Every finding on record at Total Home Health Services Inc

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: December 3, 4, 5, and 6, 2024 Active Census: 77 During this Emergency Preparedness survey, Total Home Health Services, Inc. was found to be in compliance with the Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers at 42 CFR at 42 CFR 484.102.

This visit was for a Federal Recertification and State Re-Licensure survey of a Home Health Agency. Survey dates: December 3, 4, 5, and 6, 2024 12 Month Unduplicated Skilled Census: 315 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. A1 12/17/2024 Abbreviations used in report: Home Health Aide [HHA], Director of Nursing [DON], Clinical Supervisor [CS], Registered Nurse [RN], Plan of Care [POC], Start of Care [SOC], Occupational Therapist [OT], Skilled Nurse [SN], Physical Therapist [PT], Certified Occupational Therapy Assistant [COTA], and centimeters [cm].

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.

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.

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.

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.

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.

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.

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)

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.

This visit was a recertification, re-licensure, and emergency preparedness survey. The survey visit took place from 12/7/2021 to 12/17/2021. Facility ID: 004658 At this Emergency Preparedness survey, Total Home Health Care was found to be in compliance with 42 CFR 484.102 Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers for Home Health Agencies.

This visit was a recertification, re-licensure, and emergency preparedness survey. The survey visit took place from 12/7/2021 to 12/17/2021. Facility ID: 004658 These deficiencies reflect State Findings cited in accordance with 410 IAC 17. Refer to state form for additional state findings. quality reviewed completed 01/24/22

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 OASIS data accurately reflected the patient’s status in 1 of 1 discharged patients receiving therapy services only (#12). The findings include: Record review on 12/17/2021, evidenced an undated agency policy titled, “REPORTING OASIS DATA”, which stated, “ … During the comprehensive assessment, clinicians will record OASIS data … Data must accurately reflect the patient’s status at the time of the assessment….” Record review evidenced an agency policy titled, “COMPREHENSIVE ASSESSMENT”, revised 1/8/2019, which stated, “ … POLICY All patient [sic] shall receive a patient – specific comprehensive assessment that accurately reflects their current health status … The comprehensive assessment includes, but is not limited to: a. The patient’s medical, nursing, rehabilitative, social and discharge planning needs. b. An assessment of the patient’s current health status … a head to toe assessment, vital signs, allergies, a review of all systems, skin integrity, and nutritional status….” Clinical record review for patient #12 on 12/14/2021, start of care 6/19/2021, primary diagnosis of Rotator cuff tear / rupture of right shoulder, evidenced an agency document titled, “PT [physical therapy] VISIT”, dated 7/7/2021, and signed by PT [physical therapist] W, which stated, “ … Functional Limitations … Pain … patient ambulates … with 4 wheeled walker….” Clinical record review evidenced an agency document titled, “OASIS [the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality]-D1 Discharge”, dated 7/7/2021, and signed by the clinical supervisor. The assessment had a subsection titled, “FUNCTIONAL STATUS”, which indicated the patient was able to independently transfer, walk on uneven surfaces and negotiate stairs without human assistance or assistive device. The assessment had a subsection titled, “FUNCTIONAL ABILITIES & GOALS”, which indicated the patient was independent at time of discharge in the following tasks: standing from sitting position, transferring to and from a bed to a chair, getting on and off a toilet, transfer in and out of a car, walk 10 feet, walk 50 feet, walk 150 feet, go up and down four steps, and go up and down 12 steps without a rail. Review of the OASIS discharge assessment failed to evidence the patient’s functional limitations and need to use a walker. During an interview on 12/17/2021, at 11:03 a.m., the clinical supervisor indicated the OASIS discharge assessment should reflect the patient’s condition at discharge. When informed of the findings, the clinical supervisor stated, “There is a discrepancy and there shouldn’t be.”

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the comprehensive assessment was complete in 1 of 3 active patient records reviewed with surgical wounds (#3). Record review on 12/17/2021, evidenced an agency policy titled, “COMPREHENSIVE ASSESSMENT”, revised 1/8/2019, which stated, “ … POLICY All patient [sic] shall receive a patient – specific comprehensive assessment that accurately reflects their current health status … The comprehensive assessment includes, but is not limited to: a. The patient’s medical, nursing, rehabilitative, social and discharge planning needs. b. An assessment of the patient’s current health status … a head to toe assessment, vital signs, allergies, a review of all systems, skin integrity, and nutritional status….” During observation of a home visit for patient #3 on 12/10/2021, at 9:20 a.m., RN [registered nurse] R was observed assessing the patient’s right hip. Two separate dressings were observed on the patient’s right hip. A large, non-removable surgical dressing was observed on the lower hip. A smaller dry dressing was observed on the upper hip. At 10:02 a.m., RN R was observed removing the upper hip dressing. A surgical incision was observed on the upper hip. RN R placed a new dry dressing on the upper hip surgical incision. Clinical record review for patient #3 on 12/17/2021, start of care 12/10/2021, certification period 12/10/2021 to 2/7/2022, with primary diagnosis of Aftercare following joint replacement surgery (right hip), evidenced an agency document titled, “OASIS [the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality]-D1 Start of Care”, dated 12/10/2021, and signed by RN R. This assessment failed to evidence the patient had 2 wounds to the right hip. During an interview on 12/17/2021, at 10:31 a.m., the clinical supervisor indicated the comprehensive assessment should include all wounds. 17-14-1(a)(1)(A)

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on clinical record review and interview, the home health agency failed to assess and meet the patient's needs in 1 of 2 discharged patient records reviewed receiving wound care (#11). The findings include: Record review on 12/17/2021, evidenced an agency policy titled, “PLAN OF CARE”, revised 1/8/2019, which stated, “ … 1. The plan of care will be established, periodically reviewed, and signed by a doctor or (sic) medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. 2. Physician orders are obtained prior to the initiation of care and with any changes in the plan of care … 3. The plan of care is individualized to each patient and developed through consultation with the patient / legal representative, the physician and all clinicians involved in the patient’s care. 4. The individualized plan of care will specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment….”. Clinical record review on 12/16/2021, for patient #11, start of care 9/5/2020, certification period 9/5/2020 to 11/3/2020, primary diagnosis of Encounter for change or removal of non-surgical wound dressing, evidenced an agency document titled, “OASIS [the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality]-D1 Start of Care”, dated 9/5/2021, and signed by RN [registered nurse] F. This assessment had a subsection titled, “FUNCTIONAL STATUS”, which indicated the patient depended entirely on another person for grooming, dressing, bathing, toileting, and transferring. The assessment had a subsection titled, “Visit Interventions”, which stated, “ … Multiple family in home with pt [patient] that live there and it does not appear pt has much support … Family unable to manage any care in home as they all state they have scoliosis and are unable to move pt in bed….” Clinical record review failed to evidence home health aide was offered to the patient to assist with grooming, dressing, bathing, toileting, and transferring needs. During an interview on 12/17/2021, at 10:41 a.m., the clinical supervisor indicated the plan of care is created and individualized based on the patient’s needs. On 12/17/2021, at 11:11 a.m., when queried, the clinical supervisor indicated she did not know why the patient did not receive HHA services, and stated, “I don’t have an answer. At minimum it should have been addressed.” 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 home health agency failed to ensure the plan of care was followed and individualized in 3 of 5 active patient records reviewed receiving wound care (#2, #7, #8). The findings include: 1. Record review on 12/17/2021, evidenced an agency policy titled, “PLAN OF CARE”, revised 1/8/2019, which stated, “ … 1. The plan of care will be established, periodically reviewed, and signed by a doctor or (sic) medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. 2. Physician orders are obtained prior to the initiation of care and with any changes in the plan of care … 3. The plan of care is individualized to each patient and developed through consultation with the patient / legal representative, the physician and all clinicians involved in the patient’s care. 4. The individualized plan of care will specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment….”. 2. Record review on 12/17/2021, evidenced an undated agency policy titled, “SKILLED NURSING SERVICES”, which stated, “ … The Registered Nurse will: … Provide appropriate and rehabilitative nursing procedures according to the Plan of Care….” 3. Clinical record review for patient #2 on 12/9/2021, start of care 12/3/2021, certification period 12/3/2021 to 1/31/2022, primary diagnosis of Aftercare following joint replacement surgery, evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, signed by the physician on 12/8/2021. The plan of care had a subsection titled, “Orders for Discipline and Treatment”, which stated, “ … SN [skilled nurse] to assess for surgical wound signs and symptoms of infections….” Clinical record review evidenced an agency document titled, “SKILLED NURSE VISIT”, dated 12/9/2021, and signed by RN [registered nurse] R. The visit note had a subsection titled, “Integumentary [skin]”, which stated, “ … Incision … dressing to be removed 12/9/21”. The visit note had a subsection titled, “Visit Narrative”, which stated, “Received patient sitting in recliner. 7 day surgical dressing changed using aseptic technique. Patient states that pain is better today….” Review of the visit note failed to evidence a wound assessment. During an interview on 12/17/2021, at 9:57 a.m., the clinical supervisor indicated a wound assessment should be documented on each nurse visit when a dressing change is done. When informed of the findings, the clinical supervisor indicated the nurse failed to include a “wound care worksheet” in the visit note. 4. Clinical record review for patient #7 on 12/15/2021, start of care 10/11/2021, certification period 10/11/2021 to 12/9/2021, primary diagnosis of Erysipelas [a bacterial skin infection], evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, signed by the physician on 10/28/2021. The plan of care had a subsection titled, “Orders For Discipline and Treatment”, which stated, “SN [skilled nurse] TO TEACH PATIENT / PCG [patient caregiver] & VALIDATION / RESPONSE TO TEACHINGS: 1. On signs and symptoms of potential complications / further alterations on general health status related to Erysipelas. 2. Demonstrate and validate primary caregiver’s ability for proper wound dressings care / management on Venous Stasis Ulcer [a wound on the leg or ankle caused by abnormal or damaged veins] of Right Lower Leg as prescribed observing infection control measures and safe disposal of contaminated supplies. 3. On signs and symptoms of vascular disease [an abnormal condition of the blood vessels] … 4. Critical signs and symptoms of Hypertension [ a condition in which the force of the blood against the artery walls is too high] exacerbation such as chest pain, palpitations, severe headache, dizziness, vertigo, nausea & vomiting, visual disturbances. Assist the patient / primary caregiver to identify risk factors that can be modified … 5. On signs and symptoms of nephrologic [related to the kidneys] / general complications related to Stage 3a Chronic kidney disease. 6. Pain relief measures … 7. On Signs and symptoms of COVID-19 infection … 8. SN to instruct infection control precautions … 9. SN instruct patient and caregiver: Close contacts should monitor their health … 10. Pt / PCG will demonstrate general and COVID 19 infection control precautions … 11. Energy conservation techniques, activities as tolerated with planned rest periods … 12. Safety measures … 13. Multiple medications regimen; actions / adverse effects, prescribed dietary regimen and importance of good compliance….” Clinical record review evidenced a group of documents titled, “SKILLED NURSE VISIT”. Nurse’s visit notes, signed by RN F, with the following dates failed to evidence patient / caregiver teaching about Erysipelas, wound care, vascular disease, hypertension, chronic kidney disease, and energy conservation: 10/13/2021, 10/18/2021, 10/20/2021, 10/22/2021, 10/25/2021, 10/27/2021, 10/29/2021, 11/1/2021, 11/3/2021, 11/5/2021, 11/8/2021, 11/10/2021, 11/12/2021, 11/15/2021, 11/17/2021, 11/19/2021, 11/22/2021, 11/24/2021, 11/26/2021, 11/29/2021, 12/1/2021, and 12/3/2021. During an interview on 12/17/2021, at 10:09 a.m., the clinical supervisor indicated the nurse should document all teaching completed in the visit notes. When informed of the findings, the clinical supervisor indicated the nurse was focusing on the primary diagnosis of the wound. 5. Clinical record review for patient #8 on 12/15/2021, start of care 8/18/2021, certification period 10/17/2021 to 12/15/2021, primary diagnosis of Type 2 diabetes mellitus with foot ulcer [a chronic disease where the body doesn’t produce enough or resists insulin], evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, dated 10/29/2021, and signed by the physician. The plan of care had a subsection titled, “Orders for Discipline and Treatment”, which stated, " ... CHHA [certified home health aide] Frequency: 1w9 [once a week, for 9 weeks]...." Clinical record review failed to evidence home health aide visits for the weeks of 10/24/2021 to 10/30/2021, 11/7/2021 to 11/13/2021, and 11/14/2021 to 11/20/2021. Clinical record review evidenced a group of agency documents titled, "MISSED VISIT NOTE", dated 10/26/2021, 11/9/2021, and 11/16/2021, each signed by HHA [home health aide] G. Clinical record review failed to evidence re-scheduling of the missed HHA visits. Clinical record review failed to evidence the agency provided HHA visits as ordered. During a interview on 12/17/2021, at 10:52 a.m., the clinical supervisor indicated if a visit is missed, the clinician is expected to reschedule the visit for that same week. Clinical record review evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, dated 10/29/2021, and signed by the physician, which stated, “ … SN [skilled nurse] TO PERFORM: … 5. Weigh patient weekly….” Clinical record review evidenced a group of documents titled, “SKILLED NURSE VISIT”. Review of all visit notes for the certification period 10/17/2021 to 12/15/2021 failed to evidence a patient weight. Review of the patient’s electronic medical record (Axxess) failed to evidence any patient weight since start of care on 8/18/2021. During an interview on 12/17/2021, at 10:37 a.m., the clinical supervisor indicated if a physician orders for a patient to be weighed weekly, it should be documented in the skilled nurse visit notes and visible in the patient’s record in Axxess. The clinical supervisor indicated if the nurse was unable to weigh the patient, they should communicate that to the physician and get an order to discontinue the weekly weight. When informed of the findings, the clinical supervisor reviewed the patient’s record and indicated it failed to evidence weekly patient weight. Clinical record review for patient #8 on 12/15/2021, start of care 8/18/2021, certification period 10/17/2021 to 12/15/2021, evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, dated 10/29/2021 and signed by the physician. The plan of care had a subsection titled, “Orders for Discipline and Treatment”, which stated, “ … SN [skilled nurse] TO TEACH PATIENT / PCG [patient caregiver] & VALIDATION / RESPONSE TO TEACHINGS: 1. On the signs and symptoms of hypo / hyperglycemia [low or high blood sugar] … 2. On importance of inspecting skin and feet daily … 3. Demonstrate and validate primary caregiver’s ability for proper wound dressings care / management on Diabetic ulcer … 4. On signs and symptoms of Hypertensive heart disease with heart failure … 5. On checking pulse rate every day for 1 month, then every week, and to notify physician if rate varies more than 5 beats / minute. 6. Recognize the signs and symptoms of respiratory infection and hypoxia [low oxygen levels] … 7. Teach disease process of diabetic polyneuropathy [a complication of diabetes mellitus characterized by progressive death of nerve fibers, which leads to loss of nerves, increased sensitivity, and the development of foot ulcers] … 8. Signs and symptoms of gastrointestinal compromise / complications [problems with stomach and intestines] … 9. On signs and symptoms of bleeding … 10. Pain relief measures … 11. Energy conservation techniques … 12. Safety measures … 13. Multiple medications regimen; actions / adverse effects, prescribed dietary regimen and importance of good compliance….” Clinical record review evidenced a group of documents titled, “SKILLED NURSE VISIT”. Nurse’s visit notes, signed by RN F, with the following dates failed to evidence patient / caregiver teaching about wound dressing care, inspecting feet daily, hypertensive heart failure, checking pulse rate, signs and symptoms of respiratory infection and hypoxia, diabetic polyneuropathy, gastrointestinal compromise / complications, energy conservation techniques, and safety measures: 10/18/2021, 10/20/2021, 10/22/2021, 10/25/2021, 10/27/2021, 10/29/2021, 11/1/2021, 11/3/2021, 11/5/2021, 11/8/2021, 11/10/2021, 11/12/2021, 11/15/2021, 11/17/2021, 11/19/2021, 11/22/2021, 11/24/2021, 11/26/2021, 11/29/2021, 12/1/2021, 12/3/2021, 12/6/2021, 12/8/2021, 12/10/2021, and 12/13/2021. During an interview on 12/17/2021, at 10:09 a.m., the clinical supervisor indicated the nurse should document all teaching completed in the visit notes. When informed of the findings, the clinical supervisor offered no further information. 17-13-1(a)

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the individualized plan of care included all services, safety measures, medications and treatments in 6 of 12 records reviewed receiving skilled nursing services (#1, #4, #7, #8, #9, #13). The findings include: 1. Record review on 12/17/2021, evidenced an agency policy titled, “PLAN OF CARE”, revised 1/8/2019, which stated, “ … 1. The plan of care will be established, periodically reviewed, and signed by a doctor or (sic) medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. 2. Physician orders are obtained prior to the initiation of care and with any changes in the plan of care … 3. The plan of care is individualized to each patient and developed through consultation with the patient / legal representative, the physician and all clinicians involved in the patient’s care. 4. The individualized plan of care will specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment … 5. The plan of care will include the following: … d. The frequency and duration of visits to be made … All medications and treatments; k. Safety measures to protect against injury … n. The care and services necessary to meet the patient-specific needs identified in the comprehensive assessment; o. Measurable outcomes and goals based on the patient’s diagnosis, physician’s orders, comprehensive assessment, and patient input….” 2. Record review on 12/17/2021, evidenced an agency policy revised on 1/8/2019, titled "Coordination of Patient Services." This policy stated, "… Clear written communication will be provided to the patient and caregiver/representative (if any) regarding visit schedules and frequencies consistent with the current plan of care; patient medication schedule/instructions including medication name, dosage and frequency, and medications that will be administered by agency personnel….” 3. Clinical record review for patient #1 on 12/9/2021, start of care 12/1/2021, certification period 12/1/2021 to 1/29/2022, primary diagnosis of Infection following a procedure, surgical site, evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, signed by the physician on 12/14/2021. The plan of care had a subsection titled, “Medications”, which stated, “ … BIOFREEZE [a topical pain reliever] …apply to left knee twice a day for pain By mouth….” During an interview on 12/16/2021, at 2:31 p.m., the clinical supervisor indicated all medication orders should contain the name of the medication, dosage, frequency, route, and reason for taking if the medication is ordered PRN [as needed]. When informed of the findings, the clinical supervisor indicated Biofreeze was used topically, not by mouth, and stated, “It’s a common problem [wrong route] … I can fix it…” 4. Clinical record review for patient #7 on 12/15/2021, start of care 10/11/2021, certification period 10/11/2021 to 12/9/2021, primary diagnosis of Erysipelas [a bacterial skin infection], evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, signed by the physician on 10/28/2021. The plan of care had a subsection titled, “Medications”, which stated, “ … MECLIZINE [a medication used to treat vertigo] 25 MG [milligram] ORAL TABLET 1 tab TID [three times a day] PRN [as needed] By mouth….” The plan of care failed to evidence the indication for use of the Meclizine. During an interview on 12/16/2021, at 2:31 p.m., the clinical supervisor indicated all medication orders should contain the name of the medication, dosage, frequency, route, and reason for taking if the medication is ordered PRN [as needed]. 5. Clinical record review for patient #8 on 12/15/2021, start of care 8/18/2021, certification period 10/17/2021 to 12/15/2021, primary diagnosis of Type 2 diabetes mellitus with foot ulcer [a chronic disease where the body doesn’t produce enough or resists insulin], evidenced a group of agency documents titled, “SKILLED NURSE VISIT”. Nurse’s visit notes dated 10/18/2021, 10/20/2021, and 10/22/2021, signed by RN [registered nurse] F, stated, “ … Visiting home physicians seeing pt [patient] as needed as well as Podiatrist [foot doctor] as needed….” A nurse’s visit note dated 10/25/2021, signed by RN F, stated, “ … Podiatry to be scheduled to follow pt in home for wound eval. [evaluation]….”. A nurse’s note dated 11/3/2021, signed by RN F, stated, “ … Podiatry is due to see pt later this week for wound assessment and callous removal in home….”. A nurse’s note dated 11/5/2021, signed by RN F, stated, “ … Podiatry is due to see pt later today….”. A nurse’s note dated 11/8/2021, signed by RN F, stated, “ … Podiatry saw pt late last week and removed callouses surrounding wound….”. A nurse’s note dated 11/19/2021, signed by RN F, stated, “ … Surrounding skin remains calloused. Podiatry will have to return to remove again….”. A nurse’s note dated 11/24/2021, signed by RN F, stated, “ … Message left for Podiatry….”. A nurse’s note dated 11/29/2021, signed by RN F, stated, “ … Care Coordinated with: Physician, other Name / Title Podiatry….”. A nurse’s note dated 12/6/2021, signed by RN F, stated, “ … Podiatry to see pt for callous removal this week on Wed….”. Clinical record review evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, signed by the physician on 10/29/2021. Review of the plan of care failed to evidence Podiatry. During an interview on 12/17/2021, at 10:41 a.m., the clinical supervisor indicated all therapies and services a patient is receiving should be in the plan of care. When informed of the findings, the clinical supervisor indicated the plan of care failed to evidence all treatments the patient was receiving. 6. Clinical record review for patient #13 on 12/15/2021, start of care 6/1/2021, certification period 7/31/2021 to 9/28/2021, primary diagnosis of Venous insufficiency [a condition caused by impaired leg circulation which causes swelling and skin changes], evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, signed by the physician on 9/15/2021. The plan of care had a subsection titled, “Medications”, which stated, “ … ATROPINE – DIPHENOXYLATE [an anti-diarrheal medication] 0.025 MG [milligram] – 2.5 MG ORAL TABLET 1 tablet 2 times daily as needed By mouth….”. The plan of care failed to evidence an indication for usage of the as-needed medication. During an interview on 12/16/2021, at 2:31 p.m., the clinical supervisor indicated all medication orders should contain the name of the medication, dosage, frequency, route, and reason for taking if the medication is ordered PRN [as needed]. When informed of the findings, the clinical supervisor offered no further information. 7. Clinical record review for patient #9 on 12/14/2021, start of care 10/27/2021, certification period 10/27/2021 to 12/25/2021, evidenced an agency document titled “Home Health Certification and Plan of Care.” The plan of care had a subsection titled, “Medications,” which stated, “Epi EZ Pen [used to treat emergent allergic reactions] 0.3 mg Injectable Kit As directed As directed [sic] Intramuscular (IM) ... Ester-C Plus [a vitamin/dietary supplement] As directed as directed [sic] By mouth (PO) ... Meclizine 25 mg Oral Tablet 1 tab three times daily as needed By mouth (PO) ... Alprazolam [a medication used to treat anxiety and panic disorder] 0.25 mg Oral Tablet 1 tab daily as needed By mouth (PO) ... Calcium [mineral/supplement needed for many functions of the body] 2 tabs daily By mouth (PO) ...." The plan of care failed to evidence an indication for using the medication Epi EZ Pen, the dose or time for Ester-C Plus, an indication for using the medication Meclizine, an indication for using the medication Alprazolam, and a dose amount for the medication Calcium. 8. During a home visit observation for patient #4 on 12/8/2021 at 1:00 p.m., RN H asked patient #4 about his medications. Patient #4's wife indicated the medication records were old because he does not take Glipizide [an oral medication used to control high blood sugar levels] anymore and his Lupron injection [a hormone used to treat symptoms of prostate cancer] was not listed. Clinical record review for patient #4 on 12/14/2021, start of care 7/7/2021, certification period 11/4/2021 to 1/2/2022 evidenced an agency document titled “Home Health Certification and Plan of Care.” The plan of care had a subsection titled, “Medications,” which included the following medications: Glipizide, Amlodipine Besylate [used to treat high blood pressure], Flomax [used to treat enlarged prostate], Fenofibrate [used to lower high cholesterol and high triglyceride levels], Niacin [used to treat high cholesterol and high triglyceride levels], Plavix [blood thinner], Bisoprolol Fumarate [used to treat high blood pressure], Atorvastatin [used to treat high cholesterol and triglyceride levels], Docusate Sodium [used to treat constipation], and Tylenol [a pain reliever/fever reducer]. The plan of care failed to evidence Lupron as indicated by the patient's wife as a current medication for the patient. 17-13-1(a)(1)(D)(ii, x, ix)

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 observation, record review, and interview, the agency failed to ensure all medications, services and treatments were administered only as ordered by the physician in 2 of 5 active patient records reviewed receiving wound care (#2, #7). The findings include: 1. Record review on 12/17/2021, evidenced an undated agency policy titled, “PHYSICAL THERAPY SERVICES”, which stated, “ … The Registered Physical Therapist (RPT) will: … 4. Plan and prepare a written treatment program based on the evaluation of patient data and assessment and notify the patient’s physician to obtain orders for further treatment … 6. Plan and administer prescribed physical therapy … 10. Contact the physician for approval of services prior to administering the plan of care and document the approval in the assessment….” 2. Record review evidenced an agency titled, “PLAN OF CARE”, revised 1/8/2019, which stated, “POLICY Home care services are furnished under the supervision and direction of the patient’s physician in accordance with a plan of care … Physician orders are obtained prior to the initiation of care and with any changes in the plan of care….” 3. Record review evidenced an agency titled, “PHYSICIAN ORDERS”, revised 1/8/2019, which stated, “POLICY All drugs, treatments, procedures, and care provided to patients must be ordered by a physician … 5. All additions, changes, or deletion of medications obtained by a clinician … require a verbal order….” 4. Observation of a home visit on 12/8/2021, at 1:29 p.m., patient #2, primary diagnosis of aftercare following joint replacement surgery (right knee), was observed wearing a brace on the right knee. At 1:36 p.m., PT [physical therapist] J was observed removing the knee brace and assisting the patient to exercise the knee. At 1:59 p.m., PT J reapplied the brace to the patient’s right knee. Clinical record review for patient #2, start of care 12/3/2021, certification period 12/3/2021 to 1/31/2022, evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, signed by the physician on 12/8/2021. Review of the plan of care failed to evidence an order or instruction for the patient to use a knee brace. Clinical record review of all physician orders for patient #2 failed to evidence an order for use of a knee brace. Clinical record review of all communication notes for patient #2 failed to evidence communication with physician about use of a knee brace. Clinical record review of the patient’s electronic medical record (Axxess) failed to evidence a physician order for the patient to use a knee brace. During an interview on 12/8/2021, at 2:00 p.m., PT J indicated most patients do not use a knee brace after knee replacement surgery, and stated, “I spoke to the doctor, so I know he wants it.” During an interview on 12/17/2021, at 9:50 a.m., the clinical supervisor indicated all therapies and treatments should be completed as ordered. The clinical supervisor indicated the clinical record failed to evidence an order for use of a knee brace. 5. Clinical record review for patient #7 on 12/15/2021, start of care 10/11/2021, certification period 10/11/2021 to 12/9/2021, primary diagnosis of Erysipelas [a bacterial skin infection], evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, signed by the physician on 10/28/2021. The plan of care had a subsection titled “Medications”, which stated, “PENICILLIN 250 MG [milligram] TAB 1 TAB 2xday [two times a day] x 30 days [for 30 days] By mouth….” Clinical record review evidenced an agency document titled, “SKILLED NURSE VISIT”, dated 11/17/2021, and signed by RN [registered nurse] F, which stated, “ …. Increased PCN [penicillin] to 500 mg BID [twice a day] with no end date noted at this time….”. Clinical record review of all physician orders from certification period 10/11/2021 to 12/9/2021, failed to evidence a physician’s order for the changed dose of penicillin. Clinical record review of the patient’s electronic medical record (Axxess) failed to evidence a physician order for the changed dose of penicillin. During an interview on 12/7/2021, at 10:06 a.m., the clinical supervisor indicated the nurse should do a full medication reconciliation at every visit, and if any changes are noted, the nurse should call the physician and get an order for the new or changed medication. When informed of the findings, the clinical supervisor indicated the clinical record failed to evidence an order for the changed dose of penicillin. 17-13-1(a)

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to promptly alert the physician to change in a patient's condition in 2 of 4 records reviewed receiving occupational therapy (#9, #11). The findings include: 5. Clinical record review for patient #9 on 12/14/2021, certification period 10/27/2021 to 12/25/2021, evidenced an agency document titled “Home Health Certification and Plan of Care.” The plan of care had a subsection titled, “Reporting Parameters,” which stated, “… 5. Any significant changes in clinical status...." Clinical record review for patient #9 on 12/14/2021, evidenced an agency document titled, "Skilled Nurse Visit" electronically signed by Registered Nurse X. This document had a subsection titled, "Pain Profile," which stated, "... Potential Aberrant Behavior Noted: Appears intoxicated...." This document had another subsection titled, "Visit Narrative," which stated, "... Pt has has [sic] some dizziness today. 'Feels like I'm on a boat'...." The registered nurse failed to notify the physician of a change in the patient's clinical status. 6. During an interview on 12/16/2021 at 3:35 p.m., the clinical supervisor indicated the registered nurse should have further assessed the patient and notified the physician. 17-13-1(a)(2) 1. Record review on 12/17/2021, evidenced an undated agency policy titled, “SKILLED NURSING SERVICES”, which stated, “ … The Registered Nurse will: … 10. Inform the physician and other appropriate medical personnel of changes in the patient’s condition and needs….” 2. Record review evidenced an undated agency policy titled, “PHYSICAL THERAPY SERVICES”, which stated, “ … The Registered Physical Therapist (RPT) will: … 12. Observe and record the patient’s treatment, education, response, and progress, and notify the physician of any significant changes in condition….” 3. Clinical record review on 12/16/2021, for patient #11, start of care 9/5/2020, certification period 9/5/2020 to 11/3/2020, primary diagnosis of Encounter for change or removal of non-surgical wound dressing, evidenced a group of agency documents titled, “PT [physical therapy] VISIT”, signed by PT [physical therapist] J. Review of a note dated 9/7/2021, indicated the patient’s oxygen saturation was 80%. Review of the visit note failed to evidence physician notification of the patient’s low oxygen saturation. Review of all communication notes for certification period 9/5/2020 to 11/3/2020, failed to evidence physician notification of the patient’s low oxygen saturation. Review of a note dated 9/10/2021, indicated the patient’s oxygen saturation was 87%. Review of the visit note failed to evidence physician notification of the patient’s low oxygen saturation. Review of all communication notes for certification period 9/5/2020 to 11/3/2020 failed to evidence physician notification of the patient’s low oxygen saturation. 4. During an interview on 12/17/2021, at 11:20 a.m., the clinical supervisor indicated if a clinician measured a patient’s oxygen saturation to be 80% or 87%, they should do a follow up re-assessment and call the physician. When informed of the findings, the clinical supervisor stated, “I would hope a clinician wouldn’t leave something like that.”

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 observation, record review and interview, the agency failed to provide the patient with an updated medication schedule in 2 of 9 active patients. (#4, #9) 1. Record review on 12/14/2021 evidenced an undated agency document titled "Skilled Nursing Services," which stated, "...The Registered Nurse will: ... 4. Write the medication profile at the Start of Care and update every 60 days and with any changes throughout the time of service...." 2. Clinical record review for patient #9 on 12/14/2021, start of care 10/27/2021, certification period 10/27/2021 to 12/25/2021, evidenced an agency document titled “Home Health Certification and Plan of Care.” The plan of care had a subsection titled, “Medications,” which stated, “Epi EZ Pen [used to treat emergent allergic reactions] 0.3 mg Injectable Kit As directed As directed [sic] Intramuscular (IM) ... Ester-C Plus [a vitamin/dietary supplement] As directed as directed [sic] By mouth (PO) ... Meclizine 25 mg Oral Tablet 1 tab three times daily as needed By mouth (PO) ... Alprazolam [a medication used to treat anxiety and panic disorder] 0.25 mg Oral Tablet 1 tab daily as needed By mouth (PO) ... Calcium [mineral/supplement needed for many functions of the body] 2 tabs daily By mouth (PO) ...." The plan of care failed to evidence an indication for using the medication Epi EZ Pen, the dose or time for Ester-C Plus, an indication for using the medication Meclizine, an indication for using the medication Alprazolam, and a dose amount for the medication Calcium. 3. During a home visit observation for patient #4 on 12/8/2021 at 1:00 p.m., RN H asked patient #4 about his medications. Patient #4's wife indicated the medication records were old because he does not take Glipizide [an oral medication used to control high blood sugar levels] anymore and his Lupron injection [a hormone used to treat symptoms of prostate cancer] was not listed. Clinical record review for patient #4 on 12/14/2021, start of care 7/7/2021, certification period 11/4/2021 to 1/2/2022 evidenced an agency document titled “Home Health Certification and Plan of Care.” The plan of care had a subsection titled, “Medications,” which included the following medications: Glipizide, Amlodipine Besylate [used to treat high blood pressure], Flomax [used to treat enlarged prostate], Fenofibrate [used to lower high cholesterol and high triglyceride levels], Niacin used to treat high cholesterol and high triglyceride levels], Plavix [blood thinner], Bisoprolol Fumarate [used to treat high blood pressure], Atorvastatin [used to treat high cholesterol and triglyceride levels], Docusate Sodium [used to treat constipation], and Tylenol [a pain reliever/fever reducer]. During an interview on 12/16/2021 at 3:08 p.m., the alternate clinical supervisor indicated the patient's case manager or registered nurse should reconcile the medication list at every visit.

Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinician performed full documented assessments during visits in 6 of 9 patient records reviewed receiving physical therapy (#2, #4, #5, #6, #7, #11). The findings include: 7. Clinical record review for patient #2 on 12/9/2021, start of care 12/3/2021, certification period 12/3/2021 to 1/31/2022, primary diagnosis of Aftercare following joint replacement surgery, evidenced a group of agency documents titled, “PT [physical therapy] Visit," dated 12/4/2021, 12/6/2021, and 12/9/2021, and signed by PT [physical therapist] J. Each of the PT visit notes failed to evidence a patient respiratory rate. 8. Clinical record review for patient #7 on 12/15/2021, start of care 10/11/2021, certification period 10/11/2021 to 12/9/2021, primary diagnosis of Erysipelas [a bacterial skin infection], evidenced a group of agency documents titled, “PT [physical therapy] Visit," dated 10/15/2021, 10/19/2021, 10/22/2021, 10/26/2021, 10/28/2021, 11/2/2021, 11/6/2021, and 11/22/2021 and signed by PT [physical therapist] S. Each of the PT visit notes failed to evidence a patient respiratory rate. Clinical record review evidenced an agency document titled, “Physical Therapy Reassessment / Re-Evaluation”, dated 11/9/2021, and signed by PT S, which failed to evidence a patient respiratory rate. 9. Clinical record review for patient #11 on 12/16/202, start of care 9/5/2020, certification period 9/5/2020 to 11/3/2020, primary diagnosis of Encounter for change or removal of non-surgical wound dressing, evidenced an agency document titled, “Physical Therapy Assessment / Evaluation”, dated 9/5/2020, signed by PT J, which failed to evidence a patient respiratory rate. Clinical record review evidenced a group of agency documents titled “PT [physical therapy] Visit," dated 9/7/2020 and 9/10/2020, signed by PT J, which failed to evidence a patient respiratory rate. Clinical record review evidenced an agency document titled, “Occupational Therapy Assessment / Evaluation”, dated 9/9/2020, signed by OT [occupational therapist] M, which failed to evidence a patient respiratory rate. During an interview on 12/17/2021, at 9:57 a.m., the clinical supervisor indicated therapists typically document vital signs at least once each visit. 1. Record review on 12/14/2021 evidenced an undated agency document titled, "Physical Therapy Services," which stated, "... Physical therapy services shall be provided by a Registered Physical Therapist or a Physical Therapy Assistant ... The Registered Physical Therapist (RPT) will: ... 2. Complete a patient assessment appropriate to the patient's diagnosis and age and based on patient need, and record and evaluate findings to aid in establishing or revising the treatment programs. The evaluation assessment will address: ... c. Physical assessment which may include diagnoses, vital signs, pulse oximetry readings, ...." 2. Record review on 12/14/2021 evidenced an undated agency document titled, "Occupational Therapy Services," which stated, "Occupational therapy services shall be provided by a Registered Occupational Therapist (OT) or a Certified Occupational Therapy Assistant (COTA) ... The Registered Occupational Therapist (OT) will: ... 2. Complete a patient assessment appropriate to the patient's diagnosis and age and based on patient need, and record and evaluate findings to aid in establishing or revising the treatment programs. The evaluation assessment will address: ... c. Physical assessment which may include diagnoses, vital signs, pulse oximetry readings, ...." 3. Clinical record review on 12/15/2021 for patient #4, start of care 7/7/2021, for certification period 11/4/2021 to 1/2/2022, evidenced agency documents titled “COTA [certified occupational therapist assistant] Visit," dated 11/2/2021, 11/8/2021, 11/10/2021, 11/17/2021, 11/19/2021, and 11/23/2021, all electronically signed by OTA P. Review indicated the OTA failed to assess the patient's respirations during the therapy session. 4. Clinical record review on 12/15/2021 for patient #5, start of care 9/7/2021, for certification period 9/7/2021 to 11/5/2021, evidenced agency documents titled “OT [occupational therapist] Visit," dated 9/13/2021, 9/15/20221, 9/20/2021, 9/22/2021, 9/27/2021, 9/29/2021, 10/4/2021, 10/11/2021, 10/13/2021, 10/18/2021, 10/20/2021, 10/25/2021, 10/30/2021, 11/1/2021, and 11/5/2021, all digitally signed by OT M. Review indicated the OT failed to assess the patient's respirations during the therapy session. 5. Clinical record review on 12/15/2021 for patient #6, start of care 9/16/2021, for certification period 9/16/2021 to 11/14/2021, evidenced an agency document titled “PTA [physical therapy assistant] Visit," dated 9/23/2021, 9/28/2021, 9/30/2021, 10/5/2021,10/7/2021, 10/12/2021, 10/14/2021, 10/26/2021, and 11/2/2021, all digitally signed by PTA L. Review indicated the PTA failed to assess the patient's respirations during the therapy session. 6. During an interview on 12/16/2021 at 2:12 p.m., the clinical supervisor indicated therapy was able to document respirations.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure coordination of care between disciplines in 2 of 9 active patients. (#4, #6) 1. Record review on 12/17/2021 evidenced an agency policy revised on 1/8/2019 titled "Coordination of Patient Services." This policy stated, "...All members of the home care team will coordinate services to maintain continuity of care, facilitate patient/caregiver involvement, and maximize patient outcomes. ... All clinicians involved in the patient's plan of care will contribute to an ongoing interdisciplinary assessment to discuss the patient's health status, patient needs, factors that could affect patient safety and treatment effectiveness...." 2. Clinical record review on 12/15/2021 for patient #4, start of care 7/7/2021, certification period 11/4/2021 to 1/2/2022, evidenced an agency document titled “Physical Therapy Reassessment/Re-Evaluation,” dated 11/30/2021 and electronically signed by PT [physical therapist] N, which had a subsection titled "Functional Assessment Comments: Comments" which stated, "...patient/wife reported an unwitnessed fall yesterday. Patient were walking [sic]with walker ... Patient fell. Wife saw patient on the floor laying on his side...." Further record review evidenced an agency document titled “Skilled Nurse Visit,” dated 12/2/2021 and electronically signed by RN [registered nurse] O, which had a subsection titled "Visit Narrative" which stated, "...No falls...." The physical therapist failed to report the change in patient condition to the registered nurse. 3. Clinical record review on 12/15/2021 for patient #6, start of care 9/16/2021, certification period 9/16/2021 to 11/14/2021, evidenced an agency document titled “Skilled Nurse Visit,” dated 10/11/2021, which had a subsection titled "Visit Narrative" which stated, "...New wound to right lower leg...." The registered nurse failed to report the change in patient condition to physical therapy. Clinical record review evidenced an agency document titled "PTA Visit," dated 10/12/2021, which had a subsection titled "Subjective" which stated, "...Pt [patient] reports he has a new wound on R [right] leg. Spoke with nurse ... and she confirmed...." The registered nurse failed to report the change in patient condition to the physical therapist. Clinical record review evidenced an agency document titled "Missed Visit" dated 10/19/2021, which under the "Reason" subsection stated, "No Answer to Locked Door," and under the "Comments" subsection stated, "Called client, looked all over facility, asked receptionist, knocked on door twice. No answer, unable to find client." The home health agency failed to coordinate care with the assisted living facility. Clinical record review evidenced an agency document titled "Missed Visit" dated 10/20/2021, which under the "Reason" subsection stated, "No Answer to Locked Door," and under the "Comments" subsection stated, "Client not in facility at time of SN [skilled nurse] arrival." The home health agency failed to coordinate care with the assisted living facility. Clinical record review evidenced an agency document titled "Missed Visit" dated 10/27/2021, which under the "Reason" subsection stated, "No Answer to Locked Door," and under the "Comments" subsection stated, "Receptionist states client has dialysis, leaves around noon. ... RN [registered nurse] notified." The home health agency failed to coordinate care with the assisted living facility and the dialysis center. Clinical record review evidenced an agency document titled "Missed Visit" dated 10/29/2021, which under the "Reason" subsection stated, "No Answer to Locked Door," and under the "Comments" subsection stated, "Client not at facility. ... RN notified." The home health agency failed to coordinate care with the assisted living facility. During an interview on 12/17/2021 at 9:38 a.m., the clinical supervisor indicated an in-service needs to be done on care coordination. 17-12-2(g)

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health aide failed to provide services as indicated in the aide care plan in 2 of 4 records reviewed receiving home health aide services (#1, #8). The findings include: 1. Record review on 12/17/2021, evidenced an agency policy titled, “HOME HEALTH AIDE SERVICES”, revised 1/8/2019, which stated, “ … Home health aids (sic) will provide services that are … Ordered by the physician … Included in the plan of care … The HHA [home health aide] shall provide patient services and direct care by following the care plan exactly as written by the registered nurse….” 2. Clinical record review for patient #1 on 12/9/2021, start of care 12/1/2021, certification period 12/1/2021 to 1/29/2022, primary diagnosis of Infection following a procedure, surgical site, evidenced an agency document titled, “HHA Care Plan”, dated 12/1/2021, and signed by the clinical supervisor. The HHA Care Plan had a subsection titled, “Safety Precautions”, which evidenced the following safety precautions: Anticoagulant [blood thinner] Precautions, Keep Pathway Clear, Standard Precautions / Infection Control, Emergency Plan Developed, Proper Position During Meals, Sharps Safety, Support During Transfer / Ambulation, Fall Precautions, Safety in ADL’s [activities of daily living], Slow Position Change, and Use of Assistive Devices. Clinical record review evidenced an agency document titled, “HHA Visit”, dated 12/8/2021, signed by HHA G. Review of the HHA visit note failed to evidence the HHA followed Anticoagulant [blood thinner] Precautions, Keep Pathway Clear, Standard Precautions / Infection Control, Emergency Plan Developed, Fall Precautions, Safety in ADL’s [activities of daily living], Slow Position Change, and Use of Assistive Devices. During an interview on 12/16/2021, at 2:49 p.m., the clinical supervisor indicated the HHA should perform tasks as written in the HHA Care Plan and document all tasks completed on the HHA visit notes. 3. Clinical record review for patient #8 on 12/15/2021, start of care 8/18/2021, certification period 10/17/2021 to 12/15/202, primary diagnosis of Type 2 diabetes mellitus with foot ulcer [a chronic disease where the body doesn’t produce enough or resists insulin], evidenced an agency document titled, “HHA Care Plan”, dated 10/17/2021 and signed by RN [registered nurse] F. The HHA Care Plan had a subsection titled, “Safety Precautions”, which evidenced the following safety precautions: Anticoagulant [blood thinner] Precautions, Keep Pathway Clear, Standard Precautions / Infection Control, Emergency Plan Developed, Sharps Safety, Fall Precautions, Safety in ADL’s [activities of daily living], and Use of Assistive Devices. Clinical record review evidenced a group of agency documents titled, “HHA Visit”, signed by HHA G. Review of HHA visit notes dated 10/19/2021, 11/2/2021, 11/23/2021, and 11/30/2021 failed to evidence the HHA followed Anticoagulant [blood thinner] Precautions, Keep Pathway Clear, Standard Precautions / Infection Control, Emergency Plan Developed, Sharps Safety, Fall Precautions, Safety in ADL’s [activities of daily living], and Use of Assistive Devices. During an interview on 12/16/2021, at 2:49 p.m., the clinical supervisor indicated the HHA should perform tasks as written in the HHA Care Plan and document all tasks completed on the HHA visit notes.

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient's clinical record evidenced all interventions and responses to those interventions in 4 of 9 patient records reviewed receiving physical therapy (#2, #7, #11, #12). The findings include: 1. Record review on 12/17/2021, evidenced an undated agency policy titled, “PHYSICAL THERAPY SERVICES”, which stated, “ … The Registered Physical Therapist (RPT) will: … 12. Observe and record the patient’s treatment, education, response, and progress….” 2. Record review evidenced an undated agency policy titled, “OCCUPATIONAL THERAPY SERVICES”, which stated, “ … The Registered Occupational Therapist (OT) will: … 9. Observe and record the patient’s treatment, education, response, and progress….” 3. Record review evidenced an agency policy titled, “DOCUMENTATION OF PATIENT SERVICES”, revised 9/12/2018, which stated, “POLICY Clinical documentation of patient care shall be according to accepted standards of practice to ensure authenticity, adequacy, and accuracy … 6. Documentation should include all services provided. For nursing, therapy and social worker services, documentation should include assessment findings, treatments, education, patient / caregiver response, and progress toward meeting goals….” 4. Clinical record review on 12/9/2021, for patient #2, start of care 12/3/2021, certification period 12/3/2021 to 1/31/2022, primary diagnosis of Aftercare following joint replacement surgery, evidenced a group of agency documents titled, “PT [physical therapy] Visit," dated 12/4/2021, 12/6/2021, and 12/9/2021 and signed by PT [physical therapist] J. Each of the PT visit notes failed to evidence how the patient tolerated therapy. 5. Clinical record review on 12/15/2021, for patient #7 start of care 10/11/2021, certification period 10/11/2021 to 12/9/2021, primary diagnosis of Erysipelas [a bacterial skin infection], evidenced a group of agency documents titled, “PT [physical therapy] Visit," dated 10/15/2021, 10/19/2021, 10/22/2021, 10/26/2021, 10/28/2021, 11/2/2021, 11/6/2021, and 11/22/2021 and signed by PT [physical therapist] S. Each of the PT visit notes failed to evidence how the patient tolerated therapy. 6. Clinical record review on 12/16/2021, for patient #11, start of care 9/5/2020, certification period 9/5/2020 to 11/3/2020, primary diagnosis of Encounter for change or removal of non-surgical wound dressing, evidenced an agency document titled, “Physical Therapy Assessment / Evaluation”, dated 9/5/2020, signed by PT J, which failed to evidence how the patient tolerated therapy. Clinical record review evidenced a group of agency documents titled “PT [physical therapy] Visit," dated 9/7/2020, and 9/10/2020, signed by PT J. Each of the visit notes failed to evidence how the patient tolerated therapy. 7. Clinical record review on 12/14/2021, for patient #12, start of care 6/19/2021, certification period 6/19/2021 to 8/17/2021, primary diagnosis of Rotator cuff tear / rupture of right shoulder, evidenced a group of agency documents titled, "PTA [physical therapy assistant] VISIT", dated 6/23/2021, 6/25/2021, and 6/28/2021, and signed by PTA T. Each of the visit notes failed to evidence how the patient tolerated therapy. 8. During an interview on 12/16/2021, at 2:20 p.m., the clinical supervisor indicated tasks completed during a visit should be documented in each clinician’s visit notes. When informed of the findings, the clinical supervisor offered no further documentation.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure all entries in the clinical record were complete and appropriately authenticated in 4 of 13 patient records reviewed (#2, #3, #12, #13). The findings include: 1. Record review on 12/17/2021, evidenced an agency policy titled, “DOCUMENTATION OF PATIENT SERVICES”, revised 9/12/2018, which stated, “POLICY Clinical documentation of patient care shall be according to accepted standards of practice to ensure authenticity, adequacy, and accuracy … 6. Documentation should include all services provided. For nursing, therapy and social worker services, documentation should include assessment findings, treatments, education, patient / caregiver response, and progress toward meeting goals….” 2. Record review evidenced an agency policy titled, “CLINICAL RECORDS”, revised 1/10/2018, which stated, “ … Contents of the Clinical Record: … A medication profile including dates, revisions, and drug regimen review according [sic] the medication policy….” 3. Clinical record review for patient #2 on 12/9/2021, start of care 12/3/2021, certification period 12/3/2021 to 1/31/2022, primary diagnosis of Aftercare following joint replacement surgery, evidenced an agency document titled, “PT [physical therapy] Visit," dated 12/9/2021, signed by PT [physical therapist] J. The visit note had a section titled, “Assessment”, which stated, “ … Patient has to walk with brace over R [right] knee while standing and walking and is on NWBAT status.” During an interview on 12/17/2021, at 9:50 a.m., the clinical supervisor indicated “NWBAT” was an error in documentation by PT J. The clinical supervisor stated, “it should be WBAT [weight bearing as tolerated]”. 4. Clinical record review for patient #3 on 12/17/2021, start of care 12/10/2021, certification period 12/10/2021 to 2/7/2022, with primary diagnosis of Aftercare following joint replacement surgery (right hip), evidenced an agency document titled, “OASIS [the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality]-D1 Start of Care”, dated 12/10/2021, and signed by RN [registered nurse] R. The assessment had a subsection titled, “Wound Care Flowsheet”, which stated, “ … Drainage: Serous [a thin, clear to yellow, watery fluid] … Treatment Performed: Patient has on a 7 day surgical dressing – blood noted to pad of dressing.” During an interview on 12/17/2021, at 10:31 a.m., the clinical supervisor indicated the assessment of wound drainage was unclear and stated, “I would return this [documentation]. I need clarification.” 5. Clinical record review for patient #12 on 12/14/2021, start of care 6/19/2021, primary diagnosis of Rotator cuff tear / rupture of right shoulder, evidenced an agency document titled, “OASIS [the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality]-D1 Start of Care (PT) [physical therapy]”, dated 6/19/2021, and signed by RN [registered nurse] U. This assessment had a subsection titled, “RESPIRATORY STATUS”, which stated, “ … uses albuterol inhaler as needed….” Clinical record review evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, for certification period 6/19/2021 to 8/17/2021, signed by the physician. The plan of care had a subsection titled, “Medications”, which stated, “ … albuteral [sic] sulfate [used to prevent and treat wheezing and shortness of breath] 90 mg [milligram] 2 puffs twice daily….” Review of the plan of care failed to evidence the albuterol was used as needed. During an interview on 12/17/2021, at 10:53 a.m., the clinical supervisor indicated she did not think the albuterol was as needed, but the patient’s clinical record was unclear. Clinical record review evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, for certification period 6/19/2021 to 8/17/2021, signed by the physician. The plan of care had a subsection titled, “Medical Necessity”, which stated, “ … Patient needs skilled nursing for continuous monitoring of current status….” Review of the patient’s clinical record and electronic medical record (Axxess) failed to evidence the patient was receiving skilled nursing. During an interview on 12/17/2021, at 10:56 a.m., the clinical supervisor indicated patient #12 was not receiving skilled nursing. When informed of the findings, the clinical supervisor indicated the patient did not need skilled nursing, and stated, “that should not be on there”. 6. Clinical record review for patient #13 on 12/15/2021, start of care 6/1/2021, certification period 7/31/2021 to 9/28/2021, primary diagnosis of Venous insufficiency [a condition caused by impaired leg circulation which causes swelling and skin changes], evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, signed by the physician on 9/15/2021. The plan of care had a subsection titled, “Medical Necessity”, which stated, “Patient requires skilled intervention of occupational therapy … Patient requires skilled intervention of physical therapy….” Review of the patient’s clinical record and electronic medical record (Axxess) failed to evidence the patient was receiving physical therapy or occupational therapy. During an interview on 9/17/2021, at 9:20 a.m., the clinical manager indicated the patient no longer receiving physical therapy and that the documentation was “carried over” from a previous plan of care. 17-15-1(a)(7)