Every finding on record at Tomcat Hc LLC

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: July 24, 25, 28, and 29, 2025 Active Census: 122 At this Emergency Preparedness survey, Brightstar Care of Fort Wayne was found in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 42 CFR 484.102.

This visit was for a Federal Recertification and State Re-Licensure survey of a Home Health Provider. Survey Dates: July 24, 25, 28, and 29, 2025 12-Month Unduplicated Skilled Admissions: 209 Partially Extended on 07/28/2025 at 4:55 PM This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. Abbreviations: RN-Registered Nurse, CM-Clinical Manager, HHA-Home Health Aide, POC-Plan of Care, SN-Skilled Nurse, SOC-Start of Care, ADLs-Activities of Daily Living, EMR-Electronic Medical Record QR 8/4/25 A2

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 an accurate review of all medications for 3 of 3 home visit observations with medications reviewed (Patient #5, 7 and 8). 3. Patient #7’s clinical record evidenced an initial comprehensive assessment on 06/26/2025. The comprehensive assessment failed to include a list of medications the patient was taking. During a home visit observation conducted with Patient #7 and the Alternate CM on 07/28/2025 at 11:04 AM, received a copy of Patient #7’s medication list from Person 1, a Qualified Medication Aide at Entity 2, an assisted living facility. Review of the facility medication included, but not limited to, the following medications: a) Apixaban, a blood thinner. This medication was not listed on the agency medication list. b) Carvedilol, a medication used to lower blood pressure and heart rate. This medication was not listed on the agency medication list. c) Cyclobenzaprine, a muscle relaxer. This medication was not listed on the agency medication list. d) Furosemide, a diuretic or “water pill”. This medication was not listed on the agency medication list. e) Gabapentin, a medication for nerve pain. This medication was not listed on the agency medication list. f) Glimepiride, a medication used to treat Type 2 diabetes. This medication was not listed on the agency medication list. g) Levothyroxine Sodium, a medication used to treat low thyroid hormone levels. This medication was not listed on the agency medication list. h) Meloxicam, a non-steroidal anti-inflammatory pain medication. This medication was not listed on the agency medication list. i) Potassium Chloride, used to treat low potassium levels. This medication was not listed on the agency medication list. During an interview on 07/29/2025 at 2:33 PM, RN 1 indicated she completed the initial comprehensive assessment for Patient #7 and had completed a medication reconciliation. RN 1 indicated she wasn’t sure why there were no medications in Patient #7’s medication list. During an interview on 07/29/2025 at 3:25 PM, the CM indicated there is no way for a medication to come off the medication list once it is put in, that it can only be made inactive. The CM further indicated RN 1 had been having some issues with charting lately and must not have completely submitted the medication list. Findings include: 1. The agency policy “2-006-Comprehensive Assessment” indicated the comprehensive assessment will include a review of all medications that the patient is currently using. 2. Patient #5’s clinical record evidenced a SOC on 2/13/25 and included a POC for the certification period 6/10/25 to 8/08/25. The record evidenced comprehensive assessments were completed on 2/13/25, 4/08/25 and 6/09/25. During a home visit observation conducted with Patient #5 and HHA 5 on 7/25/25 at 1:00 PM, Surveyor comparison of the home health agency’s POC medication list against the medications in the home evidenced the following discrepancies: a) Biotin (used as a supplement) was found in the home. This medication was not listed on the POC medication list. b) Melatonin (used to regulate sleep) was found in the home. This medication was not listed on the POC medication list. c) Airborne (used as a supplement) was found in the home. This medication was not listed on the POC medication list. d) Tylenol (used to treat pain/fever) was found in the home. This medication was not listed on the POC medication list. e) Miralax (used to treat constipation) was found in the home. This medication was not listed on the POC medication list. f) Bonine (used as a supplement) was found in the home. This medication was not listed on the POC medication list. g) Centrum (multivitamin used as a supplement) was found in the home. This medication was not listed on the POC medication list. h) Hydroxizine (used to treat anxiety) 50 milligram (mg) tablet was found in the home. This medication was not listed on the POC medication list. i) EpiPen (used to treat an allergic reaction) was found in the home. This medication was not listed on the POC medication list. j) Buspirone Hydrochloride (used to treat depression) 10 mg twice a day was listed on the POC medication list. Buspirone Hydrochloride 5 mg tablet was found in the home. During an interview on 7/28/25 at 12:06 PM, the CM relayed medications should be reviewed during SN visits and recertification visits. 4. Patient #8’s clinical record evidenced a SOC on 6/27/24 and included a POC for the certification period 5/29/25 to 7/27/25. The record evidenced comprehensive assessments were completed on 6/27/24, 8/23/24, 10/18/24, 12/13/24, 2/6/25, 3/31/25, 5/29/25 and 7/25/25. During a home visit observation conducted with Patient #8 and the CM on 7/25/25 at 12:15 PM, Surveyor comparison of the home health agency’s POC medication list against the medications in the home evidenced the following discrepancy: a) Diazepam (used for muscle spasms) 2 mg, One tablet at bedtime as needed for muscle spasms was not found in the home. Per Patient #8, they have not had this medication prescribed for several months due it being a controlled substance. b) Ventolin HFA (Used to treat bronchospasms) 90 microgram(mcg)/actuation, 1 puff every four hours as needed was not found in the home. Per Patient #8, they have not used this inhaler for a few months. c) Pulmicort (used to treat asthma) 90 mcg, 2 puffs every 12 hours was found in the home. This medication was not listed on the POC medication list. During an interview on 7/28/25 at 12:06 PM, the CM relayed medications should be reviewed during SN visits and recertification visits. 5. During the entrance conference on 7/24/25 at 10:55 AM, the CM indicated the medication list is reconciled against the medications in the home or physician medication list at admission and recertification. If new medications are found in the home, the physician is contacted for orders, drug regimen review is completed and the medication is added to the medication list/POC.

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 home health agency failed to ensure all required information was included in the POC for 8 of 8 active patient records reviewed (Patient #1, 2, 3, 4, 5, 6, 7, 8). Findings include: Patient #1’s clinical record evidenced a POC for certification period 07/08/2025 – 09/05/2025. The POC failed to evidence a description of Patient #1’s risk of Emergency Room visits or hospitalization. The POC failed to evidence interventions to reduce the risk of Emergency Room visits or hospitalizations. During an interview on 07/29/2025 beginning at 09:32 AM, the Clinical Manager indicated the section regarding hospital risk was not included in the agency POC template, so it was not addressed. Patient #2’s clinical record evidenced a POC for certification period 06/25/2025 – 08/23/2025. The POC failed to include a description of Patient #2’s risk of Emergency Room visits or hospitalization. The POC failed to evidence interventions to reduce the risk of Emergency Room visits or hospitalizations. During an interview on 07/29/2025 beginning at 10:45 AM, the Alternate Clinical Manager indicated the section regarding hospital risk was not included on the POC. Patient #2’s clinical record evidenced a POC for certification period 06/25/2025 – 08/23/2025. The POC evidenced a goal of “… to stay living in [Patient #2’s] home and maintaining [Patient #2’s] current level of independence for as long as possible.” During an interview beginning at 10:45 AM, the Alternate Clinical Manager indicated Patient #2 wanted to become more independent. Asked how to measure the level of independence, they indicated the goal should be more specific to be measurable. Patient #2’s clinical record evidenced a POC for certification period 06/25/2025 – 08/23/2025. The POC identified Patient #2’s medical equipment and supplies required for Patient #2’s care. The POC identified equipment and supply needs as a medication box, gloves, power chair, hospital bed, shower chair, outdoor ramps, diabetic supplies, and catheter supplies. The POC failed to include the need for a Hoyer lift (a mechanical lift to assist with transferring a patient from a bed to a chair). During an interview beginning at 10:45 AM, the Alternate Clinical Manager indicated Patient #2 required a Hoyer lift for transfers. They indicated the Hoyer lift should have been on the POC. Patient #3’s clinical record evidenced a POC for certification period 07/18/2025 – 09/15/2025. The POC failed to evidence a description of Patient #3’s risk of Emergency Room visits or hospitalization. The POC failed to evidence interventions to reduce the risk of Emergency Room visits. During an interview on 07/29/2025 beginning at 09:32 AM, the Clinical Manager indicated the section regarding hospital risk was not included in the agency POC template, so it was not addressed. Patient #3’s clinical record evidenced a POC for certification period 07/18/2025 – 09/15/2025. The POC evidenced a goal of “… demonstrate improvement in his/ her ADL/ IADL [activities of daily living/ instrumental activities of daily living] performance ….” During an interview on 07/29/2025 beginning at 09:32 AM, the Clinical Manager indicated the goal could be measured by the assessment. When asked how a different nurse would know if there was improvement, the Clinical Manager indicated the goal should be more objective. Patient #6’s clinical record evidenced a POC for certification period 07/08/2025 – 09/05/2025. The POC failed to evidence a description of Patient #6’s risk of Emergency Room visits or hospitalization. The POC failed to evidence interventions to reduce the risk of Emergency Room visits or hospitalizations. During an interview beginning at 10:45 AM, the Alternate Clinical Manager indicated Patient #6 did not have the risk of hospitalization identified because the computer did not have that section available. Patient #6’s clinical record evidenced a POC for certification period 07/08/2025 – 09/05/2025. The POC evidenced a goal of “Patient will be clean comfortable and safe in his/ her home environment from admission to discharge.” During an interview beginning at 10:45 AM, the Alternate Clinical Manager indicated they would measure the goal by asking the patient if they were satisfied with their services. When asked, the Alternate Clinical Manager indicated the goal could be more specific to be measurable. 410 IAC 17-13-1(a)(C)(xiii) 1. Review of the Care Planning Process Policy, revised 06/2024, indicated “… The medical plan of care shall meet the following… Type of services and equipment required… Risks for hospitalization if applicable… Any other appropriate items…” 2. Patient #4’s clinical record evidenced a POC for certification period 06/13/2025 to 08/11/2025. The POC failed to evidence a description of Patient #4’s risk of Emergency Room visits or hospitalization. The POC failed to evidence interventions to reduce the risk of Emergency Room visits or hospitalizations. The POC evidenced a goal of “Patient will be clean comfortable and safe in his/ her home environment from admission to discharge.” During an interview on 07/29/2025 beginning at 09:32 AM, the CM indicated the section regarding hospital risk was not included in the agency POC template, so it was not addressed. During an interview on 07/29/2025 at 2:05 PM, the CM indicated measurement of the goal would be based off the patient voicing satisfaction at that time. 3. Patient #5’s clinical record evidenced a POC for certification period 06/10/2025 to 08/08/2025. The POC failed to evidence a description of Patient #5’s risk of Emergency Room visits or hospitalization. The POC failed to evidence interventions to reduce the risk of Emergency Room visits or hospitalizations. The POC evidenced goals of “Patient will be clean comfortable and safe in his/ her home environment from admission to discharge” and “… demonstrate improvement in his/ her ADL/ IADL [activities of daily living/ instrumental activities of daily living] performance …” During an interview on 07/29/2025 beginning at 09:32 AM, the Clinical Manager indicated the section regarding hospital risk was not included in the agency POC template, so it was not addressed. During an interview on 07/29/2025 at 2:05 PM, the CM indicated measurement of the first goal would be based off the patient voicing satisfaction at that time and measurement of the second goal would be based on whether the patient improved on their independence. When asked how another nurse filling in would know how to measure the goal, she indicated the nurse would have access to previous documentation in the clinical record. 4. Patient #7’s clinical record evidenced a POC for certification period 06/26/2025 to 08/24/2025. The POC failed to evidence a description of Patient #7’s risk of Emergency Room visits or hospitalization. The POC failed to evidence interventions to reduce the risk of Emergency Room visits or hospitalizations. The POC evidenced a goal of “Patient will be clean comfortable and safe in his/ her home environment from admission to discharge.” During an interview on 07/29/2025 beginning at 09:32 AM, the CM indicated the section regarding hospital risk was not included in the agency POC template, so it was not addressed. During an interview on 07/29/2025 at 2:33 PM, RN 1 indicated she assesses the Patient every other day and speaks to the assisted living staff. 5. Patient #8’s clinical record evidenced a POC for certification period 05/29/2025 to 07/27/2025. The POC failed to evidence a description of Patient #4’s risk of Emergency Room visits or hospitalization. The POC failed to evidence interventions to reduce the risk of Emergency Room visits or hospitalizations. During an interview on 07/29/2025 beginning at 09:32 AM, the CM indicated the section regarding hospital risk was not included in the agency POC template, so it was not addressed.

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 home health agency failed to document wound care orders as received from the wound clinic for 1 of 1 home visit observation of a patient receiving wound clinic services (Patient #8). Findings include: 1. The agency policy “2-029 Wound Care” indicated to follow physician orders for frequency of dressing changes. 2. Patient #8’s clinical record evidenced physician notes received on 7/24/25 from Entity 1. This note included updated wound care orders for daily dressing changes. The clinical record for Patient #8 evidenced a wound care order was entered on 7/25/25 for wound care to be performed three times daily. The record failed to evidence an accurate wound care order. 3. During an interview on 7/28/25 at 12:06 PM, the CM verified the 7/25/25 wound care order for Patient #8 was entered incorrectly as three times daily and stated the order needed corrected reflecting the SN to perform three times a week and family to perform four times a week.

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to provide a copy of the plan of care to the patient for 2 of 2 home visit observations in a private home with review of the patient’s home folder (Patients #5, 8). Findings include: 1. Patient #5’s clinical record evidenced a SOC on 2/13/25 and included a POC for the certification period 6/10/25 to 8/08/25. The POC evidenced Patient #5 was to receive HHA services and a SN visit for recertification. During a home visit observation conducted with Patient #5 and HHA 5 on 7/25/25 at 1:00 PM, Surveyor reviewed Patient #5’s home folder documentation. The home health agency failed to provide Patient #5 a copy of the POC. During an interview on 7/28/25 at 12:06 PM, the CM relayed it was the responsibility of the RN Case Manager to provide the patient a copy of the POC at admission and with any changes. 2. Patient #8’s clinical record evidenced a SOC on 6/27/24 and included a POC for the certification period 5/29/25 to 7/27/25. The POC evidenced Patient #8 was to receive SN and HHA services. During a home visit observation conducted with Patient #8 and the CM on 7/25/25 at 12:15 PM, Surveyor reviewed Patient #8’s home folder documentation. The home health agency failed to provide Patient #8 a copy of the POC. During an interview on 7/25/25 at 12:44 PM, Patient #8 relayed he had not been given a copy of the POC. During an interview on 7/28/25 at 12:06 PM, the CM relayed it was the responsibility of the RN Case Manager to provide the patient a copy of the POC at admission and with any changes and she thought it was given to his daughter.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to provide a visit schedule to the patient for 2 of 2 home visit observations in a private home with review of the patient’s home folder (Patients #5, 8). Findings include: 1. The undated “Patient Rights” policy indicated the patient has the right to be informed of the frequency of the visits/shifts to be furnished. 2. The agency policy “2-011 Care Planning Process”, last updated 6/2024, indicated the agency shall provide the patient and/or patient representative a visit schedule including frequency of visits. 3. Patient #5’s clinical record evidenced a SOC on 2/13/25 and included a POC for the certification period 6/10/25 to 8/08/25. The POC evidenced Patient #5 was to receive HHA services four hours a day, five days a week and a SN visit for recertification. During a home visit observation conducted with Patient #5 and HHA 5 on 7/25/25 at 1:00 PM, Surveyor reviewed Patient #5’s home folder documentation. The home health agency failed to provide Patient #5 a visit schedule or calendar. During an interview on 7/25/25 at 1:12 PM, the CM asked Patient #5 if the HHA was normally late to the home visits. Patient #5 told the CM she never knew when the HHA was coming. During an interview on 7/28/25 at 12:06 PM, the CM relayed the patient was emailed a copy of the visit schedule every week. When asked to provide this email documentation, the CM was unable to provide. 4. Patient #8’s clinical record evidenced a SOC on 6/27/24 and included a POC for the certification period 5/29/25 to 7/27/25. The POC evidenced Patient #8 was to receive SN visits three times a week and HHA visits two times a week. During a home visit observation conducted with Patient #8 and the CM on 7/25/25 at 12:15 PM, Surveyor reviewed Patient #8’s home folder documentation. The home health agency failed to provide Patient #8 a visit schedule or calendar. During an interview on 7/25/25 at 12:44 PM, Patient #8 relayed he was not given a calendar or schedule of visits. He knew the nurse was seeing him three times a week for wound care. During an interview on 7/28/25 at 12:06 PM, the CM relayed the patient’s daughter was emailed a copy of the visit schedule every week. When asked to provide this email documentation, the CM was unable to provide.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to provide a copy of the current medication list to the patient for 2 of 2 home visit observations in a private home with medication reviewed (Patient #5, 8). Findings include: 1. The agency policy “2-011 Care Planning Process”, last updated 6/2024, indicated the agency shall provide the patient and/or patient representative a medication list including name, dosage and frequency. 2. Patient #5’s clinical record evidenced a SOC on 2/13/25 and included a POC for the certification period 6/10/25 to 8/08/25. During a home visit observation conducted with Patient #5 and HHA 5 on 7/25/25 at 1:00 PM, Surveyor reviewed Patient #5’s home folder documentation. The home health agency failed to provide Patient #5 a copy of the current medication list. During an interview on 7/28/25 at 12:06 PM, the CM relayed the patient was emailed a copy of the current medication list. When asked to provide this email documentation, the CM was unable to provide the documents. 3. Patient #8’s clinical record evidenced a SOC on 6/27/24 and included a POC for the certification period 5/29/25 to 7/27/25. During a home visit observation conducted with Patient #8 and the CM on 7/25/25 at 12:15 PM, Surveyor reviewed Patient #8’s home folder documentation. The home health agency failed to provide Patient #8 a copy of the current medication list. During an interview on 7/25/25 at 12:44 PM, Patient #8 relayed the home health agency had not given him a copy of the medication list. During an interview on 7/28/25 at 12:06 PM, the CM relayed the patient’s daughter was emailed a copy of the current medication list. When asked to provide this email documentation, the CM was unable to provide the docuements.

Other pertinent instructions CFR(s): 484.60(e)(4) Any other pertinent instruction related to the patient's care and treatments that the HHA will provide, specific to the patient's care needs. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to provide the patient with a copy of the aide care plan for 2 of 2 home visit observations with HHA services with review of the patient’s home folder (Patient #5 and 8). Findings include: 1. Patient #5’s clinical record evidenced a SOC on 2/13/25 and included an HHA care plan for the certification period 6/10/25 to 8/08/25. During a home visit observation conducted with Patient #5 and HHA 5 on 7/25/25 at 1:00 PM, Surveyor reviewed Patient #5’s home folder documentation. The home health agency failed to provide Patient #5 a copy of the HHA care plan. During an interview on 7/25/25 at 1:00 PM, Patient #5 relayed she was unsure what tasks the HHA was to do during her visits. 2. Patient #8’s clinical record evidenced a SOC on 6/27/24 and included an HHA care plan for the certification period 5/29/25 to 7/27/25. During a home visit observation conducted with Patient #8 and the CM on 7/25/25 at 12:15 PM, Surveyor reviewed Patient #8’s home folder documentation. The home health agency failed to provide Patient #8 a copy of the HHA care plan. During an interview on 7/25/25 at 12:44 PM, Patient #8 relayed the home health agency had not given him a copy of the aide care plan. 3. During an interview on 7/28/25 at 12:06 PM, the CM relayed the HHA care plan is discussed with the patient. The patient signs the HHA care plan during recertification and HHA supervisory visits. She confirmed the patient is not given a copy of the HHA care plan to keep in the home.

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, document review and interview, the home health agency failed to provide the patient and/or caregiver with the clinical manager information for 2 of 2 home visit observations in a private home with review of the patient’s home folder (Patient #5, 8). Findings include: 1. The agency policy “2-011 Care Planning Process”, last updated 6/2024, indicated the agency shall provide the patient and/or patient representative access to a copy of written instructions outlining: Name and contact information of the clinical manager. 2. Review of the “BrightStar Home Care Information Packet”, last updated 6/2024, failed to include the name and contact information for the Clinical Manager. 3. During a home visit observation with Patient #5 on 7/25/25 at 1:00 PM, the home health agency’s folder was reviewed and included a copy of a document titled “BrightStar Home Care Information Packet.” The document failed to evidence the name and contact information of the clinical manager. 4. During a home visit observation with Patient #8 on 7/25/25 at 12:15 PM, the home health agency’s folder was reviewed and included a copy of a document titled “BrightStar Home Care Information Packet.” The document failed to evidence the name and contact information of the clinical manager. During an interview on 7/28/25 at 12:06 PM, the CM verified the information packet did not include the name and contact information of the clinical manager.

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 employees followed standards of practice for hand hygiene, bag technique and cleaning of equipment to reduce the spread of infections for 2 of 2 home visit observations with a SN (Patient #7 and 8). Findings include: 2. During a home visit observation conducted with Patient #5 and the CM on 7/25/25 beginning at 12:15 PM, the CM cleaned the vitals equipment (blood pressure cuff, pulse ox, stethoscope and thermometer) with Clorox Disinfecting wipes and placed the clean vitals equipment on the kitchen counter to air dry. The CM failed to place the clean vitals equipment on a barrier to air dry. During an interview on 7/28/25 at 12:06 PM, the CM relayed cleaned vitals equipment should be placed on a clean area to dry. 1. Review of the Clinical Bag Technique and Cleaning Policy, revised 06/2024, indicated “… Reusable equipment is cleaned using alcohol, antiseptic spray or wipes, and/or soap and water as appropriate and left to dry according to designated dry times… Hands are cleansed prior to returning clean equipment and supplies to the bag…” 2. Review of the Hand Hygiene policy, revised 06/2024, indicated “… Hand Hygiene should be performed for the following clinical indications… Immediately before touching a patient… Immediately after glove removal…” 3. During a home visit observation on 07/28/2025 beginning at 11:04 AM, the Alternate CM provided care for Patient #7. During the visit, the Alternate CM performed hand hygiene and donned gloves, removed Patient #7’s wound dressing, doffed gloves, and then retrieved wound care supplies from a cabinet and placed them on a barrier before performing hand hygiene. After cleansing the Patient’s wound, The Alternate CM changed gloves without performing hand hygiene. The Alternate CM doffed gloves and then entered the nurse bag to pull out disinfecting wipes prior to performing hand hygiene. The Alternate CM cleaned the blood pressure cuff, stethoscope and thermometer with CVS disinfecting wipes and placed the clean vitals equipment on the same area of the barrier they had been placed after use. The CM failed to place the clean vitals equipment on a clean barrier to air dry. During an interview on 07/28/2025 at 11:41 AM, the Alternate CM indicated hand hygiene should be performed on arrival, before touching the patient, when visibly soiled, at the end of the shift, after glove removal, and prior to entering the nurse bag. When asked if she typically has separate sides of the barrier for dirty and clean equipment, the Alternate CM indicated she had asked the CM about it that morning, and the CM just said to use a barrier. 1. Review of the Clinical Bag Technique and Cleaning Policy, revised 06/2024, indicated “… Reusable equipment is cleaned using alcohol, antiseptic spray or wipes, and/or soap and water as appropriate and left to dry according to designated dry times… Hands are cleansed prior to returning clean equipment and supplies to the bag…” 2. Review of the Hand Hygiene policy, revised 06/2024, indicated “… Hand Hygiene should be performed for the following clinical indications… Immediately before touching a patient… Immediately after glove removal…” 3. During a home visit observation on 07/28/2025 beginning at 11:04 AM, the Alternate CM provided care for Patient #7. During the visit, the Alternate CM performed hand hygiene and donned gloves, removed Patient #7’s wound dressing, doffed gloves, and then retrieved wound care supplies from a cabinet and placed them on a barrier before performing hand hygiene. After cleansing the Patient’s wound, The Alternate CM changed gloves without performing hand hygiene. The Alternate CM doffed gloves and then entered the nurse bag to pull out disinfecting wipes prior to performing hand hygiene. The Alternate CM cleaned the blood pressure cuff, stethoscope and thermometer with CVS disinfecting wipes and placed the clean vitals equipment on the same area of the barrier they had been placed after use. The CM failed to place the clean vitals equipment on a clean barrier to air dry. During an interview on 07/28/2025 at 11:41 AM, the Alternate CM indicated hand hygiene should be performed on arrival, before touching the patient, when visibly soiled, at the end of the shift, after glove removal, and prior to entering the nurse bag. When asked if she typically has separate sides of the barrier for dirty and clean equipment, the Alternate CM indicated she had asked the CM about it that morning, and the CM just said to use a barrier. 4. During a home visit observation conducted with Patient #5 and the CM on 7/25/25 beginning at 12:15 PM, the CM cleaned the vitals equipment (blood pressure cuff, pulse ox, stethoscope and thermometer) with Clorox Disinfecting wipes and placed the clean vitals equipment on the kitchen counter to air dry. The CM failed to place the clean vitals equipment on a barrier to air dry. During an interview on 7/28/25 at 12:06 PM, the CM relayed cleaned vitals equipment should be placed on a clean area to dry.

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 observation, record review and interview, the RN failed to adequately assess heart tones for 1 of 1 home visit observation with a head-to-toe assessment (CM). Findings include: 1. The review of chapter 9 of Nursing Skills edited by K. Ernstmeyer and E. Christman, published in 2021, and found on the National Institutes of Health website https://www.ncbi.nlm.nih.gov/books/NBK593199/ indicated when auscultating for heart sounds, “The apical pulse should be counted over a 60-second period.” 2. The undated agency document “Briggs Protocol for Listening to Adult Heart Tones” indicated to identify the S1 (lub) and S2 (dub) heart sounds; Determine rate, rhythm (regular or irregular) and intensity; Listen for extra heart sounds (S3, S4), murmurs, clicks or rubs; and if an irregular rhythm is detected, assess the apical pulse for one full minute. 3. During a home visit observation conducted with Patient #8 and the CM on 7/25/25 beginning at 12:15 PM, observed the CM auscultate Patient #8’s heart tones at the apical site for two seconds. The CM failed to listen to the apical pulse for 60 seconds. 4. During an interview on 7/28/25 beginning at 12:06 PM, the CM relayed the heart tones should have been assessed for 30 seconds.

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 observation, record review and interview, the RN failed to perform a head-to-toe assessment for 1 of 1 home visit observation with a head-to-toe assessment ordered on the POC (CM). Findings include: 1. During a home visit observation conducted with Patient #8 and the CM on 7/25/25 beginning at 12:15 PM, observed the CM provide wound care to Patient #8’s left upper arm/shoulder area and obtain vital signs. The CM failed to perform a head-to-toe assessment as ordered on the POC. 2. During an interview on 7/28/25 beginning at 12:06 PM, the CM relayed she only performed a head-to-toe assessment on Patient #8 one time a week. She then verified the POC for Patient #8 included orders for the SN to perform a head-to-toe assessment three times a week.

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 RN provided written instructions for the HHA to use a Hoyer for transferring for 1 of 2 patients who required a Hoyer lift (Patient #2). Findings include: An agency policy dated 06/2024 outlined the care plan requirements for home health aides. The policy indicated the HHA provides services according to a care plan written by a Registered Nurse. The policy further stipulated that the aide must perform tasks as instructed by the RN. Patient #2’s clinical record evidenced an aide care plan with an effective date of 06/26/2025. The care plan identified a task of “Assist with Mobility – Transferring.” The care plan failed to indicate the aide must use a Hoyer to transfer Patient #2. During an interview beginning at 10:45 AM, the Alternate Clinical Manager indicated the care plan should include instructions to use the Hoyer for transfers.

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 observation, record review, and interview, the agency failed to ensure HHAs reported changes in the patient’s skin for 1 of 1 patients with severe sunburn (Patient #6). Findings include: 1. An agency policy dated 6/2024 outlined care coordination expectations. The policy stated, “Timely and ongoing communication is the responsibility of each team member ...” and “… Personnel will communicate changes in a timely manner.” The policy indicated care coordination included communication regarding changes in a patient’s condition. 2. During a home visit observation on 07/25/2025 at 01:30 PM, HHA 14 gave Patient #6 a shower. During the shower, Patient #6’s back was peeling from a sunburn. Observed Patient #6’s lower back to be red. On the left lower back, observed an area approximately 1½ inch across with three areas that appeared to be small open blisters. A review of HHA 14’s notes for 07/18/2025 and 07/25/2025 failed to identify the sunburn or other skin changes. A review of HHA 15’s notes for 07/19/2025 and 07/23/2025 failed to identify the sunburn or other skin issues. During an interview at the time of the observation, HHA 14 indicated it was a “really bad sunburn.” HHA 14 did not notify the RN but let the family know about it. HHA 14 indicated it was up to the family if they wanted anything done about the sunburn. During an interview on 07/28/2025 at 10:27 AM, HHA 15 indicated Patient #6 had no skin issues other than a “bad sunburn. Really bad.” HHA 15 did not notify the RN of the sunburn. HHA 15 indicated there was peeling skin and a “little reddened skin” on Patient #6’s right leg. During an interview on 07/29/2025, beginning at 10:45 AM, the Alternate Clinical Manager indicated they were not notified about the “really bad” sunburn. The Alternate Clinical Manager indicated they expected the aides to notify them about the skin condition. They indicated HHA 14 and 15 should have included the severity of the sunburn in their notes. 3. A review of HHA 14’s job description, signed and dated 06/18/2024, stated “The HHA is responsible for observing clients, reporting these observations and documenting observations ….” 4. A review of HHA 15’s job description, signed and dated 01/20/2025, stated “The HHA is responsible for observing clients, reporting these observations and documenting observations….” During an interview on 07/29/2025 beginning at 10:45 AM, the Alternate Clinical Manager indicated the aides could have notified them by phone call, sent their notes to them, or put a communication note in the EMR.

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 supervision visits for patients receiving skilled services were performed at least every 14 days for 2 of 7 active patients receiving HHA services (Patient #4, 8). Findings include: 1. Review of the Clinical Supervision of Home Health Aides Policy, revised 06/2024, indicated “… Patients receiving Home Health Aide Services as well as Skilled Nursing services shall have a Registered Nurse make a supervisory visit every fourteen (14) days. Supervisory visits are documented in the patient’s medical record on the appropriate Agency form…” 2. Review of Patient #4’s clinical record included, but not limited to, HHA supervisory visits on 06/26/2025 and 07/11/2025, 15 days later. The clinical record also included, but not limited to, twice daily HHA visits from 06/27/2025 to 07/10/2025. During an interview on 07/29/2025 at 2:05 PM, the CM indicated HHA supervisory visits should be every 14 days for patients receiving skilled services. She also indicated there probably wasn’t an HHA supervisory visit done between 06/26/2025 and 07/11/2025 because an RN case manager had recently left. 3. Review of Patient #8’s clinical record included, but not limited to, HHA supervisory visits on 06/13/2025 and 07/07/2025, 24 days later. The clinical record also included, but not limited to, twice daily HHA visits from 06/14/2025 to 07/06/2025. During an interview on 07/29/2025 at 2:05 PM, the CM indicated HHA supervisory visits should be every 14 days for patients receiving skilled services. She also indicated she saw the patient on 06/16/2025, 06/20/2025, and 06/25/2025 while HHAs were present but did not document HHA supervisory visits for those dates.

This visit was for a Federal Recertification and State re-licensure survey in conjunction with a complaint survey of a Home Health Agency. Survey dates: 7/11, 7/12, 7/13, and 7/14/22 Complaint # 29749: Substantiated: Federal and state deficiencies were not cited. This report reflects State Findings cited in accordance with 410 IAC 17.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on review, observation, and interview, the agency failed to ensure staff followed infection control policies and procedures for 2 of 3 home visit observations. (Patients #2 and #4). Findings include: 1. A review of the Centers for Disease Control on 7/15/22, “When to Perform Hand Hygiene” (https://www.cdc.gov/handhygiene/providers/), revealed that, “Multiple opportunities for hand hygiene may occur during a single care episode. Following are the clinical indications for hand hygiene: Use an Alcohol-Based Hand Sanitizer or wash with soap and water immediately before touching a patient, when hands are visibly soiled, before performing an aseptic task (e.g., placing an indwelling device) or handling invasive medical devices, after caring for a person with known or suspected infectious diarrhea, before moving from work on a soiled body site to a clean body site on the same patient, after known or suspected exposure to spores (e.g. B. anthracis, C difficile outbreaks), after touching a patient or the patient’s immediate environment, after contact with blood, body fluids or contaminated surfaces, or immediately after glove removal.” “WHEN AND HOW TO WEAR GLOVES” revealed, “Wear gloves, according to Standard Precautions, when it can be reasonably anticipated that contact with blood or other potentially infectious materials, mucous membranes, non-intact skin, potentially contaminated skin or contaminated equipment could occur. Gloves are not a substitute for hand hygiene. If your task requires gloves, perform hand hygiene prior to donning gloves, before touching the patient or the patient’s environment. Perform hand hygiene immediately after removing gloves. Change gloves and perform hand hygiene during patient care, if…moving from work on a soiled body site to a clean body site on the same patient…” 2. A review of an Agency’s policy titled, “Policy No. 9-011 Hand Hygiene” dated 9/21, revealed, “…2. When to Wash: …before and after caring for a person, contact with a patient’s skin, contact with environmental surfaces…, touching contaminated surfaces, after glove removal…” 3. A review of an Agency’s policy titled, “Policy No. 9-009 Standard Precautions Policy” dated 12/21, revealed “POLICY The Agency personnel will adhere to the following precautions and will instruct patients and family/caregivers in infection control precautions…PROCEDURE…GENERAL PRECAUTIONS-HAND HYGIENE B. Hand hygiene will be performed to prevent cross-contamination between the patient and personnel. A. Gloves…Gloves are to be worn when…i. There is actual or potential contact with blood or other potentially infectious materials…iii. Touching contaminated items or surfaces…x. Cleaning of body fluids and decontamination procedures…xiii. Handling soiled linen…c. Gloves are to be changed: i. Between tasks and procedures on the same patient, ii. After changing or cleaning an incontinent patient…e.i. Gloves are not necessarily needed for general care or during casual contact, such as bathing of intact skin…” 4. A home visit with Pt 2 was conducted on 7/12/22 at 8 am, with HHA 1. HHA 1 arrived prior to this writer, and upon entering the home, HHA 1 was gathering clothing for the patient. The HHA 1 was asked to move their vehicle, complied with the request, returned, and completed hand hygiene. HHA 1 filled 2 water basins, then proceeded to remove the patient’s blankets, heel protectors, socks, and gauze between toes without the use of gloves. HHA 1 began washing the patient’s face with plain water. HHA1 donned gloves, washed, rinsed, and dried the patient’s upper front torso, repeated the same on the patient’s back, and threw washcloths in a dirty linen basket. Doffed gloves and donned a clean pair of gloves. Washed, rinsed, and dried both lower extremities. Reached into a clean linen bin, retrieving a clean washcloth for peri care. HHA 1 removed the old brief from the patient, performed peri care, doffed gloves, and donned a clean pair of gloves. HHA stated they liked to make a mixture of Calmoseptine, barrier protective cream, and A & D ointment to apply as a protective barrier to the patient’s coccyx area, then applied Vaseline to the patient’s groin areas. HHA 1 changed gloves, touching different lotions to pick out and apply certain lotions to the patient’s face and arms, chest and back, legs, and feet. HHA 1 changed gloves, placed gauze between toes and applied socks. HHA 1 finished dressing and covering the patient, then emptied the wash basins. 5. During an interview with Adm Staff 1 on 7/13/22 at 2:45 PM, Adm Staff stated yes, I saw that, when discussing hand hygiene with HHA 1. 6. A review of an untitled, undated Agency document stated, "BrightStar Employees...our hope is for the health and safety of our clients to continue. Remaining vigilant in the procedures and processes from the CDC [Centers for Disease Control] that you have now grown accustomed to over the last year is still of utmost importance while we are still navigating the pandemic. Reminders of the processes that you should be following include: a. Utilize excellent handwashing. - Wash your hands often with soap and water for at least 20 seconds...- Wash your hands after each time you have removed your gloves... - If soap and water are not readily available, use of a hand sanitizer that contains at least 60% alcohol is a good option. Cover all surfaces of your hands and rub them together until they feel dry... d. Wear gloves when providing patient care." 7. A home visit was conducted on 7/12/22 at 9:00 AM. Home Health Aide 2 was observed preparing Patient 4 for a shower. With bare hands, HHA 2 assisted the patient with disrobing, and set the dirty laundry aside, the HHA drew back the shower curtain, turned on the faucet and waited for an acceptable temperature, assisted the patient into the shower, allowed the patient to wash as much of self as able, and assisted with the rest, including scrubbing the patient’s back with a soapy cloth. While the shower was still in progress, HHA 4 assisted with tousling the patient's hair to ensure shampoo had been rinsed out. With bare hands, HHA 4 handed the patient 2-3 disposable cleansing wipes for the patient to self-cleanse the peri area. When the patient had completed the task, with bare hands, the aide held up a small clear trash bag near the opening of the shower, close enough for the patient to insert and dispose of the now used wipes. When the shower was complete, with bare hands, HHA 4 assisted the patient in transferring out of the shower and into a nearby chair, assisted with toweling the patient off to dry the skin, and aided in dressing the patient by assisting with putting on a new brief and fresh clothes. At no time during the undressing, bathing, and dressing activities was hand hygiene performed. At no time during these activities were gloves worn by the aide. 8. In an interview on 7/12/22 at 9:30 AM with RN 3, who had been present for the home visit, when queried as to what she witnessed during the visit, spoke of the aides' attributes but refrained from speaking on infection control breaches of not wearing gloves while performing cares and not performing hand hygiene at appropriate intervals. 9. In an interview on 7/12/22 at 11:20 AM with CEO/Owner and Administrator, they acknowledged awareness of the breaches of not wearing gloves during care and failing to perform hand hygiene at appropriate intervals, and they indicated they would be bringing in HHA 4 for coaching and re-education on these discrepancies, to ensure compliance with infection control practices going forward.