Total Home Health Services Inc.

“Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient’s status at the time of assessment. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure Outcome and Assessment Information Set (OASIS) accurately reflected the patient’s status at the time of assessment in 1 of 2 active clinical records reviewed with a staged wound and a home visit (Patient #2). Findings include: The clinical record of Patient #2 included an initial comprehensive assessment completed on 10/11/2024 by RN 2. The primary diagnosis was a stage 2 pressure ulcer (partial thickness open wound where skin wears away) wound of the right buttock, and a secondary diagnosis included a stage 2 pressure ulcer of the left buttock. The wound care documentation of the comprehensive assessment included a stage 2 left buttock pressure ulcer that measured 3.4 cm long X 3.5 cm wide X .2 cm in depth and stage 2 right buttock pressure ulcer that measured 3 cm long X 4.5 cm wide X .2 cm deep. OASIS documentation at M1324 asked the stage of the most problematic unhealth pressure ulcer /injury that is stageable; the M1324 failed to evidence documentation of staged pressure ulcers, documentation was N/A (not applicable). During an interview on 12/05/2024 beginning at 12:30 PM, RN 2 relayed the reason for home health for Patient was due to pressure ulcers on the right and left buttock. During an interview on 12/06/2024 beginning at 8:10 AM, Other D, family member and caregiver for Patient #2, revealed Patient had a pressure ulcer on both the right and left buttock at the start of care with the agency.”

“Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient’s condition warrants due to a major decline or improvement in the patient’s health status, but not less frequently than- This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was updated and revised as frequently as the patient’s condition warrants due to a major decline or improvement in patient’s health status in 1 of 2 active clinical records with home visits and wounds (Patients #2). Findings include: The clinical record of Patient #2 revealed an initial comprehensive assessment, dated 10/11/2024, authored by RN 2, included the primary diagnosis Stage 2 pressure ulcer (partial thickness open wound) wound of the right buttock, and a secondary diagnosis of Stage 2 pressure ulcer of the left buttock. The comprehensive assessment included documentation that a stage 2 left buttock pressure ulcer measured 3.4cm long x 3.5cm wide X .2 cm in depth and the stage 2 right buttock pressure ulcer measured 3 cm long x 4.5 cm wide x .2 cm deep. Documentation included 1) a skin tear to the left forearm measuring 7 cm long x 2 cm wide X .2 cm deep and 2) a skin tear to the left lower leg measuring 6.5 cm long X 3.8 cm wide X .2 cm deep. Documentation from skilled nurse visit notes dated 11/04/2024, 11/08/2024, 11/11/2024, 11/14/2024, and 11/19/2024 measure the right buttock wound as 0 cm X 0 cm X 0 cm, indicating a healed wound. The clinical record failed to evidence a comprehensive reassessment to reflect the change in Patient’s condition. On 12/04/2024, SN visit note documentation revealed a newly opened wound, a stage 2 right buttock ulcer, that was treated, and a new skin tear was documented to the right lower leg skin tear that was treated. The RN failed to evidence measurements of the new wounds to the right buttock and right lower leg. The clinical record failed to evidence a comprehensive reassessment to reflect the new wounds to right buttock and right lower leg. During an interview on 12/05/2024 beginning at 3:30 PM, Clinical Manager relayed comprehensive assessment includes Outcome and Assessment information set (OASIS) information and the agency does not revise the comprehensive assessment except for every 60 days. During an interview on 12/05/2024 beginning at 12:38 PM, RN 2 relayed the right lower leg skin tear was new and the reopening of the right buttock was new at the 12/04/2024 visit. RN revealed the two new wounds were not measured and should have been. 410 IAC 17-14-1(a)(1)(B)”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure each patient received the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals for 1 of 1 active records reviewed for a recertified patient. (Patient 6) The Findings Include: The clinical record for Patient 6 included a recertification comprehensive assessment dated 11/29/24 which identified pain that interfered with activity. The plan of care for the recertification 12/03/2024 – 01/31/2024 failed to include interventions or measurable goals related to pain. During an interview on 12/6/24 beginning at 11:50 AM, the CS indicated the POC was not complete, there were no goals or interventions for pain.”

“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 their staff followed accepted standards of practice for prevention of transmission of infections in 2 of 2 home visits of patients with wounds [RN 2 and RN3]. The findings include: 1. A policy with revised date of 5/27/2024 titled “Infectious Disease Control” indicated hands should be washed when moving from a contaminated body site to a clean body site, after contact with blood, body fluids or contaminated surfaces. 2. During observation of care at the home of Patient #2 on 12/04/2024 beginning at 11:07 AM to 11:40 AM, RN 2 donned clean gloves, removed the soiled dressing from both wounds on the left forearm, then without hand hygiene and change of gloves, RN 2 applied the wound treatment and a clean dressing to each of the wounds. RN 2 donned [applied] clean gloves removed the soiled dressing from the wound on the left lower leg, then without hand hygiene and change of gloves, RN 2 applied the wound treatment and a clean dressing to the wound. RN 2 donned clean gloves removed the soiled dressing from the wound on the right lower leg, then without hand hygiene and change of gloves, RN 2 applied the wound treatment and a clean dressing to the wound. RN 2 rolled the Patient onto her right side and one open area to the left buttock and one open area to the right buttock were observed. RN2 donned clean gloves and applied ointment to both wounds without a change of gloves and hand hygiene. RN 2 donned gloves and wiped equipment used for patient care (stethoscope, blood pressure cuff, and oxygen monitor) with a disposable sanitizing wipe and immediately place them into the nurse bag. Directions on the package of the disposable sanitizing wipe indicated a wet to dry time of two minutes. On 12/5/2024 beginning at 11:30 AM RN 2 indicated she did not use hand sanitizer after removing soiled bandage and before applying new dressing and before treating one wound before another. RN2 indicated that she was not aware of dry time for the disposable sanitizing wipes. 3. During an observation of care at the home of Patient #1 on 12/4/2024 from 2:36 PM to 3:15 PM, RN 3 donned clean gloves, removed the soiled dressing from the wound on the right heel, then without hand hygiene and change of gloves, RN 2 applied the wound treatment and a clean dressing to the wound. RN 3 donned clean gloves, removed the soiled dressing from the wound on the left buttock, then without hand hygiene and change of gloves, RN 2 applied the wound treatment and a clean dressing to the wound. RN 3 donned gloves and wiped equipment used for patient care (stethoscope, blood pressure cuff, thermometer, oxygen monitor, and bandage scissors) with a disposable sanitizing wipe and immediately place them into the nurse bag. Directions on the package of the disposable sanitizing wipe indicated a wet to dry time of two minutes. On 12/4/2024 beginning at 3:07 PM RN 3 indicated she believed the dry time for the disposable sanitizing wipes to be one minute. Upon looking at disposable sanitizing wipe container label, RN 3 indicated the dry time was 2 minutes. On 12/5/2024 beginning at 3:39 PM, RN 3 indicated hand hygiene and changing gloves in between removal of old dressing and application of new dressing should be completed and indicated she did do it during the visit.”

“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 the home health aide (HHA) patient specific instructions and precautions in 1 of 1 active clinical record with home health aide (HHA) service and a home visit (Patient #2). Findings include: The clinical record for Patient #2 included an initial POC dated 10/11/2024 to 12/09/2024 with ordered services SN, PT, and OT and a diet ordered as diabetic pureed (whipped or mashed consistency). The medication list on the medical POC included a daily dose of Plavix, a blood thinner that prevents clots. The clinical record included an order dated 10/13/2024 for HHA services to begin the week of 10/20/2024 twice a week for seven weeks. The HHA POC dated 10/11/2024 to 12/09/2024, signed by RN 2, indicated Patient’s diet is diabetic. The HHA POC failed to evidence a pureed diet and anticoagulant precautions. During an interview on 12/04/2024 beginning at 12:25 PM, Clinical Manager relayed the pureed diet was not on the HHA POC nor are the bleeding precautions. 410 IAC 17-14-1(m)”

“Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the rights of the patients including consent in advance of and during treatment in 1 of 1 active clinical record review with a start of care on or after 11/23/2024 (Patient #1). Findings include: The clinical record for Patient #1 included an initial comprehensive assessment, completed on 11/23/2024, and a POC for the certification period 11/23/2024 to 01/21/2025 with ordered services SN, PT, and OT throughout the certification period. A PT and OT evaluation were completed on 11/27/2024 and an SN visit was completed 11/25/2024 that included wound care. The clinical record failed to evidence a consent for treatment from the start of care date 11/23/2024 to 12/04/2024. During the entrance conference 12/03/2024 beginning at 11:00 AM, Administrator relayed the clinical records are completely electronic and any written documents were scanned into EMR, then shredded. During an interview on 12/04/2024 beginning at 12:15 PM, Administrator relayed the consent documentation had not been scanned into the electronic medical record and was not available for review. 410 AC 17-12-3(b)(2)(D)(i)(AA)”

“Outcomes/goals have been achieved CFR(s): 484.50(d)(3) The transfer or discharge is appropriate because the physician or allowed practitioner, who is responsible for the home health plan of care and the HHA agree that the measurable outcomes and goals set forth in the plan of care in accordance with §484.60(a)(2)(xiv) have been achieved, and the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the patient no longer needs the HHA’s services; This Element is not met as evidenced by: Based on record review and interview, the agency failed to evidence the discharge was appropriate and the allowed practitioner, responsible for the home health plan of care, agreed that the patient no longer needed the services set forth in the plan of care for 1 of 1 discharged record reviewed for goals met. (Patient 9) The Findings Include: The record reviewed on 12/5/24 for Patient 9 included a discharge comprehensive assessment, dated 8/23/24, indicated Patient was discharged with goals met. The discharge summary dated 9/5/24 indicated 6 of the 14 physical therapy goals were not met. During an interview on 12/6/24 beginning at 1:00 PM, the clinical manager indicated Patient was discharged with goals met and that the PT made an error in documentation. The clinical manager was unable to provide the order for discharge. No further documentation was provided prior to survey exit.”

“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 agency failed to ensure a registered nurse conducted an initial assessment visit to determine the immediate care and support needs of the patient within 48 hours of referral for 1 of 1 active records reviewed that included a recertification period. (Patient #6) The Findings Include: The record reviewed on 12/5/24 for Patient 6 included a referral dated 5/31/24. The record included a start of care comprehensive assessment dated 6/6/24. During an interview on 12/6/24 beginning at 11:50 AM, the administrator indicated they did not know why there was a delay and there was no documentation related to the delay.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on record review and interview, the comprehensive assessment failed evidence a review of all medications the patient was currently using, to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects and or drug interactions, duplicate drug therapy, and noncompliance in 4 of 4 active records reviewed with severe drug-drug interactions (Patient #1, 2, 5, and 6). Findings Include: 3.The record reviewed on 12/4/24 for Patient 5 included a start of care comprehensive assessment dated 11/19/24 which indicated medications were reconciled with serious interactions. The record failed to evidence notification to the provider of the major drug-drug interaction between Diltiazem (a medication used to treat high blood pressure and Atorvastatin (a medication used to treat high cholesterol). During an interview on 12/4/24 beginning at 2:40 PM, the Clinical Supervisor (CS) indicated the drug-drug interaction report had not been completed and therefore was not sent to the provider for notification. 4.The record reviewed on 12/5/24 for Patient 6 included a recertification comprehensive assessment dated 11/29/24 which indicated medications were reconciled with serious interactions. The record failed to evidence notification to the provider of the major drug-drug interaction between Amiodarone (a medication used to treat irregular heartbeat) and Beta-Adrenergic Blockers (a medication used to treat high blood pressure and irregular heartbeat). During an interview on 12/6/24 beginning at 11:50 AM, the clinical supervisor indicated they do not send the drug-drug interaction report to the provider, at the time of the comprehensive assessment. The CS relayed they send the interaction report with the plan of care, regardless of interaction level. The administrator indicated record did not include documentation that the provider was notified of the drug-drug interaction. 1.The clinical record of Patient #1 revealed an initial comprehensive assessment, dated 11/23/2024, indicated the medications were reconciled and no issues were found during the review. Patient’s medications included: Breo Ellipta, Farxiga, Folic Acid, Ipratropium-Albuterol, Lasix, Lorazepam, Lyrica, Metoprolol, MiraLAX, Oxcarbazepine, Oxygen, Pantoprazole, Potassium Chloride, Prednisone, Prozac, Pulmicort, Singulair, Spironolactone, Theophylline, Tramadol, and Trazodone. The medication interaction report on the electronic medical record [EMR] revealed major interactions between the following: Lorazepam and Tramadol, Tramadol and Lyrica, Lorazepam and Tramadol, Prozac and Tramadol, Trazodone and Tramadol, Prozac and Trazadone, and Potassium and Spironolactone. The clinical record failed to evidence physician notification of major drug interactions within Patient’s home medication list. During an interview on 12/04/2024 beginning at 12:15 PM, Clinical Manager relayed the major medication interactions were not provided to the physician. 2.The clinical record of Patient #2 revealed an initial comprehensive assessment, dated 10/11/2024, included Patient’s medication list included Omeprazole and Plavix. The EMR drug interaction report identified a major drug interaction between Plavix and Omeprazole. The clinical record failed to evidence the drug interaction report, from the comprehensive assessment at start of care dated 10/11/2024, was provided to Patient’s primary care physician until 11/05/2024. During an interview on 12/04/2024 beginning at 12:25 PM, Clinical Manager relayed the medications interactions were usually sent to the physician with the plan of care.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure the individualized plan of care included the types of services, supplies, equipment required, nutritional requirements, medications and treatments, and or safety measures to protect against injury for 6 of 7 active records reviewed. (Patient 1, 2, 3, 4, 5, and 7) The Findings Include: 5.The record reviewed on 12/5/24 for Patient 7 included a comprehensive assessment dated 11/12/24 indicated the patient was on hemodialysis three times per week. The plan of care failed to evidence safety measures for fistula care nor dietary restrictions for a dialysis patient. During an interview on 12/5/24 beginning at 1:30 PM, staff nurse at Other Entity G indicated Patient 7 had a 36-ounce daily fluid restriction and received hemodialysis every Tuesday, Thursday and Saturday. During an interview on 12/6/24 beginning at 11:15 AM, the Clinical Supervisor indicated they would expect the plan of care to include safety measures for fistula care and any dietary restrictions. The Clinical Supervisor indicated they were not included on the plan of care for Patient 7. 1. The clinical record of Patient #1 revealed an initial POC dated 11/23/2024 to 01/21/2025. The POC, signed by RN #1, included the ordered services for SN, PT, and OT; the POC did not include Entity F, the assisted living facility [ALF] where Patient #1 resides, nor did it specify the services provided by Entity F for Patient. During an interview on 12/04/2024 at 12:15 PM, the Clinical Manager stated that Patient #1 resided in Entity F, an ALF. She revealed that the initial POC for Patient #1 had not yet been reviewed and that she did not know if Entity F or the services they provided were listed in the POC. On 12/05/2024 at 3:30 PM, RN 1 confirmed that Patient #1 required assistance with activities of daily living and received health services from Entity F. 2. A review of Patient #2’s clinical record revealed an initial POC dated 10/11/2024 to 12/9/2024. The POC included orders for the following services: SN once a week for one week, twice a week for four weeks, and once a week for one week, PT twice a week for four weeks, then once a week for four weeks, and OT with a frequency of “evaluate and treat.” The medical POC did not specify OT frequency or individualized OT goals. An OT evaluation was completed on 10/18/24, and a separate OT POC dated 10/11/2024 to 12/9/2024 listed OT visit frequency as once a week for one week, then twice a week for six weeks starting on 10/18/24. The OT POC included Patient #2’s OT goals. The POC also included a medication list that with Plavix (a blood thinner) for daily use; the POC failed to specify bleeding precautions as a safety need. An order for home health aide (HHA) services, signed by RN 2 on 10/11/24, ordered HHA twice a week for seven weeks starting the week of 10/20/2024; the medical POC failed to include HHA services or frequency. During an interview on 12/4/2024 at 12:25 PM, the Clinical Manager stated that Patient #2’s POC did not include OT frequency, care, or goals, noting that OT had a separate POC. She also confirmed that bleeding precautions were not included as a safety measure on Patient #2’s POC but should have been. 3. A review of Patient #3’s clinical record revealed an initial POC dated 11/22/24 to 1/20/25. The POC included ordered services for skilled nursing (SN) once a week for two weeks, twice a week for two weeks, and once a week for five weeks. The POC identified the principal diagnosis as hypertension. However, a referral for home health services dated 11/19/24 and signed by the patient’s primary care physician listed additional diagnoses, including dyslipidemia, memory deficit, tinnitus, and pulmonary emphysema. The POC failed to document these diagnoses or the reason for admission to home health services. During an observation on 12/04/2024 at 9:47 AM, RN 1 revealed that the main reason for home health care for Patient #3 was memory issues. On 12/4/2024 at 12:02 PM, Patient #3’s family member and caregiver, Other C, confirmed that the reason for home health care was short-term memory loss. On 12/5/2024 at 1:30 PM, the Clinical Manager stated that the POC for Patient #3 was still under review by quality assurance and had not been completed. 4. During a home visit on 12/4/2024 at 4:00 PM, Patient #4 was observed with a urostomy, a surgically created opening to allow urine to drain from the body. The urostomy had a collection bag attached to collect urine. A test meter for INR (international normalized ratio) was also observed in the patient’s home. A review of Patient #4’s clinical record revealed a POC dated 11/12/2024 to 1/10/2025. The POC listed Warfarin (a blood thinner) under the patient’s medication list. However, the POC did not document the use of an INR test meter as part of the patient’s durable medical equipment (DME) nor the frequency of INR testing. The POC also failed to include documentation of the caregiver’s role, the services provided by the caregiver, or the company providing the caregiver services. Additionally, the POC did not include documentation of urostomy supplies under DME or supplies, nor did it contain treatment orders for urostomy care or stoma care. During an interview with Patient #4 on 12/4/2024 at 4:00 PM, the patient stated that RN #5 provided urostomy care, including changing the urostomy bag once a week. The patient also revealed that the INR test meter was used to conduct a blood test using a finger stick once a week and stated they were trained and comfortable using the device. Additionally, the patient relayed that a caregiver provided personal care seven days a week. On 12/5/2024 at 1:30 PM, Other A, a family member and healthcare representative for Patient #4, confirmed that they were responsible for managing the patient’s health care. Other A stated that Patient #4 was attempting to save money but had to pay out-of-pocket for personal care services provided seven days a week by the agency’s sister company, Entity B. On 12/6/2024 at 12:00 PM, RN #5 stated that she provided urostomy care for Patient #4 twice a week at every visit. This care included cleansing the urostomy stoma with saline and attaching a new urostomy bag.”

“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 drugs, services, and treatments were administered only as ordered by a physician in 4 of 4 active clinical records reviewed with a home visits (Patients # 1, 2, 3, and 4). Findings include: 1.The agency policy titled “Coordination of Patient Services,” revised 01/2019, indicated the patient’s physician will be notified of missed visits via fax or clinician will contact the physician when there is a clinical impact on the patient. 2. The clinical record for Patient #1 included an initial POC for the certification period 11/23/2024 to 01/21/2025 with orders for 1) SN services once a week for one week then three times a week for 8 weeks with orders for wound care, 2) PT was ordered 2 times a week for 8 weeks, and 3) OT once a week for eight weeks. RN 3 provided care to Patient on 11/25/24 and 11/27/24 and a PT and OT evaluations were conducted on 11/27/2024. The clinical record failed to evidenced documentation of physician orders for the medical care provided. The POC failed to evidence a physician’s signature, and the clinical record failed to evidence a verbal order for the medical care provided beginning 11/23/2024 through 12/03/2024. During an interview on 12/04/2024 beginning at 12:15 PM, Clinical Manager relayed there was not an order for treatments. She revealed she wrote an order for Patient’s care on 12/04/2024. 3. The clinical record for Patient #2 included an initial POC dated 10/11/2024 to 12/09/2024 with ordered services SN once a week for one week, twice a week for four weeks, then once a week for one week, PT twice a week for four weeks then once a week for four weeks, and OT frequency noted as evaluate and treat. An OT evaluation was completed 10/18/24. The record included a separate OT POC dated 10/11/24 to 12/9/14 with OT visit frequency of once a week for one week then twice a week for six weeks starting 10/18/24 and included Patient OT goals. The medical POC and the OT POC were signed by Patient’s primary care physician on 11/14/24. The clinical record failed to evidence verbal orders for treatments and therapies provided beginning at the start of care on 10/11/24 to 11/14/24. During an interview on 12/04/2024 beginning at 12:25 PM, Clinical Manager relayed the clinical record did not include physician orders for services to include frequencies, treatments, nor therapies. 4. The clinical record for Patient #3 included an initial POC dated 11/22/2024 to 01/20/2025 with ordered services SN once a week for two weeks, twice a week for two weeks, and once a week for five weeks for assessments, education, and medication review. The initial start of care visit included a comprehensive assessment dated 11/22/2024 with subsequent SN visits on 11/27/24 and 12/04/2024. The clinical record included a verbal order, dated 11/22/2024, for SN visits once a week for two weeks, twice a week for two weeks, and once a week for five weeks. The plan of care failed to evidence a physician’s signature. The clinical record failed to evidence a verbal order for the specific nursing care provided from 11/22/2024 to 12/04/2024. During an interview on 12/04/2024 beginning at 10:40, Clinical Manager relayed there was no order for specific care provided to Patient. 5. During a home visit observation on 12/04/2024 at 4:00 PM, Patient #4 was observed with a urostomy, a surgically created opening to allow urine to drain from the body. The patient had a device attached to collect urine. The clinical record for Patient #4 revealed an initial plan of care dated 11/12/2024 to 01/10/2025 with the services ordered, SN twice a week for nine weeks, PT once a week for one week then twice a week for eight weeks, and OT once a week for four weeks. The clinical record evidenced RN 5 completed SN visits on 11/14/2024, 11/18/2024, 11/20/20/2024, 11/25/2024, 11/27/2024 and 12/02/2024; the visits included documentation of wound treatments provided to Patients right forearm and indicated urostomy care was provided during each visit. The clinical record failed to evidence the plan of care was signed by Patient’s attending physician nor did the clinical record evidence orders for the home health services, treatments, and therapies provided by SN, PT, nor OT from the start of care to 12/05/2024. During an interview 12/04/2024 at 4:00 PM, Patient #4 stated that RN 5 provided urostomy care, including changing the urostomy bag once a week. In a separate interview on 12/6/2024 at 12:00 PM, RN 5 stated that she provided urostomy care twice a week for Patient #4 at every visit. This care included cleansing the urostomy stoma with saline and attaching a new urostomy bag. RN 5 relayed she had provided care to Patient; she had not yet submitted the POC to the physician to be signed and denied obtaining verbal nor written orders before the provision of care. 410 IAC 17-13-1(a)”

“Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA’s internal policies. (4) When services are provided on the basis of a physician or allowed practitioner’s verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA’s policies, must document the orders in the patient’s clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA’s internal policies. This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure services were provided based on a physician or allowed practitioner’s verbal orders, or verbal orders were authenticated and dated by the physician or allowed practitioner for 2 of 2 active records reviewed with use of anticoagulants or identified increased risk of bleeding. (Patient #5,6) The Findings Include: The record on 12/4/24 for Patient #5 included a POC for the recertification period 11/19/2024- 1/17/2025 indicated a SN visit frequency of 1 visit per week for 1 week, 2 visits per week for 2 weeks, 1 visit per week for 6 weeks, PT visit frequency of 1 visit per week for 1 week, 2 visits per week for 4 weeks, 1 visit per week for 4 weeks; and an OT visit frequency of 1 visit per week for 4 weeks. The record failed to evidence documentation verbal or written order was obtained for SN, PT or OT services as written on the POC. During an interview on 12/4/24 beginning at 2:40 PM, the Clinical Supervisor indicated there was no documentation that written or verbal orders were obtained. 2.The record on 12/5/24 for Patient 6 indicated OT visits were made on 11/08/2024, 11/16/2024, 11/25/2024, and 11/28/2024. The POC for the recertification period 10/4/24 – 12/2/24 failed to evidence an order for OT. During an interview on 12/6/24 beginning at 11:50 AM, the clinical supervisor indicated the OT wrote a clinical note for weekly visits, indicated there should have been a written order and be included on the POC, it was not.”

“Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This Element is not met as evidenced by: Based on observation and interview, the agency failed to ensure written instructions outlining an treatments and therapy to be administered by agency personnel in 1 of 1 active clinical record reviewed with a home visit with physical therapy (Patient #4). Findings include: During a home visit observation on 12/04/2024 beginning at 4:00 PM, an agency folder was present with documentation of Patient’s visit schedule and failed to evidence written documentation of therapies, treatments, nor services. The clinical record for Patient #4 included an initial POC dated 11/18/2024 to 01/10/2025 with the following services ordered: skilled nurse (SN) once a week for nine weeks, physical therapy (PT) once a week for one week then twice a week for eight weeks, and occupational therapy (OT) once a week for four weeks. During an interview on 12/04/2024 beginning at 4:00 PM, Patient #4 relayed the agency folder in the home contained all paperwork provided by the agency. Patient denied having received written documentation of treatments and therapies provided by agency. Patient denied knowing treatments and therapies to be expected from the agency.”

“Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure their skilled professionals who provide services to patients prepared clinical notes for 4 of 4 [Patient # 1, 2, 4, and 5] active records reviewed with home visits and 1 of 1 [Patient #8] discharged record reviewed for hospitalization. The Findings Include: # The agency policy titled “Documentation of Patient Services,” revised 05/2023, indicated clinical notes including skilled nursing notes, home health aide notes, therapy visit notes, evaluations and assessments, physician orders, and communications were expected within 48 hours of visit date and times. # The clinical record for Patient #1 included an initial POC dated 11/23/2024 to 01/21/2025 with ordered services as SN once a week for one week then three times a week for eight weeks, PT twice a week for 8 weeks, and OT once a week for eight weeks. On 12/03/24, the SN visit note for the 11/30/24 visit was undocumented. On 12/06/2024, the SN visit note for 12/02/2024 was not completed. During an interview on 12/04/2024 beginning at 12:15 PM, Administrator relayed the 11/30/2024 there was no SN visit made, the visit was missed, and the skilled nurse visit on 12/03/2024 was completed, yet not documented. # # The clinical record of Patient #2 revealed an initial comprehensive assessment completed on 10/11/2024 by RN 2 that included the primary diagnosis indicated stage 2 pressure ulcer (partial thickness open wound where skin wears away) wound of the right buttock, and a secondary diagnosis included stage 2 pressure ulcer of the left buttock. The wound care documentation of the comprehensive assessment included a stage 2 left buttock pressure ulcer that measured 3.4cm long X 3.5cm wide X .2 cm in depth, a stage 2 right buttock pressure ulcer that measured 3 cm long X 4.5 cm wide X .2 cm deep, a skin tear to the left forearm measuring 7 cm long X 2 cm wide X .2 cm deep, and a skin tear to the left lower leg measuring 6.5 cm long X 3.8 cm wide X .2 cm deep. Right buttock wound was measured at 0 cm X 0 cm X 0 cm for SN visits on 11/4/24, 11/08/2024, 11/11/2024, 11/14/2024, and 11/19/2024. On 12/04/2024, SN visit note documentation revealed a stage 2 right buttock ulcer that was treated and not measured, only noted as pea sized. A new skin tear was documented to the right lower leg skin tear that was treated and not measured. The clinical record failed to evidence measurements of newly opened right buttock pressure ulcer nor the new right lower leg skin tear. During an interview on 12/05/2024 beginning at 12:38 PM, RN 2 relayed the right lower leg skin tear was new and the reopening of the right buttock was new at the 12/04/2024 visit. RN revealed the two new wounds were not measured but should have been. During an interview on 12/06/2024 beginning at 8:10 AM, Other D, family member and caregiver for Patient #2, revealed Patient had the right lower leg skin tear that started 2 to 3 weeks ago and the RN had been treating the wound since it appeared. # The clinical record for Patient #4 revealed an initial plan of care dated 11/12/2024 to 01/10/2025 that included services ordered included SN twice a week for nine weeks, PT once a week for one week then twice a week for eight weeks, and OT once a week for four weeks. On 12/04/2024, a Certified Occupational Therapist Assistant (COTA) scheduled 11/19/2024 was undocumented. On 12/06/2024, a PT scheduled visits for Patient was undocumented on 12/02/2024. During an interview on 12/04/2024 beginning at 3:20 PM, Administrator relayed the COTA visit on 11/19/2024 was completed but the COTA had not yet documented the care. Administrator indicated the PT visit for 12/2/24 but was not yet documented. # The closed clinical record of Patient #8 included a referral for home health services dated 06/28/2024 with SN, PT and OT as ordered services. A start of care comprehensive assessment dated 07/08/2024 was completed by RN 2 and included care coordination with PT and OT. The comprehensive assessment indicated Patient #8 requires 24-hour supervision and needs assistance to groom, dress, bathe, toilet, eat, transfer, and ambulate. The clinical record included an evaluation by PT on 07/23/2024. A physician’s order dated 07/18/2024 revealed OT was discontinued due to goals met. The clinical record failed to evidence an evaluation, assessment, nor goals set by OT before Patient was transferred from agency care on 07/27/2024. During an interview on 12/05/2024 beginning at 1:30 PM, Administrator relayed the discharge for OT due to goals met was a documentation error. 410 IAC 17-14-1(a)(1)(E), 17-14-1(c)(5) The clinical record for Patient 5 indicated OT visits were made on 11/27/24 and 11/29/24. The record failed to evidence documentation for the visits. During an interview on 12/4/24 beginning at 2:40 PM the Clinical Supervisor indicated there was no documentation for the 11/27/24 or 11/29/24 visits.”

“Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This Element is not met as evidenced by: Based on record review and interview, the agency administrator failed to ensure the agency employed qualified personnel in 1 of 2 home health aide [HHA] files reviewed [HHA 1]. Findings include: The personnel record for HHA#1 failed to evidence an active HHA certification. Review of the Indiana Professional Licensing Agency revealed HHA #1 certification expired in August of 2023. During an interview on 12/05/2024 beginning at 2:00 PM, Administrator relayed she identified, on 12/03/2024, the certification was expired and rescheduled her patients with another HHA. 410 IAC 17-12-1(d)(3)”

“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 record review and interview, the agency failed to ensure the agency adopted and provided services in accordance with current clinical practice guidelines and standards of practice in 1 of 1 active clinical record with a home visit with new wounds assessed (Patient #2). Findings include: The clinical record of Patient #2 revealed a skilled nurse note dated 12/04/2024 with documentation of two new wounds, a pea sized opening noted in a previously healed right buttock area on 11/05/2024, and a new skin tear was noted to the right lower extremity. The right buttock and right lower leg wounds were treated but the record failed to evidence wound measurements. During an interview on 12/03/2024 beginning at 2:30 PM, Clinical Manager relayed there was not wound care policy, the clinicians were instructed to measure wounds weekly. During an interview on 12/05/2024 beginning at 12:38 PM, Registered nurse (RN) 2 relayed the right lower leg skin tear was new and the reopening of the right buttock was new at the 12/04/2024 visit. RN revealed the two new wounds were not measured and should have.”