Every finding on record at Senior Support Services Inc

This visit was for a Federal Recertification and State Re-licensure survey of a Provider. Survey Dates: July 20, 21, 25, 26, and 27, 2022 Census: 35 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. During this Federal Recertification Survey, New Horizons Home Healthcare was found to be out of compliance with Conditions of Participation 42 CFR 484. 60 Care planning, coordination, and quality of care; 484. 65 Quality assessment/performance improvement; and 484.80: Home Health Aide Services. Based on the Condition-level deficiencies during the July 27, 2022, survey, your HHA was subject to a partial or extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on July 21, 2022. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating or being the site of a home health aide training, skills competency, and / or competency evaluation program for a period of two years beginning July 27, 2022, and continuing through July 26, 2024.

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 record review and interview, the agency failed to ensure it provided all patients with the correct name, address, and telephone number of the QIO (Quality Improvement Organization that manages all beneficiary complaints and quality of care reviews) for 1 of 1 agency. Findings include: Review of an undated agency document titled “Patients’ Rights & Responsibilities” indicated “… the client has the right to be advised of federally funded & state funded entities that serve the area where the client resides … Quality Improvement Organization ….” The document failed to evidence the correct QIO name and contact information. During an interview on 07/20/2022 at 3:50PM, when asked what QIO the agency works with, the administrator indicated that information is just for Medicare agencies. The administrator could not evidence documents that the information was provided.

HHA can no longer meet the patient's needs CFR(s): 484.50(d)(1) The transfer or discharge is necessary for the patient's welfare because the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the HHA can no longer meet the patient's needs, based on the patient's acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA's capabilities; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure discharged patients were informed when the agency could no longer meet their needs and failed to ensure all discharged patients were assisted with identifying entities in their geographic area who could meet their needs for 2 of 2 discharged clinical records reviewed (Patients #1 and 5). Findings include: 1. Review of an undated agency policy C-500, copyright Briggs Corporation, Home Care Operational Guidelines, titled “Client Discharge Process” indicated “… client’s need for continuing care to meet physical … needs are identified and clients are told in a timely manner of the need to plan for discharge or transfer to another … organization … clients are informed of the reason for discharge and anticipated needs for services after discharge … a discharge plan shall be developed that is documented in writing and includes all written/verbal instructions regarding the client’s ongoing care needs and available resources provided to the client and family … if there are unmet needs and the agency is no longer able to meet those needs, documentation will demonstrate that appropriate notice was given (verbal and written) ….” Review of an addendum to policy C-500, titled “Client Discharge Process” dated 01/25/2017 indicated “the patient and the patients legal representative must being {sic} notified 15 days before services are stopped ...." 2. Review of an undated agency policy C-360, copyright Briggs Corporation, Home Care Operational Guidelines, titled “Coordination of Client Services” indicated “… when clients have needs that require on-going services or cannot be met by the agency, a discharge care conference shall be conducted … the conference will … develop a discharge plan … the discharge plan shall include written/verbal instruction regarding ongoing care needs and information about resources available ….” 3. Review of an undated agency document titled “Patients’ Rights & Responsibilities” indicated “… the agency may only transfer or discharge the client from the agency if … the transfer or discharge is necessary for the client’s welfare because the agency and the physician who is responsible for the home health plan of care agree that the agency can no longer meet the client’s needs, based on the client's acuity … the agency must arrange a safe, prompt, and appropriate transfer to other care entities when the needs of the patient exceed the agency’s capabilities ….” 4. Record review for Patient #1, start of care 01/25/2018 and discharge date 03/11/2022, contained a plan of care for certification period 03/05/2022-05/03/2022 with primary diagnosis of quadriplegia (paralysis of all 4 limbs) that indicated “… HHA (home health aide) 4-6 hours/day, 1-2 visits/day, 5-7 days/wk (week) ….” A. Review of an agency document titled “Recertification, Comprehensive Assessment” signed and dated by assistant director of nursing on 03/03/2022, indicated “… discharge plans … no anticipated d/c (discharge) ….” B. Review of an agency document titled “Case Conference” dated 03/09/2022 and signed by director of nursing, assistant director of nursing, and scheduler, indicated “… patient and family member were notified that staff member that routinely provides care will be unavailable due to an emergency. We are attempting to locate additional staff ….” C. Review of an agency document titled “Physician’s Orders” dated 03/11/2022 and signed by assistant director of nursing, indicated “… D/C form home health service per request ….” D. Review of an agency document titled “Discharge Summary” dated 03/11/2022 and signed by the assistant director of nursing, indicated “… pt. (patient) will be receiving services with other agency starting 3/11/22 … last home visit date 03/10/2022 … indicate reason and date … discharge date: 03/11/2022 … per pt request … written instructions given to patient/caregiver (no response selected) … verbal instructions given to patient/family member with v/u (verbal understanding) …. “ 5. Review of a document titled “Complaint Form” dated 03/11/2022 and received by director of nursing indicated “… description of the complaint … on 03/09/2022 patient and family member were notified that staff member that routinely provides care will be unavailable due to an emergency, we are attempting to locate additional staff. Offered to assist with finding another agency to provide services, family member declined assistance … resolution of the complaint … on 03/11/2022 patient notified agency will be receiving services from another agency and requested discharge … was the person making the complaint satisfied with the resolution … yes ….” 6. During a phone interview with Patient #1 on 07/20/2022 at 2:15PM, Patient #1 relayed they did not request the discharge and did not go willingly, that the agency told him / her they had to be discharged due to staffing. When asked, Patient #3 relayed the agency did not assist them to find another home health service, and indicated “… Other A helped me. I paid out of pocket until last week when I got a different service that is covered by my insurance ….” 7. During an interview on 07/20/2022 at 3:50PM, when asked for evidence of agency communication with patient regarding the discharge and the discharge notice provided to patient, the assistant director of nursing indicated the agency used a 30-day notice form and relayed had a conversation with patient’s family member regarding other area agencies. The clinical record failed to evidence documentation of communication with patient regarding their discharge, assistance to find other provider of care, and failed to evidence a discharge notice form. 8. During a phone interview on 07/21/2022 at 3:10PM, when asked about the discharge for Patient #1, Other A indicated had spoken with Patient who relayed that the home health aide who provided services was off of work due to surgery and Patient #1 understood the home health aide would return to work and provide some hours to Patient but couldn’t work all of them, so the agency told Patient #1 their services would be discontinued. 9. Record review for Patient #5, start of care 01/26/2018 and discharge 02/09/2022, contained a plan of care for certification period 01/04/2022-03/04/2022 with primary diagnosis of chronic pain that indicated “… HHA (home health aide) 2-4 hours/day, 1-2 visits/day, 5-7 days/wk (week) ….” A. Review of unsigned agency documents titled “Missed Visits”, for dates 01/28/2022, 01/29/2022, 01/30/2022, 01/31/2022, 02/01/2022, 2/02/2022, 02/03/2022, 02/04/2022, 02/05/2022, 02/06/2022, 02/07/2022, 02/08/2022 and 02/09/2022, with fax confirmation date of 03/07/2022, indicated “… this is to notify that based on your order visit frequency; a home visit … was not made … for the following reason … aide (HHA) … no staff ….” B. Review of an agency document titled “Case Conference” dated 01/26/2022 and signed by director of nursing and assistant director of nursing, indicated “… discussed staffing and notified patient of discharge date effective 02/09/2022 due to staff availability … offered to locate another agency to provide services … patient declined ….” C. Review of an agency document titled “Discharge Summary” dated 02/09/2022 and signed by the assistant director of nursing, indicated “… pt given 14 day notice of discharge 01/26/2022 … staff unable to cont (continue) to provide care … no other staff available … D/C on 02/09/2022 … last home visit date 01/27/2022 … condition at discharge … refused d/c visit … discharge planning … DC’d (discharged) … written instructions given to patient/caregiver (yes or no not selected) … verbal …. “ D. Review of an untitled document, dated 01/26/2022 and signed by director of nursing and assistant director of nursing, indicated “… this is to inform you that … is giving you a 15 day notice of discharge … services will end on 02/09/2022 … patient signature … sent to patient ….” 10. During a phone interview with Patient #5 on 07/25/2022 at 12:00PM, when asked if the agency offered to arrange home health services with another agency, Patient #5 indicated no, that he/she contacted Other B and was provided with a list of home health agencies and it took several weeks to find a home health agency that accepted their insurance. Patient #5 indicated they did not receive documentation by mail or in hand regarding a notice of discharge; Patient relayed they received a phone call from the scheduler that they were being discharged. 11. During a phone interview with Other C on 07/25/2022 at 1:49PM, when asked for the reason of resignation from the agency, Other C indicated when Patient #5 left the agency there were no hours of work available. Other C relayed they resigned on 03/10/2022. 12. During an interview on 07/25/2022 at 2:45PM, the director of nursing indicated the agency should mail discharge notices by certified mail, but this does not always happen. No further information was provided by the agency by survey exit. 13. During an interview on 07/26/2022 at 3:00PM, when asked for documentation of aide care services were provided to Patient #5 from 01/28/2022 through 02/09/2022, and discharged on 02/09/2022, the director of nursing indicated the patient’s home health aide resigned and the agency did not have any staff available to provide aide services in the area in which Patient #5 resided. No further information was provided by the agency by survey exit.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to evidence the Plan of Care included all durable medical equipment (See G574); failed to ensure all patient care orders, including verbal orders, were incorporated into the plan of care (See G576); failed to ensure the physician orders for home health aide visits were carried out (See G578); failed to ensure all services were provided as ordered by a physician (See G580); and failed to ensure all patients were provided with the name and contact information of the home health agency clinical manager (director of nursing) (See G622). The cumulative effect of these systemic problems resulted in the home health agency’s inability to ensure the provision of quality health care for the Conditions of Participation 42 CFR 484.60 Care planning, coordination, and quality of care.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to include in the Plan of Care (POC) all durable medical equipment (DME) for 2 of 5 active patient records reviewed (Patient #4 and 6). Findings include: 1. An undated agency policy copyright Briggs Corporation, Home Care Operational Guidelines, C-580 titled “Plan of Care,” indicated but was not limited to "…The Plan of Care shall be completed in full to include…medical supplies and equipment required….” 2. The clinical record of Patient #4 was reviewed on 07/20/2022-07/21/2022 and indicated a start of care date of 08/09/2021. Skilled Nurse visit notes dated 07/14/2022 and 07/15/2022 indicated “walker” in the musculoskeletal section of the assessment. A home visit was conducted on 07/21/2022 starting at 10:03AM. During the visit, Patient #4 was observed using a rollator walker. The clinical record failed to evidence the rollator walker was included in the DME portion of the POC nor in any physician orders prior to the home visit on 07/21/2022. 3. The clinical record of Patient #6 was reviewed on 07/25/2022 and indicated a start of care date of 06/10/2022. A comprehensive assessment (CA) dated 06/10/2022 indicated “bipap” in the cardiopulmonary section of the assessment. The clinical record failed to evidence the bipap machine was included in the DME portion of the POC. 4. During an interview on 07/21/2022 beginning at 3:23PM, Administrative Staff (AS) #1 confirmed the Plan of Care should include all DME/supplies required by the patient. 410 IAC 17-13-1(a)(1)(D)(ii)

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patient care orders, including verbal orders, were incorporated into the plan of care for 1 of 5 active clinical records reviewed (Patient #7). Findings include: 1. Review of an undated agency policy C-580, copyright Briggs Corporation, Home Care Operational Guidelines titled “Plan of Care” indicated “… verbal/telephone orders shall be obtained from the client’s physician for changes in the Plan of Care ….” 2. Clinical record for Patient # 7, with start of care 5/01/2019 , included the document titled “Home Health Certification and Plan of Care” for certification period 6/14/2022 to 8/12/2022, that failed to evidence the signed interim physician orders received, dated 5/13/22 and 6/02/22, were incorporated into the current plan of care. The record evidenced document titled “Physician’s Orders,” signed and dated 4/21/2022 by the assistant director of nursing, signed and dated 05/13/2022 by physician indicated “… change to Ticagrelor (medication used to prevent a life-threatening heart attack or stroke, or death in people who have had a heart attack) 20mg PO (by mouth) daily ….” Review of an agency document titled “Physician’s Orders” signed and dated 05/12/2022 by assistant director of nursing, signed and dated 06/02/2022 by physician indicated “… Sucralfate (medication used to treat and prevent ulcers) 500mg/5ml take 10ml PO 4 times daily … take on empty stomach 1 hour before meals … Fish Oil (supplement used to lower blood pressure and decrease cholesterol) 1400mg 1 tab (tablet) PO daily ….” Review of an agency document titled “Physician’s Orders” signed and dated 05/19/2022 by assistant director of nursing, signed and dated 06/02/2022 by physician indicated “… Magnesium (supplement used to improve blood pressure) 400mg 1 tab PO at HS (bedtime) ….” During an interview on 07/26/2022 at 3:00PM, when asked why medications ordered on 04/12/2022, 05/12/2022 and 05/19/2022 were not included in the plan of care with certification period beginning 06/14/2022, the director of nursing and assistant director of nursing indicated they would need to look at chart. No further documentation was received from the provider by survey exit, 7/27/22.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physician orders for home health aide visits were carried out for 1 of 3 patients receiving home health aide only services (#5). Findings include: Review of an undated agency policy C-580, copyright Briggs Corporation, Home Care Operational Guidelines titled “Plan of Care” indicated “…. Professional staff (registered nurse) shall promptly alert the physician to any changes that suggest a need to alter the Plan of Care ….” Record review for Patient #5, start of care 01/26/2018 and discharge 02/09/2022, contained a plan of care for certification period 01/04/2022 – 03/04/2022 that indicated “… HHA: 2-4 hours/day, 1-2 visits/day, 5-7 days/wk (week) ….” Review of unsigned agency documents titled “Missed Visits”, for dates 01/28/2022, 01/29/2022, 01/30/2022, 01/31/2022, 02/01/2022, 2/02/2022, 02/03/2022, 02/04/2022, 02/05/2022, 02/06/2022, 02/07/2022, 02/08/2022 and 02/09/2022, with fax confirmation date of 03/07/2022, indicated “… this is to notify that based on your order visit frequency; a home visit … was not made … for the following reason … aide (HHA) … no staff ….” The plan of care failed to evidence the registered nurse requested a change in the HHA visit frequency order from the physician. During an interview on 07/26/2022 at 3:00PM, when asked why a patient did not receive HHA services from 01/28/2022 – 02/09/2022, and then was discharged on 02/09/2022, the director of nursing indicated the HHA assigned, lived in the area in which the patient resided, resigned and the agency did not have any other HHA available to cover this patient’s visits. No further documentation was received from the provider by survey exit.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all services provided were ordered by a physician for 1 of 4 active patients with skilled nurse services (Patient #3). Findings include: 1. Review of an undated agency policy D-125, copyright Briggs Corporation, titled “Clinical Competency Checklist – Registered Nurse”, indicated “… delivers services according to the Plan of Care ….” 2. Review of an undated agency policy C-580, copyright Briggs Corporation, Home Care Operational Guidelines titled “Plan of Care” indicated “… the plan of care shall be completed in full to include … treatments, and procedures ….” 3. Record review for Patient #3, start of care 11/21/2019, contained a plan of care for certification period 07/08/2022-09/05/2022 that indicated “… patient rcvd (received) NO (nursing order) for Zpak (Zithromax is an antibiotic used to treat bacterial infections) on 06/14/2022 for URI (upper respiratory infection). Patient tested negative this date. Patient was retested on 06/16/2022 and positive ….” The plan of care failed to evidence physician orders for the skilled nurse to perform the Covid test of patient. A. Review of an agency document titled “Skilled Nurse Visit Note”, dated 06/14/2022, indicated “… dry cough … nasal discharge … awaiting f/u (follow-up) order ….” B. Review of an agency document titled “Physician’s Orders”, dated 06/14/2022, indicated “… covid test negative … start Zithromax … x (times) 4 days URI ….” C. Review of an agency document titled “Skilled Nurse Visit Note”, dated 06/16/2022, indicated “… tested positive for Covid … cough/sore throat … continue on Z-Pak ….” D. Review of an agency document titled “Physician’s Orders,” dated 06/16/2022, indicated “… tested positive for Covid ….” E. Review of an agency document titled “Case Conference”, dated 07/07/2022, indicated “… recent changes in condition … tested negative on 06/14/2022 … Zpak 06/14/2022 … dx (diagnosis) of Covid … positive on 06/16/2022 ….” 4. During a phone interview with patient’s family member on 07/21/2022 at 2:15PM, the family member indicated Patient called them after each nurse visit and told family member they were tested twice for COVID by the nursing staff. 5. During an interview on 07/21/2022 at 3:23PM, when asked who can perform a Covid test on a patient, the administrator indicated a skilled nurse can perform the test when a physician order is received.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure all patients were provided with the name and contact information of the home health agency clinical manager (director of nursing) for 2 of 2 records reviewed for patients who had home visit observations and had a patient handbook that could be located in their home (Patient #2 and 3), with the potential to affect all 38 patients of the agency. Findings include: Review of an undated agency document titled “Patient Information Handbook” indicated “… problem solving procedure … if you have a complaint or concern you can reach us at … and ask for the Director of Nursing ….” This patient information handbook which is left in the patient home at time of admission failed to evidence the name and contact information of the agency’s clinical manager. During a home visit with Patient #2 on 07/21/2022 at 12:00PM, review of the Patient Information Handbook failed to provide the name and contact information of the clinical manager. Asked patient if knew the name and contact information of agency clinical manager. Patient indicated did not know. During a home visit with Patient #3 on 07/21/2022 at 1:00PM, review of the Patient Information Handbook failed to provide the name and contact information of the clinical manager. During an interview on 07/25/2022 at 2:45PM, when asked what information is provided to patients regarding the contact information for agency employees, the assistant director of nursing indicated they receive information about the scheduler, director of nursing and assistant director of nursing. When asked where the name and contact information of clinical manager for patients is located, the director of nursing indicated will need to look. On 07/26/2022 at 9:00AM, the director of nursing provided a copy of page 6 from the Patient Information Handbook which provided the phone number of agency and the title, Director of Nursing. During a home visit with Patient #4 on 07/21/2022 at 10:03AM, review of the Patient Information Handbook failed to provide the name and contact information of the clinical manager.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the QAPI (quality assessment and performance improvement) program included the measurement and analysis of each indicator (agency areas identified and in need of improvement) (See G642); failed to ensure their QAPI plan included areas of high-risk, high volume and problem-prone, and the actions implemented were measured to ensure improvement was sustained (See G656); failed to ensure performance improvement projects were conducted that reflected the scope and complexity of the agency services and operations and failed to ensure documentation of performance improvement projects included the reasons for conducting the project and the measurable progress of the projects (See G658); and failed to ensure the agency maintained an ongoing QAPI program (See G660). The cumulative effect of this systemic problem resulted in the agency being out of compliance with the Condition of Participation 484.65 Quality assessment/performance improvement. 410 IAC 17-12-2(a)

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the QAPI (quality assessment and performance improvement) program included the measurement and analysis of each indicator (agency areas identified as needing improvement) for 1 of 1 agency. Findings include: Review of an undated agency policy B-260, copyright Briggs Corporation, Home Care Operational Policies titled “Performance Improvement” indicated “… agency shall establish a performance improvement plan to continuously measure, assess, and improve the performance of clinical and other processes ….” On 07/26/2022, the agency provided a QAPI binder that contained employee in-service logs, infection control policies, and quality improvement (QI) meeting minutes, dated 04/29/2022. The indicator listed in the QI meeting minutes included monthly infection rates for 01/2022 – 06/2022. The QAPI failed to evidence the measurement and analysis of the infection control indicator. During an interview on 07/26/2022 at 3:00PM, the assistant director of nursing [ADON] relayed that the agency's QAPI measurements included review of infection control to prevent spread and reoccurrence of infections, for patients and employees. The ADON relayed the area was selected for improvement of patient care . When asked what measures the agency put into place, the ADON indicated the agency documents all antibiotics prescribed to the Patient, all patients with Covid, and employee education. During an interview on 07/26/2022 at 3:00PM, when asked what the outcome of the measures were put in place, the ADON was unable to provide documentation and relayed the measures helped with the infection control of patients.

Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure their QAPI (quality improvement and performance improvement) plan included areas of high-risk, high volume and problem-prone, and the actions implemented were measured to ensure improvement was sustained for 1 of 1 agency. Findings include: Review of an undated agency policy B-260, copyright Briggs Corporation, Home Care Operational Policies titled “Performance Improvement” indicated “… agency shall establish a performance improvement plan to continuously measure, assess, and improve the performance of clinical and other processes … data will be systematically collected to measure process and outcome … data will be assessed to … evaluate whether outcomes were achieved ….” On 07/26/2022, the agency provided a QAPI binder with quality improvement (QI) meeting minutes, dated 04/29/2022, topic listed in QI meeting minutes included monthly infection rates for 01/2022 – 06/2022. The QI meeting minutes and QAPI binder failed to evidence the measurement of implemented actions and failed to evidence the outcome of the implemented actions for infection rates. During an interview on 7/26/2022 at 3:00PM, when asked for documentary evidence of the outcome of the measures put into place, the assistant director of nursing was unable to provide documentation and relayed the measures helped with the infection control of patients. 410 IAC 17-12-2(a)

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure performance improvement projects were conducted that reflected the scope and complexity of the agency services and operations and failed to ensure documentation of performance improvement projects included the reasons for conducting the project and the measurable progress of the projects for 1 of 1 agency. Findings include: Review of an undated agency policy B-260, copyright Briggs Corporation, Home Care Operational Policies titled “Performance Improvement” indicated “… agency shall establish a performance improvement plan to continuously measure, assess, and improve the performance of clinical and other processes … identify deviations from agency and professional standards and pursue improvement opportunities by assessment, planning and evaluation … data will be assessed to … evaluate whether outcomes were achieved … the plan will target the performance of existing processes and outcomes ….” On 07/26/2022, the agency provided a QAPI binder with quality improvement (QI) meeting minutes dated 04/29/2022. Topic listed in QI meeting minutes included monthly infection rates for 01/2022 – 06/2022. The QI meeting minutes and QAPI binder failed to evidence performance improvement projects reflected the scope and complexity of the agency services and operations and failed to evidence documentation of the performance improvement projects that included the reasons for conducting and the measurable progress of the projects. During an interview on 07/26/2022 at 12:45PM, when asked what performance improvement projects the agency is working on, the director of nursing indicated agency is working on infection control with tracking of patients on antibiotics, patient infections and patients with Covid. During an interview on 07/26/2022 at 3:00PM, when asked what the outcome of the measures put into place were, the assistant director of nursing was unable to provide documentation.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record review and interview, the Governing Body failed to ensure the agency maintained an ongoing quality improvement program (QAPI) for 1 of 1 agency. Findings include: Review of an undated agency policy B-100, copyright Briggs Corporation, Home Care Operational Guidelines titled “Governing Body” indicated “… the governing body shall assume … responsibility for the operation of Agency … purpose … to ensure clients (patients) are provided with appropriate, quality services ….” The policy failed to evidence the governing body’s role with QAPI. Review of an undated agency policy B-260, copyright Briggs Corporation, Home Care Operational Policies titled “Performance Improvement” indicated “… agency shall establish a performance improvement plan to continuously measure, assess, and improve the performance of clinical and other processes ….” The agency failed to provide any other QAPI policies. On 07/26/2022, the agency provided a QAPI binder that contained employee in-service logs, infection control policies, and quality improvement (QI) meeting minutes dated 04/29/2022. Topic listed in QI meeting minutes included monthly infection rates for 01/2022 – 06/2022. The QA meeting minutes failed to evidence governing body discussion included infection control measures put into place and the outcome of those measures. During an interview on 07/26/2022 at 12:45PM, the director of nursing indicated the agency's performance improvement projects was working on infection control and they tracked patients on antibiotics, patient infections, and patients with Covid.

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, policy review, and interview the home health agency failed to follow accepted standards of practice and their own policies to prevent the transmission of infections and communicable diseases for 1 of 3 skilled nurse visits observed (Patient #4). Findings include: 1. Review of an undated agency policy C-160, copyright Briggs Corporation, Home Care Operational Guidelines titled “Position: Licensed Practical/Vocational Nurse” indicated but was not limited to “…essential functions/areas of accountability…demonstrates knowledge of safety/infection control practices...” 2. A home visit observation was conducted on 07/21/2022 starting at 10:03AM with Patient #4 (start of care 08/09/2021) and Licensed Practical Nurse (LPN) #2. During the visit, the LPN used disinfectant wipes on equipment that had been used on the patient and then immediately placed the items into the nursing bag. The disinfectant wipes packaging indicated a recommended dry time of 4 minutes. 3. During an interview on 7/21/22 beginning at 3:23PM, Administrative Staff (AS) #1 confirmed staff should allow items to dry per manufacturer’s recommendations, after wiping, and before returning items to the bag. 410 IAC 17-12-1(m)

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 ensure their COVID-19 vaccine policy evidenced contingency plans for employees who were not fully vaccinated for COVID-19 for 1 of 1 agency. Findings include: Review of undated and untitled policy 403-A, provided by the administrator on 07/21/2022 contained the name of a different agency within the policy. The policy indicated “… precautions taken for unvaccinated COVID-19 employees … disposable mask to be worn by all employees when in … patient’s home ….” Review of an agency policy dated 11/05/2021 and titled “Mandatory Covid-19 Vaccine Policy and Procedure” indicated “… reasonable accommodations for exempt staff … staff members should wear proper face coverings and other protective equipment to help reduce the spread of Covid-19 ….” The agency policy failed to evidence contingency plans for employees who were not fully vaccinated for Covid-19. During an interview on 07/20/2022 at 3:50PM, when asked what mitigating measures the unvaccinated employees follow, the administrator indicated unvaccinated employees wear masks, check their temperatures, and get tested if symptomatic. During an interview on 07/21/2022 at 3:10PM, when asked what the practice regarding employees wearing masks in the home of patients, the assistant director of nursing indicated all employees in the patient homes wear masks and the unvaccinated employees wear N95 (respiratory protective mask designed to achieve a close facial fit and efficient filtration of airborne particles) masks.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure an accurate assessment was completed in 1 of 5 active clinical records reviewed (Patient #4). Findings include: 1. Review of an undated agency policy C-145 titled “Home Health Aide Care Plan” indicated “…a thorough, well-organized, comprehensive and accurate assessment …will be completed for all clients…." 2. Review of an undated agency policy C-680, copyright Briggs Corporation, Homecare Operational Guidelines, titled “Clinical Documentation” indicated “…purpose… to ensure there is an accurate record of the services provided…” 3. Review of an undated agency document C-210, copyright Briggs Corporation, titled “Position: Registered Nurse” indicated “… consistently demonstrates competency with… assessment skills as applied to the client…” 4. Clinical record review was completed on 07/25/22 for Patient #4, start of care 08/09/2022, for certification period 06/05/2022-08/3/2022. Review of skilled nurse (SN) visit notes dated 06/08, 06/16, 06/20, 06/27, 06/30, 07/01, 07/05, 07/07, 07/08, 07/12, and 07/13/2022 indicated “… assessment and observation signs and symptoms… cardiovascular: WNL (within normal limits)… edema (puffiness caused by excess fluid trapped in the body’s tissues) …RLE (right lower extremity)… LLE (left lower extremity)…respiratory: WNL… orthopnea (discomfort when breathing while lying flat)… digestive: WNL… bowel incontinence (loss of control over bowel movements)… genitourinary: WNL… bladder incontinence (loss of bladder control)… “ Review of SN visit notes dated 06/09, 06/14, and 06/22/2022 indicated “… assessment and observation signs and symptoms… cardiovascular: WNL… edema… RLE… LLE…” Review of SN visit notes dated 06/10, 06/17, and 07/11/2022 indicated “… assessment and observation signs and symptoms… cardiovascular: WNL (within normal limits)… edema (puffiness caused by excess fluid trapped in the body’s tissues) …RLE (right lower extremity)… LLE (left lower extremity)… respiratory: WNL… orthopnea… ” Review of SN visit notes dated 06/15 and 06/21/2022 indicated “… assessment and observation signs and symptoms… cardiovascular: WNL (within normal limits)… edema (puffiness caused by excess fluid trapped in the body’s tissues) …RLE (right lower extremity)… LLE (left lower extremity)… respiratory: WNL… orthopnea… genitourinary: WNL… bladder incontinence….” Review of SN visit notes dated 06/23, 06/28, 06/29, 07/04, and 07/06/2022 indicated “… assessment and observation signs and symptoms… cardiovascular: WNL… edema …RLE … LLE … digestive: WNL… bowel incontinence… genitourinary: WNL… bladder incontinence ….” Review of a SN visit note dated 06/24/2022 indicated “… assessment and observation signs and symptoms… cardiovascular: WNL… edema …RLE … LLE… genitourinary: WNL… bladder incontinence …” Review of SN visit notes dated 07/14 and 07/15/2022 indicated “… musculoskeletal: WNL… walker…” 5. During an interview on 07/21/2022 beginning at 3:23PM, AS #3 indicated “WNL” was marked for a patient if it was within that patient’s normal limits and indicated that this was a consistent practice within the agency. During the interview, AS #1, 2, and 3 were not aware why the clinician documented "WNL” on visit notes when problems for the system were documented.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the skilled nurse failed to ensure services were provided as ordered on the plan of care for 1 of 4 patients receiving skilled nursing services (Patient #7). Findings include: Review of an undated agency policy C-210, copyright Briggs Corporation, title “Position: Registered Nurse” indicated “… follows an individualized plan of care … provides skilled interventions ….” Record review for Patient #7, start of care 05/01/2019, contained a plan of care for certification period 06/14/2022 – 08/12/2022 with primary diagnosis of type II diabetes that indicated “… orders for discipline and treatments … SN (skilled nurse) … up to 5 visits/month … SN to administer/supervise patient … administration of Ozempic (medication to improve blood sugar in adults with type 2 diabetes) … medications … Ozempic 0.5 mg SQ (inject a medication into the tissue layer between the skin and the muscle.) injection weekly ….” Review of an agency document titled “Recertification, Comprehensive Assessment,” dated 06/13/2022, indicated “… professional services … skilled observation for up to 5 v (visits) mo (month) … set up meds every 1 week ….” Review of agency documents titled “Skilled Nurse Visit Note” for dates 06/16/2022, 06/23/2022, 06/30/2022, and 07/07/2022, indicated “… patient interventions … med set (medication set up) ….” Review of skilled nurse visit notes failed to evidence the skilled nurse administered or supervised the patient with administration of weekly injection, Ozempic. During an interview on 07/26/2022 at 3:00PM, when asked where the skilled nurse documents the administration and/or monitoring of weekly injections, the director of nursing relayed the skilled nurse is to document the intervention in the nurses note. No further documentation was received, from the provider, by survey exit.

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 the home health aide competency evaluation included documentation of the evaluation of home health aide skills while performing required tasks with a patient or pseudo patient (person acting as a patient) and/or included documentation of completion of all the required tasks (See G768); failed to ensure the home health aide care plan was specific to the needs of the patient (See G798); failed to ensure the home health aides provided services that were ordered and included in the plan of care and consistent with the aide care plan (See G800); and the registered nurse failed to ensure the home health aide provided aide services, per policy, and followed the care plan (See G818). The cumulative effect of these systemic problems resulted in the agency’s inability to ensure patients received appropriate care and services which could result in the agency not providing quality health care, thus being out of compliance with Condition of Participation 42 CFR 484.80: Home Health Aide Services. 410 IAC 17-14-1(1)(A)

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 the home health aide (HHA) competency evaluation failed to evidence the evaluation of home health aide skills was while performing required tasks with a patient or pseudo patient (person acting as a patient) and included documentation of completion of all the required tasks for 2 of 5 active home health aides hired after 01/01/2021 (HHA 5 and 6). Findings include: 1. Review of an undated agency document titled “Position: Home Health Aide” indicated “… qualifications … successful completion of … competency evaluation ….” 2. Review of an undated agency document titled “Home Health Aide Competency Checklist” indicated “… check skills being demonstrated … initial and date which skill is evaluated … ● mandated-must be performed on a client (patient) or a pseudo-client ….” 3. Review of a document dated 2010, copyright CMS Federal Register, Home Care Direct Care Provider Training Manual, titled “Home Health Aide/Hospice Aide Competency Checklist” indicated “… evaluated by … 4-demonstration … 3-written/case scenario … 2-oral answer … in signing below, I certify that the competency testing … and the skills with *ASTERICKS have been conducted on a live patient/pseudo-patient ….” 4. Review of HHA 5 personnel record on 07/27/2022, with hire date 04/01/2022, included a document titled “Home Health Aide/Hospice Aide Competency Checklist”, dated 04/04/2022 and signed by the assistant director of nursing [ADON] for an initial competency evaluation. The document indicated the skills to be performed on a live patient or pseudo-patient, included bed, tub and sponge bath, sink, tub and bed shampoo, denture care, bedpan and urinal use, transfer techniques, walking assistance with cane, and assistance with wheelchair. The document indicated these skills were completed by an oral answer and failed to evidence completion of skills on a patient or pseudo patient. 5. Review of HHA 6 personnel record on 07/27/2022, with hire date 02/16/2022, included a document titled “Home Health Aide/Hospice Aide Competency Checklist”, dated 02/23/2022 and signed by the ADON for an initial competency evaluation. The document indicated the skills to be performed on a live patient or pseudo-patient included bed, tub and sponge bath, sink, tub and bed shampoo, denture care, bedside commode, use of bedpan and urinal, catheter care, transfer techniques, assistance with walking with crutches, and assistance with wheelchair. The document indicated these skills were demonstrated by an oral answer and failed to evidence completion of all skills on a patient or pseudo patient. 6. During an interview on 07/26/2022 at 3:00PM, the director of nursing indicated, when there is not a patient to perform a bed bath or a transfer for the aide competency, the individual being evaluated and the and nurse verbally walk through the skill. 7. During an interview on 07/27/2022 at 12:00PM, when asked if home health aide competency skills that were to be completed on a patient or pseudo patient were documented as completed with a written / case scenario, the administrator indicated the skill was talked through with the home health aide in the scenario. 410 IAC 17-14-1(1)(A)

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the HHA (home health aide) care plan was specific to the needs of the patient for 6 of 6 record reviews with HHA services (Patient #1, 3, 4, 5, 6, and 7). Findings include: 1. Review of an undated agency policy C-751, copyright Briggs Corporation, Home Care Operational Guidelines titled “Home Health Aide Care Plan” indicated “… documentation that the client’s care is individualized to his / her specific needs ….” 2. Record review for Patient #1, start of care 01/25/2018 and discharge 03/11/2022, contained a plan of care for certification period 03/05/2022-05/03/2022 that indicated “… safety measures … universal precautions (standard set of guidelines to prevent the transmission of bloodborne pathogens from exposure to blood and other potentially infectious materials) … fall precautions … skin breakdown precautions … bleeding precautions … seizure precautions ….” Review of an agency document titled “Home Health Care, Care Plan, HHA” initialed by administrator on 01/03/2022, indicated per pt (patient) request was selected for complete/partial bed bath, assist tub/shower/chair, assist with dressing, oral care, shampoo hair, comb hair, skin care, peri-care (cleaning the private areas of a patient), nail care, shave, prepare meal, assist with feeding, encourage fluids, make bed/change linen, dishes, trash, sweep/mop, dust, vacuum, laundry. The home health aide care plan failed to evidence specific, individualized tasks for the patient. Review of an agency document titled “Home Health Care, Care Plan, HHA” initialed by administrator on 01/03/2022, indicated “… safety measures … universal precautions ….” The home health aide care plan failed to evidence the safety measures indicated in the plan of care. 3. Record review for Patient #3, start of care 11/21/2019, contained a plan of care for certification period 07/08/2022-09/05/2022 that indicated “… safety measures … universal precautions … fall precautions … skin breakdown precautions … bleeding precautions ….” Review of an agency document titled “Home Health Care, Care Plan, HHA” initialed by administrator on 07/07/2022, indicated per pt (patient) request was selected for complete/partial bed bath, assist tub/shower/chair, assist with dressing, oral care, dentures, shampoo hair, comb hair, skin care, peri-care, nail care, shave, prepare meal, make bed/change linen, dishes, trash, sweep/mop, dust, vacuum, laundry. The home health aide care plan failed to evidence specific, individualized tasks for the patient. Review of an agency document titled “Home Health Care, Care Plan, HHA” initialed by administrator on 07/07/2022, indicated “… safety measures … universal precautions ….” The home health aide care plan failed to evidence the safety measures indicated in the plan of care. 5. Record review for Patient #5, start of care 01/26/2018 and discharge 02/09/2022, contained a plan of care for certification period 01/04/2022-03/04/2022 that indicated “… safety measures … universal precautions … fall precautions ….” Review of an agency document titled “Home Health Care, Care Plan, HHA” initialed by administrator on 01/03/2022, indicated per pt (patient) request was selected for complete/partial bed bath, assist tub/shower/chair, assist with dressing, oral care, shampoo hair, comb hair, skin care, peri-care, nail care, prepare meal, make bed/change linen, dishes, trash, sweep/mop, dust, vacuum, laundry. The home health aide care plan failed to evidence specific, individualized tasks for the patient. Review of an agency document titled “Home Health Care, Care Plan, HHA” initialed by administrator on 01/03/2022, indicated “… safety measures … universal precautions ….” The home health aide care plan failed to evidence the safety measures indicated in the plan of care. 5. Record review for Patient #7, start of care 05/01/2019, contained a plan of care for certification period 06/14/2022-08/12/2022 that indicated “… safety measures … universal precautions … fall precautions … skin breakdown precautions … bleeding precautions ….” Review of an agency document titled “Home Health Care, Care Plan, HHA” signed by administrator on 02/16/2022, indicated per pt (patient) request was selected for assist tub/shower/chair, and dentures. The home health aide care plan failed to evidence specific, individualized tasks for the patient. Review of an agency document titled “Home Health Care, Care Plan, HHA” signed by administrator on 02/16/2022, indicated “… safety measures … universal precautions … other ….” The home health aide care plan failed to evidence the safety measures indicated in the plan of care. 6. During an interview on 07/21/2022 at 3:23PM, when asked why the home health aide care plan would have tasks selected as per patient request, the director of nursing and the assistant director of nursing indicated the patient does not want some tasks done at each HHA visit. When asked how the HHA knows what to do for a patient if the patient cannot request due to cognitive (thinking, reasoning, or remembering) reasons, the assistant director indicated the patient family member or nurse would let the HHA know what tasks to perform. Record review for Patient #4, start of care 08/09/2021, contained a plan of care for certification period 06/05/2022-08/03/2022 that indicated “… safety measures … universal precautions … fall precautions … keep pathways clear … safety with sharps … infection control …” Review of an agency document titled “Home Health Care, Care Plan, HHA” initialed by administrator on 04/05/2022, indicated per pt (patient) request was selected for complete/partial bed bath, assist tub/shower/chair, assist with dressing, oral care, shampoo hair, comb hair, skin care, peri-care, nail care, prepare meal, assist with feeding, make bed/change linen, dishes, trash, sweep/mop, dust, vacuum, laundry. The home health aide care plan failed to evidence specific, individualized tasks for the patient. Review of an agency document titled “Home Health Care, Care Plan, HHA” initialed by administrator on 04/05/2022, indicated “… safety measures … universal precautions ….” The home health aide care plan failed to evidence the safety measures indicated in the plan of care. Record review for Patient #6, start of care 06/10/2022, contained a plan of care for certification period 06/10/2022-08/08/2022 that indicated “… safety measures … universal precautions … fall precautions … skin breakdown precautions … safety with assistive devices … keep pathways clear … 24 hour supervision … aspiration precautions ….” Review of an agency document titled “Home Health Care, Care Plan, Respite” signed by Administrative Staff (AS) #3 on 06/10/2022, indicated per pt request was selected for complete/partial bed bath, assist tub/shower/chair, assist with dressing, oral care, shampoo hair, comb hair, skin care, peri-care, nail care, shave, prepare meal, make bed/change linen, dishes, trash, sweep/mop, dust, vacuum, laundry. The home health aide care plan failed to evidence specific, individualized tasks for the patient. Review of an agency document titled “Home Health Care, Care Plan, Respite” signed by AS #3 on 06/10/2022, indicated “… safety measures …” with nothing marked or written in the section. The home health aide care plan failed to evidence the safety measures indicated in the plan of care.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review, observation, and interview, the home health agency failed to ensure the home health aide [HHA] provided services that as ordered and included in the plan of care and consistent with the aide care plan in 1 of 4 active clinical records reviewed with orders for home health aide services (HHA # 1). The findings include: Review of an undated agency policy C-751, copyright Briggs Corporation, Home Care Operational Guidelines titled “Home Health Aide Care Plan” indicated “… care plan, identifying duties to be performed by the Home Health Aide … home health aide staff will follow the identified plan ….” Clinical record review was completed on 07/25/2022 for Patient #7, start of care 05/01/2019, for certification period 06/14/2022-08/12/2022. Review of an agency document titled “Home Health Care, Care Plan, HHA (home health aide)", signed by administrator on 06/13/2022, indicated “… assist tub/shower/chair … per pt (patient) request … dentures … per pt request … uses cane … walker … w/c (wheelchair) … continent … universal precautions (standard set of guidelines to prevent the transmission of bloodborne pathogens from exposure to blood and other potentially infectious materials) … other … self-admin (administration) of meds remind … make bed/change linen … dishes … trash … sweep/mop ….” Record review of agency documents titled “Home Health Care, Care Plan, HHA” used by HHA for documentation of tasks performed on visits, with dates 06/20/2022, 06/23/2022, 06/30/2022, and 07/11/2022, indicated HHA #1 performed the following tasks not on the HHA care plan, “… assist with dressing … skin care … prepare meal … up with assistance ….” Documentation of visits with dates 06/27/2022 and 07/04/2022, indicated HHA #1 performed the following tasks not on the HHA care plan “… assist with dressing … peri-care (cleaning the private areas of a patient) … prepare meal … up with assistance ….” During an interview on 07/21/2022 at 3:23PM, when asked if it is acceptable for a HHA to perform tasks not on the HHA care plan, the administrator indicated it was not. Clinical record review was completed on 07/25/22 for Patient #4, start of care 08/09/2021, for certification period 06/05/2022-08/3/2022. Review of an agency document “Home Health Care, Care Plan, HHA,” signed by RN #1 on 08/09/2021, indicated “…activity level…independent…” This agency document did not indicate, “…self-admin of meds remind…” and instead indicated. “…SN [skilled nurse] will administer…” Review of an agency document “Home Health Care, Care Plan, HHA,” used by HHA #2 for documentation of tasks performed on a visit on 07/07/2022, indicated HHA #2 performed the following tasks not on the care plan “…activity level…uses walker…self-admin of meds remind…” During a home visit with Patient #4 on 07/21/2022 starting at 10:03AM, Patient #4 was observed using a rollator walker while in the care of HHA #3.

HH aide supervision elements CFR(s): 484.80(h)(4)(i-vi) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements: (i) Following the patient's plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional; (ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family; (iii) Demonstrating competency with assigned tasks; (iv) Complying with infection prevention and control policies and procedures; (v) Reporting changes in the patient's condition; and (vi) Honoring patient rights. This ELEMENT is not met as evidenced by: Based on record review and interview, the registered nurse (RN) failed to ensure the home health aide (HHA) provided aide services per policy and followed the care plan for 1 of 4 active records reviewed with home health aide service (HHA #1). Findings include: 1. Review of an undated agency policy C-210, titled “Position: Registered Nurse” indicated “… supervises applicable home care team members ….” 2. Review of an undated agency policy C-680, titled “Clinical Documentation” indicated “… purpose … to ensure that there is an accurate record of the services provided ….” 3. Record review was completed on 07/25/2022 for Patient #7, start of care 5/01/2019, for the certification period 06/14/2022 – 08/12/2022. The record included a document titled “Home Health Care, Care Plan, HHA” used by HHA to document the tasks performed during their visits, dated 6/20/22, 6/23/22, 6/30/22, and 7/11/22, that evidenced HHA #1 performed the following tasks that were not on the HHA care plan, “… assist with dressing … skin care … prepare meal … up with assistance ….” Documentation of aide visits notes dated 6/27/22 and 7/04/22, indicated HHA #1 performed the following tasks that were not on the HHA care plan “… assist with dressing … peri-care (cleaning the private areas of a patient) … prepare meal … up with assistance ….” Record review of agency documents titled “Supervisory Visit Record Home Health Aide” completed by administrator, a RN, and dated 6/27/22 and 7/11/22, indicated “… Home Health Aide Performance … the home health aide(s) implements and follows client’s (patient’s) care plan? … yes ….” 4. During an interview on 7/25/22 at 2:45PM, the administrator indicated the scheduler usually lets the RN know when a HHA is documenting tasks and care that was not on the care plan so that the aide care plan can be updated or changed.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency’s governing body has failed to follow its own policies and failed to review the agency’s policies, budget, operational plans, or quality assessment and performance improvement program since the last recertification survey potentially negatively affecting all current patients. Findings include: 1. Review of an undated agency policy B-100 titled “Governing Body” indicated “… policy… the governing body shall assume full legal authority and responsibility for the operation of the agency… purpose… to ensure clients are provided with appropriate, quality services… the duties and responsibilities of the governing body shall include:… adopt and periodically review and approve the administrative and personnel policies, client care policies and procedures… the annual operating budget… and capital expenditure plan…oversee the management and fiscal affairs of the agency…this shall include budget preparation, and reviewing/ monitoring financial information and organizational operations….” 2. Review of an undated agency policy B-140 titled “Agency Budget Planning” indicated “policy…agency, under the direction of the governing body, shall prepare an overall plan and budget… this will include an annual operating budget and a long term capital expenditure plan…purpose… to determine whether the agency’s financial plan is appropriate to meet the needs of the agency staff and clients… annual operating budget: …there shall be an annual operating budget that shall include all anticipated income and expenses related to items that would, under generally accepted accounting principles, be considered income and expense items… the budget reflects the goals and objectives of the agency… this budget is prepared before the beginning of the fiscal year…the budget is approved by the governing body… and revised as needed… capital expenditure plan: … there shall be a capital expenditure plan for at least a three (3) year period… the overall plan and budget will be reviewed and updated at least annually by the governing body of the agency…it will include consideration of the appropriateness of the plan for providing care and services to meet client’s needs…the review and updating of the budget includes any strategic plans, and impact of the budget on the ability of the staff to provide client care, treatment and services… annual review of all policies that relate to the budget, financial management, and changes recommendations for the financial viability of the agency…” 3. Record review of governing body minutes dated from date of last survey, 7/23/2019, to 7/27/22. The review failed to evidence a review of an agency budget, review of any operational plans, a review of any quality assessment and performance improvement and failed to evidence policy reviews were completed except for notes that indicted “Special Meeting of the Governing Body…” dated 11/05/2021 to approve the policy titled “Mandatory COVID-19 Vaccine Policy and Procedure.” 4. Record review of an agency document “Annual Agency Evaluation,” signed by Corporate Staff (CS) #1, Administrative Staff (AS) #1, and AS #2, documented, “the governing body functions in accordance with its written rules and regulations… yes… minutes of meetings show that the GB [governing body] have taken action on all business for which the GB is responsible… yes… the advisory group [AG] functions in accordance with its written rules and regulations… yes… minutes of meetings show that the AG has considered problems, offered recommendation to the governing body and carried out their functions… yes…budgets, audits, accounting and billing are carried out according to agency policy … yes….” 5. During an interview on 7/27/22, beginning at 2:30PM, the alternate administrator confirmed there were no other governing body minutes to provide. The administrator confirmed there was no annual budget review, capital expenditure plan review nor QAPI review in the governing body minutes. The administrator indicated the governing body / budget policies were probably approved when the agency opened, and stated, “Since COVID we have been in the field and everything else is neglected.” The administrator clarified that the advisory group information on the “Annual Agency Evaluation” was a mistake; there was no advisory group. 410 IAC 17-12-1(b)(3)

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 record review and interview, the agency failed to ensure 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 comes first) with the potential to affect all 38 patients of the agency. Findings include: Review of an undated agency document titled “Patient Information Handbook” included a section titled “Notice of Privacy Practices,” that indicated “… right to inspect and copy … may charge you a reasonable fee for the copying, mailing, or other related expenses … will respond within 30 days of receipt of such request ….” During an interview on 7/20/22 at 3:50PM, the assistant director of nursing indicated when a patient or patient representative requests a copy of heir medical record, the agency requests the patient / patient representative to wait 24 hours before they pick up their copies at the agency office and indicated there were no fees charged.