care” contained a cover page with space to write the name and phone number of the clinical manager to place in home binder during visit on 3/15/2022.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure they implemented, maintained, and evaluated a Quality Assessment and Performance Improvement (QAPI) program that showed measurable improvement in outcomes; failed to collect, tabulate, analyze, and trend relevant data to include complaints and adverse events; failed to conduct any performance improvement projects; failed to focus on the indicators of hospital admissions and re-admission. The Governing Body failed to supervise and approve a QAPI program that was ongoing and was implemented across the parent and its 8 branches. The Governing Body failed to ensure the agency had access to all data required to maintain the QAPI program and to take necessary actions which could improve the safety and the delivery of care to the agency's patients, for 1 of 1 QAPI program reviewed. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure patients received quality care in a safe environment, which resulted in non-compliance with 42 CFR 484.65, Condition of Participation: Quality Assessment/Performance Improvement. Findings included: 1. On 3/14/2022 at 10:50 AM, a document titled “Patient Orientation for Home Health Care,” was provided by Employee K. A review of the document evidenced “...Policies...This book contains information regarding your rights ... as a patient ... The home health agency must protect and promote the exercise of these rights as follows … The patient has the right to receive care of the highest quality." 2. On 3/14/2022, the administrator provided meeting minutes for each of its 8 branches for 2022. The meeting minutes for the week ending 1/29/2022, for the Indianapolis branch of the agency state "Additional Notes … HHA (Home Health Agency) reporting and grievances go to [name of State Quality & Compliance Lead out of Chicago Illinois.] 3. Meeting minute notes for quarter 3 of the agency's QAPI program meeting for 2021 were provided by the administrator on 3/14/2021. A review indicated but was not limited to; "Summary of findings … Indy East … patient missing 9/15. Last home visit 9/14. No other information." Included in the QAPI minutes were the following: Seymour branch hospitalizations included 10 emergency room visits … other … 1 car accident involving an employee and client with injuries/ER visit unknown, 15 falls, and 3 infections. Indy West branch indicated 3 hospitalizations and 1 fall. Indy East branch indicated 5 hospitalizations and 2 falls with injuries. Terre Haute branch indicated 4 emergency room visits with 4 admissions. Bloomington, Richmond, and Lafayette state "No information." The Seymour branch was the only location out of 8 branches and 1 parent location that reported patient infections. Seymour reported 3 total infections. 4. On 3/11/2022, at 1:18 p.m., the administrator was asked to provide any information related to COVID-19 infections or exposures. He stated he would have to look into it to see if there was documentation. 5. On 3/11/2022 at 10:10 a.m., the administrator provided a spreadsheet listing possible patient infections with symptoms similar to COVID-19. The document indicated for quarter 3, July-September of 2021, there were 210 suspected patient and staff infections and failed to evidence documentation of follow-up to identify the type of infections, any treatments, and resolution of the infections. 6. A review of hospitalizations failed to evidence the agency had tracked the cause of patient hospitalizations to determine if the hospitalizations were related to an adverse patient event or infection, failed to track and follow up on a missing patient complaint, and failed to follow up and determine the cause of patient/staff infections, any treatments, and resolution of the infections. 7. During an interview on 3/21/2022, at 1:18 p.m., the administrator was asked about the outcome of the missing person notated in their QAPI documents. The administrator stated he/she would have to find out. He/she stated he did not have access to complaints/grievances once they were entered into the system. When queried on the "system," the administrator stated it was a program called RisKonnect, that the staff input complaints and grievances, and then an outside entity took over from there. The administrator stated he/she did not have oversight or access to RisKonnect, but could request information about the missing patient. When asked about the investigation by the outside entity, the administrator stated he/she was not sure of the name of the entity, but someone associated with corporate-owned entity 1 investigated complaints and grievances placed into the RisKonnect system. He indicated if the outside entity had any questions, the administrator was notified. The administrator failed to track and follow up on complaints and adverse events. The Governing body failed to ensure the home health agency could maintain a complete and effective agency-wide QAPI program by having removed access to relevant data. 8. Meeting minute notes for quarter 3 and quarter 4 of the agency's QAPI program meeting for 2021 were provided by the administrator on 3/14/2021. A review of the meeting minutes indicated 3 infections from July-September of 2021 and 3 infections from October-December of 2021. The documents failed to identify the type of infection, any treatment, or resolution. 9. A review of the agency's QAPI program evidenced the Seymour branch was the only location out of 8 branches and 1 parent location that reported patient infections in the QAPI documents. Seymour reported 3 total infections and failed to identify the type of infection, any treatment, or resolution. 10. On 3/21/2022, at 1:18 p.m. The administrator and alternate administrator were asked how they monitored their infection control effectiveness with no data in the QAPI program. They stated the program RisKonnect [an outside entity] analyzed the data. They indicated they were unable to access this data and did not provide oversight over RisKonnect, but could request specific information from the outside entity when needed. Both indicated not knowing the name of this outside entity. They indicated all information was controlled by the Corporate Owned Entity 1, not the agency itself. When asked if the agency trended the data collected, the administrator stated the outside entity program did that. 11. During an interview on 3/21/2022, at 1:18 p.m., the administrator was asked how they determined what performance improvement projects were needed without all necessary data available, what projects the agency currently had in progress, and if they had any improvement projects related to infections or COVID-19 vaccinations. The administrator stated they had no performance improvement projects. When asked if the agency had no areas needing improvement, the administrator stated "maybe one of the branches was working on something, and would have to check with them." No further information was provided. 12. On 3/21/2022 at 2:05 p.m., the alternate administrator provided a job description for the Area Clinical Manager that indicated but was not limited to; "Job Summary: The Area Clinical Manager (ACM) under the direct supervision of the Director, Clinical Operations and in partnership with the Director, Regional Operations will be responsible for managing all clinical processes … Maintains the Quality Assurance and Performance Improvement (QAPI) program for each office … provides all updates to the program." 13. During an interview on 3/21/2022 at 1:18 p.m., the administrator stated the governing body was a part of their QAPI meetings. A review of meeting minutes failed to evidence the governing body had reviewed or supervised the QAPI program. The Governing Body members were on the attendance logs for the QAPI meetings, however; the QAPI meetings had a signature page that failed to evidence Governing Body signatures, and the undated and untimed signature page was used for both quarterly meetings. 410 IAC 17-12-2(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 record review and interviews, the home health agency failed to create, maintain, and implement written policies and procedures which were compliant with requirements for CMS (Center for Medicare & Medicaid) vaccine mandate issued on January 14, 2022. 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 all 1,931 active patients who received services from the home health agency, for the Condition of Participation 484.70, Infection Prevention & Control. (See G687) *

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and implement policies and procedures to ensure all agency staff is in compliance with the Center for Medicare and Medicaid Services COVID-19 vaccination mandate for 1 of 1 agency reviewed with the potential to affect all 1,931 active patients of the agency. Findings include: A review of a January 14th, 2022 dated document, the Center for Medicaid and Medicare Services (CMS) issued titled “QSO 22-07-ALL,” that indicated, but was not limited to; “The guidance in this memorandum specifically applies to the following states … Indiana …These changes are necessary to protect the health and safety of patients and staff during the COVID-19 public health emergency. CMS expects all providers’ and suppliers’ staff to have received the appropriate number of doses by the timeframes specified in the QSO-22-07 unless exempted as required by law, or delayed as recommended by CDC. Facility staff vaccination rates under 100% constitute non-compliance under the rule … Within 30 days after issuance of this memorandum … Policies and procedures are developed and implemented for ensuring all facility staff, regardless of clinical responsibility or patient or resident contact are vaccinated for COVID-19; and 100% of staff have received at least one dose of COVID-19 vaccine, or have a pending request for, or have been granted a qualifying exemption, or identified as having a temporary delay as recommended by the CDC, the facility is compliant under the rule; or Less than 100% of all staff have received at least one dose of COVID-19 vaccine, or have a pending request for, or have been granted a qualifying exemption, or identified as having a temporary delay as recommended by the CDC, the facility is non-compliant under the rule.” A review of a document issued by the Center for Medicaid and Medicare Services (CMS) titled “Attachment G: Home Health Agencies,” indicated, but was not limited to; HHAs [Home Health Agencies] must have a process for ensuring all staff … have received at least a single-dose, or the first dose of a multi-dose COVID-19 vaccine series prior to providing any care, treatment, or other services for the facility and/or its patients. The policy must also ensure those staff who are not yet fully vaccinated, or who have been granted an exemption or accommodation as authorized by law, or who have a temporary delay, adhere to additional precautions that are intended to mitigate the spread of COVID-19 ... From 30-60 days following issuance of this memorandum, the expected minimum threshold for use in these determinations will be 80%. From 60-90 days following issuance of this memorandum, the expected minimum threshold will be 90%. From 90 days on, the expected minimum threshold will be 100%. States should work with their CMS location for cases that exceed these thresholds, yet pose a threat to patient health and safety not otherwise addressed by the criteria below: Immediate Jeopardy: 40% or more of staff remain unvaccinated creating a likelihood of serious harm.” During an interview on 3/10/2022 at 1:33 p.m. RN (Registered Nurse) B was asked to provide all COVID-19 policies and procedures related to the new vaccine mandate, a list of all staff and their vaccination status, including the percent of vaccinated staff, and the position or role of each staff member, including staff who are in direct contact with patients, regardless of frequency of contact, and all office staff. During an interview on 3/10/2022 at 2:00 p.m. the administrator was made aware of the request previously made for all COVID-19 vaccination policies and procedures and a list of staff to include their vaccination status. During an interview on 3/10/2022 at 2:30 p.m. the administrator was asked directly, "What is your COVID-19 Vaccination Policy?" The administrator immediately ran out of the room without responding. On 3/10/2022 at 3:09 p.m., the Administrator returned and recited a document he indicated he had just transcribed during a conversation with his Governing Body, “A cross-departmental team reviewed regs [regulations], laws, and all the changes related to the various mandates as they were being issued, and we made it a priority to comply. We believe we are correct that the vaccination policy was not required for this office. If we are mistaken, then we will do what it takes to become compliant.” On 3/10/2022, the administrator provided the results of a voluntary survey, sent to employees during September of 2021, which that indicated of the 923 employees that responded to the voluntary survey only 35% claimed to be vaccinated. A review of a copy of the COVID-19 exposure log was provided by the administrator on 3/11/2022 at 10:10 a.m. The document indicated 4 patients and 10 caregivers had potentially exposed each other from February 14, 2022, to March 10th, 2022. The notes included for 8 of the 14 exposures indicated the agency requested a COVID-19 test and was awaiting the results prior to the employees' return. The agency's failure to locate the results of caregivers' test results has the potential to affect any of the agency's 1,931 active patients to whom these home health aides make care visits. During an interview on 3/11/2022 at 10:15 a.m. and 11:15 a.m., the administrator was asked to provide the results of the above COVID-19 tests. He stated both times he would have to look into it. The results were not provided prior to survey exit. A review of a policy titled “Covid-19 Vaccination Administration Policy,” with a revised date of 1-28-2022, was provided by the administrator on 3/11/2022 at 1:40 p.m. The document indicated but was not limited to; “This policy is for Help at Home business units, including those regulated by the Centers for Medicare and Medicaid Service ‘CMS’ and those regulated by the city of Philadelphia mandate. Help at Home follows all federal, state, and local COVID-19 requirements that affect our employees and business operations … associates hired after the effective date of this policy, must be in one of the following categories within 30 days of their start date: Confirmed Fully Vaccinated … Partially Vaccinated … Medical/Religious Exemption.” A review of a list of active home health aides was provided by the administrator on 3/10/2022 at 4:40 p.m. Forty-one (41) new home health aides had been hired after the release of the 1/14/2022 new Covid-19 vaccination QSO. The data provided by the administrator indicated the agency has an estimated 850-900 employees. The administrator was unable to provide documentation and did not know if any of the 41 new hires had been vaccinated, partially vaccinated, or had received a vaccination exemption. During an interview on 3/21/2022 at 1:18 p.m., the administrator was asked if the agency tracked infections in their QAPI (Quality Assurance & Performance Improvement) plan and he stated, "Yes." When asked to provide the evidence of the infections being tracked he stated everything was placed in a program (Risk Connect) that was managed by a corporate owner sponsored entity [name not known by administrator] based out of Chicago, Illinois. The administrator and alternate administrator both stated they did not have complete access or oversight of the Risk Connect program. They stated they can only request certain data when needed from the corporate owner-sponsored entity that monitored the data. The administrator indicated not knowing the name of this entity. When asked if the agency trended the data collected, the administrator stated the outside entity program did that. When asked what performance improvement projects the agency currently had, and if they had any improvement projects related to infections or vaccinations, the administrator stated they had no performance improvement projects. When asked if the agency had no areas needing improvement, the administrator stated "maybe one of the branches are working on something I will have to check with them."

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure all home health aides had completed an establishment of skills competency program (See G768;) failed to ensure all home health aide’s had proper documentation of their competencies in their personnel files (See G772;) and failed to ensure all aides had a plan of care created by a registered nurse prior to performing patient care (See G798). The cumulative effect of these systemic problems resulted in the agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 484.80, Home Health Aide Services. Findings include: *

Home health aide qualifications CFR(s): 484.80(a) Standard: Home health aide qualifications. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure all home health aides successfully completed their competency evaluation program for 6 of 6 home health aide full personnel records reviewed (HHA BBB, HHA DDD, HHA EEE, HHA FFF, HHA R, and HHA GGG.) Findings include: HHA R’s, hire date 12/01/2020 complete personnel record was reviewed on 03/16/2022. The record indicated HHA R received 2.8 hours of online training completed by 02/21/2022 and skills check-off in a lab on 03/07/2022 that failed to follow the agency’s own policy and failed to evidence if the tasks were performed on a pseudo patient or what steps were used to quality HHA R to be added to the state home health aide registry. Evidence included: A copy of HHA R’s Home Health Aide Registry license with an issuance date of 03/08/2022. During an interview on 03/16/2022 at 12:51 PM, Employee R, HHA indicated the home health aide training took 3.5 hours in a lab setting. 1. A document, last revised 1/4/2022, titled “Competency Assessment” was provided by the alternate administrator on 3/17/2022 at 11:15 a.m. The document indicated but was not limited to; “Competencies for … Home Health Aides (HHA) … the home health aide must demonstrate … successful completion of a competency evaluation program. The home health aide will have completed the competency evaluation program if he/she demonstrates competency in a minimum of eleven (11) of the twelve areas required in federal guidelines … the following subject areas marked with an * must be evaluated after observation of the home health aide’s performance of the tasks with a client. The other subject areas may be evaluated through written examination, oral examination, and/or after observation of home health aide with a client or pseudo patient … Safe transfer techniques and ambulation* Normal range of motioning and positioning* Appropriate and safe grooming techniques in personal hygiene and grooming including* … specific directions … must be documented with the client care plan in a step-by-step format that is used for training and competency evaluation … for clients receiving a tub bath, the HHA will receive an in-home competency assessment to demonstrate providing a successful tub bath before the aide is scheduled to work with that client.” 2. HHA B’s, hire date 1/18/2022, complete personnel record was reviewed on 3/15/2020. The record indicated HHA B received 1 hour and 11 minutes of online training and a skills check-off in a lab that failed to follow the agency's own policy and failed to evidence if the tasks were performed on a pseudo patient or what steps were used to qualify HHA B to be added to the state home health aide registry. Evidenced includes: A copy of HHA B’s Registry license with an issued date of 1/25/2022 issued 28 days prior to the agency’s competency check off of HHA B. A document titled “Competency Assessment-HHA” dated 2-25-2022 indicated that all 12 required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 2/25/2022 and signed by the evaluator RN D. The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home. 2. HHA D’s, hire date 02/02/2022 complete personnel record was reviewed on 3/18/2020. The record indicated HHA D received 4.5 hours of in-services and a skills check-off in a lab that failed to follow the agency's own policy and failed to evidence if the tasks were performed on a pseudo patient or what steps were used to qualify HHA D to be added to the state home health aide registry. Evidence included: A document titled “Caregiver Information Sheet” was retrieved on 3/18/2022 from HHA D’s personnel file that indicated a hire date of 10/31/2019. A document titled “Employment Application” was retrieved on 3/18/2022 that indicated a hire date of 2/02/2022. A copy of HHA D’s Home Health Aide Registry license with an issuance date of 12/12/2019. A document titled “Competency Assessment-HHA” dated 2/02/2022 indicated that all 12 required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 2/02/2022 and signed by the evaluator RN E. The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home. 3. HHA E’s, hire date 7/22/2021, complete personnel record was reviewed on 3/16/2020. The record indicated HHA E received 5 hours of in-services and a skills check-off in a lab that failed to follow the agency's own policy and failed to evidence if the tasks were performed on a pseudo patient or what steps were used to qualify HHA E to be added to the state home health aide registry. Evidence included: A copy of HHA E’s Home Health Aide Registry license with an issuance date of 08/03/2021. A document titled “Competency Assessment-HHA” dated 07/29/2021 indicated that all 12 required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 07/29/2021 and signed by the evaluator RN F. The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home. 4. HHA F’s, hire date 02/16/2022, complete personnel record was reviewed on 3/16/2020. The record indicated HHA G received 3 hours and 13 minutes of online training and a skills check-off in a lab that failed to follow the agency's own policy and failed to evidence if the tasks were performed on a pseudo patient or what steps were used to qualify HHA F to be added to the state home health aide registry. Evidence included: A copy of HHA F’s Home Health Aide Registry license with an issuance date of 02/02/2022. A document titled “Competency Assessment-HHA” dated 02/17/2022 indicated that all 12 required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. The skill Plan of care was marked with the word, “Yes” and an arrow facing down through all other skills then dated at the bottom of the arrow 02/17/22 and signed by the evaluator RN G The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home. 5. HHA G’s, hire date of 12/15/2021, complete personnel record was reviewed on 3/16/2020. The record indicated HHA G received a skills check-off in a lab that failed to follow the agency's own policy and failed to evidence if the tasks were performed on a pseudo patient or what steps were used to qualify HHA G to be added to the state home health aide registry. Evidence included: A copy of HHA G’s Home Health Aide Registry license with an issuance date of 12/16/2021. A document titled “Competency Assessment-HHA” dated 12-16-2021 indicated that all 12 required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 12/16/2021 and signed by the evaluator RN E. The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home. 6. During an interview on 03/17/2022 at 2:00 p.m. the alternate administrator stated she doesn’t know why their competency program policy states some skills must be observed in the home because that is not their policy, and she would have to look into it. No further information was provided. 7. During an interview on 3/17/2022 the alternate administrator stated HHA B’s competency dated a month after being added to the registry is probably an error and they dated it wrong, she wasn’t sure but knows they wouldn’t have done it that way.

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure all home health aides successfully completed their competency evaluation program for 6 of 6 home health aide full personnel records reviewed (HHA BBB, HHA DDD, HHA EEE, HHA FFF, HHA R, and HHA GGG.) Findings include: 1. Review of a document, last revised 1/4/2022, titled “Competency Assessment,” provided by the alternate administrator on 3/17/2022 at 11:15 a.m., evidenced the document indicated but was not limited to; “Competencies for … Home Health Aides (HHA) … the home health aide must demonstrate … successful completion of a competency evaluation program. The home health aide will have completed the competency evaluation program if he/she demonstrates competency in a minimum of eleven (11) of the twelve areas required in federal guidelines … the following subject areas marked with an * must be evaluated after observation of the home health aide’s performance of the tasks with a client. The other subject areas may be evaluated through written examination, oral examination, and/or after observation of a home health aide with a client or pseudo patient … Safe transfer techniques and ambulation* Normal range of motioning and positioning* Appropriate and safe grooming techniques in personal hygiene and grooming including* … specific directions … must be documented with the client care plan in a step-by-step format that is used for training and competency evaluation … for clients receiving a tub bath, the HHA will receive an in-home competency assessment to demonstrate providing a successful tub bath before the aide is scheduled to work with that client.” 2. A review of home health aide (HHA) BBB, personnel file evidence a hire date 1/18/2022. The complete personnel record was reviewed on 3/15/2020. The record indicated HHA BBB received 1 hour and 11 minutes of online training and a skills check-off in a lab that failed to follow the agency's policy, failed to evidence if the tasks were performed on a pseudo patient or actual patient, or what steps were used to qualify HHA BBB to be added to the state home health aide registry. The review evidenced a copy of HHA BBBB’s registry license with an issue date of 1/25/2022, issued 28 days before the agency’s competency check off of HHA BBB. A review of a document titled “Competency Assessment-HHA,” dated 2-25-2022, indicated all 12 skills required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 2/25/2022, and signed by the evaluator RN D. The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home. 3. A review of HHA DDD’s, personnel file on 3/18/2022, evidenced a hire date of 2/2/2022. The record indicated HHA DDD received 4.5 hours of in-services and a skills check-off in a lab and the documentation failed to follow the agency's policy. The personnel file check-off failed to evidence if the tasks were performed on a pseudo patient or what steps were used to qualify HHA DDD to be added to the state home health aide registry. The review evidenced a document titled “Caregiver Information Sheet,” retrieved on 3/18/2022, from HHA DDD’s personnel file with a hire date of 10/31/2019 (different than 2/2/22 above.) A review of a document titled “Employment Application,” was retrieved on 3/18/2022, which indicated a hire date of 2/02/2022. The personnel file contained a copy of HHA DDD’s Home Health Aide Registry license with a date of issuance of 12/12/2019. A review of a document titled “Competency Assessment-HHA,” dated 2/2/2022, indicated that all 12 skills required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 2/02/2022, and signed by the evaluator RN E. The competency assessment failed to evidence the agency completed the required skills performed on a patient in their home as required by agency policy. 4. A review on 3/16/2022, of HHA EEE’s personnel file, evidenced a date of hire of 7/22/2021. The document evidenced HHA EEE received 5 hours of in-services and a skills check-off in a lab, and failed to follow the agency's policy. The document failed to evidence if the tasks were performed on a pseudo patient or what steps were used to qualify HHA EEE to be added to the state home health aide registry. A review of a copy of HHA EEE’s Home Health Aide Registry license evidenced an issuance date of 8/3/2021. A review of a A review of a document titled “Competency Assessment-HHA,” dated 07/29/2021 indicated that all 12 required skills by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 07/29/2021, and signed by the evaluator RN F. The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home, as required by agency policy. 5. A review on 3/16/2022, of the personnel file of HHA FFF, evidenced a date of hire of 2/16/2022. The record indicated HHA FFF received 3 hours and 13 minutes of online training and a skills check-off in a lab that failed to follow the agency's policy and failed to evidence if the tasks were performed on a pseudo patient or what steps were used to qualify HHA FFF to be added to the state home health aide registry. A review of a copy of HHA FFF’s Home Health Aide Registry license evidenced an issuance date of 2/2/2022. A review of a document titled “Competency Assessment-HHA,” dated 02/17/2022, indicated that all 12 required skills by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, and range of motion, transferring, positioning, and repositioning. The skills document was marked with the word, “Yes” and an arrow pointed down through all other skills, then dated at the bottom of the arrow, 02/17/22, and was signed by the evaluator RN G The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home, as required by agency policy. 6. A review of the personnel file of HHA GGG, on 3/16/2022, evidenced a hire date of 12/15/2021. The record indicated HHA GGG received a skills check-off in a lab that failed to follow the agency's policy and failed to evidence if the tasks were performed on a pseudo patient or what steps were used to qualify HHA GGG to be added to the state home health aide registry. A review of a copy of HHA GGG’s Home Health Aide Registry license evidenced an issuance date of 12/16/2021. A review of a document titled “Competency Assessment-HHA,” dated 12-16-2021, indicated that all 12 required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 12/16/2021, and signed by the evaluator RN E. The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home, as required by agency policy. 7. During an interview on 03/17/2022 at 2:00 p.m., the alternate administrator stated not knowing why their competency program policy stated some skills must be observed in the home because that is not their practice and she would have to look into it. No further information was provided. The alternate administrator stated HHA B’s competency dated a month after being added to the registry was probably an error and they had dated it wrongly, she wasn’t sure but knew they wouldn’t have done it that way. 8. A review of HHA R’s personnel file on 3/16/2022, evidenced a hire date of 12/1/2020. The record indicated HHA R received 2.8 hours of online training completed by 02/21/2022, and skills check-off in a lab on 3/07/2022, that failed to follow the agency’s policy, and failed to evidence if the tasks were performed on a pseudo patient or what steps were used to quality HHA R to be added to the state home health aide registry. A review of a copy of HHA R’s Home Health Aide Registry license evidenced an issuance date of 03/08/2022. 9. During an interview on 03/16/2022 at 12:51 PM, Employee R, HHA, indicated the home health aide training took 3.5 hours in a lab setting.

Documentation of competency evaluation CFR(s): 484.80(c)(5) The HHA must maintain documentation which demonstrates that the requirements of this standard have been met. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all home health aide personnel files contained documentation identifying what measures/steps were used to verify an employee was competent for specific tasks and failed to document which skills were performed on a patient versus a pseudo patient for 5 of 5 home health aide personnel records reviewed. (HHA B, HHA D, HHA E, HHA F, and HHA G.) Findings include: 1. A document, last revised 1/4/2022, titled “Competency Assessment” was provided by the alternate administrator on 3/17/2022 at 11:15 a.m. The document indicated but was not limited to; “Competencies for … Home Health Aides (HHA) … the home health aide must demonstrate … successful completion of a competency evaluation program. The home health aide will have completed the competency evaluation program if he/she demonstrates competency in a minimum of eleven (11) of the twelve areas required in federal guidelines … the following subject areas marked with an * must be evaluated after observation of the home health aide’s performance of the tasks with a client. The other subject areas may be evaluated through written examination, oral examination, and/or after observation of home health aide with a client or pseudo patient … Safe transfer techniques and ambulation* Normal range of motioning and positioning* Appropriate and safe grooming techniques in personal hygiene and grooming including* … specific directions … must be documented with the client care plan in a step-by-step format that is used for training and competency evaluation … for clients receiving a tub bath, the HHA will receive an in-home competency assessment to demonstrate providing a successful tub bath before the aide is scheduled to work with that client.” 2. HHA B’s, hire date of 1/18/2022, complete personnel record was reviewed on 3/15/2020. The record evidenced the following: A document titled “Competency Assessment-HHA” dated 2-25-2022 indicated that all 12 competencies required by federal regulations, were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 2/25/2022 and signed by the evaluator RN D. The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home. The agency failed to include documentation in a step-by-step format that was used for the training and competency in the employee’s personnel file. 3. HHA D’s complete personnel record was reviewed on 3/18/2020. The record evidenced the following: A document titled “Caregiver Information Sheet” was retrieved on 3/18/2022 from HHA D’s personnel file that indicated a hire date of 10/31/2019. A document titled “Competency Assessment-HHA” dated 2/02/2022 indicated that all 12 required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 2/02/2022 and signed by the evaluator RN E. The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home. The agency failed to include documentation in a step-by-step format that was used for the training and competency in the employee’s personnel file. 4. HHA E’s, hire date of 07/22/2021, complete personnel record was reviewed on 3/16/2020. The record evidenced the following: A copy of HHA E’s Home Health Aide Registry license with an issuance date of 08/03/2021. A document titled “Competency Assessment-HHA” dated 07/29/2021 indicated that all 12 required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 07/29/2021 and signed by the evaluator RN F. The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home. The agency failed to include documentation in a step-by-step format that was used for the training and competency in the employee’s personnel file. 5. HHA F’s, hire date of 02/16/2022, complete personnel record was reviewed on 3/16/2020. The record evidenced the following: A document titled “Competency Assessment-HHA” dated 02/17/2022 indicated that all 12 competencies required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. The skill Plan of care was marked with the word, “Yes” and an arrow facing down through all other skills then dated at the bottom of the arrow 02/17/22 and signed by the evaluator RN G The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home. The agency failed to include documentation in a step-by-step format that was used for the training and competency in the employee’s personnel file. 6. HHA G’s, hire date of 12/15/2021, complete personnel record was reviewed on 3/16/2020. The record evidenced the following: A document titled “Competency Assessment-HHA” dated 12-16-2021 indicated that all 12 competencies required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 12/16/2021 and signed by the evaluator RN E. The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home. The agency failed to include documentation in a step-by-step format that was used for the training and competency in the employee’s personnel file. 7. During an interview on 03/17/2022 at 2:00 p.m. the alternate administrator stated she doesn’t know why their competency program policy states some skills must be observed in the home because that is not their policy, and she would have to look into it. No other information was provided and stated HHA B’s competency dated a month after being added to the registry is probably an error and they dated it wrong, she wasn’t sure but knows they wouldn’t have done it that way. 8.. During an interview on 3/17/2022 at 2:00 p.m. the administrator stated the form titled “Competency Assessment-HHA” is the form the agency used to determine if the HHA was competent to be placed on the home health aide registry. The administrator verified the documentation was not complete to demonstrate the federal requirements for an HHA had been met.

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 home health aide had a plan of care created by a registered nurse instructing each home health aide on what tasks to complete in the home for 7 of 7 home visits. (Patients 10, 11, 14, 15, 16, 17, 27). Findings include: A home visit with Patient #17 was conducted on 03/15/2022 at 10:00 AM, with Employee R, home health aide. Copy of home health aide care plan not found in patient home and Employee R, home health aide indicated had not received a home health aide care plan for this patient. 1. A document titled “Supervision of Staff” was provided by the administrator on 3/21/2022. The document indicated but was not limited to; “The Nursing Supervisor or designated Registered Nurse (RN) will give the Home Health Aide direction for client care by the way of the care plan … A Registered Nurse must review the Home Health Aide Plan with the Home Health Aide before the first client visit.” 2. During a home on 3/14/2022 at 1:30 p.m. for patient #10, the patient only had a plan of care from 3 certification periods prior. No updated information in the home. 3. During a home visit on 3/14/2022 at 1:30 p.m. for patient #16 the agency failed to ensure their was an aide plan of care in the home. 4. During a home visit on 3/15/2022 at 9:00 a.m. with patient #11, RN H stated there was not a home health aide plan of care or patient plan of care in the home, so he/she just made one today and brought it for the patient. 5. During a home visit on 3/15/2022 at 10:00 a.m. with patient #17 there was no plan of care in the home. When asked how HHA R knows what tasks to perform he/she stated he/she just does what the agency or patient #17’s grandma tells them to do. 6. During a home visit on 3/15/2022 at 10:00 AM, Patient #15 was unable to locate a folder/binder from Help at Home. Employee M, Home Health Aide, was not able to locate a current folder/binder in the patient’s home, containing updated medication instructions and care instructions. “ 7. During a home visit on 3/15/2022 at 3:00 p.m. patient #14 HHA B stated he/she does some of the items on the plan of care and in the morning another HHA does others but the tasks are not identified which aide is responsible for which task. 8. During a home visit on 3/14/2022 at 2:59 PM, with Employee L, Registered Nurse Clinical Manager, they confirmed that Patient #16 did not have updated information in a folder or binder. They reported, “we are behind a little” … we are making new binders now. 9. During a home visit on 3/17/2022, at 12:00 PM with patient #27, certification period 2/11/2022 to 4/11/2022, Employee #UU, Home Health Aide, reported employee C, Registered Nurse, delivered an updated folder/binder this morning, that included an updated plan of care, medication instructions, patient’s care needs, and agency contact information. Patient # 27 confirmed just receiving a new binder this AM. 10. During an interview on 3/15/2022 at 1:10 PM, with the Alternate Administrator, she confirmed the plan of care and information should be in the patient’s home binder and “they (referring to agency) usually replace them each recert. (recertification)…they are typically in a white binder, usually keep all plans of care, admission paperwork, handbook, and any medication changes. “

Officer, a director, agent, managing employee CFR(s): 484.100(a)(2) The name and address of each person who is an officer, a director, an agent, or a managing employee of the HHA as defined in §420.20l, §420.202, and §420.206 of this chapter. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide the names of all managing employees of the agency for 1 of 1 agency reviewed. Findings include: 1. On 3/10/2022 at 12:37 p.m., a list of all active employees including contracted employees was requested from RN B. 2. On 3/10/2022 at 2:10 p.m., a document titled, " Organization Chart," was provided by the administrator. The organizational chart identified the Governing Body at the top of the chart then proceeding down was the administrator, alternate administrator, nursing supervisor, and alternate supervisor. The administrator had 3 branches directly under them and then a fourth branch manager who provided oversite to all nurses, field staff, patients, and the 24/7 on-call. 3. During an interview on 3/10/2022 at 12:03 p.m., the administrator identified the agency’s license contained 8 branches and 1 parent location. 4. On 3/10/2022 at 4:40 p.m., the administrator provided a list of all home health aides employed by the agency. Requested a list of all personnel for the agency to include office staff. 5. On 3/15/2022, RN Z anonymously provided a copy of an email that was sent from an employee with the title, "State Quality & Compliance Lead," located in Chicago, Illinois, and distributed to the administrator, Governing Body Member 2, the Lafayette Clinical Supervisor, and 7 other unidentified employees. The email indicated but was not limited to; “Remember you all report to [administrators name], the administrator. Do not mention Area Leaders, Area Clinical Leaders, [Governing Body Member B’s name, Governing Body Member C’s name] or myself as they’re not part of the license’s organization chart per IDH (Indiana Department of Health). Do not mention consolidations of agencies. You have simply received referrals from [name of another agency with multiple licenses throughout Indiana owned by the same entity.] 6. On 3/21/2022 at 2:05 p.m., the alternate administrator provided copies of employee offer letters and signatures of acceptance of employees not listed on the personnel rosters provided. The documents included the following: An 8/31/2021 signed letter that stated "Dear [RN P], Help and Home is excited to offer you the position of Area Clinical Manager in our Winchester location! This is a full time 40 hour per week position." Review of a job description for Area Clinical Manager indicated but was not limited to; "Job Summary: The Area Clinical Manager (ACM) under the direct supervision of the Director, Clinical Operations and in partnership with the Director, Regional Operations will be responsible for managing all clinical processes … Supervisory Responsibilities … handles discipline and termination of employees … provides oversight for home visits and day-to-day office processes as needed … Maintains the Quality Assurance and Performance Improvement (QAPI) program for each office …provides all updates to the program." A 9/03/2021 signed letter was reviewed that stated "Dear [RN Q], Help and Home is excited to offer you the position of Territory Clinical Manager in our Seymour location! This is a full-time 40 hours per week position." Review of a job description for Area Clinical Manager indicated but was not limited to; "Job Summary: The Territory Clinical Manager (TCM) under supervision of the Area Clinical Manager will serve as back-up for clinical managers with admissions and provides oversite for home visits and day-to-day office processes as needed … Supervisory Responsibilities … handles discipline and termination of employees … Evaluate, monitor, and review all recertification's, grievances, and ROCs, while ensuring all appropriate documents are included as required." An 8/25/2021 signed letter was reviewed that stated "Dear [RN Y], On behalf of Help at Home, Inc, I am pleased to offer you the position of Territory Clinical Manager in our Lafayette, Terre Haute, Adaptive Terre Haute, and Adaptive Lafayette offices reporting the area Area Clinical Manager. As a Territory Clinical Manager, you will be responsible for all nursing facets in the Lafayette, Terre Haute, Adaptive Terre Haute, and Adaptive Lafayette offices, including without limitations, training field staff, patient services matters, business development, general functions, as well as all additional tasks assigned." The letter was signed by the agency's former administrator. The agency administrator offered a job to RN Y for a position for 2 separate licenses but was the administrator only over the one licensed agency. An 8/20/2021 signed letter was reviewed that stated "Dear [RN Z], On behalf of Help at Home, Inc, I am pleased to offer you the position of Territory Clinical Manager in our Bloomington and Bedford office reporting the Area Clinical Manager." An 8/31/2021 signed letter was reviewed that stated "Dear [RN M], Help and Home is excited to offer you the position of Area Clinical Manager in our Bloomington location! This is a full time 40 hour per week position." 7. During an interview on 3/17/2022 at 2:00 p.m., the administrator and alternate administrator were asked why employees were directed to conceal other managing employees from the surveyors and the alternate administrator stated it was just to avoid confusion. 8. During an interview on 3/08/2022 at 1:30 PM, with RN M, RN M stated they were only affiliated with Entity 2. RN M stated he/she closed the Bloomington Branch of Entity 2 on 12/31/2022, discharged all of their patients, and was not informed of the agency taking over that location. RN M stated Entity 2 and the agency never merged or acquired one or the other. 9. During an interview on 3/21/2022 at 2:00 PM, the administrator and the alternate administrator indicated RN M, with entity 2, was dually employed with this agency. The administrator stated RN M was an area leader in the region and provided a copy of RN M's signed employment offer letter with this agency. 410 IAC 17-10-1(d)(2)

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 Governing Body failed to ensure essential administrative and supervisory functions were not delegated to an outside entity which precluded the administrator from being effective in supervising and managing the home health agency; the administrator failed to be responsible for all day-to-day operations (See G948); failed to ensure a clinical manager was always available (See G950); failed to ensure the agency hired qualified personnel (See G952); failed to ensure all branches reported to the parent agency (See G970); and failed to ensure the agency had direct support and administrative control (See G974.) Findings include: The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 484.105, Organization and administration of services. 410 IAC 17-12-1(a)(1) Findings include: [The Governing Body failed to ensure its essential administrative and supervisory functions were not delegated to another entity which precluded the administrator from being effective in supervising and managing the home health agency QAPI by having delegated these to an outside entity.] 1. A job description for Area Clinical Manager was provided by the alternate administrator on 03/21/2022 at 2:05 p.m. A review of the document indicated but was not limited to; "Job Summary: The Area Clinical Manager (ACM) under the direct supervision of the Director, Clinical Operations and in partnership with the Director, Regional Operations will be responsible for managing all clinical processes … Supervisory Responsibilities … handles discipline and termination of employees … provides oversight for home visits and day-to-day office processes as needed … Maintains the Quality Assurance and Performance Improvement (QAPI) program for each office …provides all updates to the program." 2. During an interview on 3/10/2022, at 1:00 p.m. , the administrator stated RN M was the Area Clinical Manager for the agency. When provided an updated roster RN M was no longer listed as an employee. 3. A job description for Territory Clinical Manager was provided by the alternate administrator on 03/21/2022 at 2:05 p.m. A review of the document indicated but was not limited to; "Job Summary: The Territory Clinical Manager (TCM) under supervision of the Area Clinical Manager will serve as back-up for clinical managers with admissions and provides oversite for home visits and day-to-day office processes as needed … Supervisory Responsibilities … handles discipline and termination of employees … Evaluate, monitor, and review all recertification's, grievances, and ROCs, while ensuring all appropriate documents are included as required." 4. On 3/11/2022, the administrator was asked to provide any information related to COVID-19 infections or exposures. He stated he would have to look into it or see if there was something they had he did not know. 5. On 3/14/2022, the administrator provided meeting minutes for each branch for 2022. A review of the meeting minutes for the week ending 1/29/2022, for the Indianapolis branch of the agency state "Additional Notes … HHA (Home Health Agency) reporting and grievances go to [name of State Quality & Compliance Lead out of Chicago Illinois]. 6. On 3/15/2022, RN Z provided a copy of an email anonymously that was sent from an employee with the title State Quality & Compliance Lead located in Chicago, Illinois, and distributed to the administrator, Governing Body Member 2, the Lafayette Clinical Supervisor, and 7 other unidentified employees. The email indicated but was not limited to; “Remember you all report to [administrators name], the administrator. Do not mention Area Leaders, Area Clinical Leaders, [Governing Body Member B’s name, Governing Body Member C’s name], or myself as they’re not part of the license’s organization chart per IDH (Indiana Department of Health). Do not mention consolidations of agencies. You have simply received referrals from Adaptive [another agency with multiple licenses throughout Indiana owned by the same entity]. 7. During an interview on 3/21/2022, at 1:18 p.m., the administrator was asked if the agency tracked infections in their QAPI (Quality Assurance & Performance Improvement) plan and he stated yes. When asked to provide the evidence of the infections being tracked he stated everything is placed in a program (Riskonnect) that was managed by the corporate owner sponsored entity 1 [name not known by administrator] based out of Chicago, Illinois. The administrator and alternate administrator both stated they did not have complete access or oversight of the Riskonnect program. They stated they can only request certain data when needed from the corporate owner-sponsored entity that monitored the data. The administrator indicated not knowing the name of this entity. When asked if the agency trended the data collected, the administrator stated the outside entity program did. 8. During an interview on 3/21/2022, at 1:18 p.m., the administrator was asked how they determined what performance improvement projects were needed without the data available, what projects the agency currently had in progress, and if they had any improvement projects related to infections or vaccinations, the administrator stated they have no performance improvement projects. When asked if the agency had no areas needing improvement, the administrator stated, "maybe one of the branches was working on something I will have to check with them." The administrator did not know if the agency was working on any projects. There were no improvement projects for complaints and adverse events, a missed opportunity for improvement because the administrator did not have access to all agency data [RisKonnect.] 9. During an interview on 3/21/2022, at 1:18 p.m., the administrator was asked about the outcome of the missing person notated in their QAPI The administrator stated he/she would have to find out. He/she stated he did not have access to grievances once they are entered into the system [RisKonnect.] 10. During an interview on 3/21/2022, at 1:18 p.m., the administrator was asked from where the area and territory leader personnel files were retrieved and the administrator responded they got them from HR (human resources). When asked where HR was located, the administrator stated they did not know. When asked how the administrator got a hold of HR the administrator, stated they emailed an HR email address requesting information they needed and received it back. The administrator did not know who HR consisted of or where HR for the agency was located. The administrator stated they believed they knew one employee who was in HR, but that employee was on vacation.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the administrator failed to be responsible for all day-to-day operations for 1 of 1 agency reviewed. Findings include: 1. A job description for Area Clinical Manager was provided by the alternate administrator on 03/21/2022 at 2:05 p.m. A review of the document indicated but was not limited to; "Job Summary: The Area Clinical Manager (ACM) under the direct supervision of the Director, Clinical Operations and in partnership with the Director, Regional Operations will be responsible for managing all clinical processes … Supervisory Responsibilities … handles discipline and termination of employees … provides oversight for home visits and day-to-day office processes as needed … Maintains the Quality Assurance and Performance Improvement (QAPI) program for each office …provides all updates to the program." 2. During an interview on 3/10/2022, at 1:00 p.m., the administrator stated RN M was the Area Clinical Manager for the agency. When provided an updated roster RN M was no longer listed as an employee. 3. A job description for Territory Clinical Manager was provided by the alternate administrator on 03/21/2022 at 2:05 p.m. A review of the document indicated but was not limited to; "Job Summary: The Territory Clinical Manager (TCM) under supervision of the Area Clinical Manager will serve as back-up for clinical managers with admissions and provides oversite for home visits and day-to-day office processes as needed … Supervisory Responsibilities … handles discipline and termination of employees … Evaluate, monitor, and review all recertification's, grievances, and ROCs, while ensuring all appropriate documents are included as required." 4. On 3/11/2022, the administrator was asked to provide any information related to COVID-19 infections or exposures. He stated he would have to look into it or see if there was something they had he did not know. 5. On 3/11/2022 at 10:10 a.m., the administrator provided a spreadsheet listing possible patient infections with symptoms similar to COVID-19. The document indicated for quarter 3, July-September of 2021 210 suspected patient and staff infections with no follow-up. The administrator was asked for test results for employees suspected 3 separate times and was unable to gain access to the results. 6. On 3/14/2022, the administrator provided meeting minutes for each branch for 2022. The meeting minutes for the week ending 1/29/2022 for the Indianapolis branch of the agency state "Additional Notes … HHA (Home Health Agency) reporting and grievances go to [name of State Quality & Compliance Lead out of Chicago Illinois]. 7. On 3/15/2022, RN Z provided a copy of an email anonymously that was sent from an employee with the title State Quality & Compliance Lead located in Chicago, Illinois, and distributed to the administrator, Governing Body Member 2, the Lafayette Clinical Supervisor, and 7 other unidentified employees. The email indicated but was not limited to; “Remember you all report to [administrators name], the administrator. Do not mention Area Leaders, Area Clinical Leaders, [Governing Body Member B’s name, Governing Body Member C’s name] or myself as they’re not part of the license’s organization chart per IDH (Indiana Department of Health). Do not mention consolidations of agencies. You have simply received referrals from Adaptive [another agency with multiple licenses throughout Indiana owned by the same entity]. 8. During an interview on 3/21/2022, at 1:18 p.m., the administrator was asked if the agency tracked infections in their QAPI (Quality Assurance & Performance Improvement) plan and he stated yes. When asked to provide the evidence of the infections being tracked he stated everything is placed in a program (Riskonnect) that was managed by the corporate owner sponsored entity 1 [name not known by administrator] based out of Chicago, Illinois. The administrator and alternate administrator both stated they did not have complete access or oversight of the Riskonnect program. They stated they can only request certain data when needed from the corporate owner-sponsored entity that monitored the data. The administrator indicated not knowing the name of this entity. When asked if the agency trended the data collected, the administrator stated the outside entity program did. 9. During an interview on 3/21/2022, at 1:18 p.m., the administrator was asked how they determined what performance improvement projects were needed without the data available, what projects the agency currently had in progress, and if they had any improvement projects related to infections or vaccinations, the administrator stated they have no performance improvement projects. When asked if the agency had no areas needing improvement, the administrator stated, "maybe one of the branches was working on something I will have to check with them." The administrator did not know if the agency was working on any projects. 10. During an interview on 3/21/2022, at 1:18 p.m., the administrator was asked about the outcome of the missing person notated in their QAPI The administrator stated he/she would have to find out. He/she stated he did not have access to grievances once they are entered into the system. 11. During an interview on 3/21/2022, at 1:18 p.m., the administrator was asked from where the area and territory leader personnel files were retrieved and the administrator responded they got them from HR (human resources). When asked where HR was located, the administrator stated they did not know. When asked how the administrator got a hold of HR the administrator, stated they emailed an HR email address requesting information they needed and received it back. The administrator did not know who HR consisted of or where HR for the agency was located. The administrator stated they believed they knew one employee who was in HR, but that employee was on vacation. 410 IAC 17-12-1(b)(3) 410 IAC 17-12-1(c)(1)

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on record review and interview, the Governing Body failed to ensure the clinical manager was available during all operating hours for 1 of 1 home health agency reviewed. Findings include: On 3/14/22 at 10:50 AM, A document titled “Patient Orientation for Home Health Care,” was provided by Employee K, Lafayette Branch Manager. The document indicated but was not limited to; “Our offices hours are Monday through Friday from 9:00 a.m. to 5:00 p.m., except on the following holidays: Memorial Day, July Fourth, Labor Day, Thanksgiving, Christmas Day and New Year’s Day … After Hours Coverage: We provide 24-hour on-call services, 7 days per week to ensure that you receive necessary home care services.” On 3/08/2022, a phone call was placed to the agency’s Bloomington branch at 3:15 p.m. during business hours. An answering system directed emergencies to call 911 or leave a voice mail and a call back would be received as soon as possible. On 3/08/2022, a phone call was placed to the agency’s Bloomington branch at 3:20 p.m. during business hours. An answering system directed emergencies to call 911 or leave a voice mail and a call back would be received as soon as possible, the voice box mail was full and unable to accept messages. 2. On 3/15/2021 the agency’s after-hours phone number was called. The call was answered by a recording that directed patients to leave a voicemail to receive a callback. The voicemail then states the voicemail box is full and terminated the phone call. On 3/08/2022 at 12:30 p.m. during an interview with Patient 3’s power of attorney (POA), the POA stated having made multiple attempts to reach the administrator and have been unsuccessful. They stated even during business hours the agency will not answer their phone. During an interview with HHA V, on 3/08/2022 at 12:15 p.m., HHA V stated that ever since September of 2021, when Entity 3 took over the agency, patients are unable to get a hold of someone at the agency. HHA V stated those that who do have to call repeatedly and occasionally during hours someone will answer, but after-hours patients complain they do not receive a callback. During an interview with the administrator on 3/21/2022, at 1:18 p.m., the administrator stated all complaints were placed into a program (RisKonnect.) The administrator stated they didn’t have access or oversight of the program and could only request specific information. The administrator stated he was not sure who had full oversight but that it was someone from a corporate-owned entity 1. 410 IAC 17-12-1(d)

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all staff met all the requirements for qualification as an agency home health aide (HHA) for 5 of 5 home health aide personnel records reviewed (HHA BBB, HHA DDD, HHA EEE, HHA FFF, and HHA GGG.) Findings include: 1. A document, last revised 1/4/2022, titled “Competency Assessment,” was provided by the alternate administrator on 3/17/2022 at 11:15 a.m. A review of the document evidenced; “Competencies for … Home Health Aides (HHA) … the home health aide must demonstrate … successful completion of a competency evaluation program. The home health aide will have completed the competency evaluation program if he/she demonstrates competency in a minimum of eleven (11) of the twelve areas required in federal guidelines … the following subject areas marked with an * must be evaluated after observation of the home health aide’s performance of the tasks with a client. The other subject areas may be evaluated through written examination, oral examination, and/or after observation of home health aide with a client or pseudo patient … Safe transfer techniques and ambulation* Normal range of motioning and positioning* Appropriate and safe grooming techniques in personal hygiene and grooming including* … specific directions … must be documented with the client care plan in a step-by-step format that is used for training and competency evaluation … for clients receiving a tub bath, the HHA will receive an in-home competency assessment to demonstrate providing a successful tub bath before the aide is scheduled to work with that client.” 2. Review of the personnel file for HHA BBB’s, hire date of 1/18/2022, on 3/15/2020, evidenced the following: A copy of HHA BBB’s Registry license with an issued date of 1/25/2022, issued 28 days prior to the agency’s competency check off of HHA BBB. A review of a document titled “Competency Assessment-HHA,” dated 2-25-2022 indicated that all 12 required skills by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 2/25/2022 and signed by the evaluator RN D. The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home, as required by agency policy. 2. HHA DDD’s complete personnel record was reviewed on 3/18/2020. The record evidenced the following: A document titled “Caregiver Information Sheet,” was retrieved on 3/18/2022, from HHA DDD’s personnel file that indicated a hire date of 10/31/2019. A document titled “Employment Application,” was retrieved on 3/18/2022, and indicated a hire date of 2/02/2022. A copy of HHA DDD’s Home Health Aide Registry license with an issuance date of 12/12/2019. A document titled “Competency Assessment-HHA,” dated 2/02/2022 indicated that all 12 skills required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 2/02/2022, and signed by the evaluator RN E. The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home, as required by agency policy. 3. HHA EEE’s, hire date 7/22/2021, complete personnel record was reviewed on 3/16/2020. The record evidenced the following: A copy of HHA EEE’s Home Health Aide Registry license with an issuance date of 8/3/2021. A document titled “Competency Assessment-HHA,” dated 7/29/2021, indicated that all 12 skills required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 07/29/2021 and signed by the evaluator RN F. The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home, as required by agency policy. 4. A review of HHA FFF’s personnel record evidenced a hire date of 02/16/2022. The complete personnel record was reviewed on 3/16/2020. The record evidenced the following: A copy of HHA FFF’s Home Health Aide Registry license with an issuance date of 2/2/2022. A document titled “Competency Assessment-HHA,” dated 02/17/2022. indicated that all 12 skills required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. The skill Plan of care was marked with the word, “Yes” and an arrow facing down through all other skills then dated at the bottom of the arrow 02/17/22 and signed by the evaluator RN G The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home, as required by agency policy. 5. HHA GGG’s, hire date of 12/15/2021, complete personnel record was reviewed on 3/16/2020. The record evidenced the following: A copy of HHA GGG’s Home Health Aide Registry license with an issuance date of 12/16/2021. A document titled “Competency Assessment-HHA” dated 12-16-2021 indicated that all 12 required by federal regulations were completed in a lab including tub baths, transfer techniques, Hoyer lift use, range of motion, transferring, positioning, and repositioning. All skills were marked completed on 12/16/2021 and signed by the evaluator RN E. The competency assessment failed to evidence the agency completed the required skills to be observed with a client in a client’s home. 6. During an interview on 03/17/2022 at 2:00 p.m., the alternate administrator stated she didn't know why the agency's competency program policy stated some skills must be observed in the home because that is not their practice, and she would have to look into it. No other information was provided. The alternate administrator stated HHA BBB’s competency, dated a month before being added to the registry, was probably an error and they dated it wrong, she wasn’t sure but knew they wouldn’t have done it that way. 410 17-12-1(d)(3)

Parent-branch relationship CFR(s): 484.105(d) Standard: Parent-branch relationship. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the parent location provided direct control and supervision over all of its branches for 1 of 1 agencies reviewed. Findings include: 1. A job description for Area Clinical Manager was provided by the alternate administrator on 03/21/2022 at 2:05 p.m. The document indicated but was not limited to; "Job Summary: The Area Clinical Manager (ACM) under the direct supervision of the Director, Clinical Operations and in partnership with the Director, Regional Operations will be responsible for managing all clinical processes … Supervisory Responsibilities … handles discipline and termination of employees … provides oversight for home visits and day-to-day office processes as needed … Maintains the Quality Assurance and Performance Improvement (QAPI) program for each office …provides all updates to the program." 2. During an interview on 3/10/2022, the administrator stated RN M was the Area Clinical Manager for the agency. When provided an updated roster RN M was no longer listed as an employee. 3. A job description for Territory Clinical Manager was provided by the alternate administrator on 03/21/2022 at 2:05 p.m. The document indicated but was not limited to; "Job Summary: The Territory Clinical Manager (TCM) under supervision of the Area Clinical Manager will serve as back-up for clinical managers with admissions and provides oversite for home visits and day-to-day office processes as needed … Supervisory Responsibilities … handles discipline and termination of employees … Evaluate, monitor, and review all recertification's, grievances, and ROCs, while ensuring all appropriate documents are included as required." 4. On 3/10/2022 at 2:10 p.m. a document titled Organization Chart was provided by the administrator. The organizational chart identifies the Governing Body at the top of the chart then proceeding down is administrator, alternate administrator, nursing supervisor, and alternate supervisor. The administrator has 3 branches directly under them and then a fourth branch manager who provides oversite to all nurses, field staff, patients, and the 24/7 on-call. 5. During an interview on 3/10/2022 at 12:03 p.m., the administrator identified the agency’s license contained 8 branches and 1 parent location which contradicted the organizational chart. 6. During an interview on 3/11/2022, at 2:00 p.m. the administrator was asked how he provided direct support and oversight over 8 branches and the parent with an unduplicated census of 4,633 patients. The administrator stated they are part of weekly meetings with each branch. 7. On 3/11/2022 at 1:35 p.m. during an interview, the administrator was asked how they maintain clinical supervision and oversight all 682 home health aides. They stated there are “layers” of supervision that directly lead to the administrator. Documentation was requested at of the layers of supervision at this time and was never received. 8. On 3/14/2022 the administrator provided meeting minutes for each branch for 2022. The meeting minutes for the week ending 1/29/2022 for the Indianapolis branch of the agency state "Additional Notes … HHA (Home Health Agency) reporting and grievances go to [name of State Quality & Compliance Lead out of Chicago Illinois]. The administrator was not listed in attendance for 5 of the 5 Bloomington branch meeting minutes provided, 5 of 5 Muncie branch meeting minutes, 9 of 9 Richmond branch meeting minutes provided, 3 of 3 Winchester branch meeting minutes provided, 6 of 6 Lafayette branch meeting minutes provided, 10 of 10 Seymour branch meeting minutes, 9 of 9 Terre Haute branch meeting minutes, 2 of 2 Indy West branch meeting minutes provided, and 10 of the 10 Indy East the parent location meeting minutes. 9. On 3/15/2022 RN Z provided a copy of an email anonymously that was sent from an employee with the title State Quality & Compliance Lead located in Chicago, Illinois, and distributed to the administrator, Governing Body Member 2, the Lafayette Clinical Supervisor, and 7 other unidentified employees. The email indicated but was not limited to; “Remember you all report to [administrators name], the administrator. Do not mention Area Leaders, Area Clinical Leaders, [Governing Body Member B’s name, Governing Body Member C’s name] or myself as they’re not part of the license’s organization chart per IDH (Indiana Department of Health). Do not mention consolidations of agencies. You have simply received referrals from Adaptive [another agency with multiple licenses throughout Indiana owned by the same entity]. 10. During an interview on 3/17/2021 at 2:00 p.m., the administrator and alternate administrator were asked why employees were directed to conceal other managing employees and the alternate administrator stated it was just to avoid confusion. 11. On 3/10/2022 at 11:00 a.m., the Lafayette clinical manager provided a document titled “Infectious Disease Reporting” revised on 01/04/2022 and on 3/10/2022 at 12:35 pm RN B, a Bloomington branch employee, provided a document titled “Infectious Disease Reporting” revised on 08/26/2021. 12. On 3/14/2022 at 11:00 am Lafayette clinical manager provided a document titled “Infection Prevention and Control Plan” revised on 01/04/2022 and on 3/14/2022 at 11:00 am RN B provided a document titled “Infection Prevention and Control Plan” revised on 08/26/2021. 13. On 3/10/2022 at 12:35 p.m., RN B in the Bloomington branch provided a document titled “OSHA Infection Control & Exposure Plan” revised 8/26/21 and on 3/14/2022 at 11:00 am Lafayette Clinical Manager provided a document titled “OSHA Infection Control & Exposure Plan” revised 01/04/2022. 14. During an interview on 3/16/2022 at 2:25 pm the Administrator when asked why each branch is handing out different versions of policies and which policy is the correct policy to be followed, the administrator stated, “I don't know I will have to check my binder, those are the most up to date” and left the room to look in the administrator’s binder for the correct policy. 15. During an interview on 3/10/2022 at 2:03 pm when asked how long the agency Bloomington branch has been at its current location the administrator stated it has always been there. When told according to state record it was a branch of entity 2 and the agency was located on S. Liberty street 6 months prior the administrator stated: "oh I do think I remember being on S. Liberty." He stated he wasn't the administrator at that time. He was the alternate administrator at that time. 16. On 3/10/2022 two Bloomington branch employees were observed introducing themselves to the administrator, when the administrator was asked why the employees did not know him, the administrator stated they do not get to the branches often but do talk on the phone a lot.

Direct support and administrative control CFR(s): 484.105(d)(2) The parent HHA provides direct support and administrative control of its branches. This ELEMENT is not met as evidenced by: Based on record review and interview, the administrator failed to provide direct support and administrative control over all 8 of its branches reporting to the parent agency, for 1 of 1 agency reviewed. Findings include: 1. Document received on XX/XX/XXXX titled "Administrator Orientation" indicates agency administrator is oriented and trained on "Role/Responsibilities" including but not limited to "oversight of Parent/Branch Operations". 2. On 3/10/2022 at 11:00 am Lafayette clinical manager provided a document titled “Infectious Disease Reporting” revised on 01/04/2022. 3. On 3/10/2022 at 12:35 pm am RN B provided a document titled “Infectious Disease Reporting” revised on 08/26/2021. 4. On 3/14/2022 at 11:00 am Lafayette clinical manager provided a document titled “Infection Prevention and Control Plan” revised on 01/04/2022. 5. On 3/14/2022 at 11:00 am RN B provided a document titled “Infection Prevention and Control Plan” revised on 08/26/2021. 6. On 3/10/2022 at 12:35 pm RN B provided a document titled “OSHA Infection Control & Exposure Plan” revised 8/26/21. 7. On 3/14/2022 at 11:00 am Lafayette Clinical Manager provided a document titled “OSHA Infection Control & Exposure Plan” revised 01/04/2022. 8. During an interview on 3/16/2022 at 2:25 pm the Administrator when asked about the difference in the versions of the policies in the agency branches, they stated, “I will have to check” and left the room to look in the administrator’s binder for the correct policy. 9. During an interview on 3/10/2022 at 1:55 pm agency Administrator stated they are not aware of any staffing issues at the branches. 10. During an interview pm 3/10/2022 at 2:03 pm agency Administrator stated they believe the Bloomington Help at Home branch has always been at its current location. When told according to state records the branch moved relocated to its current location in 9/2021 the administrator stated they had not been in their position very long. 11. On 3/11/2022 at 1:35 pm interview with agency administrator was asked how they maintain clinical supervision and oversight all 682 home health aides. They stated there are “layers” of supervision that directly lead to the administrator. Documentation was requested at of the layers of supervision at this time and was never received. 17-12-1(a)(2) 1. A job description for Area Clinical Manager was provided by the alternate administrator on 03/21/2022 at 2:05 p.m. The document indicated but was not limited to; "Job Summary: The Area Clinical Manager (ACM) under the direct supervision of the Director, Clinical Operations and in partnership with the Director, Regional Operations will be responsible for managing all clinical processes … Supervisory Responsibilities … handles discipline and termination of employees … provides oversight for home visits and day-to-day office processes as needed … Maintains the Quality Assurance and Performance Improvement (QAPI) program for each office …provides all updates to the program." 2. During an interview on 3/10/2022, the administrator stated RN M was the Area Clinical Manager for the agency. When provided an updated roster RN M was no longer listed as an employee. 3. A job description for Territory Clinical Manager was provided by the alternate administrator on 03/21/2022 at 2:05 p.m. The document indicated but was not limited to; "Job Summary: The Territory Clinical Manager (TCM) under supervision of the Area Clinical Manager will serve as back-up for clinical managers with admissions and provides oversite for home visits and day-to-day office processes as needed … Supervisory Responsibilities … handles discipline and termination of employees … Evaluate, monitor, and review all recertification's, grievances, and ROCs, while ensuring all appropriate documents are included as required." 4. On 3/11/2022 at 10:10 a.m. the administrator provided a spreadsheet listing possible patient infections with symptoms similar to COVID-19. The document indicated for quarter 3, July-September of 2021 210 suspected patient and staff infections with no follow-up. The administrator was asked for test results for employees suspected 3 separate times and was unable to gain access to the results. On 3/10/2022 at 2:10 p.m. a document titled Organization Chart was provided by the administrator. The organizational chart identifies the Governing Body at the top of the chart then proceeding down is administrator, alternate administrator, nursing supervisor, and alternate supervisor. The administrator has 3 branches directly under them and then a fourth branch manager who provides oversite to all nurses, field staff, patients, and the 24/7 on-call. During an interview on 3/10/2022 at 12:03 p.m., the administrator identified the agency’s license contained 8 branches and 1 parent location which contradicted the organizational chart. During an interview on 3/11/2022, the administrator was asked how he provided direct support and oversight over 8 branches and the parent with an unduplicated census of 4,633 patients. The administrator stated they are part of weekly meetings with each branch. On 3/14/2022 the administrator provided meeting minutes for each branch for 2022. The meeting minutes for the week ending 1/29/2022 for the Indianapolis branch of the agency state "Additional Notes … HHA (Home Health Agency) reporting and grievances go to [name of State Quality & Compliance Lead out of Chicago Illinois]. The administrator was not listed in attendance for 5 of the 5 Bloomington branch meeting minutes provided, 5 of 5 Muncie branch meeting minutes, 9 of 9 Richmond branch meeting minutes provided, 3 of 3 Winchester branch meeting minutes provided, 6 of 6 Lafayette branch meeting minutes provided, 10 of 10 Seymour branch meeting minutes, 9 of 9 Terre Haute branch meeting minutes, 2 of 2 Indy West branch meeting minutes provided, and 10 of the 10 Indy East the parent location meeting minutes. On 3/15/2022 RN Z provided a copy of an email anonymously that was sent from an employee with the title State Quality & Compliance Lead located in Chicago, Illinois, and distributed to the administrator, Governing Body Member 2, the Lafayette Clinical Supervisor, and 7 other unidentified employees. The email indicated but was not limited to; “Remember you all report to [administrators name], the administrator. Do not mention Area Leaders, Area Clinical Leaders, [Governing Body Member B’s name, Governing Body Member C’s name] or myself as they’re not part of the license’s organization chart per IDH (Indiana Department of Health). Do not mention consolidations of agencies. You have simply received referrals from Adaptive [another agency with multiple licenses throughout Indiana owned by the same entity]. During an interview on 3/17/2021 at 2:00 p.m. the administrator and alternate administrator were asked why employees were directed to conceal other managing employees and the alternate administrator stated it was just to avoid confusion.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient’s discharge/transfer summary was sent to the primary care practitioner who would be responsible for providing care and services to the patient after discharge for 2 of 5 closed Records Reviewed. (Patient #6 and Patient #8) Findings include: 1. A review of an 8/26/2021 policy titled “Client Discharge Process,” was provided by RN B on 3/10/2022 at 12:35 p.m. The document indicated but was not limited to; “... A copy of the discharge summary is sent to the MD for signature, within 5 business day and the original will be filed in the client’s record\.” 2. On 3/21/2022, the complete clinical record of Patient 6 was reviewed for the certification period 8/20/2021 - 10/18/2021. The record failed to evidence a discharge summary for discharge on 10/5/2021, was completed and sent to the MD. 3. On 3/10/2022, the complete clinical record of Patient 8 was reviewed for the certification period 9/23/2021 - 11/21/2021. The record failed to evidence a discharge summary was completed and sent to the MD for the discharge of 10/4/2021. 4. Interview with Alternate administrator on 3/21/2022 at 11:30 a.m., requested the discharge summary for Patient 6 and Patient 8. Received a discharge summary dated 3/21/2022, more than 5 days after discharge, for patient #6 at 12:20 on 3/21/2022. The original discharge summary was requested from the Alternate administrator for Patient #6 at that time. The discharge summaries were not provided by the alternate administrator for Patient #8.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure all documents were properly authenticated with a date and time for 1 of 1 agency reviewed. Findings include: 1. On 3/14/2022 the administrator provided the QAPI (quality assurance and performance improvement) plan meeting minutes for quarter 3 of 2021. The quarter 3 members' present names did not match the signature pages provided by the administrator. The signature page was a blank white paper that included the title of the branch location of the agency with multiple employee signatures. There was one document for each branch. The documents failed to be authenticated with a date and time, and failed to evidence documentation the signees were present. The exact same signature page was used twice for the quarter 3 and quarter 4 QAPI meetings attendance record. 2. On 3/14/2022, the administrator provided the QAPI (quality assurance and performance improvement) plan meeting minutes for quarter 4 of 2021. The quarter 4 meeting minutes have a date of 1/13/22 but are left blank for the start time and the members present. The signature page was a blank white paper that included the title of the branch location of the agency with multiple employee signatures. There was one document for each branch. The documents failed to be authenticated with a date and time, and failed to evidence documentation the signees were present. The exact same signature page was used twice for the quarter 3 and quarter 4 QAPI meetings attendance record. 3. On 3/14/2022 the administrator provided the Governing Body Meeting minutes for 1/04/2022, 2/21/2022, and 3/09/2022, which evidenced of the exact same signature for Governing Body Member 1 and Governing Body Member 2 in the exact same location and spacing. The documents failed to evidence they were electronically signed or stamped by another individual. 4. On 3/11/2022 the administrator provided a copy of the meeting minutes for each individual branch. The meeting minutes failed to evidence who authored the documents. The documents included information related to entity 2, entity 3, entity 4, and this agency all combined although the entities had 4 separate licenses. Not all meeting minutes included a date or week to identify when created. 5. During an interview with the administrator on 3/18/2022, at 2:00 p.m., he/she stated the documents were out of order, acknowledged dates and times were missing and that there was only 1 set of signature pages for 2 quarterly QAPI meetings.

Retrieval of records CFR(s): 484.110(e) Standard: Retrieval of clinical records. A patient's clinical record (whether hard copy or electronic form) must be made available to a patient, free of charge, upon request at the next home visit, or within 4 business days (whichever comes first). This STANDARD is not met as evidenced by: Based on observation and record review, the agency failed to ensure a patient's clinical records would be made available to the patient, free of charge, upon request at the next home visit, or within 4 business days (whichever came first) for 1 of 1 home visits (Patient #17). Findings include: A home visit with Patient #17 was conducted on 03/15/2022 at 10:00 AM, with Employee R, home health aide, and Patient 17's family member present. Observed the agency folder in the home with a document titled “Notice of Health Information Practices,” which indicated “ [the agency]… will provide a summary of health information usually within 30 days … may charge a reasonable, cost-based fee ….” The document failed to evidence the correct information was provided to Patient 17 in relation to procedures for retrieval of clinical records.

This visit was for a Federal Recertification and State Re-Licensure Survey of a Medicaid Home Health provider in conjunction with 4 complaints. Complaint #: IN 00315933 Unsubstantiated. Complaint #: IN 00307150 Substantiated - Deficiencies were cited. Complaint #: IN 00306992 Unsubstantiated. Complaint #: IN 00285475 Unsubstantiated. Survey Date: 06/29/21, 06/30/21, 07/01/21, 07/02/21, 07/06/21, 07/07/21, and 07/08/21 Facility #: 004966 Provider #: 15K1023 Medicaid #: 200465840 These deficiencies reflects Sate Findings cited in accordance with 410 IAC 17. Quality Review Completed 07/20/2021 by Area 3

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on observation, record review and interview the agency failed to evidence the comprehensive assessments provided were complete and accurately reflected the patient's status, and all the patient's current health, psychosocial and cognitive status in 5 of 13 active records reviewed. (Patient #2, 5, 6, 7, 8) Findings Include: 1. Review of an undated agency policy titled "Initial Assessments/Comprehensive Assessments" Policy #9.5.1 indicated, "Policy Each patient admitted by the Agency will have appropriate initial assessments performed and documented ...Procedure 1. Each patient admitted will receive a comprehensive assessment. The assessment will reflect the patient's current health status and include information to demonstrate the patient's progress toward achievement of desired outcomes ..." 2. Review of an undated agency policy titled "Reassessments/Update of the Comprehensive Assessment" Policy #9.6.1 indicated, "Policy Each patient will have appropriate reassessments performed and documented ...Procedure 1. The comprehensive assessment ...must be updated and revised as frequently as the patient's condition warrants ...Recertification: the last 5 days of every 60 days ...3. Staff will additionally reassess each patient on an ongoing basis to evaluate current problems and needs as well as to adjust the care provided. Such reassessments will be documented ..." 3. During a home visit at patient #2's home on 7/2/21 at 11:15 AM, when Employee I, RN case manager queried about pain the patient stated, "My neck gets really sore. My back pain has improved with meds." Patient #2 then showed soft collar cushion for neck and demonstrated how she moves she lounge in a better positioned back if pain starts. The caregiver of patient #2 stated, "Her pain would be a 10 if not for those pain pills." Caregiver further indicated patient had chest pain and had to take nitroglycerin twice for chest pain and patient's blood pressure has been high. Patient #2 stated, "The chest pain wasn't like I use to have it and have to take 3 pills before when I had it." When the RN case manager queried about her last bowel movement, the RN case manager stated the doctor has recently added prunes to her diet due to constipation. Review of the recertification comprehensive assessment dated 05/03/21 indicated "No changes since last assessment" under psychosocial, cardiac status, and fall risk assessment. The comprehensive assessment failed to evidence the patient's current health status of cardiac issues evidenced by multiple medication changes as follow: on 04/28/21 discontinue Hydralazine 25mg by mouth daily in AM, discontinue Hydralazine 50mg by mouth at noon & evening, start HCTZ(Hydrochlorothiazide) 25mg by mouth at noon, on 04/08/21 Discontinue HCTZ 25mg tablet by mouth daily, discontinue Hydralazine 50 mg by mouth three times daily, start Hydralazine 25mg by mouth daily in AM, stat Hydralazine 50mg by mouth twice daily at noon & evening, Start HCTZ 12.5 by mouth daily, on 04/06/21 Hydralazine 50mg by mouth three times daily on 04/06/21, on 04/01/21 discontinue Amlodipine 2.5 mg daily at bedtime, on 03/30/21 Discontinued Hydralazine 25mg by mouth in AM Start Hydralazine three times daily. The comprehensive assessment failed to evidence the patient's current health status. 4. During a home visit with patient #6 on 07/01/21 at 3:00 PM patient stated, "I would like to ride my stationary bike. I also want to get my meds straightened out they keep sending me so much. I also have to cut down on my fruit. I gained weight and the doctor said there is a lot of sugar in fruit." Patient #6 indicated she had issues getting her breathing masks for her nighttime machine. When queried about falls patient indicated she had a fall. Review of the recertification comprehensive assessment dated 05/03/21 indicated, "No changes since last assessment" under psychosocial, neuro status, musculoskeletal status. The comprehensive assessment failed to evidence the patient's current health status with musculoskeletal status received a new walker and had a fall. Patient #6 has Cerebral palsy and Epilepsy as diagnoses neuro status not addressed. The comprehensive assessment failed to evidence the patient's current health status. 5. During a home visit on 07/02/21 at 3:30 PM observed poster signs on patient's living room wall that gave patient #7 steps to take when upset, when hears voices, and to wear gloves to protect hands form injury. Employee D, RN (Registered Nurse) case manager was not observed asking any questions regarding psychosocial or depression. When queried by the RN case manager regarding falls the patient indicated that patient #7 had fallen in the bathroom slipped on water and showed the RN the bruising on left leg. The clinical record of patient #7 was reviewed on 07/30/21 and revealed a start of care date of 05/13/20. The record contained a recertification comprehensive assessment dated 05/06/21 indicated "no changes since previous assessment" under clinical findings in psychosocial, neuro status, musculoskeletal status. The comprehensive assessment failed to evidence the patient's current health status psychosocial diagnosis of Bipolar, Schizophrenia, and Depression. Patient #7 indicated has fallen in the bathroom and uses a walker for ambulation. The comprehensive assessment failed to evidence the patient's current health status. 6. These findings were reviewed with the administrator/clinical manager and alternate administrator/alternate clinical manager on 07/01/21 at 1:45 PM to 2:10 PM in which they had no further information or documentation to provide.7. Review of clinical record of Patient #5, revealed the patient has Diagnoses of Moderate Intellectual Disabilities, unsteady gait, HTN (Hypertension), Anemia, Hypothyroidism, Anxiety Disorder Major Depressive Disorder, GERD (Gastric esophageal reflux disease), Epilepsy, Rheumatoid Arthritis, and Obesity. Review of comprehensive assessment completed on 04/26/2021 for certification period of 04/29/2021,-06/27/2021; Mental Status was marked N/A (not applicable), Psychosocial was not completed, "Inability to cope with altered health status as evidenced by: ...." "How does the patient's psychosocial condition affect functional ability and/or safety" was not addressed. A review of comprehensive assessment dated 06/23/2021 for the certification period 06/28/2021-08/26/2021, diagnoses Epilepsy, Anxiety Disorder, Major Depressive Disorder, rheumatoid Arthritis, and GERD were not listed on comprehensive assessment. The Mental Status was marked N/A (not applicable) and Psychosocial was not completed. During an interview on 7/1/2021 at 1:50 PM, the primary diagnosis on the plan of care was discussed but yet the recertification comprehensive assessment is marked "N/A" as well as some psychosocial areas were left blank. When asked if a patient has a mental illness, would the agency expect documentation on the assessment, the administrator responded, "Absolutely." 8. A review of clinical record of Patient #8, revealed the patient has Diagnoses of Chronic Pain Syndrome, Diabetes, COPD (Chronic Obstructive Pulmonary Disease), Generalized Weakness, Degenerative Disc disease Edema, and CHF (Congested Heart Failure). A review of a comprehensive assessment dated 05/26/2021 for certification period 05/30/2021-07/28/2021, under Sensory status, the code for vision was not completed, under Diabetic Foot exam, it was checked N/A, under Musculoskeletal, it was check that there was no problem but documented patient has weakness in lower extremities related to back pain, the question of "How does the patient's condition affect their functional ability and/or safety" was not completed. 410 IAC 17-14-1(a)(1)(A)(B)

Strengths, goals, and care preferences CFR(s): 484.55(c)(2) The patient's strengths, goals, and care preferences, including information that may be used to demonstrate the patient's progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the HHA; This ELEMENT is not met as evidenced by: 9. The clinical record of patient #3, SOC (start of care date) 07/05/2013, was reviewed 06/30/202,. The record contained a plan of care for a recertification period of 05/12/2021-07/10/2021. Patient diagnosis included: TIAs' (Transient Ischemic Attacks) and cerebral infarction without residual deficits, History of Falls, HTN, Diabetes Mellitus, Gastro-esophageal reflux disease, Functional Urinary incontinence, Major Depressive Disorder, Chronic Kidney Disease, Stage 3, Anemia, Gout, Unspecified Speech disturbances, and Constipation. A review of the recertification assessment dated 05/04/2021, failed to evidence patient strengths, goals, and care preferences. 10. The clinical record of patient #4, SOC 04/05/2021, was reviewed 06/30/2021. The record contained a plan of care for a recertification period of 06/04/2021-08/02/2021. Patient diagnosis included: Muscle Weakness, Gastro-esophageal reflux disease without esophagitis, Essential hypertension, Type 2 Diabetes Mellitus, Fibromyalgia, Chronic Obstructive Pulmonary Disease, Rheumatoid Arthritis, Other Idiopathic peripheral autonomic Neuropathy, Urinary Incontinence, Full incontinence of feces, and Shortness of breath. A review of recertification assessment dated 06/02/2021, failed to evidence patient strengths, goals, and care preferences. 11. The clinical record of patient #5, SOC 03/08/2006, was reviewed 06/30/2021. The record contained a plan of care for a recertification period of 04/29/2021-06/27/2021. Patient diagnosis included: Moderate Intellectual Disabilities, Unsteady Gait, HTN (Hypertension), Anemia, History of Colon Cancer, Hypothyroidism, GERD (Gastro-esophageal reflux disease), Anxiety Disorder, Major Depressive Disorder. A review of the recertification comprehensive assessment dated 06/23/2021, failed to evidence patient strengths, goals, and care preferences. 12. The clinical record of patient #8, SOC 06/10/2019, was reviewed 06/30/2021. The record contained a plan of care for a recertification period of 05/30/2021-07/28/2021. Patient diagnosis included: Chronic Pain, Type 2 DM (Diabetes Mellitus), COPD (Chronic Obstructive Pulmonary Disease), and Muscle Weakness. A review of the recertification comprehensive assessment dated 05/26/2021, failed to evidence patient strengths, goals, and care preferences. 13. The clinical record of patient #12, SOC 07/10/2020, was reviewed 07/06/2021. The record contained a plan of care for a recertification period of 05/06/2021-07/04/2021. Patient diagnosis included: Chronic Back Pain, Chronic Obstructive Pulmonary Disease, End Stage Renal Disease, Dysphasia, and Diabetes. A review of the recertification comprehensive assessment dated 05/04/2021, failed to evidence patient strengths, goals, and care preferences. 14. The clinical record of patient #13, SOC 03/10/2020, was reviewed 07/06/2021. The record contained a plan of care for a recertification period of 05/04/2021-07/02/2021. Patient diagnosis included: CVA (Cardiac Vascular Accident) with Right Side Weakness/Paralysis, Diabetes Mellitus, Depression, and Hypertension. A review of the recertification assessment dated 04/30/2021, failed to evidence patient strengths, goals, and care preferences. 15. These findings were reviewed with the administrator/clinical manager and alternate administrator/alternate clinical manager on 07/06/21 at 4:45 PM to 4:30 PM in which they had no further information or documentation to provide. 16. During an interview on 07/07/21 at 4:15 PM, when queried about goals being patient specific/ individualized, an example of patient #6's plan of care indicating, "Patient will maintain medication compliance throughout the cert period" and the patient expressing their goals was to ride their stationary bike, the administrator/clinical manager stated, "Absolutely". Based on record review and interview, the agency failed to ensure comprehensive assessments contained patient goals, strengths, and care preferences for 12 of 13 active records reviewed. (Patient #2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13) Findings include: 1. Review of Agency's Policy titled "Initial Assessments/Comprehensive Assessments" Policy #9.5.1 indicated, "Each patient admitted by the Agency will have appropriate initial assessments performed and documented ... Procedure ...7. The Initial Comprehensive Assessment also includes: ...Strengths, goals and care preferences, including information that may be used to demonstrate the patient's progress toward achievement of the goals identified by the patient and measurable outcomes identified by the Agency ..." 2. Review of Agency's Policy titled, "IX Provision of Care, Treatment, and Services (PC), policy Initial Assessments/Comprehensive Assessments, 9.5.1", indicated "Each patient admitted by the Agency will have appropriate initial assessments performed and documented. Procedure #7, The initial comprehensive Assessment also includes, Strengths, goals and care preferences, including information that may be used to demonstrate the patient's progress toward achievement of the goals identified by the patient and measurable outcomes identified by the Agency." 3. The clinical record of patient #2 was reviewed on 06/30/21 and indicated a start of care date of 09/18/18. The record contained a plan of care for the recertification period of 05/05/21 to 07/03/21 that indicated diagnoses, Muscle Weakness, Pain disorder with psychological factors, Scoliosis, Arthritis, Idiopathic Progressive Neuropathy, Restless Leg Syndrome, Essential Hypertension, Heart Failure, Hypothyroidism, and Hyperlipidemia. A review of the recertification comprehensive assessment dated 05/03/21, failed to evidence weaknesses, patient care preferences, and patient centered goals. 4. The clinical record of patient #6 was reviewed on 06/30/21 and indicated a start of care date of 09/17/18. The record contained a plan of care for the recertification period of 05/04/21 to 07/02/21 that indicated diagnoses, Cerebral Palsy, Epilepsy, IBS (Irritable Bowel Syndrome), Spastic Bladder, Acid Reflux, Chronic Constipation, Arthritis, and Migraines. A review of the recertification comprehensive assessment dated 05/03/21, failed to evidence patient care preferences, weaknesses, measurable outcomes, and patient centered goals. During a home visit with patient #6 on 07/01/21 at 3:00 PM patient stated, "I would like to ride my stationary bike. I also want to get my meds [medications] straightened out, they keep sending me so much. I also have to cut down on my fruit. I gained weight and the doctor said there is a lot of sugar in fruit." 5. The clinical record of patient #7 was reviewed on 07/30/21 and indicated a start of care date of 05/13/20. The record contained a plan of care for the recertification period of 05/08/21 to 07/06/21 that indicated diagnoses, Chronic Pain, Bipolar/Schizophrenia, Hypothyroidism, GERD (Gastric Esophageal Reflux Disease), History of Seizures, MDD (Major Depressive Disorder), Generalized Weakness, Arthritis, and Depression. A review of the recertification comprehensive assessment dated 05/06/21, failed to evidence patient care preferences, weaknesses, measurable outcomes, and patient centered goals. 6. The clinical record of patient #9 was reviewed on 07/06/21 and indicated a start of care date of 08/03/17. The record contained a plan of care for the recertification period of 05/14/21 to 07/12/21 that indicated diagnoses, Cognitive Impairment, Autistic disorder, Seizure disorder, and GERD (Gastric Esophageal Reflux Disease). A review of the recertification comprehensive assessment dated 05/10/21, failed to evidence patient care preferences, weaknesses, measurable outcomes, and patient centered goals. 7. The clinical record of patient #10 was reviewed on 07/07/21 and indicated a start of care date of 02/05/21. The record contained a plan of care for the recertification period of 04/06/21 to 06/04/21 that indicated diagnoses, Altered mental status unspecified, Autistic disorder, Seizure disorder, and Acne. A review of the recertification comprehensive assessment dated 04/01/21, failed to evidence patient care preferences, weaknesses, measurable outcomes, and patient centered goals. 8. The clinical record of patient #11 was reviewed on 07/07/21 and indicated a start of care date of 10/5/15. The record contained a plan of care for the recertification period of 05/10/21 to 07/08/21 that indicated diagnoses, Generalized Weakness, CHF (Congestive Heart Failure), TIA (Transient Ischemic Attack), Chronic Pain, Constipation, Cardiac Dysrhythmia, Pacemaker, GERD (Gastric Esophageal Reflux Disease), and Overactive Bladder. A review of the recertification comprehensive assessment dated 05/07/21, failed to evidence patient care preferences, strengths, weaknesses, measurable outcomes.

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: 6. The clinical record of patient #3, SOC (start of care) 07/05/2013, was reviewed 06/30/2021. The record contained a plan of care for a recertification period of 05/12/2021-07/10/2021. Patient diagnoses included: TIAs' (Transient Ischemic Attacks) and cerebral infarction without residual deficits, History of Falls, HTN (Hypertension), DM (Diabetes Mellitus), GERD (Gastro-esophageal reflux disease), Urinary incontinence, Major Depressive Disorder, Chronic Kidney Disease Stage 3, Anemia, Gout, Unspecified Speech disturbances, and Constipation. A review of the Home Health Certification/ Recertification Plan of Care dated 05/04/202, revealed orders for Hha home (health aide services) 1-2 hours/day, 3-5 days per week for 9 weeks to assist with ADL's(activities of daily living) and IADL's (instrumental activities of daily living). The measurable goals and outcomes revealed: "Patients ADL's and IADL's will be met this cert period with the assistance of the home health aide. Patient's safety will be enhanced through the home care service as evidenced by no injuries from falls within certification period of time." The agency failed to ensure an individualized plan of care that identifies patient-specific measurable outcomes and goals. 9. The clinical record of patient #4, SOC 04/05/2021, was reviewed 06/30/2021. The record contained a plan of care for a recertification period of 06/04/2021-08/02/2021. Patient diagnoses included: Muscle Weakness, Gastro-esophageal reflux disease without esophagitis, Essential hypertension, Type 2 Diabetes Mellitus, Fibromyalgia, Chronic Obstructive Pulmonary Disease, Rheumatoid Arthritis, Other Idiopathic peripheral autonomic Neuropathy, Urinary Incontinence, Full incontinence of feces, and Shortness of breath. A review of the Home Health Certification/ Recertification Plan of Care dated 06/02/2021, revealed orders for home health aide services 1-2 hours/visit, 2-3 times a week for 9 weeks to assist with ADL's and IADL's. The goals revealed were: "No declared goals at this time". The measurable goals and outcomes revealed: "The patient's safety will be enhanced throughout the home care services as evidenced by no injuries from falls within cert period of time. Patient's ADL's and IADL's will be met this certification period with the assistance of the home health aide. The agency failed to ensure an individualized plan of care that identifies patient-specific measurable outcomes and goals. 10. The clinical record of patient #5, SOC 03/08/2006, was reviewed 06/30/2021. The record contained a plan of care for a recertification period of 04/29/2021-06/27/2021. Patient diagnoses included: Moderate Intellectual Disabilities, Unsteady Gait, HTN (Hypertension), Anemia, History of Colon Cancer, Hypothyroidism, GERD (Gastro-esophageal reflux disease), Anxiety Disorder, Major Depressive Disorder. A review of the Home Health Certification/Recertification Plan of Care Order dated 06/23/2021, revealed orders for Hha (home health aide services) 1-3 hours per visit, 1-2 days per week x 9 weeks to assist with ADL's and IADL's. The measurable goals and outcomes: "The patient's safety will be enhanced throughout ....Patient's ADL's and IADL's will be met....". The agency failed to ensure an individualized plan of care that identifies patient-specific measurable outcomes and goals. 11. The clinical record of patient #8, SOC 06/10/2019, was reviewed 06/30/2021. The record contained a plan of care for a recertification period of 05/30/2021-07/28/2021. Patient diagnosis included: Chronic Pain, Type 2 DM (Diabetes Mellitus), COPD ( Chronic Obstructive Pulmonary Disease), and Muscle Weakness. A review of the Home Health Certification/Recertification Plan of Care Order dated 05/26/2021, revealed orders for home health aide services 1-2 hour visit, 3-5 days/week x 9 weeks for assistance with ADL's and IADL's. The Measurable Goals and outcomes revealed: "Patient's ADL's and IADL's will be met...The patient's safety will be enhanced throughout ...." The agency failed to ensure an individualized plan of care that identifies patient-specific measurable outcomes and goals. 12. The clinical record of patient #12, SOC 07/10/2020, was reviewed 07/06/2021. The record contained a plan of care for a recertification period of 05/06/2021-07/04/2021. The Patient diagnoses included: Chronic Back Pain, COPD, End Stage Renal Disease, Dysphasia, and DM. A review of the Home Health Plan of Care/Certification dated 05/04/2021, revealed orders for home health aide services 7-8 hours/visit, 4-5 days/week x 9 weeks for assistance with ADL's and IADL's. Measurable Goals and Outcomes revealed: "Patient's ADL's and IADL's will be met..The patient's safety will be..." The agency failed to ensure an individualized plan of care that identifies patient-specific measurable outcomes and goals. 13. The clinical record of patient #13, SOC 03/10/2020, was reviewed 07/06/2021. The record contained a plan of care for a recertification period of 05/04/2021-07/02/2021. Patient diagnosis included: CVA (Cardiac Vascular Accident) with Right Side Weakness/ Paralysis, Diabetes Mellitus, Depression, and Hypertension. A review of the Home Health Plan of Care/Certification dated 04/30/2021, revealed orders for home health aide services for 9-11 hours/visit, 2-4 days/week x 9 weeks for assistance with ADL's and IADL's. The Patient/ Representative Identified Measurable Goals and Outcomes revealed: Patient will remain at current level of independence through the certification period. The Measurable Goals and Outcomes revealed: "Patient's ADL's and IADL's will be met....The patient's safety will be...". The agency failed to ensure an individualized plan of care that identifies patient-specific measurable outcomes and goals. 14. These findings were reviewed with the administrator/clinical manager and alternate administrator/alternate clinical manager on 07/06/21 at 4:45 PM to 4:30 PM in which they had no further information or documentation to provide. 410 AC 17-13-1 (a) Based on observation, record review, and interview the agency failed to ensure patient needs were met by failing to provide home health aide services for 2 (Patient #7, 9) out of 12 active records reviewed of patients receiving home health aide services and failed to ensure all plan of care were individualized for 10 out of 13 active patients (Patient #3, 4, 5, 7, 8, 9, 10, 11, 12, 13). Findings Include: 1. Review of an undated agency policy titled "Plan of Care-CMS #485 and Physician Orders" Policy #9.9.1 indicated, " ... Procedure ...2. Each patient must receive an individualized written plan of care, including 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 measurable outcomes that Agency anticipates will occur as a result of implementing and coordinating the plan of care. ... Services must be furnished in accordance with accepted standards of practice ..." 2. During a home visit on 07/02/21 at 3:30 PM, observed poster signs on patient's living room wall that gave patient #7 steps to take when upset, when hears voices, and to wear gloves to protect hands from injury. The RN case manager queried the patient regarding falls, in which the patient responded they had fallen in the bathroom, slipped on water, and showed the RN the bruising on left leg. Patient #7 stated, "When am I going to get my showers and aide again, haven't had one since last month?" The RN case manager stated, "We are working on it." The clinical record of patient #7 was reviewed on 07/30/21 and revealed a start of care date of 05/13/20. The record contained a plan of care for the recertification period of 05/08/21 to 07/06/21, with diagnoses of Chronic Pain, Bipolar/ Schizophrenia, Hypothyroidism, GERD (Gastric Esophageal Reflux Disease), History of Seizures, MDD (Major Depressive Disorder), Generalized Weakness, Arthritis, and Depression. Review of home health aide visit notes evidenced the following: Missed visits awaiting staffing 06/04/21, 06/08/21, 06/10/21, 06/15/21, 06/17/21, 06/22/21, 06/29/21, 06/08/21, and 07/01/21. A review of the plan of care for the recertification period of 05/08/21 to 07/06/21 indicated " ...Orders for Discipline and Treatments (specify Amount/ Frequency/ Duration): ... HHA 1 hr/d, 1-3 days/week x 9 weeks to assist with ADL's and IADL's ... Measurable Goals and Outcomes: Patient's ADL's and IADL's will be met this cert period with the assistance of the home health aide. The patient's safety will be enhanced throughout the home care service as evidenced by no injury r/t falls or seizures within the cert period time.... " The agency failed to evidence an individualized patient care needs and goals and failed to ensure they provided home health aide services as ordered per the plan of care. 3. The clinical record of patient #9 was reviewed on 07/06/21 and indicated a start of care date of 08/30/17. The record contained a plan of care for the recertification period of 03/15/21 to 05/13/21 that indicated diagnoses, Cognitive Impairment, Autistic disorder, Seizure disorder, and GERD. A review of the plan of care for the recertification period of 03/15/21 to 05/13/21 indicated " ...Orders for Discipline and Treatments (specify Amount/ Frequency/ Duration): HHA 1-3 h/d, 3-5 days/week x 9 weeks to assist with ADL's and IADL's ...Measurable Goals and Outcomes: Patient's ADL's and IADL's will be met this cert period with the assistance of the home health aide. The patient's safety will be enhanced throughout the home care service as evidenced by no injury r/t falls or seizures within a 60 day period of time ...." The plan of care failed to evidence individualized patient care needs and individualized patient centered goals. Review of home health aide visit notes evidenced the following: Missed visits on 04/02/21, 05/04/21, 05/05/21, 05/19/21 thru 05/21/21. Review of an agency document dated 05/25/21 titled "Missed Visit Form" indicated, "All available staff refused shifts." The agency failed to provide home health aide services as ordered per the plan of care and provide a frequency specific to the patient's care needs. 4. The clinical record of patient #10 was reviewed on 07/07/21 and indicated a start of care date of 02/05/21. The record contained a plan of care for the recertification period of 04/06/21 to 06/21/21 that indicated diagnoses, Altered mental status unspecified, Autistic disorder, Seizure disorder, and Acne. Review of a plan of care for the recertification period of 04/06/21 to 06/04/21 indicated " ...Orders for Discipline and Treatments (specify Amount/ Frequency/ Duration): HHA 1-2 hour/visit, 5-7 days/week x 9 weeks to assist with ADL's and IADL's. HHA to apply bilateral AFO's (Ankle foot orthosis) every visit ... Measurable Goals and Outcomes: Patient's ADL's and IADL's will be met this cert period with the assistance of the home health aide. The patient's safety will be enhanced throughout the home care service as evidenced by no injury r/t falls this cert period of time. The patient will remain free of injury r/t seizures this cert period ...." The plan of care failed to evidence individualized patient care needs and individualized patient centered goals. 5. The clinical record of patient #11 was reviewed on 07/07/21 and indicated a start of care date of 10/07/15. The record contained a plan of care for the recertification period of 05/10/21 to 07/08/21 that indicated diagnoses, Generalized Weakness, CHF, TIA, Chronic Pain, Constipation, Cardiac Dysrhythmia, Pacemaker, GERD, and Overactive Bladder. Review of a plan of care for the recertification period of 05/10/21 to 07/08/21 indicated " ...Orders for Discipline and Treatments (specify Amount/ Frequency/ Duration): HHA 2-4 hrs/visit, 1-2vs (visits)/day, 5-7 days/week x 9 weeks to assist with ADL's and IADL's. HHA ... Measurable Goals and Outcomes: Patient's ADL's and IADL's will be met this cert period with the assistance of the home health aide. The patient's safety will be enhanced throughout the home care service as evidenced by no injury r/t falls within cert period ..." The plan of care failed to evidence individualized patient care needs and individualized patient centered goals.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: 9. The clinical record of patient #3, SOC (start of care) 07/05/2013, was reviewed 06/30/2021. Patient diagnoses included: TIAs' (Transient Ischemic Attacks) and cerebral infarction without residual deficits, History of Falls, HTN (Hypertension), DM (Diabetes Mellitus), GERD (Gastro-esophageal reflux disease), Urinary incontinence, Major Depressive Disorder, Chronic Kidney Disease Stage 3, Anemia, Gout, Unspecified Speech disturbances, and Constipation. A review of the Home Health Certification/Recertification Plan of Care dated 05/04/2021 and assessment dated 05/04/2021, revealed patient is taking Metoprolol Tartrate 100 mg 2 times a day, Hydralazine 50 mg 4 times a day, and Amlodipine 10 mg 1 x a day for HTN (blood pressure). The Patient/Family is to check patient's blood sugar daily. The Plan of Care failed to evidence diabetic foot care and physician call parameters with blood sugars and vital signs. The Hha (home health aide) provides ADL's (activities of daily living), Monday through Friday, the Plan of Care Hha orders revealed Hha services 1-2 hr/day, 3-5 days/week x 9 weeks. The agency failed to provide an individualized Plan of Care with patient centered goals. 10. The clinical record of patient #4, SOC 04/05/2021, was reviewed 06/30/2021. Patient diagnoses included: Muscle Weakness, Gastro-esophageal reflux disease without esophagitis, Essential hypertension, Type 2 Diabetes Mellitus, Fibromyalgia, Chronic Obstructive Pulmonary Disease, Rheumatoid Arthritis, Other Idiopathic peripheral autonomic Neuropathy, Urinary Incontinence, Full incontinence of feces, and Shortness of breath. A review of the Home Health Certification/ Recertification Plan of Care dated 06/02/2021 and assessment dated 06/02/2021, revealed there were Pain Goals on the Pain assessment, with patient pain goals 0-4/10., the Plan of Care revealed the patient "Declared no goals". The patient has COPD and HTN and is receiving O2 2L Nasal Cannula Continuous and a CPAP machine, being monitored and supplied by Other K. Patient is taking Metoprolol 25 mg 2 times day for HTN (blood pressure). The Plan of Care failed to evidence diabetic foot care, CPAP settings and physician call parameters with oximeter (oxygen) readings and blood pressure ranges. The agency failed to provide an individualized Plan of Care with patient centered goals. 11. The clinical record of patient #5, SOC 03/08/2006, was reviewed 06/30/2021. Patient diagnoses included: Moderate Intellectual Disabilities, Unsteady Gait, HTN (Hypertension), Anemia, History of Colon Cancer, Hypothyroidism, GERD (Gastro-esophageal reflux disease), Anxiety Disorder, Major Depressive Disorder. A review of the Home Health Certification/ Recertification Plan of Care dated 06/23/2021 and assessment dated 06/23/2021, revealed the patient is taking Furosemide 20 mg 2 x day, Metoprolol Succinate ER 25 mg (blood pressure), and Losartan-hydrochlorothiazide (blood pressure) 100 mg 1 x day for HTN (blood pressure). The Plan of Care failed to evidence physician call parameters ranges for blood pressure and patient centered goals. The Agency failed to provide an individualized Plan of Care with patient centered goals. 12. The clinical record of patient #8, SOC 06/10/2019, was reviewed 06/30/2021. Patient diagnosis included: Chronic Pain, Type 2 DM (Diabetes Mellitus), COPD (Chronic Obstructive Pulmonary Disease), and Muscle Weakness. A review of the Home Health Certification/Recertification Plan of Care dated 05/26/2021 and assessment dated 05/26/2021 revealed diabetic foot exam failed to be completed on assessment. The Plan of Care failed to evidence diabetic foot care. The patient is to perform glucometer readings (blood sugar testing) daily in AM before breakfast, the Plan of Care failed to evidence physician call parameters for glucometer readings. The Agency failed to evidence an individualized plan of care with patient centered goals. 13. The clinical record of patient #12, SOC 07/10/2020, was reviewed 07/06/2021. Patient diagnoses included: Chronic Back Pain, COPD, End Stage Renal Disease, Dysphasia, and DM. A review of the Home Health Certification/Recertification Plan of care dated 05/04/2021 and a recertification comprehensive assessment dated 05/04/2021, revealed patient is receiving midodrine 5 mg 3 times a week before dialysis for hypotension (low blood pressure) and 5 mg 3 times a week during dialysis. The Plan of Care failed to indicate physician call parameter ranges for blood pressure. The assessment revealed patient has Pain goals of "0-3, progress toward pain goal, met, ongoing, monitoring required". The Plan of Care failed to identify pain goals. The assessment revealed family member(s) checks patient's blood sugar weekly. The Plan of Care failed to evidence glucometer readings and physician call parameters. The Agency failed to evidence an individualized plan of care with patient centered goals. 14. The clinical record of patient #13, SOC 03/10/2020, was reviewed 07/06/2021. Patient diagnosis included: CVA (Cardiac Vascular Accident) with Right Side Weakness/Paralysis, Diabetes Mellitus, Depression, and Hypertension. A review of the Home Health Certification/Recertification Plan of Care dated 04/30/2021 and assessment dated 04/30/2021 revealed the patient is to receive Hha services 9-11 hrs per visit, 2-4 days per week. Per record review, Hha services are being provided 4 days a week, 10 - 11 hours each day. Patient is receiving Metoprolol 100 mg 2 times a day and Amlodipine 5 mg 1 time a day for HTN (blood pressure), the Plan of Care failed to identify physician call parameters for blood pressure readings. The Plan of Care failed to identify diabetic foot care. The agency failed to to provide an individualized Plan of Care with patient centered goals. 15. These findings were reviewed with the administrator/clinical manager and alternate administrator/alternate clinical manager on 07/06/21 at 4:45 PM to 4:30 PM in which they had no further information or documentation to provide. 16. During an interview on 07/07/21 at 4:15 PM, when queried about goals being patient specific/ individualized, an example of patient #6's plan of care indicating, "Patient will maintain medication compliance throughout the cert period" and the patient expressing their goals was to ride their stationary bike, the administrator/clinical manager stated, "Absolutely". 410 AC 17-13-1(d)(iii)(xii) Based on observation, record review and interview, the agency failed to ensure the individualized plan of care, failed to ensure the plan of care included nutritional requirements, all accurate medications, treatments, all safety measures, all necessary interventions to address the underlying risk factors and the specific education and training to be provided, measurable outcomes and goals identified by the home health agency and patient, for 11 of 13 active patients. (Patient #2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 13) Findings Include: 1. Review of an undated agency policy titled "Plan of Care-CMS #485 and Physician Orders" Policy #9.9.1 indicated, " ...Procedure ...2. Each patient must receive an individualized written plan of care, including 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 measurable outcomes that Agency anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice ...4. The individualized plan of care must include the following ...The frequency and duration of visits made ...A description of the patient's risk for emergency department visits and hospital readmission, and all necessary interventions to address underlying risk factors ...Patient specific interventions and education, measurable outcomes and goals identified by the Agency and the patient ...14. Recertification requirements include: ...A revised plan of care must reflect current information concerning the patient's updated comprehensive assessment, and contain information the patient's progress toward the measurable goals identified by the Agency and patient in the plan of care ..." 2. During a home visit at patient #2's home on 7/2/21 at 11:15 AM, when Employee I, RN case manager queried about pain the patient stated, "My neck gets really sore. My back pain has improved with meds." Patient #2 then showed soft collar cushion for neck and demonstrated how she moves she lounge in a better positioned back if pain starts. Entity M of patient #2 stated, "Her pain would be a 10 if not for those pain pills." Entity M further indicated patient had chest pain and had to take nitroglycerin twice for chest pain and patient's blood pressure has been high. Patient #2 stated, "The chest pain wasn't like I use to have it and have to take 3 pills before when I had it." When the RN case manager queried about her last bowel movement client stated, "I had one this morning." RN case manager indicated the doctor has recently added prunes to her diet due to constipation. The clinical record of patient #2 was reviewed on 06/30/21 and indicated a start of care date of 09/18/18 and contained an agency document titled "Medication Profile" indicated the following: Hydralazine 50 mg (milligrams)/ tab (tablet) ½ tablet by mouth three times per day. If B/P (blood pressure) is lower than 120/60 in the evening hold that dose, Furosemide 20 mg by mouth daily at noon, HCTZ 25 mg by mouth daily at noon, Isosorbide Mononitrate 90 mg ER 1 tab by mouth daily in the morning, Lisinopril 40 mg by mouth daily at bedtime, Clopidogrel 75 mg; 1 tab by mouth daily, Aspirin 81 mg 1 tab by mouth daily at bedtime, Nitroglycerin 0.4 mg SL (sublingual); 1 tab every 5 minutes as needed for chest pain up to 3 times. If not resolved after 3 tabs notify MD (Medicine Doctor) and call 911, Carvedilol 3.125 mg 1 tab by mouth daily in the morning, Oxycodone-Acetaminophen 5-325 mg; tab by mouth four times daily, Diclofenac Topical 1% gel apply 2 gm (grams) topical four times daily as needed for pain, Gabapentin 100 mg by mouth 1 tab every morning and 2-3 tabs every night, Senna with Docusate 8.5-50 mg 1 tab by mouth daily at bedtime, Sorbitol 70% 10 ml (milliliters) by mouth daily, and Polyethylene Glycol 3350; 17 gm mixed with 8 oz(ounces) of H20 (water) by mouth daily at bedtime as needed for constipation. The daughter is to check B/P. The record contained a plan of care for the recertification period of 05/05/21 to 07/03/21 that indicated diagnoses, Muscle Weakness, Pain disorder with psychological factors, Scoliosis, Arthritis, Idiopathic Progressive Neuropathy, Restless Leg Syndrome, Essential Hypertension, Heart Failure, Hypothyroidism, and Hyperlipidemia with " Orders for Discipline and Treatments(Specify Amount/ Frequency/ Duration): SN 1hr (hour)/visit, 1 day/week x 9 weeks to assess VS (Vital Signs)& all body systems, set up medications and monitor medication compliance every visit ...HHA (Home Health Aide) 3-5hr/visit, 3-5 days/week x 9 weeks to assist with ADLs (Activities of Daily Living) and IADLS (Instrumental Activities of Daily Living) .. .Measurable Goals and Outcomes: The patient's safety will be enhanced throughout the home care service as evidenced by no injury r/t (related to) falls within the cert period of time. The patient's hygiene and personal care needs will be met this cert period with the assistance of the HHA. The patient will maintain medication compliance throughout the cert period ..." The plan of care failed to evidence that the daughter is to check the patient's B/P, call parameters for blood pressure, pulse, and weight gain, education to be provided, CHF interventions, pain interventions, constipation interventions with measurable outcomes and goals. 3. During a home visit with patient #6 on 07/01/21 at 3:00 PM patient stated, "I would like to ride my stationary bike. I also want to get my meds straightened out they keep sending me so much. I also have to cut down on my fruit I gained weight and the doctor said there is a lot of sugar in fruit." Patient #6 indicated she had issues getting her breathing masks for her night time machine. The clinical record of patient #6 was reviewed on 06/30/21 and indicated a start of care date of 09/17/18. The record contained a plan of care for the recertification period of 05/04/21 to 07/02/21 that indicated diagnoses, Cerebral Palsy, Epilepsy, IBS (Irritable Bowel Syndrome), Spastic Bladder, Acid Reflux, Chronic Constipation, Arthritis, and Migraines. This plan of care indicated, " ...Measurable Goals and Outcomes: To remain at current level of independence throughout the cert period...Orders for Discipline and Treatments (Specify Amount/ Frequency/ Duration): SN (Skilled Nurse) 1 hr (hour)/visit, 1 day every other week x 9 weeks to assess vital signs and all body systems and prefill med planner and assess medication compliance every visit ..." The plan of care failed to evidence interventions and goals for constipation, interventions and goals for IBS, interventions and goals for pain, individualized patient centered goals, failed to address CPAP (Continuous Positive Airway Pressure), a breathing machine used for individuals who stop breathing at night, settings and call parameters for oxygen saturations, the measurement of oxygen. 4. During a home visit on 07/02/21 at 3:30 PM observed poster signs on patient's living room wall that gave patient #7 steps to take when upset, when hears voices, and to wear gloves to protect hands form injury. Employee D, RN (Registered Nurse) case manager was not observed asking any questions regarding psychosocial or depression. When queried by the RN case manager regarding falls patient indicated that patient #7 had fallen in the bathroom slipped on water and showed the RN the bruising on left leg. Patient #7 stated to surveyor, " When am I going to get my showers and aide again haven't had one since last month?" The RN case manager stated, "We are working on it." The clinical record of patient #7 was reviewed on 07/30/21 and indicated a start of care date of 05/13/20. The record contained a plan of care for the recertification period of 05/08/21 to 07/06/21 that indicated diagnoses, Chronic Pain, Bipolar/ Schizophrenia, Hypothyroidism, GERD (Gastric Esophageal Reflux Disease), History of Seizures, MDD (Major Depressive Disorder), Generalized Weakness, Arthritis, and Depression with " ... Orders for Discipline and Treatments (specify Amount/ Frequency/ Duration): SN 1 hr/visit, 1 d (day)/week x 9 weeks to assess VS & all body systems, set up medications and monitor medication compliance every visit ...Measurable Goals and Outcomes: ... Client will remain compliant with medication regimen for this cert period ...Patient/ Representative Measurable Goals and Outcomes: None at this time." The plan of care failed to evidence individualized patient care needs. The plan of care failed to address interventions for depression and Bipolar/ Schizophrenia, pain interventions and goals, constipation interventions and goals, and patient centered goals. 5. The clinical record of patient #9 was reviewed on 07/06/21 and indicated a start of care date of 08/30/17. The record contained a plan of care for the recertification period of 03/15/21 to 05/13/21 that indicated diagnoses, Cognitive Impairment, Autistic disorder, Seizure disorder, and GERD. " ...Orders for Discipline and Treatments (specify Amount/ Frequency/ Duration): HHA 1-3 h/d, 3-5 days/week x 9 weeks to assist with ADL's and IADL's ...Measurable Goals and Outcomes: ... Patient/ Representative Measurable Goals and Outcomes: Caregiver declines to set a goal at this time." The plan of care failed to evidence patient centered goals. During a phone interview with patient #9's caregiver Entity N on 07/06/21 at 1:45 PM when queried about queried about complaint regarding staffing stated, "I am a Theology teacher. We have a prior authorization for 5 days a week 2 hours in the AM and 3 hours in the afternoon so I can teach my classes Monday thru Friday. I do not have consistent staff. They even have pulled my aide to send to another patient. They have terrible communication. The scheduler one time she isn't there anymore told my Entity O when she called to say they could not staff that day that he better go to plan B. Entity O had to go to work and could not stay and watch patient #9. I have told them consistently to let me know on my phone if there is a staffing issue do not call my home phone. Patient #9 need 24 hour supervision you cannot take your eyes off him. I had to have my Entity P sit in the garage with him one time and it was cold out because they could not staff. They know my work hours patient #9 needs consistency due to his behaviors. The prior authorization is for the hours I work." 6. The clinical record of patient #10 was reviewed on 07/07/21 and indicated a start of care date of 02/05/21. The record contained a plan of care for the recertification period of 04/06/21 to 06/21/21 that indicated diagnoses, Altered mental status unspecified, Autistic disorder, Seizure disorder, and Acne. Review of a plan of care for the recertification period of 04/06/21 to 06/04/21 indicated " ...Orders for Discipline and Treatments (specify Amount/ Frequency/Duration): HHA 1-2 hour/visit, 5-7 days/week x 9 weeks to assist with ADL's and IADL's. HHA to apply bilateral AFO's (Ankle foot orthosis) every visit ... Measurable Goals and Outcomes: Patient's ADL's and IADL's will be met this cert period with the assistance of the home health aide. The patient's safety will be enhanced throughout the home care service as evidenced by no injury r/t falls this cert period of time. The patient will remain free of injury r/t seizures this cert period ...Patient/ Representative Measurable Goals and Outcomes: CG (Caregiver) doesn't wish to set pt (patient) specific goal ..." The plan of care failed to evidence individualized patient care needs in regards to prevention of skin impairments related to AFO with measurable goals and patient centered goals. 7. The clinical record of patient #11 was reviewed on 07/07/21 and indicated a start of care date of 10/07/15. The record contained a plan of care for the recertification period of 05/10/21 to 07/08/21 that indicated diagnoses, Generalized Weakness, CHF, TIA, Chronic Pain, Constipation, Cardiac Dysrhythmia, Pacemaker, GERD, and Overactive Bladder. Review of a plan of care for the recertification period of 05/10/21 to 07/08/21 indicated " ...Orders for Discipline and Treatments (specify Amount/ Frequency/ Duration): HHA 2-4 hrs/visit, 1-2vs (visits)/day, 5-7 days/week x 9 weeks to assist with ADL's and IADL's. HHA ... Measurable Goals and Outcomes: Patient's ADL's and IADL's will be met this cert period with the assistance of the home health aide. The patient's safety will be enhanced throughout the home care service as evidenced by no injury r/t falls within cert period ..." The plan of care failed to include interventions for the home health aide to weigh patient and report weight gains 2 plus a day to the case manager. The plan of care failed to include interventions for the home health aide to monitor the patient's bowel movements and report to the case manager if the patient does not have a bowel movement in 72 hours. The plan of care failed to include interventions for the home health aide to report increased pain to case manager and give a pain scale of reporting. The plan of care failed to have goals for the patient's pain, constipation, and heart failure. 8. During an interview on 07/07/21 at 4:15 PM, when queried about goals being patient specific/ individualized, an example of patient #6's plan of care indicating, "Patient will maintain medication compliance throughout the cert period" and the patient expressing their goals was to ride their stationary bike, the administrator/clinical manager stated, "Absolutely".

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 observations, record review, and interview the agency failed to use standard precautions to prevent the transmission of infections and communicable diseases for 3 of 7 home visits conducted. (Patients #1, #3, and #5) Findings include: 1. Review of an agency policy titled, V. Infection Prevention and Control (IC), revealed "5.2.1 POLICY The Agency has developed, and implemented infection control practices that conform to OSHA regulations, CDC guidelines, state and local regulations and currently accepted standards of practice...5.6.1 Blood and body fluid precautions will be followed for all patients...5.7.1 Hand hygiene will be done by all employees and Home Care Infection Control Guidelines for COVID-19". 2. During a home visit observation on 06/30/2021 at 8:45 AM at Patient's #1 home, with Employee D RN (registered nurse), and Employee M Hha (home health aide), Employee M was observed applying gloves, without any hand hygiene, began assisting patient #1 with undressing, ambulation into bathroom, showering, drying off, assisting to bedroom, assisting with dressing, all while using the same pair of gloves. After the patient was fully dressed, with same gloves, Employee M handed the alarm and necklace for patient to put on. Employee M was observed placing their personal bag on the chair without the use of a barrier. During an interview on 06/30/2021 at 11 am, Employee D was queried about the home visit, in which Employee D admitted the aide did not use hand hygiene properly. 3. During a home visit observation on 07/02/2021 at 06:55 AM at Patient's #3 home with Employee K Hha ( home health aide). Employee K answered the door without wearing a mask. Employee K stated patient #3 was not awake. Employee K went into the bedroom, with no mask, woke patient #3 up and assisted patient #3 to bathroom. Employee K had not used hand hygiene, no gloves, and no mask. Employee K brushed Patient #3 hair and assisted the patient to the kitchen. Employee K, not wearing mask or gloves, and had not performed hand hygiene, fixed patient a drink to take medications, put drink on table, went to medication box, emptied medications onto their non-gloved hand and without use of hand hygiene, put pills into cup for patient. Employee K then started washing dishes, no hand hygiene performed and gloves not applied. 4. During a home visit observation on 07/02/2021 at 09:45 AM at Patient's #5, Employee F RN (registered nurse) was observed performing hand hygiene at the sink, placed a paper towel barrier on patient #5's bed, and put clip board and notebook/IPad directly on patient's bed without barrier. 410 IAC 17-12-1 (m)