Every finding on record at Visiting Nurse Association of Western New York, Inc.

This Statement of Deficiencies is the result of the complaint investigation for complaint #2638824 initiated on 11/19/2025 and the conducted concurrently with the post certification visit (Event: 6586D-H2) from 12/02/2025 to 12/12/2025. During the survey the following were reviewed: 3 patient records, the agency's complaint log, and the agency's complaint investigation. Interviews were conducted with the Director of Clinical Operations, Chief Quality and Safety Officer and various professional staff. Findings were discussed during the exit conference on 12/12/2025 The complaint was substantiated. The following deficiencies were identified: G528 and G442

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on review of clinical records, agency policy and procedure, and staff interviews, for one (1) of five (5) patients (Patient #1), the clinical record lacks documented evidence that the Notice of Medicare Non-Coverage was provided to the patient before being discharged from the agency. Failure to complete the Notice of Medicare Non-Coverage form with the patient prior to discharge has the potential to result in negative patient outcomes. The agency failed to provide the patient with a Notice of Medicare Non-Coverage form prior to discharge as evidenced by the following: Patient #1 – This 74-year-old patient with diagnoses of pressure ulcer right hip, unstageable, unspecified open wound, left thigh, and Alzheimer’s disease was admitted to the home care agency on 08/23/2025. Review of the Discharge-Transfer Summary Report dated 09/03/2025 revealed the following: - Episode Status: Discharged - Episode End Date: 09/03/2025 The clinical record lacks documented evidence that the Notice of Medicare Non-Coverage was discussed and provided to the patient before the patient was discharged from the agency. In an email dated 11/20/2025 at 04:13 PM, the Chief Quality and Safety Officer stated, “I am not able to locate it.” Additionally, during interview on 12/09/2025 at 09:48 AM, the Chief Quality and Safety Officer stated they could not find a notice of non-coverage. Additionally, the Chief Quality and Safety Officer stated they are not sure if the patient was notified of the intent to discharge at the 09/03/2025 visit discharge. Lastly, the Chief Quality and Safety Officer stated that the agency leaves a calendar in the patient’s home that specifies the number of visits they plan on doing so the patient should have been aware that the 09/03/2025 visit was the last planned visit.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: (1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on review of patient care records, agency policy and procedure, and interview with agency staff for two (2) of five (5) patient records (Patient #’s 1 and 3), the agency failed to ensure the initial comprehensive assessment was of sufficient scope to identify patient needs. Failure to ensure the initial comprehensive assessment is complete and accurate has the potential for unmet patient needs and possible negative outcomes. This was cited in Event #: Review of the agency’s policy entitled “Initial Assessment/Reassessment” effective 07/22/2022 revealed the following: “3. The care provider will gather information which will include at least the following: A. A comprehensive assessment of the patient’s health status and needs…” Patient #1 – This 74-year-old patient with diagnoses of pressure ulcer right hip, unstageable, unspecified open wound, left thigh, and Alzheimer’s disease was admitted to the home care agency on 08/23/2025. Review of the Annual Visit (patient referral) dated 08/22/2025 revealed the patient’s physician documented the following: - The patient has a post along the right hip that the patient’s wife wanted checked out. There is a 1.2 centimeter by 8-millimeter painless ulcer along the patient’s right hip; - Exam reveals a 1.2 centimeter by 8-millimeter painless ulcer along the right hip. There is a rim of erythema with central eschar without exudates; and - Assessment #6: Pressure ulcer of right hip. Plan per below: Mupirocin 2% to affected area(s) three times daily. Order: Home Care. Review of the Home Health Certification and Plan of Care for certification period 08/23/2025 to 10/21/2025 revealed the following orders: - Patient has pressure ulcer on the right hip that is non stageable due to nonviable tissue and a trauma wound to the left posterior thigh; wife will learn wound care; - Skilled nurse to perform skin assessment; Instruct patient/caregiver on skin assessment; - Skilled nurse to perform/teach wound care to right hip non stageable pressure ulcer due to nonviable tissue and trauma/skin tear to left posterior thigh. Cleanse with wound cleanser, hydrogel to wound bed, and cover with gentle boarder foam dressing. Clean/aseptic technique. Skilled Nurse to teach wife to perform wound care two (2) times per week; and - Skilled Nurse one (1) time per week for three (3) weeks. Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission dated 08/23/2025 lacks documented evidence of an assessment of the non-stageable right hip pressure ulcer and left posterior thigh trauma wound that provides a complete picture of the wound status since admission and reflects the patient's current wound assessment. The Skilled Nurse failed to perform a complete assessment of the patient's wounds. During interview on 11/20/2025 at 10:08 AM, the Registered Nurse stated at the initial visit they would have just assessed the wound and demonstrated the wound care to the patient’s care giver. The Registered nurse stated that the teaching of the wound care would have happened at the subsequent visit. Additionally, the Registered Nurse stated that they would have assessed the receptiveness of the caregiver at the initial visit as well. Patient #3 – This 82-year-old patient with diagnoses of left femur fracture, pressure ulcer of the sacral region, and Type 2 diabetes was admitted to the home care agency on 09/22/2025. Review of the Home Health Certification and Plan of Care for certification period 09/22/2025 to 11/20/2025 revealed the following orders: - Stage II on right sacrum (0.6 by 0.4 by 0.2; no unit of measurement specified), no drainage or signs/symptoms of infection. Stage I on left sacrum, non-blanching. Family currently applying barrier cream to both areas and leaving open to air. Wound photos obtained and uploaded to chart, per protocol, and - Physical therapist to perform skin assessment. Review of the PT (Physical Therapy) OASIS (Outcome and Assessment Information Set) Admission dated 09/22/2025 revealed the Physical Therapist documented the patient has a Stage II on their right sacrum (0.6 by 0.4 by 0.2; no unit of measurement specified), no drainage or signs/symptoms of infection. Stage I on left sacrum, non-blanching. Family currently applying barrier cream to both areas and leaving open to air. Wound photos obtained and uploaded to chart, per protocol. There is a lack of documented evidence of wound measurements and a comprehensive assessment of the left sacral wound. The Physical Therapist failed to perform a complete assessment of the patient's wounds. During interview on 12/08/2025 at 02:07 PM, the Physical Therapist stated that she did not obtain wound measurements for the left sacral wound because it was not an open area. The Physical Therapist stated that to the best of their knowledge they assessed, cleaned, and photographed the wounds. Additionally, the Physical Therapist stated they referred in nursing, who started the next day, to manage the patient’s wounds.

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on review of clinical records and interview with staff, for one (1) of five (5) patients (Patient #3), the agency failed to review and/or revise the Plan of Care in accordance with patient needs. Failure to review and/or revise the Plan of Care in accordance with patient needs, places patients at risk for unmet needs and poor quality of care. Patient #3 – This 82-year-old patient with diagnoses of left femur fracture, pressure ulcer of the sacral region, and Type 2 diabetes was admitted to the home care agency on 09/22/2025. Review of the Home Health Certification and Plan of Care for certification period 09/22/2025 to 11/20/2025 revealed an order for SN (Skilled Nurse) one (1) time a week for one (1) week, and two (2) times a week for two (2) weeks. Review of the Physician Order dated 09/24/2025 revealed the following: Coccyx Stage II pressure ulcer, 100% non-granulation tissue, moderate drainage. 1. Cleanse wound with vashe moistened gauze for 5 minutes. 2. Pat dry. 3. Apply collagen to wound bed. 4. Cover with bordered foam dressing. Secure with transparent draping, two (2) times per week and as needed for soiling or dislodged dressing. Using clean aseptic technique. 5. Educate patient/caregiver on pressure relief over the area. Review of the Client Coordination Note Report dated 10/01/2025 revealed the agency received a telephone call from the patient’s friend cancelling all visits for 10/02/2025 because the patient was admitted to the hospital. Review of the Client Coordination Note Report dated 10/08/2025 revealed the patient was discharged from the hospital on 10/08/2025 and was transferred to subacute rehab. On 12/08/2025 at 02:30 PM, the surveyor requested the discharge summary from the sub-acute rehab stay and none was provided. Review of the patient care record revealed the Registered Nurse completed a resumption of care on 11/15/2025. Review of the Resumption of Care Orders dated 11/15/2025 lacked documented evidence of an updated nursing frequency (the previous nursing frequency would have ended week three, 10/05/2025 to 10/11/2025, as stated in the initial Home Health Certification and Plan of Care for certification period 09/22/2025 to 11/20/2025). The agency failed to review and/or revise the Plan of Care in accordance with patient needs. During interview on 12/09/2025 at 09:15 AM, the Registered Nurse stated they are not sure what happened there. The Registered Nurse stated that it appears as though the initial nursing frequency would have ended the week the patient went in to the hospital and would have needed to be updated at the resumption of care visit that took place on 11/15/2025.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on review of clinical records and interview with staff, for four (4) of five (5) patients (Patient #s: 2, 3, 4, and 5), the agency failed to provide care in accordance with the written Plan of Care. Failure to ensure patient care is provided in accordance with the written Plan of Care has the potential for unmet patient needs, care being provided that is inconsistent with the physician’s intentions, and possible negative outcomes. The agency failed to ensure services were provided in accordance with the written Plan of Care as evidenced by: Patient #3 – This 82-year-old patient with diagnoses of left femur fracture, pressure ulcer of the sacral region, and Type 2 diabetes was admitted to the home care agency on 09/22/2025. Review of the Physician Order dated 09/24/2025 revealed the following order: Coccyx Stage II pressure ulcer, non-granulation tissue, moderate drainage. 1. Cleanse wound with vashe moistened gauze for five (5) minutes. 2. Pat dry. 3. Apply collagen to wound bed. 4. Cover with bordered foam dressing. Using aseptic technique. 5. Educate patient/caregiver on pressure relief over the area. Review of the RN (Registered Nurse) Subsequent Visit dated 09/29/2025 revealed the Registered Nurse documented they cleansed the patient’s sacrum with warm soapy water, patted the wound dry, and applied protective ointment. The Registered Nurse failed to perform wound care as ordered. During interview on 12/05/2025 at 09:18 AM, the Registered Nurse stated the new wound supplies were delivered to the patient’s house on 09/27/2025. The Registered Nurse stated that they are not quite sure why the documentation says they did the old wound care because that should not have been the case. The Registered Nurse stated that they had the supplies, but that the family had been using barrier cream all along. Patient #5 – This 77-year-old patient with diagnoses of unstageable pressure ulcer right heel, Stage II pressure ulcer right buttock, and Type II diabetes mellitus with diabetic polyneuropathy was admitted to the home care agency on 10/16/2025. Review of the Home Health Certification and Plan of Care for certification period 10/16/2025 to 12/14/2025 revealed the following orders: - SN (Skilled Nurse) two (2) times per week for one (1) week and three (3) times a week for three (3) weeks; - Stage II pressure injury to right buttock and unstageable pressure ulcer to right heel; and - Skilled Nurse to perform/teach pressure ulcer care to buttock. Cleanse with vashe soak for three (3) to five (5) minutes. Apply Santyl to wound bed and cover with foam dressing three (3) times weekly and as needed. Unstageable pressure injury to right heel. Apply betadine to wound bed and cover with abdominal pad and wrap in rolled gauze daily. A. Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission Visit dated 10/16/2025 revealed the Registered Nurse completed wound care as ordered. Review of the RN (Registered Nurse) Subsequent Visit dated 10/18/2025 revealed the Registered Nurse documented the patient and daughter declined wound care due to no available supplies in the home. The Skilled Nurse failed to perform wound care as ordered. During interview on 12/05/2025 at 01:27 PM, the Director of Clinical Operations stated that the first supply order was delivered on 10/20/2025 and the breakdown that caused the supply delay occurred at the start of care. B. Review of the Coordination Note dated 10/21/2025 revealed the Licensed Practical Nurse attempted to call the patient to schedule a visit and was unable to get an answer or leave a voicemail. The Licensed Practical Nurse notified the physician of the canceled visit. Review of the Coordination Note dated 10/25/2025 revealed the Registered Nurse documented the following: - Daughter will do wound care today (Saturday – 10/25/2025) (this did not meet the ordered frequency for nursing/wound care); - Requested Monday (10/27/2025) visit be moved to Tuesday (10/28/2025); and - Confirmed for Tuesday (10/28/20225) and Thursday (10/30/2025) next week for nursing (this did not meet the ordered frequency for nursing/wound care); The Registered Nurse failed to provide nursing services as per the plan of care. During interview on 12/05/2025 at 09:00 AM, The Registered Nurse stated wound care was not done on the 18th because the daughter declined it. The Registered Nurse stated that no visit was made on the 21st because they could not get ahold of the patient. The Registered Nurse stated no visit was done on the 22nd. Additionally, the Registered Nurse stated that no visit was done on the 23rd because the daughter was not there. Lastly, the Registered Nurse stated that they did not notify the doctor of the missed visits and the inability to complete wound care as ordered. Patient #4 – This 68-year patient with the diagnoses of amyotrophic lateral sclerosis and dysphagia was admitted to the home care agency on 09/15/2025. Review of the Add On Discipline order dated 10/17/2025 revealed the following order: Skilled Nurse for administration of bladder instillation/irrigation with 60-100 cubic centimeters of normal saline as needed (no indication specified). Review of the RN (Registered Nurse) High Risk Subsequent Visit dated 10/23/2025 revealed the Registered Nurse documented that they instilled 30 milliliters of normal saline and they instructed the daughter and client on irrigation. The Registered Nurse failed to perform bladder irrigation as ordered. During interview on 12/08/2025 at 01:15 PM, the Registered Nurse stated that they typically documented that they instilled thirty milliliters’ times 2 and that would add up to the ordered amount of 60. The Registered Nurse stated that on this day they may have forgotten to specify the times two in their documentation. Patient #2 – This 49-year-old patient with diagnoses of encounter for surgical aftercare following surgery on the circulatory system, presence of aortocoronary bypass graft, and chronic combined systolic and diastolic heart failure was admitted to the home care agency on 10/02/2025. Review of the Physician Order dated 10/16/2025 revealed Skilled Nursing one (1) week one (1) effective 10/20/2025. Review of the clinical record from 10/02/2025 to 12/05/2025 lacked documented evidence that a skilled nurse visit was completed the week of 10/19/205 to 10/25/2025. During an interview on 12/05/2025 at 01:02/PM, the Registered Nurse stated that they messed up and should have changed the visit from a RN11 (Subsequent Visit) to a RN18 (Discharge from agency Visit). The Registered Nurse continued to state that originally the patient was to be seen by the physician on 12/12/2025 or 12/13/2025, and the plan was to discharge after the physician visit, but the patient did not want to pay the co-pay and that is why the patient was discharged on the 12/15/2025.

The following statement of deficiencies represents the results of the unannounced on-site complaint investigation # 115963 of VNA of Western New York Certified Home Health Agency conducted on 06/10/2025 through 06/11/2025. The survey consisted of a review of three (3) clinical records, pertinent policies and procedures, clinical protocols and the agency's complaint investigation. Pre-survey activities consisted of review on 06/10/2025 of the agency’s Health Commerce System account, complaint history and Certification and Survey Provider Enhanced Reports (CASPER) for the period 05/10/2025 to 05/31/2025. The Director of Quality, Clinical Manager and clinical staff were interviewed. Findings were reviewed at the exit on 06/11/2025. The allegations in complaint # 115963 were determined unsubstantiated. The following deficiency unrelated to the complaint allegations was identified as a result of the survey: Federal tag: G-528

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: (1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on a review of clinical records, agency policy and procedure and staff interviews, it was determined in one (1) of one (1) patients (Patients # 3), requiring a resumption of care assessment, that the comprehensive assessment for the resumption of care was not of sufficient scope to ensure all patient needs are identified. Specifically, the patient’s wound was not measured during the resumption of care visit. Failure to ensure the comprehensive assessment is complete has the potential for the patient to receive inappropriate care. The agency failed to ensure the resumption of care comprehensive assessments was complete as evidenced by the following: Patient #3- This 68-year-old patient with diagnoses that include encounter for attention to cystostomy, benign prostatic hyperplasia with lower urinary tract symptoms and schizophrenia was admitted to the home care agency on 01/16/2025. The patient was hospitalized on 05/21/2025 for treatment of a newly developed wound on the left posterior leg and discharged home on 05/28/25. Review of the agency policy entitled Initial Assessment/Reassessment effective 05/2025 revealed “The care provider will gather information which will include at least the following: A. A comprehensive assessment of the patient’s health status and needs.” Review of the RN Resumption of Care Visit Note dated 05/29/2025 revealed the Registered Nurse (RN) documented that the chief reason the patient has been referred to home care is for wound care, and that the wound would be managed by nursing. The RN further documented that a picture of the wound was obtained and that the wound was unstageable due to slough covering the wound bed. The wound assessment revealed no measurements of the wound were taken on that visit because the RN “forgot to measure.” During interview on 06/11/2025 at 11:28 AM the RN stated, “I know I measured it.” The RN further stated that the RN did not see that the measurements were documented in the clinical record. The VNA Manager stated that the visit was a co-visit with the RN and the VNA Manager and that the VNA Manager also believed that the RN obtained wound measurements. Upon further review of the record, the VNA Manager verified that no wound measurements are documented in the clinical record on that date of the visit.

The following statement of deficiencies represents the results of a partial extended re-certification survey of VNA of Western New York Certified Home Health Agency conducted on 03/04/2025 through 03/10/2025 and included complaint investigations 107325 and 103110. A standard re-certification survey was initiated on 03/04/2025. Deficient practices were identified within Level 1 standards in 484.55 Condition and resulting in a partial extended survey on 03/05/2025. The survey consisted of a review of 17 (seventeen) clinical records including 5 (five) discharge records, 9 (nine) personnel records for professional and paraprofessional personnel, 1 (one) contract, and 7 (seven) observational home visits. The survey included a review of pertinent policies and procedures, Quality Improvement Meeting minutes for the past 12 months, agency’s Admission Packet, the Emergency Preparedness Plan, and Complaint Log. Pre-survey activities consisted of review on 03/03/2025 date of the agency’s Health Commerce System account, Criminal History Record Check, potentially avoidable reports for the period 12/01/2023 - 11/30/2024, and the agency’s compliance with report submissions for the 2023 statistical report and the Emergency Drill conducted in 2019. The total number of active patients was 3636. The Directors of Clinical Operations, Clinical Managers, Director of Quality Improvement, and staff were interviewed. Findings were reviewed at the exit conference on 03/10/2025. The allegations in complaints 107325 and 103110 were determined substantiated. The following deficiencies are identified as a result of the survey: G-0372, G-0410, G-0442, G-0520, G-0528, G-0536, G-0544, G-0574, G-0576, G-0580, G-0590, G-0610, G-0716, G-0808, G-0984, J-0708, J-1136, J-1168, J-1260, J-1426, J-1444, and W-0610.

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on record reviews and staff interviews, the agency failed to ensure that all completed Outcome and Assessment Information Set assessments (M0090) were transmitted to the State/Centers for Medicare and Medicaid Services when completed. This is evident for one (1) of one (1) clinical records reviewed that required transmission (Patient #5). Failure to ensure that all completed Outcome and Assessment Information Set assessments are transmitted to the Centers for Medicare and Medicaid Services contractor or state within 30 (thirty) days has the potential for negative patient outcomes. The agency failed to ensure that all completed Outcome and Assessment Information Set assessments (M0090) are transmitted to the Centers for Medicare and Medicaid Services contractor or state within 30 (thirty) days as evidenced by: Pre-survey the "Home Health Agency Error Summary Report" on 03/03/2025 revealed the agency has 477 (four hundred seventy-seven) late submissions of the Outcome and Assessment Information Set assessments (M0090) from 01/01/2024 to 12/31/2024. Patient #5 – This 79-year-old patient with the diagnoses of heart disease of native coronary artery, chronic obstructive pulmonary disease, and chronic kidney disease was admitted to the home care agency on 11/20/2024. Review of the Registered Nurse Outcome and Assessment Information Set Start of Care completed by the Registered Nurse revealed the Outcome and Assessment Information Set Assessment (M0090) was completed on 11/20/2024. Review of the Home Health Agency Error Submission Report provided by the agency on 03/05/2025 at 12:45 revealed the patient’s Outcome and Assessment Information Set Assessment (M0090) was submitted on 12/31/2024, 41 (forty-one) days after the assessment was complete. During interview on 03/10/2025 at 11:14 AM, the Director of Operations stated the clinical documentation team reviews the Outcome and Assessment Information Set Assessments prior to submission and did not know why it was submitted late. The agency is working on implementing a better workflow to ensure this does not recur.

Information to patient CFR(s): 484.50(a)(1) Provide the patient and the patient's legal representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to the patient: This ELEMENT is not met as evidenced by: Based on review of clinical records, agency policies and procedures, and interviews with staff, for one (1) of seventeen (17) patients (Patient #17 ), the agency failed to ensure a legal representative (an individual who has been legally designated or appointed as the patient's health care decision maker), a power of attorney for health care decision-making, or a designated health care agent are provided written notice of the patient's rights and responsibilities. Failure to provide written notice of the patient's rights and responsibilities to all patients or their proxies, has the potential for negative patient outcomes. The agency failed to ensure a legal representative (an individual who has been legally designated or appointed as the patient's health care decision maker), a power of attorney for health care decision-making, or a designated health care agent are provided written notice of the patient's rights and responsibilities as evidenced by: Review of the agency policy entitled “Initial Assessment/ Reassessment” effective 07/22/2022 revealed the following: 2. On an initial visit, prior to providing any services, the care provider will review and complete with the patient the following information. For a resumption of care visit, the care provider will assure that the patient has the following information from the initial visit: E. Information regarding Advanced Directives. Ask the patient if they have a current Advance Directive. Leave information regarding Advanced Directives with the patient and obtain a copy of any current Advance Directive. Patient #17- This 71-year-old patient with the diagnoses of unspecified fracture of the right femur, subs for closed fracture with routine healing, unspecified alzheimer’s disease, and dementia in other disease classified elsewhere, unspecified severity without behaviors/ psychosis/ mood disturbance/ anxiety was admitted to the home care agency on 05/26/2024. Review of the History and Physical dated 05/04/2024 revealed the physician documented the following: Capacity: Patient lacks capacity for medical decision making. Review of the Patient Agreement dated 05/26/2024 revealed the patient’s spouse signed the agreement for the patient. Review of the Home Health Certification and Plan of Care for 05/26/2024 to 07/24/2024 revealed the patient’s advanced directives include a Health Care Proxy. Review of the clinical record lacks documentation indicating who is the patient’s Health Care Proxy. During interview on 03/07/2025 at 2:47 PM, the Physical Therapist stated that at the admission visit, the patient’s spouse said he was the patient’s Health Care Proxy. The Physical Therapist stated they did not see a completed Health Care Proxy before allowing the patient’s spouse to sign the paperwork.

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on review of clinical records, agency policy and procedure, and staff interviews, for one (1) of seventeen (17) patients (Patient #13), the clinical record lacks documented evidence that the Notice of Medicare Non-Coverage (NOMNC) was provided to the patient before being discharged from the agency. Failure to complete the Notice of Medicare Non-Coverage form with the patient prior to discharge has the potential to result in negative patient outcomes. The agency failed to provide the patient with a Notice of Medicare Non-Coverage form prior to discharge as evidenced by the following: Patient #13- This 78-year-old patient with the diagnoses of malignant neoplasm of left kidney, except renal pelvis, essential (primary) hypertension, and paroxysmal atrial fibrillation was admitted to the home care agency on 09/10/2024. Review of the Discharge-Transfer Summary Report dated 09/24/2024 revealed the following: - Episode Status: Discharged - Episode End Date: 09/24/2024 The clinical record lacks documented evidence that the Notice of Medicare Non-Coverage (NOMNC) was discussed and provided to the patient before the patient was discharged from the agency. During interview on 03/06/2025 at 03:49 PM, the Director of Clinical Operations stated the Notice of Medicare Non-Coverage was not done and is not in the clinical record.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with staff, for four (4) of seventeen (17) patients (Patient #s: 1, 3, 5 and 13 ) the agency failed to ensure that a comprehensive assessment consistent with the patient's needs was performed within five (5) calendar days after the Start of Care. Failure to ensure a comprehensive assessment is complete and accurate has the potential for unmet patient needs and possible negative outcomes. The agency failed to ensure that a comprehensive assessment consistent with the patient's needs was performed within five (5) calendar days after the Start of Care as evidenced by: Patient #1 – This 35-year-old patient with the diagnoses of aftercare following surgery for neoplasm, neoplasm of unspecified behavior of other specified sites, and malignant neoplasm of unspecified testis was admitted to the home care agency on 02/25/2025. Review of the Physical Therapy Outcome Assessment and Information Set Admission Note dated 02/2/52025 revealed “Consults also placed for Skilled Nursing, Occupational Therapy, Medical Social Work, and Registered Dietician.” Review of the clinical record revealed the Registered Dietician provided the first visit on 03/06/2025, nine (9) days after the start of care. During interview on 03/07/2025 at 11:40 AM, the Physical Therapist stated the Registered Dietician consult was submitted late, it was an oversight. Patient #3 – This 91-year-old patient with the diagnoses of influenza, benign prostatic hyperplasia with lower urinary tract symptoms, and retention of urine was admitted to the home care agency on 02/18/2025. Review of the Home Health Certification and Plan of Care for 02/18/2025 to 04/18/2025 revealed the order for Speech Therapy effective 02/23/2025 once a week for one week. Review of the clinical record revealed the Speech Therapist provided the first visit on 03/06/2025, 11(eleven) days after the order was placed and 16 (sixteen) days after the start of care. During interview on 03/07/2025 at 11:05 AM, the Director of Quality Improvement stated there is no documentation to explain the delay. Patient #5 – This 78-year-old patient with the diagnoses of difficulty ambulating, chronic obstructive pulmonary disease (COPD) with oxygen dependency, and non-insulin dependent type 2 diabetes was admitted to home care agency on 11/20/2024. A. Review of the referral orders on 11/15/2024 revealed: “Skilled Nurse: assessment, medication/disease management/education, assess needs, Physical Therapy/Occupational Therapy: Evaluate and treat.” Review of the Home Health Certification and Plan of Care for 11/20/2024 to 1/18/2025 revealed the order for Physical Therapy effective 12/15/2024 once a week for one week. Review of the clinical record revealed the Physical Therapist provided the first visit on 12/16/2024, one (1) day after the order was placed and twenty-six (26) days after the start of care. During interview on 3/10/2024 at 9:26AM the Director of Branch Operations confirmed that Physical Therapy was ordered on the initial referral at start of care and was unaware of any explanation for the delay in the start of care of the service. The Director of Branch Operations further confirmed that the expectation is the initial Physical Therapy visit should have occurred within five (5) days of the referral order. B. Review of the Home Health Certification and Plan of Care for 11/20/2024 to 1/18/2025 revealed the order for Occupational Therapy effective 12/01/2024 once a week for one week. Review of the clinical record revealed the Occupational Therapist provided the first visit on 12/05/2024, four (4) days after the order was placed and fifteen (15) days after the start of care. During interview on 3/10/2024 at 09:26AM the Director of Branch Operations confirmed that Occupational Therapy was ordered on the initial referral at start of care and was unaware of any explanation for the delay in the start of care of the service. The Director of Branch Operations further confirmed that the expectation is the initial occupational therapy visit should have occurred within five (5) days of the referral order. Patient #13- This 78-year-old patient with the diagnoses of malignant neoplasm of left kidney, except renal pelvis, essential (primary) hypertension, and paroxysmal atrial fibrillation was admitted to the agency on 09/10/2024. Review of the Client Care Coordination Referral Note dated 09/07/2024 revealed “Facility discharge date: 09/08/2024…Physical Therapy to evaluate and treat.” Review of the Physical Therapy Add-On Evaluation Visit Report dated 09/19/2024 revealed that the Physical Therapist's initial visit with the patient occurred on 09/19/2024 and that the Physical Therapist determined that the patient did not qualify for Physical Therapy. Review of the Home Health Certification and Plan of Care for certification period 09/10/2024 to 11/08/2024 revealed the following order: “Frequency/ Duration of Visits: Physical Therapy; effective 09/15/2024; one (1) visit for one (1) week.” Review of the clinical record lacks documentation explaining why Physical Therapy services were delayed until 09/19/2024, nine (9) days after the patient was discharged from the facility. During interview on 03/06/2025 at 03:16 PM, the Registered Nurse stated they were unable to recall the reason for the delay in Physical Therapy services, and why the order was changed to the week of 09/15/2024. Additionally, there was no documentation in the record to explain the delay.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: (1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on review of patient care records, and interview with agency staff for sixteen (16) of seventeen (17) patient records (Patient #’s: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 17), the agency failed to ensure the initial comprehensive assessment was of sufficient scope to identify patient needs. Failure to ensure the initial comprehensive assessment is complete and accurate has the potential for unmet patient needs and possible negative outcomes. HV Patient #10- This 57-year-old patient with the diagnoses of neurogenic bowel, not elsewhere classified, quadriplegia, C5-C7 incomplete, and autonomic dysreflexia was admitted to the home care agency on 04/17/2017. A. Review of the Registered Nurse Recertification Without Skill Visit Note dated 01/03/2025 revealed the Registered Nurse documented patient’s mother as an emergency contact. During an observational home visit on 03/07/2025 at 10:40 AM, the patient stated that the patient’s mother died a year ago. During interview on 03/10/2025 at 10:08 AM, the Registered Nurse stated they were unaware that the patient’s mother died and was no longer available as an emergency contact or caregiver. B. Review of the Registered Nurse Recertification Without Skill Visit Note dated 01/03/2025 revealed the Registered Nurse documented, Indicate Genitourinary Assessment: (Mark all that apply): Indwelling/Suprapubic Catheter. Review of the Home Health Certificate and Plan of Care for 01/05/2024 to 03/05/2025 revealed an order for “Skilled Nurse to perform observation and assessment of genitourinary status and intervene to minimize complications of disease process. Skilled Nurse to provide instruction, regarding management of disease process including pathophysiology, nutrition/fluid requirements, and medication regimen.” Review of the clinical record lacks documentation indicating which physician manages the indwelling/suprapubic catheter. During interview on 03/10/2025 at 10:27 AM, the Registered Nurse stated that the patient’s indwelling/suprapubic catheter is managed monthly by the urologist, and this should have been included in the medical orders. C. Review of the Registered Nurse Recertification Without Skill Visit Note dated 01/03/2025 revealed the Registered Nurse documented patient is unable to leave home without assistance. During an observational home visit on 03/10/2025 at 10:36 AM, the patient stated that they own a mobility van that was modified to accommodate a wheelchair, and the patient is able to independently drive self to work. Review of the clinical record lacks documented evidence of the patient’s ability to leave home without assistance. During interview on 03/10/2025 at 10:06 AM, the Manager Branch Office stated they believe the patient drives independently. During interview on 03/10/2025 at 10:06 AM, the Director Branch Operations stated the patient works outside of the home. During interview on 03/10/2025 at 10:07 AM, the Registered Nurse stated there is no documentation indicating who accompanies the patient to appointments and is unable to recall who is responsible for accompanying the patient. D. Review of the Home Health Certification and Plan of Care from 01/05/2025 to 03/05/2025 revealed an order for the licensed professional to report vital signs falling outside the following established parameters…"O2 (oxygen) less than 92." Review of the Registered Nurse Recertification Without Skill Visit Note dated 01/03/2025 lacks an assessment of the patient’s oxygen level. During interview on 03/10/2025 at 10:03 AM, the Registered Nurse stated they were unable to recall the patient’s oxygen level during the visit. Additionally, the Registered Nurse stated that it is the agency's expectation that oxygen levels are monitored if there are parameters to notify the physician. E. Review of the clinical record lacks documented evidence the patient’s immunization status was assessed. During interview on 03/10/2025 at 10:12 AM, the Registered Nurse stated the patient’s immunization status was not discussed during the nursing visit. F. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/10/2025 at 10:12 AM, the Registered Nurse stated palliative care needs were not discussed during the nursing visit. Patient #8 - This 19-year-old patient with the diagnoses of acute leukemia of unspecified cell type not achieve remission, encounter for antineoplastic chemotherapy, and other acute pancreatitis without necrosis or infection was admitted to the home care agency on 12/23/2024. A. Review of the Home Health Certification and Plan of Care for 02/21/2025 to 04/21/2025 revealed an order for licensed professional to report vital signs falling outside the following established parameters… "O2 (oxygen) less than 92." Review of the Registered Nurse Infusion Outcome and Assessment Information Set Admission Note dated 12/23/2024 and the Registered Nurse Infusion Subsequent Visit Note dated 03/05/2025 lack documented evidence that the patient’s oxygen level was assessed. During interview on 03/06/2025 at 02:51 PM, the Registered Nurse stated the oxygen level was not assessed during the visits, however, it is expected that oxygen is monitored if there are parameters to notify the physician. B. Review of the clinical record lacks documented evidence the patient’s immunization was assessed. During interview on 03/06/2025 at 02:27 PM, the Registered Nurse stated they were unable to recall if the patient’s immunization status was assessed or documented during the nursing assessment. C. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/06/2025 at 02:27 PM, the Registered Nurse was unable to recall if the patient’s need for palliative care was assessed or documented during the nursing assessment. Patient #13- This 78-year-old patient with the diagnoses of malignant neoplasm of left kidney, except renal pelvis, essential (primary) hypertension, and paroxysmal atrial fibrillation was admitted to the home care agency on 09/10/2024. A. Review of the clinical record lacks documented evidence the patient’s immunization was assessed. During interview on 03/06/2025 at 03:31 PM, the Director of Clinical Operations stated the clinician is expected to ask the patient and document the patient’s immunization status. B. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/06/2025 at 03:27 PM, the Director of Clinical Operations stated the patient’s need for palliative care was not documented during the nursing assessment. Patient #11- This 73- year- old patient with the diagnoses encounter for surgical aftercare following surgery on digestive system, diverticuli of the intestines, part unspecified, with perforation and abscess without bleed, and retention of urine, unspecified was admitted to the home care agency on 02/08/2025. A. Review of the clinical record lacks documented evidence the patient’s pneumonia immunization status was assessed. During interview on 03/07/2025 at 01:01 PM, the Registered Nurse stated that the patient’s pneumonia immunization status was not reviewed. B. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/07/2025 at 01:01 PM, the Registered Nurse stated that potential palliative care needs were not discussed with the patient. C. Review of the Registered Nurse Outcome Assessment and Information Set Visit Report dated 02/08/2025 revealed the Registered Nurse documented the following: “Respiratory: Indicate other respiratory issue: Sleep apnea- Utilizes CPAP (continuous positive airway pressure).” Review of the Home Health Certification and Plan of Care for 02/08/2025 to 04/08/2025 lacks an order for continuous positive airway pressure. During interview on 03/07/2025 at 01:19 PM, the Registered Nurse stated that continuous positive airway pressure should be on the Plan of Care, but it is not. D. Review of the Registered Nurse Outcome Assessment and Information Set Visit Report dated 02/08/2025 revealed the Registered Nurse documented the following: “Narrative: Gait is unsteady with rolling walker.” Review of the Home Health Certification and Plan of Care for 02/08/2025 to 04/08/2025 lacks an order for a rolling walker. During interview on 03/07/2025 at 01:25 PM, the Registered Nurse stated that the patient does use a rolling walker, and there should be an order for it. E. Review of the Home Health Certification and Plan of Care for 02/08/2025 to 04/08/2025 revealed the order for “Repatha sureclick 140 milligrams/per milliliter subcutaneous pen injector; subcutaneously; 1 milliliter; every other week; for hyperlipidemia; administered by patient every two (2) weeks.” Review of the Home Health Certification and Plan of Care for 02/08/2025 to 04/08/2025 lacks an order for a sharps container. During interview on 03/07/2025 at 01:23 PM, the Registered Nurse stated that sharps management was not discussed. There should be an order for the sharps container. Patient #2 - This 72- year- old patient with the diagnoses of aftercare following joint replacement surgery, presence of right artificial knee joint, and essential primary hypertension was admitted to the home care agency on 02/19/2025. A. Review of the clinical record lacks documented evidence the patient’s pneumonia immunization status was assessed. During interview on 03/07/2025 at 2:10 PM, the Branch Manager stated that the clinician did not document the patient’s pneumonia immunization status. B. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/07/2025 at 2:11 PM, the Branch Manager stated that the clinician did not assess the patient’s need for palliative care. C. Review of the “Medicine Consult Note” (Referral to agency) dated 02/17/2025 revealed the Physician’s Assistant recommended the following treatment: "Deep Vein Thrombosis Prophylaxis: Thrombo- Embolic Deterrent (TED) Stockings." Review of the Home Health Certification and Plan of Care for 02/19/2025 to 04/19/2025 lacks an order for Thrombo- Embolic Deterrent Stockings. During interview on 03/07/2025 at 2:24 PM, the Branch Manager stated the clinician did not document Thrombo- Embolic Deterrent Stockings under Durable Medical Equipment on the Plan of Care, so it is unclear whether the patient is using them. Patient #17- This 71- year- old patient with the diagnoses of unspecified fracture of the right femur, subs for closed fracture with routine healing, unspecified alzheimer’s disease, and dementia in other disease classified elsewhere, unspecified severity without behaviors/ psychosis/ mood disturbance/ anxiety was admitted to the home care agency on 05/26/2024. A. Review of the clinical record lacks documented evidence the patient’s immunization was assessed. During interview on 03/07/2025 at 02:38 PM, the Physical Therapist stated that they did not ask the patient about the pneumonia vaccine. Additionally, the Physical Therapist stated that it is required to ask about influenza vaccination between October and April, and since the patient was admitted in May, the Physical Therapist did not ask if the patient had the influenza vaccine. B. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/07/2025 at 02:39 PM, the Physical Therapist stated they briefly thought of palliative care for this patient, but the patient was ordered for restorative physical therapy, so possible palliative care needs were not discussed. Patient #4 – This 62- year -old patient with the diagnoses of type 2 diabetes mellitus with foot ulcer, non- pressure chronic ulcer other part left foot, cutaneous abscess of right foot, and acquired absence of right great toe was admitted to the home care agency on 10/19/2024. A. Review of the clinical record lacks documented evidence the patient’s immunization was assessed. During interview on 03/07/2025 at 11:25 AM, the Registered Nurse stated it was assessed but was not documented in the visit note. B. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/07/2025 at 11:25 AM, the Registered Nurse stated there was no assessment of palliative care needs. Patient #12- This 69-year-old patient with the diagnoses of chronic obstructive pulmonary disease with exacerbation, hypertension and anxiety was admitted to the home care agency on 02/24/2025. A. Review of the clinical record lacks documented evidence the patient’s immunization status was assessed. During interview on 03/07/2025 at 12:28 PM, the Registered Nurse stated the immunization status was assessed but not documented. B. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/07/2025 at 12:28PM, the Registered Nurse stated there was no assessment of palliative care needs. Patient #15- This 91- year -old patient with the diagnoses of pressure ulcer of right heel stage 3, peripheral vascular disease, venous insufficiency, and paroxysmal atrial fibrillation was admitted to the home care agency on 05/20/2023. A. Review of the clinical record lacks documented evidence the patient’s pneumonia immunization was assessed. During interview on 03/07/2025 at 10:46 AM, the Registered Nurse stated the pneumonia immunization status was not assessed. B. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/07/2025 at 10:46 AM, the Registered Nurse stated they were not aware the palliative care needs were to be assessed. Patient #5 – This 78-year-old patient with the diagnoses of difficulty ambulating, chronic obstructive pulmonary disease (COPD) with oxygen dependency, and non-insulin dependent type 2 diabetes was admitted to home care agency on 11/20/2024. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/10/2025 at 09:25AM, the Registered Nurse confirmed that an assessment for the need of palliative care was not completed. Patient #9 – This 69-year-old male with the diagnoses of status post left total knee replacement on 02/25/2025 and hypertension was admitted to the home care agency on 02/26/2025. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/7/2025 at 04:10PM, the Physical Therapist confirmed that an assessment for the need for palliative care was not completed. The agency failed to ensure the initial comprehensive assessment was of sufficient scope to identify patient needs as evidenced by: Patient #1 – This 35-year-old patient with the diagnoses of aftercare following surgery for neoplasm, neoplasm of unspecified behavior of other specified sites, and malignant neoplasm of unspecified testis was admitted to the home care agency on 02/25/2025. A. Review of the clinical record lacks documented evidence the patient’s immunization was assessed. During interview on 03/07/2025 at 11:47 AM, the Physical Therapist stated it was assessed but not documented in the visit note. B. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/07/2025 at 11:47 AM, the Physical Therapist stated they did not document an assessment of palliative care needs. Patient #3 – This 91-year-old patient with the diagnoses of influenza, benign prostatic hyperplasia with lower urinary tract symptoms, and retention of urine was admitted to the home care agency on 02/18/2025. A. Review of the clinical record lacks documented evidence the patient’s immunization was assessed. During interview on 03/07/2025 at 11:08 AM, the Registered Nurse stated it was assessed but not documented. B. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/07/2025 at 11:09AM, the Registered Nurse stated they did not document an assessment of palliative care needs. Patient #6 – This 95-year-old patient with the diagnoses of heart failure and hypertension was admitted to the home care agency on 02/26/2025. A. Review of the clinical record lacks documented evidence the patient’s immunization was assessed. During interview on 03/07/2025 at 10:48 AM, the Registered Nurse stated the immunization status was not documented. B. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/07/2025 at 10:48 AM, the Registered Nurse stated it was assessed but not documented, the Registered Nurse thought she was only supposed to document if palliative care was needed. Patient #14 – This 41-year-old patient with the diagnoses of infection following a procedure, bacteremia, and staphylococcus as the cause of disease was admitted to the home care agency on 06/25/2024. A. Review of the clinical record lacks documented evidence the patient’s immunization was assessed. During interview on 03/07/2025 at 12:16 PM, the Director of Operations stated the immunization status was not documented. B. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/07/2025 at 12:17 PM, the Director of Operations stated it was not documented. Patient #7 – This 59-year-old patient with the diagnoses of malignant neoplasm of small intestine, iron deficiency anemia, and encounter for adjustment of ventricular assist device was admitted to the home care agency on 02/19/2025. Review of the clinical record lacks documented evidence the patient’s need for palliative care was assessed. During interview on 03/07/2025 at 10:37 AM, the Registered Nurse stated the patient did not need palliative care services but did not document that in the record.

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 review of clinical records, agency policy and procedure, and interviews with agency staff, for eleven (11) of seventeen (17) patients (Patient #s: 2, 3, 4, 5, 6, 8, 9, 11, 12, 15, and 17) the clinical record lacked documented evidence of a complete review of all medications the patient is currently using to identify any potential adverse effects and drug reactions or concerns. Failure to conduct a complete medication review has the potential for the patient to experience medication side effects or to receive incorrect medication dosages. Patient #4 – This 62- year -old patient with the diagnoses of type 2 diabetes mellitus with foot ulcer, non- pressure chronic ulcer other part left foot, cutaneous abscess of right foot, and acquired absence of right great toe was admitted to the home care agency on 10/19/2024. Review of the Home Health Certification and Plan of Care for 10/19/2024 to 12/27/2024 revealed the following orders: - ammonium lactate 12 percent (%) lotion apply to feet daily - cholecalciferol (vitamin D3) 50 mcg(micrograms) by mouth 1 capsule daily - ferrous sulfate 325 mg (milligrams) 1 tablet daily -fluticasone propionate 50 mcg nasal spray suspension 2 (two) spray 2 (two) times daily -linezolid 600 mg 1 tablet 2 times daily -pantoprazole 20 mg tablet 1 tablet daily Review of Hospital Discharge Medication List dated 10/18/2024 lacks orders for the medications. Review of the clinical record lacks documented evidence the Registered Nurse contacted the physician regarding the discrepancies. During interview on 03/07/2025 at 11:30 AM, the Registered Nurse stated being unsure of having any discussion with physician regarding the identified discrepancies. B. Review of the Home Health Certification and Plan of Care for 10/19/2024 to 12/27/2024 revealed the order for ammonium lactate 12 percent (%) lotion apply to feet daily. Review of Hospital Discharge Medication List dated 10/18/2024 revealed an order for ammonium lactate 12 percent (%) lotion apply to feet daily 2 times daily. Review of the clinical record lacks documented evidence the Registered Nurse contacted the physician regarding the discrepancies. During interview on 03/07/2025 at 11:30 AM, the Registered Nurse was unsure of having any discussion with physician regarding the identified discrepancy. Patient #12- This 69-year-old patient with the diagnoses of chronic obstructive pulmonary disease with exacerbation, hypertension and anxiety was admitted to the home care agency on 02/24/2025. Review of the facility discharge medication list dated 02/20/2025 revealed the following orders: - ipratropium-albuterol 0.5 mg-2.5 mg (milligrams) 3 mls (milliliters) inhalation solution every 4 (four) hours as needed for chronic obstructive pulmonary disease (COPD) -tylenol 325 mg every 6 (six) hours as needed for pain Review of the Home Health Certification and Plan of Care for 02/24/2025 to 02/24/2025 lacks orders for the medications. Review of the clinical record lacks documented evidence the Registered Nurse contacted the physician regarding the discrepancies. During interview on 03/07/2025 at 12:25 PM, the Registered Nurse stated the physician was contacted but this was not documented. Patient #15- This 91- year -old patient with the diagnoses of pressure ulcer of right heel stage 3, peripheral vascular disease, venous insufficiency, and paroxysmal atrial fibrillation was admitted to the home care agency on 05/20/2023. Review of the Home Health Certification and Plan of Care for 05/20/2023 to 07/18/2023 revealed the following orders: - melatonin 3 mg 1 capsule at bedtime - metoprolol succinate extended release 100 mg tablet 1 tablet twice a day - nitrofurantoin macrocystal 100 mg capsule 1 capsule twice a day Review of the referral to the agency dated 05/17/2023 lacks orders for the medications. Review of the clinical record lacks documented evidence of the discrepancy and follow-up clarification with the physician. During interview on 03/07/2025 at 01:28 PM, the Registered Nurse Quality Manager stated the medications on the plan of care did not match the referral to the agency. The agency failed to ensure a complete review of all medications the patient is currently using to identify any potential adverse effects and drug reactions or concerns as evidenced by: Review of the undated “Medication Reconciliation” training revealed the following: Physical Therapy Process: - At start of care, documented in the clinical summary who assists the patient with medications, overt issues, and any education provided, Registered Nurse referral. - This documentation will go to the Drug Regimen Review nurse. - Clinical Documentation Improvement will review Drug Regimen Review nurse documentation and edit as appropriate for your review/acceptance as you will have received an email with the Drug Regimen Review nurse information. - The Drug Regimen Review nurse will complete the review of the patient’s drug regimen using homecare homebase system and will document findings in a coordination note and electronically mail the findings to you, the Physical Therapist. Review of the “Therapist Process for Medication Review” updated 04/05/2023 revealed “If there is an issue with reconciliation at start of care (medications in home and medications on most recent medication list from medical doctor or facility discharge summary with referral to now match) – the provider/medical doctor must be called. Issues explained and in response to these – any new orders or a current/correct medication list must be faxed over or called in to branch office nurse or central intake nurse. It is the responsibility of the therapist to follow up on receipt of any faxed orders.” Review of the “Medication Reconciliation Process” dated 07/13/2022 revealed “Medication reconciliation at start of care and resumption of care involves the process of comparing medications in the home… to the medication list from the physician or the discharge instruction sheet… clarify and verify with the physician any discrepancies with a medication, dose, route, or frequency.” Patient #3 – This 91-year-old patient with the diagnoses of influenza, benign prostatic hyperplasia with lower urinary tract symptoms, and retention of urine was admitted to the home care agency on 02/18/2025. Review of the hospital discharge dated 02/17/2025 revealed the order for nitroglycerin (nitrostat 0.4 milligram sublingual tablet) 1 tablet sublingual every five (5) minutes as needed for chest pain. Review of the Home Health Certification and Plan of Care for 02/18/2025 to 04/18/2025 lacks an order for the nitrostat. Review of the clinical record lacks documented evidence the Registered Nurse contacted the physician regarding the discrepancy. During interview on 03/07/2025 at 11:03 AM, the Registered Nurse stated the nitrostat was not ordered. Patient #6 – This 95-year-old patient with the diagnoses of heart failure and hypertension was admitted to the home care agency on 02/26/2025. Review of the hospital discharge dated 02/24/2025 revealed the order for albuterol 90 micrograms/actuation inhaler two puffs, four (4) times daily. Review of the Home Health Certification and Plan of Care for 02/26/2025 to 04/26/2025 lacks an order for albuterol. Review of the clinical record lacks documented evidence the Registered Nurse contacted the physician regarding the discrepancies. During interview on 03/07/2025 at 10:46 AM, the Registered Nurse stated they did call the physician but did not specify discussing albuterol. Patient #9 – This 69-year-old patient with the diagnoses of status post left total knee replacement on 02/25/2025 and hypertension was admitted to the healthcare agency on 02/26/2025. A. Review of the After Visit Summary dated 02/25/2025 revealed the order: tylenol take 2 (two) tablets (650 milligrams total) by mouth every six (6) hours for 10 (ten) days. Review of the Home Health Certification and Plan of Care for 02/26/2025 to 04/26/2025 revealed the order: tylenol 325 milligrams tablet 2 (two) tablets every 6 (six) hours orally as needed for pain. Review of the Total Knee Replacement Postop instructions dated 02/25/2025, revealed the order: tylenol: 2 (two) tablets every 6 (six) hours around the clock for one (1) week, then can take as needed. Review of the clinical record lacks documented evidence the Physical Therapist or Registered Nurse contacted the physician regarding the discrepancy. During interview on 03/07/2025 at 04:15PM, the Physical Therapist stated being unable to recall seeing the medication instructions in the discharge summary at the patient’s home, so they did not add to medication list or clarify with physician. B. Review of the After Visit Summary dated 02/25/2025, the medication list revealed the order: aspirin take 1 tablet (81mg total) by mouth in the morning and 1 tablet (81mg total) by mouth before bedtime. Do all this for 14 (fourteen) days. Take one tablet twice daily for 14 days then once daily for 4 weeks. Review of the Home Health Certification and Plan of Care for 02/26/2025 to 04/26/2025 revealed the order for aspirin 81 milligram tablet, delayed release 1 tablet two (2) times daily orally for prevention. Review of the Total Knee Replacement Postop instructions dated 02/25/2025 revealed the order for aspirin 81 milligram tablet twice a day for two (2) weeks, then once per day for four (4) more weeks. Review of the clinical record lacks documented evidence the Physical Therapist or Registered Nurse contacted the physician regarding the discrepancy. During interview on 03/07/2025 at 04:15PM, the Physical Therapist stated being unable to recall seeing the medication instructions in the discharge summary at the patient’s home, so they did not add to medication list or clarify with physician. C. Review of the After Visit Summary dated 02/25/2025 revealed the order for oxycodone 5 milligram immediate release tablet. Take 1 tablet (5 milligrams total) by mouth every four (4) hours if needed for severe pain (pain scale 7-10) for up to seven (7) days. Max amount daily: 30 milligrams. Review of the Home Health Certification and Plan of Care for 02/26/2025 to 04/26/2025 revealed the order for oxycodone 5mg tablet 1 tablet every five (5) hours orally as needed for pain. Review of the Total Knee Replacement Postop instructions dated 02/25/2025, the medications on discharge revealed the order for oxycodone1 tablet every four to six (4-6) hours as needed for breakthrough pain. Review of the clinical record lacks documented evidence the Physical Therapist or Registered Nurse contacted the physician regarding the discrepancy. During interview on 03/07/2025 at 04:15PM, the Physical Therapist stated being unable to recall seeing the medication instructions in the discharge summary at the patient’s home, so they did not add to medication list or clarify with physician. D. Review of the After Visit Summary dated 02/25/2025, the medication list revealed the order for tramadol 50 milligram tablet. Take 1 tablet (50mg total) by mouth every six (6) hours for seven (7) days. Max daily amount 200 milligrams. Review of the Home Health Certification and Plan of Care for 02/26/2025 to 04/26/2025 revealed the order for tramadol 50 milligrams tablet 1 tablet every six (6) hours orally as needed for pain. Review of the Total Knee Replacement Postop instructions dated 02/25/2025 revealed the order for tramadol: 1 pill every six (6) hours around the clock for one (1) week, then as needed. Review of the clinical record lacks documented evidence the Physical Therapist or Registered Nurse contacted the physician regarding the discrepancy. During interview on 03/07/2025 at 04:15PM, the Physical Therapist stated being unable to recall seeing the medication instructions in the discharge summary at the patient’s home, so they did not add to medication list or clarify with physician. Patient #5 – This 78-year-old patient with the diagnoses of difficulty ambulating, chronic obstructive pulmonary disease (COPD) with oxygen dependency, and non-insulin dependent type 2 diabetes was admitted to home care agency on 11/20/2024. A. Review of the Home Health Certification and Plan of Care for 11/20/2024 to 1/18/2025 revealed the order for tylenol 325 milligram tablet every 6 (six) hours as needed for pain. Review of the primary care physician note within the referral revealed “internal medicine progress note – telephone visit” dated 11/14/2024, the current outpatient medication list lacks orders for tylenol. Review of the clinical record lacks documented evidence the Registered Nurse discussed the medication discrepancy with the physician. During interview on 3/10/2025 at 09:32AM, the Registered Nurse stated recalling a phone discussion about the medication with the nurse at patient's primary care office, but did not document it. B. Review of the Home Health Certification and Plan of Care for 11/20/2024 to 1/18/2025 revealed orders for miralax 17gram oral powder packet daily and as needed for constipation. Review of the primary care physician note within the referral “internal medicine progress note – telephone visit” dated 11/14/2024 lacks an order for the medication. Review of the clinical record lacks documented evidence the Registered Nurse discussed the medication discrepancy with the physician. During interview on 3/10/2025 at 09:32AM, the Registered Nurse stated recalling a phone discussion about the medication with the nurse at patient's primary care office, but did not document it. C. Review of the physician order dated 11/21/2024 at 12:39 PM revealed "per faxed medication list patient to resume trazadone, buspar, Lexapro, vitamin B12, and duoneb (as needed)." Review of the Home Health Certification and Plan of Care for 11/20/2024 to 1/18/2025 lacks orders for the medications. Review of clinical record lacks documented evidence the Registered Nurse contacted the patient and/or patient spouse to discuss medication discrepancy and resumption of medication. During interview on 03/10/2025 at 09:27AM the Registered Nurse stated being unable to remember if the Registered Nurse placed a call to follow up with patient or spouse after receiving clarification orders regarding the medication discrepancy. During interview on 03/10/2025 at 09:28AM the Director of Branch Operations confirmed that it is the agency's expectation that there is medication reconciliation follow up with documentation. Patient #11- This 73- year- old patient with the diagnoses of encounter for surgical aftercare following surgery on digestive system, diverticuli of the intestines, part unspecified, with perforation and abscess without bleed, and retention of urine, unspecified was admitted to the home care agency on 02/08/2025. A. Review of the Discharge Summary dated 02/07/2025 revealed the following medications: - coq10, oral, daily; - hyoscyamine0.125 milligrams sublingual tablet; 0.125 milligrams = one (1) tablet; as needed every six (6) hours; sublingual; - macrobid 100 milligrams oral capsule; 100 milligrams = one (1) capsule; oral; twice daily; - simethicone 20 milligrams/ per 0.3 milliliters oral suspension; 80 milligrams- 1.2 milliliters; as needed at bedtime; - sucralfate 1 gram, oral. Review of the Home Health Certification and Plan of Care for 02/08/2025 to 04/08/2025 lacks documented evidence of orders for the medications. Review of the clinical record lacks documented evidence the Registered Nurse contacted the physician regarding the discrepancies. During interview on 03/07/2025 at 01:15 PM, the Registered Nurse stated the medications were likely not present in the patient’s home at the time of the visit, medications are not added to the Plan of Care until physically seen in the home. The Registered Nurse further stated that a medication reconciliation is done at each visit, then any changes are addressed with the physician to be added to the Plan of Care. B. Review of the Discharge Summary dated 02/07/2025 revealed the following orders: - caltrate 600+ D oral tablet; one (1) tablet; oral; twice daily; - famotidine 20 milligram oral tablet; 20 milligrams= one (1) tablet; oral; daily; - high potency vitamin D3 25 micrograms (1000 international units) oral capsule; 25 micrograms= one (1) capsule; oral; twice daily; - repatha 140 milligrams; subcutaneous; every month; - vitamin B12 1000 microgram oral tablet; 1000 micrograms = one (1) tablet; oral; twice daily. Review of the Home Health Certification and Plan of Care for 02/08/2025 to 04/08/2025 revealed the following orders: - caltrate with vitamin D3 600 milligrams- 20 micrograms (800 Unit) tablet; oral; two (2) tablets; two (2) times daily; - famotidine 40 milligram tablet; by mouth; one (1) tablet; daily; - D3 DOTS 50 micrograms (2000 international units) tablet; oral; one (1) tablet; daily; - repatha sureclick 140 milligrams/ per milliliter subcutaneous pen injector; subcutaneous; one (1) milliliter; every other week; - mecobalamin (vitamin B12) 2500 microgram chewable tablet; oral; one (1) tablet; daily: Review of the clinical record lacks documented evidence the Registered Nurse contacted the physician regarding the discrepancies. During interview on 03/07/2025 at 01:18 PM, the Registered Nurse stated that each of these medications and doses were reviewed with the physician, but they failed to document the phone call. C. Review of the Home Health Certification and Plan of Care for 02/08/2025 to 04/08/2025 revealed the following orders: - alprazolam 0.5 milligram tablet; oral; one (1) tablet; as directed; take thirty (30) minutes prior to magnetic resonance imaging (MRI); - saline nasal 0.65% spray aerosol; each nostril; one (1) spray; every four (4) hours/ as needed for dryness. Review of the Discharge Summary dated 02/07/2025 lacks orders for the medications. Review of the clinical record lacks documented evidence the Registered Nurse contacted the physician regarding the discrepancies. During interview on 03/07/2025 at 01:18 PM, the Registered Nurse stated that each of these medications were reviewed with the physician, but they failed to document the phone call. D. Review of the Home Health Certification and Plan of Care for 02/08/2025 to 04/08/2025 revealed the following medication order: - miralax 17 gram/ per dose oral powder; oral; 17 grams; daily. The order lacks directions to stir and dissolve in any four (4) to eight (8) ounces of beverage, then drink as directed by the manufacturer. The order lacks instructions on how to reconstitute the medication. During interview on 03/07/2025 at 01:13 PM, the Registered Nurse stated the reconstitution directions should be included in the order but were omitted. E. Review of the Physician Order to Schedule a Resumption of Care Visit dated 02/28/2025 revealed the following list of discharge medications: - calcium- vitamin D (caltrate 600+ D oral tablet); one (1) tablet; oral; twice daily; - famotidine 20 milligram oral tablet; one (1) tablet; oral; every day. Review of the Discharge Medication list lacks orders for the medications. Review of the clinical record lacks documented evidence the Registered Nurse contacted the physician regarding the discrepancies. F. Review of the Physician Orders for Resumption of Care dated 03/01/2025 revealed the following orders: - caltrate with vitamin D3 600 milligrams- 20 micrograms (800 Unit); two (2) tablets; two (2) times daily; oral; Start/ End: 02/08/2025; - famotidine 40 milligram tablet; one (1) tablet; daily; oral; Start/ End: 02/08/2025; - miralax 17 gram/ per dose oral powder; oral; 17 grams; daily; Start/ End: 02/08/2025; - saline nasal 0.65% spray aerosol; each nostril; one (1) spray; every four (4) hours/ as needed for dryness; Start/ End: 02/08/2025. Review of the Home Health Certification and Plan of Care for 02/08/2025 to 04/08/2025 lacks orders for the medications. Review of the clinical record lacks documented evidence the Registered Nurse contacted the physician regarding the discrepancies. During interview on 03/07/2025 at 01:44 PM, the Registered Nurse stated that these medications were already listed in the record and the Registered Nurse did not alter these medications. Additionally, the Registered Nurse stated they focused on the new medications and did not closely review the existing medications. G. Review of the Physician Order to Schedule a Resumption of Care Visit dated 02/28/2025 revealed the following discharge medication: - fluconazole 100 milligram oral tablet; one (1) tablet; oral; every day for five (5) days; Review of the Physician Orders for Resumption of Care dated 03/01/2025 revealed the following order medication order: - fluconazole 100 milligram tablet; one (1) tablet; daily; oral; Start/ End: 03/01/2025. The order lacks an end date. During interview on 03/07/2025 at 01:40 PM, the Registered Nurse stated that they forgot to enter the end date. H. Review of the Physician Order to Schedule a Resumption of Care Visit dated 02/28/2025 revealed the following discharge medication: - albuterol (equivalent to proair) 90 microgram/ per inhalation aerosol; two (2) inhalations; once daily. Review of the Physician Orders for Resumption of Care dated 03/01/2025 revealed the following order medication order: - Ventolin 90 microgram/ actuation aerosol inhaler; two (2) puffs; four (4) times daily/ as needed; inhalation; Start/ End: 02/08/2025. During interview on 03/07/2025 at 01:50 PM, the Registered Nurse stated that the correct order was for albuterol, it was changed, the ventolin was discontinued. Furthermore, the Registered Nurse stated that the medications were discussed with the physician but not documented. Patient #17- This 71- year- old patient with the diagnoses of unspecified fracture of the right femur, subs for closed fracture with routine healing, unspecified alzheimer’s disease, and dementia in other disease classified elsewhere, unspecified severity without behaviors/ psychosis/ mood disturbance/ anxiety was admitted to the home care agency on 05/26/2024. Review of the Transfer/ Discharge Report (from Sub- Acute Rehabilitation Facility) dated 05/20/2025 revealed the following medication orders: - aspirin 81milligram oral tablet delayed release; 81 milligrams; give one (1) tablet by mouth two (2) times daily for deep vein thrombosis prophylaxis until 05/31/2024; - loperamide hydrochloride oral tablet 2 milligrams; give one (1) tablet by mouth every six (6) hours as needed for loose stools; do not exceed six (6) doses in twenty- four (24) hours; - milk of magnesia suspension 1200 milligrams/ per 15 milliliters; give thirty (30) milliliters by mouth every twenty- four (24) hours as needed for constipation; - bisacodyl suppository; insert 10 milligrams rectally every twenty- four (24) hours as needed for constipation; - fleet enema 7-19 grams/ per 118 milliliters; insert one (1) applicatorful rectally every twenty- four (24) hours as needed for constipation; - acetaminophen oral tablet 325 milligrams; give two (2) tablets by mouth every six (6) hours as needed for pain or temp over 101; two (2) tablets= 650 milligrams; max dose 3000 milligrams per twenty- four (24) hours; - tramadol hydrochloride oral tablet 50 milligrams; give one (1) tablet by mouth every six (6) hours as needed for pain; - tylenol oral tablet 325 milligrams; give two (2) tablets by mouth every six (6) hours as needed for pain. Review of the Home Health Certification and Plan of Care for certification period 05/26/2024 to 07/24/2024 revealed an order for aspirin 81 milligram tablet, delayed release; one (1) tablet daily for blood clot prevention. The Home Health Certification and Plan of Care lacks documented evidence of orders for loperamide, milk of magnesia. Bisacodyl, fleet enema, tramadol or as needed acetaminophen/tylenol. Review of the clinical record lacks documented evidence the Registered Nurse contacted the physician regarding the discrepancies. During interview on 03/07/2025 at 02:40PM, the Physical Therapist stated that all the medications were reviewed with the physician, but each medication discussed was not documented. Additionally, at 02:48 PM, the Director of Clinical Operations stated the bowel medications and as needed acetaminophens were standing orders at the Sub-Acute Rehabilitation facility that were stopped at the patient’s discharge home. Patient #2- This 72- year- old patient with diagnoses that include aftercare following joint replacement surgery, presence of right artificial knee joint, and essential primary hypertension was admitted to the home care agency on 02/19/2025. Review of the Registered Nurse Outcome Assessment and Information Set Visit Report dated 02/19/2025 revealed the Physical Therapist documented the following: “Therapy Assessment/ Plan: Telephone call to the physician, the Physical Therapist was directed to a confidential nursing voicemail. The Physical Therapist left a message that the patient did not receive celecoxib from the pharmacy, although it is listed on the discharge summary medication list, the call back number was provided.” Review of the Client Coordination Note Report dated 02/20/2025 revealed the Physical Therapist documented the following: “Note Type: Clinical Significant Medication Issue; Note: Briefly describe the medication issue and follow up: The patient was not given the celecoxib from the pharmacy although it is listed on the discharge summary. Phone call placed with the physician and left a voicemail discussion the medication issue. Call back number provided. Awaiting call back. Was medication follow-up completed by midnight the next calendar day? To be determined.” Review of the clinical record lacks documented evidence of resolution of this medication discrepancy. During interview on 03/07/2025 at 02:19 PM, the Branch Manager stated that there is no further documented follow- up on the medication issue.

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 clinical record review and staff interview for five (5) of seventeen (17) patients (Patient #’s: 5, 10, 12, 13, and 14), requiring updates to the comprehensive assessment based on a major change in the patient's health status, the agency failed to ensure the assessments were of sufficient scope to identify current patient needs. Failure to ensure comprehensive assessments contain complete and accurate information has the potential for unmet patient needs. HV Patient #12- This 69-year-old patient with the diagnoses of chronic obstructive pulmonary disease with exacerbation, hypertension and anxiety was admitted to the home care agency on 02/24/2025. During an observational home visit on 03/04/2025 at 03:15 PM, the patient reported they were taking miralax for constipation. Review of the Home Health Certification and Plan of Care for 02/24/2025 to 04/24/2025 lacks an order for miralax. Review of the Licensed Practical Nurse Subsequent Visit Noted dated 03/04/2025 revealed the following assessment: Meds reconciled, no discrepancies noted. Review of the clinical record lacks documentation that there was follow-up with the physician regarding the medication the patient reported taking. During interview on 03/07/2025 at 12:32 PM, the Licensed Practical Nurse stated they forgot and that there was no follow-up with the physician regarding the specified medication. The agency failed to ensure comprehensive assessments based on major changes in the patient’s health status were of sufficient scope to identify current patient needs as evidenced by: Patient #14 – This 41-year-old patient with the diagnoses of infection following a procedure, bacteremia, and staphylococcus as the cause of disease was admitted to the home care agency on 06/25/2024. Review of the Registered Nurse Subsequent Visit Note dated 07/05/2024 revealed “Patient complaining of increased pain at wound site, as well as green drainage from wound, as well as bloody drainage. Patient also has been having persistent nausea and vomiting over several days. At visit, this writer didn’t see any green drainage from wound, but did note a moderate amount of bloody drainage. Due to all of these symptoms, this writer made recommendation that patient go to emergency room, as it seems wound has become infected. Patient declined, wanted medical doctor called first. Call placed to (medical doctor), spoke to Registered Nurse and reported above to her. Registered Nurse from office to call patient and make recommendations.” Review of the Registered Nurse Infusion Subsequent Visit Note dated 07/06/2024 lacks documented evidence the Registered Nurse followed up on the patient’s symptoms and whether the patient received a call from the physician. During interview on 03/07/2025 at 12:12 PM, the Registered Nurse, IV (intravenous) and Pediatric Team Manager stated there is no documented evidence the Registered Nurse follow-up with the patient or physician. Patient #5 – This 78-year-old patient with the diagnoses of difficulty ambulating, chronic obstructive pulmonary disease (COPD) with oxygen dependency, and non-insulin dependent type 2 diabetes was admitted to home care agency on 11/20/2024. A. Review of Coordination Note completed by Registered Nurse on 12/03/2024 at 10:39AM revealed the following: "Patient and caregiver are both agreeable to skilled nursing discharge this date. They are still hoping to have Physical Therapy and Occupational Therapy evaluations with the goals of getting the patient back on her stair glide so she can get out of her bedroom again. She hasn’t left the bedroom for many months." Review of the clinical record lacks documented evidence the Registered Nurse followed up on the patient’s continued need for Physical Therapy and Occupational Therapy, and delay in start of therapy services. During interview on 03/10/2025 at 09:43AM, the Registered Nurse stated that they did not follow up because they knew the services were ordered, and Occupational and Physical therapy would come when they could. B. Review of Coordination Note completed by Occupational Therapist on 12/06/2024 at 04:41AM revealed the following: "Her husband stated that before she went on hospice which she is no longer on she had portable oxygen making it much easier for her to complete tasks. Patient’s husband is also overwhelmed as a caregiver. This Occupational Therapist mentioned maybe talking to a social worker to find additional resources. Patient states that he’s overwhelmed with the patient constantly asking about food and the menu. Patient said that he’s overwhelmed with making all the meals, but he does get it done. This Occupational Therapist discussed signing up for meals on wheels. Patient’s caregiver said that they like to keep the doors locked and the meals on wheels people in the past have come too early. This Occupational Therapist suggested that they leave out an insulated cooler out on the stoop so that he can bring meals in when he is ready. Caregiver stated that’s possibly a good idea and he will look into it further.' Review of the clinical record lacks documented evidence the Occupational Therapist followed up on the patient’s potential need for portable oxygen as well as a social services referral. During interview on 03/10/2025 at 09:58AM, the Director of Branch Operations stated being unable to speak for the Occupational Therapist as to whether any follow up was completed but did confirm that there is no documented evidence of follow up in the patient’s record. Patient #10 - This 57-year-old patient with the diagnoses of neurogenic bowel, not elsewhere classified, quadriplegia, C5-C7 incomplete, and autonomic dysreflexia was admitted to the agency on 04/17/2017. A. Review of the Licensed Practical Nurse Subsequent Visit Note dated 01/22/2025 revealed the Licensed Practical Nurse documented the “patient to have cysto [cystoscopy] this afternoon.” Review of the Licensed Practical Nurse Subsequent Visit Note dated 01/24/2025 revealed the Licensed Practical Nurse documented “patient cysto [cystoscopy] yesterday showed 3 large bladder stones. Patient scheduled for removal of these Feb. 11th.” Review of the clinical record lacks documented evidence the Registered Nurse followed up with the patient or patient’s physician regarding the cystoscopy, bladder stones and removal of bladder stones. During interview on 03/10/2025 at 10:51 AM, the Registered Nurse stated being unable to recall if the Registered Nurse followed up with the patient or physician. B. Review of the Licensed Practical Nurse Subsequent Visit Note dated 03/10/2025 revealed the Licensed Practical Nurse documented “bactrim will be added to patient’s allergies moving forward…this notation sent to case manager via email.” The clinical record lacks documented evidence of the patient’s allergy to the medication. During interview on 03/10/2025 at 10:49 AM, the Registered Nurse stated that the allergy should have been added to the patient’s record and was not. Patient #13- This 78-year-old with the diagnoses of malignant neoplasm of left kidney, except renal pelvis, essential (primary) hypertension, and paroxysmal atrial fibrillation was admitted to the agency on 09/10/2024. Review of the Registered Nurse Subsequent Visit Note dated 09/19/2024 revealed the Registered Nurse documented the following: - Vital Sign Alert: Blood Pressure 154/62 - Comments: System phone call to physician office. Reported elevated blood pressure. Patient denies headache, dizziness, lightheadedness. Informed physician that we requested patient to keep record of blood pressures at home. Chart set up. Receptionist put message into the record for the physician. Review of the Registered Nurse Discharge from Agency Visit Note dated 09/24/2024 lacks documented evidence the Registered Nurse followed up on the patient’s high blood pressure and whether the nurse or patient received a call back from the physician. During interview on 03/06/2025 at 04:11 PM, the Director of Clinical Operations stated there is no documented evidence the Registered Nurse follow-up with the physician.

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 review of clinical records and staff interviews for five (5) of seventeen (17) patients (Patient #s: 5, 8, 9, 10, and 16) the agency failed to develop individualized Plans of Care that are complete and accurate and address the total needs of the patients. Failure to ensure comprehensive individualized plans of care are developed has the potential for unmet patient needs. Patient #5 – This 78-year-old patient with the diagnoses of difficulty ambulating, Chronic Obstructive Pulmonary Disease (COPD) with oxygen dependency, and non-insulin dependent type 2 diabetes was admitted to home care agency on 11/20/2024. A. Review of the Home Health Certification and Plan of Care for 11/20/2024 to 1/18/2025 revealed the following orders for diabetes management: Skilled Nurse to instruct patient about diabetes management to include diet, skin care, Blood Glucose Testing Trulicity 3 milligrams/0.5 milliliters subcutaneous pen injector, 3 milligrams injection weekly every Tuesday for diabetes. Review of the clinical record lacks documented evidence that an order was obtained for glucometer testing strips, needles for subcutaneous injection, and sharps container. During interview on 03/10/2025 at 09:35AM, the Registered Nurse stated the necessary supplies were within the home and confirmed that the orders should have been in the medical record but were not. B. Review of the Physician Order dated 11/21/2024 revealed the following order: ipratropium 0.5 milligrams - albuterol 3 milligrams/3milliliter nebulization solution. Inhale one (1) nebule via nebulizer four times daily as needed for chronic obstructive pulmonary disease. Review of the clinical record lacks documented evidence that an order was obtained for a nebulizer and supplies. During interview on 03/10/2025 at 09:28AM, the Registered Nurse confirmed that an order was not obtained for the required medical equipment. C. Review of Occupational Therapy Recertification with Skill Visit Note dated 01/14/2025 revealed that through utilization of the fall risk assessment tool completed the occupational therapist determined the patient is at risk for falls. Review of the Home Health Certification and Plan of Care for 01/19/2025 to 03/19/2025 revealed the following safety measures: diabetic precautions, oxygen precautions, and universal precautions. It is not documented on the plan of care that the patient is a fall risk. During interview on 03/10/2025 at 09:57AM, the Director of Branch operations confirmed that the plan of care did not include that patient is at risk for falls or on fall precautions and that it should have been documented as a safety measure. Patient #9 – This 69-year-old patient with the diagnoses of status post left total knee replacement on 2/25/2025 and hypertension was admitted to the home care agency on 02/26/2025. Review of the After Visit Summary dated 02/25/2025, the total knee replacement postop discharge instructions revealed: "Dos: Wear your compression stockings until your follow up appointment. Remove at night and reapply in the morning." Review of the Home Health Certification and Plan of Care for 02/26/2025 to 04/26/2025 lacks orders for compression stockings. During interview on 03/07/2025 at 04:12PM the Physical Therapist states she cannot remember whether the discharge instructions included orders for compression stockings and confirmed that if it was listed in discharge instructions it is expected to be noted in the plan of care but does not see it documented. HV Patient #10 - This 57-year-old patient with the diagnoses of neurogenic bowel, not elsewhere classified, quadriplegia, C5-C7 incomplete, and autonomic dysreflexia was admitted to the agency on 04/17/2017. A. During observational home visit on 03/07/2025 at 10:25 AM, the surveyor observed the Home Health Aide transfer the patient from the wheelchair to the bed using a slide board. Review of the Licensed Practical Nurse Subsequent Visit Note dated 01/20/2025 revealed the Licensed Practical Nurse documented the patient “was assisted out of bed 15-20 minutes later to his bedside commode with the use of his slide board.” Review of the clinical record from 01/05/2025 (most recent recertification period) to 03/10/2025 (last day of survey) lacks an order for a slide board. During interview on 03/10/2025 at 10:25 AM, the Registered Nurse stated the patient uses a slide board to transfer from the wheelchair to bed and it should have been included on the medical orders. B. During an observational home visit on 03/07/2025 at 10:29 AM, the surveyor observed the Home Health Aide put thrombo-embolus deterrent (ted) stockings on the patient’s lower legs. Review of the clinical record from 01/05/2025 (most recent recertification period) to 03/10/2025 (last day of survey lacks an order for the ted stockings, including the amount of compression and instructions for application. During interview on 03/10/2025 at 10:36 AM, the Registered Nurse stated the patient wears ted stockings. Additionally, the Registered Nurse stated that there should be an order for the ted stockings. C. Review of the Home Health Certification and Plan of Care for 01/05/2025 to 03/05/2025 revealed the following: - Diagnosis of Type 2 diabetes mellitus without complications… - An order for “Skilled Nurse to instruct patient about diabetes management to include diet, skin care, blood glucose testing prn [as needed]”… - Durable medical equipment- glucometer, lancets and test strips. Review of the clinical record from 01/05/2025 (most recent recertification period) to 03/10/2025 (last day of survey lacks an order that includes the blood sugar parameters that are to be reported to the physician. During interview on 03/10/2025 at 10:15 AM, the Registered Nurse stated parameters stating when to contact the physician should have been included in the orders. Patient #8- This 19-year-old patient with the diagnoses of acute leukemia of unspecified cell type not achieve remission, encounter for antineoplastic chemotherapy, and other acute pancreatitis without necrosis or infection was admitted to the agency on 12/23/2024. A. Review of the Registered Nurse Infusion Recertification Visit dated 02/17/2025 revealed the Registered Nurse documented the following: 2. Attention to mediport IV access for site care and line maintenance…Cleansed site area with chlorhexidine solution applicator using back and forth scrubbing motion for 30 seconds. Allowed site area to dry completely, then inserted huber needle. Ensured 20G x ¾ in huber needle placement by validating positive blood return, then flushed and labs drawn per lab note. Deaccesed. Review of the Home Health Certificate and Plan of Care for 02/21/2025 to 04/21/2025 lacks an order that includes the size of the huber needle to be used for the mediport access. During interview on 03/06/2025 at 02:13 PM, the Registered Nurse stated there are different sizes of huber needles. Additionally, the order should have included the size of the huber needle. B. Review of the Home Health Certification and Plan of Care for 02/21/2025 to 04/21/2025 revealed an order for Lantus Solostar Units-100 Insulin 100 unit/milliliter (3 milliliter) subcutaneous pen blood glucose monitoring before meals three times a day and 3 units Lispro 100 unit/ milliliter every meal three times a day. Initiate with steroid therapy and report blood glucose results daily to determine when blood glucose monitoring and insulin can be held. Review of the clinical record lacks documented evidence an order was obtained for diabetic glucometer and testing supplies. During interview on 03/06/2025 at 02:17 PM, the Registered Nurse stated that the glucometer and testing supplies were not included because the patient was not currently prescribed a steroid and did not need to take Lantus. The agency failed to develop individualized Plans of Care that are complete and accurate and address the total needs of the patients as evidenced by: Patient #16 – This 71-year-old patient with the diagnoses of venous insufficiency, lymphedema, and chronic ulcer of the left lower leg with fat layer exposed was admitted to the home care agency on 06/05/2022. Review of the Home Health Certification and Plan of Care for 11/27/2023 to 01/25/2024 revealed the following: "The patient has an allergy to adhesive glue... Skilled Nurse to perform/teach wound care to left upper leg measures 12 centimeters x 7 centimeters x 0.2 centimeters, thigh wound orders: cleanse with vashe, apply santyl, then hydrofera blue, then foam. Change three (3) times a week. Left buttocks measures 8 centimeters x 6 centimeters x 0.1 centimeters left buttock wound: apply triad, apply foam, change three (3) times a week using clean/aseptic technique.' The order lacks documentation stating what is used for securing the wound dressing to the patient. During interview on 03/07/2025 at 09:47 AM, the Registered Nurse stated they were using tegaderm to secure the dressing, but it was not included on the plan of care.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on clinical record review and staff interview, three (3) of seventeen (17) patient records (Patient #'s: 5, 10, and 16) lacked evidence an order was obtained to update the Plan of Care to reflect the patient's status. Failure to obtain an order to update the Plan of Care has the potential for agency staff to act on inaccurate and incomplete information, and places patient health and welfare at risk. The agency failed to ensure that an order was obtained to update the Plan of Care to reflect the patient's status as evidenced by: Patient #16 – This 71-year-old patient with the diagnoses of venous insufficiency, lymphedema, and chronic ulcer of the left lower leg with fat layer exposed was admitted to the home care agency on 06/05/2022. Review of the Registered Nurse Visit Note Dated 12/08/2023 revealed “(patient) states she is unable to use vashe. Need order for wound spray will clarify with wound medical doctor.” Review of the clinical record lacks an order for wound spray. During interview on 03/07/2025 at 10:05 AM, the Registered Nurse, Clinical Manager stated there was not an order for the wound spray. Patient #5 – This 78-year-old patient with the diagnoses of difficulty ambulating, Chronic Obstructive Pulmonary Disease (COPD) with oxygen dependency, and non-insulin dependent type 2 diabetes was admitted to home care agency on 11/20/2024. Review of Add-On Discipline order dated 12/16/2024 at 3:48PM revealed an order for the following: Physical Therapy effective 12/15/2024 two (2) times per week for four (4) weeks and then one (1) time per week for one (1) week. Review of the clinical record revealed missed Physical Therapy visits on the following dates: 12/20/2024, 12/24/2024, 12/27/2024, and 01/01/2025. Review of the clinical record lacks orders for a change in frequency of Physical Therapy due to missed visits. During interview on 03/10/2025 at 09:53 AM, the Director of Branch Operations stated that no orders were obtained for change in frequency of visits. HV Patient #10- This 57-year-old with the diagnoses of neurogenic bowel, not elsewhere classified, quadriplegia, C5-C7 incomplete, and autonomic dysreflexia was admitted to the agency on 04/17/2017. A. During an observational home visit on 03/07/2025 at 10:35 AM, the surveyor observed the home health aide empty the patient’s urinary catheter and secure to patient’s leg with leg band. Review of the clinical record lacks an order for the home health aide to assist the patient with catheter care. During interview on 03/10/2025 at 10:35 AM, the Registered Nurse stated that there should be an order for the home health aide to assist patient with catheter care. B. Review of the Licensed Practical Nurse Subsequent Visit Note dated 02/23/2025 revealed the Licensed Practical Nurse documented “per patient, wdr [doctor] plans to send cephalexin and methylprednisone to pharmacy, medication list will need to be updated at next visit…this narrative emailed to cm [case manager] nurse.” Review of the Licensed Practical Nurse Subsequent Visit Note dated 02/25/2025 revealed the Licensed Practical Nurse documented the “patient has started abt [antibiotic] and prednisone for potential cellulitis brought on by use of bactrim to left flank area…this notation sent to case manager via email.” The clinical record lacks orders for the medications. During interview on 03/10/2025 at 10:49 PM, the Registered Nurse stated the medications were not added to the medication list and should have been.

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 review of clinical records, and interviews with agency staff, nine (9) of seventeen (17) patients (Patient #s: 2, 5, 8, 10, 11, 13, 14, 15, and 17), the agency failed to ensure drugs and treatments are administered in accordance with physician orders. Failure to administer drugs and treatments without a physician's order has the potential to result in poor quality of care. Patient #17- This 71- year- old patient with the diagnoses of unspecified fracture of the right femur, subs for closed fracture with routine healing, unspecified alzheimer’s disease, and dementia in other disease classified elsewhere, unspecified severity without behaviors/ psychosis/ mood disturbance/ anxiety was admitted to the home care agency on 05/26/2024. Review of the Home Health Certification and Plan of Care for 05/26/2024 to 07/24/2024 revealed the order “Licensed Professional to report vital signs falling outside of the established parameters. Temp lower than 96.8 greater than 100.4, pulse less than 60 greater than 100, respirations less than 12 greater than 24, systolic blood pressure less than 95 greater than 140, diastolic blood pressure greater than 89, oxygen saturation less than 92 percent.” A. Review of the Physical Therapy Subsequent Visit Note dated 05/28/2024 lacks documented evidence the Physical Therapist assessed the patient’s respiration rate. During interview on 03/07/2025 at 03:42 PM, the Director of Clinical Operations stated that agency expectation is that the clinician should have taken the patient’s respiratory rate. B. Review of the Occupational Therapy Add-on Evaluation Visit Note dated 06/03/2024 lacks documented evidence the Occupational Therapist assessed that respiration rate. During interview on 03/07/2025 at 03:37 PM, the Physical Therapist stated that they typically do not obtain a respiratory rate unless the patient is short of breath. Additionally, the Manager of Rehabilitation stated that usually a pulse oximetry can assist in monitoring a patient’s respiratory status. C. Review of the Physical Therapy Subsequent Visit Notes revealed the Physical Therapist’s documentation lacks the following: - On 06/04/2024, 06/06/2024, and 06/13/2024, the documentation lacks assessment of the patient’s temperature and respiratory rate. - On 06/07/2024, the documentation lacks assessment of the patient’s temperature, pulse, blood pressure and pulse oximetry. - On 06/11/2024, the documentation lacks assessment of the patient’s temperature, pulse and blood pressure. During interview on 03/07/2025 at 03:18 PM, the Physical Therapist stated that the patient would often pull off the blood pressure cuff before the Physical Therapist was finished obtaining blood pressures or would get agitated when trying to obtain vital signs. The Physical Therapist also stated that they did not always document this, but they should have. Patient #2- This 72- year- old patient with the diagnoses of aftercare following joint replacement surgery, presence of right artificial knee joint, and essential primary hypertension was admitted to the home care agency on 02/19/2025. Review of the Home Health Certification and Plan of Care for 02/19/2025 to 04/19/2025 revealed the order “Licensed Professional to report vital signs falling outside of the established parameters. Temperature lower than 96.8 greater than 100.4, pulse less than 60 greater than 100, respirations less than 12 greater than 24, systolic blood pressure less than 95 greater than 140, diastolic blood pressure greater than 89, oxygen saturation less than 92 percent.” Review of the Physical Therapy Subsequent Visit Notes dated 02/21/2025, 02/24/2025, 02/27/2025, and 03/04/2025 lack documented evidence the Physical Therapist assessed temperature and respiration rate at each visit. During interview on 30/07/2025 at 02:08 PM, the Physical Therapist stated that they are unbale to remember why the patient’s temperature or respiratory rate were not obtained at those visits. Patient #11- This 73- year- old patient with the diagnoses of encounter for surgical aftercare following surgery on digestive system, diverticuli of the intestines, part unspecified, with perforation and abscess without bleed, and retention of urine, unspecified was admitted to the home care agency on 02/08/2025. Review of the Registered Nurse Resumption of Care Visit Note Report dated 03/01/2025 revealed the Registered Nurse documented that the patient requested a Home Health Aide for assistance with Activities of Daily Living. Review of the Physician Orders for Resumption of Care dated 03/01/2025 revealed the following order: Home Health Aide effective 03/02/2025, one (1) per week for one (1) week, and two (2) times per week for four (4) weeks. Review of the clinical record lacks documented evidence of a Home Health Aide placement. During interview on 03/10/2025 at 11:34 AM, the Registered Nurse stated that the agency is trying to get an aide placed, but one has not been placed as of this time. Patient #5 – This 78-year-old patient with the diagnoses of difficulty ambulating, Chronic Obstructive Pulmonary Disease (COPD) with oxygen dependency, and non-insulin dependent type 2 diabetes was admitted to home care agency on 11/20/2024. A. Review of the Home Health Certification and Plan of Care for 11/20/2024 to 01/18/2025 revealed the following order: Licensed Professional to report vital signs falling outside of the following established parameters. Temperature lower than 96.8 greater than 100.4, pulse less than 60 greater than 100, respirations less than 12 greater than 24, systolic blood pressure less than 95 greater than 140, diastolic blood pressure greater than 89, oxygen saturation less than 92 percent. Review of the Occupational Therapy Reassessment Visit Note dated 12/31/2024 lacks documented evidence the Occupational Therapist assessed oxygen saturation. During interview on 03/10/2025 at 09:56AM, the Director of Branch Operations confirmed there was no oxygen saturation level documented and that it should have been obtained and documented at visit by Occupational therapist. Review of the Physical Therapy Recertification and Add-On Evaluation Visit Note dated 01/14/2025 lacks documented evidence the Physical Therapist assessed oxygen saturation. During interview on 03/10/2025 at 09:50AM, the Physical Therapist confirmed there was no oxygen saturation level documented and that it should have been obtained and documented at visit. B. Review of the Home Health Certification and Plan of Care for 11/20/2024 to 1/18/2025 revealed the following: oxygen gas for inhalation – 2.5 (two and a half) liters oxygen continuous for chronic obstructive pulmonary disease. Review of the Occupational Therapy Add-On Discipline Description Visit Note dated 12/05/2024 revealed: Therapy Assessment/Plan – Patient as on two liters of continuous oxygen via nasal cannula. Vital Signs - oxygen saturation level 99 (ninety-nine) percent on oxygen 2 (two) liters. During interview on 03/10/2025 at 09:52AM the Director of Branch Operations stated that she cannot answer to what the occupational therapist saw on concentrator during visit but does confirm that documentation states in both the vital signs and the narrative inaccurately state that the patient is on 2L of oxygen, so she assumes that is the amount of oxygen the patient was using during visit. Review of the Occupational Therapy Subsequent Visit Note dated 12/11/2024 revealed: vital signs – oxygen saturation 96 percent on 2 liters. During interview on 03/10/2025 at 9:55AM the Director of Branch Operations stated she assumes the amount of oxygen documented is the amount of oxygen the patient was using during visit. Review of the Occupational Therapy Subsequent Visit Note dated 12/19/2024 revealed: vital signs – oxygen saturation 98 percent on 2 liters. During interview on 3/10/2025 at 9:55AM the Director of Branch Operations stated she assumes the amount of oxygen documented is the amount of oxygen the patient was using during visit. Review of the Occupational Therapy Subsequent Visit Note dated 12/23/2024 revealed: vital signs – oxygen saturation 96 percent on 2 liters. During interview on 3/10/2025 at 9:55AM the Director of Branch Operations stated she assumes the amount of oxygen documented is the amount of oxygen the patient was using during visit. C. Registered Nurse Subsequent Visit Note dated 11/26/2024 revealed the following: patient's flu shot administered in her right deltoid, tolerated well. Review of the clinical record lacks documented evidence that an order was obtained for the influenza vaccination. During an interview on 03/10/2025 at 09:39AM the Registered Nurse stated that the patient requested the vaccination at the start of care visit and the agency has a standing order for administration of the influenza vaccine. The Registered Nurse confirmed that no supplemental order is obtained or activated for a patient when a standing order is utilized. Patient #15- This 91- year -old patient with the diagnoses of pressure ulcer of right heel stage 3, peripheral vascular disease, venous insufficiency, and paroxysmal atrial fibrillation was admitted to the home care agency on 05/20/2023. Review of the Home Health Certification and Plan of Care for 01/15/2024 to 03/14/2024 revealed the order “Skilled Nurse to report weight gain of greater than 3 (three) pounds in one day or greater than 5 (five) pounds in one week for heart failure.” Review of the Registered Nurse Subsequent Visit Note dated 01/19/2024, 01/22/2024 and 01/26/2024 lack documented evidence the Registered Nurse assessed the patient’s weight daily. During interview on 03/07/2025 at 12:36 PM, the Registered Nurse stated the weights were done by the caregiver daily, and that she reviewed the weights, but those weights were not documented. The agency failed to ensure drugs and treatments are administered in accordance with physician orders as evidenced by: Patient #14 – This 41-year-old patient with the diagnoses of infection following a procedure, bacteremia, and staphylococcus as the cause of disease was admitted to the home care agency on 06/25/2024. Review of the Home Health Certification and Plan of Care for 06/25/2024 to 08/23/2024 revealed the order “Licensed Professional to report vital signs falling outside of the established parameters. Temp lower than 96.8 greater than 100.4, pulse less than 60 greater than 100, respirations less than 12 greater than 24, systolic blood pressure less than 95 greater than 140, diastolic blood pressure greater than 89, oxygen saturation less than 92 percent.” Review of the Physical Therapy Add-On Evaluation Note dated 07/03/2024 lacks documented evidence the Physical Therapist assessed temperature and respiration rate. During interview on 03/07/2025 at 12:14 PM, the Registered Nurse, IV (intravenous) and Pediatric Team Manager stated those vital signs were not documented. HV Patient #8- This 19-year-old with the diagnoses of acute leukemia of unspecified cell type not achieve remission, encounter for antineoplastic chemotherapy, and other acute pancreatitis without necrosis or infection was admitted to the home care agency on 12/23/2024. A. During an observational home visit on 03/05/2025 at 09:25 AM, this surveyor observed the Registered Nurse draw up 6 (six) milliliters blood and discard. Review of the Registered Nurse Visit Note dated 02/26/2025 revealed the Registered Nurse documented: “obtained lab specimen via vascular access…drew up and discarded 6 milliliters blood.” Review of the Home Health Certification and Plan of Care for 02/21/2024 to 04/21/2025 revealed an order for skilled nurse to draw up and discard 10 (ten) milliliters blood. During interview on 03/06/2025 at 02:35 PM, the Registered Nurse stated the order should be written for between 5 (five) to 7 (seven) milliliters of waste and does not. Additionally, what was drawn and discarded should not be different from the medical orders. B. Review of the Home Health Certification and Plan of Care for 02/21/2024 to 04/21/2025 revealed an order for skilled nurse to draw up and discard 10 milliliters blood. Review of the Registered Nurse Infusion Subsequent Visit dated 02/24/2025 revealed the Registered Nurse documented 5 (five) -7 (seven) milliliters of blood was drawn up and discarded. During interview on 03/06/2025 at 02:58 PM, the Registered Nurse stated they were unaware that the order was to draw up and discard 10 milliliters of blood. C. Review of the Registered Nurse Infusion Subsequent Visit Note dated 02/26/2025 revealed the Registered Nurse documented only medication currently taking is amlodipine and bactrim while on chemotherapy hold. Review of the Home Health Certification and Plan of Care for 02/21/2024 to 04/21/2025 revealed the following orders: - Cyproheptadine 4 milligram tablet one (1) tablet three (3) times daily; - Famotidine 20 milligram tablet one (1) tablet two (2) times daily; - Granisetron HCL 1 milligram tablet one (1) tablet two (2) times daily; and - Milk thistle 150 milligram capsule 180 milligram capsules four (4) times daily During interview on 03/06/2025 at 02:32 PM, the Registered Nurse stated the patient takes the daily medications only while receiving chemotherapy. Additionally, there was not a discussion with the doctor to switch medications from daily to as needed while patient is receiving chemotherapy. There should have been orders indicating what the patient is currently taking. Patient #13- This 78-year-old with the diagnoses of malignant neoplasm of left kidney, except renal pelvis, essential (primary) hypertension, and paroxysmal atrial fibrillation was admitted to the home care agency on 09/10/2024. A. Review of the Home Health Certification and Plan of Care for 09/10/2024 to 11/08/2024 revealed the order for “Licensed Professional to report vital signs falling outside of the established parameters…respirations less than 12 (twelve) greater than 24 (twenty-four).” Review of the Physical Therapy Add-On Evaluation Note dated 09/19/2024 lacks documented evidence the Physical Therapist assessed the respiration rate. During interview on 03/06/2025 at 03:56 PM, the Manager of Rehabilitation stated the respiratory rate should have been assessed and was not documented. B. Review of the Registered Nurse Subsequent Visit Note dated 09/19/2024 revealed the Registered Nurse documented “patient to have staples removed from incision Monday 09/23/2024. Plan for discharge 09/24/2024.” Review of the Registered Nurse Discharge From Agency Visit note dated 09/24/2024 revealed the Registered Nurse documented the following: - Yes, the patient has at least one (observable) surgical wound. - #1- Left abdominal left lower quadrant, surgical incision (inactivated 09/24/2024) …change in wound status, inactivate wound-discharged, wound assessed, yes. The clinical record lacks documented evidence that the patient’s wound was assessed at discharge. During interview on 03/06/2024 at 03:37 PM, the Registered Nurse stated they were unable to confirm if patient was seen by the physician and when the patient’s staples were removed, Additionally, the Registered Nurse states recalling that the staples were not present and just a pin hole remaining for the surgical wound but did not document the assessment. Patient #10- This 57-year-old with diagnoses of neurogenic bowel, not elsewhere classified, quadriplegia, C5-C7 incomplete, and autonomic dysreflexia was admitted to the home care agency on 04/17/2017. Review of the Home Health Certification and Plan of Care for 01/05/2025 to 03/05/2025 revealed an order for Licensed professional to report vital signs falling outside of the following established parameters…"O2 [oxygen] saturation less than 92.” Review of the clinical record lacks documented evidence that the oxygen level was obtained during the Licensed Practical Nurse Subsequent Visits on 01/06/2025, 01/08/2025, 01/10/2025, 01/14/2025, 01/16/2025, 01/22/2025, 01/24/2025, 01/28/2025, 02/05/2025, 02/11/2025, 02/13/2025, 02/19/2025, 02/21/2025, 02/25/2025, 02/27/2025, and 03/01/2025. During interview on 03/10/2025 at 10:45 AM, the Registered Nurse stated that it would be expected that the licensed practical nurse should be documenting the patient’s oxygen level in order to notify provider if it is below 92 percent.

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 review of clinical records and interviews with staff for three (3) of seventeen (17) patients (Patient #s: 11, 13, and 16), the agency failed to ensure the physician is notified of changes in the patient's condition or needs that suggest the Plan of Care may need to be altered. Failure to promptly notify the physician to changes in the patient's condition or needs that may suggest that outcomes are not being achieved and/or the Plan of Care should be altered has the potential to result in unmet patient needs and negative patient outcomes. Patient #11- This 73- year- old patient with the diagnoses that include encounter for surgical aftercare following surgery on digestive system, diverticuli of the intestines, part unspecified, with perforation and abscess without bleed, and retention of urine, unspecified was admitted to the home care agency on 02/08/2025. Review of the Registered Nurse Resumption of Care Visit Note dated 03/01/2025 revealed the Registered Nurse documented the following: "Nutritional: Nutritional Approaches: Check all the Nutritional Approaches that apply on admission: Mechanically altered diet- requires change in texture of food or liquids (e.g., pureed food, thickened liquids); Therapeutic diet (e.g., low salt, diabetic, low cholesterol).” Review of the clinical record from 03/01/2025 to 03/10/2025 (last day of survey) lacks documented evidence the Registered Nurse contacted the physician regarding the need for a mechanically altered diet. Additionally, the clinical record lacks an order for the special diet. During interview on 03/07/2025 at 01:32 PM, the Registered Nurse stated the patient developed issues with swallowing and the physician was not made aware. Patient #13- This 78-year-old with the diagnoses of malignant neoplasm of left kidney, except renal pelvis, essential (primary) hypertension, and paroxysmal atrial fibrillation was admitted to the agency on 09/10/2024. Review of the Home Health Certification and Plan of Care for 09/10/2024 to 11/08/2024 revealed the order for Skilled Nurse two (2) week two (2), one (1) week one (1). Review of the Client Coordination Narrative Note dated 09/17/2024 revealed the Registered Nurse documented the following: "10:00 AM phone call to patient to schedule time for visit today. Patient had concerns regarding nursing visits. This writer offered to have nurse manager call her regarding her concerns. Did not want visit today, visit may be rescheduled pending results of conversation between patient and manager." Review of the Client Coordination Narrative Note dated 09/17/2024 revealed the Registered Nurse documented the following: "5:00 PM phone call to patient after speaking with manager, to set up visit for Wednesday 9/18. Patient states she cannot have visit on Wednesday as she has a MD visit on 09/18/2024. Visit rescheduled for 09/19/2024. Manager notified." Review of the clinical record revealed a Skilled Nursing Visit was completed on 09/19/2024. Review of the clinical record lacks documented evidence a Skilled Nursing visit occurred or documentation that the physician was notified of the missed skilled nursing visit for the week of 09/15/2024. During interview on 03/06/2025 at 04:03 PM, the Manager of Clinical Services stated there is no documentation of a call to the physician about the missed visit. The agency failed to ensure the physician is notified of changes in the patient's condition or needs that suggest the Plan of Care may need to be altered as evidenced by: Patient #16 – This 71-year-old patient with the diagnoses of venous insufficiency, lymphedema, and chronic ulcer of the left lower leg with fat layer exposed was admitted to the home care agency on 06/05/2022. A. Review of the Licensed Practical Nurse Visit Note dated 12/01/2023 revealed “Patient depressed and is no longer going to continue with dialysis.” Review of the clinical record lacks documented evidenced the Licensed Practical Nurse spoke with the physician regarding the patient’s desire to stop dialysis and feeling depressed. During interview on 03/07/2025 at 10:22 AM, the Registered Nurse, Clinical Manager stated there is no documentation of a call to the physician. B. Review of the Registered Nurse Visit Note dated 12/06/2023 revealed “patient has been having visual hallucinations this morning.” Review of the clinical record lacks documented evidence the Registered Nurse spoke with the physician regarding the patient’s hallucinations. During interview on 03/07/2025 at 09:50 AM, the Director of Operations stated the clinician did document leaving a message for the physician but did not document a call back to discuss the patient's change in condition. C. Review of the Home Health Certification and Plan of Care for 11/27/2023 to 01/25/2024 revealed the order “Licensed Professional to report vital signs falling outside of the established parameters. Temp lower than 96.8 greater than 100.4, pulse less than 60 greater than 100, respirations less than 12 greater than 24, systolic blood pressure less than 95 greater than 140, diastolic blood pressure greater than 89, oxygen saturation less than 92 percent.” Review of the Registered Nurse Visit Note dated 12/06/2023 revealed the patient’s blood pressure is 180/90. Review of the clinical record lacks documented evidence the Registered Nurse spoke with the physician regarding the patient’s high blood pressure. During interview on 03/07/2025 at 09:50 AM, the Director of Operations stated the clinician did document leaving a message for the physician but did not document a call back to discuss the patients change in condition.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on review of clinical records and staff interview for two (2) of seventeen (17) patients (Patient #'s: 13 and 14) the agency failed to ensure the patient/caregiver receives appropriate education regarding the care and services identified in the Plan of Care. Failure to provide appropriate education has the potential to result in the patient receiving inadequate care and could result in patient harm. Patient #13- This 78-year-old patient with the diagnoses of malignant neoplasm of left kidney, except renal pelvis, essential (primary) hypertension, and paroxysmal atrial fibrillation was admitted to the home care agency on 09/10/2024. Review of the Home and Health Certificate and Plan of Care for 09/10/2024 to 11/08/2024 revealed an order for “Skilled Nurse to perform/teach wound care to incision/staples site located left abdomen. Patient may shower letting water run over incision, dry thoroughly and leave open to air (OTA) using clean/aseptic technique.” Review of the clinical record from 09/10/2024 to 03/10/2025 (last day of survey) lacks documented evidence that education was provided, and wound care was redemonstrated by the patient/caregiver. During interview on 03/06/2025 at 03:29 PM, the Registered Nurse stated that it is expected the patient/caregiver redemonstrates wound care competence and it was not done. The agency failed to ensure the patient/caregiver receives appropriate education regarding the care and services identified in the Plan of Care as evidenced by: Patient #14 – This 41-year-old patient with the diagnoses of infection following a procedure, bacteremia, and staphylococcus as the cause of disease was admitted to the home care agency on 06/25/2024. Review of the Home Health Certification and Plan of Care for 06/25/2024 to 08/23/2024 revealed “Skilled Nurse to perform/teach wound care to incision/suture site located lower abdomen cleanse with normal saline. Pack open area with iodoform packing strips, cover with gauze and abdominal pad. Change dressing daily using clean/aseptic technique.” Review of the Registered Nurse Infusion Outcome Assessment and Information Set Admission Note dated 06/25/2024 revealed “Patient’s sister who is Registered Nurse will complete wound care on non-nursing days.” Review of the clinical record from 06/25/2024 to 03/10/2025 (last day of survey) lacks documented evidence the sister received appropriate education and performed a re-demonstration of wound care. During interview on 03/07/2025 at 12:04 PM, the Director of Operations stated there is no documentation that the sister was taught how to perform wound care.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with staff, for eight (8) of seventeen (17) patients (Patient #s: 2, 4, 5, 8, 10, 11, 15 and 16), the agency failed to prepare and document complete and accurate clinical notes. Failure to document complete and accurate clinical and progress notes has the potential for unmet patient needs. Patient #4 – This 62- year -old patient with the diagnoses of type 2 diabetes mellitus with foot ulcer, non- pressure chronic ulcer other part left foot, cutaneous abscess of right foot, and acquired absence of right great toe was admitted to the home care agency on 10/19/2024. Review of the Registered Nurse Outcome Assessment and Information Set Admission Note dated 10/19/52024 revealed the following assessment: Diabetes: -Is the client taking Insulin - no -Is the client taking an antidiabetic agent -yes Review of the Home Health Certification and Plan of Care for 10/19/2024 to 12/17/2024 revealed the order for Humulin R regular insulin 100 unit/ml (milliliters) injection 35 units 3 times a day with meals. During interview on 03/07/2025 at 11: 24 AM, the Registered Nurse stated she checked no in error. The Registered Nurse added she is aware the patient is taking insulin. Patient #15- This 91- year -old patient with diagnoses of pressure ulcer of right heel stage 3, peripheral vascular disease, venous insufficiency, and paroxysmal atrial fibrillation was admitted to the home care agency on 05/20/2023. Review of the Licensed Practical Nurse Visit Note dated 01/31/2024 revealed the following assessment: Pain: - Are you having pain – yes - Indicate the location of pain (ask the patient to point to the area- If more than one area, ask which is more bothersome). Type (acute, chronic, recent onset) and quality of pain (aching, burning, cramping) -Right shoulder Review of the Licensed Practical Nurse narrative note dated 01/31/2024, revealed the Licensed Practical Nurse documented the patient denies pain today. During interview on 03/07/2025 at 12:50 PM, the Licensed Practical Nurse stated the documentation was in error. Patient #8- This 19-year-old patient with the diagnoses of acute leukemia of unspecified cell type not achieve remission, encounter for antineoplastic chemotherapy, and other acute pancreatitis without necrosis or infection was admitted to the home care agency on 12/23/2024. A. Review of the Client Care Coordination Lab Drop Off Note dated 02/24/2025 revealed the Registered Nurse documented the following: - Date lab dropped off: 2/25/2025 - Specimen type: CBC (Complete Blood Count) and CMP (Comprehensive Metabolic Panel) - Color and number of each tube delivered: Mint and Lavender. Review of the clinical record lacks documentation of the number of specimen tubes that were dropped off at the lab, and the actual date the tubes were dropped off. It is unclear why the documentation states that the laboratory specimens were dropped off on a future date. During interview on 03/06/2025 at 02:54 PM, the Registered Nurse stated there is a discrepancy in the date, it was completed on 02/25/2025. Additionally, one mint and one lavender specimen tube was dropped off. B. Review of the Registered Nurse Visit Note dated 02/24/2025 revealed the Registered Nurse documented the following: - Indicate port dressing type (mark all that apply): Other (specify); - Describe other port dressing: not applicable; and - Indicate port dressing condition (Mark all that apply): Other (specify). During interview on 03/06/2025 at 02:57 PM, the Registered Nurse stated the documentation was an error; there was no dressing over the port. C. Review of the Review of the Home Health Certification and Plan of Care for 02/21/2025 to 04/21/2025 revealed an order for licensed professional to report vital signs falling outside the following established parameters…"O2 (oxygen) less than 92." During interview on 03/06/2025 at 02:11 PM, the Registered Nurse stated that there was no order to monitor patient's oxygen levels. Additionally, the oxygen parameters to notify the physician was pre-populated in error. Patient #10- This 57-year-old with diagnoses of neurogenic bowel, not elsewhere classified, quadriplegia, C5-C7 incomplete, and autonomic dysreflexia was admitted to the agency on 04/17/2017. A. Review of the Aide Visit Notes dated 01/05/2025, 01/07/2025, 01/09/2025, 01/10/2025, 01/11/2025, 01/13/2025, 01/14/2025, 01/16/2025, 01/17/2025, 01/18/2025, 01/19/2025, 01/20/2025, 01/22/2025, 01/23/2025, 01/24/2025, 01/27/2025, 01/28/2025, 01/30/2025, 01/31/2025, 02/01/2025, 02/02/2025, 02/03/2025, 02/04/2025, 02/06/2025, 02/07/2025, 02/10/2025, 02/11/2025, 02/13/2025, 02/14/2025, 02/15/2025, 02/16/2025, 02/17/2025, 02/18/2025, 02/20/2025, 02/21/2025, 02/22/2025, 02/24/2025, 02/252025, 02/27/2025, 02/28/2025, 03/01/2025, 03/02/2025, and 03/03/2025 revealed the Home Health Aide documented the following: - Service: Any Change in Patient Condition must be phoned into the office and documented in a coor [coordination note]; - Completed: Y [yes]. During interview on 03/10/2025 at 10:42 AM, the Registered Nurse stated that answering "yes" would indicate that the aide completed the task. Additionally, the aide may have misread the question and documented the answer in error. Furthermore, there are no care coordination notes from the Home Health Aide indicating any change in the patient’s condition. B. Review of the Aide Care Plan dated 01/05/2025 revealed an order for Specialized Procedures - Home Health Aides only - provide the following specialized procedures: Perform therapy program on non-bowel days. Review of the Aide Visit Note dated 01/08/2025, 01/11/2025, 01/22/2025, 01/28/2025, and 02/19/2025 revealed the Licensed Practical Nurse documented the following: - Service: Perform Therapy Program - Completed: Y [yes] Review of the Licensed Practical Nurse Subsequent Visit Note dated 01/08/2025, 01/11/2025, 01/22/2025, 01/28/2025, and 02/19/2025 revealed the Licensed Practical Nurse documented bowel regimen completed. During interview on 03/10/2025 at 10:44 AM, the Director Branch Operations stated that the Licensed Practical Nurse documented in error that the therapy program was completed during the aide visit. Patient #11- This 73- year- old patient with the diagnoses that include encounter for surgical aftercare following surgery on digestive system, diverticuli of the intestines, part unspecified, with perforation and abscess without bleed, and retention of urine, unspecified was admitted to the home care agency on 02/08/2025. A. Review of the Registered Nurse Outcome Assessment and Information Set Visit Report dated 02/08/2025 revealed the Registered Nurse documented the following: “Care Management: Special Treatments, Procedures, and Programs: Check all of the following treatments, procedures and programs that apply on admission: C1. Oxygen Therapy; Indicate type of administration of oxygen therapy on admission: C4. High- concentration.” Review of the clinical record lacks documented evidence that the patient utilizes oxygen therapy. During interview on 03/07/2025 at 01:22 PM, the Registered Nurse stated that they meant to reference the patient’s continuous positive airway pressure (CPAP), but documented oxygen in error. B. Review of the Registered Nurse Outcome Assessment and Information Set Visit Report dated 02/08/2025 revealed the Registered Nurse documented the following: “Medications: Management of injectable medications: Patient’s current ability to prepare and take all prescribed injectable medications reliably and safely, including administration of correct dosage at the appropriate times/ intervals. Excludes Intravenous Medications: Not Applicable- No injectable medications prescribed.” Review of the Home Health Certification and Plan of Care for 02/08/2025 to 04/08/2025 revealed an order for the following medication: “Repatha sureclick 140 milligrams/ per milliliter subcutaneous pen injector; subcutaneously; 1 milliliter; every other week; for hyperlipidemia; administered by patient every two (2) weeks.” During interview on 03/07/2025 at 01:23 PM, the Registered Nurse stated that “Not applicable” was an error, and that the patient is taking an injectable medication. C. Review of the Registered Nurse Resumption of Care Visit Report dated 03/01/2025 revealed the Registered Nurse documented the following: “Wound Care Provided: Portion of surgical incision open on abdomen. Measurements and photo obtained. Minimal drainage, cleanse with wound cleanser, cover with DCD (dry, clean dressing), daily and as needed if soiled.” Review of the Physician Orders for Resumption of Care dated 03/01/2025 revealed the following wound care orders: “Skilled Nurse to perform/ teach wound care the dehisced midline abdominal surgical incision: Cleanse with wound cleanser, cover with DSD (dry, sterile dressing), daily and as needed for soiled or dislodged dressing.” During interview on 03/07/2025 at 01:36 PM, the Registered Nurse stated that “DSD” on the physician order is a typo, the agency does not provide sterile dressings in the patient’s homes. Patient #2- This 72- year- old patient with diagnoses that include aftercare following joint replacement surgery, presence of right artificial knee joint, and essential primary hypertension was admitted to the home care agency on 02/19/2025. Review of the Physical Therapist Outcome Assessment and Information Set Visit Report dated 02/19/2025 revealed the Physical Therapist documented the following: “Environmental: Patient Living Situation: Which of the following best describes the patient’s residential circumstance and availability of assistance: Patient lives alone; Neurologic: Indicate Patient’s mental status: Alert, oriented to person, oriented to place, oriented to time, able to follow multi-step commands, able to follow simple commands; Medications: Management on oral medications: Patient’s current ability to prepare and take all oral medications reliably and safely, including administration of the correct dosage at the appropriate times/ intervals. Excludes injectable and intravenous medications: 3- Unable to take medication unless administered by another person.” Review of the clinical records lacks documented evidence regarding why the patient is unable to administer their own medications, or who would administer medications to the patient. During interview on 03/07/2025 at 02:22 PM, the Branch Manager stated that they are unsure why the clinician documented that the patient could not administer the medications, and the clinician’s documentation is inconsistent with the overall picture of the patient’s condition and functional status. Patient #5 – This 78-year-old patient with the diagnoses of difficulty ambulating, chronic obstructive pulmonary disease (COPD) with oxygen dependency, and non-insulin dependent type 2 diabetes was admitted to home care agency on 11/20/2024. Review of the Home Health Certification and Plan of Care for 11/20/2024 to 1/18/2025 revealed the following: Oxygen gas for inhalation – 2.5 (two and a half) liters oxygen continuous for chronic obstructive pulmonary disease. A. Review of the Registered Nurse Visit Note dated 11/25/2024 revealed the following assessment: oxygen saturation level 96 percent on Oxygen 2 (two) liters. During interview on 03/10/2025 at 09:36 AM, the Registered Nurse stated documenting 2 (two) liters inside the assessment was an error, but did document the patient was 96 percent on 2.5 (two and a half) liters of oxygen within the narrative of visit note. B. Review of the Physical Therapy Add-On Evaluation Visit Note dated 12/16/2024 revealed the following assessment: oxygen saturation level 100 (one hundred) percent on room air. During interview on 03/10/2025 at 09:45 AM, the Physical Therapist stated he checks the oxygen concentrator and tubing each visit, and documenting room air was an error. C. Review of the Physical Therapy Visit Note dated 01/03/2025 revealed the following assessment: oxygen saturation level 99 percent on oxygen 2 (two) liters. During interview on 03/10/2025 at 09:48 AM, the Physical Therapist stated he checks the oxygen concentrator and tubing each visit, and documenting room air was an error. D. Review of the Physical Therapy Visit Note dated 01/07/2025 revealed the following assessment: oxygen saturation level 99 percent on oxygen 2 (two) liters. During interview on 03/10/2025 at 09:50 AM, the Physical Therapist stated he checks the oxygen concentrator and tubing each visit, and documenting room air was an error. E. Review of the Physical Therapy Visit Note dated 01/09/2025 revealed the following assessment: oxygen saturation level 99 percent on oxygen 2 (two)liters. During interview on 03/10/2025 at 09:50 AM, the Physical Therapist stated he checks the oxygen concentrator and tubing each visit, and documenting room air was an error. The agency failed to prepare and document complete and accurate clinical notes as evidenced by: Patient #16 – This 71-year-old patient with the diagnoses of venous insufficiency, lymphedema, and chronic ulcer of the left lower leg with fat layer exposed was admitted to the home care agency on 06/05/2022. A. Review of the Licensed Practical Nurse Visit Notes dated 11/29/2023 and 12/01/2023 revealed the following assessment: IV (intravenous) access: - Does patient have an IV access – yes - Indicate vascular access type – central line Review of the Home Health Certification and Plan of Care for 11/27/2023 to 01/24/2024 lacks an order for a central line. During interview on 03/07/2025 at 09:47 AM, the Registered Nurse, Clinical Manager stated the patient has a fistula that is only accessed at dialysis. There is information on the plan of care regarding the patient’s dialysis. B. Review of the Home Health Certification and Plan of Care for 11/27/2023 to 01/25/2024 revealed “Skilled Nurse to perform/teach wound care to left upper leg…cleanse with vashe, apply santyl, then hydrofera blue, then foam. Change three times a week. Left buttocks… apply triad, apply foam, change three times a week using clean/aseptic technique.” Review of the Review of the Licensed Practical Nurse Visit Notes dated 11/29/2023 and 12/01/2023, and the Registered Nurse Visit Note dated 12/04/2023 revealed the Skilled Nurses copied and pasted the patient’s entire Home Health Certification and Plan of Care for 11/27/2023 to 01/25/2024, including information not pertinent to the wounds. The Skilled Nurses failed to document only what wound care was provided. During interview on 03/07/2025 at 10:00 AM, the IV (intravenous) and Pediatric Team Manager and Director of Operations stated the expectation is for the Skilled Nurses to only document exactly what wound care was provided. C. Review of the Registered Nurse Visit Note Dated 12/08/2023 revealed “(patient) states she is unable to use vashe. Need order for wound spray will clarify with wound medical doctor.” Review of the Registered Nurse Visit Note dated 12/11/2023 revealed the following wound care: Skilled Nurse to perform/teach wound care to left upper leg measures 12 centimeters x 7 centimeters x 0.2 centimeters left thigh wound orders: cleanse with vashe, apply santyl, then hydrofera blue, then foam. Change three (3) times a week. Using clean aseptic technique. Wound cleaned with vashe. Santyl applied to woundbed. Hydrafera blue applied over santyl. Fiam dressing applied and secured with clear tape.” During interview on 03/07/2025 at 10:05 AM, the Registered Nurse, Clinical Manager stated they did not use vashe but used wound spray. The documentation was copied and pasted and therefore does not reflect the wound care that was done. D. Review of the Home Health Certification and Plan of Care for 11/27/2023 to 01/25/2024 revealed “Skilled Nurse to report weight gain of greater than three (3) lbs (pounds) in one (1) day or greater than five (5) lbs (pounds) in one (1) week.” Review of the Licensed Practical Nurse Visit Note dated 11/29/2023 revealed the patient weighed 209.5 lbs (pounds). Review of the Licensed Practical Nurse Visit Note dated 12/01/2023 revealed the patient weighed 293 lbs (pounds). During interview on 03/07/2025 at 10:23 AM the Director of Operations stated the weight of 209.5 lbs (pounds) was a typo.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This ELEMENT is not met as evidenced by: Based on review of clinical records and interview with agency staff, for one (1) of four (4) patients receiving Home Health Aide (HHA) services (Patient #10), the agency failed to ensure the HHA is supervised at least every fourteen (14) days. Failure to provide adequate supervision of paraprofessional staff places patients at risk for negative outcomes and unmet patient needs. Patient #10- This 57-year-old patient with the diagnoses of neurogenic bowel, not elsewhere classified, quadriplegia, C5-C7 incomplete, and autonomic dysreflexia was admitted to the home care agency on 04/17/2017. Review of the Home Health Certification and Plan of Care for 01/05/2025 to 03/05/2025 revealed the order: "HHA seven (7) times per week for eight (8) weeks, four (4) times a week for one (1) week." Review of the Registered Nurse Recertification Without Skill Visit Note dated 01/03/2025 revealed the Registered Nurse documented the following: Was a home health aide supervisory performed: Yes Indicate reason for supervisory visit: Direct supervision Review of the clinical record from 01/03/2025 to 03/05/2025 lacks documented evidence that the aide was supervised the week of 01/12/2025, 01/26/2025, 02/09/2025, and 02/23/2025. The clinical record lacks documented evidence of aide supervision every fourteen (14) days. During interview on 03/10/2025 at 10:17 AM, the Registered Nurse stated aide supervisions were not completed for those weeks. During interview on 03/10/2025 at 10:19 AM, the Director Branch Operations stated the aide supervisions are missing from the clinical record.

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 review of clinical records, agency policy and procedure, and staff interview, for two (2) of seventeen (17) patients (Patient #'s 8 and 16), the agency failed to follow agency policies and procedures, current clinical practice guidelines and accepted professional standards when providing services. Failure to follow agency policies and procedures and ensure compliance with accepted professional standards has the potential to result in unmet patient needs and inadequate care. HV Patient #8- This 19-year-old patient with the diagnoses of acute leukemia of unspecified cell type not achieve remission, encounter for antineoplastic chemotherapy, and other acute pancreatitis without necrosis or infection was admitted to the home care agency on 12/23/2024. Review of the agency policy entitled “Laboratory Specimen Collection, Storage, Transportation and Requisitions” effective date 10/19/2021 revealed “Procedure: B. Double identify the patient (i.e., ask patient to state first and last name and date of birth…G. Collect specimen per the appropriate specimen collection procedure.” During an observational home visit on 03/05/2025 at 09:30 AM, this surveyor observed the Registered Nurse draw labs without double identifying the patient before the lab specimen was collected. During interview on 03/06/2025 at 02:51 PM, the Registered Nurse stated the patient’s identification should have been verified before the labs were collected. The agency failed to follow agency policies and procedures, current clinical practice guidelines and accepted professional standards when providing services as evidenced by: Review of the undated “Skin and Wound Care – Assessment: Wound” procedure revealed the following: "Wounds and patients change, therefore wounds need to be reassessed regularly and treated according to the changing needs of the patient and the wound: a. In home care, a professional reassessment of most wounds is indicated at least once a week. b. Reassessment and documentation of the wound should include: 1) Wound measurements." Patient #16 – This 71-year-old patient with the diagnoses of venous insufficiency, lymphedema, and chronic ulcer of the left lower leg with fat layer exposed was admitted to the home care agency on 06/05/2022. A. Review of the Home Health Certification and Plan of Care for 11/27/2023 to 01/25/2024 revealed “Skilled Nurse to perform/teach wound care to left upper leg…cleanse with vashe, apply santyl, then hydrofera blue, then foam. Change three times a week. Left buttocks… apply triad, apply foam, change three times a week using clean/aseptic technique.” Review of the clinical record from 11/26/2023 to 12/02/2023 and 12/03/2023 to 12/09/2023 lacks documented evidence of wound measurements for each week. During interview on 03/07/2025 at 10:21 AM, the Registered Nurse and Registered Nurse, IV (intravenous) and Pediatric Team Manager stated the wound was not measured during that time period, but it is expected they are done weekly. Review of the Home Health Certification and Plan of Care for 11/27/2023 to 01/25/2024 revealed “Skilled Nurse to assess and monitor patient’s pain level and effectiveness of pain control therapy. Skilled Nurse to report increase in pain level to physician for prompt intervention and instruct patient on pharmacologic and non-pharmacologic measures to mitigate pain such as distraction, imagery, deep breathing, relaxation, calming self-statements, and meditation.” B. Review of the undated “Pain Management – Assessment: Screening and Assessment” revealed the following: "Comprehensive pain assessment 1. Inquire and observe if the pain is affecting the patient’s ability to perform activities of daily living, including sleeping and activities that are meaningful to the patient. 1. Ask about physical characteristics of the pain: a. Location b. Intensity c. Quality d. Pattern e. Aggravating factors f. Alleviating factors g. Associated symptoms 2. Ask about the patient’s pain management plan: a. Pain medication b. Pain medication side effects c. Other treatments d. History of abuse 7. If patient has pain, take action to relieve the pain through a joint care planning meeting with the patient and the care team. Do not document the patient has pain and do nothing about it." Review of the Registered Nurse Visit Note dated 12/04/2023 revealed the following pain assessment: - Are you having pain? Yes - Indicate the location of pain… type… and quality: bilateral lower extremity and back pain - Indicate the formalized pain scale selected to assess the patient’s pain: numeric rating scale - How would you rate your paint right now on scale of 0 (zero the least) to 10 (ten the worst)? 7 Review of the clinical record lacks documented evidence the Registered Nurse completed a full pain assessment per agency policy and lacks documented evidence the physician was notified. During interview on 03/07/2025 at 10:24 AM, the Director of Operations stated the assessment is incomplete and the clinician did not alert the physician of the patient’s pain level. C. Review of the Registered Nurse Visit Note dated 12/06/2023 revealed the following pain assessment: - Are you having pain? Yes - Indicate the location of pain… type… and quality: hips, joints - Indicate the formalized pain scale selected to assess the patient’s pain: numeric rating scale - How would you rate your paint right now on scale of 0 (zero the least) to 10 (ten the worst)? 9 Review of the clinical record lacks documented evidence the Registered Nurse completed a full pain assessment per agency policy and lacks documented evidence the physician was notified. During interview on 03/07/2025 at 10:26 AM, the Registered Nurse stated a message was left for the physician but there is no documentation of follow-up. D. Review of the Registered Nurse Visit Note dated 12/08/2023 revealed the following pain assessment: - Are you having pain? Yes - Indicate the location of pain… type… and quality: bilateral hip pain - Indicate the formalized pain scale selected to assess the patient’s pain: numeric rating scale - How would you rate your paint right now on scale of 0 (zero the least) to 10 (ten the worst)? 9 Review of the clinical record lacks documented evidence the Registered Nurse completed a full pain assessment per agency policy and lacks documented evidence the physician was notified. During interview on 03/07/2025 at 09:58 AM, the Director of Clinical Operations stated there is documented evidence of a call to the physician however it does not specify issues with pain. There is no documented evidence of follow-up with the patient’s pain. E. Review of the Registered Nurse Visit Note dated 12/11/2023 revealed the following pain assessment: - Are you having pain? Yes - Indicate the location of pain… type… and quality: spinal arthritis - Indicate the formalized pain scale selected to assess the patient’s pain: numeric rating scale - How would you rate your paint right now on scale of 0 (zero the least) to 10 (ten the worst)? 8 Review of the clinical record lacks documented evidence the Registered Nurse completed a full pain assessment per agency policy and lacks documented evidence the physician was notified. During interview on 03/07/2025 at 10:00 AM, the Director of Operations stated there is documented evidence of a call to the physician however it does not specify issues with pain. There is no documented evidence of follow-up with the patient’s pain.

The following statement of deficiencies represents the results of a complaint survey (97622) against VNA of Western New York Certified Home Health Agency initiated on 05/01/2023. Significant findings were identified within the Condition of Participation 484.5 (G406)- Patient Rights resulting in further expansion of the survey to an extended survey. On 05/05/2023, an Immediate Jeopardy (IJ) was declared based on evidence of actual patient harm for 1 of 2 quadriplegic patients (Patient #2) that did not receive all services outlined in the plan of care and for treatment or care that failed to be furnished. The likelihood of patient harm for 2 of 2 quadriplegic patients (Patient #1 and #2) was identified and it was determined that the likelihood that the adverse outcome could result in serious harm, impairment or death for current and future patients if not corrected. IJ deficiencies were identified in tags G436, G480 and G482. The agency was presented with the IJ Template on 05/05/2023 at 05:04 PM. The survey consisted of a review of 3 clinical records including 3 personnel records for professional and paraprofessional personnel, and 1 observational home visit. The survey also included a review of pertinent policies and procedures. The agency's census is 4705. Pre-survey activities completed on 04/27/2023 included review of the agency's Health Commerce System account. The Director of Quality, Director of Clinical Operations, Director of Patient Services, Director of Clinical operation s for Erie County and agency staff were interviewed throughout the survey. IJ findings were reviewed on 05/05/2023 and all other findings were reviewed during the exit conference on 05/10/2023. The following IJ deficiencies are being cited: G436, G480 and G482. The following non-IJ deficiencies are being cited: G374, G574, G606, G618, G716 and G800.

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 review of the agency's Outcome Assessment Information Set (OASIS) submissions, clinical records, and interviews with agency staff for one (1) of three (3) patients (Patient #1), the agency failed to ensure OASIS data accurately reflects the patient's status at the time of the assessment. Failure to ensure accurate documentation of OASIS data has the potential for negative outcomes. Patient #1 – This 74-year-old patient with diagnoses that include coronary artery disease (CAD), pressure ulcers of the buttock, right foot infection and quadriplegia was admitted to the home health agency on 04/12/2023. Review of the Home Health Certification and Plan of Care for certification period 04/12/2023 to 06/10/2023 revealed the following diagnoses: Pressure ulcer of right heel, stage 3, pressure ulcer of left buttock, stage 3 and pressure ulcer of right buttock, stage 2. Review of the RN (Registered Nurse) OASIS Admission Visit Note dated 04/12/2023 revealed the RN documented the patient's integumentary status as follows: - Does the patient have at least one unhealed pressure ulcer/injury at stage 2 or higher: Yes; - Current number of unhealed pressure ulcer/injuries at stage 2: 0 (zero); -Current number of unhealed pressure ulcer/ injuries at stage 3: 2 (two); - Stage of most problematic unhealed pressure ulcer/injury that is stageable: 3 (three); and - Wound assessment of right buttock stage 2 pressure ulcer: Length 5.0 centimeters (cm), Width 3.5 cm, Depth 0.2 cm with minimal serosanguinous drainage noted. The RN failed to ensure OASIS data accurately reflects the patient’s status. During interview on 05/05/2023 at 12:10 PM time, the Director of Clinical Operations stated the RN who completed the admission assessment is unavailable for interview. The Director of Clinical Operations stated the patient had a stage 2 pressure ulcer on the right buttock and the OASIS staging question was answered incorrectly.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on record reviews and interviews with the Director of Quality, Director of Clinical Operations, Director of Patient Services, Director of Clinical Operations for Erie County and agency staff, it was determined this condition was not met as evidenced by: Failure to provide all services outlined in the plan of care for two of three patients. See G436 Failure to furnish care and treatment that is consistent for two of three patients. See G480. Failure to provide incontinent care, resulting in neglect for one of three patients. See G482 The cumulative effect of these systemic issues related to ensuring patient rights are maintained, resulted in negative outcomes for Patients # 1, and 2 and the potential for negative outcomes for the agency's patient population. Please refer to citations G- 0436, G- 0480 and G- 0482 for the findings under this condition.

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on clinical record reviews and staff interview for two (2) of three (3) patients (Patient #’s 1 and 2), the agency failed to provide all services outlined in the plan of care. Failure to ensure patients receive all services as outlined in the plan of care violates patients’ rights. This tag is part of the Immediate Jeopardy. Patient #1 – This 74-year-old patient with diagnoses that include coronary artery disease (CAD), pressure ulcers of the buttock, right foot infection and quadriplegia was admitted to the home health agency on 04/12/2023. Review of the Home Health Certification and Plan of Care (POC) for certification period 04/12/2023 to 06/10/2023 revealed the patient’s diagnoses as: Pressure Ulcer of Right Heel, stage 3, Pressure ulcer of left buttocks, stage 3, and pressure ulcer of right buttock, stage 2. The POC requires the Skilled Nurse (SN) to perform skin assessment, instruct patient/caregiver about importance of proper positioning to relieve pressure. Instruct patient /care giver on use of pressure relieving measures and devices, proper hygiene, and role of nutrition for maintaining skin integrity. SN to perform/teach pressure ulcer care to right heel: 1) Cleanse wound with NS (Normal Saline), 2) Apply vashe soak for 5 (five) minutes, 3) Apply ACTi coat to wound, 4) Apply Alginate to wound, 5) Cover with foam dressing and Kerlix. SN to perform/teach pressure ulcer care to buttocks: 1) Cleanse with soap and water/bath wipes, 2) Apply Triad mixed with Nystatin powder, 3) Cover with foam dressing PRN (as needed) soiling. Review of the RN OASIS Admission revealed the Registered Nurse (RN) documented the patient had two unhealed pressure ulcers at stage 3 full thickness tissue loss. The wound assessment revealed the RN assessed and documented the presence of two pressure ulcers as follows: (1.) Right low buttock, stage 2 and (2.) Right mid heel, stage 3. No other pressure ulcers were documented. It is uncertain whether the stage 3 left buttock pressure ulcer existed. Review of the Visit Notes from 04/13/2023 to 04/23/2023 lacked documented evidence of the existence of the stage 3 left buttock pressure ulcer. Review of the 04/24/2023 Visit Note revealed the Skilled Nurse (SN) documented the patient had a stage 3 pressure ulcer of the left buttock. There is no documentation of a wound assessment to this newly identified wound, no evidence the SN notified the physician of the presence of the wound or obtained an order to treat the wound; however, the SN documented that the patient’s caregiver provided care to the wound. There is no evidence that the SN educated the caregiver on wound care, as there were no orders for wound care to this wound, and no documentation as to what wound care was provided. The skilled nurse failed to assess, measure, treat and notify the physician of the stage 3 pressure ulcer of the left buttock. During interview on 05/05/2023 at 11:15 AM, the SN stated she did not notify the physician of the newly identified wound or obtain an order to treat the wound. The SN further added that the patient was on services prior to this admission so she assumed the patient’s caregiver was independent with the care. Patient #2 – This 52-year-old patient with diagnoses that include hidradenitis suppurativa, osteitis deformans of unspecified bone and quadriplegia unspecified was admitted to the home health agency on 03/05/2023. The agency failed to ensure the patient received all services as outlined in the plan of care as evidenced by the following: Review of the facility discharge instructions and Patient Information Report dated 02/28/2023 revealed the patient was being discharged from a skilled nursing facility (SNF) where the patient resided from 07/24/2020 until 02/28/2023. Upon discharge to an apartment, where the patient would live alone, the patient would receive 4 hours of personal care aide services (PCA) arranged through a Licensed Home Care Service Agency (LHCSA). The SNF made arrangements for the patient to have a hospital bed, a wheelchair, and mechanical lift to be delivered to the home when the patient arrived, and the patient’s brother was taught how to assist the patient with bed mobility and mechanical lift transfers, which required a two person assist. The discharge instructions requested that the Certified Home Health Agency provide Nursing, Physical Therapy, Occupational Therapy and Social Work services. A.) Review of the Home Health Certification and Plan of Care for certification period 03/05/2023 to 05/03/2023 revealed the order for Skilled Nursing (SN) services to be delivered as 2 WK2 (two visits for two weeks), 1 Wk1 (one visit for one week). Additionally, the SN is to perform skin assessments, instruct patient/caregiver about importance of proper positioning to relieve pressure, instruct patient/caregiver on use of pressure relieving measures and devices. Instruct patient/caregiver on skin assessment, proper hygiene and role of nutrition for maintaining skin integrity. Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission Visit Note dated 03/05/2023 revealed the RN documented the patient is incontinent of bowel and bladder, is contracted and completely immobile, has no pressure ulcers/injuries or stageable pressure ulcers, is dependent on others for all activities of daily living and instrumental activities of daily living, is in a bed that is too small for the patient, and the RN was unable to turn the patient in bed to conduct an assessment of the patient’s skin integrity. Review of the Visit Note Report dated 03/08/2023 revealed the SN documented the patient’s integumentary was within normal limits (WNL). During interview on 05/02/2023 at 01:05 PM, the SN stated during the 03/08/2023 visit the patient was not turned during the skin assessment, and the patient’s backside was not assessed. Review of the Visit Note Reports dated 03/14/2023, 03/23/2023 and 03/28/2023 revealed the SN documented the patient’s integumentary was intact with scars noted. During interview on 05/02/2023 at 02:08 PM, the Licensed Practical Nurse (LPN) stated she documented the patient’s skin was intact on 03/14/2023, 03/23/2023 and 03/28/2023 but was unable to reposition the patient to complete a full skin assessment and did not document this. Review of the Visit Note Report dated 04/18/2023 revealed the SN documented the patient has multiple scattered stage 2 pressure ulcers to the right low buttock and wounds were unable to be evaluated due to the patient’s bed being too narrow and the inability to completely turn the patient in order to leave on side to complete a full wound assessment. The SN failed to perform skin assessments as outlined in the Plan of Care. B.) Review of the Home Health Certification and Plan of Care for certification period 03/05/2023 to 05/03/2023 revealed the order for Physical Therapy (PT) to evaluate to determine condition, evaluate the home environment to eliminate structural barriers and improve safety to increase functional independence and perform skin assessments. Review of the Visit Notes from 03/09/2023 to 04/03/2023 revealed the PT failed to assess the patient’s skin due to the inability to reposition the patient safely. The PT failed to perform skin assessments as outlined in the Plan of Care. During interview on 05/02/2023 at 01:40 PM, the PT stated being unable to reposition the patient alone due to his size, the undersized hospital bed and safety concerns, and as a result was unable to assess the patient’s backside. During interview on 05/03/2023 at 11:12 AM, the Director of Clinical Operations stated there is no documentation in the identified visits of skin assessments to the patient’s posterior upper and lower body being conducted. C.) Review of the Home Health Certification and Plan of Care (POC) for certification period 03/05/2023 to 05/03/2023 revealed “DME (Durable Medical Equipment) in home include hospital bed which is too small for patient.” Additionally, “Physical Therapist to evaluate to determine condition…evaluate home environment to eliminate structural barriers and improve safety to increase functional independence.” Furthermore, there is no order for a pressure relieving mattress. Review of the Visit Note Report dated 04/04/2023 revealed the PT documented the patient has contractures to bilateral hips and left shoulder, pain and paresis in bilateral lower extremities. Patient is immobile and noted to have both lower extremities hanging off the edge of bed, requiring a second person to support him and prevent from rolling off the bed. Patient requires a wider bed to improve safety of care and requires two (2) people to assist in all hygiene care due to limited space in current bed. Patient requires an air mattress for pressure relief. Review of the clinical record revealed the patient did not have an appropriately sized, pressure relieving hospital bed and functional motorized wheelchair delivered to the home until 04/25/2023 (fifty-one days after the patient was admitted to the agency). Review of the PT Visit Notes revealed the PT failed to act timely to obtain a proper bed or notify the supervisor and facility of the need to transfer the patient to a safe environment. The agency failed to obtain operational and appropriate DME within a timely manner or transfer the patient to a supervised environment until a safe plan of care was developed. During interview on 05/02/2023 at 01:23 PM, the PT stated her focus was on obtaining a replacement hospital bed and motorized wheelchair for the patient and failed to address the safety issues and inability to reposition the patient without two (2) people that the agency staff were faced with. D.) Review of the Patient Information Report and Facility Discharge Instructions dated 02/28/2023 requested the patient be evaluated for Social Work (SW). Review of the Home Health Certification and Plan of Care (POC) for certification period 03/05/2023 to 05/03/2023 revealed Patient request SW for home delivered meals and PERS (personal emergency response system). Review of the clinical record revealed the Medical Social Worker (MSW) conducted an initial visit on 03/28/2023 (twenty-three days after the patient was admitted). The agency failed to ensure the patient received SW as ordered within five (5) days of the patient’s admission. During interview on 05/03/2023 at 10:43 AM, the Director of Clinical Operations stated the admitting RN failed to initiate a Social Work referral at the time of the initial assessment.

Treatment or care CFR(s): 484.50(e)(1)(i)(A) (i)(A) Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately; and This ELEMENT is not met as evidenced by: Based on clinical record reviews, agency policy and procedure and staff interview for two (2) of three (3) patients (Patient #’s 1 and 2), the agency failed to ensure care and treatments is provided based on patient needs. Failure to provide all care and treatments to patients as needed has the potential for patient harm. This tag is part of the Immediate Jeopardy. The agency failed to ensure care and treatment is provided based on patient needs as evidenced by the following: Patient #2 – This 52-year-old patient with diagnoses that include hidradenitis suppurativa, osteitis deformans of unspecified bone and quadriplegia unspecified was admitted to the home health agency on 03/05/2023. A.) Review of the Home Health Certification and Plan of Care for certification period 03/05/2023 to 05/03/2023 revealed the order for Skilled Nursing (SN) services to be delivered as 2 WK2 (two visits for two weeks), 1 Wk1 (one visit for one week). Additionally, the SN is to perform skin assessment. Instruct patient/caregiver about importance of proper positioning to relieve pressure, instruct patient/caregiver on use of pressure relieving measures and devices. Instruct patient/caregiver on skin assessment, proper hygiene and role of nutrition for maintaining skin integrity. Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission Visit Note dated 03/05/2023 revealed the RN documented the patient is incontinent of bowel and bladder, is contracted and completely immobile, has no pressure ulcers/injuries or stageable pressure ulcers, is dependent on others for all activities of daily living and instrumental activities of daily living, is in a bed that is too small for the patient, and the RN was unable to turn the patient in bed to conduct an assessment of the patient’s skin integrity. Review of the Visit Note Report dated 03/08/2023 revealed the SN documented the patient’s integumentary was within normal limits (WNL). During interview on 05/02/2023 at 01:05 PM, the SN that performed the 03/08/2023 visit stated that the patient was not turned during the skin assessment, and the patient’s backside was not assessed. Review of the Visit Note Reports dated 03/14/2023, 03/23/2023 and 03/28/2023 revealed the SN documented the patient’s integumentary was intact with scars noted. During interview on 05/02/2023 at 02:08 PM, the Licensed Practical Nurse (LPN) stated she documented the patient’s skin was intact on 03/14/2023, 03/23/2023 and 03/28/2023 but was unable to reposition the patient to complete a full skin assessment and did not document this. Review of the RN Subsequent Visit Note dated 04/05/2023 revealed the RN obtained a photo of open wounds to an unspecified site. The visit note lacks an assessment and measurements of the newly identified posterior wounds. During interview on 05/03/2023 at 10:09 AM, the RN acknowledged not completing a wound assessment of the newly identified wounds but could not recall why it was not conducted. Review of the Visit Note Report dated 04/18/2023 revealed the SN documented the patient has multiple scattered stage 2 pressure ulcers to the right low buttock and wounds were unable to be evaluated due to the patient’s bed being too narrow and the inability to completely turn the patient in order to leave on side to complete a full wound assessment. The agency failed to ensure care and treatments are provided as ordered. During interview on 05/03/2023 at 11:12 AM, the Director of Clinical Operations stated there is no documentation in the identified visits of skin assessments being fully conducted. B.) Review of the Home Health Certification and Plan of Care for certification period 03/05/2023 to 05/03/2023 revealed the order for Physical Therapy (PT) as to evaluate to determine condition…”Physical Therapist to perform skin assessment, instruct patient/caregiver about careful skin assessment and hygiene. Instruct patient/caregiver about importance of proper positioning to relieve pressure, maintaining skin integrity.” Review of the PT Add-On Evaluation (initial assessment) dated 03/09/2023 revealed the PT did not conduct an assessment of the patient’s skin. Review of the clinical record revealed the PT conducted visits on the following dates: 03/09/2023, 03/13/2023, 03/17/2023, 03/27/2023, 04/04/2023 and 04/10/2023. Review of the PT Visit Notes from 03/09/2023 to 04/03/2023 revealed the PT failed to assess the patient’s skin during visits occurring between this time period. The agency failed to ensure care and treatments are provided as ordered. During interview on 05/02/2023 at 01:40 PM, the PT stated being unable to reposition the patient alone due to his size, the undersized hospital bed and safety concerns, and as a result was unable to assess the patient’s backside. C.) Review of the Verbal Order dated 04/05/2023 revealed the following wound care to the left buttock stage 2 pressure ulcers (2) - cleanse with soap and water, apply Triad (cream) to wound bed, perform daily, Home Health Aide (HHA) to do opposite agency. Review of the Verbal Order dated 04/11/2023 revealed the following order: pressure ulcer on buttocks, until supplies are available, cleanse with soap and water, pat dry, apply barrier cream such as Calmoseptine twice daily, caregiver to do on days no nurse visit. Review of the clinical record lacks documented evidence the patient receives Home Health Aide Services. Review of the clinical record lacks documented evidence a caregiver was instructed and demonstrated independence performing wound care. Review of the clinical record from 04/05/2023 to 05/01/2023 reveals the SN made the following visits to the patient to perform wound care: 04/05/2023, 04/06/2023, 04/11/2023, 04/18/2023, 04/22/2023, 04/25/2023 and 04/28/2023. The agency failed to ensure care and treatments are provided as ordered. During interview on 05/03/2023 at 10:25 AM, the RN stated the aides from the (licensed home care services agency, LHCSA) were instructed to apply the barrier cream to the open areas when they were in the home twice daily, but this was not documented. The RN stated being unaware the aides (LHCSA aides) are Personal Care Aides (PCA’s) and the ordered wound care is outside of their scope of practice to perform. Patient #1 – This 74-year-old patient with diagnoses that include coronary artery disease (CAD), pressure ulcers of the buttock, right foot infection and quadriplegia was admitted to the home health agency on 04/12/2023. Review of the Home Health Certification and Plan of Care for certification period 04/12/2023 to 06/10/2023 revealed the following diagnoses and orders: Diagnoses include Pressure ulcer of right heel, stage 3, pressure ulcer of left buttock, stage 3 and pressure ulcer of right buttock, stage 2; Skilled Nurse 3 (times) per week for 8 (eight) weeks, and 4 ( four ) times per week for 1 (one ) week. The Plan of Care (POC) requires the Skilled Nurse (SN) to perform skin assessments and instruct patient/caregiver about importance of proper positioning to relieve pressure. Instruct patient /caregiver on use of pressure relieving measures and devices, proper hygiene, and role of nutrition for maintaining skin integrity. SN to perform/teach pressure ulcer care to right heel: 1) Cleanse wound with NS (Normal Saline), 2) Apply Vashe soak for 5 (five) minutes, 3) Apply Acticoat to wound, 4) Apply Alginate to wound, 5) Cover with foam dressing and Kerlix. SN to perform/teach pressure ulcer care to buttocks: 1) Cleanse with soap and water/bath wipes, 2) Apply Triad mixed with Nystatin powder, 3) Cover with foam dressing PRN (as needed) soiling. A,) Review of the RN OASIS Admission revealed the Registered Nurse (RN) documented the patient had two unhealed pressure ulcers at stage 3 full thickness tissue loss. The wound assessment revealed the RN assessed and documented the presence of two pressure ulcers as follows: (1.) Right low buttock, stage 2 and (2.) Right mid heel, stage 3. No other pressure ulcers were documented. It is uncertain whether the stage 3 left buttock pressure ulcer existed. The RN assessment lacks evidence of obtaining orders for a stage 3 left buttock pressure ulcer. There is also lack of evidence of teaching to the caregiver. The agency failed to ensure care and treatments are provided as ordered. During interview on 05/05/2023 at 11:19 AM, the Registered Nurse (RN) stated the patient did have a stage 3 pressure ulcer to the left buttock and she inactivated the wound assessment in error. B.) Review of the agency policy and procedure entitled “Guidelines; Wound and Skin Care” revised 03/11/2009 revealed “Measure all wounds weekly, measure length, width and depth.” Review of the clinical record from 04/09/2023 to 04/15/2023 (week one) revealed SN visits were conducted on 04/12/2023 and 04/15/2023. The orders are for three visits per week. Review of the clinical record lacks documented evidence the patient and/or physician cancelled a visit for the identified week. Review of the clinical record from 04/16/2023 to 04/22/2023 revealed the SN conducted visits on 04/17/2023, 04/19/2023 and 04/21/2023. The identified visits lack documentation of wound measurements being obtained for the identified week. Review of the clinical record from 04/23/2023 to 04/29/2023 revealed SN conducted visits on 04/24/2023, 04/26/2023 and 04/28/2023. The identified visits lack documentation of a wound assessment and measurements being obtained for the right buttock. Review of SN visits occurring between 04/12/2023 to 04/24/2023 lack documentation of assessments, orders and wound care being performed for the stage 3 left buttocks pressure ulcer. The agency failed to ensure care and treatments are provided as ordered. During interview on 05/05/2023 at 11:10 AM, the Director of Clinical Operations stated there was no documentation to clarify the identified issues.

Mistreatment, neglect or abuse CFR(s): 484.50(e)(1)(i)(B) (i)(B) Mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of patient property by anyone furnishing services on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on clinical record reviews and staff interview for one (1) of three (3) patients (Patient #2), the agency failed to ensure care and treatment is provided when requested and needed. Specifically, the Physical Therapist failed to provide incontinent care or arrange for the provision of incontinent care timely, and in a safe environment. Failure to provide all care and treatments as needed has the potential risk for negative patient outcomes. This tag is part of the Immediate Jeopardy. Patient #2 – This 52-year-old patient with diagnoses that include hidradenitis suppurativa, osteitis deformans of unspecified bone and quadriplegia unspecified was admitted to the home health agency on 03/05/2023. Review of the PT (Physical Therapy) Subsequent Visit Note dated 03/13/2023 revealed the PT documented the “Patient presents in bed noted to have soiled sheets and chuck pad. Patient states no aide came on Sunday (previous day). His brother came by this morning but did not assist in hygiene care. Therapist attempted to assist patient changing chuck pad, however, unable to successfully roll patient on side despite maximal effort. Due to contractures in both hips, pain, paralysis patient is unable to shift weight, reach or participate in bed mobility in a meaningful way. Due to differences in body stature and limited room in his current hospital bed, this therapist is not able to provide enough assistance to successfully roll patient in bed.” The PT failed to request assistance for the provision of incontinent care and failed to facilitate transfer of the patient to a safe environment for the provision of care. During interview on 05/02/2023 at 01:28 PM, the PT stated she was unable to care for the patient’s incontinence during the identified visit and left assuming the patient would be cared for by the licensed agency aide that evening, and did not arrange for additional agency staff to perform a joint visit to assist in caring for the patient. Additionally, the PT stated the Physician had been notified of barriers and safety concerns regarding caring for the patient but the PT failed to document this.

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 review of clinical records and staff interviews for two (2) of three (3) patients (Patient #’s 1 and 2), the agency failed to develop individualized plans of care (POC) that are complete and accurate and address the total needs of the patients. Failure to ensure that a comprehensive individualized plan of care is developed has the potential for unmet patient needs. Patient #2 – This 52-year-old patient with diagnoses that include hidradenitis suppurativa, osteitis deformans of unspecified bone and quadriplegia unspecified was admitted to the home health agency on 03/05/2023. Review of the Home Health Certification and Plan of Care for certification period 03/05/2023 to 05/03/2023 revealed an order for Doxycycline Hyclate 50 mg (milligram) oral tablet, 1 (one) tablet 2 (two) times daily for a skin infection. The order fails to specify the duration to administer the antibiotic. The agency failed to develop an individualized POC that is complete, accurate and addressed the total needs of the patient. During interview on 05/02/2023 at 01:03 PM, the Director of Clinical Operations stated the Registered Nurse that conducted the admission assessment is unavailable for interview and stated the duration of the antibiotic failed to be specified. Patient #1 – This 74-year-old patient with diagnoses that include coronary artery disease (CAD), pressure ulcers of the buttock, right foot infection and quadriplegia was admitted to the home health agency on 04/12/2023. Review of the Home Health Certification and Plan of Care for certification period 04/12/2023 to 06/10/2023 revealed the diagnosis of paraplegia unspecified. The POC fails to specify the patient is a quadriplegic secondary to a cervical spine injury. The agency failed to develop an individualized POC that is complete, accurate and addressed the total needs of the patient. During interview on 05/05/2023 at 02:07 PM, the Director of Quality stated the Registered Nurse that conducted the admission assessment is unavailable for interview and stated this was an error with coding.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on review of clinical records and interview with agency staff, for one (1) of three (3) patients (Patient #2), the agency failed to effectively coordinate services to support the objectives of the plan of care. Failure to ensure adequate coordination and communication occurs, has the potential to result in poor quality of care. Patient #2 – This 52-year-old patient with diagnoses that include hidradenitis suppurativa, osteitis deformans of unspecified bone and quadriplegia unspecified was admitted to the home health agency on 03/05/2023. A.) Review of the PT (Physical Therapy) DC (Discharge) Of PT Services (Not From Agency) dated 04/10/2023 revealed the PT documented the plan is to refer Physical Therapy back when the ordered equipment (hospital bed and motorized wheelchair) are in place at patient’s home or with any changes in function. Review of the LPN (Licensed Practical Nurse) Subsequent Visit Note dated 04/25/2023 revealed the LPN documented the patient has a new motorized wheelchair and hospital bed in the home. The visit note lacks documentation of communication with any agency staff that the awaited equipment is confirmed in the patient’s home. The LPN failed to ensure care coordination with the Registered Nurse (RN) Case Manager to support plan of care objectives. During interview on 05/02/2023 at 02:40 PM, the LPN stated he failed to notify anyone that the patient’s new equipment was in the home at the identified visit. B.) Review of the Patient Information Coordination Note dated 03/05/2023 revealed the patient was receiving 4 hours Personal Care Aide (PCA) services provided by a Licensed Home Care Services Agency (LHCSA) not affiliated with the Certified Home Health Agency (CHHA). Review of the clinical record from 03/05/2023 to 04/03/2023 revealed there is no documented evidence the CHHA communicated or coordinated patient care with the LHCSA. Review of the Patient Information Coordination Note dated 04/04/2023 revealed the Physical Therapist (PT) documented that during the PT’s visit with the patient, the LHCSA Registered Nurse (RN) and PCA were present. At that time, the patient’s functional status was discussed to include the need for two person assist with safe turning and positioning the patient in bed, and for the provision of patient hygiene. During the visit, multiple open areas were discovered on the patient’s bottom. Review of the Physician Order dated 04/05/2023 revealed an order for wound care to the stage 2 pressure ulcers on the patient’s left buttock was obtained. The order specified that the HHA (Home Health Aide) was to perform wound care. Review of the clinical record lacks documented evidence the patient receives Home Health Aide Services but receives PCA services provided by the LHCSA. Additionally, there is no documented evidence the CHHA communicated or attempted to coordinate care with the LHCSA for the provision of wound care. The home health agency RN failed to ensure care coordination with the licensed agency RN to support plan of care objectives. During interview on 05/03/2023 at 10:24 AM, the RN stated he did not communicate with the licensed agency RN regarding having the licensed agency aides perform wound care to the patient’s open wounds. C.) Review of the OT (Occupational Therapy) Add- On Evaluation Visit Note dated 03/14/2023 revealed the OT documented that the LHCSA aides reported that the patient has pressure ulcers and the wounds will be addressed by the agency (CHHA) nursing staff. The OT note lacks documented evidence that the OT informed the CHHA RN about the patient’s need for wound care to the identified pressure ulcers. The OT failed to ensure care coordination with the nursing staff to support plan of care objectives. During interview on 05/02/2023 at 01:55 PM, the Rehabilitation Manager stated the OT was unavailable for interview. The Rehabilitation Manager stated there is no documentation that nursing staff were notified of the reported pressure ulcers to evaluate.

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 review of clinical records and interview with agency staff, for one (1) of two (2) patients receiving Physical Therapy (PT) services (Patient #2), the PT failed to ensure a safe and effective environment was established prior to discharging the patient from therapy services. Failure to ensure a safe discharge plan in in place upon discharge has the potential to place patients at risk for harm. Patient #2 – This 52-year-old patient with diagnoses that include hidradenitis suppurativa, osteitis deformans of unspecified bone and quadriplegia unspecified was admitted to the home health agency on 03/05/2023. Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission Visit Note dated 03/05/2023 revealed the RN documented the patient is completely immobile and unable to make any changes in body or extremity position without assistance. Durable medical equipment in the home includes a hospital bed which is too small for the patient, a motorized wheelchair and a mechanical lift. The patient is requesting a new hospital bed. Additionally, the RN stated being unable to perform a full skin assessment due to the inability to turn the patient in the undersized bed. Review of the Home Health Certification and Plan of Care for certification period 03/05/2023 to 05/03/2023 revealed Durable Medical Equipment is documented as “none”, the patient was referred to the agency after a prolonged stay at a skilled nursing facility (SNF), lived alone, is dependent on caregivers for activities of daily need (ADL) and transfers using a hoyer lift… the patient’s wheelchair is currently broken and needs a new one…the PT is to evaluate/assess and develop a plan of care address deficits in strength, safety, transfers (when functional equipment available), provide techniques to improve bed mobility, instruct others in safe transfers with appropriate body mechanics, perform skin assessments, instruct on importance of proper positioning to relieve pressure, use of pressure relieving devices and role of nutrition for maintaining skin integrity. Additionally, a PT “ evaluation will be completed and a plan of care to increase functional independence will be established…patient will demonstrate bed mobility improved to a Min A (minimal assist) leading to increased safety and independence in the home… skin breakdown will be identified and measures to resolve breakdown implemented promptly.” Review of the PT Add- On Evaluation dated 03/09/2023 (the PT initial assessment of the patient) revealed the PT documented the patient’s has contractures to the left ankle, hip and upper extremities, is immobile, the power wheelchair is broken rendering the patient as bedbound. Additionally, the patient is a maximum assist with bed mobility, the patient is receiving twenty-eight (28) hours of Personal Care Aide (PCA) services per week, and the family is to provide care, but is unreliable. Review of the Patient Information Report dated 03/09/2023 revealed that the PT documented “Patient does not qualify for bariatric bed based on HT (height)/WT (weight), therapist to call local loan closets.” Review of the clinical record from 03/09/2023 to 04/10/2023 revealed the PT was attempting to obtain approval for a new motorized wheelchair and appropriately sized hospital bed with a pressure relieving mattress for the patient. Review of the PT Subsequent Visit Note dated 03/13/2023 revealed the PT documented the patient is unable to shift weight, participate in bed mobility and has limited range of motion in current hospital bed. PT unable to provide enough assistance to successful roll the patient in bed. Positioning the head and foot of the current hospital bed is the only means of pressure relief. Review of the PT Subsequent Visit Note dated 04/04/2023 revealed the PT documented the patient was seen for a potential discharge from PT services but upon reassessment would benefit from continued follow-up to address equipment needs and mobility. RN and Personal Care Aide (PCA) from licensed agency were present during PT visit. With these two (2) additional assists, was able to roll patient dependently. Patient’s lower extremities noted to be hanging off edge of bed, requiring second person to support and prevent patient from rolling off. During this process, multiple open areas were discovered on patient’s bottom. Patient would benefit from a wider bed to improve safety of care and requires all hygiene care to be performed in bed. Due to limited space in his current bed, this task requires two people to perform. Additionally, an air mattress would allow for improved pressure relief and reduce risk of worsening skin breakdown. Review of the DC (Discharge) of PT Services (Not From Agency) dated 04/10/2023 revealed the PT documented the patient requires two assist for bed mobility tasks due to size of current bed limiting the patient’s ability to roll fully onto either side. Two people are required to support at edge of bed and prevent the patient rolling out. Letter of justification for new motorized wheelchair and case communication note describing need for wider hospital bed sent to vendor. At this time, no further need for PT is necessary. The PT failed to ensure a safe and effective environment was established prior to discharging services. During interview on 05/02/2023 at 01:53 PT, the PT stated that after sending equipment justification for a larger hospital bed and motorized wheelchair to the vendor, she believed there were no further PT needs until the equipment was be delivered to the home. The PT planned to re-evaluate the patient at a later date for additional services. The PT acknowledged discharging the patient without having a plan for the patient to be mobilized within the current inadequately sized bed with minimal pressure relief. The PT stated discussions had occurred with the patient and physician regarding the unsafe home situation, but the discussions were not documented.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with staff, for one (1) of three (3) clinical records (Patient #2), the agency failed to ensure clinicians prepare and document complete and accurate clinical notes. Failure to prepare and document complete clinical notes has the potential for unmet patient needs. Patient #2 – This 52-year-old patient with diagnoses that include hidradenitis suppurativa, osteitis deformans of unspecified bone and quadriplegia unspecified was admitted to the home health agency on 03/05/2023. Review of the Patient Information Coordination Note dated 04/05/2023 revealed the Registered Nurse (RN) documented the patient’s stage 2 wounds to the left buttock were assessed and a wound paste was ordered for treatment. Review of the wound picture of the patient dated 04/05/2023 revealed a photo of open wounds to an unidentified area. The photo lacks documentation of a wound assessment and measurements. Review of the RN Subsequent Visit Note dated 04/05/2023 revealed the RN documented an integumentary assessment that is within normal limits (WNL). The documentation is inconsistent. It is unclear whether the patient has pressure ulcers to the left buttock. During interview on 05/03/2023 at 10:05 AM, the RN stated the patient had stage 2 pressure ulcers to the left buttock and he documented incorrectly in the identified assessment.

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 review of clinical records and staff interview for one (1) of three (3) patients receiving aide services (Patient #2), the agency failed to ensure care assigned was within the aide’s scope of practice. Failure to assign tasks within an aide’s scope of practice has the potential to result in inadequate care. HV Patient #2 – This 52-year-old patient with diagnoses that include hidradenitis suppurativa, osteitis deformans of unspecified bone and quadriplegia unspecified was admitted to the home health agency on 03/05/2023. Review of the Patient Information Coordination Note dated 03/31/2023 revealed the patient is authorized to receive eight (8) hours of Personal Care Aide (PCA) services from the Licensed Home Care Services Agency (LHCSA). The care is divided into four (4) hours every morning and four (4) hours every evening. Review of the Physician Order dated 04/05/2023 revealed an order for wound care to the patient’s stage 2 pressure ulcers on the left buttock as follows: cleanse areas with soap and water, apply Triad (barrier cream) to wound beds daily. Additionally, the order specified that the HHA (Home Health Aide) was to perform the wound care opposite of the home health agency Nurse. Review of the Verbal Order dated 04/11/2023 revealed the following order: pressure ulcer on buttocks, until supplies are available, cleanse with soap and water, pat dry, apply barrier cream such as Calmoseptine twice daily, caregiver to do on days no nurse visit. Review of the clinical record lacked documented evidence that HHA services were ever ordered by the agency. There is evidence that the agency is aware that the patient receives PCA services provided by the LHCSA. Review of the clinical record lacks documented evidence that the agency made contact with the patient’s family/ patient caregiver to discuss the patient’s needs, the family’s willingness to participate in the patient’s care, the extent to the type and amount of care the family/caregiver would be willing to provide, and the willingness to be instructed and demonstrate effective and appropriate wound care. On 05/02/2023 at 10:00 AM, an observational home visit was conducted to observe the care provided to the patient by the Certified Home Health Agency (CHHA) Registered Nurse (RN). During the visit, the LHCSA Personal Care Aide (PCA) was present in the patient’s home. The CHHA RN reported that during a previous visit with the patient he directed a LHCSA PCA to apply barrier cream to the patient’s open wounds, and he did not document the intervention. When requested to know whether the CHHA RN coordinated the need for wound care with the LHCSA, the CHHA RN stated that he was not aware that he needed to do so. Additionally, the CHHA RN stated that he was not knowledgeable about the scope of a PCA, nor did he know the certification levels of the PCA’s in the patient’s home. The RN inappropriately assigned tasks to a licensed agency PCA and failed to assign tasks within the scope of the PCA’s care and services. During interview on 05/03/2023 at 10:23 AM, the RN stated he believed the aides working with the patient were Home Health Aides and they could apply the topical cream to the patient’s wounds. He stated being unaware that the licensed agency RN must be involved and is responsible for making any changes to the aide plan of care.

The following statement of deficiencies represents the results of an onsite complaint investigation survey (96276 and 94301) of VNA of Western NY, initiated on 04/18/2023 and completed on 04/19/2023. The survey consisted of a review of three (3) clinical records, pertinent policies and procedures and complaint log. Interviews were conducted throughout the survey with the Director of Quality Improvement and various professional staff. The certified home health agency (CHHA) census was 4,829 patients.­­­­ The agency had four (4) patients actively infected with COVID-19. Findings were reviewed at the exit conference on 04/19/2023. The complaint 96276 was substantiated. The complaint 94301 was not substantiated. The following deficiencies are being cited: G- 0514, G- 0520, G- 0526, G- 0536, G- 0578, G- 0590, G- 0598, G- 0608 and G- 0610.

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 review of clinical records, agency policy and procedure and staff interview, for one (1) of two (2) patients (Patient #1) the agency failed to ensure the Registered Nurse (RN) conducted an initial assessment of the patient within 48 (forty-eight) hours of referral, the patient's return home, or on the physician-ordered start of care date. Failure to conduct the initial assessment within the required time frames has the potential to result in unmet patient needs and negative patient outcomes. Patient #1 – This 89-year-old patient with diagnoses that include hypertensive heart disease with heart failure, acute on chronic systolic heart failure and paroxysmal atrial fibrillation was admitted to the home health agency on 04/03/2023. Review of the agency policy and procedure entitled Initial Assessment/ Reassessment dated 11/01/2011 revealed “An initial visit will be made within twenty-four (24) hours of receipt and acceptance of a community referral or return from institutional placement unless: 1. the patient’s physician orders otherwise; 2. there is written documentation that the patient or family refuses such a visit; 3. there is written documentation of unsuccessful attempts to contact patient/ family.” Review of the Medical Record Coordination Notes Referral dated 03/28/2023 revealed the patient was discharged from the facility and referred to the agency on 03/28/2023. Review of the Medical Record Coordination Notes Case Conference dated 03/29/2023 revealed the patient called the agency on 03/29/2023 and requested the initial assessment visit occur on 04/02/2023. Review of the RN OASIS (Outcome and Assessment Information Set) Admission Note dated 04/03/2023 revealed the initial assessment was completed on 04/03/2023, twenty-four (24) hours after the date the patient requested the visit be rescheduled to. Review of the clinical record lacks documentation of the patient and/ or physician requesting the initial visit be delayed until 04/03/2023. The agency failed to conduct the initial visit on the patient/ physician requested start date. During interview on 04/19/2023 at 11:05 AM, the Genesee, Livingston, Orleans and Wyoming counties (GLOW) Branch Manager stated the RN that performed the initial assessment was unavailable for interview and stated there was no documentation of the reason the visit did not occur on 04/02/2023.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with staff, for one (1) of two (2) patients (Patient #1), the agency failed to ensure that a comprehensive assessment consistent with the patient's needs was performed within five (5) calendar days after the Start of Care (SOC). Failure to ensure a comprehensive assessment is complete and accurate has the potential for unmet patient needs and possible negative outcomes. Patient #1 – This 89-year-old patient with diagnoses that include hypertensive heart disease with heart failure, acute on chronic systolic heart failure and paroxysmal atrial fibrillation was admitted to the home health agency on 04/03/2023. Review of the Medical Record Coordination Notes Intake dated 03/28/2023 revealed the patient was referred to the agency on 03/28/2023 and requested to be evaluated for Skilled Nursing (SN) and Physical Therapy (PT). Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission Note dated 04/03/2023 revealed the initial assessment was completed on 04/03/2023, twenty-four hours later than requested by the patient. Review of the Medical Record Coordination Notes Case Conference dated 04/07/2023 revealed the PT initiated contact with the patient on 04/07/2023, planned a PT evaluation for the week of 04/09/2023 and the patient was in agreement. Review of the Physician Order dated 04/08/2023 obtained by the agency PT involved with scheduling revealed: “Original Physical Therapy orders are greater than 5 (five) days old due to scheduling conflicts. PT evaluation to occur during week of 04/09/2023.” Review of the PT Add- On Evaluation dated 04/11/2023 revealed the PT performed an initial assessment of the patient on 04/11/2023 (eight days after the delayed start of care date). The PT failed to complete a comprehensive assessment of the patient within five (5) calendar days after the start of care. During interview on 04/19/2023 at 11:42 AM, the Genesee, Livingston, Orleans and Wyoming counties (GLOW) Branch Manager stated the PT that obtained the order to delay PT due to scheduling conflicts was unavailable for interview. The GLOW Branch Manager stated there was no documentation that the scheduling conflicts causing a delay were requested by the patient and/ or physician. During interview on 04/19/2023 at 11:34 AM, the PT stated the initial visit on 04/11/2023 was soonest she could evaluate the patient.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on review of clinical records and interview with agency staff for two (2) of two (2) patients (Patient #s: 1 and 2), the agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient's status and needs. Failure to ensure comprehensive assessments accurately reflect the patient status and needs has the potential for unmet patient needs and the potential for negative patient outcomes. Patient #1 – This 89-year-old patient with diagnoses that include hypertensive heart disease with heart failure, acute on chronic systolic heart failure and paroxysmal atrial fibrillation was admitted to the home health agency on 04/03/2023. A.) Review of the facility Discharge Summary dated 03/28/2023 revealed the patient has obstructive sleep apnea and uses a continuous positive airway pressure (CPAP) machine at night. Review of the Home Health Certification and Plan of Care for certification period 04/03/2023 to 06/01/2023 revealed the patient has an order for a CPAP machine. Review of the RN (Registered Nurse ) OASIS (Outcome and Assessment Information Set) Admission Visit Note dated 04/03/2023 lacks an assessment of the CPAP being in the home, compliance using and functionality. The agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient’s status and needs. During interview on 04/19/2023 at 12:55 PM, the Genesee, Livingston, Orleans and Wyoming Counties (GLOW) Branch Manager stated the RN that performed the initial assessment is unavailable for interview. The GLOW Branch Manager stated the RN failed to document an assessment of the CPAP machine. B.) Review of the RN OASIS Admission Visit Note dated 04/03/2023 lacks an assessment of the patient’s immunization status. The agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient’s status and needs. During interview on 04/19/2023 at 12:57 PM, the GLOW Branch Manager stated the RN failed to document an assessment of the patient’s immunizations. Patient #2 - This 60-year-old patient with diagnoses that include atherosclerotic heart disease, hypertension, and status post coronary artery bypass graft (CABG) was admitted to the home health agency on 02/15/2023. A.) Review of the RN OASIS Admission Visit Note dated 02/15/2023 lacks an assessment of the patient’s immunization status. The agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient’s status and needs. During an interview on 04/19/2023 at 12:21 PM, the RN stated she failed to document an assessment of the patient’s immunizations. B.) Review of the Home Health Certification and Plan of Care for the certification period 02/15/2023 to 04/15/2023 revealed the following SN (Skilled Nurse) order: -Wound care to left leg hematoma, cleanse with wound cleanser apply dry clean dressing daily using clean/aseptic technique. Review of the SN OASIS Initial Visit Note dated 02/15/2023 lacks documentation of dressing supplies in the home or being delivered to the home for daily wound dressing changes. The agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient’s status and needs. During interview on 04/19/2023 at 12:40 PM, the Clinical Director of Erie County stated that the patient was responsible for getting her own supplies due to her insurance being out of network with Medline (agency supplier), but that staff should have left some supplies in the home. The Clinical Director further added she will look for documentation that supplies were left in the home, but no further documentation was provided.

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 review of clinical records and interview with staff, two (2) of two (2) patient records (Patient #'s: 1 and 2) lack documented evidence of a complete review of all medications the patient currently uses to identify any potential adverse effects, drug reactions, or concerns. Failure to conduct a complete medication review and to ensure the medication regime is appropriate has the potential for the patient harm. Patient #1 – This 89-year-old patient with diagnoses that include hypertensive heart disease with heart failure, acute on chronic systolic heart failure and paroxysmal atrial fibrillation was admitted to the home health agency on 04/03/2023. A.) Review of the facility Discharge Summary (agency referral) dated 03/28/2023 revealed an order for Amiodarone 200 mg (milligram) by mouth once daily starting 05/07/2023. Review of the Home Health Certification and Plan of Care for certification period 04/03/2023 to 06/01/2023 revealed an order for Amiodarone 200 mg tablet, 1 (one) tablet daily by mouth. The order fails to specify to start taking on 05/07/2023. Review of the clinical record lacks documentation of clarification of the medication discrepancy. The Registered Nurse (RN) failed to identify and reconcile the medication discrepancy identified in the facility Discharge Summary and the plan of care (POC). During interview on 04/19/2023 at 12:50 PM, the Genesee, Livingston, Orleans and Wyoming counties (GLOW) Branch Manager stated the RN that performed the initial assessment is unavailable for interview. The GLOW Branch Manager acknowledged the order on the POC fails to specify the start date identified in the facility Discharge Summary. B.) Review of the facility Discharge Summary dated 03/28/2023 revealed an order for Naloxone 4 mg/ actuation nasal spray, 1 (one) spray by nasal route as needed. Review of the Home Health Certification and Plan of Care for certification period 04/03/2023 to 06/01/2023 lacks documentation of an order for Naloxone. Review of the clinical record lacks documentation of clarification of the medication discrepancy. The RN failed to identify and reconcile the medication discrepancy identified in the facility Discharge Summary and the POC. During interview on 04/19/2023 at 12:52 PM, the GLOW Branch Manager stated the RN was unavailable for interview and acknowledged there is no documentation clarifying the Naloxone discrepancy. Patient #2 - This 60-year-old patient with diagnoses that include atherosclerotic heart disease, hypertension, and status post coronary artery bypass graft (CABG) was admitted to the home health agency on 02/15/2023. A.) Review of the facility referral to the agency dated 02/13/2023 revealed the following medication orders: - Acetaminophen 650 mg by mouth every 4 (four) hours PRN (as needed) for pain; - Amitriptyline HCL 50 mg tablet, 1 (one) tablet by mouth nightly; -Calcium carbonate 1,000 mg by mouth 4 (four) times daily PRN for supplement. - Furosemide 20 mg by mouth daily; - Meclizine HCL 25 mg by mouth 3 (three) times daily PRN; and - Metoprolol succinate 100 mg tablet, 1 (one) tablet by mouth nightly. Do not crush or chew. Review of the Home Health Certification and Plan of Care for certification period 02/15/2023 to 04/15/2023 lacks documented evidence of orders for the identified medications. Review of the clinical record lacks documentation of clarification of the medication discrepancies. The RN failed to identify and reconcile the medication discrepancies identified in the facility referral and POC. During interview on 04/19/2023 at 01:10 PM, the Clinical Director of Erie County stated the RN contacted the physician to report the discrepancies but failed to document this. B.) Review of the Home Health Certification and Plan of Care for certification period 02/15/2023 to 04/15/2023 revealed orders for the following medications: - Acetaminophen 500 mg 2(two) tablet oral every 6 (six) hours PRN for pain; - Amitriptyline 100 mg 1 (one) tablet oral at bedtime; and -Metoprolol Succinate ER (Extended Release) 50 mg 1 (one) tablet oral 2 (two) times daily. Review of the clinical record lacks documentation of clarification of the medication discrepancies. The RN failed to identify and reconcile the medication discrepancies identified on the POC. During interview on 04/19/2023 at 01:10 PM, the Clinical Director of Erie County stated the RN contacted the physician to report the discrepancies but failed to document this.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on review of clinical records and interviews with agency staff, for one (1) of two (2) patients (Patient #1), the agency failed to provide services in accordance with physician orders. Failure to ensure patient care is provided in accordance with physician orders has the potential for patients to receive poor care and for health care needs to go unmet. Patient #1 – This 89-year-old patient with diagnoses that include hypertensive heart disease with heart failure, acute on chronic systolic heart failure and paroxysmal atrial fibrillation was admitted to the home health agency on 04/03/2023. A.) Review of the Home Health Certification and Plan of Care for certification period 04/03/2023 to 06/01/2023 revealed the following Skilled Nurse orders: - Observe and assess cardiovascular system to identify changes and intervene to minimize complications; and - Report weight gain of > (greater than) 3 (three) LBS (pounds) in 1 (one) day or > 5 (five) LBS in one week. Review of the LPN (Licensed Practical Nurse) Subsequent Visit Note dated 04/06/2023 revealed the LPN documented the following: “Patient has +1 (plus one) edema to bilateral legs and feet. Patient is not checking weight (and) has a hard time seeing scale. Writer advised patient and his daughter (that) writer will drop off a scale from our office.” The assessment lacks documentation of the LPN obtaining the patient’s weight. The agency failed to provide services in accordance with physician orders. During interview on 04/19/2023 at 11:26 AM, the LPN stated his scale had broken the week prior to the visit and he had not gone to the agency to obtain a replacement scale prior to making the patient’s visit. During interview on 04/19/2023 at 11:28 AM, the Genesee, Livingston, Orleans and Wyoming counties (GLOW) Branch Manager stated it is expected that clinicians carry working scales with them for home visits and the LPN should have obtained a replacement scale prior to making the identified patient visit. B.) Review of the Home Health Certification and Plan of Care for certification period 04/03/2023 to 06/01/2023 revealed the following Skilled Nurse orders: - Observe and assess cardiovascular system to identify changes and intervene to minimize complications; and - Report weight gain of > (greater than) 3 (three) LBS (pounds) in 1 (one) day or > 5 (five) LBS in one week. Review of the DC (Discharge) of SN (Skilled Nurse) Services (Not From Agency) Visit Note dated 04/14/2023 revealed the Registered Nurse (RN) documented the patient had 1+ pitting edema to the right and left lower extremities and feet, a Respiratory Assessment was not obtained and the patient was unable to weigh himself due to dizziness. There is no documentation that a weight was recorded or obtained during the assessment. The agency failed to provide services in accordance with physician orders. During interview on 04/19/2023 at 11:15 AM, the RN stated she assessed the patient’s lung sounds and weight but failed to document this. C.) Review of the Add On Discipline Orders dated 04/11/2023 revealed the following Physical Therapy (PT) orders: - Effective 04/09/2023, 2WK3 (two visits weekly for three weeks); - Therapist to observe and assess for heart failure symptoms to identify changes and intervene to minimize complications; and - Therapist to provide skilled teaching related to heart failure including identification and prompt reporting of new symptoms and management of ongoing symptoms to prevent exacerbation. Review of the PT Add-On Evaluation Visit Note dated 04/11/2023 revealed the PT documented edema was present in the right and left lower extremities and feet and lung sounds were not assessed. There is no documentation of a weight being obtained or recorded from the patient. Review of the PT Subsequent Visit Note dated 04/13/2023 revealed the PT documented edema was present in the right and left lower extremities and feet and lung sounds were not assessed. There is no documentation of a weight being obtained or recorded from the patient. The agency failed to provide services in accordance with physician orders. During interview on 04/19/2023 at 11:38 AM, the PT stated the documentation reflected what was assessed during the identified visits but teaching regarding signs and symptoms of heart failure was provided.

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 review of clinical records and interviews with agency staff for one (1) of two (2) patients (Patient #1), the agency failed to ensure the physician is notified of changes in the patient's condition or needs that suggest the Plan of Care (POC) may need to be altered. Failure to promptly notify the physician to changes in the patient's condition or needs that may suggest that outcomes are not being achieved and/or the POC should be altered has the potential to result in unmet patient needs and negative patient outcomes. Patient #1 – This 89-year-old patient with diagnoses that include hypertensive heart disease with heart failure, acute on chronic systolic heart failure and paroxysmal atrial fibrillation was admitted to the home health agency on 04/03/2023. Review of the Home Health Certification and Plan of Care for certification period 04/03/2023 to 06/01/2023 revealed the following Skilled Nurse (SN) orders: - Observe and assess cardiovascular system to identify changes and intervene to minimize complications; and - Report weight gain of > (greater than) 3 (three) LBS (pounds) in 1 (one) day or > 5 (five) LBS in one week. Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission Visit Note dated 04/03/2023 revealed the RN documented the patient’s weight was 170 lbs (pounds). Review of the LPN (Licensed Practical Nurse) Subsequent Visit Note dated 04/06/2023 revealed the LPN documented the following: “Patient has +1 (plus one) edema to bilateral legs and feet. Patient is not checking weight (and) has a hard time seeing scale. Writer advised patient and his daughter (that) writer will drop off a scale from our office.” The assessment lacks documentation of the LPN obtaining the patient’s weight and notifying the physician that weights are not being monitored as ordered. Review of the clinical record from 04/06/2023 to 04/13/2023 lacks documentation of a functional scale being in the patient’s home and daily weights being obtained and/or recorded. Review of the clinical record lacks documentation the physician was notified that daily weights are not being obtained and monitored as per the POC. The agency failed to ensure the physician was notified of changes in the patient's condition or needs that suggest the POC may need to be altered. During interview on 04/19/2023 at 11:13 AM, the LPN stated he did not notify the physician of the patient not checking daily weights and that there was not a functional scale in the home when it was identified on 04/06/2023. During interview on 04/19/2023 at 11:14 AM, the RN stated the physician was not notified that daily weights were not being obtained on the patient.

Discharge plans communication CFR(s): 484.60(c)(3)(ii) (ii) Any revisions related to plans for the patient's discharge must be communicated to the patient, representative, caregiver, all physicians or allowed practitioner's issuing orders for the HHA plan of care, and the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any). This ELEMENT is not met as evidenced by: Based on clinical record review, agency policy and procedure and interview with staff, for one (1) of two (2) discharged patients (Patient #1), the agency failed to ensure that discharge planning was communicated with the patient/caregiver and the responsible physician prior to discharge from the agency. Failure to communicate discharge planning has the potential for unmet patient needs. Patient #1 – This 89-year-old patient with diagnoses that include hypertensive heart disease with heart failure, acute on chronic systolic heart failure and paroxysmal atrial fibrillation was admitted to the home health agency on 04/03/2023. Review of the agency policy and procedure entitled “Discharge of Patient” dated 11/01/2011 revealed: “F. The patient will be discharged by the discipline or the agency after notification to the physician and in consultation with the patient and any other professional staff involved in the plan of care. G. The decision to discharge patients from the agency will be based upon the following circumstances: The medical and treatment objectives are met, and the patient can function independently or with other types of community support services.” Review of the LPN (Licensed Practical Nurse) Subsequent Visit Note dated 04/06/2023 lacks documentation of discharge planning with the patient and physician. Review of the Medical Record Coordination Case Conference Note dated 04/11/2023 lacks documentation of discharge planning occurring during the subsequent telephone call with the patient. Review of the clinical record lacks documentation of communication with patient/ caregiver and the physician regarding discharge planning prior to the Skilled Nurse (SN) discharge on 04/14/2023. Review of the DC (Discharge) of SN Services (Not From Agency) dated 04/14/2023 revealed the Registered Nurse (RN) documented the following: - Edema present 1+ (one plus) to the right and left lower extremities and feet; - Respiratory Findings: Not assessed; - Instructed client/ caregiver on monitoring weight daily, recording on a weight log and symptoms of heart failure to notify the physician for; - Comments: Patient did not take weight this morning due to poor balance but does verbalize purpose for daily weights. Physician and Physical Therapist notified of SN discharge. Review of the DC of SN Services (Not From Agency) dated 04/14/2023 lacks documentation of the following: - A weight being obtained and monitored by the clinician; - The patient’s cardiopulmonary status has stabilized; and - The patient/ caregiver are in agreement to being discharged from Skilled Nursing services. The agency failed to ensure the patient was medically stable and discharge planning was communicated to the patient/ caregiver and physician prior to discharge from agency. During interview on 04/19/2023 at 11:22 AM, the RN stated the patient and caregiver were agreeable to discharge and discharge planning had occurred but failed to be documented. The RN stated the patient may have benefitted by being monitored by Skilled Nursing for an additional period of time.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with agency staff for two (2) of two (2) patients (Patient #'s 1 and 2), the agency failed to coordinate care delivery and ensure patient needs are addressed. Failure to coordinate care delivery has the potential for negative patient outcomes. Patient #2 - This 60-year-old patient with diagnoses that include atherosclerotic heart disease, hypertension, and status post coronary artery bypass graft (CABG) was admitted to the home health agency on 02/15/2023. Review of the Visit Note dated 02/15/2023 revealed the RN document plan for next visit: Wound care, but no date as to when the visit will take place. Review of the clinical record lacks documented evidence of a visit being performed after the initial admission visit. Review of the Visits to Orders Comparison Report (agency calendar) dated 02/17/2023 revealed the RN visit was scheduled for the patient on 02/17/2023 and was missed. Missed reason: Cancel visit. Review of the clinical record lacks documented evidence the patient called and cancelled the visit or that the agency attempted to conduct a visit. The agency failed to ensure the RN followed up to ensure a home visit was made to the patient. During interview on 04/19/2023 at 01:10 PM, the Clinical Director of Erie County stated she will look for documentation regarding why the visit was cancelled. However, no further documentation was provided of the reason the visit did not occur on 02/17/2023. Patient #1 – This 89-year-old patient with diagnoses that include hypertensive heart disease with heart failure, acute on chronic systolic heart failure and paroxysmal atrial fibrillation was admitted to the home health agency on 04/03/2023. Review of the Home Health Certification and Plan of Care for certification period 04/03/2023 to 06/01/2023 revealed the following Skilled Nurse (SN) orders: - Observe and assess cardiovascular system to identify changes and intervene to minimize complications; and - Report weight gain of > (greater than) 3 (three) LBS (pounds) in 1 (one) day or > 5 (five) LBS in one week. Review of the LPN (Licensed Practical Nurse) Subsequent Visit Note dated 04/06/2023 revealed the LPN documented that the patient was not checking his weight daily due to having a hard time seeing the scale. The LPN stated he would deliver a new scale to the patient’s home. Review of the clinical record lacks documentation the LPN delivered a scale to the patient’s home for daily weight monitoring. Review of the Medical Record Coordination Case Conference Note dated 04/11/2023 revealed the Registered Nurse (RN) documented making a telephone call to the patient and advised that the RN would drop off a scale later in the day on 04/11/2023 and additionally provide education on importance of daily weights and symptoms that should be reported to the physician. Review of the clinical record lacks documentation of the RN delivering a scale to the patient’s home. Review of the Medical Record Coordination Discharge Summary Note dated 04/14/2023 revealed the RN documented the patient was provided a scale and will monitor his weights daily. The agency failed to coordinate care delivery to ensure a scale was provided to the patient in a timely manner. During interview on 04/19/2023 at 11:31 AM, the LPN stated planning to deliver a new scale to the patient on 04/10/2023 but due to calling in sick, did not deliver the scale. During interview on 04/19/2023 at 11:10 AM, the RN stated a home visit was made on 04/11/2023 to deliver a new scale to the patient and provide additional teaching but failed to be documented.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on review of clinical records and staff interview for one (1) of two (2) patients (Patient #1), the agency failed to ensure the patient/caregiver receives appropriate education regarding the care and services identified in the plan of care (POC). Failure to provide appropriate education has the potential to result in the patient receiving inadequate care and could result in patient harm. Patient #2 - This 60-year-old patient with diagnoses that include atherosclerotic heart disease, hypertension, and status post coronary artery bypass graft (CABG) was admitted to the home health agency on 02/15/2023. Review of the Home Health Certification and Plan of Care for certification period 02/15/2023 to 04/15/2023 revealed an order for Skilled Nursing (SN) to perform/teach wound care to left leg hematoma, cleanse with wound cleanser, apply dry clean dressing daily using clean/aseptic technique. Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission Visit Note dated 02/15/2023 lacks documented evidence the RN observed the patient or caregiver demonstrating wound care independently. Review of the clinical record lacks documentation any further agency visits were conducted. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to independently provide wound care as ordered. During interview on 04/19/2023 at 12:32 PM, the RN stated that she did not observe the patient/caregiver providing wound care.

The following statement of deficiencies represents the results of a partial extended re-certification survey of VNA of WNY Certified Home Health Agency conducted on 05/23/2022 through 05/31/2022 and included complaint investigation 70699 and a COVID-19 vaccination survey. The agency reports six (6) patients who are COVID-19 positive. A standard re-certification survey was initiated on 05/23/2022. Deficient practices were identified within Level 1 standards in G-574 resulting in a partially extended survey. The survey consisted of a review of 23 (twenty-three) clinical records including eight (8) discharge records, seven (7) personnel records for professional and paraprofessional personnel, two (2) contracts, and seven (7) observational home visits. The survey included a review of pertinent policies and procedures, Quality Improvement Meeting minutes for the past 12 (twelve) months, agency's Admission Packet, the Emergency Preparedness Plan, and Complaint Log. The patient census is 6,582. Pre-survey activities consisted of review on 05/16/2022 of the agency's Health Commerce System account, Potentially Avoidable Reports dated 03/2021 to 02/2022 and the agency's compliance with submissions of statistical reports and Emergency Drills. The Director of Quality Improvement, Branch Managers, Clinical Director, and various professional and paraprofessional staff were interviewed. Findings were reviewed at the exit conference on 05/31/2022. The allegations in complaint 70699 were determined substantiated. The following deficiencies are identified as a result of the survey: G- 0514, G- 0520, G- 0526, G- 0536, G- 0544, G- 0574, G-0576, G- 0578, G- 0580, G- 0586, G- 0590, G- 0610, G- 0706, G- 0716, G- 0964, G- 0984, G- 1022, J- 0404, J- 1512, R-0510, R-0610, R-0702, and R-1022.

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 review of clinical records, agency policy and procedure and staff interview for one (1) of twenty-three (23) patients (Patient #18), the agency failed to ensure the Registered Nurse (RN) conducted an initial assessment of the patient within forty-eight (48) hours of referral, the patient's return home, or on the physician-ordered start of care date. Failure to conduct the initial assessment within the required time frame has the potential to result in unmet patient needs and negative patient outcomes. Patient #18 – This 51-year-old patient with diagnoses that include rectal adenocarcinoma with metastasis to liver and an acute deep vein thrombosis was referred to the home care agency on 03/26/2022. Review of the facility Discharge Summary dated 03/25/2022 revealed the patient was discharged from the hospital on 03/25/2022. On 05/27/2022 at 02:07 PM, the surveyor requested a copy of the hospital referral for home care services, none was provided. During interview on 05/31/2022 at 01:25 PM, the Clinical Director stated the hospital uses an electronic portal to refer patients to the home health agency. She stated the referral for this patient was initiated on 03/26/2022 but was not completed by the hospital until 03/27/2022. When requested, the Clinical Director stated she was unable to provide documentation of the identified referral process. Review of the Client Coordination Note dated 03/26/2022 revealed the patient’s family called the home care agency On-Call Registered Nurse (RN) on 03/26/2022 and reported the patient was discharged from the hospital on 03/25/2022. The family reported the patient was dehydrated and declining, and a request was made for a RN home visit to be made as soon as possible. The On-Call RN told the family the status of the patient still stated hospitalized, and the start of care visit was not scheduled at this time. Additionally, the family was told if the patient required immediate care, that the patient should return to the hospital. Review of the clinical record lacks documented evidence the agency followed through on the referral process in order to ensure a start of care assessment visit was completed within 48 hours of the patient’s referral/discharge from the hospital. Without the documented evidence showing the actual referral date, it is unclear what the actual date of the referral was; however, the patient was discharged from the hospital on 03/25/2022. In accordance with the CMS Discharge Planning Rule hospitals are required to discharge the patient, and also transfer or refer the patient where applicable, along with his or her necessary medical information (current course of illness and treatment, post-discharge goals of care, and treatment preferences), at the time of discharge, to not only the appropriate post-acute care service providers and suppliers, facilities, agencies, but also to other outpatient service providers and practitioners responsible for the patient’s follow-up or ancillary care. Based on this rule, the agency should have received the referral and all pertinent information required to provide care for this patient at the time the patient was discharged from the hospital on 03/25/2022. Review of the Client Coordination Note dated 03/28/2022 revealed the RN made three (3) attempts to call the patient and spouse to set up a start of care visit for 03/28/2022. Review of the Client Coordination Note dated 03/28/2022 revealed the patient’s spouse called to report the patient had died. The agency failed to conduct an initial assessment within forty-eight (48) hours of the patient's return home from the hospital. During interview on 05/27/2022 at 02:02 PM, the Erie Branch Manager stated the start of care visit could have been expedited when the family called the On-Call RN on 03/26/2022 requesting home care assistance, but this did not occur.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with staff, for three (3) of seventeen (17) patients receiving therapy services (Patient #'s: 7, 14, and 20), the agency failed to ensure that a comprehensive assessment, consistent with the patient's needs, was performed within five (5) calendar days after the Start of Care (SOC). Failure to ensure a comprehensive assessment is complete and accurate has the potential for unmet patient needs and possible negative outcomes. Patient #7 – This 88-year-old patient with diagnoses that include hypertensive heart disease with heart failure, acute on chronic systolic (congestive) heart failure, and non-st elevation myocardial infarction was admitted to the home care agency on 05/11/2022. Review of the Client Coordination Notes Report written by the Registered Nurse (RN) on 05/11/2022 revealed a referral to Physical Therapy (PT) was made on 05/11/2022. Review of the Client Coordination Notes Report written by the PT on 05/20/2022 (nine (9) days after the start of care) revealed the PT spoke with the spouse who said the patient is unavailable for evaluation today. Review of the clinical record revealed the PT conducted the initial visit on 05/24/2022, 13 (thirteen) days after the start of care. The PT failed to complete a comprehensive assessment of the patient within five (5) calendar days after the start of care. During an interview on 05/27/2022 at 08:54 AM, the Director of Quality Improvement stated she would look for a reason for the delay as well as communication with the physician, but no further information was provided. Patient #14 – This 76-year-old patient with diagnoses that include a stage 3 pressure ulcer to the right heel, type II diabetes mellitus and atherosclerotic heart disease was admitted to the home care agency on 05/23/2021. Review of the Client Coordination Notes Report (Hospital Referral) written by the Licensed Practical Nurse (LPN) dated 05/29/2021 revealed the patient was hospitalized from 05/25/2021 to 05/28/2021 and referrals for Skilled Nursing, PT and OT were requested. Review of the Medical Record Coordination Notes Report written by the PT, dated 06/04/2021 revealed the PT scheduled the initial PT visit for 06/07/2021. Review of the clinical record revealed the PT conducted the initial visit on 06/07/2021 (nine days after the resumption of care). The PT failed to complete a comprehensive assessment of the patient within five (5) calendar days after the resumption of care. During interview on 05/27/2022 at 02:50 PM, the Erie Clinical Director stated the PT was not available for interview. She additionally stated the PT delayed the initial therapy assessment and there was no documentation to clarify why there was a delay. Patient #20 – This 52-year-old patient with diagnoses that include a stage 3 pressure ulcer to sacrum, stage 3 pressure ulcer to left buttock and paraplegia was admitted to the home care agency on 09/23/2021. Review of the Client Coordination Note Report written by the Intake LPN, dated 09/23/2021 revealed a referral for SN (Skilled Nursing), PT, SP (Speech Pathologist) and RD (Registered Dietitian) was made on 09/23/2021. Review of the clinical record revealed the RD completed an initial assessment on 10/06/2021 (thirteen days after the start of care). The RD failed to complete a comprehensive assessment of the patient within five (5) calendar days after the start of care. During interview on 05/27/2021 at 04:30 PM, the Erie Clinical Director stated the Dietitian was unavailable for interview. She additionally stated there was no documentation in the record to explain the RD delay.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on review of clinical records and interview with agency staff for two (2) of twenty-three (23) patients (Patient #s: 14 and 17), the agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient's status and needs. Failure to ensure comprehensive assessments accurately reflect the patient status and needs has the potential for unmet patient needs and the potential for negative patient outcomes. Patient #17 – This 58-year-old patient with diagnoses that include pressure ulcer of the right buttock, unstageable, acute kidney failure, and type II diabetes mellitus with diabetic chronic kidney disease was admitted to the home care agency on 02/13/2022. This patient was listed on the agency’s potentially avoidable patient listing report for emergent care for hypo/hyperglycemia. Review of the Home Health Certification and Plan of Care for certification period 02/13/2022 to 04/12/2022 revealed the patient tests “blood glucoses as needed.” Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) lacks documented evidence the RN obtained a baseline blood glucose. The agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient's status and needs. During interview on 05/27/2022 at 01:40 PM, the RN stated she did not obtain a blood glucose during her visit. Patient #14 – This 76-year-old patient with diagnoses that include a stage 3 pressure ulcer to the right heel, type II diabetes mellitus and atherosclerotic heart disease was admitted to the home care agency on 05/23/2021. Review of the Client Coordination Note Report written by the Intake Licensed Practical Nurse (LPN) dated 05/22/2021 revealed the patient was discharged on 05/21/2021 and was currently on 4 Liters of oxygen via nasal cannula. Review of the Home Health Certification and Plan of Care for certification period 05/23/2021 to 07/21/2021 revealed the patient is oxygen dependent. Review of the Registered Nurse (RN) Outcome and Assessment Information Set (OASIS) Admission Visit Note dated 05/23/2021 revealed the RN documented the patient has shortness of breath but lacks documented evidence of an assessment of the patient’s use of oxygen. The agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient's status and needs. During interview on 05/27/2022 at 02:25 PM, the Erie Clinical Director stated the RN failed to include an assessment of the patient’s oxygen use.

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 clinical record review and interviews with staff, for fourteen (14) of twenty-three (23) clinical records (Patient #'s: 1, 2, 3, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15 and 19) lacks documented evidence of a complete review of all medications the patient currently uses to identify any potential adverse effects, drug reactions, or concerns. Failure to conduct a complete medication review and to ensure the medication regime is appropriate has the potential for the patient harm. Review of the agency's policy entitled "Therapist Process for Medication Review" dated 01/27/2022 revealed "The therapist conducts the comprehensive assessment of the patient including prescribed, over the counter, nutritional supplements, herbals, and oxygen... The therapist will notify the physician (who is responsible for the medication reconciliation - the primary MD (medical doctor) in rehab cases) if there are any level 1 (one) or level 2 (two) drug interactions at the visit or any other overt issues regarding medications." Patient #3 – This therapy only 51-year-old patient with diagnoses that include aftercare following joint replacement surgery and presence of artificial right joint was admitted to the home care agency on 05/13/2022. A.) Review of the referral to the agency dated 05/12/2022 revealed the order for tolterodine 1 mg (milligram) tablet by mouth twice a day. Review of the Home Health Certification and Plan of Care for certification period 05/13/2022 to 07/11/2022 revealed the order for tolterodine 1 mg tablet by mouth daily. The Physical Therapist (PT) failed to identify and reconcile the medication discrepancy identified in the referral for services and the POC. During interview on 05/27/2022 at 12:06 PM, the PT stated she did speak with the physician to clarify the order but failed to document the conversation. B.) Review of the referral to the agency dated 05/12/2022 revealed the following orders: - B-complex multivitamin take 1 tablet by mouth each day, 5000 mcg (micrograms) - Cefadroxil 500 mg by mouth twice a day for 14 (fourteen) days - Polyethylene glycol 17 gram packet one time a day as needed Review of the Home Health Certification and Plan of Care for certification period 05/13/2022 to 07/11/2022 lacks documented evidence of orders for those medications. The PT failed to identify and reconcile the medication discrepancy identified in the referral for services and the POC. During interview on 05/27/2022 at 12:06 PM, the PT stated she did speak with the physician to clarify the orders but failed to document the conversation. C.) Review of the Home Health Certification and Plan of Care for certification period 05/13/2022 to 07/11/2022 revealed the order for meloxicam 7.5 mg daily. Review of the referral to the agency dated 05/12/2022 lacks an order for meloxicam. The PT failed to identify and reconcile the medication discrepancy identified in the referral for services and the POC. During interview on 05/27/2022 at 12:06 PM, the PT stated she did speak with the physician but failed to document the conversation. Patient #19 – This 67-year-old patient with diagnoses that include epididymitis, type II diabetes mellitus with diabetic chronic kidney disease, and hypertensive chronic kidney disease was admitted to the home care agency on 11/08/2021. A.) Review of the Home Health Certification and Plan of Care for certification period 11/08/2021 to 01/06/2022 revealed the order for linezolid 600 mg tablet (an antibiotic) daily. The order lacks an end date. During interview on 05/27/2022 at 03:14 PM, the RN stated the antibiotic should have an end date, but the order does not include that date. The RN (Registered Nurse) failed to identify and reconcile the medication discrepancy identified in the referral for services and the POC. B.) Review of the Home Health Certification and Plan of Care for certification period 11/08/2021 to 01/06/2022 revealed the order for metoprolol tartate 25 mg tablet take 2 (two) tablets by mouth daily for a total of 50 mg. Review of the discharge summary dated 11/06/2021 revealed the order for metoprolol tartate 25 mg oral tablet 12.5 mg = 0.5 tablet BID (twice a day). The RN failed to identify and reconcile the medication discrepancy identified in the referral for services and the POC. During interview on 05/27/2022 at 03:15 PM, the RN stated the dose on the discharge summary is correct and the order on the POC needs to be changed. C.) Review of the Home Health Certification and Plan of Care for certification period 11/08/2021 to 01/06/2022 revealed the orders for fargixa 10 mg tablet by mouth daily and ozempic 1mg (4 mg/3mL (milliliters)) subcutaneous pen injector, inject 1 mg subcutaneous every week. Review of the discharge summary dated 11/06/2021 lacks orders for fargixa and ozempic. The RN failed to identify and reconcile the medication discrepancy identified in the referral for services and the POC. During interview on 05/27/2022 at 03:17 PM, the RN stated he did speak to the physician about these medications but did not document it. Patient #12 – This 80-year-old patient with diagnoses that include hypertensive heart disease with heart failure, heart failure, unspecified, peripheral vascular disease, unspecified was admitted to the home care agency on 05/10/2022. A.) Review of the Home Health Certification and Plan of Care for certification period 05/10/2022 to 07/08/2022 revealed the order for vitamin D3 125 mcg (micrograms) (5,000 unit) tablet oral daily. Review of the referral to the agency dated 05/09/2022 lacks an order for vitamin D3. The RN failed to identify and reconcile the medication discrepancy identified in the referral for services and the POC. During interview on 05/27/2022 at 08:59 AM, the RN stated she called the physician but did not document the call. B.) Review of the referral to the agency dated 05/09/2022 revealed the following orders: - Naproxen sodium 220 mg tablet by mouth daily as needed for pain - Omeprazole 20 mg capsule by mouth daily Review of the Home Health Certification and Plan of Care for certification period 05/10/2022 to 07/08/2022 lacks orders for the medications. The RN failed to identify and reconcile the medication discrepancy identified in the referral for services and the POC. During interview on 05/27/2022 at 08:59 AM, the RN stated she called the physician but did not document the call. Patient #5 – This 67-year-old patient with diagnoses that include essential hypertension and unspecified atrial fibrillation was admitted to the home care agency on 05/13/2022. Review of the discharge summary dated 05/11/2022 revealed the following orders: - Celebrex 120 mg oral tablet daily - Hydrochlorothiazide 25 mg capsule oral daily - Potassium 20 mEq (milliequivalent) oral daily Review of the Home Health Certification and Plan of Care for certification period 05/13/2022 to 07/11/2022 lacks documented evidence of those medications. The RN failed to identify and reconcile the medication discrepancy identified in the referral for services and the POC. During interview on 05/27/2022 at 12:11 PM, the RN stated she did call the physician and learned the patient stopped those medication but did not document the call. Patient #11 – This 59-year-old patient with diagnoses that include aftercare following joint replacement surgery and unilateral osteoarthritis, left hip was admitted to the home care agency on 05/18/2022. Review of the referral to the agency dated 05/17/2022 revealed the order for cephalexin 500 mg oral capsule, take 1 (one) capsule by mouth 4 (four) times a day for 5 (five) days. Start 05/16/2022, end 05/21/2022. Review of the Home Health Certification and Plan of Care for certification period 05/18/2022 to 07/16/2022 revealed the order for cephalexin 500 mg every 6 (six) hours but lacks an end date. The RN failed to identify and reconcile the medication discrepancy identified in the referral for services and the POC. During interview on 05/27/2022 at 09:16 AM, the RN stated she failed to add the end date to the order. Patient #15 – This 67-year-old patient with diagnoses that include aftercare following joint replacement surgery, presence of artificial right hip joint, and essential hypertension was admitted to the home care agency on 11/03/2021. Review of the Home Health Certification and Plan of Care for certification period 11/03/2021 to 01/01/2022 revealed the orders for docusate sodium 100 mg capsule twice a day and tylenol extra strength 500 mg tablet every six (6) hours PRN (as needed) for pain. Review of the referral to the agency dated 11/02/2021 lacks orders for the medications. The RN failed to identify and reconcile the medication discrepancy identified in the referral for services and the POC. During interview on 05/27/2022 at 08:48 AM, the RN stated she spoke with the physician but did not document the conversation. Based on clinical record review and interviews with staff, for fifteen (15) of twenty-three (23) clinical records (Patient #'s: 1, 2, 3, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15 and 19) lack documented evidence of a complete review of all medications the patient currently uses to identify any potential adverse effects, drug reactions, or concerns. Failure to conduct a complete medication review and to ensure the medication regime is appropriate has the potential for the patient harm. Findings are: Review of the agency policy entitled "Therapist Process for Medication Review" dated 01/27/2022 revealed "The therapist conducts the comprehensive assessment of the patient including prescribed, over the counter, nutritional supplements, herbals, and oxygen... The therapist will notify the physician (who is responsible for the medication reconciliation - the primary MD (medical doctor) in rehab cases) if there are any level 1 (one) or level 2 (two) drug interactions at the visit or any other overt issues regarding medications." Patient #1 – This 77-year-old therapy only patient with diagnoses that include a superior fracture to the right pubis, left ankle sprain and essential hypertension was admitted to the home care agency on 05/11/2022. A.) Review of the facility referral to the agency dated 05/04/2022 revealed the following medication orders: - Acetaminophen 500 milligrams (mg) 1 (one) tablet by mouth every 6 (six) hours, not to exceed 3 gms (grams) per 24 (twenty-four) hours; - Thera (Multiple Vitamin) 1 tablet by mouth daily; - Miralax Oral Powder 17 gms by mouth daily; - Wellbutrin SR oral tablet extended release 12 (twelve) hour 150 mg 1 (one) tablet by mouth daily; - Tobradex ophthalmic suspension 0.3-0.1% (percent) 1 (one) drop in both eyes daily as needed for allergies; and - Dulcolax oral tablet delayed release 5 mg 1 (one) tablet by mouth daily as needed for bowel management. Review of the Home Health Certification and Plan of Care for certification period 05/11/2022 to 07/09/2022 lacks documented evidence of orders for the identified medications. Review of the Client Coordination Note Report dated 05/11/2022 revealed the PT documented no issues were found during the medication reconciliation review. The PT failed to identify and reconcile the medication discrepancy identified in the referral for services and the plan of care (POC). During interview on 05/27/2022 at 09:48 AM, the PT stated she reported to the physician that the patient was not taking the identified medications but did not document this. B.) Review of the Home Health Certification and Plan of Care for certification period 05/11/2022 to 07/09/2022 revealed orders for the following medications: - Alprazolam 0.25 mg 1 (one) tablet oral 2 (two) times daily PRN (as needed) for anxiety; and - Cetirizine 10 mg 1 (one) tablet oral daily. Review of the facility referral to the agency lacks orders for Alprazolam and Cetirizine. Review of the clinical record lacks documented evidence of clarification of the medication discrepancies. The PT failed to identify and reconcile medication discrepancies identified in the referral for services and the POC. During interview on 05/27/2022 at 09:55 AM, the PT stated the medications were confirmed by review of the prescription bottles in the home but she did not document this. Patient #2 – This 46-year-old patient with diagnoses that include multiple sclerosis and non-compliance was admitted to the home care agency on 05/11/2022. A.) Review of the Patient Information Report Physician Referral dated 05/04/2022 revealed the following medication orders: - “Take Tums twice a day and Pepcid 20 mg twice a day on the days of the steroid infusion.” Review of the Home Health Certification and Plan of Care for certification period 05/11/2022 to 07/09/2022 lacks documented evidence of orders for the identified medications. Review of the clinical record lacks documented evidence of clarification of the identified medications. The RN failed to identify and reconcile the medication discrepancies identified in the referral for services and the POC. During interview on 05/27/2022 at 12:15 PM, the Cattaraugus/Alleghany Branch Manager stated the RN was not available for interview. She stated the RN contacted the physician to report the discrepancies but failed to document this. B.) Review of the Home Health Certification and Plan of Care for certification period 05/11/2022 to 07/09/2022 revealed the following medication orders: - Baclofen 10 mg tablet oral 2 (two) times daily; - Clonazepam 0.5 mg 1 (one) tablet oral daily; and - Gabapentin 100 mg 1 (one) capsule oral 2 (two) times daily. Review of the Patient Information Report Physician Referral dated 05/04/2022 lacks orders for the identified medications. Review of the clinical record lacks documented evidence of clarification of the identified medications. The RN failed to identify and reconcile the medication discrepancies identified in the referral for services and the POC. During interview on 05/27/2022 at 12:18 PM, the Cattaraugus/Alleghany Branch Manager stated the RN was not available for interview. She stated the RN contacted the physician to report the discrepancies but failed to document this. Patient #6 – This 67-year-old patient with diagnoses that include a myocardial infarction, atherosclerotic heart disease and hypertension was admitted to the home care agency on 05/10/2022. Review of the Patient Information Report Physician Referral dated 05/03/2022 revealed a medication order for Lidocaine 5% ointment apply topically 3 (three) times daily as needed for pain. Review of the Home Health Certification and Plan of Care for certification period 05/10/2022 to 07/08/2022 lacks an order for Lidocaine. Review of the clinical record lacks documented evidence of clarification of the medication discrepancy. The RN failed to identify and reconcile the medication discrepancy identified in the referral for services and the POC. During interview on 05/27/2022 at 11:40 AM, the RN stated she does not believe the patient had lidocaine in the home but failed to document this. Patient #8 – This 85-year-old patient with cellulitis of the left toe, congestive heart failure and stage 4 kidney disease was admitted to the home care agency on 04/14/2022. A.) Review of the physician referral for home care dated 04/12/2022 revealed the patient was taking the following medications: - Hyoscyamine Sulfate 0.125 mg 1-2 (one to two) tabs (tablets) SL (sublingual) q 2 hrs (every two hours) PRN for secretions; - Miralax 17 g (gram) by mouth daily; and - Senna 8.6 mg take 1 (one) tablet by mouth at bedtime. Review of the Home Health Certification and Plan of Care for certification period 04/14/2022 to 06/12/2022 lacks orders for the identified medications. Review of the clinical record lacks documented evidence of clarification of the identified medication discrepancies. The RN failed to identify and reconcile the medication discrepancies identified in the referral for services and the POC. During interview on 05/27/2022 at 11:30 AM, the Rural Branch Manager, of Genesee, Livingston, Orleans, Wyoming (GLOW) counties stated the RN was unavailable for interview. She stated she did not see any documentation to clarify the discrepancy and would look for additional documentation. No further information was provided for clarification. B.) Review of the Home Health Certification and Plan of Care for certification period 04/14/2022 to 06/12/2022 revealed orders for the following medications: - Milk of Magnesia 400 mg/5 ml (milliliter) suspension 30 (thirty) ml oral daily/PRN; and - Morphine Concentrate 100 mg/5 ml solution 0.25- 0.5 ml oral every 2 (two) hours PRN for palliative care. Review of the physician referral for home care dated 04/12/2022 lacks orders for Milk of Magnesia and Morphine. Review of the clinical record lacks documented evidence of clarification of the identified medication discrepancies. The RN failed to identify and reconcile the medication discrepancies identified in the referral for services and the POC. During interview on 05/27/2022 at 11:35 AM, the Rural Branch Manager, of Genesee, Livingston, Orleans, Wyoming (GLOW) counties stated the RN was unavailable for interview. She stated she did not see any documentation to clarify the discrepancies and would look for additional documentation. No further information was provided for clarification. Patient #9 – This 63-year-old patient with diagnoses that include atrial fibrillation, hypertension and congestive heart failure was admitted to the home care agency on 05/06/2022. Review of the Patient Information Report Physician Referral dated 04/28/2022 revealed the patient was taking Dextromethorphan- Guaifenesin 10-100 mg/ 5 ml, 5 (five) ml’s oral every 4 (four) hours PRN. Review of the Home Health Certification and Plan of Care for certification period 05/06/2022 to 07/04/2022 lacks an order for Dextromethorphan- Guaifenesin. Review of the clinical record lacks documented evidence of clarification of the medication discrepancy. The RN failed to identify and reconcile the medication discrepancy identified in the referral for services and the POC. During interview on 05/27/2022 at 10:30 AM, the RN stated the patient reported she is not taking the medication but the RN failed to document this. Patient #10 – This 68-year-old patient with diagnoses that include sepsis, pneumonia and multiple sclerosis was admitted to the home care agency on 05/07/2022. A.) Review of the Patient Information Report Facility Intake dated 05/02/2022 revealed the patient was taking the following medications: - Cranberry Fruit 1(one) capsule by mouth daily; - Esomeprazole 40 mg by mouth 2 (two) times daily; - Acetaminophen 325 mg 2 (two) tablets by mouth every 6 (six) hours as needed; - Meclizine 12.5 mg 1 (one) tablet by mouth 3 (three) time daily as needed for dizziness. Review of the Home Health Certification and Plan of Care for certification period 05/07/2022 to 07/05/2022 lacks orders for the identified medications. Review of the clinical record lacks documented evidence of clarification of the identified medication discrepancies. The RN failed to identify and reconcile the medication discrepancies identified in the referral for services and the POC. During interview on 05/27/2022 at 10:25 AM, the RN stated it was an oversight that the medications were not included on the POC. B.) Review of the Patient Information Report Facility Intake dated 05/02/2022 revealed the patient was taking Risperidone 1 mg by mouth nightly. Review of the Home Health Certification and Plan of Care for certification period 05/07/2022 to 07/05/2022 revealed an order for Risperidone 0.5 mg 1 (one) tablet oral daily. Review of the clinical record lacks documented evidence of clarification of the Risperidone dosing. The RN failed to identify and reconcile the medication discrepancy identified in the referral for services and the POC. During interview on 05/27/2022 at 10:27 AM, the RN stated she confirmed the dose of Risperidone by the medication bottle in the home but did not document this. Patient #13 – This 91-year-old patient with diagnoses that include a stage 2 pressure ulcer to the left buttock, emphysema and hypertension was admitted to the home care agency on 02/12/2021. Review of the physician encounter note dated 01/11/2021 attached with the referral for home care dated 01/29/2021 revealed the patient was taking the following medications: - Digoxin 125 mcg (microgram) 1 (one) tablet oral daily; - Xarelto 15 mg 1 (one) tablet oral daily; - Omeprazole 20 mg 1 (one) capsule by mouth once a day; - Duloxetine HCL 30 mg 1 (one) capsule by mouth every day; - Daily Multiple Vitamin 1 (one) tablet oral daily; - Magnesium Oxide 400 mg 1 (one) tablet oral daily; - Potassium Chloride ER 20 meq (milliequivalent) 1 (one) tablet oral daily; - Preser Vision/Lutein oral capsule take as directed; - RA Stool Softener 100 mg 1 (one) capsule twice daily as needed; - Vitamin B12 1000 mcg 1 (one) tablet oral daily as directed; and - Vitamin C 500 mg 1 (one) tablet by mouth every day. Review of the Home Health Certification and Plan of Care for certification period 02/12/2021 to 04/12/2021 lacks orders for the identified medications. Review of the Patient Information Report dated 02/12/2021 revealed the RN documented being unable to complete a medication reconciliation review during the start of care visit as the medication bottles were with the patient’s son, outside of the home. Review of the clinical record lacks documentation of clarification of the identified medication discrepancies. The clinician failed to identify and reconcile the medication discrepancies identified in the referral for services and the POC. During interview on 05/27/2022 at 12:55 PM, the RN stated medication reconciliation did not occur as the son had the patient’s medications with him at the start of care visit. During interview on 05/27/2022 at 12:57 PM, the Erie Branch Manager stated the medications should have been clarified at a subsequent visit but does not see documentation of this occurring. Patient #14 – This 76-year-old patient with diagnoses that include a stage 3 pressure ulcer to the right heel, type II diabetes mellitus and atherosclerotic heart disease was admitted to the home care agency on 05/23/2021. A.) Review of the facility Discharge Summary revealed the patient was hospitalized from 05/25/2021 to 05/28/2021 and was discharged on Aspirin 81 mg EC oral tablet. Review of the Resumption of Care Orders dated 05/30/2021 lacks an order for Aspirin. Review of the clinical record lacks documented evidence of clarification of the Aspirin order. The RN failed to identify and reconcile the medication discrepancy identified in the discharge summary and the POC. During interview on 05/27/2022 at 02:40 PM, the Erie Clinical Director stated the RN is unavailable for interview. She stated the Resumption of Care Orders include all the medications the patient is currently taking. She stated there is no documentation to clarify the Aspirin discrepancy. B.) Review of the facility Discharge Summary revealed the patient was hospitalized from 05/25/2021 to 05/28/2021 and was discharged on Gabapentin 600 mg oral 2 (two) times daily. Review of the Resumption of Care Orders dated 05/30/2021 revealed an order for Gabapentin 300 mg 1 (one) capsule 2 (two) times daily. Review of the clinical record lacks documented evidence of clarification of the Gabapentin discrepancy. The RN failed to identify and reconcile the medication discrepancy identified in the discharge summary and the POC. During interview on 05/27/2022 at 02:42 PM, the Erie Clinical Director stated the RN is unavailable for interview. She stated the Resumption of Care Orders include all the medications the patient is currently taking. She stated there is no documentation to clarify the Gabapentin discrepancy.

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 clinical record review and staff interview for one (1) of (23) patients (Patient # 20), the agency failed to ensure the comprehensive assessment is updated and revised to reflect changes in the patient's health status. Failure to ensure comprehensive assessments are updated and revised, has the potential for negative patient outcomes. Patient #20 – This 52-year-old patient with diagnoses that include a stage 3 pressure ulcer to sacrum, stage 3 pressure ulcer to left buttock and paraplegia was admitted to the home care agency on 09/23/2021. Review of the Home Health Certification and Plan of Care for certification period 03/22/2022 to 05/20/2022 revealed an order for the Skilled Nurse to provide skin assessments and provide instruction of the gastrostomy/jejunostomy (feeding tube) management to include care of site, equipment and preparation/administration of tube feedings. Review of the RN (Registered Nurse) Recert (Recertification) with Skill Visit Note Report dated 05/18/2022 revealed the RN documented the following “Patient reports PEG (percutaneous endoscopic gastrostomy) is flushing well and feeds are running as ordered with no concerns or questions. (The visit lacks an assessment of the PEG site). The SN failed to ensure the updated comprehensive assessment included documentation of the PEG site. During interview on 05/27/2022 at 04:10 PM, the RN stated she did not document on the PEG site in the identified assessment.

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 review of clinical records and staff interviews for ten (10) of twenty-three (23) patients (Patient #s: 2, 3, 5, 7, 8, 12, 14, 15, 19, 20 and 23) the agency failed to develop individualized plans of care (POC) that are complete and accurate and address the total needs of the patients. Failure to ensure that a comprehensive individualized plan of care is developed has the potential for unmet patient needs. Patient #19 – This 67-year-old patient with diagnoses that include epididymitis, type II diabetes mellitus with diabetic chronic kidney disease, and hypertensive chronic kidney disease was admitted to the home care agency on 11/08/2021. Review of the RN (Registered Nurse ) OASIS (Outcome and Assessment Information set) Admission Note dated 11/08/2021 revealed the patient has a dialysis catheter and goes to dialysis three (3) times a week. A.) Review of the Home Health Certification and Plan of Care for certification period 11/08/2021 to 01/06/2022 lacks orders for the dialysis catheter to include who is responsible. B.) Review of the Home Health Certification and Plan of Care for certification period 11/08/2021 to 01/06/2022 lacks documentation regarding the patient’s need for dialysis or the frequency. The agency failed to develop individualized POC that are complete and accurate and address the total needs of the patients. During interview on 05/27/2022 at 03:18 PM, the RN stated this information was not included on the POC. The dialysis center is responsible for the dressing change. C.) Review of the Home Health Certification and Plan of Care for certification period 11/08/2021 to 01/06/2022 revealed the orders for Humalog kwikpen insulin 100 unit/mL (milliliters) subcutaneous inject 40 units subcutaneously as directed. The order lacks a frequency. The agency failed to develop individualized POC that are complete and accurate and address the total needs of the patients. During interview on 05/31/2022 at 12:05 PM, the Director of Quality Improvement stated there is no frequency. Patient #12 – This 80-year-old patient with diagnoses that include hypertensive heart disease with heart failure, heart failure, unspecified, peripheral vascular disease, unspecified was admitted to the home care agency on 05/10/2022. A.) Review of the Home Health Certification and Plan of Care for certification period 05/10/2022 to 07/08/2022 revealed the order for SN (Skilled Nurse) 2wk1 (twice a week first week), 1wk3 (once a week for next three weeks), 1 (one) PRN (as needed). Review of the Home Health Certification and Plan of Care for certification period 05/10/2022 to 07/08/2022 lacks an indication for the PRN SN visits. The agency failed to develop individualized POC that are complete and accurate and address the total needs of the patients. During interview on 05/27/2022 at 08:55 AM, the RN stated she did not put an indication for the PRN SN visits. B.) Review of the Home Health Certification and Plan of Care for certification period 05/10/2022 to 07/08/2022 revealed the order for diclofenac 3% (three percent) topical gel daily for pain. Review of the Home Health Certification and Plan of Care for certification period 05/10/2022 to 07/08/2022 lacks a location for application of the topical gel. The agency failed to develop individualized POC that are complete and accurate and address the total needs of the patients. During interview on 05/27/2022 at 08:56 AM, the RN stated she did not specify where the patient is to apply the gel. Patient #15 – This 67-year-old patient with diagnoses that include aftercare following joint replacement surgery, presence of artificial right hip joint, and essential hypertension was admitted to the home care agency on 11/03/2021. A.) Review of the RN OASIS Admission Note dated 11/03/2021 revealed the patient is using TED (Thrombo-Embolus Deterrent) stockings. Review of the Home Health Certification and Plan of Care for certification period 11/03/2021 to 01/01/2022 lacks documented evidence of an order for TED stockings to include frequency and who is responsible. B.) Review of the RN OASIS Admission Note dated 11/03/2021 revealed the patient is using an incentive spirometer. Review of the Home Health Certification and Plan of Care for certification period 11/03/2021 to 01/01/2022 lacks documented evidence of an order for an incentive spirometer to include frequency. The agency failed to develop individualized POC that are complete and accurate and address the total needs of the patients. During interview on 05/27/2022 at 08:50 AM, the RN stated there are no orders for the TED stockings or incentive spirometers. Patient #3 – This 51-year-old patient with diagnoses that include aftercare following joint replacement surgery and presence of artificial right joint was admitted to the home care agency on 05/13/2022. Review of the PT (Physical Therapy) OASIS Admission Note dated 05/13/2022 revealed the PT documented the patient has a non-removable dressing in place. Review of the Home Health Certification and Plan of Care for certification period 05/13/2022 to 07/11/2022 lacks documentation specifying when the dressing can be removed and when the follow-up visit with the surgeon takes place. The agency failed to develop individualized POC that are complete and accurate and address the total needs of the patients. During interview on 05/27/2022 at 12:05 PM, the PT stated the information is on the referral to the agency, but she did not put it on the POC. Patient #5 – This 67-year-old patient with diagnoses that include essential hypertension and unspecified atrial fibrillation was admitted to the home care agency on 05/13/2022. Review of the Home Health Certification and Plan of Care for certification period 05/13/2022 to 07/11/2022 revealed the order for eliquis (a blood-thinning agent) 5 mg (milligrams) daily. Review of the Home Health Certification and Plan of Care for certification period 05/13/2022 to 07/11/2022 revealed the following safety measures: “heart healthy diet.” The agency failed to develop individualized POC that are complete and accurate and address the total needs of the patients. During interview on 05/27/2022 at 12:12 PM, the RN stated she meant to put bleeding precautions under safety precautions but documented incorrectly. Patient #7 – This 88-year-old patient with diagnoses that include hypertensive heart disease with heart failure, acute on chronic systolic (congestive) heart failure, and non-st elevation myocardial infarction was admitted to the home care agency on 05/11/2022. Review of the Home Health Certification and Plan of Care for certification period 05/11/2022 to 07/09/2022 revealed the order for Skilled Nursing (SN) 2wk1 (twice a week first week), 1 every 2wk2 (one every two weeks for the next two weeks), 2 (two) PRN (as needed). Review of the Home Health Certification and Plan of Care for certification period 05/11/2022 to 07/09/2022 lacks an indication for the PRN SN visits. The agency failed to develop individualized POC that are complete and accurate and address the total needs of the patients. During interview on 05/27/2022 at 08:51 AM, the RN stated she did not put an indication for the PRN SN visits. Patient #23 – This 69-year-old patient with diagnoses that include end stage renal disease, type I diabetic mellitus, and atrial fibrillation was admitted to the home care agency on 09/25/2021. Review of the Home Health Certification and Plan of Care for certification period 09/25/2021 to 11/23/2021 revealed the order for SN1wk1 (once a week first week), 3wk3 (three times a week for three weeks), 2wk1 (twice a week for the next week), 1 PRN (as needed). Review of the POC lacks an indication for the PRN nursing frequency. The agency failed to develop individualized POC that are complete and accurate and address the total needs of the patients. During interview on 05/27/2022 at 03:30 PM, the RN stated there is no indictor for the PRN visit. Patient #2 – This 46-year-old patient with diagnoses that include multiple sclerosis and non-compliance was admitted to the home care agency on 05/11/2022. A.) Review of the Registered Nurse (RN) Infusion OASIS (Outcome and Assessment Information Set) Admission Visit Note Report dated 05/11/2022 revealed the RN administered the monthly intravenous (IV) steroid infusion over one (1) hour during the visit and the patient tolerated the infusion very well. Review of the Home Health Certification and Plan of Care for certification period 05/11/2022 to 07/09/2022 lacks monitoring instructions to occur prior, during and post the IV steroid infusion. The agency failed to develop individualized POC that is complete and accurate and address the total needs of the patient. During interview on 05/27/2022 at 12:20 PM, the Cattaraugus/Alleghany Branch Manager stated the RN was not available for interview. The Branch Manager stated the POC lacks monitoring instructions for the administering the IV infusion and they should be specified. B.) Review of the RN Infusion OASIS Admission Visit Note Report dated 05/11/2022 revealed the patient has an IV pole and a walker that is used in the home. Review of the Home Health Certification and Plan of Care for certification period 05/11/2022 to 07/09/2022 lacks specification of the walker and infusion supplies being used in the home. The agency failed to develop an individualized POC that is complete and accurate and addresses the total needs of the patient. During interview on 05/27/2022 at 12:22 PM, the Cattaraugus/Alleghany Branch Manager stated the RN was not available for interview. The Branch Manager stated the supplies and equipment identified are not specified on the POC and should be. Patient #8 – This 85-year-old patient with cellulitis of the left toe, congestive heart failure and stage 4 kidney disease was admitted to the home care agency on 04/14/2022. Review of the Home Health Certification and Plan of Care for certification period 04/14/2022 to 06/12/2022 revealed an order for a Home Health Aide (HHA) 1wk2 (one time per week for two weeks), for assistance with bathing, skin care, hair care, dressing, toileting, ambulation, transfers and IADLS (instrumental activities of daily living). Review of the Aide Care Plan Report dated 04/14/2022 lacks instructions of observations to report to the supervising nurse. The agency failed to develop an individualized POC that is complete and accurate and addresses the total needs of the patient. During interview on 05/27/2022 at 11:28 AM, the Rural Branch Manager of Genesee, Livingston, Orleans, Wyoming (GLOW) counties stated the RN was unavailable for interview. The Branch Manager stated the RN failed to specify the identified aide instructions. Patient #14 – This 76-year-old patient with diagnoses that include a stage 3 pressure ulcer to the right heel, type II diabetes mellitus and atherosclerotic heart disease was admitted to the home care agency on 05/23/2021. A.) Review of the Home Health Certification and Plan of Care for certification period 05/23/2021 to 07/21/2021 revealed the following orders: - Skilled Nurse to perform random blood glucose analysis Q (every) PRN (as needed); and - Humulin R Regular U (units)- 100/ml (milliliter) injection solution daily/PRN, sliding scale managed by wife. The orders lack specification of the sliding scale to follow. The agency failed to develop an individualized POC that is complete and accurate and addresses the total needs of the patient. During interview on 05/27/2022 at 02:12 PM, the Erie Clinical Director stated the sliding scale orders should have been included on the POC. B.) Review of the Home Health Certification and Plan of Care for certification period 05/23/2021 to 07/21/2021 revealed the patient has a BIPAP (bilevel positive airway pressure, used to treat sleep apnea) that is used overnight. The POC lacks orders for the BIPAP settings the patient uses. The agency failed to develop an individualized POC that is complete and accurate and addresses the total needs of the patient. During interview on 05/27/2022 at 02:15 PM, the Erie Clinical Director stated the BIPAP settings should have been included on the POC and were not. C.) Review of the Home Health Certification and Plan of Care for certification period 05/23/2021 to 07/21/2021 revealed the patient is oxygen dependent. The POC lacks oxygen orders to include the amount, duration and mode of administration. The agency failed to develop an individualized POC that is complete and accurate and addresses the total needs of the patient. During interview on 05/27/2022 at 02:17 PM, the Erie Clinical Director stated the Oxygen orders were missing on the POC and should have been specified. Patient #20 – This 52-year-old patient with diagnoses that include a stage 3 pressure ulcer to sacrum, stage 3 pressure ulcer to left buttock and paraplegia was admitted to the home care agency on 09/23/2021. Review of the Home Health Certification and Plan of Care for certification period 09/23/2021 to 11/21/2021 revealed the following medication orders: - Budesonide 0.5 mg/2 ml suspension for nebulization 2 (two) ml’s 2 (two) times daily; and - Ipratropium 0.5 mg- Albuterol 3 mg (2.5 mg base)/ 3 ml nebulization solution, administer every 4 (four) hours/ PRN for shortness of breath. The POC lacks an order for the nebulizer machine to administer the identified medications with. The agency failed to develop an individualized POC that is complete and accurate and addresses the total needs of the patient. During interview on 05/27/2022 at 04:28 PM, the RN stated the patient did not have a nebulizer in the home but this was not documented.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on clinical record review and staff interview, two (2) of twenty-three (23) patient records (Patient #"s: 15 and 19) lacked evidence an order was obtained to update the Plan of Care (POC) to reflect the patient's status. Failure to obtain an order to update the POC has the potential for agency staff to act on inaccurate and incomplete information, and places patient health and welfare at risk. Patient #19 – This 67-year-old patient with diagnoses that include epididymitis, type II diabetes mellitus with diabetic chronic kidney disease, and hypertensive chronic kidney disease was admitted to the home care agency on 11/08/2021. A.) Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission Note dated 11/08/2021 revealed the RN documented the patient’s wife has been applying biofreeze to the patient’s knees for pain relief. Review of the clinical record lacks an order for biofreeze. During interview on 05/27/2022 at 03:43 PM, the RN stated he did not obtain an order for biofreeze. B.) Review of the RN Subsequent Visit Note dated 11/15/2021 revealed the patient had taken tylenol for a low-grade fever. Review of the clinical record lacks an order for tylenol. During interview on 05/27/2022 at 03:24 PM, the RN stated there is not an order for tylenol. C.) Review of the Client Coordination Note Report dated 02/09/2022 revealed the patient is following a 48 (forty-eight) ounce fluid restriction daily. Review of the clinical record lacks an order for a fluid restriction. During interview on 05/27/2022 at 03:48 PM, the Branch Manager stated there is no order for a fluid restriction. Patient #15 – This 67-year-old patient with diagnoses that include aftercare following joint replacement surgery, presence of artificial right hip joint, and essential hypertension was admitted to the home care agency on 11/03/2021. A.) Review of the Client Coordination Note Report written by the Licensed Practical Nurse (LPN) revealed “follow-up on urine specimen, and complaints of rash to therapist. Spoke with nurse. Urine looks ok. Maybe irritation from catheter.” Review of the Physician Order dated 11/09/2021 revealed an order for urinalysis with reflex to culture (urine sample). Review of the clinical record lacks an order for a catheter. During interview on 05/27/2022 at 09:05 AM, the Rural Branch Manager stated the patient did not have a catheter and speculated that the LPN (who was unavailable for interview) used a straight catheter to obtain the urine sample, however there was no order for the LPN use the straight catheter. B.) Review of the PT (Physical Therapy) Discharge from Agency Note revealed the patient was discharged on 11/19/2021 and the physician was notified of the patient’s discharge on that date. Review of the clinical record lacks an order for the patient’s discharge. During interview on 05/27/2022 at 09:00 AM, the Director of Quality Improvement stated she would look for the order however no further documentation was provided.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on review of clinical records, policies and procedures and interviews with agency staff, for six (6) of twenty-three (23) patients (Patient #’s: 6, 12, 13, 15, 19, and 23), the agency failed to provide services in accordance with physician orders. Failure to ensure patient care is provided in accordance with physician orders has the potential for patients to receive poor care and for health care needs to go unmet. Patient #12 – This 80-year-old patient with diagnoses that include hypertensive heart disease with heart failure, heart failure, unspecified, peripheral vascular disease, unspecified was admitted to the home care agency on 05/10/2022. Review of the Home Health Certification and Plan of Care for certification period 05/10/2022 to 07/08/2022 revealed the following order: “Skilled Nurse to report weight gain of > 3lbs. (greater than three pounds) in 1 (one) day or > 5lbs. (greater than five pounds) in one (1) week for patient with heart failure.” A.) Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) dated 05/10/2022 lacks documented evidence the RN obtained a weight. The agency failed to provide services in accordance with physician orders. During interview on 05/27/2022 at 08:55 AM, the RN stated she did not document a weight. B.) Review of the RN Phone – Billable Phone Visit Note dated 05/16/2022 lacks documented evidence the RN inquired about the patient’s weight. The agency failed to provide services in accordance with physician orders. During interview on 05/27/2022 at 09:20 AM, the RN stated she did not document a weight. Patient #15 – This 67-year-old patient with diagnoses that include aftercare following joint replacement surgery, presence of artificial right hip joint, and essential hypertension was admitted to the home care agency on 11/03/2021. Review of the Home Health Certification and Plan of Care for certification period 11/03/2021 to 01/01/2022 revealed the order for SN (Skilled Nurse) twice a week for two (2) weeks. Review of the Client Coordination Note Report dated 11/05/02021 revealed the patient’s spouse declined nursing services on 11/05/2021. Review of the clinical record from 11/03/2021 (start of care) to 11/06/2021 revealed the patient received SN services on 11/03/2021, one day less than what is ordered. The agency failed to provide services in accordance with physician orders. During interview on 05/27/2022 at 09:00 AM, the RN stated she did not call the physician or obtain an order to change the frequency for SN services that week. Patient #19 – This 67-year-old patient with diagnoses that include epididymitis, type II diabetes mellitus with diabetic chronic kidney disease, and hypertensive chronic kidney disease was admitted to the home care agency on 11/08/2021. Review of the Physician’s Order dated 02/04/2022 revealed the patient is to receive nursing services three (3) times a week for four (4) weeks. Review of the Client Coordination Note Report dated 02/18/2022 revealed the patient asked to cancel nursing visits on 02/18/2022 and 02/21/2022. Review of the clinical record for the week of 02/13/2022 to 02/19/2022 revealed the patient received nursing services on 02/14/2022 and 02/16/2022, one (1) day less than what is ordered. The agency failed to provide services in accordance with physician orders. During interview on 05/27/2022 at 03:49 PM, the Branch Manager stated there was no order to update the frequency of nursing services. Patient #23 – This 69-year-old patient with diagnoses that include end stage renal disease, type I diabetic mellitus, and atrial fibrillation was admitted to the home care agency on 09/25/2021. A.) Review of the Clinical Intake dated 09/22/2021 revealed the patient was referred to home care to receive nursing, PT (Physical Therapy), and OT (Occupational Therapy) services. Review of the Home Health Certification and Plan of Care for certification period 09/25/2021 to 11/23/2021 revealed the order for OT effective 10/03/2021 1wk1 (once a week first week). Review of the clinical record revealed the OT called the patient on 09/27/2021 and 09/28/2021 but made no further attempts or visits from 09/29/2021 to 12/17/2021 (date of discharge). Review of the clinical record lacks an order to cancel OT services. The agency failed to provide services in accordance with physician orders. During interview on 05/27/2022 at 03:36 PM, the Director of Clinical Operations stated the OT never got in and there is no documentation to explain why. B.) Review of the Home Health Certification and Plan of Care for certification period 09/25/2021 to 11/23/2021 revealed the order for SN 1wk1 (once a week for first week), 3wk3 (three times a week for next three weeks). Review of the clinical record revealed for the week of 09/26/2021 to 10/02/2021 the patient received SN services on 09/28/2021 and 09/30/2021, one (1) day less than what is ordered. The agency failed to provide services in accordance with physician orders. During interview on 05/27/2022 at 03:42 PM, the Clinical Manager stated there was a missed visit and the physician was not notified. Patient #6 – This 67-year-old patient with diagnoses that include a myocardial infarction, atherosclerotic heart disease and hypertension was admitted to the home care agency on 05/10/2022. Review of the Home Health Certification and Plan of Care for certification period 05/10/2022 to 07/08/2022 revealed an order for Skilled Nurse to assess the patient’s cardiovascular system and report weight gain of > (greater than) 3 (three) lbs (pounds) in 1 (one) day or > 5 (five) lbs in one week. Review of the RN (Registered Nurse) Subsequent Visit Note Report dated 05/13/2022 lacks documented evidence of a weight being obtained or recorded. Review of the RN (Registered Nurse) Subsequent Visit Note Report dated 05/17/2022 lacks documented evidence of a weight being obtained or recorded. Review of the RN (Registered Nurse) Subsequent Visit Note Report dated 05/20/2022 lacks documented evidence of a weight being obtained or recorded. The agency failed to provide services in accordance with physician orders. During interview on 05/27/2022 at 11:50 AM, the RN stated the patient’s weight should have been documented at each visit and was not. Patient #13 – This 91-year-old patient with diagnoses that include a stage 2 pressure ulcer to the left buttock, emphysema and hypertension was admitted to the home care agency on 02/12/2021. Review of the agency policy entitled “Initial Assessment/ Reassessment” dated 11/01/2011 revealed “B. Each discipline that is referred in addition to the primary discipline, must respond by conducting an assessment visit within 10 (ten) days from the initial start of care.” Review of the Home Health Certification and Plan of Care for the certification period 02/12/2021 to 04/12/2021 revealed an order for MSW (masters prepared Social Worker) Effective 02/14/2021 1wk1 (one time a week for one week) to assess social and emotional factors related to the patient’s illness. Review of the MSW Add-on Evaluation Visit Note Report dated 03/05/2021 revealed the MSW did not evaluate the patient until 03/05/2021 (twenty-one days after the start of care visit). Review of the clinical record lacks documented evidence of a request from the patient and/or physician to delay the service. The agency failed to provide services in accordance with physician orders. During interview on 05/27/2022 at 01:28 PM, the RN stated the MSW was not available for interview. The RN stated there was no indication why the visit was delayed and that the physician was aware of the delay.

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 review of clinical records and interviews with agency staff, for two (2) and twenty-three (23) patients (Patient #s: 9 and 17), the agency failed to ensure drugs and treatments are administered in accordance with physician orders. Failure to administer drugs and treatments without a physician's order has the potential to result in poor quality of care. Patient #17 – This 58-year-old patient with diagnoses that include pressure ulcer of the right buttock, unstageable, acute kidney failure, and type II diabetes mellitus with diabetic chronic kidney disease was admitted to the home care agency on 02/13/2022. A.) Review of the Home Health Certification and Plan of Care for certification period 02/13/2022 to 04/12/2022 revealed the order for OT 1wk1 (Occupational Therapy once during the first week). Review of the clinical record lacks documented evidence OT attempted a visit with the patient. The agency failed to ensure drugs and treatments are administered in accordance with physician orders. During interview on 05/27/2022 at 01:46 PM, the Clinical Services Manager stated OT did not call or visit the patient, and there is no communication with the physician regarding the lack of services. B.) Review of the Home Health Certification and Plan of Care for certification period 02/13/2022 to 04/12/2022 revealed the order for HHA (Home Health Aide) 2wk1 (twice a week for first week), 3wk7 (three times a week for seven weeks), 2wk1 (twice a week for one week). Review of the clinical record lacks documented evidence the patient received HHA services. The agency failed to ensure drugs and treatments are administered in accordance with physician orders. During interview on 05/24/2022 at 02:58 PM, the Director of Quality Improvement stated the patient had a consumer directed aide, so the agency did not provide aides services, however there is no communication with the physician or order to change the HHA frequency or cancel HHA services from the agency. C.) Review of the Home Health Certification and Plan of Care for certification period 02/13/2022 to 04/12/2022 revealed the order for PT (Physical Therapy) 1wk1 (once a week the first week). Review of the clinical record revealed the PT called the patient on 02/14/2022 to schedule a visit for Wednesday at 11:30 AM. Review of the clinical record from 02/14/2022 to 05/23/2022 (date of survey) lacks documented evidence the PT provided services. The agency failed to ensure drugs and treatments are administered in accordance with physician orders. During interview on 05/27/2022 at 01:47 PM, the Clinical Service Manager stated there is no documentation regarding why PT didn’t make the visits and no communication with the physician. Patient #9 – This 63-year-old patient with diagnoses that include atrial fibrillation, hypertension and congestive heart failure was admitted to the home care agency on 05/06/2022. A.) Review of the PTA (Physical Therapy Assistant) Subsequent Visit Note Report dated 05/20/2022 revealed the PTA documented the patient uses Voltaren gel to relieve her back pain. Review of the clinical record lacks an order for Voltaren gel. The agency failed to ensure drugs and treatments are administered in accordance with physician orders. During interview on 05/27/2022 at 11:05 AM, the PTA stated she is unable to obtain physician orders but forgot to notify the Nurse that the patient was using the Voltaren gel for pain. B.) Review of the PTA Subsequent Visit Note Report dated 05/24/2022 revealed the PTA documented the patient was taking Tylenol 500 mg (milligrams), 2 (two) tabs morning and night to relieve back pain. Review of the clinical record lacks an order for Tylenol. The agency failed to ensure drugs and treatments are administered in accordance with physician orders. During interview on 05/27/2022 at 11:07 AM, the PTA stated she should have reported the Tylenol use to her supervising PT or the Nurse but did not do so.

Review and revision of the plan of care CFR(s): 484.60(c) Standard: Review and revision of the plan of care. This STANDARD is not met as evidenced by: Review of clinical records and interviews with staff for two (2) of twenty-three (23) patients (Patient #s: 14 and 19), the agency failed to ensure the Plan of Care (POC) is reviewed and revised to reflect the patient's status. Failure to ensure the POC is updated and revised has the potential to result in negative patient outcomes. Patient #14 – This 76-year-old patient with diagnoses that include a stage 3 pressure ulcer to the right heel, type II diabetes mellitus and atherosclerotic heart disease was admitted to the home care agency on 05/23/2021. A.) Review of the Home Health Certification and Plan of Care for certification period 07/22/2021 to 09/19/2021 revealed the patient checks BS (blood sugar) daily and takes Lantus Solostar U (units)- 100 Insulin 100 unit/ ml (milliliter), 10 (ten) units daily at bedtime subcutaneous. The orders lack blood glucose parameters to notify the physician for. The agency failed to ensure the POC is reviewed and revised to reflect the patient's status. During interview on 05/27/2022 at 02:50 PM, the Erie Clinical Director stated the RN was not available to interview. She stated the POC should have included the blood glucose parameters to notify the physician for. B.) Review of the Home Health Certification and Plan of Care for certification period 07/22/2021 to 09/19/2021 revealed the following orders: - Skilled Nurse to apply plurogel (used to soften wound debris) to bilateral foot wounds, cover with foam dressing and wrap with kerlix 3X (three times) weekly using clean aseptic technique; and - Santyl (used to remove dead tissue from wounds) 250 unit/ gram topical ointment apply daily with wound care as directed. The orders are unclear regarding the wound topical to be used and the frequency to perform wound care. The agency failed to ensure the POC is reviewed and revised to reflect the patient's status. During interview on 05/27/2022 at 02:44 PM, the Erie Clinical Director stated the RN was not available to interview. She additionally stated the patient was no longer having Santyl applied to his wounds at the time of the recertification and it should not be on the POC. Patient #19 – This 67-year-old patient with diagnoses that include epididymitis, type II diabetes mellitus with diabetic chronic kidney disease, and hypertensive chronic kidney disease was admitted to the home care agency on 11/08/2021. Review of the RN (Registered Nurse) Recertification with Skill Note dated 01/05/2022 revealed the patient has a dialysis catheter and goes to dialysis three (3) times a week. A.) Review of the Home Health Certification and Plan of Care for certification period 11/08/2021 to 01/06/2022 lacks orders for the dialysis catheter to include who is responsible. B.) Review of the Home Health Certification and Plan of Care for certification period 01/07/2022 to 03/07/2022 lacks documentation regarding the patient’s need for dialysis and the frequency. The agency failed to ensure the POC is reviewed and revised to reflect the patient's status. During interview on 05/27/2022 at 03:18 PM, the RN stated this information was not included on the POC. Additionally, the dialysis center is responsible for the dressing change.

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 review of clinical records and interviews with staff for two (2) of twenty-three (23) patients (Patient #'s: 13 and 22), the agency failed to ensure the physician is notified of changes in the patient's condition or needs that suggest the Plan of Care (POC) may need to be altered. Failure to promptly notify the physician to changes in the patient's condition or needs that may suggest that outcomes are not being achieved and/or the POC should be altered has the potential to result in unmet patient needs and negative patient outcomes. Patient #13 – This 91-year-old patient with diagnoses that include a stage 2 pressure ulcer to the left buttock, emphysema and hypertension was admitted to the home care agency on 02/12/2021. Review of the Home Health Certification and Plan of Care for certification period 02/12/2021 to 04/12/2021 revealed orders for “Skilled Nurse to perform/teach pressure ulcer care to left upper buttock. Cleanse with NS (normal saline)/ wound cleanser, pat dry, cover with DCD (dry clean dressing) using clean/ aseptic techniques daily and PRN (as needed) until further wound recommendation.” Review of the RN (Registered Nurse) Subsequent Visit Note Report dated 03/01/2021 revealed the RN documented the left buttock wound is pink with a small amount of serosanguinous drainage and she performed the left upper buttock wound care as ordered. Additionally, the RN documented the patient immediately ripped off the applied dressing and stating she would only apply lidocaine and a band-aid to the area. Review of the clinical record lacks documented evidence the physician was notified of the patients refusal to have the prescribed wound care performed and subsequent wound care the patient wanted to receive. The agency failed to ensure the physician is notified of changes in the patient's condition or needs that suggest the POC may need to be altered. During interview on 05/27/2022 at 01:18 PM, the RN stated she notified the physician of the patients refusal of the ordered wound care but did not document this. Patient #22 – This 78-year-old patient with diagnoses that include pressure ulcer of the sacral region, stage 4, osteomyelitis, and heart failure was admitted to the home care agency on 03/18/2020. Review of the Home Health Certification and Plan of Care for certification period 03/18/2020 to 05/16/2020 revealed the order “Skilled nurse to perform/teach pressure ulcer care to buttocks/coccyx. Cleanse would with acetic acid. Pack with packing strips. Cover with dry, clean dressing. Wound care is currently performed three (3) times daily, spouse has learned and willing to perform during times without nurses.” Review of the PTA (Physical Therapist Assistant) Visit dated 10/15/2021 revealed the PTA documented “increased drainage and foul odor noted” (from wound). Email to (wound team member) who plans to schedule to see client next week to reassess.” Review of the clinical record lacks documented evidence the physician was notified of the changes. The agency failed to ensure the physician is notified of changes in the patient's condition or needs that suggest the POC may need to be altered. During interview on 05/31/2022 at 11:47 AM, the Branch Manager stated there is no documentation that the physician was notified of the changes.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on review of clinical records and staff interview for seven (7) of twenty-three (23) patients (Patient #'s: 13, 14, 15, 17, 19, 22, and 23), the agency failed to ensure the patient/caregiver receives appropriate education regarding the care and services identified in the plan of care (POC). Failure to provide appropriate education has the potential to result in the patient receiving inadequate care and could result in patient harm. Patient #13 – This 91-year-old patient with diagnoses that include a stage 2 pressure ulcer to the left buttock, emphysema and hypertension was admitted to the home care agency on 02/12/2021. Review of the Home Health Certification and Plan of Care for certification period 02/12/2021 to 04/12/2021 revealed orders for “Skilled Nurse to perform/teach pressure ulcer care to left upper buttock. Cleanse with NS (normal saline)/ wound cleanser, pat dry, cover with DCD (dry clean dressing) using clean/ aseptic techniques daily and PRN (as needed) until further wound recommendation. Pt (Patient) independent on non- nursing days.” Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission Note dated 02/12/2021 lacks documented evidence the patient/caregiver demonstrated the ability to perform the daily wound care and the next scheduled nursing visit was scheduled for 02/17/2021. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to perform wound care. During interview on 05/27/2022 at 01:25 PM, the Erie Clinical Director stated there is no documentation to ensure the patient/ caregiver demonstrated the wound care and this should have been included in the visit documentation. Patient #14 – This 76-year-old patient with diagnoses that include a stage 3 pressure ulcer to the right heel, type II diabetes mellitus and atherosclerotic heart disease was admitted to the home care agency on 05/23/2021. Review of the Home Health Certification and Plan of Care for certification period 05/23/2021 to 07/21/2021 revealed the following orders: - “Cleanse right heel with NS/ wound cleanser, pat dry, apply nickel thick layer of Santyl (used to remove wound debris) to wound bed followed by DCD and kerlix daily and PRN using clean/ aseptic technique. Caregiver needs teaching. - Cleanse left inner ankle with NS/ wound cleanser, pat dry. Apply foam dressing 3x (three times) weekly using clean/ aseptic technique. Caregiver needs teaching. - Cleanse left outer foot with NS/ wound cleanser, pat dry, apply plurogel (used to soften wound debris) followed by foam dressing 3x weekly using clean/ aseptic technique. Caregiver needs teaching.” Review of the RN OASIS Admission Visit Note Report dated 05/23/2021 lacks documented evidence the patient/ caregiver demonstrated the ability to perform the wound care. Review of the RN Subsequent Visit Note Report dated 05/25/2021 revealed the next nursing visit after the initial visit occurred on 05/25/2021 and lacks documented evidence the patient/ caregiver were instructed and demonstrated the ability to perform the wound care. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to perform wound care. During interview on 05/27/2022 at 02:30 PM, the Erie Clinical Director stated there was no documentation regarding the patient/ caregiver demonstrating the wound care and it should have been included in the documentation. Patient #17 – This 58-year-old patient with diagnoses that include pressure ulcer of the right buttock, unstageable, acute kidney failure, and type II diabetes mellitus with diabetic chronic kidney disease was admitted to the home care agency on 02/13/2022. This patient was listed on the agency’s potentially avoidable patient listing report for emergent care for hypo/hyperglycemia. A.) Review of the Home Health Certification and Plan of Care for certification period 02/13/2022 to 04/12/2022 revealed the patient tests “blood glucoses as needed.” Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission Note dated 02/13/2022 lacks documented evidence the RN observed the patient or caregiver obtain a blood glucose. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to independently obtain a blood glucose. During interview on 05/27/2022 at 01:40 PM, the RN stated she did not watch the caregiver demonstrate obtaining a blood glucose because it was done before she arrived, and also the caregiver stated she felt comfortable doing it at this time. B.) Review of the Home Health Certification and Plan of Care for certification period 02/13/2022 to 04/12/2022 revealed the order “Skilled nurse to perform/teach pressure ulcer care to wound upper buttock, right, unstageable. Irrigate/cleanse wound and periwound area with normal saline or soap/water, rinse thoroughly, pat dry. Apply/cover with dry, clean dressing. Secure with tape… Caregiver educated regarding care to be provided on non-nursing homecare days.” Review of the RN OASIS Admission Note dated 02/13/2022 lacks documented evidence the RN observed the patient or caregiver providing wound care. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to provide wound care as ordered. During interview on 05/27/2022 at 01:40 PM, the RN stated she did not observe the caregiver providing wound care. Patient #19 – This 67-year-old patient with diagnoses that include epididymitis, type II diabetes mellitus with diabetic chronic kidney disease, and hypertensive chronic kidney disease was admitted to the home care agency on 11/08/2021. A.) Review of the Home Health Certification and Plan of Care for certification period 11/08/2021 to 01/06/2022 revealed the orders for Humalog kwikpen insulin 100 unit/mL (milliliters) subcutaneous inject 40 units subcutaneously as directed and ozempic 1 mg/dose k (4mg/3ml) subcutaneous pen injector inject 1 mg subcutaneously every week. Review of the RN OASIS Admission Note dated 11/08/2021 lacks documented evidence the patient/caregiver demonstrated the ability to correctly administer subcutaneous medication. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to administer subcutaneous medication. During interview on 05/27/2022 03:10 PM, the RN stated he did observe the caregiver administer the medication but did not document that. B.) Review of the Home Health Certification and Plan of Care for certification period 11/08/2021 to 01/06/2022 revealed the following order “skilled nurse to perform/teach wound care to incision/suture site located at scrotum. Irrigate with NS (normal saline), cleanse with wound cleanser or NS, pack with iodoform gauze, cover with DCD (dry, clean, dressing) using clean/aseptic technique. To be changed daily and prn (as needed) soiling. Nursing to change 3 (three) times a week. Family to change on non nursing day.” Review of the RN OASIS Admission Note dated 11/08/2021 lacks documented evidence the patient/caregiver demonstrated the ability to perform wound care. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to perform wound care. During interview on 05/27/2022 at 03:10 PM, the RN stated the observation was made at subsequent visits but was not documented. Patient #15 – This 67-year-old patient with diagnoses that include aftercare following joint replacement surgery, presence of artificial right hip joint, and essential hypertension was admitted to the home care agency on 11/03/2021. Review of the Home Health Certification and Plan of Care for certification period 11/03/2021 to 01/01/2022 revealed the patient is ordered enoxaparin 40 mg (milligrams)/0.4 mL (milliliters) subcutaneous injection daily. Review of the RN OASIS Admission Note dated 11/03/2021 lacks documented evidence the RN observed the patient or caregiver demonstrate administering the medication. Review of the clinical record lacks documented evidence the patient received appropriate education regarding administering a subcutaneous medication. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to independently a subcutaneous medication. During interview on 05/27/2022 at 08:50 AM, the RN stated she does not remember if the patient demonstrated administering the medication. The Director of Quality Improvement stated she would look for documentation, but no further information was provided. Patient #22 – This 78-year-old patient with diagnoses that include pressure ulcer of the sacral region, stage 4, osteomyelitis, and heart failure was admitted to the home care agency on 03/18/2020. Review of the Home Health Certification and Plan of Care for certification period 03/18/2020 to 05/16/2020 revealed the order “Skilled nurse to perform/teach pressure ulcer care to buttocks/coccyx. Cleanse would with acetic acid. Pack with packing strips. Cover with dry, clean dressing. Wound care is currently performed three (3) times daily, spouse has learned and willing to perform during times without nurses.” Review of the RN OASIS Admission Note dated 03/18/2020 lacks documented evidence the patient/caregiver demonstrated the ability to perform wound care. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to perform wound care. During interview on 05/31/2022 at 11:40 AM, the RN stated the spouse demonstrated wound care, but she did not document that. Patient #23 – This 69-year-old patient with diagnoses that include end stage renal disease, type I diabetic mellitus, and atrial fibrillation was admitted to the home care agency on 09/25/2021. Review of the Home Health Certification and Plan of Care for certification period 09/25/2021 to 11/23/2021 revealed the order “Skilled Nurse to perform/teach wound care to incision/suture site located left thigh. Cleanse with skintegrity, pack open surgical incisions with normal saline moistened packing strip. Cover with abd (army battle dressing) pad and wrap with kerlex. Using clean/aseptic technique.” Wound care is performed daily. Review of the RN OASIS Admission Note dated 09/25/2021 lacks documented evidence the patient/caregiver demonstrated the ability to perform wound care. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to perform wound care. During interview on 05/31/2022 at 03:35 PM, the Director of Operations stated the RN did not document observing the patient or caregiver performing wound care.

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 review of clinical records and interview with agency staff for two (2) of twenty-three (23) patients (Patient #’s 9 and 12), the agency failed to ensure ongoing interdisciplinary assessments and communication between skilled professionals occurred to meet the patient's needs and goals. Failure to ensure there are ongoing interdisciplinary assessments and communication has the potential for negative patient outcomes. Patient #12 – This 80-year-old patient with diagnoses that include hypertensive heart disease with heart failure, heart failure, unspecified, peripheral vascular disease, unspecified was admitted to the home care agency on 05/10/2022. Review of the LPN (Licensed Practical Nurse) Subsequent Visit Note dated 05/12/2022 revealed the LPN assessed the patient, however the visit note lacks documented evidence the LPN communicated her findings to the Registered Nurse (RN). The agency failed to ensure ongoing interdisciplinary assessments and communication between skilled professionals occurred to meet the patient's needs and goals. During interview on 05/27/2022 at 09:20 AM, the LPN stated she called the RN and relayed all information to her after the visit, however this is not documented in the clinical record. Patient #9 – This 63-year-old patient with diagnoses that include atrial fibrillation, hypertension and congestive heart failure was admitted to the home care agency on 05/06/2022. Review of the LPN (Licensed Practical Nurse) Subsequent Visit Note Report dated 05/09/2022 revealed the LPN assessed the patient, however the visit note lacks documented evidence the LPN communicated her findings to the Registered Nurse (RN). Review of the LPN Subsequent Visit Note Report dated 05/16/2022 revealed the LPN assessed the patient, however the visit note lacks documented evidence the LPN communicated her findings to the RN. The agency failed to ensure ongoing interdisciplinary assessments and communication between skilled professionals occurred to meet the patient's needs and goals. During interview on 05/27/2022 at 10:30 AM, the Rural Branch Manager of Genesee, Livingston, Orleans, Wyoming (GLOW) counties stated it is the agency expectation that the LPN reports off to the Case Manager Nurse after each visit made. During interview on 05/27/2022 at 10:45 AM, the LPN stated she sent the RN a copy of her visit notes but she did not document doing this.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with agency staff, for two (2) of twenty-three (23) patients (Patient #'s: 13 and 14), the agency failed to ensure clinicians prepare and document complete and accurate clinical and progress notes. Failure to prepare or document complete clinical and progress notes has the potential for unmet patient needs. Based on review of clinical records and interviews with agency staff, for two (2) of twenty-three (23) patients (Patient #'s: 13 and 14), the agency failed to ensure clinicians prepare and document complete and accurate clinical and progress notes. Failure to prepare or document complete clinical and progress notes has the potential for unmet patient needs. Patient #13 – This 91-year-old patient with diagnoses that include a stage 2 pressure ulcer to the left buttock, emphysema and hypertension was admitted to the home care agency on 02/12/2021. A.) Review of the Home Health Certification and Plan of Care for certification period 02/12/2021 to 04/12/2021 revealed the patient has a stage 2 pressure ulcer of the left buttock and Skilled Nurse is ordered to perform/ teach pressure ulcer care to left upper buttock. Wound care includes: cleanse with NS (normal saline)/ wound cleanser, pat dry, cover with DCD (dry clean dressing) using clean/ aseptic technique daily and PRN (as needed) until further wound recommendation. Review of the Client Coordination Note Report dated 02/12/2021 revealed the Registered Nurse (RN) performed a wound consult on the right buttocks and recommended cleansing right buttock wound with wound cleanser and applying Triad paste (used to heal wounds) to area 3 (three) times per week. The documentation regarding the location of the patient’s buttock wound is unclear. During interview on 05/27/2022 at 01:10 PM, the RN stated the patient’s wound was located on the left buttock and the RN performing the wound consult documented incorrectly. B.) Review of the Home Health Certification and Plan of Care for certification period 02/12/2021 to 04/12/2021 revealed orders for Oxygen 3 (three) liters continuous. Review of the LPN (Licensed Practical Nurse) Subsequent Visit Note Report dated 02/17/2021 revealed the following respiratory assessment: - Lungs clear, O2 (Oxygen) use, shortness of breath, cough; - Mode of O2 administration- Nasal cannula, continuous; and - Rate of O2- 2 (two) L (liters). The documentation regarding the rate of Oxygen the patient is using is unclear. During interview on 05/27/2022 at 01:35 PM, the LPN stated the 2L was a typographical error and she meant to document the patient uses 3L. Patient #14 – This 76-year-old patient with diagnoses that include a stage 3 pressure ulcer to the right heel, type II diabetes mellitus and atherosclerotic heart disease was admitted to the home care agency on 05/23/2021. Review of the Home Health Certification and Plan of Care for certification period 05/23/2021 to 07/21/2021 revealed the following medication orders: - Humulin R Regular U (unit)- 100 Insulin 100 unit/ml (milliliter) injection daily/PRN (as needed). Sliding Scale managed by wife. - Lantus Solostar U-100 Insulin 100 unit/ml (3 ml) 10 (ten) units daily at bedtime subcutaneous. Review of the RN Subsequent Visit Note Report dated 07/02/2021 revealed the RN documented the patient is not taking insulin or any antidiabetic agent at this time. The documentation is unclear if the patient is taking Humulin Regular and Lantus Insulin to manage his diabetes. During interview on 05/27/2022 at 02:55 PM, the Erie Clinical Director stated the RN was unavailable for interview. She stated the patient is ordered to take two types of insulin and the identified documentation from 07/02/2021 is incorrect.

Coordinate referrals; CFR(s): 484.105(c)(3) Coordinating referrals, This ELEMENT is not met as evidenced by: Based on a review of clinical records and interviews with agency staff for one (1) of two (2) non-admissions to home care (Patient #18), the agency failed to ensure referrals for home care are coordinated. Failure to coordinate referrals may lead to negative patient outcomes. Patient #18 – This 51-year-old patient with diagnoses that include rectal adenocarcinoma with metastasis to liver and an acute deep vein thrombosis was referred to the home care agency on 03/26/2022. Review of the facility Discharge Summary dated 03/25/2022 revealed the patient was discharged from the hospital on 03/25/2022. Her home care needs included: Skilled Nursing for medication reconciliation and instruction, pain management, twice daily wound care, twice daily Lovenox injections for a new deep vein thrombosis, colostomy/ fistula care, education on home oxygen and assessments while undergoing chemotherapy. The patient also required a home Physical Therapy evaluation due to deconditioning. On 05/27/2022 at 02:07 PM, the surveyor requested a copy of the hospital referral for home care services, none was provided. During interview on 05/31/2022 at 01:25 PM, the Clinical Director stated the facility uses an electronic portal to refer patients to the home health agency. She stated the referral to the agency was initiated on 03/26/2022 but was not completed by the facility until 03/27/2022. When requested, the Clinical Director stated she was unable to provide documentation of the identified referral process. Review of the Client Coordination Note dated 03/26/2022 revealed the patient’s family called the home care agency On-Call Registered Nurse (RN) on 03/26/2022 and reported the patient was discharged from the hospital on 03/25/2022. The family reported the patient was dehydrated and declining, and a request was made for a RN home visit to be made as soon as possible. The On-Call RN told the family the status of the patient still stated hospitalized, and the start of care visit was not scheduled at this time. Additionally, the family was told if the patient required immediate care, that the patient should return to the hospital. Review of the clinical record lacks documented evidence the agency followed through on the referral process in order to ensure a start of care assessment visit was completed within 48 hours of the patient’s referral/discharge from the hospital. Without the documented evidence showing the actual referral date, it is unclear what the actual date of the referral was; however, the patient was discharged from the hospital on 03/25/2022. In accordance with the CMS Discharge Planning Rule hospitals are required to discharge the patient, and also transfer or refer the patient where applicable, along with his or her necessary medical information (current course of illness and treatment, post-discharge goals of care, and treatment preferences), at the time of discharge, to not only the appropriate post-acute care service providers and suppliers, facilities, agencies, but also to other outpatient service providers and practitioners responsible for the patient’s follow-up or ancillary care. Based on this rule, the agency should have received the referral and all pertinent information required to provide care for this patient at the time the patient was discharged from the hospital on 03/25/2022. Review of the clinical record lacks documented evidence the On-Call RN contacted the hospital, physician and agency supervisor to facilitate and coordinate an assessment of the patient on 03/26/2022 once informed of the decline of the patient and a request was made for a RN home visit to occur as soon as possible. Review of the Client Coordination Note dated 03/28/2022 revealed the RN made three (3) attempts to call the patient and spouse to set up a start of care visit on 03/28/2022. Review of the Client Coordination Note dated 03/28/2022 revealed the patient’s spouse called to report the patient had died. The agency failed to coordinate care with the hospital and the physician to facilitate an assessment of the declining patient. During interview on 05/27/2022 at 02:02 PM, the Erie Branch Manager stated the start of care visit could have been expedited when the family called the On-Call RN on 03/26/2022 requesting home care assistance, but this did not occur.

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 review of clinical records, policy and procedure, and interview with agency staff, for seven (7) of twenty-three (23) patients (Patient #’s: 8, 13, 14, 16, 18, 22, and 23), the agency failed to follow agency policies and procedures, current clinical practice guidelines, and accepted professional standards when providing services. The issues are: - The agency failed to ensure wound measurements were obtained at a minimum of once per week, per agency policy and procedure. - The agency failed to perform the initial visit within twenty-four (24) hours of the receipt of a referral, per agency policy and procedure. - The agency failed to ensure each discipline referred in addition to the primary discipline, conducts an assessment visit within 10 (ten) days from the start of care, per agency policy and procedure. Failure to ensure compliance with accepted professional standards has the potential to result in unmet patient needs and inadequate care. Patient #8 – This 85-year-old patient with cellulitis of the left toe, congestive heart failure and stage 4 kidney disease was admitted to the home care agency on 04/14/2022. Review of agency policy and procedure entitled “Guidelines: Wound and Skin Care” revised 03/11/2009 revealed “Intact surgical incisions do not require measurements. Measure all other wounds weekly.” Review of the Home Health Certification and Plan of Care for certification period 04/14/2022 to 06/12/2022 revealed the patient has a left 1st (first) toe wound that requires wound care to include: cleanse with Skintegrity, apply Hydrogel (used to promote wound healing) to wound bed, cover with DCD (dry clean dressing), secure with rolled gauze and tape, perform 2x (two times) a week and PRN (as needed) if soiled. Review of the clinical record revealed the patient received the following Skilled Nursing (SN) visits for the week from 04/17/2022 to 04/23/2022 on: 04/18/2022, 04/20/2022 and 04/21/2022. Review of the SN Visit Note Reports for 04/18/2022, 04/20/2022 and 04/21/2022 lack documentation of wound measurements to the left 1st toe. Review of the clinical record revealed one (1) Skilled Nursing visit was made the week of 05/01/2022 to 05/07/2022, occurring on 05/03/2022. Review of the LPN (Licensed Practical Nurse) Subsequent Visit Note Report dated 05/03/2022 lacks documentation of wound measurements to the left 1st toe. The agency failed to ensure wound measurements were obtained at a minimum of once per week, per agency policy. During interview on 05/27/2022 at 11:25 AM, the LPN stated the wound was unable to be measured but she did not document this. During interview on 05/27/2022 at 11:37 AM, the Rural Branch Manager of Genesee, Livingston, Orleans, Wyoming (GLOW) counties stated the RN was unavailable for interview. She stated she would check for an explanation of why the wound was not measured the week of 04/17/2022. No further documentation was provided by the agency. Patient #13 – This 91-year-old patient with diagnoses that include a stage 2 pressure ulcer to the left buttock, emphysema and hypertension was admitted to the home care agency on 02/12/2021. Review of the agency policy and procedure entitled “Initial Assessment/ Reassessment” dated 11/01/2011 revealed “Each discipline that is referred in addition to the primary discipline, must respond by conducting an assessment visit within 10 (ten) days from the initial start of care.” Review of the Home Health Certification and Plan of Care revealed an order for MSW (Masters prepared Social Worker) Effective 02/14/2021 1 WK 1 (one time a week for one week). Review of the MSW Add-On Evaluation Visit Note Report dated 03/05/2021 revealed the MSW made the initial social work visit on 03/05/2021 (twenty-one days after the initial start of care nursing visit). Review of the clinical record lacks documentation of a patient and/or physician request to delay the MSW until 03/05/2021. The agency failed to ensure the MSW was initiated within ten days of the initial start of care date. During interview on 05/27/2022 at 01:28 PM, the RN stated the MSW was not available for interview. The RN stated there was no indication why the visit was delayed and that the physician was notified of the delay. Patient #14 – This 76-year-old patient with diagnoses that include a stage 3 pressure ulcer to the right heel, type II diabetes mellitus and atherosclerotic heart disease was admitted to the home care agency on 05/23/2021. This patient was on the Potentially Avoidable Event Patient Listing Report for being discharged to the community with an unhealed stage 2 pressure ulcer. Review of agency policy and procedure entitled “Guidelines: Wound and Skin Care” revised 03/11/2009 revealed “Intact surgical incisions do not require measurements. Measure all other wounds weekly.” Review of the RN Resumption of Care Visit Note Report dated 05/30/2021 revealed the patient has the following wounds requiring wound care: a distal pretibial left diabetic ulcer, a mid left dorsum diabetic ulcer and a stage 3 right heel pressure ulcer. Review of the Resumption of Care orders dated 05/30/2021 revealed wound orders to bilateral foot wounds to include: cleanse with Skintegrity, apply Plurogel (used to soften wound debris) and cover with Foam and Kerlix using clean/ aseptic technique 3X (three times) weekly. Review of the clinical record revealed the patient received SN visits for the week from 06/06/2021 to 06/12/2021 on: 06/07/2021, 06/09/2021, and 06/11/2021. Review of the SN Visit Note Reports for 06/07/2021, 06/09/2021 and 06/11/2021 lack documentation of the two left lower extremity diabetic ulcers and the stage 3 right heel pressure ulcer wound measurements. Review of the clinical record revealed the patient received SN visits for the week from 06/13/2021 to 06/19/2021 on: 06/16/2021 and 06/18/2021. Review of the SN Visit Note Reports for 06/16/2021 and 06/18/2021 lack documentation of the two left lower extremity diabetic ulcers and the stage 3 right heel pressure ulcer wound measurements. Review of the clinical record revealed the patient received SN visits for the week from 06/20/2021 to 06/26/2021 on: 06/21/2021, 06/23/2021 and 06/25/2021. Review of the SN Visit Note Reports for 06/21/2021, 06/23/2021 and 06/25/2021 lack documentation of the two left lower extremity diabetic ulcers and the stage 3 right heel pressure ulcer wound measurements. Review of the clinical record revealed the patient received SN visits for the week from 06/27/2021 to 07/03/2021 on: 06/28/2021, 06/30/2021 and 07/02/2021. Review of the SN Visit Note Reports for 06/28/2021, 06/30/2021 and 07/02/2021 lack documentation of the two left lower extremity diabetic ulcers and the stage 3 right heel pressure ulcer wound measurements. Review of the clinical record revealed the patient received SN visits for the week from 07/04/2021 to 07/10/2021 on: 07/07/2021 and 07/10/2021. Review of the SN Visit Note Reports for 07/07/2021 and 07/10/2021 lack documentation of the two left lower extremity diabetic ulcers and the stage 3 right heel pressure ulcer wound measurements. Review of the clinical record revealed the patient received SN visits for the week from 07/11/2021 to 07/17/2021 on: 07/12/2021, 07/14/2021 and 07/16/2021. Review of the SN Visit Note Reports for 07/12/2021, 07/14/2021 and 07/16/2021 lack documentation of the two left lower extremity diabetic ulcers and the stage 3 right heel pressure ulcer wound measurements. Review of the RN Recert (Recertification) with Skill Visit Note Report dated 07/20/2021 revealed the patient has the following wounds requiring wound care: left distal pretibial diabetic ulcer, left mid dorsum diabetic ulcer, stage 3 right heel pressure ulcer and right forearm skin tear. Review of the Home Health Certification and Plan of Care for certification period 07/22/2021 to 09/19/2021 revealed the following wound care orders: - SN to apply Plurogel to bilateral foot wounds, cover with Foam dressing and wrap with Kerlix 3X weekly and PRN. - SN to cleanse right forearm with NS/ wound cleanser, pat dry, apply Foam dressing 2X weekly using clean aseptic technique. Review of the clinical record revealed the patient received SN visits for the week from 07/25/2021 to 07/31/2021 on: 07/26/2021, 07/28/2021 and 07/30/2021. Review of the SN Visit Note Reports for 07/26/2021, 07/28/2021 and 07/30/2021 lack documentation of the two left lower extremity diabetic ulcers and the stage 3 right heel pressure ulcer wound measurements. The agency failed to ensure wound measurements were obtained at a minimum of once per week, per agency policy. During interview on 05/27/2022 at 02:50 PM, the Erie Clinical Director acknowledged the identified weekly wound measurements were not completed and stated the wounds should have been measured weekly. Patient #18 – This 51-year-old patient with diagnoses that include rectal adenocarcinoma with metastasis to liver and an acute deep vein thrombosis was referred to the home care agency on 03/26/2022. Review of the agency’s policy and procedure entitled “Initial Assessment/Reassessment” dated 11/01/2011 revealed “As indicated by the needs of the individuals, an initial visit, or resumption of care visit will be made within twenty-four (24) hours of receipt and acceptance of a community referral or return from institutional placement.” Review of the facility Discharge Summary dated 03/25/2022 revealed the patient was discharged from the hospital on 03/25/2022. On 05/27/2022 at 02:07 PM, the surveyor requested a copy of the hospital referral for home care services, none was provided. During interview on 05/31/2022 at 01:25 PM, the Clinical Director stated the hospital uses an electronic portal to refer patients to the home health agency. She stated the referral to the agency was initiated on 03/26/2022 but was not completed by the facility until 03/27/2022. When requested, the Clinical Director stated she was unable to provide documentation of the identified referral process. Review of the Client Coordination Note dated 03/26/2022 revealed the patient’s family called the home care agency On-Call Registered Nurse (RN) on 03/26/2022 and reported the patient was discharged from the hospital on 03/25/2022. The family reported the patient was dehydrated and declining, and a request was made for a RN home visit to be made as soon as possible. The On-Call RN told the family the status of the patient still stated hospitalized, and the start of care visit was not scheduled at this time. Additionally, the family was told if the patient required immediate care, that the patient should return to the hospital. Review of the clinical record lacks documented evidence the agency followed through on the referral process in order to ensure a start of care assessment visit was completed within 24 hours of the patient’s referral/discharge from the hospital, as stated in the agency policy. Review of the Client Coordination Note dated 03/28/2022 revealed the RN made three (3) attempts to call the patient and spouse to set up a start of care visit for 03/28/2022 (three days after the facility discharge). The agency failed to follow agency policy and procedure and perform the initial visit within twenty-four (24) hours of the receipt of a referral or hospital discharge. During interview on 05/27/2022 at 02:02 PM, the Erie Branch Manager stated the start of care visit could have been expedited when the family called the On-Call RN on 03/26/2022 requesting home care assistance, but this did not occur. Review of the agency’s policy entitled “Initial Assessment/Reassessment” dated 11/01/2011 revealed “As indicated by the needs of the individuals, an initial visit, or resumption of care visit will be made within twenty-four (24) hours of receipt and acceptance of a community referral or return from institutional placement.” Patient #16 – This 65-year-old patient with diagnoses that include other diseases of stomach and duodenum, peritonitis, and covid-19 was admitted to the home care agency on 12/23/2021. Review of the discharge summary revealed the patient was discharged home from the hospital on 12/18/2021. Review of the Patient Information Report revealed the referral was placed on 12/18/2021, and the first call from the agency to the patient occurred on 12/21/2021, three (3) days after the patient was discharged home. The agency failed to perform the initial visit within twenty-four (24) hours of the receipt of a referral. During interview on 05/27/2022 at 11:56 AM, the Director of Quality Improvement stated she would look for documentation. No further information was provided. Patient #22 – This 78-year-old patient with diagnoses that include pressure ulcer of the sacral region, stage 4, osteomyelitis, and heart failure was admitted to the home care agency on 03/18/2020. Review of the Clinical Intake dated 03/16/2020 revealed the patient was referred to the home care agency on 03/16/2020. Review of the clinical record revealed the initial visit occurred on 03/18/2020, two (2) days after referral. The agency failed to perform the initial visit within twenty-four (24) hours of the receipt of a referral. During interview on 05/27/2022 at 11:09 AM, the Branch Manager stated she would look for documentation to explain the delay but no information was provided. Patient #23 – This 69-year-old patient with diagnoses that include end stage renal disease, type I diabetic mellitus, and atrial fibrillation was admitted to the home care agency on 09/25/2021. Review of the Clinical Intake dated 09/22/2021 revealed the patient was referred to the home care agency on 09/22/2021. Review of the clinical record revealed the initial visit occurred on 09/25/2021, three (3) days after referral. The agency failed to perform the initial visit within twenty-four (24) hours of the receipt of a referral. During interview on 05/27/2022 at 03:39 PM, the Clinical Manager stated there is no documentation to explain the delay.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on review of clinical records, agency policy and procedure and staff interview, for one (1) of eight (8) discharged patients (Patient #14), the Registered Nurse (RN) failed to prepare and document a complete discharge summary process. Failure to ensure a comprehensive discharge summary is prepared, containing all required components, at the time of discipline discharge has the potential for unmet patient needs. Review of agency policy entitled “Discharge of Patient” dated 11/01/2011 revealed “A. A discharge plan will be initiated prior to closure by a discipline or agency discharge to assure a timely, safe, and appropriate transition for the patient. F. The patient will be discharged by the discipline or the agency after notification to the physician and in consultation with the patient and any other professional staff involved in the plan of care.” Patient #14 – This 76-year-old patient with diagnoses that include a stage 3 pressure ulcer to the right heel, type II diabetes mellitus and atherosclerotic heart disease was admitted to the home care agency on 05/23/2021. This patient was on the Potentially Avoidable Event Patient Listing Report for being discharged to the community with an unhealed stage 2 pressure ulcer. Review of the Client Coordination Note Report dated 07/27/2021 revealed the RN documented contacting the insurance company regarding a denial for further home care services due to the wounds not meeting insurance criteria for home care and the last day covered would be 07/30/2021. The RN contacted the patient’s spouse and physician to report the denial and explain the appeal process. Review of the RN Subsequent Visit Note Report dated 07/30/2021 revealed the RN documented performing the following wound care to the right heel stage 3 pressure ulcer, the left pretibial diabetic ulcer and the left mid dorsum diabetic ulcer: apply plurogel (used to soften wound debris) to all wounds, apply foam dressing and kerlix three times weekly and as needed if dressing compromised. The RN documented the spouse requests the agency not discharge the patient until the appeal is complete. The RN performed wound teaching with spouse and spouse verbalized being comfortable doing care short term. Review of the Client Coordination Note Report dated 08/07/2021 revealed the agency was notified by the insurance company that the appeal for home health was denied for services after 07/30/2021. Review of the clinical record lacks documented evidence of any home care visits occurring between 07/30/2021 and 08/09/2021 (date the agency completed the discharge paperwork). Review of the RN Discharge Data Collection Only- No Visit Made Visit Note Report dated 08/09/2021 revealed the patient was discharged from the agency on 07/30/2021. Review of the clinical record lacks documented evidence of discharge planning with the physician for ongoing wound monitoring and assessments upon home care discharge. The agency failed to complete discharge planning with the physician regarding unhealed wounds at the time of discharge. During interview on 05/27/2022 at 02:33 PM, the Erie Clinical Director stated there was no documentation of discharge planning with the physician regarding the unhealed wounds.

The following Statement of Deficiencies represents the results of an on-site complaint investigation survey (NY00275954 and NY00270561) of VNA of Western NY Certified Home Health Care Agency (CHHA) conducted on 06/07/2021 and 06/08/2021 by staff of the Western Regional Office of the New York State Department of Health. The survey consisted of a review of three (3) clinical records and pertinent documentation. The Director of Clinical Services, Director of Branch Operations, Director of Clinical Operations, Senior Director of Clinical Operations, and Branch Manager were interviewed. Findings were reviewed at the exit conference on 06/09/2021. The following deficiencies are being cited as a result of the survey: G-0476 and G-0578.

Investigation of complaints CFR(s): 484.50(e)(1) Standard: Investigation of complaints. The HHA must-- This STANDARD is not met as evidenced by: Based on review of clinical records, agency policy and procedure, agency complaint log, and interviews with staff for one (1) of one (1) patients (Patient #2) the agency failed to adequately document, investigate, and resolve complaints. Failure to ensure the complete investigation and resolution of all patient complaints, has the potential for negative patient outcomes. Findings are: Patient #2 - This 63-year-old patient with diagnoses that include multiple sclerosis, neuromuscular dysfunction of bladder, unspecified, and anxiety was admitted to the home care agency on 08/29/2019. Review of the agency's policy and procedure entitled "Patient/Customer Complaints" dated 05/20/2019 revealed the following: "Policy: B. The agency will investigate any complaints made by a patient, the patient's representative (if any), and the patient's caregiver(s) and family, including but limited to the following topics: Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately ...D. Immediate attention must be given to all complaints in order to assure quality of care for patients and to promote customer satisfaction ...I. The organization documents both the existence of the complaint and the resolution of the complaint and takes action to prevent further potential violations, including retaliation, while the complaint is being investigated. Procedure: A. When an associate becomes aware that a complaint is being made, the associate will document the complaint ... D. A Complaint Report will be initiated by the manager or associate taking the complaint, including ...E. The Complaint Report will be forwarded to the manager. The manager will further investigate the complaint, complete with the appropriate associate and render immediate actions, as needed ...J. The completed Complaint Report will be entered in the Complaint Log in the Quality Management Department. The Agency will maintain documentation of all complaints that it receives, copies of investigations and responses to clients." Review of the Client Episode Coordination Notes Report dated 04/26/2021 revealed the Branch Manager documented the following: - Spoke to the Office for the Aging (OOA) who reports the patient claims the agency is not reliable; - Explained that the patient has had several recent hospitalizations and each time she is in [the hospital] the HHA (Home Health Aide) is assigned a new patient to fill the opening, so the schedule has changed several times in the past few months; - The OOA states there is no one in the home and her only caregiver is her son who can no longer assist due to medical reasons; - Per the patient's RN (Registered Nurse) the patient has private help whom the RN has spoken with at her last visit on 04/15/2021; and - I explained to the OOA that the agency does not typically provide an HHA to assist with personal care when there is one already in the home. Review of the 2021 Complaint Log received at 09:00 AM on 06/08/2021 lacked documented evidence of a complaint received for the above referenced incident. The agency failed to follow their policy and procedure and adequately document, investigate, and resolve complaints. During interview on 06/08/2021 at 11:06 AM, the Branch Manager stated the patient's son called to complain about staffing on 04/28/2021, and she verbally notified another agency employee about it; however, she stated that she never wrote a note about the conversation. Additionally, the Branch Manager stated that she should have filled out a STARS report and logged it in the [complaint] log, because that is the agency's expectation.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician orders. This STANDARD is not met as evidenced by: Based on review of clinical records and interviews with staff, for three (3) of three (3) patients (Patient #s: 1, 2, and 3), the agency failed to provide services in accordance with the physician orders and Plan of Care (POC). Specifically, the agency failed to provide Home Health Aide (HHA) services in accordance with the physician orders/POC. Failure to ensure patient care is provided in accordance with physician orders and the Plan of Care has the potential for patients to receive poor care and health care needs to go unmet. Findings are: Patient #1 - This 68-year-old patient with diagnoses that include hemiplegia following cerebral infarction affecting the left non-dominant side, pressure ulcer of the sacral region, stage 4 and pressure ulcer of the of the left buttock, stage 3 was admitted to the home care agency on 01/03/2020. Review of the Home Health Certification and Plan of Care for certification period 12/28/2020 to 02/25/2021 revealed the following orders: HHA five (5) times a week for eight (8) weeks, four (4) times a week for one (1) week, and home health aide services for assistance with bathing, skin care, hair care, dressing, toileting, transfer, ROM (Range of Motion), and other secondary to functional limitations which prevents self-care. There is no willing/able caregiver to provide for hygiene needs. Review of the clinical record from 01/07/2021 to 01/25/2021 lacked documented evidence of a HHA visit on 01/15/2021, 01/18/2021, 01/19/2021, 01/20/2021, 01/21/2021, 01/22/2021, and 01/25/2021. Review of the Client Coordination Note Report dated 01/15/2021 revealed a staffing specialist documented "HHA unavailable for 01/15/2021: called patient, spoke with caregiver and advised that HHA unable to come in today and that I do not have a sub (substitute). I also advised the caregiver that I would let the case manager know the same." Review of the Client Coordination Note Report dated 01/18/2021 revealed a staffing specialist documented "HHA not available for 01/18/2021: called patient, spoke with the patient's spouse and advised the spouse of same and that the nurse was scheduled to come today. No sub (substitute) aide available for this case." Review of the Client Coordination Note Report dated 01/19/2021 revealed an employee documented "HHA not available 01/19/2021 to 01/22/2021: spoke with the patient's spouse and advised the patient's spouse that the HHA is unable to come in this week and that I have no (sub) substitute aides. E-mailed case manager regarding the same." Review of the Client Coordination Note Report dated 01/25/2021 revealed a staffing specialist documented "HHA not available 01/25/2021 to 01/29/2021: called patient, spoke with caregiver and advised that HHA is not available to come in this week and that I did have a sub (substitute) aide for today (01/25/2021). Patient's caregiver declined the sub (substitute) aide for today (01/25/2021)." Review of the Client Coordination Note Report dated 01/25/2021 revealed a staffing specialist documented the following:" I wanted to let you (case manager) know that the HHA is still off from work until further notice. I spoke with the patient's spouse this morning and advised the patient's spouse of the same. I did have an aide open today from 01:00 PM to 03:00 PM to send in and the patient's spouse declined. The patient and caregiver are both aware that there is really no aide availability and the patient's spouse mentioned will be using private aides." The agency failed to provide HHA services in accordance with the POC. During an interview on 06/08/2021 at 10:00 AM, the Manager of Clinical Services stated the HHA frequency was not met. The Director of Clinical Operations and the Senior Director of Clinical Operations stated that a substitute aide should have been offered but since there was no substitute aide the Registered Nurse (RN) should have offered to provide care and that the patient's doctor should have been notified of the missed HHA visits. Patient #2 - This 63-year-old patient with diagnosis that include multiple sclerosis, neuromuscular dysfunction of bladder, unspecified, and anxiety was admitted to the home care agency on 08/29/2019. A.) Review of the Home Health Certification and Plan of Care for certification period 12/21/2020 to 02/18/2021 revealed that the HHA is to provide services three times (3) times per week for eight (8) weeks, and two (2) times per week for one week. Review of the patient record from 12/21/2020 to 02/18/2021 lacked documented evidence of three (3) HHA visits during the weeks of 01/24/2021 to 01/30/2021 and 02/07/2021 to 02/13/2021. Review of the patient record from 12/21/2020 to 02/18/2021 lacked documented evidence of two (2) HHA visits during the week of 02/14/2021 to 02/18/2021 (the last day of the certification period). The agency failed to provide HHA services in accordance with the POC. During interview on 06/08/2021 at 10:30 AM, the Branch Manager stated that the case manager should have notified the physician of the missed visits/frequency changes and that an order should have been obtained. Additionally, the Branch Manager stated that the case manager did not do this for any of the missed visits. B.) Review of the Home Health Certification and Plan of Care for certification period 02/19/2020 to 04/19/2021 revealed that the HHA is to provide services two (2) times per week for one week, one (1) time per week for one (1) week, and three times (3) times per week for six (6) weeks effective 02/21/2021. Review of the patient care record revealed the patient was hospitalized from 03/13/2021 to 03/17/2021. Review of the Resumption of Care dated 03/24/2021 revealed that the HHA is to provide services one (1) time per week for one week three times (3) times per week for three (3) weeks, and one (1) time per week for one (1) week, effective 03/21/2021. Review of the patient record from 03/21/2021 to 03/27/2021 lacked documented evidence of one (1) HHA visits during the week of 03/21/2021 to 03/27/2021. Review of the patient record from 03/28/2021 to 04/03/2021 lacked documented evidence of three (3) HHA visits during the week of 03/28/2021 to 04/03/2021. The agency failed to provide HHA services in accordance with the POC. During interview on 06/08/2021 at 10:29 AM, the Branch Manager stated that there was no order generated to the doctor for the missed visits/change in visit frequency. C.) Review of the patient care record revealed the patient was hospitalized from 04/09/2021 to 04/13/2021. During interview on 06/08/2019 at 10:35 AM, the Branch Manager stated that the nurse made a home visit on 04/15/2021 and completed the resumption of care and re-certification on this date. Review of the Home Health Certification and Plan of Care for certification period 04/20/2021 to 06/18/2021 revealed that the HHA is to provide services one (1) time per week for one (1) week and two (2) times per week for eight weeks. Review of the patient record from 04/20/2021 to 06/07/2021 lacked documented evidence of two (2) HHA visits during the week of 04/25/2021 to 05/01/2021, 05/02/2021 to 05/08/2021, 05/09/2021 to 05/15/2021, 05/24.2021 to 05/29/2021, and 05/30/2021 to 06/05/2021. The agency failed to provide HHA services in accordance with the POC. During interview on 06/08/2021 at 10:55 AM, the Branch Manager stated that there was no order generated to the doctor for the missed visits/change in visit frequency. Patient #3 - This 52-year-old patient with diagnoses that include amyotrophic lateral sclerosis, encounter for adjustment and management of venous access device, and encounter for attention to gastrostomy was admitted to the home care agency on 05/12/2020. Review of the Home Health Certification and Plan of Care for certification period 05/07/2021 to 07/05/2021 revealed that the HHA is to provide services two (2) times a week for eight (8) weeks and one (1) time a week for one (1) week effective 05/09/2021. Review of the patient record from 05/09/2021 to 06/07/2021 lacked documented evidence of two (2) HHA visits during the weeks of 05/09/2021 to 05/15/2021, 05/16/2021 to 05/22/2021, and 05/23/2021 to 05/29/2021. The agency failed to provide HHA services in accordance with the POC. During interview on 06/08/2021 at 11:20 AM, the Senior Director of Clinical Operations stated "based on what I see there were no aide visits until 05/26/2021."