Every finding on record at Sofia Home Health Care LLC

This visit was for a Federal and State complaint survey of a Home Health Agency Provider. Survey Dates: July 2 and 3, 2025. Complaint: IN116532 with related and unrelated deficiencies cited. 12-Month Unduplicated Skilled Admissions: 10 Sofia Home Health Care, LLC, was in compliance with 484.105 Organization and Administration of Services Abbreviations: POC Plan of Care HHA Home Health Aide QR 7/8/25 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 POCs contained measurable goals for 3 of 3 active records reviewed (Patients #1, 2, and 3). Findings include: 1.Patient #1’s clinical record evidenced a POC for certification period 4/8/2025- 8/5/2025 and a diagnosis of spastic quadriplegic cerebral palsy (stiffness and uncontrollable movements which affect all four limbs, trunk, and face). The POC evidenced a goal of “Patient will have assistance with personal care and instrumental activities of daily living [cooking, cleaning, managing medications] with the assistance of the home health aide during plan of care.” The POC failed to evidence a measurable goal. 2. Patient #2’s clinical record evidenced a POC for certification period 6/9/2025- 8/7/2025, with diagnoses of hypertension (high blood pressure) and Type 2 Diabetes. The POC included an order for “Medication set up once every 2 weeks for 9 weeks and evidenced a goal of “Patient will remain safe at home during plan of care.” The POC failed to evidence a measurable goal. 3. Patient #3’s clinical record evidenced a POC for certification period 6/24/2025- 8/22/2025 and a diagnosis of coronary artery dissection (a tear in the wall of a coronary artery which may block or restrict the blood flow to the heart). The POC included an order for “Skilled Nursing to Assess and Eval Assessment and medication set up for 60 days." “Patient will have assistance with personal care and instrumental activities of daily living with the assistance of the home health aide during plan of care.” The POC failed to evidence a measurable goals. 4. During an interview on 7/3/2025 beginning at 11:10 AM, with the Administrator and Clinical Supervisor, the Clinical Supervisor indicated each order required a goal. When asked, the Clinical Supervisor indicated the goal of “remain safe at home” lacked a measurable and patient-specific goal. The Clinical Supervisor also indicated the goal of “assistance with personal care and instrumental activities of daily living” lacked a measurable and patient- specific goal. The Administrator indicated the POCs needed to be more individualized.

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 and interview, the agency failed to ensure HHA’s performed tasks within their scope of practice for 1 of 2 patients reviewed with HHA services (Patient #1). Findings include: Patient #1’s clinical recorded included an Aide Plan of Care effective 4/10/2025 and signed by the Clinical Supervisor on 4/14/2025. The Aide POC included the tasks the aide should complete. The POC evidenced a section titled “Transportation.” That section included “Transport to: Doctor Appt [appointment].” The daily aide notes for 6/28/2025, 6/29/2025, and 7/1/2025 indicated HHA 1 transported Patient #1 “To Doctor Appt [appointment].” During an interview on 7/3/2025 beginning at 11:10 AM, with the Administrator and Clinical Supervisor, the Administrator indicated HHA 1 did transport Patient #1 to the medical appointment. They indicated they did not know aides could not transport patients. They indicated HHA 1 was a family caregiver as well as the HHA for Patient #1 and the transportation was done as a family caregiver. The Administrator could not explain why HHA 1 documented the transportation as a task they completed while in the role of the HHA.

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: March 19, 20, 21, and 24, 2025 Active Census: 8 At this Emergency Preparedness survey, Sofia Home Health Care was found in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.102.

This visit was for a Medicaid Initial Licensure survey of a Home Health Provider. Survey Dates: March 19, 20, 21, and 24, 2025 12-Month Unduplicated Skilled Admissions: 10 This survey was partially extended on March 21, 2025. Refer to State Form for State Findings. Abbreviations: RN Registered Nurse POC Plan of Care HHA Home Health Aide SOC Start of Care CM Clinical Manager SN Skilled Nurse QR A2 3/31/25

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure an initial assessment was completed within 48 hours of referral for 1 of 5 active records reviewed (Patient #1). Findings include: 1. The Initial Assessment Requirements policy indicated “… The initial assessment is conducted… Within 48 hours of referral; or… Within 48 hours of the patient’s return home; or… On the physician-ordered start-of-care date…” 2. Review of Patient #1’s clinical record included a referral intake form dated 11/07/2024 and an initial assessment dated 11/18/2024. The clinical record included a paper order for SN to evaluate and treat for home health care services. The order indicated the date it was requested was 11/13/2024, 6 days after the referral date. The home health agency failed to perform the initial assessment within 48 hours of the patient’s referral. 3. During an interview on 03/20/2025 at 1:07 PM, the CM indicated the initial assessment for Patient #1 was charted on paper because they did not have an electronic medical record at the time. 4. During an interview on 03/21/2025 at 4:17 PM, the CM indicated the initial assessment was not completed until 11 days after referral because they were waiting on a physician order. The CM relayed the order for the initial assessment was requested on 11/13/2024 and received by the agency on 11/18/2024.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure all medications the patient was currently using were identified and placed on the medication profile for 2 of 3 patients with home visit observations (Patient #1, 2). Findings include: 1. The Medication Review policy indicated “The comprehensive assessment accurately reflects the patient's status… and includes, at a minimum… Review of medications the patient is currently using in order to identify any potential adverse effects and drug reactions… The nurse performs ongoing medication monitoring… and includes the information necessary for creating an accurate medication history, and a complete medication profile…” 2. On 03/21/2024, observed HHA 1, a relative of Patient #1, providing care for Patient #1. When asked if the patient took anything for pain, HHA 1 presented a bottle of Naproxen, a medication used for pain and swelling. HHA 1 indicated Patient #1 took Naproxen once daily for pain. Review of Patient #1’s clinical record included a comprehensive assessment dated 01/29/2025 which included a narrative note indicating the Patient said they took Naproxen for pain. The medication profile failed to include Naproxen. During an interview on 03/20/2025 at 1:07 PM, the CM indicated she requested a medication list from the physician which did not include Naproxen so she didn’t add it to the patient’s medication list. 3. On 03/21/2024, observed the CM provide SN care for Patient #2. During the home visit, Person 1, a relative of Patient #2, indicated Patient #1 used Diclofenac gel, a topical medication used for pain, daily for pain ever since it was filled and presented the tube. The prescription Diclofenac gel was dated 12/21/2024. Review of Patient #2’s clinical record included a medication profile. The medication profile failed to include Diclofenac gel. During an interview on 03/24/2025 at 1:02 PM, the CM indicated she was not aware Patient #2 had Diclofenac gel in the home and was using it daily.

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 ensure all required information was included on the POC for 5 of 5 active patient records reviewed (Patient #1, 2, 3, 4, 5). Findings include: 1. The Plan of Care Requirements policy indicated “… The individualized plan of care includes the following… All pertinent diagnoses… The types of services, supplies, and equipment required… The frequency and duration of visits to be made…” 2. Review of Patient #1’s clinical record included a POC for certification period 02/10/2025 to 04/10/2025. The POC failed to include the frequency and duration of SN services, duration of HHA services, and pertinent diagnoses of seasonal allergies and constipation. During an interview on 03/20/2025 at 1:07 PM, the CM indicated the frequency and duration of services should be on the POC, but they did not know at the time the POC was created During an interview on 03/21/2025 at 4:38 PM, the CM indicated Patient #1 took Flonase, a nasal spray used to treat sinus inflammation, for seasonal allergies and took Docusate Sodium, a stool softener, for constipation. The CM further indicated she had not added the pertinent diagnoses of seasonal allergies and constipation to the POC because the consultant had told her if the patient had a lot of diagnoses, she didn’t have to put them all. 3. Review of Patient #2’s clinical record included a POC for certification period 02/19/2025 to 04/19/2025. The POC failed to include the pertinent diagnosis of constipation and failed to include the duration for HHA services. During an interview on 03/20/2025 at 4:48 PM, the CM indicated she did not put constipation on the POC diagnosis list and did not put the duration of HHA services in the POC because she did not know to do that at the time the POC was created. 4. RN 1 was observed providing care for Patient #3 on 03/24/2025 at 11:00 AM. Observed Patient #3 with a blood glucose monitor on the right arm. Review of Patient #3’s clinical record included a POC for certification period 02/07/2025 to 04/07/2025. The POC failed to include the patient’s blood sugar monitor and pertinent diagnoses of nerve pain and mental health issues. During an interview on 03/21/2025 at 4:24 PM, the CM indicated the patient took Gabapentin, a medication used to treat nerve pain and numbness, for nerve pain and took Mirtazapine, an antidepressant, and Sertraline, an antidepressant, for mental problems. The CM indicated because she didn’t know at the time to put all current diagnoses, she didn’t. The CM further indicated Patient #3 had a blood glucose monitor but failed to see it in the POC. 5. Review of Patient #4’s clinical record included a POC for certification period 01/27/2025 to 03/27/2025. The POC failed to include the pertinent diagnoses of insomnia, difficulty falling and/ or staying asleep; depression; and gastrointestinal upset. During an interview on 03/24/2025 at 1:12 PM, the CM indicated Patient #4 was taking Melatonin, a dietary supplement used to promote sleep, for insomnia; Sertraline for depression; and Zofran for gastrointestinal upset. The CM indicated she did not put those diagnoses in the POC. 6. Review of Patient #5’s clinical record included a POC for certification period 02/07/2025 to 04/07/2025. The POC failed to include duration of SN and HHA services. During an interview on 03/24/2025 at 3:49 PM, the CM indicated she didn’t know at the time the POC was created the durations had to be included.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to notify the patient’s physician of the need to alter the POC for 2 of 5 active patient records reviewed (Patient # 1, 2). Findings include: 1. The Physician Notification to Alter the POC policy indicated “… The patient record must demonstrate evidence that the physician was promptly informed of any changes that suggest a need to alter the plan of care… If the home health organization provides fewer visits than the physician orders, it has altered the plan of care and the physician must be notified. The organization is required to maintain documentation in the patient record indicating that the physician was notified and is aware of the missed visit…” 2. Review of Patient #1’s clinical record included a POC for certification period 12/09/2024 to 02/09/2025 which included orders for HHA visits to be conducted 4 hours per day every day. The record indicated HHA services began on 01/22/2025. The record failed to evidence the physician was notified of the need to alter the POC due to the missed HHA visits from 12/09/2025 to 01/21/2025. Patient #1’s record also included a comprehensive assessment dated 01/29/2025 which included a narrative note indicating the Patient said they took Naproxen for pain. The Patient’s POC medication list failed to include Naproxen. During an interview on 03/20/2025 at 1:07 PM, the CM indicated she did not notify the physician Patient #1 was taking a medication that was not on the medication list. During an interview on 03/24/2025 at 3:55 PM, the CM indicated Patient #1’s physician had not been notified of the delay in the patient receiving HHA services ordered in the POC. 3. Review of Patient #2’s clinical record included a POC for certification period 02/19/2025 to 04/19/2025 which included orders for HHA visits to be conducted 4 hours per day every day. The record indicated HHA services had not yet begun. The record failed to evidence the physician was notified of the need to alter the POC due to missed HHA visits from 02/19/2025 to 03/24/2024. During an interview on 03/24/2025 at 3:56 PM, the CM indicated Patient #2’s physician had not been notified of the patient not receiving the HHA services ordered in the POC.

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 home health agency failed to ensure staff followed infection control procedures related to bag technique for 2 of 2 RNs observed (CM, RN 1). Findings include: 1.The Equipment / Supplies policy indicated “… Equipment that is owned by the organization, or for which it is responsible, is cleaned and disinfected, according to current manufacturers’ guidelines and, in accordance with the type of equipment and level of infection risk…” 2. On 03/21/2025 at 9:36 AM, observed the CM provided care for Patient #2. At 10:03 AM, the CM wiped the blood pressure cuff, thermometer, pulse oximeter, and stethoscope with wipes and placed on the clean barrier. The CM indicated the wipes were Sani-cloth wipes. The CM then placed the blood pressure cuff, thermometer, pulse oximeter, and stethoscope into the nurse bag at 10:04, one minute later. The CM failed to wait for the manufacturer’s recommended wet time of two minutes for disinfection before placing the items into the nurse bag. During an interview on 03/24/25 at 1:02 PM, the CM indicated she thought the manufacturer recommended wet time for Sani-cloth wipes was two minutes. 3. On 03/24/2025 at 11:00 AM, observed RN 1 provided care for Patient #3. RN 1 wiped the pulse oximeter, stethoscope, thermometer, pen light, and blood pressure cuff, and placed each directly into the nurse bag after wiping. RN 1 indicated the wipes were Sani-cloth wipes. During an interview on 03/24/2025 at 11:59 AM, RN 1 relayed the Sani-cloth wipes container indicated the manufacturer’s recommended wet time for disinfection was two minutes.

Aides are members of interdisciplinary team CFR(s): 484.80(g)(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient's condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA's policies and procedures. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure HHA visit notes were turned into the agency to be incorporated into the clinical record for 1 of 4 active records reviewed of patients receiving HHA services (Patient #3). Findings include: 1. The Submission of Clinical Record Visits policy indicated “… Home health aide notes must be submitted, once weekly, with their timesheets…” 2. Review of Patient #3’s clinical record failed to include HHA visit notes. 3. During an interview on 03/21/2025 at 4:24 PM, the CM indicated the aide visit notes were not in Patient #3’s clinical record because the aide was having trouble charting in the electronic record. 4. During an interview on 03/24/2025 at 1:09 PM, the CM indicated she didn’t know how often HHA visit notes should be turned in when charting on paper.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure HHA supervisory visits were conducted every 14 days for 4 of 4 active records reviewed of patients receiving HHA services (Patient # 1, 3, 4, 5). Findings include: 1. The Aide Supervision policy indicated “… If home health aide services are provided to a patient, who is receiving skilled nursing… a registered nurse… who is familiar with the patient, the patient’s plan of care, and the written patient instructions, must make an onsite visit to the patient’s home, no less frequently than every 14 days…” 2. Review of Patient 1’s clinical record included a POC for certification period 02/10/2025 to 04/10/2025 which included orders for SN services with no frequency or duration and HHA visits to be conducted 4 hours per day every day. The record included an HHA supervisory visit performed on 02/18/2025 with the next HHA supervisory visit performed on 03/05/2025, 15 days later. HHA visits were conducted daily between the two supervisory visits. The agency failed to perform HHA supervisory visits at least every 14 days. During an interview on 03/20/2025 at 1:07 PM, the CM indicated aide supervisory visits were to be conducted every 14 days, and they try to do them every 14 days. 3. Review of Patient 3’s clinical record included a POC for the certification period 02/07/2025 to 04/07/2025 with orders for SN services once every two weeks for nine weeks and HHA services every day for four hours per day. The record included HHA visits daily, including but not limited to, from 01/20/2025 to 03/18/2024. The record included an HHA supervisory visit on 02/04/2025, 15 days after the 01/20/2025 HHA visit. The next HHA supervisory visit was on 02/18/2025, 14 days later. The next HHA supervisory visit was on 03/05/2024, 15 days later. The next HHA supervisory visit was on 03/24/2025, 19 days later. The agency failed to perform HHA supervisory visits at least every 14 days. During an interview on 03/21/2025 at 4:24 PM, the CM indicated the HHA supervisory visits were probably not being completed every 14 days because the HHA notes were not in the electronic medical record. 4. Review of Patient 4’s clinical record included a POC for certification period 01/27/2025 to 03/27/2025 with orders for SN services to be performed once every two weeks for 60 days and HHA services every day for four hours per day. The record included but not limited to daily HHA visits from 01/27/2024 through 03/20/2024. The record included an HHA supervisory visit on 02/18/2025, 22 days after the 01/27/2025 HHA visit. The next HHA supervisory visit was on 03/05/2025, 15 days later. As of 03/20/2025, 15 days later, no further HHA supervisory visits had been conducted. The agency failed to conduct HHA supervisory visits at least every 14 days. During an interview on 03/24/2025 at 1:12 PM, the CM indicated she did not know prior to the 02/18/2025 HHA supervisory visit that the HHA supervisory visits were supposed to be every 14 days. The CM further indicated an HHA supervisory visit was supposed to have been conducted on 03/19/2025, but they did not get to it because of the surveys. 5. Review of Patient 5’s clinical record included a POC for certification period 02/07/2025 to 04/07/2025 with orders for SN services to be performed once every two weeks for 60 days and HHA services every day for four hours per day. The record included, but not limited to, daily HHA visits from 01/20/2025 through 03/21/2024. The record included an HHA supervisory visit on 02/04/2025, 15 days after the 01/20/2025 HHA visit. The next HHA supervisory visit was on 02/18/2025, 14 days later. The next HHA supervisory visit was on 03/05/2025, 15 days later. As of 03/21/2025, 16 days later, no further HHA supervisory visits had been performed. The agency failed to conduct HHA supervisory visits at least every 14 days. During an interview on 03/24/2025 at 1:12 PM, the CM indicated no HHA supervisory visits were conducted prior to February 2025 because the agency did not know they were supposed to. The CM indicated there were 15 days between the 02/18/2025 and 03/05/2025 HHA supervisory visits because she counted wrong that time. The CM further indicated there was supposed to be an HHA supervisory visit on 03/19/2025 but that it was missed due to the stress of the survey.