Every finding on record at Mcauley Seton Home Care Corporation

The following statement of deficiencies represents the results of a partial extended re-certification survey of McAuley Seton Home Care conducted on 04/29/2024 to 05/02/2024. A standard re-certification survey was initiated on 04/29/2024. Deficient practices were identified within Level 1 standards in G-580 (only as ordered by a physician/allowed practitioner) on 04/30/2024 resulting in a partial extended survey. The survey consisted of a review of eighteen (18) clinical records including six (6) discharged records, fifteen (15) personnel records of professional personnel and seven (7) observational home visits. The survey included a review of pertinent policies and procedures, Quality Improvement Meeting minutes for the past twelve (12) months, agency's Admission Packet, infection control policies and protocols, the Emergency Preparedness Plan, and Complaint Log. The current patient census is 1667. Pre-survey activities consisted of review on 04/22/2024 of the agency's Health Commerce System account, Home Care Registry, Potentially Avoidable Report for 01/01/2023 - 12/31/2023, and the Home Health Agency Error Summary Report for 04/22/2023 to 04/22/2024. The Vice President of Patient Care Services, Director of Patient Services Home Care, Director of Quality and Education, Clinical Managers, and various professional staff were interviewed. Findings were reviewed at the exit conference on 05/02/2024. The following deficiencies are identified as a result of the survey: G0372, G0428, G0516, G0520, G0528, G0536, G0544, G0574, G0580, G0608, G0610, G0716, G0718, J1426, and R610.

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 #18). 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 04/22/2024 revealed the agency has 347 (three hundred and forty-seven) late submissions of the Outcome and Assessment Information Set assessments (M0090) from 04/22/2023 to 04/22/2024. Patient #18 – This 72-year-old therapy-only patient with the diagnoses of aftercare following joint replacement surgery, presence of right artificial hip joint, and hyperlipidemia was admitted to the home care agency on 06/22/2023 and discharged on 07/06/2023. Review of the Physical Therapy Outcome and Assessment Information Set Start of Care completed by the Physical Therapist revealed the Outcome and Assessment Information Set Assessment (M0090) was completed on 06/22/2023. Review of the Home Health Agency Error Submission Report provided by the agency on 05/01/2024 at 02:15 PM revealed the patient’s Outcome and Assessment Information Set Assessment (M0090) was submitted on 07/25/2023 (33 (thirty-three) days after the assessment was complete. During interview on 05/01/2024 at 02:00 PM, the Vice President of Patient Services stated the agency is on a new electronic medical record system and realized that whenever there is even just a small change to the person’s assessment, the system marks it as a resubmission. The agency now has a process in place to minimize reports of false late submissions by manually going through each change. However, this record was a true late submission.

Property and person treated with respect CFR(s): 484.50(c)(1) Have his or her property and person treated with respect; This ELEMENT is not met as evidenced by: Based on an observational home visit and staff interview, for one (1) of eighteen (18) patients (Patient #10) the agency nurse failed to accommodate the patient's request for disposal of soiled dressings in the patient's home. Failure to accommodate reasonable patient requests has the potential to result in limiting the patient’s rights and inclusion as an active partner in the delivery of care. The agency failed to ensure the patient’s right to respect for person during the home visit was accommodated as evidenced by: HV Patient #10- This 86- year-old patient with the diagnoses of venous insufficiency (chronic)(peripheral), non-pressure chronic ulcer part of right lower leg with unspecified severity, and essential (primary) hypertension was admitted to the home care agency on 04/19/2024. During an observational home visit on 05/01/2024 at 01:23 PM, the patient requested, on three separate occasions, for the nurse not to put the bag of soiled wound care dressings in her kitchen garbage can. She requested the nurse put them on top of the kitchen garbage can (not inside) or in the garage garbage can. The nurse interrupted the patient while putting soiled dressings in the kitchen garbage can after she was asked not to. The patient shrugged her shoulders and supinated her hands on the third request and stated, “I will take it to the garage myself”. During interview on 05/02/2024 at 10:28 AM, the Registered Nurse stated the patient did request for soiled dressings not to be put in the kitchen garbage. During an interview on 05/02/2024 at 10:30 AM, the Vice President of Patient Services stated that it is not acceptable for the nurse to ignore the patient's requests. This is not what the agency does, and it will be addressed.

Skilled professional performs assessment CFR(s): 484.55(a)(2) When rehabilitation therapy service (speech language pathology, physical therapy, or occupational therapy) is the only service ordered by the physician or allowed practitioner, who is responsible for the home health plan of care, and if the need for that service establishes program eligibility, the initial assessment visit may be made by the appropriate rehabilitation skilled professional. This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with agency staff, for two (2) of ten (10) therapy-only patients (Patient #'s 11 and 16), the agency failed to ensure the Physical Therapist conducted an initial assessment of the patient within twenty-four (24) hours of referral 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. The agency failed to ensure the Physical Therapist conducted an initial assessment of the patient within 24 (twenty-four) hours of referral or on the physician-ordered start of care date as evidenced by: Patient #11 – This 71-year-old therapy-only patient with the diagnoses of idiopathic aseptic necrosis of left femur, hypertensive heart and chronic kidney disease with heart failure and stage one through stage four chronic kidney disease, and congestive heart failure was admitted to the home care agency on 04/12/2024. Review of the Referral Intake completed by the Registered Nurse on 04/05/2024 revealed the patient was referred to the home care agency on 04/05/2024. Review of the Referral Intake completed by the Registered Nurse on 04/05/2024 revealed the patient requested the start date of 04/10/2024. Review of the clinical record lacks documentation to explain why the start of care was 04/12/2024, 48 (forty-eight) hours after the requested start of care date of 04/10/2024. During interview on 05/02/2024 at 10:06 AM, the Vice President of Patient Services stated the Physical Therapist called and stated the patient requested the start of care date be moved to 04/12/2024 due to renovations in the home. However, the Physical Therapist stated she failed to document the request in the patient record. Patient #16 – This 83-year-old therapy only patient with diagnoses that include bilateral primary osteoarthritis of knee, unspecified asthma and hypertensive heart disease with heart failure was admitted to the home care agency on 07/07/2023. Review of the Referral for Services dated 07/01/2023 revealed the patient was referred to the agency on 07/01/2023 and the patient’s daughter requested the agency start of care occur on 07/03/2023. Review of the Physical Therapy Outcome and Assessment Information Set Start of Care revealed the initial assessment was completed on 07/07/2023, six (6) days after the patient was referred to the agency for services. Review of the clinical record lacks documentation of a delay of services and physician notification after the 07/03/2023 start of care request. During interview on 05/01/2024 at 09:10 AM, the Physical Therapist stated the patient’s daughter requested the start of care be delayed from the 07/03/2023 to 07/07/2023 but failed to be documented and the physician was not notified of the delay until 07/07/2023.

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 eighteen (18) patient records (Patient #12), 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 the following: Patient #12 – This 72-year-old therapy-only patient with diagnoses of spinal stenosis, acute bilateral lower back pains, and paroxysmal atrial fibrillation was admitted to the home care agency on 04/05/2024. Review of the Home Care Referral dated 04/03/2024 revealed the patient was to be evaluated for Physical Therapy, Occupational Therapy, Home Health Aide and Social work services. Review of the Home Health Certification and Plan of Care for 04/05/2024 to 06/03/2024 revealed an order for Social Work for long term planning. Review of the clinical record revealed the Social Worker initiated contact with the patient on 04/16/2024, ten (10) days after the start of care. During interview on 05/02/2024 at 10:53 AM, the Social Worker stated she had contacted the patient who requested the visit at a later date but failed to document this.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on review of patient care records and interview with agency staff for one (1) of eighteen (18) patient records (Patient #5), 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. The agency failed to ensure the initial comprehensive assessment was of sufficient scope to identify patient needs as evidenced by: Patient #5 – This 64-year-old patient with the diagnoses of malignant neoplasm of cardia, secondary malignant neoplasm of bone, and secondary and unspecified malignant neoplasm of lymph node was admitted to the home care agency on 03/30/2024. Review of the Home Health Plan of Cate dated 03/30/2024 revealed the following: - Wound care: drain. - Caregiver to perform drain care to abdomen daily and as needed if soiled or not intact to consist of: remove old dressing, cleanse with normal saline, pat dry, apply gauze dressing, secure with tape. - Intervention: Skilled observation and assessment of wound. Review of the Skilled Nurse Outcome and Assessment Information Set Start of Care dated 03/30/2024 revealed the Registered Nurse documented “Caregiver instructed on drain care, able to redemonstrate without issue.” Review of the Skilled Nurse Outcome and Assessment Information Set Start of Care dated 03/30/2024 lacks documented evidence of an assessment of the drain site. During interview on 05/02/2024 at 10:40 AM, the Registered Nurse stated she did assess the site during the dressing change but did not document the assessment in the visit note.

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 interview with agency staff for two (2) of ten (10) therapy-only patients (Patient #'s:12 and 13), the clinical records 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. The agency failed to ensure a complete review of all medications the patient currently uses to identify any potential adverse effects, drug reactions, or concerns as evidenced by the following: Patient #12 – This 72-year-old therapy only patient with diagnoses of spinal stenosis, acute bilateral lower back pains, and paroxysmal atrial fibrillation was admitted to the home care agency on 04/05/2024. Review of the facility referral to the agency dated 04/05/2024 revealed an order for artificial tears one percent instill 1(one) drop in both eyes every 6 (six) hours as needed for dry eyes. Review of the Home Health Plan of Care for 04/05/2024 to 06/03/2024 revealed an order for artificial tears ophthalmic solution 1 (one) drop into both eyes 4(four) times daily as needed for dry eyes. Review of the clinical record lacks documented evidence of clarification of the artificial tears ophthalmic solution dosing. The Physical Therapist failed to identify and reconcile the medication discrepancy identified in the referral for services and the Plan of Care. During interview on 05/02/2024 at 11:20 AM, the Physical Therapist stated she picked the wrong dose from the medication pick list by error and did not clarify the dosing discrepancy with the physician but should have contacted the physician regarding the identified discrepancy. The agency failed to ensure a complete review of all medications the patient currently uses to identify any potential adverse effects, drug reactions, or concerns as evidenced by the following: Patient #13 – This 66-year-old therapy only patient with diagnoses that include broken internal right knee prosthesis, mechanical loosening of internal left knee prosthetic joint and essential hypertension was admitted to the home care agency on 03/24/2023. Review of the facility After Visit Summary dated 03/23/2023 revealed the patient was discharged from the facility on the following medications: - gabapentin 300 milligrams by mouth three (3) times a day; and - methotrexate 2.5 milligram tablet, take one (1) time per week, three (3) pills every wednesday morning and three (3) pills every wednesday evening. Review of the Home Health Plan of Care from 03/24/2023 to 05/22/2023 lacks medication orders for gabapentin and methotrexate. Review of the clinical record lacks documentation of acknowledgement and clarification of the identified medication discrepancies. During interview on 05/01/2024 at 10:40 AM, the Physical Therapist stated the identified medications failed to get ordered on the plan of care due to her failure to enter their corresponding start dates.

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 three (3) of eighteen (18) patients (Patient #’s: 2, 13 and 17), 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. The agency failed to ensure the assessments were of sufficient scope to identify current patient needs as evidenced by: Patient #2 – This 62-year-old patient with the diagnoses of hypertensive heart disease with heart failure, chronic obstructive pulmonary disease, and type II diabetes mellitus without complications was admitted to the home care agency on 04/06/2024. Review of the Home Health Plan of Care dated 04/06/2024 revealed the patient uses oxygen 4 (four) liters per minute continuously. Review of the Physical Therapy Initial Evaluation dated 04/11/2024 revealed the Physical Therapist documented the following assessment: Home oxygen safety: patient uses oxygen in the home: no. During interview on 05/02/2024 at 10:52 AM, the Physical Therapist stated the patient was using oxygen during the visit. The assessment was documented in error. Patient #17 - This 69-year-old patient with diagnosis including spondylolisthesis, lumbar stenosis, and lumbar ligamentum flavum hypertrophy was admitted to the agency for Physical Therapy only on 09/06/2023. This patient was identified on the Potentially Avoidable Event Patient Listing Report for Development of Urinary Tract Infection. Review of the Physical Therapy Home Visit Note dated 09/08/2023 revealed the Physical Therapist documented the patient’s last bowel movement was on 08/31/2023. Review of the Physical Therapy Home Visit Note dated 09/08/2023 lacks documentation of the Physical Therapist assessing the patient for constipation. During interview on 05/02/2024 at 09:22 AM, the Physical Therapist stated that he did not assess the patient for constipation but did notify the physician that the patient’s last bowel movement was eight (8) days ago. The agency failed to ensure the assessments were of sufficient scope to identify current patient needs as evidenced by: Patient #13 – This 66-year-old therapy only patient with diagnoses that include broken internal right knee prosthesis, mechanical loosening of internal left knee prosthetic joint and essential hypertension was admitted to the home care agency on 03/24/2023. Review of the Physical Therapy Home Visit Note dated 03/28/2023 revealed the patient was constipated and the last bowel movement had occurred on 03/21/2023. Additionally, the Physical Therapist documented speaking with the Physician Assistant who recommended increasing the patient’s water intake and starting miralax. Review of the clinical record lacks documentation of follow-up regarding the patient starting miralax for constipation. During interview on 05/01/2024 at 09:40 AM, the Physical Therapist stated the patient reported having a bowel movement at the next visit occurring on 03/30/2023, without taking miralax. The Physical Therapist stated the patient also reported she was not going to obtain and use miralax but 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 observational home visit, clinical records and staff interviews for five (5) of eighteen (18) patients (Patient #’s: 5, 10, 13, 15 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 that a comprehensive individualized plan of care is developed has the potential for unmet patient needs. 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: HV Patient #10- This 86- year-old patient with the diagnoses of venous insufficiency (chronic)(peripheral), non-pressure chronic ulcer part of right lower leg with unspecified severity, and essential (primary) hypertension was admitted to the home care agency on 04/19/2024. Review of Home Health Plan of Care dated 04/19/2024 revealed the following orders for wound care: Skilled nurse, patient, and caregiver to perform dressing change to right pretibial venous ulcer wound. Effective date 04/19/2024. Dressing change to consist of: - Utilizing clean technique. - Remove old dressing and discard. - Cleanse with normal saline. - Pat dry. - Apply xerforom to wound bed. - Cover with bordered foam. - Change wound dressing three (3) times weekly and as needed if integrity of dressing is compromised. During an observational home visit on 05/01/2024 at 01:15 PM the patient was observed wearing a tubigrip the over wound bandage. During interview on 05/02/2024 at 10:26 AM, the Registered Nurse stated the tubigrip was not ordered, but should have been. The plan of care is incomplete. 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 #5 – This 64-year-old patient with the diagnoses of malignant neoplasm of cardia, secondary malignant neoplasm of bone, and secondary and unspecified malignant neoplasm of lymph node was admitted to the home care agency on 03/30/2024. Review of the Home Health Plan of Care dated 03/30/2024 revealed the patient receives outpatient chemotherapy but lacks documentation regarding what medication is being given while at chemotherapy. The plan of care is incomplete. During interview on 05/02/2024 at 10:40 AM, the Registered Nurse stated the medication was not listed on the after-visit summary and she did not call the physician to find out what medication was being given. Patient #15 – This 68-year-old therapy-only patient with the diagnoses of fracture of unspecified part of neck of left femur, unspecified fall, and urine retention was admitted to the home care agency on 07/26/2023 and discharged on 08/10/2023. Review of the Physical Therapy Outcome and Assessment Information Set Start of Care dated 07/26/2023 revealed the Physical Therapist documented “history of chronic urinary retention – foley catheter intact – patient states has to make appointment with urologist for catheter removal once able to ambulate independently to the bathroom. Review of the Home Health Plan of Care dated 07/26/2023 lacks an order for a foley catheter. The plan of care is incomplete. During interview on 05/02/2024 at 09:34 AM, the Physical Therapist stated there is no order for the foley, it was an oversight. 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 the following: Patient #13 – This 66-year-old therapy only patient with diagnoses that include broken internal right knee prosthesis, mechanical loosening of internal left knee prosthetic joint and essential hypertension was admitted to the home care agency on 03/24/2023. A.) Review of the Physical Therapy Outcome and Assessment Information Set Start of Care dated 03/24/2023 revealed the Physical Therapist documented the patient’s diabetes is managed with diet, an oral hypoglycemic medication and is independent with blood glucose testing. Review of the Home Health Plan of Care from 03/24/2023 to 05/22/2023 lacks an order for diabetic supplies. During interview on 05/01/2024 at 10:44 AM, the Physical Therapist stated it was an oversight that the diabetic supplies were left off the plan of care. B.) Review of the Physical Therapy Outcome and Assessment Information Set Start of Care dated 03/24/2023 revealed the Physical Therapist documented the patient was unable to get to and from the toilet but was able to use a bedside commode. Review of the Home Health Plan of Care from 03/24/2023 to 05/22/2023 lacks an order for the bedside commode being used by the patient. During interview on 05/01/2024 at 10:46 AM, the Physical Therapist stated it was an oversight the bedside commode was not included on the plan of care.

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 observational home visit, review of clinical records and interviews with agency staff, three (3) of eighteen (18) patients (Patient #’s: 5, 6 and 13), 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. The agency failed to ensure drugs and treatments are administered in accordance with physician orders as evidenced by: HV Patient #6 - This 61-year-old patient with the diagnoses of encounter for change or removal of nonsurgical wound dressing, necrotizing fasciitis, and type II diabetes mellitus with diabetic neuropathy, unspecified was admitted to the home care agency on 03/13/2024. A.) Review of the Home Health Plan of Care dated 04/29/2024 revealed the following orders for negative pressure wound therapy: skilled nurse to perform dressing change to right groin fourniers wound. Effective date 03/22/2024. Dressing change consist of: Utilizing clean technique. Remove old dressing and discard. Cleanse with normal saline. Pat dry as appropriate. Apply skin protectant to peri-wound. Apply anasept gel to slough areas. Apply dressing from negative pressure wound therapy kit to wound using black foam. Set therapy cycle on negative pressure wound therapy pump to continuous. Set pressure on negative pressure wound therapy pump 125 millimeters of mercury. Change dressing three (3) times weekly and as needed if integrity of dressing is compromised. During an observational home visit on 04/29/2024 at 04:10 PM, the Registered Nurse used wound cleanser to cleanse the patient’s wound. During interview on 05/02/2024 at 12:12 PM, the Registered Nurse she misread the wound care order and used wound cleanser instead of normal saline as ordered. B.) During an observational home visit on 04/29/2024 at 04:13 PM, the Registered Nurse failed to apply anasept to slough areas of wound. During interview on 05/02/2024 at 12:15 PM, the Registered Nurse stated she was unable to recall if she applied anasept to wound bed as ordered. The agency failed to ensure drugs and treatments are administered in accordance with physician orders as evidenced by: Patient #5 – This 64-year-old patient with the diagnoses of malignant neoplasm of cardia, secondary malignant neoplasm of bone, and secondary and unspecified malignant neoplasm of lymph node was admitted to the home care agency on 03/30/2024. Review of the Home Health Plan of Care dated 03/30/2024 revealed the following orders for Skilled Nursing: 1 (one) visit every week for 1 (one) week, 3 (three) visits as needed for wound complications, 3 (three) visits every week for 4 (four) weeks. Review of the clinical record from 04/07/2024 to 04/13/2024 revealed the Skilled Nurse completed two (2) home visits, one (1) less than what is ordered. During interview on 05/02/2024 at 10:50 AM, the Vice President of Patient Services stated the Registered Nurse did not meet the ordered frequency and there is no documentation to state why. The agency failed to ensure drugs and treatments are administered in accordance with physician orders as evidenced by the following: Patient #13 – This 66-year-old therapy only patient with diagnoses that include broken internal right knee prosthesis, mechanical loosening of internal left knee prosthetic joint and essential hypertension was admitted to the home care agency on 03/24/2023. A.) Review of the Home Health Plan of Care from 03/24/2023 to 05/22/2023 revealed an order to assess the patient’s vital signs and notify the Physician/ Physician Assistant/Nurse Practitioner if the systolic blood pressure is 90 millimeters of mercury or less or 180 millimeters of mercury or greater and/ or diastolic blood pressure is 60 millimeters of mercury or less or 110 millimeters of mercury or greater. Review of the Physical Therapy Home Visit Note dated 04/04/2023 lacks documentation of a blood pressure being obtained or the patient refusing an assessment of the blood pressure. During interview on 05/01/2024 at 09:53 AM, the Physical Therapist states the patients blood pressure was obtained but is unable to explain why it did not get documented in the identified assessment. B.) Review of the Home Health Plan of Care from 03/24/2023 to 05/22/2023 revealed a medication order for tramadol 50 milligrams, one (1) tablet by mouth every six (6) hours for seven (7) days, end date 03/30/2023. Review of the Physical Therapy Home Visit Notes dated 04/01/2023, 04/03/2023, 04/04/2023, 04/06/2023 and the Physical Therapy Outcome and Assessment Information Set Discharge dated 04/10/2023 revealed the Physical Therapist documented the following pain relief comments: acceptable relief with rest, repositioning, cryotherapy, acetaminophen and tramadol as needed. Review of the clinical record lacks an order for tramadol after it was discontinued 03/30/2023. During interview on 05/01/2024 at 09:42 AM, the Vice President of Patient Services stated upon review of the electronic medical record, the patient had an as needed order for tramadol initiated on 03/23/2023 but it failed to be added to the agency plan of care.

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 one (1) of eighteen (18) patients (Patients #17), 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. The agency failed to coordinate care as evidenced by the following: Patient #17 - This 69-year-old therapy-only patient with the diagnoses of spondylolisthesis, lumbar stenosis, and lumbar ligamentum flavum hypertrophy was admitted to the agency on 09/06/2023 and discharged on 09/22/2023. This patient was identified on the Potentially Avoidable Event Patient Listing Report for Development of Urinary Tract Infection. Review of the Home Health Plan of Care dated 09/06/2023 revealed the following orders for pain management: Instruct patient/caregiver pain management techniques such as immobilization, rest/activity, massage, avoiding stress, medications. Instruct in pharmacologic and non-pharmacologic pain management techniques. Review of the Home Health Visit Note dated 09/08/2023 revealed the Physical Therapist documented that the patient’s ordered oxycodone-acetaminophen (Percocet) 7.5-325 milligrams tablets ended on 09/07/2023. Additionally, on that date the patient reports feeling “lousy”, having chills, a low-grade fever and increased pain. The Physical Therapist documented that the physician’s office was contacted, and the Physical Therapist spoke with an agent of the physician, but received no new orders. Review of clinical record from 09/08/2023 to 09/13/2024 lacks documented evidence the Physical Therapist followed up with the physician and the patient to ensure the patient had appropriate pain management, the physician was aware of the patient’s symptoms and to ensure the patient was safe. Review of the Home Health Visit Note dated 09/14/2023 revealed the Physical Therapist documented the patient continued to have pain, the patient was afebrile, and the patient’s husband reported that the physician ordered hydrocodone-acetaminophen (Norco). During interview on 05/02/2024 at 09:24 AM, the Physical Therapist stated there was no further communication with the physician but upon next visit 09/14/2024 there was new pain medication in home.

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 observational home visit, review of clinical records, and staff interview, for one (1) of eighteen (18) patients (Patient #6), 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. 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: HV Patient #6 - This 61-year-old patient with the diagnoses of encounter for change or removal of nonsurgical wound dressing, necrotizing fasciitis, and type II diabetes mellitus with diabetic neuropathy, unspecified was admitted to the home care agency on 03/13/2024. Review of the Home Health Plan of Care dated 04/29/2024 revealed the following orders for interruption of negative pressure wound therapy: - If negative pressure wound therapy is off greater than two (2) hours, may apply a normal saline moistened gauze dressing; cover with gauze dressing, secure with tape until the negative pressure wound therapy can be restarted. Review of Supplemental Orders dated 04/09/2024 revealed the following: - Instruct patient/caregiver in disease process, pain management, signs/symptoms of infection, nutrition to promote wound healing, and wound care/dressing. - Patient/caregiver to perform wound care once taught. During an observational home visit on 04/29/2024 at 04:08 PM, the patient did not have negative pressure wound therapy and the wound was covered with a clear dressing. Review of the clinical record lacks documented evidence the caregiver received appropriate wound care education. The agency failed to ensure the caregiver was able to successfully re-demonstrate the ability to independently perform wound care for interruption of negative pressure wound therapy. During interview on 05/02/2024 at 12:17 PM, the Registered Nurse stated the nurse is expected to educate the caregiver and document that the caregiver was able to re-demonstrate wound care. The patient’s husband covered the wound with the incorrect dressing because he was not properly educated.

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 one (1) of eighteen (18) patients (Patient #’s: 6) receiving services, the agency failed to ensure clinicians prepare and document complete and accurate clinical and progress notes. Failure to prepare or document complete clinical and accurate progress notes has the potential for unmet patient needs The agency failed to prepare or document complete clinical and accurate progress notes as evidenced by the following: Patient # 6 – This 61-year-old patient with the diagnoses of encounter for change or removal of non-surgical wound dressing, necrotizing fasciitis, and Type 2 diabetes mellitus with diabetic neuropathy, unspecified, was admitted to the home care agency on 03/13/2021. A.) Review of the Home Health Plan of Care dated 03/13/2024 revealed the agency’s vital sign parameters are to notify the physician/Physician Assistant/Nurse Practitioner if pulse ox is less than 90 percent. Review of the Home Care Visit dated 03/27/2024 revealed the Physical Therapist documented the patient’s blood oxygen levels (SpO2) at 87 percent. Review of the clinical record lacks documented evidence of the Physical Therapist notifying the physician of blood oxygen level below 90 percent. During an interview on 05/02/2024 at 09:31 AM, the Physical Therapist stated the blood oxygen level was 97 percent and her documentation was an error. B.) Review of the Home Care Visit note dated 04/25/2024 revealed the Registered Nurse documented that the patient’s last bowel movement was on 04/26/2024. During an interview on 05/01/2024 at 03:31 PM, the Registered Nurse stated that the date of last bowel movement was entered incorrectly and should have been dated as the same day as her visit. She will add an amendment to the chart to correct.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with agency staff, for one (1) of eighteen (18) patients (Patient #’s: 17), the agency failed to ensure there was effective communication and follow-up with the physician involved in the patient’s plan of care. Failure to communicate with the physician involved in the patient's care has the potential for unmet patient needs and negative outcomes. The agency failed to communicate with the physician involved in the patient's care as evidence by the following: Patient #17 - This 69-year-old therapy-only patient with the diagnoses of spondylolisthesis, lumbar stenosis, and lumbar ligamentum flavum hypertrophy was admitted to the home care agency on 09/06/2023. This patient was identified on the Potentially Avoidable Event Patient Listing Report for Development of Urinary Tract Infection. A.) Review of the Home Health Visit Note dated 09/08/2023 revealed the Physical Therapist documented leaving a voicemail for the physician reporting the following: “feels lousy, chills, increased pain, low grade T (temperature), no BM (bowel movement).” Review of the Home Health Visit Note dated 09/08/2023 revealed the Physical Therapist documented that the patient’s next appointment with the physician is 09/11/2023. Review of the clinical record lacks documentation the Physical Therapist communicated with the physician regarding the increased pain or the lack of bowel movements after patient’s appointment with physician. During interview on 05/02/2024 at 09:31 AM the Physical Therapist stated he did not communicate with the physician regarding the increased pain or the lack of bowel movements. B.) Review of the Home Health Visit Note dated 09/14/2023 revealed the Physical Therapist documented the patient had continued complaints of pain and reported the physician was calling in a stronger prescription. Review of the Home Health Visit Note dated 09/14/2023 revealed the Physical Therapist documented the patient had had a visit with the surgeon and has an appointment to see the primary care provider the following week. Review of the Home Health Visit Note dated 09/20/2023 revealed the Physical Therapist documented the patient is on antibiotic for treatment of a urinary tract infection. Review of clinical record lacks documented evidence of communication between the Physical Therapist and the physician regarding the patient’s continued pain. During interview on 05/02/2024 at 09:31 AM the Physical Therapist stated he did not communicate with the physician regarding the patient’s continued pain.

A post certification visit (PCV) and COVID-19 vaccination survey for McAuley Seton Home Care was conducted on 03/29/2022 to 03/31/2022 as a follow up to the recertification survey that was conducted 06/14/2021 to 06/18/2021. The PCV survey included a review of five (5) clinical records and three (3) personnel records. Interviews were conducted with the Director of Patient Services (DPS), Director of Nursing Regional Central Home Care, and professional staff. All findings were discussed during the exit conference on 03/31/2022. The home health agency census was 1587. The agency reports 8 (eight) patients who are COVID-19 positive. The following deficiencies have been corrected: G-0578 and J-1456. The following deficiencies remain uncorrected: G-0536, G-0574, G-0576, G-0586, G-0610, and 0716. No new deficiencies were identified as a result of this survey and the COVID-19 vaccination survey was in compliance.

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, agency policy and procedure, and interview with agency staff, three (3) of five (5) clinical records (Patient #'s: 1, 3, and 5) 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. Review of the agency’s policy entitled “Medication Administration” dated 08/26/2021 revealed “A drug regimen review is a comprehensive review of all medications the patient is currently using in order to identify but is not limited to: any potential adverse effects, significant drug interactions, duplicate drug therapy and noncompliance with drug therapy... During the initial admission visit the admitting clinician performs a comprehensive review of all medications including over the counter medications that the patient is currently taking… When a discrepancy in medication is identified, the clinician should contact the ordering medical provider i.e. (for example) physician to verify the medication regimen.” Patient #5 – This 74-year-old patient with diagnoses that include myelodysplastic syndrome, encounter for adjustment and management of vascular device, and type II diabetes mellitus with diabetic chronic kidney disease, stage 3 was admitted to the home care agency on 01/28/2022. A.) Review of the Discharge from Cancer Center Summary dated 01/19/2022 revealed the following orders: - Potassium Chloride 20 mEq (milliequivalent) oral tablet, extended release 1 (one) tablet orally 2 (two) times a day - Methadone 5 mg (milligrams) oral tablet 0.5 tab orally 2 times a day Review of the Home Health Certification and Plan of Care for certification period 01/28/2022 to 03/28/2022 revealed the following orders: - Potassium Chloride CR (K-tab) 20mEq ER (extended release) tablet. Take 20 mEq by mouth 1 (one) time each day - Methadone (Dolophine) 5 mg (milligrams) tablet. Take 5 mg by mouth 2 (two) times a day Review of the SN (Skilled Nurse) IV (intravenous) OASIS (outcome and assessment information set) Start of Care Note dated 01/28/2022 revealed the Registered Nurse (RN) documented the following drug regimen review: “Issues found during review.” Review of the clinical record lacks documented evidence the physician was notified of the medication discrepancies. During interview on 03/30/2022 at 10:42 AM, the Infusion RN stated she called the physician’s office and went through each of the patient’s medications and doses, however the medications that were discussed were not specified in the clinical record. B.) Review of the Discharge from Cancer Center Summary dated 01/19/2022 revealed the following orders: - Gabapentin 100 mg (milligrams) oral capsule 1 (one) cap orally once a day - Finasteride 5 mg oral tablet 1 tab orally once a day Review of the Home Health Certification and Plan of Care for certification period 01/28/2022 to 03/28/2022 lacks orders for Gabapentin and Finasteride. Review of the clinical record lacks documented evidence the physician was notified of the medication discrepancies. During interview on 03/30/2022 at 01:20 PM, the Infusion RN stated she called the physician’s office and went through each of the patient’s medications and doses, however the medications that were discussed were not specified in the clinical record. The Director of Patient Services (DPS) stated he agreed the medications are not on the POC and could not find documentation explaining why. Patient #1 – This 78-year-old patient with diagnoses that include type II diabetes mellitus with foot ulcer, non-pressure chronic ulcer of other part of right foot with fat layer exposed, and nonrheumatic aortic valve stenosis was admitted to the home care agency on 03/13/2022. Review of the After Visit Summary (from wound clinic) dated 03/10/2022 revealed the following medication orders: - Atorvastatin 10 mg (milligrams) tablet take 1 (one) tablet by mouth once daily - Cephalexin 500 mg capsule - Gentamicin 0.1 % (percent) cream Review of the Home Health Certification and Plan of Care for certification period 03/13/2022 to 05/11/2022 lacks orders for Atorvastatin, Cephalexin, and Gentamicin cream. Review of the SN (Skilled Nurse) OASIS (outcome and assessment information set) Start of Care Note dated 03/13/2022 revealed the Registered Nurse (RN) documented the following drug regimen review assessment: “no issues found during review.” Review of the clinical record lacks documented evidence the physician was notified of the medication discrepancies. During interview on 03/30/2022 at 10:35 AM, the RN stated the Gentamicin cream was discontinued during the hospitalization however there is no documentation in the clinical record. She stated she does not recall why the other medications are not on the POC. She states she discussed the medications with the physician but failed to document specifically which medications were discussed. Patient #3 – This 73-year-old patient with diagnoses that include pneumonia due to methicillin resistant staphylococcus aureus and hemophilus influenzae and bacteremia was admitted to the home care agency on 03/11/2022. Review of the agency’s policy entitled “Medication Administration” dated 08/26/2021 revealed “A drug regimen review is a comprehensive review of all medications the patient is currently using in order to identify but is not limited to: any potential adverse effects, significant drug interactions, duplicate drug therapy and noncompliance with drug therapy... During the initial admission visit the admitting clinician performs a comprehensive review of all medications including over the counter medications that the patient is currently taking… When a discrepancy in medication is identified, the clinician should contact the ordering medical provider i.e. (for example) physician to verify the medication regimen.” A.) Review of the facility At Home Medication Worksheet provided on 03/11/2022 upon patient discharge revealed the following: Allergies: No known allergies; andAtorvastatin 80 mg 1 (one) tab orally once a day (at bedtime). Review of the Home Health Certification and Plan of Care for certification period 03/11/2022 to 05/09/2022 revealed the following orders: Atorvastatin 80 mg (milligram) tablet, take 80 mg by mouth 1 (one) time each day andAllergies: Atorvastatin, Penicillins. Review of SN (Skilled Nurse) IV (Intravenous) OASIS (Outcome and Assessment Information Set) Start of Care Note dated 03/11/2022 revealed the Registered Nurse (RN) documented that no issues were found while completing the drug regimen review and medication reconciliation has been reviewed with the MD (physician)/ designee. Additionally, the RN documented there were no identified discrepancies from the transition paperwork. The documentation lacks acknowledgment of the medication allergy and the physician being aware and agreeable to the patient taking Atorvastatin. During interview on 03/29/2022 at 04:20 PM, the Director of Patient Services (DPS) stated that per a pre-admission cardiology note in the electronic record, the patient does not have a true allergy to Atorvastatin, but when taken by the patient, the medication is less effective. He stated the record lacks documentation that specifies the referring physician is aware of the reaction to Atorvastatin and is agreeable to the patient continuing to take it. During interview on 03/30/2022 at 09:05 AM, the DPS stated the referring physician was notified on 03/30/2022 at 08:45 AM of the medication allergy (lack of therapeutic effect) and wants the patient to continue to take the identified medication. B.) Review of the facility At Home Medication Worksheet provided on 03/11/2022 upon patient discharge revealed the following medication instructions: - Acetaminophen 325 mg take 2 (two) tab(s) orally every 4 (four) hours as needed for mild pain; - Alprazolam 0.25 mg take 1 (one) tab orally 2 (two) times a day as needed for anxiety; and - Oxycodone 10 mg take 1 (one) tab orally every 4 (four) hours as needed for pain. Review of the Home Health Certification and Plan of Care for certification period 03/11/2022 to 05/09/2022 lacks orders for Acetaminophen, Alprazolam and Oxycodone. Review of the clinical record lacks documented evidence the physician was notified of the medication discrepancies. During interview on 03/30/2022 at 03:30 PM, the Infusion RN stated she overlooked adding Acetaminophen and Alprazolam to the plan of care. She stated she thought Oxycodone and Percocet were one and the same. She documented Percocet on the medication orders instead of Oxycodone. She stated the patient is taking Oxycodone, not Percocet. C.) Review of the Home Health Certification and Plan of Care for certification period 03/11/2022 to 05/09/2022 revealed the following orders: - Nitroglycerin 0.4 mg SL (sublingual) tablet, place 0.4 mg under the tongue every 5 (five) minutes if needed for chest pain; - Incruse Ellipta 62.5 mcg (microgram)/ actuation inhalation, inhale 1 (one) puff 1 (one) time each day; and - Percocet 10-325 mg tablet, take 1 (one) tablet by mouth every 4 (four) hours if needed for severe pain. Review of the facility At Home Medication Worksheet provided on 03/11/2022 upon patient discharge lacks instructions for the patient to be taking Nitroglycerin, Incruse Ellipta and Percocet. Review of the clinical record lacks documented evidence the physician was notified of the medication discrepancies. During interview on 03/30/2022 at 03:40 PM, the Infusion RN stated she thought Oxycodone and Percocet were one and the same. She documented Percocet on the medication orders instead of Oxycodone. She stated the patient is taking Oxycodone, not Percocet. She also stated she believed all the meds the patient was taking were the same as on the referral discharge med list and did not clarify the identified discrepancies with the physician. D.) Review of the facility At Home Medication Worksheet provided on 03/11/2022 upon patient discharge revealed the following medication instructions: - Enoxaparin 40 mg/ 0.4 ml (milliliter) injectable solution, 40 mg(s) subcutaneously once a day; and - Albuterol 2.5 mg/3 ml (0.83%) (0.83 percent) inhalation solution, 3 ml inhaled every 6 (six) hours as needed. Review of the Home Health Certification and Plan of Care for certification period 03/11/2022 to 05/09/2022 revealed the following medication orders: - Albuterol 0.63 mg/3 ml nebulizer solution, take 0.63 mg by nebulization every 4 (four) hours if needed for shortness of breath or wheezing; and - Enoxaparin 40 mg/0.4 ml syringe, 40 mg by abdominal subcutaneous route 4 (four) times a day. Review of the clinical record lacks documented evidence the physician was notified of the medication discrepancies. During interview on 03/30/2022 at 03:45 PM, the Infusion RN stated she documented the wrong dosages of the identified medications on the POC and the patient was taking the medications as specified on the referral discharge med list.

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 three (3) of five (5) patients (Patient #’s: 3, 4, and 5) 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 #5 – This 74-year-old patient with diagnoses that include myelodysplastic syndrome, encounter for adjustment and management of vascular device, and type II diabetes mellitus with diabetic chronic kidney disease, stage 3 was admitted to the home care agency on 01/28/2022. A.) Review of the SN (Skilled Nurse) IV (intravenous) OASIS (outcome and assessment information set) Start of Care Note dated 01/28/2022 revealed the Registered Nurse (RN) documented “patient continues with outpatient chemotherapy.” Review of the Home Health Certification and Plan of Care for certification period 01/28/2022 to 03/28/2022 lacks documentation specifying what chemotherapy medication the patient is receiving and the frequency. The agency failed to develop individualized plans of care that are complete and accurate and address the total needs of the patients. During interview on 03/30/2022 at 10:48 AM, the Infusion RN stated she did not include the patient’s chemotherapy treatment on the POC. On 03/30/2022 at 01:05 PM, the Director of Patient Services (DPS) added that it is difficult to get information regarding the patient’s treatment from the cancer center. They do not provide names of treatment to the home care agency, and the treatment changes visit to visit. The agency will work on finding a way to add a general statement to say the patient is receiving a chemotherapeutic agent from that agency. B.) Review of the Case Communication Note dated 02/02/2022 revealed “all lab work obtained and monitored at (cancer center).” Review of the Home Health Certification and Plan of Care for certification period 01/28/2022 to 03/28/2022 lacks documentation specifying who is obtaining and monitoring the patient’s lab work. The agency failed to develop individualized plans of care that are complete and accurate and address the total needs of the patients. During interview on 03/30/2022 at 10:50 AM, the Infusion RN stated she did not include this information on the POC. Patient #3 – This 73-year-old patient with diagnoses that include pneumonia due to methicillin resistant staphylococcus aureus and hemophilus influenzae and bacteremia was admitted to the home care agency on 03/11/2022. Review of the intravenous (IV) Electronic Prescription Message (electronic prescription) from the referring physician revealed the following medication orders: - Vancomycin 1.5 g (gram) intravenous injection, 1.5 gram(s) IV every 12 (twelve) hours, infuse over 1.5 hrs (hours) in dextrose 5% in water 275 ml, Days supply: 16 (sixteen) days; and - Ceftriaxone 1 g injection, 1 gram(s) IV once a day infuse over 30 minutes, Days Supply: 2 (two) days. Review of the Home Health Certification and Plan of Care for certification period 03/11/2022 to 05/09/2022 revealed the following orders: - Vancomycin 1.5 gram vial for injection, infuse 1.5 g into a venous catheter 2 (two) times a day over 60 minutes: and - Ceftriaxone 1 gram recon soln (reconstituted solution), infuse 1 g into a venous catheter 1 (one) time each day over 3-5 minutes. (The IV medication orders lack end dates or specification of the duration of administration). The agency failed to develop an individualized plan of care. During interview on 03/30/2022 at 03:25 PM, the Infusion Registered Nurse (RN) stated she did not include the end dates of the antibiotics on the POC. Patient #4 – This 40-year-old patient with diagnoses that include hemiplegia and hemiparesis following cerebral infarction and dysarthria was admitted to the home care agency on 03/11/2022. Review of the Home Health Certification and Plan of Care for certification period 03/11/2022 to 05/09/2022 revealed an order for Mupirocin (Bactroban) 2 % (percent) cream, apply topically 3 (three) times a day for 10 (ten) days. (The order lacks the location to apply the topical cream). The agency failed to develop an individualized plan of care. During interview on 03/30/2022 at 12:35 PM, the RN stated the cream was being applied to old burn sites on the patient’s skin but he did not specify this on the POC.

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 review of clinical records and staff interview for one (1) of five (5) patients (Patient #3) lacks evidence an order was obtained to update the plan of care (POC) to reflect the patient’s current 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 #3 – This 73-year-old patient with diagnoses that include pneumonia due to methicillin resistant staphylococcus aureus and hemophilus influenzae and bacteremia was admitted to the home care agency on 03/11/2022. Review of the Home Health Certification and Plan of Care for certification period 03/11/2022 to 05/09/2022 revealed the following order: - Percocet 10-325 mg tablet, take 1 (one) tablet by mouth every 4 (four) hours if needed for severe pain. Review of the SN (Skilled Nurse) Infusion Visit dated 03/12/2022 revealed the Registered Nurse (RN) documented the following pain assessment: - Pain details: Location: Chest, Severity: 3/10 (three out of ten with ten being worst pain imaginable), Character: Achy, Frequency: Constant, Exacerbating factors: Movement and coughing, Relieving factors: Rest and Oxycodone. Review of the Plan of Care for the certification period 03/11/2022 to 05/09/2022 lacks an order for Oxycodone. During interview on 03/30/2022 at 03:53 PM, the Infusion RN stated she thought Oxycodone and Percocet were one and the same. She documented Percocet on the medication orders instead of Oxycodone. She stated the patient is taking Oxycodone, not Percocet.

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: Based on review of clinical records and interviews with agency staff for one of (1) of one (1) patients (Patient #5) requiring recertification, the agency failed to ensure the Plan of Care (POC) was reviewed and revised to reflect the patient's current status. Failure to ensure the POC is updated and revised to reflect patient needs, has the potential to result in negative patient outcomes. Patient #5 – This 74-year-old patient with diagnoses that include myelodysplastic syndrome, encounter for adjustment and management of vascular device, and type II diabetes mellitus with diabetic chronic kidney disease, stage 3 was admitted to the home care agency on 01/28/2022. A.) Review of the SN (Skilled Nurse) IV (intravenous) OASIS (outcome and assessment information set) Recertification Note dated 03/25/2022 revealed the Registered Nurse (RN) documented “patient continues with outpatient chemotherapy.” Review of the Home Health Certification and Plan of Care for certification period 03/29/2021 to 05/27/2022 lacks documentation specifying what chemotherapy medication the patient is receiving and the frequency. The agency failed to develop individualized plans of care that are complete and accurate and address the total needs of the patients. During interview on 03/30/2022 at 10:58 AM, the Infusion RN stated she did not include the patient’s chemotherapy treatment on the POC. B.) Review of the Case Communication Note dated 02/02/2022 revealed “all lab work obtained and monitored at (cancer center).” Review of the Home Health Certification and Plan of Care for certification period 03/29/2021 to 05/27/2022 lacks documentation specifying who is obtaining and monitoring the patient’s lab work. The agency failed to develop individualized plans of care that are complete and accurate and address the total needs of the patients. During interview on 03/30/2022 at 10:59 AM, the Infusion RN stated she did not include this information on the POC. C.) Review of the agency’s policy entitled “Medication Administration” dated 08/26/2021 revealed “A drug regimen review is a comprehensive review of all medications the patient is currently using in order to identify but is not limited to: any potential adverse effects, significant drug interactions, duplicate drug therapy and noncompliance with drug therapy... During the initial admission visit the admitting clinician performs a comprehensive review of all medications including over the counter medications that the patient is currently taking… When a discrepancy in medication is identified, the clinician should contact the ordering medical provider i.e. (for example) physician to verify the medication regimen.” Review of the Discharge Summary dated 01/19/2022 revealed the following orders: - Potassium Chloride 20 mEq (milliequivalent) oral tablet, extended release 1 (one) tablet orally 2 (two) times a day - Methadone 5 mg (milligrams) oral tablet 0.5 tab orally 2 times a day Review of the Home Health Certification and Plan of Care for certification period 03/29/2022 to 05/27/2022 revealed the following orders: - Potassium Chloride CR (K-tab) 20mEq ER (extended release) tablet. Take 20 mEq by mouth 1 (one) time each day - Methadone (Dolophine) 5 mg (milligrams) tablet. Take 5 mg by mouth 2 (two) times a day Review of the clinical record lacks documented evidence the physician was notified of the medication discrepancies. During interview on 03/30/2022 at 11:00 AM, the Infusion RN stated the patient did have some medication changes from start of care to the recertification but could not find documentation explaining the changes or communication with the physician. D.) Review of the Discharge from Cancer Center Summary dated 01/19/2022 revealed the following orders: - Gabapentin 100 mg (milligrams) oral capsule 1 (one) cap orally once a day - Finasteride 5 mg oral tablet 1 tab orally once a day - Toujeo SoloStar 10 units subcutaneous once a day Review of the Home Health Certification and Plan of Care for certification period 03/29/2022 to 05/27/2022 lacks orders for Gabapentin, Finasteride, and Toujeo SoloStar insulin. Review of the clinical record lacks documented evidence the physician was notified of the medication discrepancies. During interview on 03/30/2022 at 11:00 AM, the Infusion RN stated the patient did have some medication changes from start of care to the recertification but could not find documentation explaining the changes or communication with the physician. On 03/30/2022 at 01:20 PM, the Director of Patient Services (DPS) stated he agreed the medications are not on the POC and could not find documentation explaining why.

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 five (5) patients (Patient #3), 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 #3 – This 73-year-old patient with diagnoses that include pneumonia due to methicillin resistant staphylococcus aureus and hemophilus influenzae and bacteremia was admitted to the home care agency on 03/11/2022. Review of the Home Health Certification and Plan of Care for certification period 03/11/2022 to 05/09/2022 revealed an order for a new medication, Enoxaparin 40 mg (milligrams)/0.4 ml (milliliter) syringe, 40 mg by abdominal subcutaneous route 4 (four) times a day. Review of the SN (Skilled Nurse) IV (Intravenous) OASIS (Outcome and Assessment Information Set) Start of Care dated 03/11/2022 revealed the Registered Nurse (RN) documented the following: - Management of Injectable Medications: Unable to take injectable medication unless administered by another person; - Intervention completed: Review med list/assess compliance. The assessment lacks documentation of medication instruction specific to Enoxaparin including the subcutaneous injection procedure and caregiver demonstration of the subcutaneous injection. Review of the clinical record lacks documented evidence of observing the caregiver successfully re-demonstrate the Enoxaparin injection. The RN failed to ensure the patient/caregiver received appropriate education and demonstrated proficiency administering the injection. During interview on 03/30/2022 at 03:50 PM, the Infusion RN stated the caregiver was instructed in the Enoxaparin administration, but she did not observe the caregiver administer the injection.

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 one (1) of five (5) patients (Patient #3), the agency failed to ensure clinicians prepare and document complete and accurate clinical and progress notes. Failure to prepare and document complete clinical and progress notes has the potential for unmet patient needs. Patient #3 – This 73-year-old patient with diagnoses that include pneumonia due to methicillin resistant staphylococcus aureus and hemophilus influenzae and bacteremia was admitted to the home care agency on 03/11/2022. A.) Review of the agency Referral dated 03/10/2022 revealed the following information: - Patient will require home intravenous antibiotics; - Discharge planned for 03/11/2022; - PICC (peripherally inserted central catheter) will be placed in the facility prior to discharge; and - First home care visit to occur on 03/11/2022 in evening. Review of SN (Skilled Nurse) IV (intravenous) OASIS (Outcome and Assessment Information Set) Start of Care dated 03/11/2022 revealed the RN documented the following: - Catheter Details, PICC placement date: 03/10/2022; and - LDA (Lines, Drains, Airways) and Wound Assessment: PICC double lumen left brachial vein placement date on 03/11/2022. The documentation is inconsistent. It is unclear what date the PICC line was placed. During interview on 03/30/2022 at 04:00 PM, the Infusion RN stated the PICC was placed 03/10/2022 and she made an error when she documented the PICC was placed on 03/11/2022. B.) Review of SN IV OASIS Start of Care dated 03/11/2022 revealed the RN documented the following: - Integumentary: Patient has at least one observable surgical wound; and - Wound assessment: - Incision flank upper left glued, no drainage - Old drain site left lateral flank, no drainage - Old drain site left posterior flank, sutured, scant drainage. Review of SN Infusion Visit dated 03/12/2022 revealed the RN documented the following: - Integumentary: WDL- yes - within defined limits- skin pink, warm, dry and intact; mucous membranes are moist, pink and intact; skin turgor is normal; skin intact on all pressure areas; no evidence of altered skin integrity. The documentation is inconsistent. It is unclear if the patient has an altered skin integrity to include three (3) surgical wounds. During interview on 03/30/2022 at 03:55 PM, the Infusion RN stated the patient has three surgical wounds and she documented incorrectly on the 03/12/2022 visit.

The following statement of deficiencies represents the results of a partial extended re-certification and focused COVID-19 infection control survey of McAuley Seton Home Care conducted on 06/14/2021 through 06/18/2021. A standard re-certification survey was initiated on 06/14/2021. Deficient practices were identified within Level 1 standards in G-574 (Plan of Care) resulting in a partial extended survey. The survey consisted of a review of seventeen (17) clinical records including five (5) discharged records, ten (10) personnel records of professional personnel and seven (7) observational home visits. The survey included a review of pertinent policies and procedures, Quality Improvement Meeting minutes for the past twelve (12) months, agency's Admission Packet, infection control policies and protocols regarding COVID-19, the Emergency Preparedness Plan, and Complaint Log. The current patient census is 1,554. Pre-survey activities consisted of review on 06/07/2021 of the agency's Health Commerce System account, Certification and Survey Provider Enhanced Reports (CASPER) for the period 03/2020 through 02/2021 and the agency's compliance with report submissions for the statistical report and the Emergency Drill conducted 06/11/2019 through 06/13/2019. The Vice President (VP) of Patient Care Services, Director of Nursing (DON), Clinical Managers, and various professional staff were interviewed. Findings were reviewed at the exit conference on 06/18/2021. The following deficiencies are identified as a result of the survey: G- 0536, G-0574, G-0576, G-0578, G- 0586, G-0610, G-0716, and J-1456.

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, agency policy and procedure and interview with agency staff, three (3) of seventeen (17) clinical records (Patient #'s: 2, 3, and 15) lacked 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 "Medication Administration" revised 05/2021 revealed the following: - "Therapists: PT (Physical Therapist), OT (Occupational Therapist), and SLP (Speech Language Pathologist) perform a drug regimen review as part of the comprehensive assessment. -3. During the initial admission visit the admitting clinician performs a comprehensive review of all medications and verifies the medications in the home with the medication orders given by the patient's physician. -4. When a discrepancy in medication is identified, the clinician should contact the ordering medical provider to verify the medication regimen. The patient/caregiver is instructed in the correct medication regimen, as applicable. Physician contact and patient/caregiver instructions are documented in the patient's medical record as applicable." Patient #2 - This 83-year-old therapy only patient with diagnoses that include alzheimer's disease, dementia and bipolar disorder was admitted to the home care agency on 05/30/2021. Review of the Home Health Certification and Plan of Care for the certification period 05/30/2021 to 07/28/2021 revealed the medication order for donepezil as follows: 5 milligrams (mg) by mouth every other day. Take one (1) 5 mg tablet by mouth (PO) one (1) time each day. It is unclear whether the patient should take 5 mg every day, every other day, or 5 mg one day alternating with 10 mg every other day. Review of the PT (Physical Therapy) OASIS (Outcome and Assessment Information Set) Start of Care Note dated 05/30/2021 revealed the PT documented a drug regimen review was completed. The note lacks documentation that the PT clarified the donepezil order. Review of the 05/31/2021 Case Communication Note dated 05/31/2021 revealed the Registered Nurse (RN) documented the following "medication review completed- medication profile reviewed- medication interactions identified. Physical Therapist acknowledged interaction and is to follow-up with MD (physician) and document any changes." The note lacks documented evidence the RN clarified the donepezil order. Review of the Case Communication Note dated 06/04/2021 revealed the RN documented the following "medication review/reconciliation completed, medication interaction and no nurse referral required. Telephone call to patient's wife and a comprehensive assessment of the patient's medications was completed and reviewed. A potential issue or adverse effect has been identified. Patient/ Caregiver educated on all medications including purpose, amount, frequency, and side effects. Patient/Caregiver verbalized understanding. All medications are in the home." The note lacks documented evidence the RN addressed the inconsistencies in the donepezil order. During staff interview on 06/17/2021 at 10:55 AM, the Vice President (VP) of Patient Care Services stated the therapist that performed the medication reconciliation in the home was not available for interview. The VP of Patient Care Services stated the order was unclear and should have been clarified by the Physical Therapist. Patient #3 - This 94-year-old therapy only patient with diagnoses that include dysphagia and hypertension was admitted to the home care agency on 06/07/2021. Review of the referral from the physician's office dated 06/03/2021 included a list of medications the patient was taking. The medications listed on the referral did not include vitamin B-12, vitamin D-3, folic acid and vitamin C. Review of the Home Health Certification and Plan of Care for the certification period 06/07/2021 to 08/05/2021 revealed orders for the following medication/supplements: vitamin B-12, vitamin D-3, folic acid and vitamin C. Review of the SLP (Speech Language Pathologist) OASIS (Outcome and Assessment Information Set) Start of Care Note dated 06/07/2021 revealed the SLP documented "reviewed complete assessment, diagnoses, history, allergies and medications with physician/designee. Plan of care developed and orders received." The Start of Care Note lacked documentation that the SLP was aware of or addressed the patient's use of vitamin B-12, vitamin D-3, folic acid and vitamin C with the physician. Review of the Case Communication Note dated 06/07/2021 revealed the Registered Nurse (RN) documented "medication review/ reconciliation completed, no issues." The note lacks documented evidence the RN addressed the patient's use of vitamin B-12, vitamin D-3, folic acid and vitamin C. During interview on 06/17/2021 at 02:05 PM, the SLP stated all medications the patient was taking were viewed in the home, including the vitamins. The SLP stated that the medications were reviewed and orders were verified with the physician. The SLP stated that although a general statement was documented stating that all medications were verified, there was no documentation specific to the patient's use of vitamins, or the physician's knowledge and agreement with the vitamins. Patient #15 - This 64-year-old patient with diagnoses that include neoplasm of unspecified behavior of digestive system, cirrhosis of the liver, and ascites was admitted to the home care agency on 04/12/2020. Review of the hospital Discharge Summary dated 04/11/2020 revealed an order for Trazodone HCL 50 (fifty) mg tablet 50 mg PO QHS (at night) PRN (as needed) for sleep for 30 (thirty) days. Review of the Plan of Care for certification period 04/12/2020 to 06/10/2020 revealed the order for Trazodone HCL oral tablet 50 mg is written as 1 (one) tablet, oral, every night at bedtime. The order is inconsistent with the Discharge Summary. Review of the SN OASIS Start of Care Note dated 04/12/2020 revealed the RN documented the patient takes Trazodone HCL oral tablet 50 mg, 1 (one) tablet, oral, every night at bedtime. Additionally, the RN documented that the medication dose and frequency was reconciled with the medication bottle in the home. The note lacks documentation that the RN clarified the Trazadone order with the physician. During interview on 06/17/2021 at 09:25 AM, the Clinical Manager stated the RN was not available for interview. The Clinical manager stated that there is no documentation in the clinical record to show that the RN clearly documented a discussion with the physician regarding the order for Trazodone.

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 nine (9) of seventeen (17) patients (Patient #'s: 1, 3, 4, 8, 11, 12, 13, 14, and 17) 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 that a comprehensive individualized plan of care is developed has the potential for unmet patient needs. Findings are: Patient #4 - This 76-year-old patient with diagnoses that include acute myeloblastic leukemia, ulcerative colitis and type II diabetes mellitus was admitted to the home care agency on 06/04/2021. A.) The Centers for Disease Control states "a blood sugar target is the range you try to reach as much as possible. These are typical targets: · Before a meal: 80 to 130 mg/dL. · Two hours after the start of a meal: Less than 180 mg/dL" Review of the Home Health Certification and Plan of Care (POC) for the certification period 06/04/2021 to 08/02/2021 revealed the goal for the patient's blood sugars is "to remain WNL (within normal limits) or less than seventy (70) or greater than 350 (three hundred fifty)." This goal is inconsistent with acceptable blood sugar targets. During interview on 06/17/2021 at 01:08 PM, the RN stated she made a typographical error regarding the blood sugar goals that are documented on the Plan of Care. B.) Review of the Eprescribing- Order Message (the referral for home care services) dated 06/02/2021 revealed PICC line orders for: - Normal saline flush 0.9% injectable solution, flush with ten (10) milliliters (ml) injectable two (2) times a day to each lumen of PICC line; and - Change PICC line dressing every seven (7) days. Review of the Home Health Certification and Plan of Care for the certification period 06/04/2021 to 08/02/2021 revealed orders for: - Sodium chloride injection, infuse ten (10) ml into a venous catheter if needed for line care, flush each port daily, with each blood draw and with extension tubing changes - Perform PICC flush, flush each lumen with 5 ml normal saline pre and post infusion; and - Flush PICC line with 10 ml of normal saline after TPN (total parenteral nutrition, an intravenous nutritional feeding supplement). The POC lacks an order to flush each lumen of PICC line daily with ten (10) ml normal saline IV as prescribed in the home care referral. The PICC line orders are inconsistent with the orders on the referral. During interview on 06/17/2021 at 01:05 PM, the RN stated that the PICC line orders were incorrectly documented on the POC. Patient #14 - This 64-year-old patient with diagnoses that include multiple sclerosis, urinary retention and gross hematuria was admitted to the home care agency on 12/24/2020. A.) Review of the SN OASIS Start of Care Visit dated 12/24/2020 revealed the patient uses a manual wheelchair. Review of the Home Health Certification and Plan of Care for the certification period 12/24/2020 to 02/21/2021 lacks an order for a wheelchair. During interview on 06/17/2021 at 12:45 PM, the RN stated the patient uses a manual wheelchair when out of bed, and there is no order for a wheelchair on the POC. B.) Review of the SN OASIS Start of Care Visit dated 12/24/2020 revealed the patient uses a hospital bed in the home. Review of the Home Health Certification and Plan of Care for the certification period 12/24/2020 to 02/21/2021 lacks documented evidence of an order for the hospital bed. During interview on 06/17/2021 at 12:49 PM, the RN stated the patient uses a hospital bed in the home. Additionally, there is no order for a hospital bed on the POC. Patient #8 - This 69-year-old patient with diagnoses that include chronic pain, benign paroxysmal vertigo, and type II diabetes without complications was admitted to the home care agency on 05/31/2021. Review of the Home Health Certification and Plan of Care for certification period 05/31/2021 to 07/29/2021 revealed the order for a CPAP machine, however the order lacked settings and a frequency of use. During interview on 06/17/2021 at 08:43 AM, the PT stated the CPAP settings and frequency are not documented on the POC. Patient #12 - This 73-year-old patient with diagnoses that include chronic obstructive pulmonary disease, heart failure, and anxiety disorder was admitted to the home care agency on 05/30/2021. A.) Review of the SN (Skilled Nurse) OASIS (Outcome and Assessment Information Set) Start of Care Note dated 05/30/2021 revealed the patient uses supplemental oxygen. Review of the Home Health Certification and Plan of Care for certification period 05/30/2021 to 07/28/2021 lacked documented evidence of an order for oxygen to include the route, dose, and frequency. During interview on 06/17/2021 at 08:55 AM, the Registered Nurse (RN) stated the patient uses three (3) liters per minute of oxygen via nasal cannula but there is no order for it on the POC. B.) Review of the SN OASIS Start of Care Note dated 05/30/2021 revealed the patient uses a walker. Review of the Home Health Certification and Plan of Care for certification period 05/30/2021 to 07/28/2021 lacked documented evidence of an order for the patient's walker. During interview on 06/17/2021 at 08:57 AM, the RN stated there is no order for the walker on the POC. Patient #1 - This 62-year-old patient with diagnoses that include hypertensive heart disease with heart failure, paroxysmal atrial fibrillation, and type II diabetes mellitus without complication was admitted to the home care agency on 05/24/2021. Review of the SN OASIS Start of Care Note dated 05/24/2021 revealed the patient uses supplemental oxygen. Review of the Home Health Certification and Plan of Care for certification period 05/24/2021 to 07/22/2021 lacked documented evidence of an order for oxygen to include the route, dose, and frequency. During interview on 06/17/2021 at 08:46 AM, the RN stated there is no order for oxygen on the POC. Patient #3 - This 94-year-old patient with diagnoses that include dysphagia and hypertension was admitted to the home care agency on 06/07/2021. Review of the SLP (Speech Language Pathologist) OASIS (Outcome and Assessment Information Set) Start of Care dated 06/07/2021 revealed the patient has had a lack of appetite for approximately six (6) months since receiving the COVID-19 vaccination. The patient's height and weight were recorded during the assessment and the patient's goals were identified as the following: - to feel stronger; - to improve swallowing; and - to improve appetite and gain weight. Review of the Home Health Certification and Plan of Care for the certification period from 06/07/2021 to 08/05/2021 lacked documented evidence of an order to monitor the patients weight. During interview on 06/17/2021 at 02:10 PM, the SLP stated the patient's weight was monitored weekly by the SLP. The SLP stated that the POC did not include the need to monitor weights. Patient #11 - This 79-year-old patient with diagnoses that include atherosclerotic heart disease of native coronary artery without angina pectoris, type II diabetes mellitus with diabetic chronic kidney disease, and end stage renal failure was admitted to the home care agency on 05/31/2021. Review of the Home Health Certification and Plan of Care for certification period 05/31/2021 to 07/29/2021 revealed the following order: "Humalog mix 75-25 KwikPen 100 units/mL (milliliter) inject under skin 2 (two) times daily with meals. Sliding scale 8-10 (eight to ten) units in the morning and 9-14 (nine to fourteen) units before dinner. MDD (maximum daily dose) is 30 (thirty) units a day." Review of the Home Health Certification and Plan of Care for certification period 05/31/2021 to 07/29/2021 lacked specific instructions for the sliding scale insulin administration. During interview on 06/17/2021 at 10:21 AM, the Clinical Manager stated the order is incomplete and should include more specific instructions. The RN who documented the order was unavailable for interview. Patient #13- This 68-year-old patient with diagnoses that include acute and chronic respiratory failure with hypercapnia, chronic obstructive pulmonary disease, and opioid abuse was admitted to the home care agency on 12/28/2020. Review of the SN OASIS Start of Care Note dated 12/28/2020 revealed the patient uses a walker. Review of the Home Health Certification and Plan of Care for certification period 12/28/2020 to 02/25/2021 lacked documented evidence of an order for the patient's walker. During interview on 06/17/2021 at 10:34 AM, the RN stated there is no order for the walker on the POC. Patient #17 - This 73-year-old patient with diagnoses that include malignant neoplasm of colon, diverticulosis of large intestine and secondary malignant neoplasm of liver and intrahepatic bile duct was admitted to the home care agency on 12/10/2019. Review of the oncology referral dated 12/04/2019 revealed an order for flurouracil (5FU) 500 mg/10 ml, infuse 3800 mg 5FU IV over forty-six (46) hours every two (2) weeks for six (6) doses. Review of the Plan of Care for the certification period from 12/10/2019 to 02/07/2020 revealed the order for Fluorouracil IV 500 mg/10 ml, 4056 mg IV over forty-six (46) hours every two (2) weeks. The dose on the POC is inconsistent with the referral. During interview on 05/17/2021 at 01:35 PM, the VP of Patient Care Services stated the RN that performed the initial medication reconciliation was not available for interview. The Vice President of Patient Care Services stated the IV prescription and the Plan of Care do not match and anticipates the RN made a typographical error regarding the 5FU dose on the POC.

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 seventeen (17) patient records (Patient #'s: 16 and 17) lacked evidence an order was obtained to update the Plan of Care (POC) to reflect the patient's current status. The issues are: - The POC lacks an order for Boost (nutritional supplement) (Patient #16). - The POC lacks an order for heat therapy (Patient #17). 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. Findings are: Patient #16 - This 86-year-old patient with diagnoses that include benign prostatic hyperplasia with lower urinary tract symptoms, hypertension, and chronic obstructive pulmonary disease was admitted to the home care agency on 03/19/2020. Review of the SLP (Speech Language Pathologist) Secondary Open Note dated 05/06/2020 revealed the SLP documented that the patient drinks one (1) bottle of Boost daily. Review of the Plan of Care for certification period 03/19/2020 to 05/17/2020 lacks an order for Boost supplement. During interview on 06/17/2021 at 11:02 AM, the Director of Nursing (DON) stated there is no order for the Boost. Patient #17 - This 73-year-old patient with diagnoses that include malignant neoplasm of colon, diverticulosis of large intestine and secondary malignant neoplasm of liver and intrahepatic bile duct was admitted to the home care agency on 12/10/2019. Review of the SN (Skilled Nurse) IV (intravenous) Visit Note dated 12/13/2019 revealed the Registered Nurse (RN) documented the patient has intermittent abdominal pain that is relieved with heat and medication. Review of the Plan of Care for the certification period 12/10/2019 to 02/07/2020 lacks an order for heat therapy. During interview on 05/17/2021 at 01:50 PM, the RN stated there is no order for heat on the POC.

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 interview with agency staff for one (1) of seventeen (17) patients (Patient #6), the agency failed to provide services in accordance with physician's 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. Findings are: Patient #6 - This 71-year-old patient with diagnoses that include an unspecified open wound of left leg, bradycardia and atrial fibrillation was admitted to the home care agency on 05/22/2021. Review of agency policy entitled "Patient Assessment and Reassessment" revised 05/2021 revealed "each additional discipline referred will perform an initial evaluation/assessment and develop/implement the discipline plan of care no later than ten (10) days from agency start of care date or date ordered by the physician." Review of the Home Health Certification and Plan of Care for the certification period 05/22/2021 to 07/20/2021 revealed the following OT (Occupational Therapy) orders: - 05/24/2021 to 06/02/2021: 1 (one) visit every 10 (ten) days for 10 (ten) days; and - 05/24/2021 to 06/07/2021: 1 (one) visit every 15 (fifteen) days for 15 (fifteen) days. Review of the clinical record from 05/22/2021 to 06/06/2021 lacked documented evidence of an OT visit. Review of the OT Initial Evaluation dated 06/07/2021 revealed the initial OT visit to develop/implement the Plan of Care was completed on 06/07/2021. During interview on 06/17/2021 at 09:50 AM, the Vice President of Patient Care Services (VPPCS) stated the OT should have reached out and made an initial visit within ten (10) days of the start of care date. The VPPCS stated that she could not find any documentation to reflect why the delay occurred.

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: Based on review of clinical records, agency policy and procedure and interviews with agency staff for one of (1) of two (2) patients (Patient #17) requiring recertification, the agency failed to ensure the Plan of Care (POC) was reviewed and revised to reflect the patient's current status. Failure to ensure the POC is updated and revised to reflect patient needs, has the potential to result in negative patient outcomes. Findings are: Review of the agency policy entitled "Patient Assessment and Reassessment" revised 05/2021 revealed "prior to each recertification, the patient's health, ....and the current medication regimen are reassessed and updated." Patient #17 - This 73-year-old patient with diagnoses that include malignant neoplasm of colon, diverticulosis of large intestine and secondary malignant neoplasm of liver and intrahepatic bile duct was admitted to the home care agency on 12/10/2019. Review of the oncology referral dated 12/09/2019 revealed an order for flurouracil (5FU) 500 mg/10 ml, infuse 3800 mg 5FU IV over forty-six (46) hours every two (2) weeks for six (6) doses. Review of the Plan of Care for the certification period from 02/08/2020 to 04/07/2020 revealed the order for fluorouracil as follows: IV 500 mg/10 ml, 4056 mg IV over forty-six (46) hours every two (2) weeks. The dose is inconsistent with the referral orders. Review of the clinical record from 12/10/2019 to 02/08/2020 lacked an order to change the dosage of 5FU. Additionally, there is no documentation to show that the Registered Nurse (RN) contacted the physician to verify the dosage of 5FU. During interview on 05/17/2021 at 01:45 PM, the RN stated that the dosage for 5FU was copied off of the initial plan of care because the patient was not currently receiving the chemotherapy at the time of recertification.

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 three (3) of seventeen (17) patients (Patient #'s: 1, 4, and 10), 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. Findings are: Patient #1 - This 62-year-old patient with diagnoses that include hypertensive heart disease with heart failure, paroxysmal atrial fibrillation, and type II diabetes mellitus without complication was admitted to the home care agency on 05/24/2021. Review of the Home Health Certification and Plan of Care for certification period 05/24/2021 to 07/22/2021 revealed the following orders: - Instruct patient/caregiver in insulin purpose, side effects, possible complications, administration procedure, and schedule. - Ozempic 0/25 mg (milligrams) or 0.5 mg (2 mg/1.5 mL (milliliter)) pen injector. Inject 0.25 mg under the skin one (1) time per week indications: type II diabetes mellitus Review of the SN (Skilled Nurse) OASIS (Outcome and Assessment Information Set) Start of Care Note dated 05/24/2021 revealed the SN documented "Pt (patient) able to redemo (redemonstrate) glucometer testing." There is a lack of documented evidence the SN observed the patient/caregiver demonstrate the administration of Ozempic. The RN failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to independently administer a subcutaneous diabetic medication. During interview on 06/17/2021 at 08:47 AM, the RN stated the patient verbalized how to administer the subcutaneous injection, but she did not observe the patient demonstrate proficiency with the administration of the medication. Patient #4 - This 76-year-old patient with diagnoses that include acute myeloblastic leukemia, ulcerative colitis and type II diabetes mellitus was admitted to the home care agency on 06/04/2021. Review of the Home Health Certification and Plan of Care for the certification period 06/04/2021 to 08/02/2021 revealed the following orders: -SN (Skilled Nurse) instruct the disease process management and complications of the following diagnosis: Encounter for adjustment and management of vascular access device Review of the SN IV (intravenous) Start of Care Note dated 06/04/2021 revealed the patient has a double lumen PICC (peripherally inserted central catheter) in place and the RN documented the PICC line was flushed with normal saline during the visit. The visit note lacks documented evidence the SN instructed the patient/caregiver on the disease process, management and complications of the PICC line. During interview on 06/17/2021 at 01:20 PM, the RN stated the patient/caregiver was instructed on the PICC line flushes, but documented the general statement "instructed on med administration and storage" without clearly stating there was instruction on the PICC line care and maintenance. Patient #10 - This 77-year-old patient with diagnoses that include pneumonia, atherosclerotic heart disease of native coronary artery without angina pectoris, and type II diabetes mellitus with diabetic chronic kidney disease was admitted to the home care agency on 05/30/2021. Review of the Home Health Certification and Plan of Care for certification period 05/30/2021 to 07/28/2021 revealed the order for Novolog Mix 70-30 (seventy-thirty) 100 units/mL (one hundred units per milliliter) (70-30) injection inject 10 (ten) units under skin three (3) times a day with meals. Review of the SN OASIS of Start Care Note dated 05/30/2021 lacked documented evidence that the SN observed the patient/caregiver demonstrate the administration of insulin. During interview on 06/17/2021 at 10:13 AM, the RN stated that the patient was observed administering the medication, but the RN did not document it in the visit note.

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 three (3) of seventeen (17) patients (Patient #'s: 1, 4, and 7), 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. Findings are: Patient #1 - This 62-year-old patient with diagnoses that include hypertensive heart disease with heart failure, paroxysmal atrial fibrillation, and type II diabetes mellitus without complication was admitted to the home care agency on 05/24/2021. Review of the Home Health Certification and Plan of Care for 05/24/2021 to 07/22/2021 revealed the order "Patient/caregiver to perform blood sugar testing and record daily in log ... three (3) times a day." Review of the SN (Skilled Nurse) Home Visit Note dated 05/26/2021 revealed the following endocrine incomplete assessment: - Subjective issues: diabetes - Type: type II - Blood Sugar Testing: Yes, see care plan - Foot screening: within defined limits - Results since previous home care visit or recent past for SOC (start of care): blank - HbA1c (tells average blood glucose over last three (3) months): blank During interview on 06/17/2021 at 08:30 AM, the RN stated the expectation is that the RN documents a range of blood glucoses at each visit, and the RN failed to do so on 05/26/2021. Patient #4 - This 76-year-old patient with diagnoses that include acute myeloblastic leukemia, ulcerative colitis and type II diabetes mellitus was admitted to the home care agency on 06/04/2021. Review of the SN IV (intravenous) OASIS (Outcome and Assessment Information Set) Start of Care Note dated 06/04/2021 revealed the following regarding the patient's diabetic management: - Managed with diet and oral hypoglycemic (lowers blood sugar) agent; and - The patient is independent with blood sugar testing. Review of the SN Infusion Visit Note dated 06/09/2021 revealed the RN documented the following regarding the patient's diabetic management: - Managed with diet and physician ordered hemoglobin A1c levels (blood test that shows a three-month average of blood sugar levels); and - The patient does not perform blood sugar testing. The documentation is inconsistent. It is unclear how the patient's blood sugars are monitored. During interview on 06/17/2021 at 01:25 PM, the RN stated that the documentation is inconsistent. Patient #7 - This 93-year-old patient with diagnoses that include hypertensive heart disease with heart failure, atrial fibrillation, and atherosclerotic heart disease of native coronary artery without angina pectoris was admitted to the home care agency on 05/26/2021. Review of the SN Home Visit Note dated 06/09/2021 revealed the SN documented the following:. - Clinical summary: "pain ranges from 2 (two) out of 10 (ten) to 5 (five) out of 10 (ten) - relieved with rest and acetaminophen and morphine and oxycodone." Review of the clinical record from 05/26/2021 to 06/14/2021 (date of survey) lacked documented evidence of orders for acetaminophen, morphine, and oxycodone. During interview on 06/17/2021 at 11:06 AM, the Clinical Manager (CM) stated that the RN incorrectly documented the patient's use of medications for pain relief. The CM stated that the patient's pain is relieved by rest, and the patient does not have pain medication ordered.