Every finding on record at Genesee Region Home Care Association, Inc.

The following Statement of Deficiencies represents the results of an on-site complaint investigation survey (114808) of Rochester Regional Health Home Care conducted on 04/21/2025 by staff of the Western Regional Office of the New York State Department of Health. The survey consisted of a review of three (3) clinical records and pertinent documentation. The Director of Patient Services, Assistant Director of Operations Home Care and Hospice, and Registered Nurse were interviewed. Findings were reviewed at the exit conference on 04/21/2025. Complaint 114808 was unsubstantiated; however, a Statement of Deficiencies will be issued for the following citations: G-0528 and G-0544.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: (1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on clinical record review and interview with agency staff, for one (1) of three (3) patient records (Patient #3), the agency failed to ensure the initial comprehensive assessment was of sufficient scope to identify patient needs. Specifically, the Skilled Nurse failed to assess the patient’s understanding of nutritional needs. Failure to ensure the initial comprehensive assessment is complete and accurate has the potential for unmet patient needs and possible negative outcomes. The Skilled Nurse failed to assess the patient’s understanding of nutritional needs as evidenced by: Patient #3 - This 87-year-old patient with diagnoses that include sepsis due to escherichia coli, acute cystitis without hematuria, and malignant neoplasm of pancreas unspecified was admitted to the home care agency on 03/27/2025. Review of the Start of Care Outcome and Assessment Information Set Note dated 03/27/2025 revealed the following: - Nutritional assessment: appetite: poor - Hydration: fair - Meal Pattern: no pattern - See Details: Nutritional Education - Nutritional Education Instructed On: frequent fluids Review of the Start of Care Outcome and Assessment Information Set Note dated 03/27/2025 lacks documented evidence the Skilled Nurse assessed the patient’s understanding of nutritional needs and willingness to try a dietary supplement. During interview on 04/21/2025 at 12:16 PM, the Registered Nurse stated the patient said that food was not appealing and did not want to eat. The Registered Nurse stated she educated the patient on the importance of small and frequent meals, and increased fluids, although this was not documented. The Registered Nurse did not assess the patient’s willingness to try a dietary supplement.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on clinical record review and staff interview for one (1) of three (3) patients (Patient #3), 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 #3 - This 87-year-old patient with diagnoses that include sepsis due to escherichia coli, acute cystitis without hematuria, and malignant neoplasm of pancreas unspecified was admitted to the home care agency on 03/27/2025. Review of the Start of Care Outcome and Assessment Information Set Note dated 03/27/2025 revealed the following patient measurements: - Weight: 132.0 lbs (pounds) - Height: 68.0 inches - Body Mass Index: 2Review of the Start of Care Outcome and Assessment Information Set Note dated 03/27/2025 revealed the following assessment: - Nutritional assessment: appetite: poor - Hydration: fair - Meal Pattern: no pattern - See Details: Nutritional Education - Nutritional Education Instructed On: frequent fluids Review of the Skilled Nursing Routine Visit Note dated 04/09/2025 revealed the following patient measurement: weight: 123 lbs (pounds) 6 oz (ounces). The patient lost approximately nine (9) pounds from 03/27/2025 to 04/09/2025 (13 (thirteen) days). Review of the Skilled Nursing Routine Visit Note dated 04/09/2025 revealed the following assessment: - Nutritional assessment: appetite: poor - Hydration: fair - Meal Pattern: fluids only - See Details: Nutritional Education - Nutritional Education Instructed On: frequent fluids Review of the clinical record lacks documented evidence the Skilled Nurse assessed the patient’s understanding of nutritional needs and willingness to try a dietary supplement. During interview on 04/21/2025 at 12:19 PM, the Registered Nurse stated they spoke with the patient’s primary care provider after the visit on 04/09/2025 to obtain a referral to hospice per the patient's request. The Registered Nurse stated she does not remember discussing nutrition or the possibility of introducing a supplement during any of the visits after the initial assessment.

Information to patient CFR(s): 484.50(a)(1) Provide the patient and the patient's legal representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to the patient: This ELEMENT is not met as evidenced by: Based on clinical record review and staff interview, for one (1) of five (5) patients (Patient #1) the agency failed to provide documented evidence the patient and/or patient representative received written notice of the patient's rights and responsibilities before care is furnished. Failure to provide written notice of the patient's rights and responsibilities to all patients and/or representatives, has the potential for negative patient outcomes. The agency failed to provide documented evidence the patient and/or patient representative received written notice of the patient's rights and responsibilities as evidenced by the following: Patient #1- This 44-year-old patient with the diagnoses of pressure ulcer of right buttock, stage 4, pressure ulcer of left buttock, stage 3, and acute osteomyelitis was admitted to the home care agency on 09/21/2024. Review of the clinical record lacks documented evidence the patient and/or representative were provided written notice of patient’s rights and responsibilities before care was furnished. During interview on 10/07/2024 at 01:06 PM, the Director of Patient Care Services stated the clinician thought they were conducting a resumption of care when setting up the visit. Once they realized it was a start of care they forgot to go back and complete the start of care patient rights and responsibilities.

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 clinical records, agency policy and procedure, and interview with agency staff for one (1) of five (5) patient records (Patient #3), the agency failed to ensure the initial comprehensive assessment was of sufficient scope to identify patient needs. Failure to ensure the initial comprehensive assessment is complete and accurate has the potential for unmet patient needs and possible negative outcomes. The agency failed to ensure the initial comprehensive assessment was of sufficient scope to identify patient needs as evidenced by: Review of the undated “Quick Sheet” procedure tool for the use of enteral tubes revealed “a. Assess for consistent measurement of the length of the enteral tube after the initial radiologic confirmation. The tube should be marked at the gums for an orogastric tube and at the naris for a nasogastric or nasojejunostomy tube.” Patient #3- This 34-day-old patient with the diagnoses of neonatal aspiration with respiratory symptoms, congenital laryngomalacia, and encounter for fitting and adjustment of non-vascular catheter was admitted to the home care agency on 09/21/2024. Review of the Home Health Certification and Plan of Care for 09/21/2024 to 11/29/2024 revealed the order for a “5 (five) FR (French) NG (nasogastric) tube to be changed every month and as needed by Skilled Nurse or parents.” Review of the Home Health Certification and Plan of Care for 09/21/2024 to 11/29/2024 and the Pediatric Initial Visit Note dated 09/21/2024 lacks documented evidence the Registered Nurse assessed the measurement of the length of the enteral tube per the agency’s procedure. During interview on 10/07/2024 at 03:05 PM, the Registered Nurse stated a measurement of the length of the enteral tube was not assessed or documented, but that information should have been assessed and documented in the plan of care as well as the initial visit note.

The following statement of deficiencies represents the results of a partial extended re-certification survey of Rochester Regional Home Health Agency conducted on 11/06/2023 through 11/10/2023. The active patient census was 2,855. A standard re-certification survey was initiated on 11/06/2023. Deficient practices were identified within Level 1 standards in G-536 resulting in a partially extended survey. The survey consisted of a review of 17 (seventeen) clinical records including five (5) discharge records, seven (7) personnel records for professional and paraprofessional personnel, one (1) contract, and seven (7) observational home visits. The survey included a review of pertinent policies and procedures, Quality Improvement Meeting minutes for the past 12 (twelve) months, agency's Admission Packet, the Emergency Preparedness Plan, and Complaint Log. Pre-survey activities consisted of review on 10/31/2023 date of the agency's Health Commerce System account, Potentially Avoidable Event Patient Listing Report for the period 06/01/2022 - 05/31/2023 and the agency's compliance with submissions of statistical reports and Emergency Drills. The Director of Patient Services (DPS), Team Leaders, the Clinical Regulatory Compliance Specialist, and clinical staff were interviewed. Findings were reviewed at the exit conference on 11/10/2023. The following deficiencies are identified as a result of the survey: G-0374, G-0440, G-0520, G-0526, G-0536, G-0544, G-0574, G-0578, G-0580, G-0586, G-0590, G-0608, G-0610, G-0716, G-0800, G-0984, G-1024, J-1108, J-1136, J-1156, J-1412, J-1424, and R-0510.

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on review of the agency's Outcome and Assessment Information Set (OASIS) submission, clinical record, and interview with agency staff for one (1) of five (5) discharged patients (Patient #15), the agency failed to ensure the OASIS data accurately reflects the patient's status at the time of the assessment; specifically, the Registered Nurse (RN) failed to accurately stage two (2) unhealed pressure ulcers at the time of discharge. Failure to ensure accurate documentation of OASIS data has the potential for negative outcomes. The agency failed to ensure OASIS data accurately reflects the patient’s status at the time of discharge as evidenced by the following: Patient #15 - This 82-year-old patient with diagnoses of hypertensive heart disease with heart failure, unstageable pressure ulcer of back and atherosclerotic heart disease was admitted to the home care agency on 11/04/2022 and discharged on 11/18/2022. Review of the SN (Skilled Nurse) Routine Visit Note dated 11/16/2022 revealed the patient has two unstageable pressure ulcers present, one located on the mid back inferior and a second on the mid back superior. Review of the SN (Skilled Nurse) Discharge From Agency Visit Note dated 11/18/2022 revealed the RN documented the patient has two (2) stage 2 unhealed pressure ulcers and no unstageable pressure ulcers at the time of discharge. Additionally, the RN documented skin assessments of the mid back inferior and mid back superior pressure ulcers and specified both were unstageable. During interview on 11/09/2023 at 01:20 PM, the RN stated he incorrectly documented the stage of the two pressure ulcers as stage 2 at discharge.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on clinical record review and staff interview, agency staff did not inform three (3) of seventeen (17) patients (Patient #'s: 3, 6, 7) of the extent of insurance coverage for various services available through home care. Failure to inform a patient about current fees for services violates patients' rights. Patient #6 – This 87-year-old patient with the diagnoses of weakness, dysphagia, and type 2 diabetes mellitus without complications was admitted to the home care agency on 10/24/2023. Review of the Authorization/Acknowledgement Form dated 10/24/2023 lacks evidence that the patient was informed of the extent of insurance coverage. During interview on 11/09/2023 at 01:06 PM, the Registered Nurse (RN) stated the patient’s insurance information had not been run yet so she left it blank. The Director of Patient Services (DPS) stated there may be a completed form in the record and she would look for it. No further information was provided. The agency failed to ensure patients are informed, before care is initiated, of the extent of insurance coverage for home care services as evidenced by the following: Patient #3 – This 58-year-old patient with diagnoses of unspecified atrial flutter, chronic obstructive pulmonary disease and atrial fibrillation was admitted to the home care agency on 10/17/2023. Review of the Authorization/ Acknowledgement Form dated 10/17/2023 revealed the Registered Nurse (RN) documented the patient’s insurance information and specified the patient’s co-pay amount as unknown. During interview on 11/09/2023 at 03:06 PM, the RN stated she documented unknown due to being unaware of the patient’s potential co-pay at the time the form was signed. Patient #7 – This 98-year-old patient with diagnoses of displaced fracture of first cervical vertebra, fracture of right pubis and unspecified fall was admitted to the home care agency on 10/20/2023. Review of the Authorization/ Acknowledgement Form dated 10/20/2023 lacks documentation the patient was informed of the extent of insurance coverage for home care services to be provided. During interview on 11/09/2023 at 10:40 AM, the Physical Therapist (PT) stated the patient did not have a co-pay for services but failed to document that.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with staff, for four (4) of seventeen (17) patients (Patient #s: 1, 3, 8, 16), the agency failed to ensure that a comprehensive assessment consistent with the patient's needs was performed within five (5) calendar days after the Start of Care (SOC). Failure to ensure a comprehensive assessment is complete and accurate has the potential for unmet patient needs and possible negative outcomes. The agency failed to ensure that a comprehensive assessment consistent with the patient's needs was performed within five (5) calendar days after the SOC as evidenced by the following: Patient #1 – This 62-year-old patient with the diagnoses of bipolar disorder, anxiety, and reduced mobility was admitted to the home care agency on 10/20/2023. Review of the Home Health Certification and Plan of Care for 10/20/2023 to 12/18/2023 revealed the order “Physical Therapy (PT) evaluate and treat.” Review of the clinical record from 10/20/2023 to 11/06/2023 (date of survey) lacks documented evidence the PT attempted to contact the patient. During interview on 11/09/2023 at 02:25 PM, the Clinical Business Leader stated the PT conducted the initial visit on 11/08/2023 (19 (nineteen) days after start of care). There is no clinical note to state why the visit was late or that the physician was contacted. The agency failed to ensure that a comprehensive assessment consistent with the patient's needs was performed within five (5) calendar days after the SOC as evidenced by the following: Patient #3 – This 58-year-old patient with diagnoses of unspecified atrial flutter, chronic obstructive pulmonary disease and atrial fibrillation was admitted to the home care agency on 10/17/2023. Review of the Home Care Referral dated 10/16/2023 revealed the patient was to be evaluated for Skilled Nursing (SN) and Physical Therapy (PT) services. Review of the Home Health Certification and Plan of Care for 10/17/2023 to 12/15/2023 revealed an order for PT to evaluate and treat. Review of the clinical record revealed the PT initiated contact with the patient on 10/25/2023, eight (8) days after the start of care and performed the initial PT evaluation on 10/26/2023. Patient #8 – This 57-year-old patient with diagnoses of dysphagia, attention to gastrostomy and asthma was admitted to the home care agency on 10/13/2023. Review of the Home Care Referral dated 10/13/2023 revealed the patient was to be evaluated for SN and Speech Therapy (ST) services. Review of the Home Health Certification and Plan of Care for 10/13/2023 to 12/11/2023 revealed an order for ST to evaluate and treat. Review of the clinical record revealed the ST initiated contact and performed the initial ST evaluation on 10/20/2023, seven (7) days after the start of care. Patient #16 – This 75-year-old patient with diagnoses of pleural effusion, pneumonia and malignant neoplasm of the esophagus was admitted to the home care agency on 01/04/2023. Review of the Home Care Referral dated 01/04/2023 revealed the patient was to be evaluated for SN, PT and Occupational Therapy (OT). Review of the Home Health Certification and Plan of Care for 01/04/2023 to 03/04/2023 revealed an order for PT evaluate and treat. Review of the clinical record revealed the PT initiated contact and performed the initial PT evaluation on 01/13/2023, nine (9) days after the start of care. During interview on 11/09/2023 at 03:20 PM, the Director of Patient Services stated being unaware that all disciplines requested on the referral must conduct their comprehensive assessments within five (5) days of the start of care.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on clinical record review and staff interview four (4) of seventeen (17) patients (Patient #'s: 3, 8, 14, 15), the agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient's status and needs. Failure to ensure the comprehensive assessment accurately reflects the patient status and needs has the potential for unmet patient needs and negative patient outcomes. The agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient's status and needs as evidenced by the following: Patient #14 – This 82-year-old patient with the diagnoses of aftercare following surgery for neoplasm, malignant neoplasm of prostate, and encounter for fitting and adjustment of urinary device was admitted to the home care agency on 07/27/22. This patient was identified on the Potentially Avoidable Event Patient Listing Report for developing a urinary tract infection (UTI). Review of the Home Health Certification and Plan of Care for 07/27/2022 to 09/24/2022 revealed “patient independent with BG (blood glucose) once a week.” Review of the SN Start of Care Visit Note dated 07/27/2023 lacks documented evidence the SN obtained a baseline blood glucose from the patient. During interview on 11/10/2023 at 11:15 AM, the Director of Patient Service (DPS) stated the Registered Nurse (RN) told her she did not obtain a baseline blood glucose because she thought the patient was pre-diabetic. The agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient's status and needs as evidenced by the following: Patient #3 – This 58-year-old patient with diagnoses of unspecified atrial flutter, chronic obstructive pulmonary disease and atrial fibrillation was admitted to the home care agency on 10/17/2023. Review of the Home Health Certification and Plan of Care for 10/17/2023 to 12/15/2023 revealed an order for oxygen 4 Liters per minute continuously via nose. A.) Review of the SN (Skilled Nurse) Start of Care Visit Note dated 10/17/2023 revealed the Registered Nurse (RN) documented the patient’s oxygen saturation is stable at 92 percent while wearing 3 liters of oxygen. Review of the clinical record lacks documentation of an order for oxygen 3 liters continuous. During interview on 01/09/2023 at 03:03 PM, the RN stated the patient was wearing 4 liters of oxygen in the identified visit and had documented incorrectly. B.) Review of the PT (Physical Therapy Initial Visit Note dated 10/26/2023 revealed the PT documented the patient’s oxygen saturation is 99 percent at rest wearing 3 liters of oxygen. Review of the clinical record lacks documentation of an order for oxygen 3 liters continuous. During interview on 11/09/2023 at 03:22 PM, the RN Team Supervisor stated the PT is unavailable for interview. The RN Team Supervisor stated there wasn’t an order for 3 liters of oxygen during the identified PT visit and must have been an error in documentation. Patient #8 – This 57-year-old patient with diagnoses of dysphagia, attention to gastrostomy and asthma was admitted to the home care agency on 10/13/2023. A.) Review of the Home Health Certification and Plan of Care for 10/13/2023 to 12/11/2023 revealed the patient’s diet is nothing by mouth due to dysphagia and the physician is to be notified for weight gain greater than 2 pounds in 24 (twenty-four) hours or 4 pounds in 1 (one) week. Review of the SN Start of Care Visit Note dated 10/13/2023 lacks documentation the RN obtained or recorded the patient’s weight. During interview on 11/09/2023 at 10:06 AM, the RN Team Supervisor stated the RN was unavailable for interview. She additionally stated the patient was performing daily weights but the RN failed to document the reported weight. B.) Review of the Home Health Certification and Plan of Care for 10/13/2023 to 12/11/2023 revealed an order for TED compression stockings to be applied in the AM and removed in the PM until seen by the surgeon on 10/31/2023. Review of the SN Start of Care Visit Note dated 10/13/2023 revealed the RN documented the patient and caregiver were instructed on compression but lacks an assessment of the TED stockings being in the home, understanding and management of the application and removal of the TED’s. During interview on 11/09/2023 at 10:15 PM, the Director of Patient Services stated the RN was unavailable for interview and stated there was no specific documentation of an assessment of the TED stockings, their application and removal. Patient #15 - This 82-year-old patient with diagnoses of hypertensive heart disease with heart failure, unstageable pressure ulcer of back and atherosclerotic heart disease was admitted to the home care agency on 11/04/2022. Review of the Home Health Certification and Plan of Care for 11/04/2022 to 01/02/2023 revealed the following wound care orders for a mid back pressure ulcer: cleanse with wound cleanser, apply gelling wound fiber, cover with foam dressing and change two (2) to three (3) times weekly and as needed. Review of the SN Start of Care Visit Note dated 11/04/2022 revealed the RN visualized and documented a wound assessment of the unstageable mid back pressure ulcer but documented the dressing was not changed during the SN visit. The visit note lacks documentation of anyone other then the RN performing the patient’s wound care. During interview on 11/09/2023 at 11:51 AM, the Triage RN stated she did perform the wound care to the mid back during the identified visit but documented incorrectly.

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, seven (7) of seventeen (17) clinical records (Patient #'s: 2, 7, 10, 13, 15, 16, 17) 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. 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 #2 – This 93-year-old Physical Therapy (PT) only patient with the diagnoses of hypothyroidism, hypertension, and extranodal marginal zone B-cell lymphoma was admitted to the home care agency on 09/07/2023. A.) Review of the Home Health Certification and Plan of Care for 09/07/2023 to 11/05/2023 revealed the following orders: - alendronate sodium by mouth tablet 70 mg (milligrams) 1 tablet every week - eliquis by mouth tablet 5 mg 1 tablet twice a day Review of the Discharge to Home Plan of Care dated 09/05/2023 lacks orders for the alendronate sodium and eliquis. B.) Review of the Discharge to Home Plan of Care dated 09/05/2023 revealed the following orders: - miralax 17 g (grams) daily - atorvastatin 40 mg daily at bedtime - tylenol 650 mg every 4 (four) hours as needed for pain Review of the Home Health Certification and Plan of Care for 09/07/2023 to 11/05/2023 lacks orders for the miralax, atorvastatin, and tylenol. Review of the clinical record lacks documented evidence the PT who conducted the medication reconciliation on 09/07/2023 and the Registered Nurse (RN) who conducted the medication reconciliation on 09/08/2023 identified the discrepancies or discussed the medications with the physician. During interview on 11/09/2023 at 11:00 AM, the RN stated she did not use the Discharge to Home Plan of Care to do her medication reconciliation, she only looked for interactions and safe dosages for the medications the PT documented. During interview on 11/09/2023 at 11:00 AM, the (Director of Patient Services) DPS stated the PT is unavailable for interview, but all staff will be re-educated on the process for drug review. Patient #10 – This 87-year-old patient residing in an Assisted Living Facility (ALF) with the diagnoses of urinary tract infection (UTI), chronic obstructive pulmonary disease (COPD), and hypertension was admitted to the home care agency on 10/22/203. A.) Review of the Home Health Certification and Plan of Care for 10/22/2023 to 12/20/2023 revealed the order for biafine external emulsion 1 application every day. Review of the Hospital Discharge Medication List dated 10/20/2023 lacks an order for biafine external emulsion. Review of the clinical record lacks documented evidence of the discrepancy and follow-up clarification with the physician. During interview on 11/09/2023 at 03:44 PM, the DPS stated the RN was not available for interview so she would review the record to see if there is documentation of the discrepancy. No further information has been provided. B.) Review of Resident Prescription Report (assisted living medication list) dated 11/08/2023 revealed the order for nystatin powder apply topically under breast/abdominal fold twice a day as needed for redness/fungal rash starting on 10/19/2023. Review of the Home Health Certification and Plan of Care for 10/22/2023 to 12/20/2023 lacks an order for nystatin powder. Review of the clinical record lacks documented evidence of the discrepancy and follow-up clarification with the physician. During interview on 11/09/2023 at 03:44 PM, the DPS stated the RN was not available for interview so she would review the record for an order or communication note. No further information has been provided. Patient #13 – This 67-year-old patient with the diagnoses of type 2 diabetes mellitus with foot ulcer, methicillin resistant staphylococcus aureus infection as the cause of diseases classified elsewhere, and pseudomonas was admitted to the home care agency on 09/27/2022. This patient was identified on the Potentially Avoidable Event Patient Listing Report for medication administration/side effects. Review of the Home Health Certification and Plan of Care for 09/27/2022 to 11/25/2022 revealed the following orders: - enalapril maleate by mouth tablet 10 mg 1 tablet every day - hydrochlorothiazide by mouth tablet 25 mg 1 tablet every day - metformin HCL (hydrochloride) ER (extended release) by mouth tablet extended release 24-hour 750 mg 1 tablet twice a day Review of Hospital Discharge Medication List dated 10/13/2022 lacks orders for enalapril maleate, hydrochlorothiazide, metformin HCL. Review of the clinical record lacks documented evidence of the discrepancies and follow-up clarification with the physician. During interview on 11/09/2023 at 11:15 AM, the DPS stated the RN was not available for interview so she would review the record for documentation regarding the discrepancies. No further information has been provided. Patient #17 – This 54-year-old patient with the diagnoses of malignant neoplasm of colon, encounter for adjustment and management of vascular access device, hairy cell leukemia in remission was admitted to the home care agency on 05/11/2023. Review of the Hospital Discharge Medication List dated 05/03/2023 revealed the orders for the following: - caltrate Plus PO (by mouth) - centrum Ultra Mens PO - vitamin D3 - heparin 100 unit/mL (milliliters) injection Review of the Home Health Certification and Plan of Care for 05/11/2023 to 07/09/2023 lacks orders for caltrate Plus PO, centrum Ultra Mens PO, vitamin D3, and heparin 100 unit/mL (milliliters) injection. Review of the clinical record lacks documented evidence of the discrepancies and follow-up clarification with the physician. During interview on 11/09/2023 at 09:40 AM, the RN stated she can’t remember if she spoke to the physician about the discrepancies, but she did not document doing so. 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 #7 – This 98-year-old Physical Therapy (PT) only patient with diagnoses of displaced fracture of first cervical vertebra, fracture of right pubis and unspecified fall was admitted to the home care agency on 10/20/2023. Review of the facility discharge medication list dated 10/19/2023 revealed an order for diclofenac sodium 1 percent gel, apply 2 grams to right and left knee. Review of the Home Health Certification and Plan of Care for 10/20/2023 to 12/18/2023 lacks an order for diclofenac sodium gel. Review of the clinical record lacks documentation of the discrepancy and follow-up clarification with the physician. During interview on 11/09/2023 at 10:50 AM, the PT stated the patient reported not taking the identified medication at the time of the home care admission and he did not report the discrepancy to the physician. During interview on 11/09/2023 at 11:01 AM, the RN (who conducted the medication reconciliation with the PT) stated she did not use the facility discharge medication list to conduct her medication reconciliation and only looks for interactions and appropriate dosages for the medications the PT documented. Patient #15 - This 82-year-old patient with diagnoses of hypertensive heart disease with heart failure, unstageable pressure ulcer of back and atherosclerotic heart disease was admitted to the home care agency on 11/04/2022. A.) Review of the facility discharge medication list dated 11/02/2022 revealed the patient was ordered to take the following medications: - alprazolam 0.25 mg (milligram) by mouth three times daily as needed for anxiety, maximum daily amount: 0.75 mg; and - budesonide-formoterol 160-4.5 mcg (microgram) by inhalation 2 (two) puffs 2 (two) times daily. Review of the Home Health Certification and Plan of Care for 11/04/2022 to 01/02/2023 lacks orders for alprazolam and budesonide-formoterol. B.) Review of the facility discharge medication list dated 11/02/2022 revealed an order for torsemide 5 mg by mouth every other day and 2.5 mg by mouth every other day. Review of the Home Health Certification and Plan of Care for 11/04/2022 to 01/02/2023 revealed an order for torsemide 5 mg by mouth every morning. Review of the clinical record lacks documentation of the discrepancies and follow-up clarification with the physician. During interview on 11/09/2023 at 11:57 AM, the Triage RN stated being unable to recall why there was no documentation regarding the identified discrepancies. Patient #16 – This 75-year-old patient with diagnoses of pleural effusion, pneumonia and malignant neoplasm of the esophagus was admitted to the home care agency on 01/04/2023. A.) Review of the facility discharge medication list dated 01/04/2023 revealed an order for acetaminophen 650 mg/20.3 ml (milliliter), 500 mg per gastrostomy tube every 6 (six) hours as needed. Review of the Home Health Certification and Plan of Care for 01/04/2023 to 03/04/2023 revealed an order for acetaminophen 160 mg/5 ml, 160 mg every 8 (eight) hours per jejunostomy tube as needed for pain, not to exceed 3000 mg a day. B.) Review of the facility discharge medication list dated 01/04/2023 revealed an order for famotidine 20 mg per gastrostomy tube twice daily. Review of the Home Health Certification and Plan of Care for 01/04/2023 to 03/04/2023 lacks an order for famotidine. Review of the clinical record lacks documentation of the discrepancies and follow-up clarification with the physician. During interview on 11/09/2023 at 02:31 PM, the Director of Patient Services stated there was no documentation to clarify the identified discrepancies. During interview on 11/09/2023 at 02:34 PM, the RN stated being unable to recall the identified discrepancies.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on clinical record review and staff interview for five (5) of seventeen (17) patients (Patient #'s: 3, 11, 12, 15 and 16) the agency failed to ensure the comprehensive assessment is updated and revised to reflect changes in the patient's health status. Failure to ensure comprehensive assessments are updated and revised, has the potential for negative patient outcomes. The agency failed to ensure the comprehensive assessment if updated and revised to reflect changes in the patient’s health status as evidenced by the following: Patient #3 – This 58-year-old patient with diagnoses of unspecified atrial flutter, chronic obstructive pulmonary disease and atrial fibrillation was admitted to the home care agency on 10/17/2023. Review of the Home Health Certification and Plan of Care for 10/17/2023 to 12/15/2023 revealed an order for oxygen 4 liters per minute continuously via nose. Review of the SN Resumption of Care Visit Note dated 10/30/2023 revealed the RN documented the patient was wearing 3 liters of oxygen and the oxygen saturation at rest on the 3 liters was 97 percent. Review of the clinical record lacks documentation of an updated order for 3 liters of oxygen or notification to the physician of the oxygen discrepancy. During interview on 11/09/2023 at 03:28 PM, the Registered Nurse (RN) Team Supervisor stated the RN was unavailable for interview and no documentation was found regarding clarification of the identified oxygen assessment. Patient #11 – This 83-year-old patient with diagnoses of chronic obstructive pulmonary disease, pericardial effusion and type 2 diabetes mellitus was admitted to the home care agency on 10/28/2023. Review of the SN Start of Care Visit Note dated 10/28/2023 revealed the patient was discharged from the facility on two (2) new medications, prednisone and metoprolol. The two new medications are still at the pharmacy and the family to obtain. The plan for the next visit includes to confirm her new medications metoprolol and prednisone are in the home. Review of the SN Routine Visit Note dated 10/30/2023 lacks documentation confirming the prednisone and metoprolol have been obtained, are in the home and patient instruction occurred with understanding of administration of the new medications. During interview on 11/09/2023 at 01:01 PM, the Director of Patient Services stated the RN is unavailable for interview. Additionally, she stated there is no documentation of follow-up regarding the identified medications and there should have been. Patient #12 – This 80-year-old patient with diagnoses of gastrointestinal hemorrhage, emphysema and chronic respiratory failure with hypoxia was admitted to the home care agency on 10/10/2023. Review of the Home Health Certification and Plan of Care for 10/10/2023 to 12/08/2023 revealed orders to notify the physician if resting vital signs are the following: blood pressure less than 90/50 or greater than 160/90, heart rate less than 60 or greater than 110, respirations less than 12 or greater than 28 and temperature greater than 100.4 degrees fahrenheit. Review of the SN Routine Visit Note dated 10/12/2023 lacks documentation of the RN obtaining and recording the patient’s vital signs or the patient refusing for vital signs to be obtained. During interview on 01/09/2023 at 02:52 PM, the Director of Patient Services stated the RN is unavailable for interview and vital signs should have been obtained during the identified visit. Patient #15 - This 82-year-old patient with diagnoses of hypertensive heart disease with heart failure, unstageable pressure ulcer of back and atherosclerotic heart disease was admitted to the home care agency on 11/04/2022. Review of the Home Health Certification and Plan of Care for 11/04/2022 to 01/02/2022 revealed a primary diagnosis of acute on chronic right heart failure and SN to monitor and instruct on cardiac disease management related to congestive heart failure, atrial fibrillation and hypertension. Review of the SN Routine Visit Note dated 11/14/2022 lacks documentation of a weight being obtained and/or recorded. Additionally, the cardiac assessment states the patient has no diagnosis of heart failure. During interview on 11/09/2023 at 01:16 PM, the RN stated incorrectly documenting the patient did not have heart failure. The RN stated the patient was having weights monitored by telemedicine and he failed to document the weight obtained for the identified visit. Patient #16 – This 75-year-old patient with diagnoses of pleural effusion, pneumonia and malignant neoplasm of the esophagus was admitted to the home care agency on 01/04/2023. Review of the SN Routine Visit Note dated 01/09/2023 revealed the RN documented the patient has a new stage two coccyx wound. The visit lacks an assessment of the newly identified coccyx wound. Review of the SN Routine Visit Note dated 01/11/2023 revealed the next SN visit after 01/09/2023 occurred on 01/11/2023 and the patient reported to the RN the coccyx dressing is staying in place and the pain to the area is resolved. The documentation lacks an assessment of the coccyx wound identified on 01/09/2023. During interview on 11/09/2023 at 01:59 PM, the Director of Patient Services stated the RN that made the visits was unavailable for interview. She stated she would look for documentation of a wound assessment at the identified visits. No further documentation was provided.

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 interviews with agency staff, for twelve (12) of seventeen (17) patients (Patient #'s: 1, 3, 6, 8, 10, 11, 12, 13, 14, 15, 16, 17), the agency failed to ensure Plans of Care (POCs) are of sufficient scope to address all patient needs. Failure to develop a complete and accurate POC that is comprehensive and addresses the patients' needs has the potential to result in patient harm. The agency failed to ensure POCs are of sufficient scope to address all patient needs as evidenced by the following: Patient #1 – This 62-year-old patient with the diagnoses of bipolar disorder, anxiety, and reduced mobility was admitted to the home care agency on 10/20/2023. A.) Review of the SN (Skilled Nursing) Routine Visit Note dated 10/24/2023 revealed the SN documented the patient is using heat for pain control. Review of the POC lacks an order for heat. During interview on 11/09/2023 at 02:30 PM, the Registered Nurse (RN) stated she did not obtain an order for heat. B.) Review of the Home Health Certification and Plan of Care for 10/20/2023 to 12/18/2023 revealed the order “SN evaluation and treat: surgical wound care.” Review of the POC lacks orders to address the surgical wounds and dressing. During interview on 11/09/2023 at 02:41 PM, the RN stated the staples and dressings will be removed by the physician on 10/27/2023. She did not include that information or any wound care order on the POC. C.) Review of the Physician’s Order dated 10/24/2023 revealed the order “Person responsible for testing BG (blood glucose): live-in boyfriend.” Review of the POC lacks orders for diabetic supplies, frequencies for testing, and parameters for when to call the physician. During interview on 11/09/2023 at 02:40 PM, the RN stated she called the physician to order a glucometer for the patient but did not document orders for diabetic management on the POC. Patient #6 – This 87-year-old patient with the diagnoses of weakness, dysphagia, and type 2 diabetes mellitus without complications was admitted to the home care agency on 10/24/2023. Review of the SN Routine Visit Note dated 10/24/2023 revealed the SN documented the patient does not test his blood glucose. Review of the Home Health Certification and Plan of Care for 10/24/2023 to 12/22/2023 revealed the orders to instruct on diabetes disease management and diabetic foot care but lacks documented evidence the patient chooses not to test his blood glucose. During interview on 11/09/2023 at 01:17 PM, the RN stated he did not put any information about blood glucose testing on the POC. Patient #10 – This 87-year-old patient residing in an Assisted Living Facility (ALF) with the diagnoses of urinary tract infection (UTI), chronic obstructive pulmonary disease (COPD), and hypertension was admitted to the home care agency on 10/22/203. Review of the Home Health Certification and Plan of Care for 10/22/2023 to 12/20/2023 revealed the order for biafine external emulsion 1 application every day. The order lacks a location for the topical medication. During interview on 11/09/2023 at 03:44 PM, the Director of Patient Services (DPS) stated the RN was not available for interview so she would review the record to see if there is a complete order. No further information has been provided. Patient #13 – This 67-year-old patient with the diagnoses of type 2 diabetes mellitus with foot ulcer, methicillin resistant staphylococcus aureus infection as the cause of diseases classified elsewhere, and pseudomonas was admitted to the home care agency on 09/27/2022. This patient was identified on the Potentially Avoidable Event Patient Listing Report for medication administration/side effects. Review of the Hospital Discharge Referral dated 09/27/2022 revealed the patient has a PICC (peripherally inserted central catheter) and the dressing was changed on 09/23/2023. Review of the SN Initial Visit Note dated 09/27/2022 revealed the SN documented an assessment of the PICC, and that the PICC is used for infusions and blood draws. Review of the Home Health Certification and Plan of Care 09/27/2022 to 11/25/2022 revealed the order “single lumen PICC to RUE (right upper extremity).” The order lacks a size, measurements, date placed, and when the dressing is due to be changed. During interview on 11/09/2023 at 11:10 AM, the RN stated the order was incomplete. Patient #14 – This 82-year-old patient with the diagnoses of aftercare following surgery for neoplasm, malignant neoplasm of prostate, and encounter for fitting and adjustment of urinary device was admitted to the home care agency on 07/27/22. This patient was identified on the Potentially Avoidable Event Patient Listing Report for developing a urinary tract infection (UTI). Review of the Home Health Certification and Plan of Care for 07/27/2022 to 09/24/2022 revealed the order for a 20F (twenty French) foley catheter to gravity. The POC lacks orders for the following: - foley care and who is responsible - when the foley was placed - when it is due for change During interview on 11/09/2023 at 09:49 AM, the DPS stated she does not see these orders on the POC. Patient #17 – This 54-year-old patient with the diagnoses of malignant neoplasm of colon, encounter for adjustment and management of vascular access device, hairy cell leukemia in remission was admitted to the home care agency on 05/11/2023. A.) Review of the SN Start of Care Visit Note dated 05/11/2023 revealed the patient has an implanted vascular access device (IVAD)/mediport. Review of the Home Health Certification and Plan of Care for 05/11/2023 to 07/09/2023 lacks an order for the IVAD/mediport and how it is being managed, and by whom. During interview on 11/09/2023 at 02:34 PM, the RN stated she forgot to put an order for the access device on the POC. B.) Review of the SN Start of Care Visit Note dated 05/11/2023 revealed the SN was at the patient’s home to take down the patient’s chemotherapy treatment. Review of the Home Health Certification and Plan of Care for 05/11/2023 to 07/09/2023 lacks an order for chemotherapy takedown to include a frequency and a flush. During interview on 11/09/2023 at 02:35 PM, the RN stated she did call the physician for orders but did not document them on the POC. The agency failed to ensure POCs are of sufficient scope to address all patient needs as evidenced by the following: Patient #12 – This 80-year-old patient with diagnoses of gastrointestinal hemorrhage, emphysema and chronic respiratory failure with hypoxia was admitted to the home care agency on 10/10/2023. A.) Review of the SN (Skilled Nurse) Start of Care Visit Note dated 10/10/2023 revealed the Registered Nurse (RN) documented making an internal request for Home Health Aide (HHA) services. Review of the Supplemental Order dated 10/11/2023 revealed an order for HHA 1-3x (one to three times) per week for 9 (nine) weeks. Review of the Community Home Health Time Sheet dated 10/18/2023 revealed the initial HHA service visit occurred on 10/18/2023. Review of the clinical record revealed an Aide Care Plan dated 10/30/2023, but lacks documented evidence of an aide POC for the period 10/18/2023 to 10/30/2023. During interview on 11/09/2023 at 11:38 AM, the Physical Therapist (PT) Team Supervisor stated the RN is unavailable for interview. The PT Team Supervisor stated the opening RN should have developed an aide POC when the HHA internal request was generated on 10/10/2023 but failed to. During interview on 11/09/2023 at 11:40 AM, the Director of Patient Services (DPS) acknowledged the patient failed to have an aide plan of care in place until 10/30/2023. B.) Review of the Home Health Certification and Plan of Care for 10/10/2023 to 12/08/2023 revealed orders for instruction of the use and care of a CPAP (continuous positive airway pressure) machine. The POC lacks orders for the type, frequency of use, management and CPAP settings. During interview on 11/09/2023 at 11:36 PM, the DPS stated the RN was unavailable for interview and she would look for additional orders for the CPAP. No further documentation was provided. C.) Review of the facility discharge medication list dated 10/09/2023 revealed an order for thigh high compression stockings to be worn daily as needed. Review of the Home Health Certification and Plan of Care for 10/10/2023 to 12/08/2023 lacks an order for compression stockings. During interview on 11/09/2023 at 11:38 AM, the PT Team Supervisor stated the RN was unavailable for interview. The PT Team Supervisor stated the patient wore compression stockings and the orders should have been included on the POC. Patient #16 – This 75-year-old patient with diagnoses of pleural effusion, pneumonia and malignant neoplasm of the esophagus was admitted to the home care agency on 01/04/2023. A.) Review of the SN Start of Care Visit Note dated 01/04/2023 revealed the RN documented the patient is unable to take in nutrients orally and is fed nutrients through a jejunostomy tube. Review of the Home Health Certification and Plan of Care for 01/04/2023 to 03/04/2023 revealed the patient is ordered to receive tube feedings over 16 (sixteen) hours and additionally the nutritional requirements are ordered PO (by mouth). During interview on 11/09/2023 at 02:28 PM, the RN stated the POC nutritional requirements are incorrect and meant to document NPO (nothing by mouth). B.) Review of the SN start of Care Visit Note dated 01/04/2023 revealed the RN documented the patient has a G (gastrostomy) tube present for medication administration and is connected to a drainage bag. Review of the SN Routine Visit Note dated 01/05/2023 revealed the RN documented the G tube is to be flushed with 30 ml (milliliter) of water before and after medication administration. Review of the Home Health Certification and Plan of Care for 01/04/2023 to 03/04/2023 lacks documentation of orders for G tube water flushes. Review of the clinical record lacks documentation of G tube water flushes. During interview on 11/09/2023 at 01:47 PM, the DPS stated she would look for documentation of G tube water flushes being ordered. No further documentation was provided. Patient #3 – This 58-year-old patient with diagnoses of unspecified atrial flutter, chronic obstructive pulmonary disease and atrial fibrillation was admitted to the home care agency on 10/17/2023. Review of the Home Health Certification and Plan of Care for 10/17/2023 to 12/15/2023 revealed orders to instruct in diabetes disease management and diabetic foot care and SN to check blood glucose if patient symptomatic. The POC lacks documentation of a diagnosis of diabetes mellitus. During interview on 11/09/2023 at 03:10 PM, the RN stated she left the identified diagnosis off the POC in error. Patient #8 – This 57-year-old patient with diagnoses of dysphagia, attention to gastrostomy and asthma was admitted to the home care agency on 10/13/2023. Review of the SN Start of Care Visit Note dated 10/13/2023 revealed the patient has a percutaneous endoscopic gastrostomy (PEG) tube in place that is being used to administer medications, tube feedings, water flushes and requires tube care. Review of the Home Health Certification and Plan of Care for10/13/2023 to 12/11/2023 lacks documentation of PEG tube care to include site care, dressing changes and who is managing the PEG tube care. During interview on 11/09/2023 at 10:03 AM, the RN Team Supervisor stated the RN was unavailable for interview and acknowledged the POC was missing orders for PEG tube care. Patient #11 – This 83-year-old patient with diagnoses of chronic obstructive pulmonary disease, pericardial effusion and type 2 diabetes mellitus was admitted to the home care agency on 10/28/2023. Review of the Home Care Referral dated 10/27/2023 revealed the patient was ordered oxygen 5 liters per minute continuous via nasal cannula. Review of the SN Start of Care Visit Note dated 10/28/2023 revealed the RN documented the patient is wearing oxygen at 5 liters per minute and the oxygen saturation at rest wearing the oxygen is 98 percent. Review of the Home Health Certification and Plan of Care for 10/28/2023 to 12/26/2023 revealed an order for oxygen 2 liters continuously by nasal cannula. Additionally, the RN documented in the POC summary that the patient uses 5 liters of oxygen continuously. During interview on 11/09/2023 at 12:52 PM, the Director of Patient Services (DPS) stated the RN was unavailable for interview. The DPS stated the oxygen order in the plan of care was a discrepancy and there is no documentation of clarification of the order. Patient #15 - This 82-year-old patient with diagnoses of hypertensive heart disease with heart failure, unstageable pressure ulcer of back and atherosclerotic heart disease was admitted to the home care agency on 11/04/2022. Review of the Home Health Certification and Plan of Care for 11/04/2022 to 01/02/2023 revealed a primary diagnosis of acute on chronic right heart failure and orders for torsemide (a diuretic) to be taken daily. The POC lacks orders for weights to be monitored and weight parameters to notify the physician for. During interview on 11/09/2023 at 11:41 AM, the Triage RN stated it was an oversight that the identified weight orders were not ordered 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 staff interviews, for three (3) of seventeen (17) patients (Patient #’s: 8, 12 and 16), the agency failed to provide services in accordance with physician orders. Failure to ensure patient care is provided in accordance with physician orders and the POC has the potential for patients to receive poor care and for health care needs to go unmet. The agency failed to ensure services are provided in accordance with physician orders as evidenced by the following: Patient #12 – This 80-year-old patient with diagnoses of gastrointestinal hemorrhage, emphysema and chronic respiratory failure with hypoxia was admitted to the home care agency on 10/10/2023. A.) Review of the Supplemental Order dated 10/11/2023 revealed an order for Home Health Aide (HHA) 1-3 (one to three) timed per week for 9 (nine) weeks, duration 30 (thirty) minutes to 2 (two) hours. Review of the Community Home Health Time Sheet dated 10/18/2023 revealed the first HHA service visit occurred on 10/18/2023. Review of the clinical record for the week of 10/08/2023 to 10/14/2023 lacks documentation the patient received HHA services as ordered and the physician was notified of this. During interview on 11/09/2023 at 02:42 AM, the Registered Nurse (RN) acknowledged the aide frequency was not met for the identified week. B.) Review of the Home Health Certification and Plan of Care for 10/10/2023 to 12/08/2023 revealed orders for SN 1 (one) to 3 (three) times a week for 9 (nine) weeks and 2 (two) as needed visits for status changes. Review of the Clinical Note dated 10/19/2023 revealed the RN documented “client NHNF (not home, not found), no visit made by this writer.” There is no documentation to include physician notification or plan to make additional attempts to see the patient. Review of the clinical record for the week of 10/15/2023 to 10/21/2023 lacks documentation the patient received Skilled Nurse (SN) services as ordered and the physician was notified. During interview on 11/09/2023 at 02:44 PM, the Director of Patient Services (DPS) stated the RN no longer works for the agency and she will look for additional documentation regarding the missed visit. No further documentation was provided. Patient #8 – This 57-year-old patient with diagnoses of dysphagia, attention to gastrostomy and asthma was admitted to the home care agency on 10/13/2023. Review of the Home Health Certification and Plan of Care for 10/13/2023 to 12/11/2023 revealed orders for the physician to be notified if there is a weight gain of greater than 2 (two) pounds in 24 (twenty-four) hours or 4 (four) pounds in a week. Review of the SN Routine Visit Note dated 10/20/2023 lacks documentation of the patient’s weight being obtained or recorded. Review of the SN Routine Visit Note dated 11/03/2023 lacks documentation of the patient’s weight being obtained or recorded. During interview on 11/09/2023 at 10:19 AM, the DPS stated the RN that conducted the identified visits was unavailable for interview. The DPS stated she would look for documentation of the patient’s weights being obtained or recorded for the identified visits. No further documentation was provided. Patient #16 – This 75-year-old patient with diagnoses of pleural effusion, pneumonia and malignant neoplasm of the esophagus was admitted to the home care agency on 01/04/2023. Review of the Home Health Certification and Plan of Care for 01/04/2023 to 03/04/2023 revealed orders for the exit site where a chest tube had formerly been placed to include: Leave nonremovable dressing in place over old chest tube site, remove dressing 01/05/2023. Leave open to air, if drainage present or open, clean with soap and water and cover with dry dressing and change daily and as needed. Review of the SN Routine Visit dated 01/05/2023 revealed the chest tube drain site was noted to have a small amount of serous drainage and the RN changed the dressing to the area as per the orders. The visit lacks documentation of a caregiver demonstrating independence with the daily dressing change to the old chest tube site. Review of the clinical record revealed the next SN visit occurred on 01/09/2023, four days after the daily dressing had last been documented as being changed. During interview on 11/09/2023 at 01:55 PM, the DPS stated the RN was unavailable for interview. The DPS stated there was no documentation that a caregiver was taught the wound care to explain why daily visits did not occur after 01/05/2023.

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 clinical record review and staff interview for three (3) of seventeen (17) patients (Patient #’s 8, 15 and 16), the agency failed to ensure services and treatments are administered in accordance with physician orders. Failure to administer services and treatments without a physician's order has the potential to result in poor quality of care. The agency failed to ensure services and treatments are administered in accordance with physician orders as evidenced by the following: Patient #16 – This 75-year-old patient with diagnoses of pleural effusion, pneumonia and malignant neoplasm of the esophagus was admitted to the home care agency on 01/04/2023. A.) Review of the Skilled Nurse (SN) Routine Visit Note dated 01/05/2023 revealed the Registered Nurse (RN) documented performing both the gastrostomy (G) tube site dressing change and the jejunostomy (J) tube site dressing change per care plan orders. Review of the clinical record lacks orders for the G tube site and the J tube site dressing changes. During interview on 11/09/2023 at 01:50 PM, the Director of Patient Services (DPS) stated the RN was unavailable for interview. The DPS stated she would look for orders for the identified dressing changes. No further documentation was provided. B.) Review of SN Routine Visit Note dated 01/05/2023 revealed the RN documented the patient has a new reddened, intact area on coccyx and the patient’s caregiver was instructed to apply calmoseptine ointment and apply a foam dressing over the area to protect it. Review of the SN Routine Visit Note dated 01/09/2023 revealed the RN documented the patient’s coccyx wound is now a stage 2 pressure ulcer and instructed the caregiver to wash the area with soap and water, apply calmoseptine to the wound until the foam dressings arrive. Review of the clinical record lacks orders for wound care to the coccyx wound. During interview on 11/09/2023 at 01:50 PM, the DPS stated the RN that conducted the two identified visits is unavailable for interview. The DPS stated she would look for orders for the identified coccyx wound. No further documentation was provided. Patient #8 – This 57-year-old patient with diagnoses of dysphagia, attention to gastrostomy and asthma was admitted to the home care agency on 10/13/2023. Review of the SN Routine Visit Note dated 10/20/2023 revealed the RN documented the skin around the percutaneous endoscopic gastrostomy (PEG) tube was intact and the RN changed the dressing around the tube per the plan of care. Review of the SN Routine Visit Note dated 10/27/2023 revealed the RN documented the patient’s skin around the PEG tube was intact and the RN changed the dressing per plan of care. Review of the clinical record lacks an order for a PEG tube exit site dressing change. During interview on 11/09/2023 at 10:24 AM, the DPS stated the RN that conducted the identified visits was unavailable for interview. The DPS stated she would look for an order for the PEG tube exit site dressing change. No further documentation was provided. Patient #15 - This 82-year-old patient with diagnoses of hypertensive heart disease with heart failure, unstageable pressure ulcer of back and atherosclerotic heart disease was admitted to the home care agency on 11/04/2022. Review of the Home Health Certification and Plan of Care for 11/04/2022 to 01/02/2023 revealed a wound care order for a mid back pressure ulcer to include cleansing with wound cleanser, applying gelling wound fiber and covering with foam dressing 2 (two) to 3 (three) times weekly and as needed. Review of the SN Routine Visit Note dated 11/09/2022 revealed the RN documented in addition to the mid back inferior pressure ulcer the patient has a new mid back wound and wound care was completed per order to new wound. Review of the clinical record lacks wound care orders for the new mid back wound identified on 11/09/2022. During interview on 11/09/2022 at 01:12 PM, the RN stated being unable to recall why an order was not obtained for wound care to the second back wound.

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 three (3) of seventeen (17) patients (Patient #’s: 12, 14 and 16), the agency failed to ensure the Plan of Care (POC) is reviewed and revised to reflect the patient's status. Failure to ensure the POC is updated and revised to reflect patient needs, has the potential to result in negative patient outcomes. The agency failed to ensure the POC is reviewed and revised to reflect the patient's status as evidenced by the following: Patient #14 – This 82-year-old patient with the diagnoses of aftercare following surgery for neoplasm, malignant neoplasm of prostate, and encounter for fitting and adjustment of urinary device was admitted to the home care agency on 07/27/22. This patient was identified on the Potentially Avoidable Event Patient Listing Report for developing a urinary tract infection (UTI). Review of the Home Health Certification and Plan of Care for 07/27/2022 to 09/24/2022 revealed the order for a 20F (twenty French) foley catheter to gravity. Review of the Skilled Nursing (SN) Routine Visit Note dated 08/04/2022 revealed the SN documented “patient had urologist appointment yesterday. Foley and staples removed.” Review of the clinical record lacks documented evidence the SN obtained an order to discontinue the foley to revise the POC. During interview on 11/09/2023 at 09:37 AM, the Registered Nurse (RN) stated she did not revise the POC after learning the foley was removed. The agency failed to ensure the POC is reviewed and revised to reflect the patient's status as evidenced by the following: Patient #12 – This 80-year-old patient with diagnoses of gastrointestinal hemorrhage, emphysema and chronic respiratory failure with hypoxia was admitted to the home care agency on 10/10/2023. A.) Review of the Supplemental Order dated 10/11/2023 revealed an order for Home Health Aide (HHA) 1 (one) to 3 (three) times weekly for 9 (nine) weeks, duration 30 (thirty) minutes to 2 (two) hours. The order lacks the treatment to be performed. During interview on 11/09/2023 at 02:43 PM, the Registered Nurse (RN) acknowledged the order lacks the treatment the HHA is to be providing to the patient. B.) Review of the Supplemental Order dated 10/26/2023 revealed the HHA is to assist with additional equipment to include: oxygen tubing, right calf brace and TED (thromboembolic deterrent) stocking. The order lacks specification of the location and duration the TED stockings are to be worn. During interview on 11/09/2023 at 11:27 AM, the Physical Therapist (PT) Team Supervisor stated she omitted the identified TED stocking instructions accidentally from the order. Patient #16 – This 75-year-old patient with diagnoses of pleural effusion, pneumonia and malignant neoplasm of the esophagus was admitted to the home care agency on 01/04/2023. Review of the Phone Oncall/ Unscheduled Visit Note dated 01/06/2023 revealed the patient was having severe abdominal pain and the caregiver was questioning if the volume of the jejunostomy (J) tube flushes that had been 150 milliliters (ml) before and after each tube feeding could be contributing to the pain. The RN contacted the physician and documented the J tube flushes were being changed to 50 ml before and after each tube feeding to which the caregiver was understanding and agreeable to. Review of the clinical record lacks documentation of an order for the new J tube flushing volume before and after tube feeds. During interview on 11/09/2023 at 01:40 PM, the RN stated it was an oversight that a new order was not completed for the identified J tube flushes.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on a review of clinical records and staff interviews for two (2) of seventeen (17) patients (Patient #’s: 15 and 16), the agency failed to ensure the physician is notified of changes in the patient’s condition or needs that suggest that the Plan of Care (POC) may need to be altered. Failure to promptly notify the physician to changes in the patient’s condition or needs that may suggest that outcomes are not being achieved and/ or the POC should be altered has the potential to result in unmet patient needs and negative patient outcomes. The agency failed to ensure physicians are promptly notified to changes in the patient’s condition or needs that may affect the POC as evidenced by the following: Patient #15 - This 82-year-old patient with diagnoses of hypertensive heart disease with heart failure, unstageable pressure ulcer of back and atherosclerotic heart disease was admitted to the home care agency on 11/04/2022. A.) Review of the Skilled Nurse (SN) Routine Visit Note dated 11/09/2022 revealed the Registered Nurse (RN) documented the patient had a new mid back superior unstageable pressure ulcer that had developed since the last SN visit occurring on 11/04/2023. The new wound was open, covered with 100 percent slough and draining moderate amounts of serosanguinous drainage. The visit note lacks documentation the physician was notified of the development of the new wound and orders were obtained for wound care. During interview on 11/09/2023 at 01:12 PM, the RN stated being unable to recall why the physician was not notified and orders obtained for the identified back wound. B.) Review of the SN Start of Care Visit Note dated 11/04/2022 revealed the patient’s weight measured 100 pounds using the patient’s scale and the patient was dyspneic with exertion wearing 4 liters of continuous oxygen. Review of the Physical Therapy (PT) Initial Visit Note dated 11/10/2022 revealed the patient’s weight was verbally reported as being 113 pounds and the patient was short of breath at rest wearing oxygen at 4 liters continuously. The visit note lacks documentation the physician was contacted regarding the change in status. During interview on 11/09/2023 at 10:33 PM, the PT stated he may have used a different scale than the patient’s causing the weight discrepancy. Patient #16 – This 75-year-old patient with diagnoses of pleural effusion, pneumonia and malignant neoplasm of the esophagus was admitted to the home care agency on 01/04/2023. Review of the SN Routine Visit Note dated 01/05/2023 revealed the RN documented the patient had a new reddened intact pressure area on the coccyx and the caregiver was instructed to apply calmoseptine ointment and a foam dressing over the area to protect it. The visit note lacks documentation the physician was notified of the new pressure area and obtained orders for wound care to the area. Review of the SN Routine Visit note dated 01/09/2023 revealed the RN documented the patient’s coccyx wound was open and had developed into a new stage 2 pressure ulcer. Additionally, the RN documented the caregiver was instructed to wash area with soap and water and apply calmoseptine to the wound until the foam dressings were in the home. The visit note lacks documentation the physician was notified of the new stage 2 pressure ulcer and obtained orders for wound care to the area. During interview on 11/09/2023 at 01:56 PM, the Director of Patient Services (DPS) stated the RN that made the two identified visits was unavailable for interview. The DPS stated she would look for additional documentation of the physician being notified of the identified changes. No further documentation was provided.

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, agency policy and procedure, and interviews with agency staff for one (1) of seventeen (17) patients (Patients #13), the agency failed to coordinate care delivery and ensure patient needs are addressed. Failure to coordinate care delivery has the potential for negative patient outcomes. Patient #13 – This 67-year-old patient with the diagnoses of type 2 diabetes mellitus with foot ulcer, methicillin resistant staphylococcus aureus infection as the cause of diseases classified elsewhere, and pseudomonas was admitted to the home care agency on 09/27/2022. This patient was identified on the Potentially Avoidable Event Patient Listing Report for medication administration/side effects. Review of the SN (Skilled Nursing) Routine Visit Note dated 10/03/2022 revealed the SN documented “patient reports signs and symptoms of yeast infection… MD (medical doctor) notified.” Review of the clinical record from 10/03/2022 to 10/11/2022 lacks documented evidence there was follow-up on the patient’s symptoms. During interview on 11/09/2023 at 03:30 PM, the Director of Patient Services (DPS) stated the RN was not available for interview so she would review the record for follow-up. No further information has been provided.

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: 8, 15 and 16), the agency failed to ensure patients and/or caregivers receive 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. The agency failed to ensure patients and caregivers receive education and training regarding care and services identified in the POC as evidenced by the following: HV Patient #8 – This 57-year-old patient with diagnoses of dysphagia, attention to gastrostomy and asthma was admitted to the home care agency on 10/13/2023. During an observational home visit on 11/07/2023 at 09:30 AM, the patient verbalized that he and his spouse perform the gastrostomy tube exit site dressing change independently. Review of the clinical record lacks documentation the patient and/or spouse were instructed and demonstrated back the gastrostomy tube exit site dressing change and were determined independent. During interview on 11/09/2023 at 10:16 AM, the Registered Nurse (RN) Team Supervisor stated the clinician was unavailable for interview and she would look for documentation regarding the identified teaching. No further documentation was provided. Patient #15 - This 82-year-old patient with diagnoses of hypertensive heart disease with heart failure, unstageable pressure ulcer of back and atherosclerotic heart disease was admitted to the home care agency on 11/04/2022. Review of the Home Health Certification and Plan of Care for 11/04/2022 to 01/02/2023 revealed an order for wound care to the mid back pressure ulcer to include cleanse with wound cleanser, apply gelling wound fiber, cover with foam dressing and change every two to three times weekly and as needed. Review of the Skilled Nurse (SN) Discharge From Agency Visit Note dated 11/18/2022 revealed the patient had one (1) unstageable pressure ulcer located on the mid back inferior and another unstageable pressure located on the mid back superior. The RN documented performing dressing changes to both wounds per care plan orders. Additionally, the patient reported he is moving out of area in two (2) days to stay at son’s home. The RN documented wound care was reviewed with patient for son to perform. The visit note lacks documentation the son was present, agreeable to assume responsibility for the wound care and was instructed and demonstrated the wound care. During interview on 11/09/2023 at 01:25 PM, the RN stated being unable to recall the patient. During interview on 11/09/2023 at 01:27 PM, the Director of Patient Services (DPS) stated she would look for additional documentation regarding the son being instructed in the wound care. No further documentation was provided. Patient #16 – This 75-year-old patient with diagnoses of pleural effusion, pneumonia and malignant neoplasm of the esophagus was admitted to the home care agency on 01/04/2023. Review of the SN Routine Visit Note dated 01/05/2023 revealed the RN documented the patient had a new reddened intact pressure area on the coccyx and the caregiver was instructed to apply calmoseptine ointment and a foam dressing over the area to protect it. The documentation lacks instruction to include demonstration of the caregiver performing the wound care and being determined independent. Review of the clinical record lacks documentation the caregiver demonstrated the identified wound care and was determined independent. During interview on 11/09/2023 at 02:02 PM, the Director of Patient Services (DPS) stated the RN was unavailable for interview and would look for any documentation regarding education and demonstration of the identified wound care. No further documentation was provided.

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 fourteen (14) patients (Patient #’s: 4, 12, 13), receiving skilled nursing services, the Skilled Nurse (SN) failed to prepare or document complete clinical and progress notes. Failure to prepare or document complete clinical and progress notes has the potential for unmet patient needs. The SN failed to prepare or document complete clinical and progress notes as evidenced by the following: Patient #4 – This 63-year-old patient with the diagnoses of aortocoronary bypass graft, atherosclerotic heart disease, and hypertension was admitted to the home care agency on 10/22/2023. Review of the SN Routine Visit Note dated 10/25/2023 revealed the SN assessed three (3) surgical wounds located at the sternum, groin, and medial lower left extremity and documented “dressing changed this visit: yes, per orders, see Care Plan.” Review of the Home Health Certification and Plan of Care for 10/22/2023 to 12/20/2023 revealed the order for “sternum: dry dressing to be removed 10/25/2023” but lacks orders for dressing changes for the groin and medial lower left extremity surgical wounds. During interview on 11/09/2023 at 09:32 AM, the Licensed Practical Nurse (LPN) stated the patient had gauze dressing on the sternum that was to be removed on 10/25/2023 and the other two wound were open to air. Her documentation of a dressing change was an error. Patient #13 – This 67-year-old patient with the diagnoses of type 2 diabetes mellitus with foot ulcer, methicillin resistant staphylococcus aureus infection as the cause of diseases classified elsewhere, and pseudomonas was admitted to the home care agency on 09/27/2022. This patient was identified on the Potentially Avoidable Event Patient Listing Report for medication administration/side effects. Review of the Hospital Discharge Referral dated 09/27/2022 revealed the patient has a PICC (peripherally inserted central catheter) in place and the date of the dressing change was 09/23/2023. Review of the SN Start of Care Visit Note dated 09/27/2022 revealed the SN documented the dressing was last changed on 09/24/2023. During interview on 11/09/2023 at 11:10 AM, the Registered Nurse (RN) stated the dressing was last changed on 09/23/2023 and her assessment was an error. The SN failed to prepare or document complete clinical and progress notes as evidenced by the following: Patient #12 – This 80-year-old patient with diagnoses of gastrointestinal hemorrhage, emphysema and chronic respiratory failure with hypoxia was admitted to the home care agency on 10/10/2023. Review of the SN Routine Visit Note dated 10/12/2023 revealed the Registered Nurse (RN) documented the patient does not use oxygen within the respiratory assessment. Additionally, the RN documented the patient was instructed on oxygen and verbalized understanding of the instruction. During interview on 11/09/2023 at 02:45 PM, the Director of Patient Services (DPS) stated the RN no longer works for the agency. The DPS acknowledged the identified documentation was inconsistent and it was unclear if the patient was using oxygen or not.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on review of clinical records and interview with agency staff, for one (1) of two (2) patient's receiving Home Health Aide Services (HHA) (Patient #12), the agency failed to ensure the HHA provides services as directed on the aide plan of care (POC). Specifically, the HHA performed tasks not assigned on the aide care plan. Failure to follow the Plan of Care has the potential to result in inadequate care. The agency failed to ensure the HHA provided services as directed on the aide POC as evidenced by the following: Patient #12 – This 80-year-old patient with diagnoses of gastrointestinal hemorrhage, emphysema and chronic respiratory failure with hypoxia was admitted to the home care agency on 10/10/2023. A.) Review of the clinical record revealed the patient received the following HHA services between 10/10/2023 to 10/28/2023: - For the week of 10/15/2023 to 10/21/2023- HHA service visits occurred on 10/18/2023 and 10/20/2023; and - For the week of 10/22/2023 to 10/28/2023- HHA service visits occurred on 10/23/2023, 10/25/2023 and 10/27/2023. Review of the Community Home Health Time Sheets revealed the HHA performed the following unassigned tasks on 10/18/2023, 10/20/2023, 10/23/2023, 10/25/2023 and 10/27/2023: - Performed shower; - Performed incontinence skin care; - Shampooed, combed and brushed hair; - Brushed patient’s teeth; - Cleaned and filed patient’s nails; - Provided toileting assistance; - Performed partial assistance with dressing; - Provided ambulation assist with patient’s rolling walker and oxygen; - Provided transfer assistance; - Prepared and served a meal; - Provided medication reminders; - Performed light housekeeping; and - Performed laundry using machine in home. Review of the clinical record lacks documentation of an aide care plan being developed until 10/30/2023. During interview on 11/09/2023 at 11:27 AM, the Physical Therapist (PT) Team Supervisor stated the Registered Nurse (RN) was unavailable for interview. The PT Team Supervisor stated the RN who put in the referral for HHA services never completed an aide plan of care, as was supposed to occur, and an aide care plan was developed on 10/30/2023 when the error was realized. B.) Review of the Aide Care Plan dated 10/30/2023 revealed the HHA is assigned the following tasks: - Shower two to three times weekly; - Skin Care- for incontinence, wash hands/feet, apply lotion two to three times weekly; - Shampoo, comb/brush hair two to three times weekly; - Oral care two to three times weekly; - Nail care, clean and file two to three times weekly; - Assist with toileting two to three times weekly; - Partial assist with dressing two to three times weekly; - Ambulation standby assist with rollator and oxygen two to three times weekly; - Transfer standby assist two to three times weekly; - Assist with meal, prepare and serve as needed two to three times weekly; - Assist with rollator and oxygen two to three times weekly; - Medication reminder two to three times weekly; - Light housekeeping two to three times weekly; - Laundry two to three times weekly; and - Apply brace to right calf two to three times weekly. Review of the HHA CellTrak Visit Form (aide documentation) for 11/01/2023 and 11/03/2023 revealed the HHA documented performing the following task not assigned on the aide plan of care: - Assisted with applying TED (thrombo-embolic deterrent) stocking. During interview on 11/09/2023 at 11:25 PM, the Physical Therapist stated she created the aide care plan on 10/30/2023 and omitted assigning the task of applying the TED stocking to the care plan in error.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on review of clinical records, agency policy and procedure, and staff interview, for one (1) of seventeen (17) patients (Patient #13), the agency failed to follow agency policies and procedures, current clinical practice guidelines and accepted professional standards when providing services. Failure to follow agency policies and procedures and ensure compliance with accepted professional standards has the potential to result in unmet patient needs and inadequate care. Patient #13 – This 67-year-old patient with the diagnoses of type 2 diabetes mellitus with foot ulcer, methicillin resistant staphylococcus aureus infection as the cause of diseases classified elsewhere, and pseudomonas was admitted to the home care agency on 09/27/2022. This patient was identified on the Potentially Avoidable Event Patient Listing Report for medication administration/side effects. Review of the agency’s policy entitled “Infusion: Vascular Access Devices/Infusion Related Procedures” revised 11/2022 revealed the following: G. PICC (peripherally inserted central catheter) measurements are done with every dressing change and records in the EMR (electronic medical record). 1. Arm circumference 10 (ten) cm (centimeters) above the antecubital fossa. 2. External length in cm of the PICC to the proximal wing on the catheter. I. While performing IV (intravenous) dressing changes, the site will be assessed for signs and symptoms of infections and complications. Review of the Home Health Certification and Plan of Care for 09/27/2022 to 11/25/2022 revealed the order "PICC – dressing change weekly and prn (as needed): integrity. Clean site with chlorhexidine or alcohol and betadine. Allow to air dry. Apply securement device, antimicrobial patch, extension tubing (if needed), and NAD (non-adherent dressing). Apply transparent dressing." Review of the SN (Skilled Nursing) Routine Visit Note dated 09/30/2022 revealed the SN documented “PICC dressing changed” but lacks an assessment of the PICC in accordance with the agency’s policy. Review of the SN Routine Visit Note dated 10/17/2022 revealed the SN documented “PICC dressing changed” but lacks an assessment of the PICC in accordance with the agency’s policy. The agency failed to follow agency policies and procedures, current clinical practice guidelines and accepted professional standards when providing services. During interview on 11/09/2023 at 03:40 PM, the Director of Patient Services (DPS) stated the SN should have documented a complete assessment during the dressing change.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on review of clinical records and staff interviews, for one (1) of seventeen (17) patients (Patient #12), the agency failed to ensure all documentation by professional staff is appropriately authenticated in accordance with accepted standards of practice. Failure to authenticate documentation with an electronic signature and professional credentials has the potential for patients to receive care from unlicensed staff. The agency failed to ensure all documentation by professional staff is appropriately authenticated as evidenced by the following: Patient #12 – This 80-year-old patient with diagnoses of gastrointestinal hemorrhage, emphysema and chronic respiratory failure with hypoxia was admitted to the home care agency on 10/10/2023. Review of the Skilled Nurse (SN) Routine Visit Note dated 10/12/2023 lacks documented evidence of the SN’s professional credentials. During interview on 11/09/2023 at 02:50 PM, the Director of Patient Services (DPS) stated the Registered Nurse (RN) that made the 10/12/2023 visit no longer works for the agency. The DPS stated an error was made and her credentials were never entered into the electronic medical record during the period of time she worked at the agency.

A post certification visit (PCV) for Rochester Regional Health Home Care was conducted on 10/28/2021 to 11/10/2021 as a follow up to the recertification survey that was conducted on 11/05/2020 to 11/13/2020 and included complaint investigations #NY00273270 and #NY00276951. The allegations in complaint #NY00273270 were determined unsubstantiated. The allegation in complaint #NY00276951 was determined substantiated. The survey consisted of a review of five (5) clinical records including one (1) discharge record, and one (1) record that was evaluated for home care, along with pertinent policies and procedures and the Complaint Log. The survey also consisted of a review of the agency's implementation of the New York State Department of Health (NYS DOH) Guidance as it pertains to COVID-19. The agency reports 8 patients who are COVID-19 positive. Interviews were conducted with the Director of Patient Services, Assistant Director of Patient Services, and clinical staff. All findings were discussed during the exit conference on 11/10/2021. The home health agency census was 2,805. The following deficiencies have been corrected: G-0526, G-0440, G-0544, G-0578, G-0586, W-0407, and R-0510. The following deficiencies remain uncorrected: G-0536, G-0574, G-0576, G-0590, G-0610, G-0716, and G-0800. The following deficiencies were identified as a result of this survey: G-0608, G-0718, and G-1022.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on clinical record review and interviews with agency staff, for two (2) of five (5) clinical records (Patient #'s: 3 and 5) lacks documented evidence of a complete review of all medications the patient currently uses to identify any potential adverse effects, drug reactions, or concerns. Specifically, the Registered Nurse (RN) failed to identify and reconcile all medication discrepancies identified in the referral for services and the Plan of Care (POC). 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 policy entitled “Medication Management” revised 12/09/2019 revealed the following: “A drug regimen review will be completed at a minimum, at start of care, resumption of care, recertification and at discharge. The PHV (Professional Home Visitor) shall reconcile the medication list by comparing it to at least one of the following: hospital discharge orders, written physician documentation, medication the patient is taking, bottles and packaging or medication administration record from residential facility, if applicable. When the PHV becomes aware of a medication discrepancy the PHV shall report this, as appropriate to the: physician, case manager, supervising therapist, other disciplines involved and appropriate pharmacy, if a dispensing error. A supplemental order may be required to clarify discrepancies.” Patient #3 – This 57-year-old patient with diagnoses that include bipolar disorder, alcoholic cirrhosis of liver and type II diabetes mellitus was admitted to the home care agency on 10/15/2021. A.) Review of the Ambulatory Progress Note (Physician referral to the home care agency) dated 10/05/2021 revealed the following medication orders: - Melatonin 10 mg (milligrams) SL (sublingual) tablet, take 10 mg by mouth at bedtime; - Nystatin Topical Powder apply 1 application topically 3 (three) times daily as needed (under abdominal folds/groin); - Sodium Chloride 0.65% nasal spray 2 sprays by nasal route 4 (four) times daily as needed for congestion; and - Thiamine HCL, Vitamin B1, 100 mg take 1 (one) tablet by mouth daily. Review of the Home Health Certification and Plan of Care for 10/15/2021 to 12/13/2021 lacks orders for Melatonin, Nystatin Topical Powder, Sodium Chloride Nasal Spray and Thiamine. Review of the clinical record lacks documented evidence that the physician was contacted regarding the medication discrepancies identified. B.) Review of the Ambulatory Progress Note (Physician referral to the home care agency) dated 10/05/2021 revealed the following medication orders: - Oxycodone 15 mg, take 7.5 mg by mouth every 8 (eight) hours: - Pantoprazole 40 mg tablet, take 1 (one) tablet by mouth 2 (two) times a day; and - Spironolactone 25 mg tablet, take 12.5 mg by mouth daily. Review of the Home Health Certification and Plan of Care for 10/15/2021 to 12/13/2021 revealed the following medication orders: - Oxycodone HCL 15 mg tablet, 5 mg TID (three times a day) PO (by mouth). - Pantoprazole Sodium 40 mg tablet, take 1 (one) tablet QD (every day) PO; and - Spironolactone 25 mg tablet 1 (one) tablet QD PO. Review of the clinical record lacks documented evidence that the physician was contacted regarding the discrepancies identified. C.) Review of the Home Health Certification and Plan of Care for 10/15/2021 to 12/13/2021 revealed the following orders: - Neomycin Sulfate 500 mg tablet 3 (three) tablets BID (two times a day) PO; - Propranolol HCL 20 mg tablet 1 (one) tablet BID PO; - Advil 200 mg tablet 2 (two) tablets as needed PO prn pain q (every) 8 (eight) hours; and - Tums 500 mg tablet 2 (two)- 3 (three) tablets as needed PO prn indigestion q 8 (eight) hours. Review of the Ambulatory Progress Note (Physician referral to the home care agency) dated 10/05/2021 lacks orders for Neomycin Sulfate, Propranolol HCL, Advil and Tums. Review of the clinical record lacks documented evidence that the physician was contacted regarding the medication discrepancies identified. The RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 10/29/2021 at 09:05 AM, the Assistant Director of Patient Services stated the RN who completed the 10/15/2021 assessment was unavailable to interview. During interview on 10/29/2021 at 09:10 AM, the Director of Branch Operations stated she would look for additional documentation to clarify the discrepancies. She stated occasionally physician referrals with visit note information arrive after the intake is created and possibly the RN did not have the office visit note information while completing the medication reconciliation. Patient #5- This 90-year-old patient with diagnoses that include COVID-19, pneumonia due to coronavirus disease, chronic obstructive pulmonary disease was admitted to the home care agency on 10/17/2021. A.) Review of the referral to the agency dated 10/15/2021 revealed the following orders: - Spironolactone 25 mg (milligrams) tablet 0.5 tablet by mouth daily - Vitamin E 1000 units capsule take 400 units by mouth daily Review of the Home Health Certification and Plan of Care for 10/17/2021 to 12/15/2021 lacks orders for Spironolactone and Vitamin E. Review of the clinical record lacks documented evidence that the physician was contacted regarding the medication discrepancies identified. The RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 10/29/2021 at 09:48 AM, the RN stated she looked at the after-visit summary (AVS) that was in the patient’s home, along with the bottles in the patient’s home and must have missed these medications. B.) Review of the referral to the agency dated 10/15/2021 revealed the order for Fluticasone-Salmeterol 100-50 mcg (micrograms)/dose diskus inhaler (commonly known as Advair) inhale 1 puff by mouth every 12 hours. Review of the Home Health Certification and Plan of Care for 10/17/2021 to 12/15/2021 revealed the order Advair diskus inhaler aerosol powder breath activated 100-50 mcg/dose 1 inhalation every evening. Review of the clinical record lacks documented evidence that the physician was contacted regarding the medication discrepancies identified. The RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 10/29/2021 at 09:49 AM, the RN stated she did not recall speaking to the physician regarding this discrepancy. C.) Review of the Home Health Certification and Plan of Care for 10/17/2021 to 12/15/2021 revealed the following orders: - Ibuprofen by mouth tablet 200 mg 1-2 tablets every 12 hours by mouth for pain - Lidocaine external patch 4% (percent) 1 patch every 12 hours external as needed for pain - Osteo Bi-Flex triple strength by mouth 1 tablet every morning Review of the referral to the agency dated 10/15/2021 revealed the patient is to stop taking the Lidocaine patch and lacks orders for Ibuprofen or Osteo Bi-Flex. Review of the clinical record lacks documented evidence that the physician was contacted regarding the medication discrepancies identified. The RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 10/29/2021 at 09:49 AM, the RN stated she had some difficulty sorting out the patient’s old medications with what she is currently taking but did not document communication with the physician regarding the discrepancies.

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, agency policies and procedures, and staff interviews for three (3) of five (5) patients (Patient #s: 2, 3, 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. The issues are: - The POC lacks locations for administration of topical medications (Patient #2). - The POC lacks a rate for an infusion per policy (Patient #2). - The frequencies for bathing the patient on the aide POC are inconsistent with the order for Home Health Aide (HHA) frequencies (Patient #5). - The POC lacks an order for blood glucose testing (Patient #3). Failure to ensure that a comprehensive individualized plan of care is developed has the potential for unmet patient needs. Patient #2 – This 71-year-old patient with diagnoses that include aphasia following cerebral infarction, chronic lymphocytic leukemia of B-cell type not having achieved remission, and urethral stricture was admitted to the home care agency on 05/05/2021. A.) Review of the Home Health Certification and Plan of Care for 05/05/2021 to 07/03/2021 revealed the orders: - Calcipotriene External Ointment 0.005% 1 application 2 times a day external - Halobetasol Propionate External Cream 0.05% 1 application every day external Review of the POC lacks documented locations for administration of the topical medications. The POC lacks locations for administration of topical medications. During interview on 10/29/2021 at 10:15 AM, the Registered Nurse (RN) stated she did not include a location for the topical medications on the POC. B.) Review of the agency’s policy entitled “Immunoglobin (IGG)” approved 02/16/2021 revealed “D. Administration of subcutaneous IgG is per physician orders.” Review of the Home Health Certification and Plan of Care for 05/05/2021 to 07/03/2021 revealed the order for Xembify (IgG) subcutaneous solution 10 gm/50 ml 10 grams every week subcutaneous, Thursdays. Review of the POC lacks documented evidence of a rate of infusion or instructions for administration. The POC lacks a rate for an infusion per policy. During interview on 10/29/2021 at 10:15 AM, the RN stated that the medication was not in the home at the start of care. When the medication did become available is when she learned it was an infusion versus an injection. She states she forgot to go back to revise the order. Patient #5- This 90-year-old patient with diagnoses that include COVID-19, pneumonia due to coronavirus disease, chronic obstructive pulmonary disease was admitted to the home care agency on 10/17/2021. Review of the Home Health Certification and Plan of Care for 10/17/2021 to 12/15/2021 revealed the order for HHA 1 (one) to 3 (three) times a week for nine (9) weeks, each visit is three (3) hours of duration. Review of the clinical record from 10/17/2021 to 10/23/2021 revealed the HHA provided services on 10/22/2021. Review of the aide POC revealed the RN directs the HHA to provide partial showers 2 (two) to 3 (three) times a week. The frequencies for bathing the patient on the aide POC are inconsistent with the order for HHA frequencies. During interview on 10/29/2021 at 09:46 AM, the RN stated the standard order for HHA services is 1 to 3 times a week. The patient’s caregiver has agreed to help bath the patient on the days the HHA is not there. However, the aide POC should only reflect what services the HHA is providing and not account for what the caregiver is doing. Patient #3 – This 57-year-old patient with diagnoses that include bipolar disorder, alcoholic cirrhosis of liver and type II diabetes mellitus was admitted to the home care agency on 10/15/2021. Review of the Home Health Certification and Plan of Care for 10/15/2021 to 12/13/2021 revealed the following orders: - DME (Durable Medical Equipment) / Supplies: diabetic testing equipment; - Assess blood glucose (BG); - Notify MD of BG less than 70 or greater than 250 mg/ dl (milligrams per deciliter); - Person responsible for testing BG: Self; and - Patient, Caregiver or SN (Skilled Nurse) to check BG. Review of the clinical record lacks documented evidence of an order for blood glucose testing to include a frequency. The POC lacks an order for the frequency to perform blood glucose testing. During interview on 10/29/2021 at 09:10 AM, the Director of Branch Operations stated the SN who developed the POC is off and unable to be interviewed. The Director of Branch Operations stated the frequency to check the BG’s is not specified on the POC and should be.

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, one (1) of five (5) patient records (Patient #2) lacked evidence an order was obtained to update the Plan of Care (POC) to reflect the patient's status. Specifically, the clinical record lacks an order to discharge the patient. 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 #2 – This 71-year-old patient with diagnoses that include aphasia following cerebral infarction, chronic lymphocytic leukemia of B-cell type not having achieved remission, and urethral stricture was admitted to the home care agency on 05/05/2021. Review of the discharge summary dated 10/28/2021 (date of survey) revealed the patient was discharged on 05/17/2021 (approximately 5 months prior to date of discharge summary). Review of the clinical record from 05/05/2021 to 05/17/2021 lacks an order to discharge the patient. The clinical record lacks an order to discharge the patient. During interview on 11/01/2021 at 11:25 AM, the Director of Patient Services stated the agency did not obtain an order to discharge the patient.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with agency staff, for one (1) of five (5) patients (Patient #3), the agency failed to ensure the physician is notified of changes in the patient's condition or needs that suggest that the Plan of Care (POC) may need to be altered. Specifically, the Registered Nurse (RN) failed to notify the physician of changes in blood glucose monitoring and medication noncompliance. Failure to promptly notify the physician to changes in the patient's condition or needs that may suggest that outcomes are not being achieved and/or the POC should be altered has the potential to result in unmet patient needs and negative patient outcomes. Patient #3 – This 57-year-old patient with diagnoses that include bipolar disorder, alcoholic cirrhosis of liver and type II diabetes mellitus was admitted to the home care agency on 10/15/2021. Review of the Home Health Certification and Plan of Care from 10/15/2021 to 12/13/2021 revealed the patient is ordered to take Metformin HCL ER 500 milligrams (mg’s) two times a day by mouth for lowering blood glucoses (BG's) and BG’s are to be assessed by patient, caregiver or SN (Skilled Nurse) (frequency of testing not specified). The Physician is to be notified of BG’s less than 70 or greater than 250 mg/dl (milligram per deciliter). Review of the SN Start of Care Further Visits Planned Visit Note dated 10/15/2021 revealed the RN documented the following: - Frequency of BG testing (actual- not ordered): BID (twice daily); - Blood Glucose: Post prandial (taken after a meal) blood glucose this visit: 343; - Comments: History of non-compliance with medications; - Care Coordination: BG at time of visit 343, MD aware, reviewed all meds.” The 10/15/2021 visit documentation lacks documented evidence the physician was notified of medication non-compliance identified. Review of the SN Routine Visit Note dated 10/20/2021 revealed the RN documented the following: - “Frequency of BG testing (actual- not ordered): PRN (as needed); - Blood Glucose: Random BG this visit: 248; - Comments: Patient only tests on occasion and encouraged to test more frequently. - Care Coordination: It appears the patient only took approximately 50% of medications in last week (mediset filled on 10/15/2021). Nurse encouraged patient to take all meds as ordered. MD made aware.” The 10/20/2021 visit documentation lacks documented evidence the physician was notified the patient is now testing BG’s as needed. Review of the SN Routine Visit Note dated 10/27/2021 revealed the RN documented the following: - “Frequency of BG testing (actual- not ordered): Daily; - Blood Glucose: Post prandial blood glucose this visit: 436; - Comments: MD made aware of elevated BG levels. - Care Management: Pt. did take approximately 80% of meds this past week (mediset filled 10/20/2021). MD called about elevated BG levels and also requested refills for medications needed.” The 10/27/2021 visit documentation lacks documented evidence the physician was notified of the change in BG testing frequency and medication non-compliance identified. Review of the clinical record lacks documented evidence the physician was notified of identified changes in the patient’s diabetic status. The RN failed to notify the physician regarding changes in the patient’s status. During interview on 10/29/2021 at 09:15 AM, the Director of Branch Operations stated the RN was off and unavailable to be interviewed. She stated she would look for additional documentation regarding physician notification of the identified changes in status. On 11/01/2021 at 10:00 AM, the Clinical Regulatory Compliance Specialist sent an electronic message (email) to this Surveyor that stated on 10/27/2021 (twelve days after the start of care), the RN documented notifying the physician of elevated BG’s and refills needed for medications. She specified based on that documentation, it is implied that “the BG frequency was in the process of being determined and medications and compliance would have been discussed during this call.”

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 five (5) patients (Patient #2), the agency failed to coordinate care delivery to meet the patient's needs. Specifically, the agency failed to ensure the patient received medication as ordered. Failure to coordinate care delivery has the potential for negative patient outcomes. Patient #2 – This 71-year-old patient with diagnoses that include aphasia following cerebral infarction, chronic lymphocytic leukemia of B-cell type not having achieved remission, and urethral stricture was admitted to the home care agency on 05/05/2021. Review of the referral to the agency dated 05/04/2021 revealed the order for IgG (Immunoglobulin G) 10 grams/50 mL (milliliters) (20% (percent)) solution 10 grams, abdominal subcutaneous, weekly on Thursday. The medication was last given on 04/29/2021. Review of the Home Health Certification and Plan of Care for 05/05/2021 to 07/03/2021 revealed the order for Xembify (IgG) subcutaneous solution 10 gm/50 ml 10 grams every week subcutaneous, Thursdays. Review of the Start of Care further visits planned Visit Note dated 05/05/2021 revealed the Registered Nurse (RN) documented “Patient has IGG subcutaneous injection each Thursday, patient used to administer to self but since coming home, patient’s spouse will need to administer… SN (Skilled Nurse) visit tomorrow for injection would be helpful for patient’s spouse to demonstrate.” Review of the Clinical Note dated 05/06/2021 revealed the RN documented a phone call to the patient’s wife to set up visit to review subcutaneous injections. The medication was not delivered, and it was discovered the physician did not order it, and it should be delivered by the following Monday. Review of the Routine Visit Note dated 05/10/2021 revealed the LPN (Licensed Practical Nurse) documented “patient is due for subcutaneous medication, writer not familiar with process, notified MD (medical doctor)/CM (case manager). CM to set up with patient. Review of the Routine Visit Note dated 05/14/2021 revealed the RN documented “Patient’s IGG subcutaneous infusion will be rescheduled early next week on Monday… IV (intravenous) specialist will co-visit with SN to provide education for spouse.” Review of the discharge summary dated 10/28/2021 (date of survey) revealed the patient was discharged on 05/17/2021, “wife requesting all home care services cancelled… Per TMS (Team Medical Secretary) MD (medical doctor) was notified by wife that she was cancelling all home care services.” Review of the clinical record from 05/05/2021 to 05/17/2021 lacks documented evidence the RN’s administered the medication, or that the physician was notified after the notification made by the LPN on 05/10/2021. The agency failed to ensure the patient received medication as ordered. During interview on 10/29/2021 at 10:00 AM, the RN stated while she was doing the start of care visit, she thought the subcutaneous medication was an injection (because it was not in the home and the referral was not clear). When the LPN (not available for interview) went to the home on 05/10/2021 she discovered the medication was an infusion and not an injection. At that time contacted the case manager, she did not administer the medication. However, it was not passed on to the RN (not available for interview) who went to the home on 05/14/2021 that the medication is an infusion. The RN did not feel comfortable administering the medication and at that time requested a co-visit with an RN from the IV team early the following week. She stated the IV team should have been consulted on the first visit in which it was discovered the medication is to be administered as an infusion, but that communication did not happen.

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 #2), the agency failed to ensure the patient/caregiver receives appropriate education regarding the care and services identified in the plan of care (POC). Failure to provide appropriate education has the potential to result in the patient receiving inadequate care and could result in patient harm. Patient #2 – This 71-year-old patient with diagnoses that include aphasia following cerebral infarction, chronic lymphocytic leukemia of B-cell type not having achieved remission, and urethral stricture was admitted to the home care agency on 05/05/2021. Review of the referral to the agency dated 05/04/2021 revealed the order for IgG (Immunoglobulin G) 10 grams/50 mL (milliliters) (20% (percent)) solution 10 grams, abdominal subcutaneous, weekly on Thursday. The medication was last given on 04/29/2021. Review of the Home Health Certification and Plan of Care for 05/05/2021 to 07/03/2021 revealed the order for Xembify (IgG) subcutaneous solution 10 gm/50 ml 10 grams every week subcutaneous, Thursdays. Additionally, the SN (Skilled Nurse) is ordered to “provide individualized medication instruction and regimen.” Review of the Start of Care further visits planned Visit Note dated 05/05/2021 revealed the Registered Nurse (RN) documented “Patient has IGG subcutaneous injection each Thursday, patient used to administer to self but since coming home, patient’s spouse will need to administer… SN (Skilled Nurse) visit tomorrow for injection would be helpful for patient’s spouse to demonstrate.” Review of the Clinical Note dated 05/06/2021 revealed the RN documented a phone call to the patient’s wife to set up visit to review subcutaneous injections. The medication was not delivered, and it was discovered the physician did not order it, and it should be delivered by the following Monday. Review of the Routine Visit Note dated 05/10/2021 revealed the LPN (Licensed Practical Nurse) documented “patient is due for subcutaneous medication, writer not familiar with process, notified MD (medical doctor)/CM (case manager). CM to set up with patient. Review of the Routine Visit Note dated 05/14/2021 revealed the RN documented “Patient’s IGG subcutaneous infusion will be rescheduled early next week on Monday… IV (intravenous) specialist will co-visit with SN to provide education for spouse.” Review of the discharge summary dated 10/28/2021 (date of survey) revealed the patient was discharged on 05/17/2021, “wife requesting all home care services cancelled… Per TMS (Team Medical Secretary) MD (medical doctor) was notified by wife that she was cancelling all home care services.” Review of the clinical record from 05/05/2021 to 05/17/2021 lacks documented evidence the patient’s spouse received education regarding the administration of the subcutaneous infusion. The agency failed to ensure the patient’s spouse received education regarding the administration of the subcutaneously infused medication. During interview on 10/29/2021 at 10:00 AM, the RN stated while she was doing the start of care visit, she thought the subcutaneous medication was an injection (because it was not in the home and the referral was not clear). When the LPN (not available for interview) went to the home on 05/10/2021 she discovered the medication was an infusion and not an injection. At that time contacted the case manager, she did not administer the medication. However, it was not passed on to the RN (not available for interview) who went to the home on 05/14/2021 that the medication is an infusion. The RN did not feel comfortable administering the medication and at that time requested a co-visit with an RN from the IV team early the following week. She stated the IV team should have been consulted on the first visit in which it was discovered the medication is to be administered as an infusion, but that communication did not happen.

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. Specifically, inconsistent documentation exists regarding medication reconciliation. Failure to ensure clinical notes accurately reflect the patient's current status has the potential for unmet patient needs. Patient #3 – This 57-year-old patient with diagnoses that include bipolar disorder, alcoholic cirrhosis of liver and type II diabetes mellitus was admitted to the home care agency on 10/15/2021. Review of the SN (Skilled Nurse) Start of Care- Further Visits Planned Visit Note dated 10/15/2021 revealed the SN documented the following regarding medication reconciliation: - “Did a complete drug regimen review identify potential clinically significant medication issues? Yes- issues found during review. - Did the agency contact a physician (or physician- designee) by midnight of the next calendar day and complete prescribed /recommended actions in response to the identified potential clinically significant medication issues? Yes. - Medication Reconciliation: No discrepancies identified. - Review of drug regimen comments: History of medication non-compliance.” The clinical record is inconsistent regarding if issues were identified with medication reconciliation. During interview on 10/29/2021 at 09:22 AM, the Clinical Team Manager stated the Registered Nurse (RN) that completed the 10/15/2021 assessment is off and unable to be interviewed. She stated the RN identified medication non-compliance problems during the visit. She surmised that the RN found no issues when looking at the medication bottles in the home and documented no discrepancies were identified.

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 clinical record review and staff interview for one (1) of five (5) clinical records (Patient #2), the agency failed to ensure agency staff communicated with the patient's physician regarding the failure to administer a medication as ordered. Failure to communicate with the physician involved in the patient's care has the potential for unmet patient needs and negative outcomes. Patient #2 – This 71-year-old patient with diagnoses that include aphasia following cerebral infarction, chronic lymphocytic leukemia of B-cell type not having achieved remission, and urethral stricture was admitted to the home care agency on 05/05/2021. Review of the referral to the agency dated 05/04/2021 revealed the order for IgG (Immunoglobulin G) 10 grams/50 mL (milliliters) (20% (percent)) solution 10 grams, abdominal subcutaneous, weekly on Thursday. The medication was last given on 04/29/2021. Review of the Home Health Certification and Plan of Care for 05/05/2021 to 07/03/2021 revealed the order for Xembify (IgG) subcutaneous solution 10 gm/50 ml 10 grams every week subcutaneous, Thursdays. Review of the Start of Care further visits planned Visit Note dated 05/05/2021 revealed the Registered Nurse (RN) documented “Patient has IGG subcutaneous injection each Thursday, patient used to administer to self but since coming home, patient’s spouse will need to administer… SN (Skilled Nurse) visit tomorrow for injection would be helpful for patient’s spouse to demonstrate.” Review of the Clinical Note dated 05/06/2021 revealed the RN documented a phone call to the patient’s wife to set up visit to review subcutaneous injections. The medication was not delivered, and it was discovered the physician did not order it, and it should be delivered by the following Monday. Review of the Routine Visit Note dated 05/10/2021 revealed the LPN (Licensed Practical Nurse) documented “patient is due for subcutaneous medication, writer not familiar with process, notified MD (medical doctor)/CM (case manager). CM to set up with patient. Review of the Routine Visit Note dated 05/14/2021 revealed the RN documented “Patient’s IGG subcutaneous infusion will be rescheduled early next week on Monday… IV (intravenous) specialist will co-visit with SN to provide education for spouse.” Review of the discharge summary dated 10/28/2021 (date of survey) revealed the patient was discharged on 05/17/2021, “wife requesting all home care services cancelled… Per TMS (Team Medical Secretary) MD (medical doctor) was notified by wife that she was cancelling all home care services.” Review of the clinical record from 05/05/2021 to 05/17/2021 lacks documented evidence the RN’s administered the medication, or that the physician was notified after the notification made by the LPN on 05/10/2021. The agency failed to ensure agency staff communicated with the patient's physician regarding the failure to administer a medication as ordered. During interview on 10/29/2021 at 10:00 AM, the Director of Patient Services stated she would look for documented phone calls to the physician, only the communication from 05/10/2021 was provided.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on review of clinical records and interview with agency staff, for one (1) of one (1) patients receiving Home Health Aide Services (Patient #5), the agency failed to ensure the Home Health Aide (HHA) provides services as directed on the aide plan of care (POC). Failure to follow the Plan of Care has the potential to result in inadequate care. Patient #5- This 90-year-old patient with diagnoses that include COVID-19, pneumonia due to coronavirus disease, chronic obstructive pulmonary disease was admitted to the home care agency on 10/17/2021. Review of the Home Health Certification and Plan of Care for 10/17/2021 to 12/15/2021 revealed the order for HHA 1 (one) to 3 (three) times a week for nine (9) weeks, each visit is three (3) hours of duration. Review of the clinical record from 10/17/2021 to 10/23/2021 revealed the HHA provided services on 10/22/2021. Review of the aide POC revealed the RN directs the HHA to provide partial showers 2 (two) to 3 (three) times a week. The agency failed to ensure the HHA provides services as directed on the aide plan of care. During interview on 10/29/2021 at 09:46 AM, the RN stated The HHA did not see the patient twice that week so did not assist with bathing 2 (two) to 3 (three) times a week as ordered.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on review of clinical records, agency policy and procedure, and interviews with agency staff, for one (1) of one (1) discharged patients (Patient #2), the agency failed to send the completed discharge summary to the primary care practitioner within 5 (five) business days of the date of the order for discharge. Failure to send the discharge summary to the primary care practitioner within the required timeframe has the potential for unmet patient needs and an unsafe discharge. Review of the agency’s policy entitled “Agency Admission and Discharge” dated 02/11/2019 revealed “A discharge summary is available to the physician upon request.” Patient #2 – This 71-year-old patient with diagnoses that include aphasia following cerebral infarction, chronic lymphocytic leukemia of B-cell type not having achieved remission, and urethral stricture was admitted to the home care agency on 05/05/2021. Review of the discharge summary dated 05/17/2021 revealed the patient was discharged on 05/17/2021. Review of the clinical record lacks documented evidence the agency sent the discharge summary to the primary care provider within 5 (five) business days of the patient’s discharge. During interview on 10/29/2021 at 10:10 AM, the Director of Patient Services stated she would look for documented evidence to state when the discharge summary was sent to the physician. No further information was provided.