Every finding on record at Elite Home & Nursing Care LLC

An Emergency Preparedness survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey dates: 10/30/2024, 10/31/2024, and 11/01/2024. Active Census: 12 At this Emergency Preparedness survey, Elite Nursing & Home Care, was not found in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CRF 484.102.

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness plan was developed by utilizing a facility-based and community-based risk assessment utilizing an all hazards approach (E006); failed to include a process for cooperation and collaboration with local emergency preparedness officials (E0009); failed to include in the policy and procedures the process for informing state and local officials of patients in need of evacuation from their homes (E0019); failed to include in the policy and procedures the process for following up with on-duty staff and patients to determine if services are needed (0021); failed to include in the policy and procedures a system of medical documentation that protects patient information and confidentiality (E0023); failed to develop an emergency preparedness communication plan (E0029); and failed to evidence emergency preparedness training was provided at time of hire (E0037). Findings include: Review of a document titled “Emergency Preparedness Disaster Plan” dated 2020 failed to evidence an all-hazards risk assessment, failed to include the collaboration and communication with local emergency preparedness officials, failed to include in the policy the process for informing state and local officials of patients in need of evacuation from homes, failed to include in the policy the process for following up with on-duty staff and patients to determine if services are needed, failed to include in the policy a system of medical documentation that protects patient information and confidentiality, failed to develop an emergency preparedness communication plans, and failed to provide emergency preparedness training at time of hire. During an interview on 11/01/2024 at 12:40 PM, when asked to see the agency hazard vulnerability analysis (HVA), the clinical manager indicated she did not know where it was and would check with the administrator. When asked how the agency determines which emergency disaster events are more common in the agency service area and patient population, the clinical manager indicated she did not know and would check with the administrator. When asked where employee and patient lists are kept including their contact information for emergency preparedness, the clinical manager indicated that information is not kept. During an interview on 11/01/2024 at 2:22 PM, when asked what emergency preparedness training employees had received, the clinical manager indicated none. When asked to see the contact information for emergency officials in the counties identified as service areas, the clinical manager indicated she has the contact information for the three counties where current patients reside and will add county contact information as patients are admitted. During an interview on 11/01/2024 at 2:47 PM, when asked to see the county emergency contact information in the agency emergency preparedness plan, the administrator indicated she adds the county emergency contact information when an admission comes on to service from another county in the agency service area. When asked to see the agency hazard vulnerability analysis (HVA), the administrator indicated completed the Entity B form today. When asked if the HVA was completed after the writer asked for it, the administrator indicated yes.

This visit was for a Federal Certification and State Licensure survey of a Home Health Provider. Survey Dates: October 30, 31, and November 1, 2024. 12-Month Unduplicated Skilled Admissions: 10 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. During this Federal Certification Survey, Elite Home & Nursing Care was found to be out of compliance with Conditions of Participation 484.65 Quality Assessment/Performance Improvement and 484.102 Emergency Preparedness. Based on the Condition-level deficiencies during the 11/01/2024 survey, your HHA was subject to an extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 10/31/2024. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating a home health aide training, skills competency and/or competency evaluation programs for a period of two years beginning 11/01/2024 and continuing through 10/31/2026. QR 11/12/24 A2

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the POC included the frequency and duration of all discipline visits and all complete and measurable goals for 3 of 4 records reviewed for patients receiving SN services only (Patient #2, 3, 6). Findings include: The POC for Patient #3 included goals of “Patient will verbalize understanding of education and take anticoagulant and antiplatelets [blood thinners] as prescribed by provider …” and “Patient will verbalize understanding of education provided, will take medications as prescribed by provider, and demonstrate use of non – pharmacological pain management techniques ….” During an interview on 10/30/2024 at 2 PM, the Clinical Manager could not identify how they measured this goal regarding education and compliance with anticoagulants and antiplatelets. The Clinical Manager indicated the non – pharmacological pain management goal could be more specific. The POC for Patient #6 included goals of “Patient / Caregiver will verbalize understanding of oxygen use safety …” and “… verbalize knowledge of the signs and symptoms of respiratory distress and when to contact agency or 911 ….” During an interview on 10/31/2024 at 2 PM, when asked how they measured the oxygen safety goal, the Alternate Clinical Manager indicated Patient #6 knew not to leave oxygen tubing all over the floor but did it anyway. When asked how they measured Patient #6’s understanding of the signs of respiratory distress and when to contact the agency or 911, they indicated when the patient’s shortness of breath was worse. The Alternate Clinical Manager indicated they thought the goals were measurable. 410 IAC 17 - 13 - 1(a)(1)(iii, xiii) Review of an agency policy titled “Care Plan” indicated the care plan will include the frequency and duration of visits and the anticipated outcome of services provided. 2. Review of the clinical record of Patient #2 included a POC for certification period 08/29/2024 – 10/27/2024 that included orders for a frequency that indicated the patient received five hours per week. The record included the following goals, but were not limited to, the patient/caregiver will verbalize understanding about safety measures within [SIC] and patient needs in home will be met. The record failed to evidence the discipline providing the hours of service and failed to evidence complete and measurable goals. During an interview on 10/30/2024 at 2:05 PM, when asked to explain the order for five hours per week, the clinical manager indicated that it was hours for Entity A and indicated the frequency and duration for the SN was not in the POC. When asked to explain how the goals, patient/caregiver will verbalize understanding about safety measures within and patient needs in home will be met are measurable, the clinical manager indicated they are not measurable and the understanding about safety measures was not complete.

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 there were physician orders for a bowel program which included digital stimulation and the use of suppositories for 1 of 1 patient records reviewed with a bowel program (Patient #1). Findings include: 1.An undated policy titled “Bowel Program/ Digital Stimulation,” copyright Briggs Healthcare, outlined instructions for digital stimulation (use of the finger to loosen fecal matter). The instructions included the use of a suppository as ordered by the physician. 2.The POC for Patient #1 evidenced a primary diagnosis of functional quadriplegia (inability to move or control the movement of the limbs). The POC included an order for “SN to administer bowel program to patient twice a week. SN to follow bowel program procedures per agency policy and notify PCP [primary care provider] of any complications. The SN visit notes for 9/6, 9/13, 9/19, 9/23, 9/26, 9/30, 10/3, 10/7, 10/14, 10/17, 10/21, 10/24, and 10/28/24, the Clinical Manager documented the completion of the bowel program, which included digital stimulation. The visit notes for 9/6 and 10/3/2024 included the use of a suppository in addition to digital stimulation. During an interview on 10/30/2024 at 3:07 PM, the Clinical Manager indicated the POC for Patient #1 included an order for the nurse to administer a bowel program per the agency policy. When asked, the Clinical Manager indicated the physician did not receive the agency policy on the bowel program. The Clinical Manager indicated the POC should have included the specific interventions of the bowel program. During the same interview, the Clinical Manager indicated the use of suppositories required a physician order and there were no orders from the physician. 410 IAC 17 - 13 - 1(a)

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 their QAPI program was capable of showing measurable improvement in indicators and failed to measure, analyze, and track quality indicators (G642); failed to utilize quality data or other relevant data, monitor the effectiveness and safety of services/ quality of care (G644); failed to ensure performance improvement activities included high risk, high volume, or problem-prone areas and lead to immediate correction of identified problems that directly or potentially threaten the health and safety of patients (G646); failed to document performance improvement plans had been implemented for identified area where the agency did not meet defined goals and failed to track adverse patient events, analyze their causes, and implement preventative actions (G654); failed to take actions aimed at performance improvement, and after implementing those actions, failed to ensure its success, and track performance to ensure improvements were 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 the governing body failed to be responsible for the ongoing program of quality improvement and patient safety was defined, implemented and maintained. During an interview on 10/30/2024 at 12:35 PM, when asked to see the agency QAPI program, the clinical manager indicated the agency has had no QAPI meetings, has not collected or tracked any data. During an interview on 10/30/2024 at 1:12 PM, when asked what type of chart or record audits had been done, the clinical manager indicated no audits have been done. On 10/31/2024 at 11:15 AM, the clinical manager provided undated documents titled “QAPI Provisional Meeting Agenda 2024 Quarter 1” and “QAPI: Improving Timeliness of Home Health Aide Training Program”. When asked when the two documents were created, the clinical manager indicated the documents were put together following the conversation the previous day with writer. During an interview on 10/31/2024 at 2:40 PM, the administrator indicated he/she and the clinical manager put together QAPI documents the previous day after writer asked to see the agency QAPI program. The cumulative effect of this systemic problem resulted in the agency being out of compliance with the Condition of Participation 484.65 Quality assessment and performance improvement. 410 IAC 17-12-2(a)

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure staff followed accepted standards of hand hygiene practices for 1 of 1 home visit observation of personal care provided by a CNA (CNA #1). Findings include: 1. A review of the Centers for Disease Control and Prevention guidance for hand hygiene for healthcare workers, available at https://www.cdc.gov /clean-hands/hcp/ clinical-safety/ index.html, identified the need for hand hygiene (either hand wash or use of alcohol- based hand sanitizer) before and after patient contact, after contact with a soiled body site, after contact with contaminated surfaces, and immediately after glove removal. 2. During a home observation on 10/31/2024 at 8:30 AM, CNA #1 was observed showering and dressing Patient #1. After putting Patient #1’s shirt and pants on, CNA 1 applied straps to anchor the catheter bag to the patient’s leg. CNA 1 removed gloves and put on Patient’s socks. During an interview on 10/31/2024 at 10:30 AM, CNA 1 indicated they did not use hand sanitizer often, but preferred to wash hands. CNA 1 indicated hand hygiene was required after removing gloves. When asked, CNA 1 indicated they thought they washed their hands after attaching catheter straps. CNA 1 indicated they forgot to do so at that time. 410 IAC 17 - 12 - 1(m)

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to provide infection control education for 1 of 2 CNAs (CNA 2). Findings include: 1.During the personnel record review on 11/1/2024, CNA 2’s training record failed to evidence infection control education. 2.The Staff Handbook, signed by CNA 2 on 9/9/2024, failed to include infection control policies or education. 3.During an interview on 11/1/2024 at 10:30 AM, the Clinical Manager indicated the infection control training was in the electronic learning program and CNA 2 did not complete the training.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the RN followed the agency clinical guidelines for disposal of discontinued medications for 1 of 3 home visit observations (Patient #5). Findings include: 1.Review of an agency policy titled “Medication Disposition or Disposal” indicated prescription medications managed by the agency that are discontinued must be destroyed by the RN with one other person as a witness. Documentation of the destruction, listing the date, quantity of the medication and signature of the witness must be recorded in the patient’s record. 2. During a home visit observation on 10/31/2024 beginning at 9:30 AM, during the refill of the pillbox in the kitchen of Patient #5, observed the clinical manager remove two medications, Farxiga (used to lower blood sugar levels) and Trazadone (used to manage depression) and place both medications in an empty medication bottle. Patient #5 was observed sitting in the living room and moving to the bathroom during the medication pillbox refill. The clinical manager indicated she would take the two discontinued medications to a medication disposal site. The observation failed to evidence Patient #5 received education about the disposal of discontinued medications and failed to evidence the clinical manager notified and included Patient #5 in the removal of the medications from the home. Review of the SN Visit Note dated 10/31/2024 and completed by the clinical manager failed to evidence patient education was provided regarding the disposal of discontinued medications and failed to evidence documentation that Patient #5 was notified of and participated in the removal of the discontinued medications from the home. During an interview on 10/31/2024 at 10:00 AM, the clinical manager indicated she had not provided education to Patient #5 regarding medication disposal of discontinued medications. During an interview on 11/01/2024 at 12:40 PM, when asked what the agency practice was regarding disposal of patient medications, the clinical manager indicated the patient can dispose of the medications by throwing them in the trash or flushing down the toilet and indicated she prefers to not transport medications. When asked to see the documentation of patient education and patient notification and participation in the removal of Farziga and Trazadone from the home, the clinical manager indicated she had not provided patient education and had not notified or included Patient #5 participation in the removal of medications from the home.

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 the clinical record contained a complete wound assessment for 1 of 2 patient records with wound assessments during the review period (Patient #6). Findings include: 1.An undated agency policy on wound care indicated a wound assessment must be thoroughly assessed, including the length, width, and depth. 2.A review of the SN visit note dated 10/9/2024 indicated Patient #6 had a surgical wound from the placement of a spinal stimulator (a device to treat chronic pain). The wound assessment on 10/9/2024 failed to include wound measurements. The narrative comments on the note stated, “Wound looks to be healing well.” During an interview on 10/31/2024 at 2 PM, when asked why there were no wound measurements, the Alternate Clinical Manager indicated the wound looked healed, so it was not measured. The Alternate Clinical Manager indicated they did not have a wound measuring device. 3.During an interview on 11/1/2024 at 12:55 PM, the Clinical Manager indicated a note should indicate if the wound is healed. If not healed, measurements are required. 410 IAC 17 - 15 - 1(a)(7)