Willcare Chha (Buffalo)

“Condition of Participation: Patient rights. CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient’s rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This Condition is not met as evidenced by: Based on record reviews and interviews with the Executive Director, Clinical Manager, Business Manager of Home Health, Patient Care Managers of Home Health, and clinical staff it was determined this condition was not met as evidenced by: Failure to obtain the patient’s or legal representative’s signature confirming that they have received a copy of the notice of rights and responsibilities. See G-0418. Failure to provide all services outlined in the plan of care. See G-0436. Failure to provide the following information orally and in writing, of (i) The extent to which payment for Home Health Agency services may be expected from Medicare, Medicaid, or any other federally funded or federal aid program known to the Home Health Agency, (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 Home Health Agency, (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 Home Health Agency must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. See G-0440. Failure to only discharge the patient if the transfer or discharge is appropriate because the physician or allowed practitioner who is responsible for the home health plan of care and the Home Health Agency agree that the measurable outcomes and goals set forth in the plan of care in accordance with §484.60(a)(2)(xiv) have been achieved, and the Home Health Agency and the physician or allowed practitioner who is responsible for the home health plan of care agree that the patient no longer needs the Home Health Agency’s services. See G-0458. The cumulative effect of these systemic issues related to the adherence to patient’s rights resulted in negative outcomes for Patients #’s: 8, 10, 11, 13, 15, and 17 and the potential for negative outcomes for the agency’s patient population.”

“Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient’s eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This Condition is not met as evidenced by: Based on record reviews and interviews with the Executive Director, Clinical Managers, Business Manager of Home Health, Patient Care Managers of Home Health, and clinical staff it was determined this condition was not met as evidenced by: Failure of the Registered Nurse to conduct an initial assessment within 48 (forty-eight) hours of referral, within 48 (forty-eight) hours of the patient’s return home, or on the physician-ordered start of care date. See G-0514. Failure to ensure nursing assessments are complete and consistently reflect the patient’s status and needs. See G-0528. Failure to conduct a review of all medications the patient is currently using. See G-0536. Failure to document information regarding the patient’s legal representative. See G-0540. Failure to update and revise the comprehensive assessment as frequently as the patient’s condition warrants. See G-0544. Failure to update the comprehensive assessment at discharge to include a summary of the patient’s progress in meeting the care plan goals. See G-0550. The cumulative effect of these systemic issues related to the performance of comprehensive assessments resulted in negative outcomes for Patients #’s: 1, 2, 5, 6, 7, 8, 10, 11, 12, 13, 14, and 17 and the potential for negative outcomes for the agency’s patient population.”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on record reviews and interviews with the Executive Directors, Business Manager of Home Health, Patient Care Managers of Home Health, and clinical staff it was determined this condition was not met as evidenced by: Failure to develop comprehensive plans of care addressing each patient’s individual needs. See G-0574. Failure to ensure all orders are on the plan of care. See G-0576. Failure to ensure drugs, services, and treatments are administered in accordance with physician orders. See G-0580. Failure to develop updated plans of care. See G-0588. Failure to promptly alert relevant physician of changes in patient’s status. See G-0590. Failure to provide communication with all physicians involved in the plan of care. See G-0602. Failure to coordinate care delivery involving patients. See G-0608. Failure to provide ongoing education. See G-0610. The cumulative effect of these systemic issues related to care planning, coordination and quality of care resulted in negative outcomes for Patients #’s: 1, 2, 3, 4, 6, 8, 9, 10, 11, 13, 14, 15, 16 and 17 and the potential for negative outcomes for the agency’s patient population.”

“Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This Standard is not met as evidenced by: Based on record reviews and staff interviews, the agency failed to ensure that all completed Outcome and Assessment Information Set assessments (M0090) were transmitted to the State/Centers for Medicare and Medicaid Services within thirty (30) days of completion. This is evident for one (1) of one (1) clinical records reviewed that required transmission (Patient #4). Failure to ensure that all completed Outcome and Assessment Information Set assessments are transmitted to the Centers for Medicare and Medicaid Services contractor or state within 30 (thirty) days has the potential for negative patient outcomes. The agency failed to ensure that all completed Outcome and Assessment Information Set assessments (M0090) are transmitted to the Centers for Medicare and Medicaid Services contractor or state within 30 (thirty) days as evidenced by: Pre-survey the “Home Health Agency Error Summary Report” on 09/09/2024 revealed the agency has 283 (two hundred and eighty-three) late submissions of the Outcome and Assessment Information Set assessments (M0090) from 09/06/2023 to 08/22/2024. Patient #4 – This 96- year-old therapy-only patient with the diagnoses of unspecified dementia with mood disturbance and anxiety, vascular dementia with psychotic disturbances and anxiety, and major depressive disorder was admitted to the home care agency on 05/15/2024 and discharged on 09/06/2024. Review of the Physical Therapy Outcome and Assessment Information Set Start of Care completed by the Physical Therapist revealed the Outcome and Assessment Information Set Assessment (M0090) was completed on 05/15/2024. Review of the Home Health Agency Error Submission Report provided by the agency on 09/11/2024 at 01:15 PM revealed the patient’s Outcome and Assessment Information Set Assessment (M0090) was submitted on 08/22/2024 (99 (ninety-nine)) days after the assessment was complete. During interview on 09/16/2024 at 01:48 PM, the Patient Care Manager of Home Health (Buffalo), Registered Nurse stated sometimes coding, or waiting on orders/clarification from physician can hold up submission but the agency is working on a process to fix the issue.”

“Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient’s status at the time of assessment. This Standard is not met as evidenced by: Based on review of the agency’s outcome assessment information set (OASIS) submissions, clinical records, and interviews with agency staff, for one (1) of seventeen (17) patients (Patient #14), the agency failed to ensure the OASIS data accurately reflects the patient’s status at the time of the assessment. Failure to ensure accurate documentation of OASIS data has the potential for negative outcomes. The agency failed to ensure OASIS data accurately reflects the patient’s status at the time of the assessment as evidenced by the following: Patient #14 – This 76-year-old patient with diagnoses that include non-pressure chronic ulcer of the left ankle and venous insufficiency was admitted to the home care agency on 08/29/2024. Review of RN (Registered Nurse) OASIS (outcome and assessment information set) Admission Visit Note dated 08/29/2024 revealed the following: - Diagnosis 1 (one)- venous insufficiency (chronic, peripheral); - Diagnosis 2 (two)- peripheral vascular disease, unspecified; - Current number of stage 1 pressure injuries: 0 (zero); - Does the patient have at least one unhealed pressure ulcer/injury at stage 2 or higher or designated as unstageable? No; - Stage of most problematic unhealed pressure ulcer/ injury that is stageable: N/A (not applicable); - Does this patient have a stasis ulcer? No; - Does this patient have a surgical wound? No; - Indicate Integumentary Assessment Findings: Wound(s). Additionally, the RN documented the patient is referred to home health after an appointment on 08/28/2024 with the primary care physician revealed chronic non-pressure left ankle ulcers. The assessment lacks documentation of the type of wound the patient has. During interview on 09/17/2024 at 12:45 PM, the RN stated the OASIS question was answered incorrectly as the patient has LLE stasis ulcers.”

“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 two (2) of seventeen (17) patients (Patient #8 and 14) 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 comprehensive assessments are updated and revised as evidenced by the following: Review of the agency’s Elsevier Nasogastric (NG) Guidance (approved Clinical Skills Online program) dated 07/2024 revealed that the guidelines covered the following topics: administration of tube feeds, NG tube placement verification, NG tube insertion, administration of medications via the NG tube, NG tube removal, assessing for gastric aspirate (residuals), skin care, irrigation of the NG tube, and measuring external portion of NG tube for migration. Patient #8- This 65-year-old patient with diagnoses that include malignant neoplasm of unspecified part of right bronchus or lung, gastrostomy malfunction and gastrostomy infection was admitted to the home care agency on 12/22/2023 and discharged 03/06/2024. A.) Review of the Home Health Certification and Plan of Care for 12/22/2023 to 02/19/2024 revealed “Skilled Nurse (SN) for instruction of gastrointestinal system including Corpak (type of Nasogastric tube), GI (gastrointestinal) hemorrhage, peritonitis due to dislodgment of existing [the patient did not have a PEG (percutaneous endoscopic gastrostomy) tube]. Corpak NG (nasogastric) tube replaced on 11/22/2023. Patient to receive Osmolite 1.5 65 ml (milliliter) /hr (hour) via Kangaroo pump continuous with 90 ml water flush every 4 (four) hours. SN to instruct on new and changed medications, those with assessed knowledge deficit, high risk medications and any applicable drug interactions. SN to instruct/ supervise patient /caregiver on strict NPO (nothing by mouth) (for patient).” Review of the clinical record revealed the SN made the following visits after the initial start of care assessment occurring on 12/22/2023: 12/26/2023, 12/29/2023, 01/03/2024, 01/22/2024, 01/29/2024, and 02/06/2024. Review of the SN visits from 12/26/2023 to 02/06/2024 revealed the following; There is no documentation the SN assessed and documented the size of the NG tube. -There is no documentation that the SN assessed tube feed residuals, per agency guidance (standards). -There is no documentation the SN obtained a baseline measurement of the external portion of the Corpak NG and verified placement of the NG by auscultation of the abdomen. -There is no documentation that the Registered Nurse (RN) contacted the physician to determine when the NG tube required replacement. During interview on 09/23/2024 at 11:00 AM, the Clinical Manager stated the Corpak NG tube does not require an assessment of residuals or the need to check for migration by measuring the external portion of the tube. During interview on 09/23/2024 at 11:19 AM, the Executive Director stated the agency has no protocol or policy to follow regarding the Corpak NG and the RN’s failed to verify and document the care/assessment for the Corpak NG that was ordered per the physician. B.) Review of the SN Visit Note dated 02/06/2024 revealed the RN documented “the patient has a new mediport to left chest, incision is open to air and well approximated, no s/sx (signs or symptoms) of infection. Discussed care of site…Site care not performed.” There is no documentation of the port insertion date, date of last port access and flush, assessment and clarification with the physician regarding future port care and maintenance. During interview on 09/17/2024 at 03:35 PM, the RN stated the Oncologist would be managing the mediport and providing all future port care and maintenance but the RN failed to document this. C.) Review of the agency policy entitled “Pain Assessment” revised 02/01/2024 revealed “The clinician will …assess pain…during each skilled visit. A score of 7 (seven) or greater on any of the pain assessment tools is indicative of severe pain, which will require physician notification and patient appropriate interventions.” Review of the Home Health Certification and Plan of Care for 12/22/2023 to 02/19/2024 revealed the order for the SN to perform the following treatments: - Instruct on non-small cell lung cancer to include disease process, nutrition and hydration status, complications, and management. - SN to monitor pain and instruct patient regarding pharmacologic and non-pharmacologic pain control measures such as deep breathing. - Additionally, there is an order for oxycodone 5 mg (milligram), take 1 (one) tablet via nasogastic tube crushed every 4 (four) hours as needed for severe pain (the plan of care does not define what is meant by severe pain). Review of the Resumption of Care Physician Order dated 01/22/2024 revealed a new order for Tylenol 325 mg crush 2 (two) tablets every 6 (six) hours and administer to NG tube for mild to moderate pain (the plan of care does not define what is meant by mild to moderate pain). Review of the SN Visit Note dated 02/06/2024 revealed the RN documented the patient reports pain 10 on scale of 0 to 10 (with 0 being no pain and 10 the worst pain), generalized and relieved with rest, prescription pain medication and over the counter medication. Pulse- 128 radial. Additionally, the RN documented, “Called and discussed elevated vital signs and increased pain with nurse [Ruth] at physician’s office.” There is no documentation that the RN assessed how often the patient had taken the oxycodone and tylenol (amount, dose, frequency) and the efficacy of the current pain regime. Furthermore, there is no documentation the RN received new orders for pain management and there is no documentation the RN implemented appropriate interventions to assist the patient with non-pharmacological pain relief measures. During interview on 09/17/2024 at 03:40 PM, the RN stated being unable to recall the specifics of the visit and acknowledged there is no documentation of assessing the type, quantity and frequency of the pain meds the patient was using at that time. Additionally, the RN stated the patient’s pain was reported to the physician’s office and recalls no changes in pain medication occurred. The RN stated this information was not documented in the patient’s record. D.) Review of the Home Health Certification and Plan of Care for 02/20/2024 to 04/19/2024 revealed orders for: - SN to instruct on administration of nasogastric feedings, Osmolite 1.5, 65 ml per hour via pump. Instructions to include safety measures, care of equipment and preparation of feedings. Flush with 90 ml of water every 4 (four) hours. - SN to instruct on new and changed medications, those with assessed knowledge deficit, high risk medications and any applicable drug interactions. The plan of care states “Patient has an NG tube with continuous feedings managed by his wife.” Review of the RN Recert with Skill Visit Note dated 02/15/2024 revealed the patient is NPO and has a NG tube in place. There is no documentation of an assessment of the size, type and date of last NG tube change, an assessment of tube feed residuals, a measurement of the external portion of the Corpak NG and evidence the RN verified placement of the NG by auscultation of the abdomen. Additionally, there is no documentation that the RN contacted the physician to determine when the NG tube required replacement. Review of the subsequent SN visits that occurred on 02/21/2024, 02/28/2024 and 03/06/2024 lack assessments of the size and type and date of last NG tube change, and no documentation that the RN assessed tube feed residuals, obtained a measurement of the external portion of the Corpak NG and verified placement of the NG by auscultation of the abdomen. Additionally, there is no documentation that the RN contacted the physician to determine when the NG tube required replacement. During interview on 09/17/2024 at 04:18 PM, the RN stated that the RN did not have much experience working with NG tubes and failed to assess the identified components of the NG tube and follow-up with the physician regarding when the NG tube needed to be replaced. During interview on 09/23/2024 at 11:00 AM, the Clinical Director stated the Corpak NG tube does not require an assessment of residuals or the need to check for migration by measuring the external portion of the tube. During interview on 09/23/2024 at 11:19 AM, the Executive Director stated the agency has no protocol or policy to follow regarding the Corpak NG and the RN failed to verify and document the care/assessment for the Corpak NG that was ordered per the physician. E.) Review of the Home Health Certification and Plan of Care for 02/20/2024 to 04/19/2024 revealed the patient has a mediport that is cared for by the Oncologist and the agency may receive orders regarding the mediport from the Oncologist. Review of the RN Recert With Skill Visit Note dated 02/15/2024 revealed the RN documented the patient has a mediport to the left chest, site clean and dry and no site care was performed. There is no documentation of the port insertion date, date of last port access and flush, assessment and clarification with the physician regarding future port care and maintenance. During interview on 09/17/2024 at 03:35 PM, the RN stated the Oncologist would be managing the mediport and providing all future port care and maintenance but failed to document this. F.) Review of the agency policy entitled “Pain Assessment” revised 02/01/2024 revealed “The clinician will …assess pain…during each skilled visit. A score of 7 (seven) or greater on any of the pain assessment tools is indicative of severe pain, which will require physician notification and patient appropriate interventions.” Review of the Home Health Certification and Plan of Care for 02/20/2024 to 04/19/2024 revealed the following orders: - SN to monitor pain and instruct patient regarding pharmacologic and non-pharmacologic pain control measures such as positioning. - SN to instruct on lung cancer with mets (metastasis) to liver to include disease process, nutrition and hydration status, complications and management. Medications ordered for pain: - Oxycodone 5 mg tablet 1 (one) tablet administered crushed through nasogastric tube every 4 (four) hours as needed for severe pain; and - Tylenol 325 mg tablet 2 (two) tablets administered crushed through nasogastric tube every 6 (six) hours for mild to moderate pain. Review of the RN Recert With Skill Visit Note dated 02/15/2024 revealed the RN documented the patient is having generalized pain rated a 10 on a 0-10 scale, pain is interfering with the patient’s activities and the pain is relieved by rest and prescription pain medication. Additionally, the RN spoke with the nurse at the physician’s office [Ruth] and a verbal order was received for the plan of care. There is no documentation of an assessment of the quantity and frequency of oxycodone the patient is using and any interventions being performed regarding the severe pain. Review of the SN Visit Note dated 02/21/2024 revealed the RN documented the patient has generalized pain rated 9 of a scale 0-10, aching, interferes with adl’s (activities of daily living) and mobility. Pain is relieved by rest and prescription pain medication. There is no documentation of an assessment of the quantity and frequency of oxycodone the patient is using, notification to the physician of the severe pain and any interventions being performed regarding the severe pain. Review of the SN Visit Note dated 02/28/2024 revealed the RN documented the patient has generalized pain rated 8 of a scale 0-10, aching, interferes with adl’s and mobility. Pain is relieved with rest and prescription pain medication. The patient continues with much discomfort and the nurse [Ruth] at physician’s office was notified. There is no documentation of an assessment of the quantity and frequency of oxycodone the patient is using, and any interventions being performed regarding the severe pain. Review of the SN Visit Note dated 03/06/2024 revealed the RN documented the patient was disoriented, none of the following non-verbal pain symptoms were noted: no vocal complaints, no facial grimaces, no bracing, no restlessness, no rubbing and no vocal complaints. Additionally, the RN documented the patient’s pulse is 124 radial, oxygen saturation is 82 % (percent) on room air, lungs diminished throughout, dyspnea noted at rest, difficult to rouse and chest retractions are observed with breathing. There is no documentation of an assessment of the quantity and frequency of pain medication the patient is using, notification to the physician of the patient’s status changes and any interventions being performed regarding the severe status changes. During interview on 09/17/2024 at 04:06 PM, the RN stated that an assessment of the quantity and frequency of pain medication being used did not occur at any of the identified visits. The RN stated being unable to recall why the physician was not notified of the patient’s severe pain on 02/21/2024. Additionally, the RN stated the physician’s office was contacted on 02/15/2024, 02/28/2024 and 03/06/2024 to report the patient’s pain but the RN failed to document this and cannot recall any changes being made to improve the patient’s pain control. G.) Review of the Home Health Certification and Plan of Care for 02/20/2024 to 04/19/2024 revealed the following orders: - SN 1 (one) visit per week for 9 (nine) weeks and 2 (two) as needed visits for NG tube complications. - Nutritional Requirements: NPO, tube feedings. - SN for instructions of administration of nasogastric feedings of osmolyte 1.5, 65 ml per hour via pump. Instructions to include safety measures, care of equipment and preparation of feedings. Flush with 90 ml of water every 4 (four) hours. - SN to instruct on lung cancer with mets (metastasis) to liver to include disease process, nutrition and hydration status, complications and management. - SN to obtain weight every visit and notify RN/ physician of weight loss of 5 (five pounds within 2 (two) weeks. Review of the RN Recert With Skill Visit Note dated 02/15/2024 revealed the following Nutrition Screen: - Major risk factors: Parenteral and/or enteral feedings; - Other risk factors: Chewing or swallowing problems; - Eats fewer than 2 (two) meals per day; - Unplanned weight loss of greater than 10 (ten) pounds in the last 6 (six) months; - Consumes less than 2 (two) servings of vegetables/day; - Consumes less than 1 (one) serving of milk/day; - Consumes less than 1 (one) servings of fruit/day; and - Takes 3 (three) or more medications or over the counter meds/day. Total Nutrition Assessment Score: 19, patient is at high nutritional risk (On 12/22/2023, the date of the patient’s admission to the agency, the patient’s Total Nutrition Assessment Score was 17). There is no evidence q weight was obtained to determine whether the patient’s weight was stable, and there is no evidence the RN requested a nutritional consult for this high nutritional risk patient. During interview on 09/17/2024 at 04:21 PM, the RN stated a referral for a nutritionist was not made as it was never considered by the RN. Patient #14 – This 76-year-old patient with diagnoses that include non-pressure chronic ulcer of the left ankle and venous insufficiency was admitted to the home care agency on 08/29/2024. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed Skilled Nursing orders to patient /caregiver on edema, to include signs and symptoms to report and management. Review of the SN Visit Note Report dated 09/03/2024 revealed the RN documented the following: - Left achilles tendon, non-pressure chronic ulcer peripheral tissue edema nonpit >=4 cm (non-pitting edema greater than or equal to four centimeters); - Obtain ankle measurement and document in vital signs, has there been an increase in ankle circumference of 2 cm (measure each ankle 1 inch above ankle’s bony prominence and if patient bilateral amputee measure abdominal girth)? “No.” - Interventions provided: SN to instruct on management of edema. The assessment lacks documented evidence of bilateral ankle measurements being obtained and recorded. During interview on 09/17/2024 at 12:08 PM, the RN stated an oversight was made at the identified visit and the patient’s ankles did not get measured, but should have been measured.”

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on conducting observational home visits, agency policy and procedure, and interviews with staff for two (2) of six (6) patients (Patient #’s 13 and 14), the agency failed to ensure clinicians follow accepted standards of infection control practices. Failure to follow accepted standards of infection control has the potential to result in negative patient outcomes. The agency failed to ensure clinicians follow accepted standards of infection control practice as evidenced by the following: HV Patient #14 – This 76-year-old patient with diagnoses that include non-pressure chronic ulcer of the left ankle and venous insufficiency was admitted to the home care agency on 08/29/2024. Review of the agency policy entitled “Wound Assessment, Documentation, and Photography” revised 09/01/2024 revealed “2. Perform wound care according to [LHC] (Corporate agency name) adopted clinical skills guidelines and physician orders.” Review of the agency protocol entitled “Wound Care Best Practices Checklist” revised 06/06/2022 revealed the following; - Competency: Infection Control - Performance Criteria/Evidence: - Perform hand hygiene and bag technique; and - clean field for wound supplies. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed the following orders: - Skilled Nurse (SN) to perform wound care to LLE (left lower extremity) BIW/PRN (twice weekly and as needed) for soiling- cleanse with NS (normal saline), apply calcium alginate AG (absorbent dressing with antibacterial silver) to open areas, wrap with Unna boot (compression dressing), secure with coban (self-adherent wrap) and tape. During an observational home visit on 09/10/2024 at 01:00 PM, the Registered Nurse (RN) was observed setting up the patient’s Unna boot supplies to be used for the dressing change on a barrier placed on the patient’s floor, a dirty surface. During interview on 09/10/2024 at 01:35 PM, the surveyor stated to the RN that the patient’s floor was not a clean surface to set up the new bandage supplies. The RN acknowledged the patient’s floor was not a clean surface and should have set up the barrier and dressing supplies on a clean surface. During interview on 09/10/2024 at 01:37 PM, the Clinical Director stated the clean barrier and new dressing supplies to be applied on the patient should not have been set up on the patient’s floor. The agency failed to ensure clinicians follow accepted standards of infection control practice as evidenced by the following: HV Patient #13- This 66-year-old patient with diagnoses that include pressure ulcer of sacral region, stage two (2), moderate protein-calorie malnutrition and spastic hemiplegia affecting right dominant side was admitted to the home care agency on 08/29/2024. Review of the agency’s policy entitled “Hand Hygiene” last revised on 05/01/2019 revealed “1. Staff performs hand hygiene by handwashing with soap and water or using an alcohol-based hand sanitizer: a. before direct contact with patients…after contact with blood, body fluids, or excretions, mucous membranes, non-intact skin, wound dressings, or contaminated surfaces…after contact with inanimate objects (including medical equipment but excluding the point of care device which is cleaned at the beginning and end of patient visit) in the immediate vicinity of the patient, before and after removal of personnel protective equipment (PPE) and at the conclusion of the visit after contact with a patient’s intact skin, (e.g., when taking vital signs, and lifting patient).” Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed the order for the Skilled Nurse to “perform/instruct patient/caregiver procedure of wound care to sacrum wound three times a week and as needed if soiled or dislodged. Caregiver to perform on non-visit days. Cleanse with normal saline. Apply aquacel if draining. Cover with foam dressing using clean technique. Instruct patient/caregiver signs/symptoms of wound infection and proper disposal of dressings.” During an observational home visit on 09/10/2024 at 12:10 PM, the surveyor observed the Registered Nurse perform wound care to the patient’s sacrum, proceed to dispose of soiled wound care dressings in the garbage, obtain stethoscope from patient’s bedside table and transition to auscultate patient’s lung sounds without performing hand hygiene. Furthermore, when the Registered Nurse disposed of the patient’s dressing, the surveyor observed the registered nurse push down on the soiled dressing so that it would not fall out of the bag. The Registered Nurse failed to follow accepted standards of practice for hand hygiene while providing care to the patient. During interview on 09/16/2024 at 12:19 PM, the Registered Nurse stated that hand hygiene should have been performed after placing soiled dressing in garbage and before listening to the patient’s lung sounds and did not realize that it wasn’t.”

“Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This Standard is not met as evidenced by: Based on an observational home visit, agency policy and procedure, and interview with staff for one (1) of seventeen (17) patients (Patient #13), the agency failed to provide infection control education to the patient and caregiver. Failure to provide infection control education to the patient and caregiver has the potential to result in negative patient outcomes. The agency failed to provide infection control education to the patient and caregiver as evidenced by the following: HV Patient #13- This 66-year-old patient with diagnoses that include pressure ulcer of sacral region, stage two (2), moderate protein-calorie malnutrition and spastic hemiplegia affecting right dominant side was admitted to the home care agency on 08/29/2024. Review of the agency policy entitled “Patient Education” last revised on 11/01/2017 revealed “3. The patient and caregiver receive ongoing information specific to the identified needs, at a level appropriate to their learning abilities, including: d. infection control: the patient and caregiver receive information about precautions to prevent and control infections, as well as signs and symptoms of infection to report”. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed the following: - Diagnosis: Pressure ulcer of sacral region, stage two (2) - Orders of Discipline and Treatments: Skilled Nurse to perform/instruct patient/caregiver procedure of wound care to sacrum wound three times a week and as needed if soiled or dislodged. Caregiver to perform on non-visit days. Cleanse with normal saline. Apply aquacel if draining. Cover with foam dressing using clean technique. Instruct patient/caregiver signs/symptoms of wound infection and proper disposal of dressings - Functional limitations: bowel/bladder (incontinence), paralysis, endurance, and ambulation During an observational home visit on 09/10/2024 at 11:58 AM, the surveyor observed that the patient’s sacral wound was without a dressing and left open to the air. Furthermore, the patient’s sister stated the patient is incontinent of urine and stool. Additionally, the patient’s sister stated that bowel movements are large and messy. The Registered Nurse failed to educate the patient and caregiver during the observational home visit, on the signs and symptoms of infection and prevention of infection with patient wound care. During interview on 09/16/2024 at 12:53 PM, the Registered Nurse stated that education was not provided to the patient or caregiver at the start of care nor, during the observational home visit and should have been.”

“Patient’s or legal representative’s signature CFR(s): 484.50(a)(2) Obtain the patient’s or legal representative’s signature confirming that he or she has received a copy of the notice of rights and responsibilities. This Element is not met as evidenced by: Based on review of clinical records and staff interviews for three (3) of seventeen (17) patients (Patients #’s: 10, 13 and 17), the agency failed to obtain either the patient’s or the patient’s legal representative’s signature confirming the patient received a copy of the patient rights and responsibilities at start of care (SOC). Failure to ensure patients have received notice of their rights and responsibilities has the potential for negative outcomes. The agency failed to obtain either the patient’s or the patient’s legal representative’s signature confirming the patient received a copy of the patient rights and responsibilities as evidenced by the following: Patient #10- This 80-year-old patient with diagnoses that include aftercare following joint replacement surgery, hypertensive chronic kidney disease with stage 1-4/unspecified chronic kidney and type two (2) diabetes mellitus with diabetic chronic kidney disease was admitted to the home care agency on 05/17/2023. Review of the Patient Admission Consent form dated 05/17/2023 revealed that the there is no documented patient/legal representative’s signature on the form to show that the patient has read (or been read to), been provided with a copy of and understand the following: Grievance Procedures, Advanced Directives, and Patient Rights and Responsibilities. During interview on 09/17/2024 at 10:31 AM, the Physical Therapist stated the patient would have been given a copy of the grievance procedures, advanced directives and patient rights and responsibilities in the start of care packet. However, the consent form does not indicate patient’s acknowledgement that copies were provided, and it should. Patient #13- This 66-year-old patient with diagnoses that include pressure ulcer of sacral region, stage two (2), moderate protein-calorie malnutrition and spastic hemiplegia affecting right dominant side was admitted to the home care agency on 08/29/2024. Review of the Patient Admission Consent form dated 08/29/2024 revealed the patient’s sister/caregiver signed the form on 08/29/2024. There is no documented evidence that the patient signed the Admission Consent form or that the patient has read (or been read to), been provided with a copy of and understand the following: Oasis Privacy Act, Notice of Anticipated Frequency, Grievance Procedures, Advanced Directives, and Patient Rights and Responsibilities. Additionally, there is no documentation to explain why the family member signed the form instead of the patient. Review of the patient clinical record lacks documented evidence that the patient’s sister is the patient’s legal representative. During interview on 09/16/2024 at 12:35 PM, the Registered Nurse stated there should be documentation to explain why the patient’s sister signed the consent form, instead of the patient, and there is not. Patient #17- This 85-year-old Therapy Only patient with diagnoses that include alzheimer’s disease with late onset, essential (primary) hypertension, and anxiety disorder, unspecified was admitted to the home care agency on 08/20/2024. Review of the Patient Admission Consent form dated 08/20/2024 revealed the agency’s Licensed Practical Nurse signed the form, but there is no patient signature acknowledging that the patient has read (or been read to), been provided with a copy of and understand the following: Oasis Privacy Act, Notice of Anticipated Frequency, Grievance Procedures, Advanced Directives, and Patient Rights and Responsibilities. During interview on 09/16/2024 at 11:03 AM, the Physical Therapist stated the patient’s son is the legal representative and was not present for the start of care and was not available to sign the consent. Instead, the agency’s Licensed Practical Nurse signed the consent because the patient was not able to do so.”

“Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This Element is not met as evidenced by: Based on a review of patient care records and staff interview for one (1) of seventeen (17) patients (Patient #8) the agency failed to ensure the patient maintained the right to participate in all decisions regarding the provision of care. Failure to uphold the patient’s right to participate in care and decisions about care and treatment has the potential for negative patient outcomes. The agency failed to maintain the patient’s right to participate in decisions regarding care as evidenced by the following: Patient #8- This 65-year-old patient with diagnoses that include malignant neoplasm of unspecified part of right bronchus or lung, gastrostomy malfunction and gastrostomy infection was admitted to the home care agency on 12/22/2023 and discharged 03/06/2024. Review of the Home Health Certification and Plan of Care from 02/20/2024 to 04/19/2024 revealed the patient has no advance directives in place. Additionally, “patient has been on services following diagnosis of lung cancer. Patient now has mets (metastasis) to liver. Patient has extreme weakness and pain. He will be going for infusion of IVIG (intravenous immune globulin) awaiting insurance approval and the plan is to start palliative chemo….Patient continues to require services for skilled assessment and education related to chemotherapy…Palliative needs assessed and patient is not interested in hospice services at this time. He did have a palliative consult however…Mental status: Forgetful; Alert and Oriented x3 (to person, place and time)…When vital signs are obtained licensed professional to report vital signs falling outside the following established parameters…O2 Sat [oxygen saturation] Review of the Client Coordination Note Report dated 03/06/2024, as a late note for 03/04/2024 revealed the Registered Nurse (RN) documented that on 03/04/2024 the RN spoke with the patient’s spouse that morning. The patient’s spouse reported that the patient’s oxygen saturation was 83 percent. There is a lack of documented evidence the RN made a visit to the patient’s home to assess the patient for a change in status, to determine whether the patient’s care and treatment are effective, and to verify the low oxygen saturations and report it to the physician. Review of Visit Note Report dated 03/06/2024 revealed the RN made a home visit and documented the following patient changes: oxygen saturation on room air is 82 percent, lungs are diminished throughout, dyspnea is noted at rest, no oxygen is in place, the patient is disoriented, difficult to rouse and is having chest retractions upon breathing. Additionally, the RN documented “much discussion on signs of end of life with sister-in-law. Following visit, writer called wife regarding assessment findings and for further discussion of hospice. Per wife’s request, writer called and discussed patient’s status with daughter and son. Wife, son and daughter would like to see if he [the patient] was (is) eligible for another round of chemo. If not, they are agreeable to hospice services.” The RN failed to remain with the patient when the patient’s status deteriorated, failed to notify the physician about the acute change in status, failed to initiate transfer to a hospital for evaluation of the patient’s acute change in status for a patient with no advance directives, and failed to adhere to the patient’s wishes to not pursue hospice services. Review of the Physician Order dated 03/08/2024 revealed an order for the patient to be discharged from the agency effective 03/06/2024 as the patient was transitioned to hospice. There is no documentation to support the rationale for discharging the patient to hospice. During interview on 09/12/2024 at 12:04 PM, the RN stated that the attending physician’s office was called on 03/06/2024 after the RN visited the patient, but the RN failed to document the call or what was discussed during the call. The RN stated that the RN left the patient after the 03/06/2024 visit because the family was waiting for a decision from the oncologist regarding chemotherapy. The RN added that hospice services were initiated on 03/06/2024. In regard to the patient’s change of status on 03/04/2024, the RN stated that when the patient’s wife called to report the low pulse oximetry, the wife reported that the patient was feeling better, and that is why a home visit was not made. The RN however, failed to document this. Regarding the 03/06/2024 visit, the RN stated that the RN left the patient because the family wanted to follow-up with the oncologist. The RN stated that the patient’s family was fine with her leaving the patient with status changes; however, the RN did not document it. During interview on 09/13/2024 at 12:03 PM, the Clinical Director stated that the RN reported that the patient was resting comfortably in bed when the RN left the patient’s home. In an email dated 09/16/2024 the Clinical Director stated that the patient was admitted to hospice services on 03/07/2024.”

“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 review of clinical records and interviews with agency staff for two (2) of seventeen (17) patients (Patient #’s 8 and 11) the agency failed to ensure that patients are informed, before care is initiated, of their potential financial liability for services provided. Failure to ensure patients are informed of their potential financial liability for services has the potential to result in the patient’s inability to exercise their rights. The agency failed to ensure patients are informed, prior to care being initiated, of their potential financial liability for services provided as evidenced by the following: Patient #8- This 65-year-old patient with diagnoses that include malignant neoplasm of unspecified part of right bronchus or lung, gastrostomy malfunction and gastrostomy infection was admitted to the home care agency on 12/22/2023 and discharged 03/06/2024. Review of the Home Health Certification and Plan of Care from 12/22/2023 to 02/19/2024 revealed the patient is to receive Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT) and Speech Therapy (ST). Review of the Patient Consent dated 12/22/2023 revealed the agency notified the patient of the provision and financial liability of SN, PT and OT services , but failed to notify the patient of the provision and financial liability of ST services. During interview on 09/17/2024 at 01:56 PM, the Registered Nurse stated an oversight was made and the service of ST was left off the Patient Consent form. Patient #11 – This 32-year-old patient with diagnoses that include fracture closure of unspecified part of the left femur and anxiety was admitted to the home care agency on 08/04/2024. Review of the Home Health Certification and Plan of Care for 08/04/2024 to 10/02/2024 revealed the patient is to receive Physical Therapy services. Review of the Patient Consent dated 08/04/2024 revealed the agency failed to notify the patient of the provision and financial liability of ST services. During interview on 09/16/2024 at 01:58 PM, the PT stated an error was made and the service of PT was left off the Patient Consent form.”

“Outcomes/goals have been achieved CFR(s): 484.50(d)(3) The transfer or discharge is appropriate because the physician or allowed practitioner, who is responsible for the home health plan of care and the HHA agree that the measurable outcomes and goals set forth in the plan of care in accordance with §484.60(a)(2)(xiv) have been achieved, and the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the patient no longer needs the HHA’s services; This Element is not met as evidenced by: Based on review of clinical records, agency policy and procedure, and staff interview for one (1) of five (5) discharged patients (Patient #8), the agency failed to ensure the patient achieved the outcomes and goals in the plan of care and that the physician agreed to the patient’s discharge. Failure to appropriately discharge the patient in agreement with the physician has the potential for negative patient outcomes. The agency failed to ensure outcomes and goals were achieved and the responsible physician agreed to discharging the patient as evidenced by the following: Review of the agency policy entitled “Patient Discharge/ Transfer Process” revised 10/01/2023 revealed “1. Any of the following reasons may be criteria for patient discharge or transfer: c. Agency and physician agree that measurable outcomes and goals in the plan of care have been achieved and patient no longer needs services.” Patient #8- This 65-year-old patient with diagnoses that include malignant neoplasm of unspecified part of right bronchus or lung, gastrostomy malfunction and gastrostomy infection was admitted to the home care agency on 12/22/2023 and discharged 03/06/2024. Review of the Home Health Certification and Plan of Care from 02/20/2024 to 04/19/2024 revealed the patient has no advance directives in place. Additionally, “patient has been on services following diagnosis of lung cancer. Patient now has mets (metastasis) to liver. Patient has extreme weakness and pain. He will be going for infusion of IVIG (intravenous immune globulin) awaiting insurance approval and the plan is to start palliative chemo….Patient continues to require services for skilled assessment and education related to chemotherapy…Palliative needs assessed and patient is not interested in hospice services at this time. He did have a palliative consult however…Mental status: Forgetful; Alert and Oriented x3 (to person, place and time)…When vital signs are obtained licensed professional to report vital signs falling outside the following established parameters…O2 Sat [oxygen saturation] Goals of care: - Patient/ caregiver will verbalize understanding of pharmacologic and non pharmacologic pain control measures as evidenced by improvement in pain levels; - Patient/ caregiver will demonstrate proper use and administration of prescribed medications; - Patient/ caregiver will demonstrate adequate knowledge of safe provision of ADL’s (activities of daily living) as evidenced by appropriate home management without complications or injury; - Patient will demonstrate oxygen saturation to optimal level; - Patient/ caregiver will verbalize/ demonstrate understanding of home safety and fall prevention; - Patient/ caregiver will understand and demonstrate compliance with treatment regimen for cancer; - Patient will maintain a stable weight throughout episode; and DC (discharge) Plan: Discharge to care of family/ caregiver under supervision of physician when all goals met. Review of the Client Coordination Note Report dated 03/06/2024, as a late note for 03/04/2024 revealed the Registered Nurse (RN) documented that on 03/04/2024 the RN spoke with the patient’s spouse that morning. The patient’s spouse reported that the patient’s oxygen saturation was 83 percent. There is a lack of documented evidence the RN made a visit to the patient’s home to assess the patient for a change in status, to determine whether the patient’s care and treatment are effective, and to verify the low oxygen saturations and report it to the physician. Review of Visit Note Report dated 03/06/2024 revealed the RN made a home visit and documented the following patient changes: oxygen saturation on room air is 82 percent, lungs are diminished throughout, dyspnea is noted at rest, no oxygen is in place, the patient is disoriented, difficult to rouse and is having chest retractions upon breathing. Additionally, the RN documented “much discussion on signs of end of life with sister-in-law. Following visit, writer called wife regarding assessment findings and for further discussion of hospice. Per wife’s request, writer called and discussed patient’s status with daughter and son. Wife, son and daughter would like to see if he [the patient] was (is) eligible for another round of chemo. If not, they are agreeable to hospice services.” The documentation lacks notification to the physician regarding acute changes or discharge planning. Review of the Physician Order dated 03/08/2024 revealed an order for the patient to be discharged from the agency effective 03/06/2024 as the patient was transitioned to hospice. There is no documentation the RN, patient and physician discussed the discharge for hospice care services or that the patient was agreeable to receive hospice care. Review of the clinical record lacks documentation the patient achieved the goals and outcomes outlined in the plan of care or that the physician agreed to discharge on or before 03/06/2024. During interview on 09/12/2024 at 12:04 PM, the Registered Nurse (RN) stated the attending physician and patient’s family were awaiting a decision from the oncology physician regarding if further chemotherapy could be pursued. On 09/17/2024 at 04:40 PM, the RN stated that the patient’s wife took the patient to the oncologist for lab work on 03/06/2024 and the oncologist told the patient that no further treatment was recommended. Additionally, the RN stated that the patient’s attending physician was aware of the oncologist’s decision, and a hospice evaluation was set up to take place later that day on 03/06/2024. Furthermore, the RN stated that none of this was documented prior to the 03/08/2024 Physician’s Order.”

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on review of clinical records, agency policy and procedure, and interviews with staff, for one (1) of seventeen (17) patients (Patient #17), the agency failed to ensure the Registered Nurse (RN) completed an initial assessment of the patient within forty-eight (48) hours of referral, the patient’s return home, or on the physician-ordered start of care date. Failure to conduct an initial assessment within the required timeframe has the potential to result in unmet patient needs and negative patient outcomes. The agency failed to ensure the Registered Nurse (RN) conducted an initial assessment of the patient within forty-eight (48) hours of the referral as evidenced by the following: Review of the agency’s policy entitled “Admission Process” last revised date 09/01/2024 revealed the following: - “Once nursing staff receives a referral, the Executive Director or Clinical Director is notified, and a qualified clinician is scheduled to make the initial assessment or admit visit… - …admission/initial visits are made within 48 hours from referral unless there is a specific physician orders start of care (SOC) date which would supersede the state established time frames.” Patient #17- This 85-year-old patient with diagnoses that include alzheimer’s disease with late onset, essential (primary) hypertension, and anxiety disorder, unspecified was admitted to the home care agency on 08/20/2024. Review of the physician order from assisted living and memory care facility dated 08/13/2024 revealed the following: - Resident Information: skin tear observed on left arm in the dining room at 12:30 PM; of unknown origin. - Physician/Provider Response or New Orders: Skilled nursing to evaluate and treat. Review of the physician order from primary care provider dated 08/13/2024 revealed the following: - Subjective: Patient presents for left arm skin tear, no known trauma or fall. Large skin tear on left arm, seen in room with nursing. - Assessment #1 comments: Skilled nursing to evaluate and treat, no signs and symptoms of infection at this time. Monitor closely. - Assessment #2 comments: Provide supportive care. Monitor for decline which is unfortunately anticipated. Continue pharmacologic regimen. Overall condition is very frail and resident is at high risk for poor outcomes and complications including infections, falls, and wounds. All methods to prevent these are being employed. Review of the referral for home care services dated 08/16/2024 revealed the following: - Nursing Care: wound assessment- evaluate and treatment recommendations- skin tear to left arm. - Physical Therapy or Occupational Therapy: for strengthening and endurance- to evaluate and treat strengthening/deconditioning. Review of the Home Health Certification and Plan of Care from 08/20/2024 to 10/18/2024 revealed the patient is to receive the following services: Physical Therapy and Occupational Therapy. Review of the Outcome and Assessment Information Set Note dated 08/20/2024 revealed the Physical Therapist completed the admission on 08/20/2024. Review of the clinical record from 08/20/2024 to 09/20/2024 lacks documented evidence that a skilled nurse went out to complete an initial assessment visit. During interview on 09/16/2024 at 10:58 AM, the Patient Care Manager of Home Health (Buffalo), Registered Nurse stated skin tear is not a skilled need for home care services, so the agency was going to get an order for therapy instead. As of exit, no further information was provided to refute the findings. During an interview on 09/16/2024 at 11:00 AM, the Executive Director (Buffalo) stated there was a conversation that physical therapy would go in because nursing was no longer needed for wound care. As of exit, no further information was provided to refute the findings.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum, the following information: (1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on review of patient care records and interview with agency staff for eight (8) of seventeen (17) patient records (Patient #’s: 1, 2, 5, 8, 12, 13, 14 and 17), the agency failed to ensure the initial comprehensive assessment was of sufficient scope to identify patient needs. Failure to ensure the initial comprehensive assessment is complete and accurate has the potential for unmet patient needs and possible negative outcomes. HV Patient #12 - This 87-year-old therapy-only patient with diagnoses that include hemiplegia following cerebral infarction, dysphagia following cerebral infarction oropharyngeal phase and essential hypertension was admitted to the home care agency on 08/05/2024. Review of the Physical Therapy Outcome and Assessment Information Set Start of Care dated 08/05/2024 lacks documented evidence that the Physical Therapist assessed the patient’s immunization status. Review of the clinical record from 08/05/2024 (start of care) to 09/09/2024 (date of survey) lacked documented evidence that the patient’s pneumonia immunization status was assessed. During interview on 09/18/2024 at 10:45 AM, the Executive Director (Buffalo) stated that the assessment of the patient’s pneumonia immunization status was not on the Outcome and Assessment Information Set and they would look for documented evidence that the assessment was completed. No further documentation was provided. Review of the agency’s Elsevier Nasogastric (NG) Guidance (approved Clinical Skills Online program) dated 07/2024 revealed that the guidelines covered the following topics: administration of tube feeds, NG tube placement verification, NG tube insertion, administration of medications via the NG tube, NG tube removal, assessing for gastric aspirate (residuals), skin care, irrigation of the NG tube, and measuring external portion of NG tube for migration. Patient #8- This 65-year-old patient with diagnoses that include malignant neoplasm of unspecified part of right bronchus or lung, gastrostomy malfunction and gastrostomy infection was admitted to the home care agency on 12/22/2023 and discharged 03/06/2024. Review of the Home Health Certification and Plan of Care for 12/22/2023 to 02/19/2024 revealed “Skilled Nurse (SN) for instruction of gastrointestinal system including Corpak (type of Nasogastric tube), GI (gastrointestinal) hemorrhage, peritonitis due to dislodgment of existing [the patient did not have a PEG (percutaneous endoscopic gastrostomy) tube]. Corpak NG tube replaced on 11/22/2023. Patient to receive Osmolite 1.5 65 ml (milliliter) /hr (hour) via Kangaroo pump continuous with 90 ml water flush every 4 (four) hours. SN to instruct on new and changed medications, those with assessed knowledge deficit, high risk medications and any applicable drug interactions. SN to instruct/ supervise patient /caregiver on strict NPO (nothing by mouth) (for patient).” Review of the Registered Nurse (RN) Outcome and Assessment Information Set (OASIS) Admission Note dated 12/22/2023 revealed the RN documented “Corpak feeding tube in place, patient is strict NPO and patient receiving Osmolite 1.5 65 ml per hour via Kangaroo pump.” There is no documentation of the size of the NG tube, and no documentation that the RN assessed tube feed residuals, obtained a baseline measurement of the external portion of the Corpak NG and verified placement of the NG by auscultation of the abdomen. Additionally, there is no documentation that the RN contacted the physician to determine when the NG tube required replacement. During interview on 09/23/2024 at 11:00 AM, the Clinical Director stated the RN was unavailable for interview. The Clinical Manager stated the Corpak NG tube does not require an assessment of residuals or the need to check for migration by measuring the external portion of the tube. During interview on 09/23/2024 at 11:19 AM, the Executive Director stated the agency has no protocol or policy to follow regarding the Corpak NG and the RN failed to verify and document the care/assessment for the Corpak NG that was ordered per the physician. Patient #14 – This 76-year-old patient with diagnoses that include non-pressure chronic ulcer of the left ankle and venous insufficiency was admitted to the home care agency on 08/29/2024. Review of the RN OASIS Admission Visit Note dated 08/29/2024 revealed the RN documented the patient’s immunization history is unknown. The assessment lacks documented follow-up with the patient’s physician to clarify when the patient last received the pneumonia and influenza vaccinations. During interview on 09/17/2024 at 12:40 PM, the RN stated the patient was unaware of the last identified vaccination dates and the RN did not follow-up with the physician to ensure the vaccination dates were obtained. Patient #1- This 67-year-old therapy only patient with the diagnoses of hemiplegia following cerebral infarction affecting left nondominant side, type II diabetes mellitus without complications and unspecified atrial fibrillation was admitted to the home care agency on 08/24/2024. Review of the Physical Therapy Outcome and Assessment Information Set Admission dated 08/24/2024 lacks documented evidence that the Physical Therapist assessed the patient’s immunization status. During interview on 09/17/2024 at 01:49 PM, the Physical Therapist stated that the entry “unknown” was entered on the assessment because the Physical Therapist only asked the patient about the influenza vaccine, and the patient could not remember the date the influenza vaccine was received. The Physical Therapist further stated that it is agency policy to ask about pneumonia vaccinations, but the Physical Therapist forgot to ask. The agency failed to ensure the initial comprehensive assessment was of sufficient scope to identify patient needs as evidenced by the following: Patient #13- This 66-year-old patient with diagnoses that include pressure ulcer of sacral region, stage two (2), moderate protein-calorie malnutrition and spastic hemiplegia affecting right dominant side was admitted to the home care agency on 08/29/2024. A.) Review of the Registered Nurse Outcome and Assessment Information Set Note dated 08/29/2024 lacks an assessment of the patient’s immunization status. During interview on 09/16/2024 at 12:04 PM, the Registered Nurse stated the information wasn’t available on the referral for the start of care and neither the patient nor the patient’s sister were able to provide the information during the visit. B.) Review of the Registered Nurse Outcome and Assessment Information Set Note dated 08/29/2024 lacks an assessment of the patient’s endocrine status. Review of the Registered Nurse Oasis Admission dated 08/29/2024 revealed the Registered Nurse documented “patient noncompliant with glucose testing every other day.” During interview on 09/16/2024 at 11:58 AM, the Registered Nurse stated the patient is diabetic and should have had an endocrine assessment completed. Patient #17- This 85-year-old Therapy only patient with diagnoses that include alzheimer’s disease with late onset, essential (primary) hypertension, and anxiety disorder, unspecified was admitted to the home care agency on 08/20/2024. Review of the clinical record lacks an assessment of the patient’s immunization status. During interview on 09/16/2024 at 11:17 AM, the Physical Therapist stated that the patient’s immunization status was not documented but should have been. Patient #2 – This 82-year-old patient with the diagnoses of type II diabetes mellitus without complications, chronic obstructive pulmonary disease, and acute and chronic respiratory failure with hypoxia was admitted to the home care agency on 08/27/2024. Review of the clinical record lacks an assessment of the patient’s immunization status. During interview on 09/17/2024 at 12:48 PM, the Registered Nurse stated the patient’s immunization status was not assessed. Patient #5 – This 76-year-old patient with the diagnoses of chronic obstructive pulmonary disease, acute and chronic respiratory failure with hypoxia and hypercapnia, and acute diastolic (congestive) heart failure was admitted to the home care agency on 08/24/2024. Review of the Home Health Certification and Plan of Care for 08/24/2024 to 10/22/2024 revealed “Skilled Nurse to provide instructions related to heart failure including but not limited to definition of heart failure, measures to prevent heart failure, signs and symptoms of heart failure, measure to manage heart failure, and possible complications of heart failure,” the order for a 1600 milliliter fluid restriction, and the order for furosemide 20 milligram tablet twice daily by mouth for heart failure. Review of the Congestive Heart Failure Process (protocol) provided to the surveyor on 09/12/2024 revealed the clinician is instructed to assess the patient’s edema in a patient with congestive heart failure. Review of the Registered Nurse Outcome and Assessment Information Set Note dated 08/24/2024 lacks documented evidence the Registered Nurse assessed the patient’s edema. During interview on 09/16/2024 at 02:43 PM, the Registered Nurse stated the patient’s edema was assessed but the assessment was not documented in the record.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on clinical record review and interview with agency staff, for ten (10) of seventeen (17) clinical records (Patient #’s: 1, 2, 6, 7, 10, 11, 12, 13, 14, and 17) lack documented evidence of a complete review of all medications the patient currently uses to identify any potential adverse effects, drug reactions, or concerns. Patient #2 – This 82-year-old patient with the diagnoses of type II diabetes mellitus without complications, chronic obstructive pulmonary disease, and acute and chronic respiratory failure with hypoxia was admitted to the home care agency on 08/27/2024. A. Review of the Home Health Certification and Plan of Care for 08/24/2024 to 10/22/2024 revealed the following orders: - acetaminophen 500 milligrams every eight hours as needed for pain oral - multivitamin 50 plus tablet daily oral Review of the physician medication list dated 07/16/2024 lacks orders for the medications. B. Review of the physician medication list dated 07/16/2024 revealed the following orders: - doxycycline hyclate 100 milligrams take one capsule by mouth - fluocinonide apply topically twice a day - risperidone one milligram take one tablet daily Review of the Home Health Certification and Plan of Care for 08/24/2024 to 10/22/2024 lacks orders for the medications. Review of the clinical record lacks documented evidence the Registered Nurse contacted the physician regarding the discrepancies between the referral to the agency and the plan of care. During interview on 09/17/2024 at 12:47 PM, the Registered Nurse stated there was a phone call to the physician’s office regarding the medications but failed to document the conversation in the record. Patient #6 – This 60-year-old patient with the diagnoses of multiple sclerosis, type II diabetes mellitus with hyperglycemia, and non-st elevation myocardial infarction was admitted to the home care agency on 11/29/2023. Review of the hospital discharge summary revealed the patient was admitted to the hospital 12/15/2023 to 12/18/2023. Review of the supplemental order dated 12/21/2023 revealed the physician ordered the Resumption of Care for 12/21/2023. A. Review of the Home Health Certification and Plan of Care for 11/29/2023 to 01/27/2024 revealed the following orders: - lisinopril 2.5 milligram tablet daily oral - metoprolol tartate 25 milligrams 0.5 tablet daily oral Review of the hospital discharge dated 12/18/2023 revealed the patient was ordered to stop taking the following medications: - lisinopril 2.5 milligram tablet - metoprolol tartate 25 milligram tablet B. Review of the hospital discharge dated 12/18/2023 revealed the following orders: - glatiramer 40 milligrams/milliliter syringe - insulin aspart 110 units/milliliter injection Review of the Home Health Certification and Plan of Care for 11/29/2023 to 01/27/2024 lacks orders for the medications. Review of the clinical record lacks documented evidence the Registered Nurse contacted the physician regarding the discrepancies between the referral to the agency and the plan of care. During interview on 09/16/2024 at 01:06 PM, the Physical Therapist stated the orders do not match the discharge instructions. Patient #11 – This 32-year-old patient with diagnoses that include fracture closure of unspecified part of the left femur and anxiety was admitted to the home care agency on 08/04/2024. A.) Review of the facility referral dated 07/03/2024 revealed the patient was taking the following medications at the facility: - acetaminophen 500 mg (milligram) tablet, give 2 (two) tablets by oral route every 8 (eight) hours as needed for pain; - senna plus 8.6 mg- 50 mg tablet, give 2 tablets by oral route once daily as needed for constipation; - bisacodyl 10 mg rectal suppository, insert 1 (one) suppository by rectal route once daily as needed for no bowel movement; and - milk of magnesia 400 mg/5 ml (milliliter) oral suspension, give 30 ml by oral route once daily as needed for constipation, followed by a full glass of 8 oz (ounces) of liquid. Review of the Home Health Certification and Plan of Care for 08/04/2024 to 10/02/2024 lacks orders for the identified medications. B.) Review of the Home Health Certification and Plan of Care for 08/04/2024 to 10/02/2024 revealed the following orders: - baclofen 5 mg tablet, take 1 (one) tablet oral 2 (two) times daily/PRN (as needed) for muscle spasms; - daily vitamin formula- minerals tablet, take 1 (one) tablet oral daily; - gabapentin 400 mg capsule, take 1 (one) capsule oral at bedtime/PRN for pain; and - norgestimate 0.18 mg/0.215 mg/0.25 mg- ethinyl estradiol 25, take 1 (one) tablet oral daily. Review of the facility referral dated 07/03/2024 lacks orders for the identified medications. Review of the clinical record lacks documented evidence the Physical Therapist (PT) clarified the discrepancies between the referral and plan of care with the ordering physician. During interview on 09/16/2024 at 02:11 PM, the PT stated the patient had a discharge summary in the home that the PT used to complete the medication reconciliation. Additionally, the PT stated the discharge summary failed to be uploaded into the patient’s record and there is no documentation to clarify the identified medication discrepancies. Patient #14 – This 76-year-old patient with diagnoses that include non-pressure chronic ulcer of the left ankle and venous insufficiency was admitted to the home care agency on 08/29/2024. Review of the physician referral dated 08/28/2024 revealed the patient is taking furosemide 40 mg and tramadol HCL 50 mg. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed the following orders: - furosemide 40 mg, take 2 (two) tablets oral daily; and - tramadol 50 mg tablet, take 1 (one) tablet 3 (three) times daily/PRN for moderate pain to the patient’s left lower extremity. Review of the clinical record lacks documentation the RN clarified the medication dose discrepancies with the ordering physician. During interview on 09/17/2024 at 12:34 PM, the RN stated the medications were reviewed with the physician but there is no documentation that clarified the identified discrepancies specifically. Home Visit Patient #12 - This 87-year-old therapy-only patient with diagnoses that include hemiplegia following cerebral infarction, dysphagia following cerebral infarction oropharyngeal phase and essential hypertension was admitted to the home care agency on 08/05/2024. Review of the referral to the home care agency dated 07/30/2024 revealed the order for magnesium oxide 250 milligrams take one tablet by mouth every day. Review of the Home Health Certification and Plan of Care for the certification period 08/05/2024 to 10/03/2024 revealed the order for magnesium oxide 400 milligrams by mouth every day. Review of the clinical record lacks documented evidence that either the Physical Therapist or Registered Nurse contacted the physician regarding the discrepancies between the referral to the agency and the plan of care. During interview on 09/16/2024 at 01:41 PM, the Physical Therapist stated there was a phone call to the physician about the medication but did not document this. Patient #7- This 87-year-old therapy only patient with the diagnoses of unspecified dementia of unspecified severity without behaviors, major depressive disorder and chronic atrial fibrillation was admitted to the home care agency on 02/09/2024. A. Review of the referral to the home care agency dated 02/06/2024 revealed the following medication orders: - vitamin D3 25 micrograms daily oral - ferrous sulfate 325 milligrams daily oral - furosemide 40 milligrams daily oral - amlopidine 10 milligrams daily oral - tamsulosin 0.4 milligrams daily oral - dutasteride 0.5 milligrams daily oral Review of the Home Health Certification and Plan of Care for 02/09/2024 to 04/08/2024 revealed the following medication orders: - amlodipine 10 milligrams daily oral - avodart 0.5 milligrams daily oral - carvedilol 3.125 milligrams daily oral - cholecalciferol 25 micrograms daily oral - donepezil 10 milligrams daily at bedtime oral - ferrous sulfate 325 milligrams daily oral - guaifenesin 100 milligrams/5 milliliters take 15 milliliters every 4 hours as needed orally - lasix 40 milligrams daily oral - milk of magnesia 400 milligrams/5 milliliters take 30 milliliters daily oral - mintox 200 milligrams- 200 milligrams- 20 milligrams/5 milliliters take 30 milliliters every 4 hours as needed orally - nystatin 100,000 unit/gram twice daily topical cream - pepto- bismol 262 milligrams/15 milliliters take 30 milliliters every 4 hours as needed orally - tab-a-vite 400 micrograms daily oral - tamsulosin 0.4 milligrams daily at bedtime oral - Tylenol 325 milligrams 2 tablets every 4 hours as needed oral Review of the Client Coordination Note Report dated 02/09/2024 revealed the Physical Therapist documented the following: Therapist Medication Collaboration: Note: Medications reviewed: (per Medication Administration Record) Name of Registered Nurse that reviewed medications: the Patient Care Manager of Home Health (Buffalo), Registered Nurse. Name and relationship of person medications were reviewed with the Facility Licensed Practical Nurse. Findings from collaboration: None Review of the clinical record from 02/09/2024 to 09/09/2024 lacks documented evidence of the Medication Administration Record the Physical Therapist used for Medication Reconciliation on 02/09/2024. During interview on 09/18/2024 at 11:25 AM, the Patient Care Manager of Home Health, Registered Nurse stated that the Medication List the Physical Therapist used for medication reconciliation was located in the clinical record and would be provided to the Surveyor. Review of the medication list provided to the Surveyor on 09/18/2024 lacked orders for carvedilol, donepezil, guaifenesin, mintox, nystatin, pepto bismol or tab-a-vite. As of exit, no further documentation was provided to refute the findings. B. Review of the clinical record revealed a Supplemental Order dated 03/06/2024 for the following Physician Order: Order Description: Medication Change as follows per Assisted Living Facility Electronic Medication Administration Records: Start Memantine 5 milligrams, one (1) tablet, by mouth, twice daily Start Vitamin D3 25 micrograms, one (1) tablet, by mouth daily Goal to improve dementia symptoms by 03/30/2024. Patient updated on changes to plan of care. Review of the Home Health Certification and Plan of Care for 02/09/2024 to 04/08/2024 revealed that cholecalciferol (vitamin D3) 25 micrograms daily oral was previously ordered at the start of care. Review of the clinical record lacks documented evidence of a discontinuation order for vitamin D3 25 micrograms after the start of care on 02/09/2024 and prior to the supplemental order dated 03/06/2024. During interview on 09/17/2024 at 11:57 AM, the Physical Therapist stated that when the new order was received on 03/06/2024, it was not seen as a duplicate order, that vitamin D3 was not seen on the patient’s current medication list. The Executive Director further stated at 11:57 AM, that vitamin D3 was added at the start of care, that no discontinue order was found for this medication so it may have been a re-order or a duplicate order. Patient #1- This 67-year-old therapy only patient with the diagnoses of hemiplegia following cerebral infarction affecting left nondominant side, type II diabetes mellitus without complications and unspecified atrial fibrillation was admitted to the home care agency on 08/24/2024. Review of the referral to the home care agency dated 08/22/2024 revealed an order for aspirin 81milligram chewable tablet, one tablet by mouth daily. Review of the Home Health Certification and Plan of Care for 08/24/2024 to 10/22/2024 revealed an order for aspirin 81 milligram tablet, delayed release, one tablet by mouth daily. Review of the clinical record lacks documented evidence that Physical Therapist reviewed the aspirin formulation with the Registered Nurse or that the physician was contacted regarding the discrepancy between the referral to the agency and the plan of care. During interview on 09/17/2024 at 01:45 PM, the Physical Therapist stated that the medication reconciliation was completed using the referral medication list. The Physical Therapist further stated that the whole label was not read to confirm whether the aspirin was chewable or delayed release, and the Physical Therapist is unsure which formulation was in the home. At 01:46 PM the Executive Director stated that there was no supplemental order to clarify this medication. The agency failed to complete a comprehensive medication reconciliation as evidenced by the following: Patient #10- This 80-year-old Therapy Only patient with diagnoses that include aftercare following joint replacement surgery, hypertensive chronic kidney disease with stage 1-4/unspecified chronic kidney and type two (2) diabetes mellitus with diabetic chronic kidney disease was admitted to the home care agency on 05/17/2023. A. Review of the Hospital Medication list received by the agency on 05/16/2023 revealed the following orders: - docusate (colace) 100 milligrams by mouth two times daily - ferrous sulfate enteric coated 325 milligram by mouth daily - gabapentin (gabapentin immediate…) 300 milligrams by mouth at bedtime - hydromorphone 0.5 milligram intravenous every two hours as needed - benzocaine-menthol topical one lozenge by mouth as directed as needed - dexamethasone (Decadron) eight milligram intravenous push on call CPOE as needed - meclizine 25 milligrams by mouth three times daily as needed - ondansetron (Zofran) four milligram intravenous push every eight hours as needed - oxycodone (oxycodone immediate release) ten milligrams by mouth every four hours as needed - benzocaine-menthol topical sore throat lozenge one lozenge by mouth every two hours as needed - tramadol (tramadol immediate release) 100 milligrams by mouth every six hours - tranexamic acid 1 gram intravenous push on call CPOE as needed. Review of the Home Health Certification and Plan of Care for 05/17/2024 to 07/15/2024 lacks orders for the aforementioned medications. B. Review of the Home Health Certification and Plan of Care for 05/17/2024 to 07/15/2024 revealed the following orders: - tylenol 8 hour 650 milligram tablet extended release oral every eight hours as needed for breakthrough pain - aspirin 325 milligram tablet oral one tablet daily - famotidine 40 milligram tablet oral 40 mg two times daily - green tea (with metabolic enhancer blend) 250 microgram-775 milligram oral table one tablet daily - humalog kwikpen (unit100) insulin 100 unit/milliliter subcutaneous three times daily/as needed for diabetes- instructions: 0-150=0; 151-200= 2; 201- 250=3; 251-300=6; 301-350=8; 351-400=10; 401-450=12; 451-500=14. - lisinopril 10 milligram tablet oral daily - miralax 17 gram oral powder packet one (1) powder in packet every other day - multivitamin 50 plus tablet oral daily - trulicity 0.75 milligram/0.5 milliliter subcutaneous pen injector administer subcutaneously once weekly Review of the Hospital Medication list received by the agency on 05/16/2023 lacks orders for the aforementioned medications. C. Review of the Client Coordination Note Report dated 05/17/2023 revealed the Physical Therapist documented the following: Spoke to [Missy] at the physician’s office regarding patient not having right dosage of tylenol and aspirin in the house and daughter was getting it. Review of the clinical record lacks documented evidence that either the Physical Therapist or Registered Nurse contacted the physician regarding the medication reconciliation and discussed the discrepancies between the medication orders listed in the hospital list and the orders on the agency the plan of care. During interview on 09/17/2024 at 11:17 AM, the Physical Therapist stated that the hospital discharge instructions and medication list should have been discussed with patient. Additionally, any discrepancies should have been discussed with the doctor and should have been documented in clinical record and was not. During interview on 09/10/2024 at 02:55 PM, the Executive Director (Wellsville) stated the agency has a difficult time getting a discharge summary from the hospital that includes a list of discharge medications. The hospital medication list provided to the agency does include medications administered during the patient’s hospitalization. The Executive Director also stated that the clinician may use the discharge summary that the patient has in the home, but should upload it to the medical record. Additionally, the clinician is supposed to document the medication reconciliation and each discrepancy that was discussed with the doctor. As of exit, no additional evidence was provided to refute the findings. Patient #13- This 66-year-old patient with diagnoses that include pressure ulcer of sacral region, stage two (2), moderate protein-calorie malnutrition and spastic hemiplegia affecting right dominant side was admitted to the home care agency on 08/29/2024. A. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed the following orders: - artificial tears (carboxymethylcellulose) 1% ophthalmic eye drops one drop four times daily as needed for dry eyes - aspirin children’s 81 milligram chewable tablet one tablet daily - diclofenac 1% topical gel apply 2 grams topically to areas of pain three times daily - nystatin 100,000 unit/gram topical cream apply to bilateral groin and genitals twice daily for fungal rash - polyethylene glycol 3350 17 gram/dose oral powder daily Review of the physician medication referral list dated 08/26/2024 lacks orders for the aforementioned medications. B. Review of the physician medication referral list dated 08/26/2024 revealed the following orders: - accu-chek guide (glucose) test strip use one strip for testing topically every other day as directed for blood glucose monitoring (limit of fifty strips every ninety days) - artificial tears polyvinyl alcohol 1.4%/povidine (preservative free) instill one drop in affected eye four times a day as needed for dry eyes, discard any remaining product after using. Do not store for future use. - brief, protection plus medium #MSC33005 brief as directed three times a day as needed for incontinence - brief, protection plus small #MSC33255 brief as directed three times a day as needed for incontinence - cleansing cloth, adult with dimethicone one cloth topically four times a day as needed to clean skin - diclofenac sodium 1% topical gel apply two grams (use dosage card) topically three times a day as needed for pain - polyethylene glycol 3350 oral powder mix one capful (17 grams) and take by mouth every day for constipation, hold for loose stools - remedy skin cleanser solution topical apply once topically every day as needed for cleansing the skin Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 lacks orders for the aforementioned medications and medical supplies. Review of the clinical record lacks documented evidence the Registered Nurse contacted the physician regarding the medication reconciliation and discussed the discrepancies between the physician medication referral list and the orders on the agency the plan of care. During interview on 09/16/2024 at 12:02 PM, the Patient Care Manager of Home Health (Buffalo), Registered Nurse stated the clinician should have been clear and documented discrepancies discussed with the physician in a narrative note and did not. Patient #17- This 85-year-old Therapy Only patient with diagnoses that include alzheimer’s disease with late onset, essential (primary) hypertension, and anxiety disorder, unspecified was admitted to the home care agency on 08/20/2024. A. Review of the Home Health Certification and Plan of Care for 08/20/2024 to 10/18/2024 revealed the following orders: - aspirin 81 milligram tablet, delayed release, one tablet daily - atorvastatin 10 milligram tablet one tablet daily - boost 0.04 gram-1 kilocalorie/milliliter oral liquid one can two times daily Review of the physician referral medication list dated 08/16/2024 revealed the following orders: - aspirin enteric coated low dose 81 milligram one by mouth every day - atorvastatin calcium 10 milligram one tablet by mouth every evening - boost one (1) can twice a day Review of the clinical record lacks documented evidence the Registered Nurse contacted the physician regarding the medication reconciliation and discussed the discrepancies between the physician medication referral list and the orders on the agency the plan of care. During interview on 09/16/2024 at 11:05 AM, the Executive Director (Buffalo) stated the clinician should have received a current medication list from the licensed practical nurse at the facility which, is attached to the patient’s clinical record. Additionally, the clinician should document any discrepancies discussed with the provider. As of exit, no additional evidence provided to refute the findings. During interview on 09/16/2024 at 11:07 AM, the Physical Therapist stated medications were reviewed with the facility licensed practical nurse and discrepancies should have been discussed with physician and documented in a narrative note.”

“The patient’s representative (if any); CFR(s): 484.55(c)(7) The patient’s representative (if any); This Element is not met as evidenced by: Based on review of clinical records, agency policy and procedure, and interviews with staff for one (1) of seventeen (17) patients (Patient # 17), the agency failed to ensure the comprehensive assessment included information regarding the patient’s representative. Failure to determine and document information regarding the patient’s legal representative has the potential to result in unmet patient needs and negative patient outcomes. The agency failed to determine and document information regarding the patient’s legal representative is evidenced as follows: Patient #17- This 85-year-old Therapy Only patient with diagnoses that include alzheimer’s disease with late onset, essential (primary) hypertension, and anxiety disorder, unspecified was admitted to the home care agency on 08/20/2024. Review of the agency policy entitled “Patient Assessment, Initial and Reassessment” last revised on 09/01/2024 revealed “Upon admission and reassessments, the qualified clinician performs the following assessment activities and collects the following data…patient’s representative, if any.” Review of the Patient Consent form and HIPPA Related Admission Agreement dated 08/20/2024 revealed the agency’s Licensed Practical Nurse (LPN) signed the consent for services. The consent is not signed by the patient or the patient’s legal representative. Review of the Home Health Certificate and Plan of Care from 08/20/2024 to 10/18/2024 revealed the patient has advanced directives in place to include a Do Not Resuscitate order. Additionally, the patient has is a Durable Power of Attorney/Surrogate Decision maker and a Living Will. Review of the clinical record revealed there is no documentation of the name and contact information of the individual(s) who are designated as the patient’s Durable Power of Attorney /Surrogate and/or legal representative to make decisions regarding this patient’s health care. During interview on 09/16/2024 at 11:03 AM, the Physical Therapist stated the patient is not able to make decisions regarding the patient’s care, and the Licensed Practical Nurse signed the forms because the family was not available during the visit. As of exit, no further information was provided to refute the findings.”

“At discharge CFR(s): 484.55(d)(3) At discharge. This Element is not met as evidenced by: Based on review of clinical records, agency policy and procedure and interview with staff for two (2) of five (5) discharged patient records (Patient #’s 8 and 10), the agency failed to document a complete agency discharge summary, discipline discharge (Outcome and Assessment Information Set discharge assessment), and failed to communicate the discharge from services and the agency with the physician, and all other disciplines involved in the plan of care. Failure to document a complete discharge summary, discharge from discipline and communicate the discharge with other disciplines including the physician has the potential for negative patient outcomes. The agency failed to document an agency discharge from discipline and communicate the discharge with all services involved in the patient’s care and the physician as evidenced by the following: Review of the agency policy entitled “Coordination Of Care, From Admit Through Discharge” revised 09/01/2024 revealed “Coordination of care with physician/authorized practitioner occurs at admission, throughout care, and at discharge….Coordination of care among disciplines through care planning processes occurs from admission to discharge.” Patient #8- This 65-year-old patient with diagnoses that include malignant neoplasm of unspecified part of right bronchus or lung, gastrostomy malfunction and gastrostomy infection was admitted to the home care agency on 12/22/2023 and discharged 03/06/2024. A.) Review of the Home Health Certification and Plan of Care from 12/22/2023 to 02/19/2024 revealed the patient is to receive the following services: Skilled Nursing, Physical Therapy, Occupational Therapy and Speech Therapy. Review of the Team Case Conference Note dated 02/06/2024 revealed the Patient Care Manager of Home Health documented the patient would continue to receive Skilled Nursing, Physical Therapy, Occupational Therapy and Speech Therapy at recertification. Review of the Client Coordination Note Report dated 02/13/2024 revealed the Speech Therapist documented the patient declined speech therapy for the remainder of the week because the patient reported not feeling well. Review of the Physician Order dated 02/16/2024 revealed the patient has declined both Physical Therapy and Occupational Therapy visits for the previous two (2) weeks and “therapy will be discontinued for now. Physical Therapy effective 02/11/2024- no visits requested/scheduled. Occupational Therapy effective 02/11/2024- no visits requested/scheduled.” Review of the clinical record from 02/11/2024 to 03/06/2024 lacks documentation that the patient received Physical Therapy, Occupational Therapy and Speech Therapy services. Additionally, there is no documentation that the patient was discharged from Physical Therapy, Occupational Therapy and Speech Therapy services and no documentation that the therapists completed a discharge from discipline or documented that the patient’s therapy services would continue during the upcoming recertification period. Furthermore, there is no documentation that the Skilled Nurse or physician were notified. During interview on 09/17/2024 at 03:00 PM, the Speech Therapist stated she failed to follow-up with the patient after the patient refused visits. Additionally, the Speech Therapist stated that a discharge from discipline was not completed, and the physician and Skilled Nurse were not notified. During interview on 09/17/2024 at 03:05 PM, the Physical Therapist stated there were no further attempts to see the patient after the refusal of services during the week of 02/11/2024 and both Physical Therapy and Occupational Therapy failed to complete a discharge from discipline. Additionally, the Skilled Nurse and physician were not notified of this. B.) Review of the Home Health Certification and Plan of Care from 02/20/2024 to 04/19/2024 revealed the patient is to receive the Skilled Nursing services. Review of the Physician Order dated 03/08/2024 revealed an order by the RN to discharge the patient from the agency effective 03/06/2024. Patient transitioned to hospice. Review of the clinical record lacks documentation the RN completed and sent a discharge summary to the physician or to the hospice that the patient transitioned to. During interview on 09/17/2024 at 04:45 PM, the Clinical Director stated a discharge summary was not completed and sent to the physician or the hospice upon discharge. The agency failed to document a complete agency discharge summary and communicate with all disciplines involved in the patient’s care including the physician as evidenced by the following: Patient #10- This 80-year-old patient with diagnoses that include aftercare following joint replacement surgery, hypertensive chronic kidney disease with stage 1-4/unspecified chronic kidney and type two (2) diabetes mellitus with diabetic chronic kidney disease was admitted to the home care agency on 05/17/2023. Review of the Home Health Certification and Plan of Care from 05/17/2023 to 07/15/2023 revealed the patient is to receive the following services: Skilled Nursing and Physical Therapy. Review of the Notice of Medicare Non-Coverage dated 05/30/2024 revealed the patient’s home care services would end effective 06/01/2023. Review of the Client Coordination Note Report dated 05/30/2024 revealed the Physical Therapist documented agency discharge at next visit. There is a lack of documented evidence that the Physical Therapist communicated with the Registered Nurse and the physician regarding the plan to discharge the patient. Review of the Client Care Coordination Report Dated 05/31/2023 revealed the Registered Nurse documented that the patient would be discharged from nursing on that date (05/31/2023). There is a lack of documented evidence that the Registered Nurse communicated with the Physical Therapist and the physician regarding the plan to discharge the patient from nursing services. Review of the Discharge Instructions dated 05/31/2023 revealed the Registered Nurse discharged the patient from nursing services on 05/31/2023. The Discharge Instructions were incomplete and did not include a full and complete list of the patient’s current medications. Review of Visit Note Report dated 05/31/2023 revealed the Registered Nurse documented that the patient was discharged from nursing services, but not the agency. There is a lack of documented evidence the Physical Therapist and physician were notified of the discharge from services. Review of the Discharge Instructions dated 06/01/2023 revealed the Physical Therapist discharged the patient from the agency. The Discharge Instructions were incomplete and did not include a list of the patient’s current medication orders. Review of the Client Coordination Note Report dated 06/01/2023 revealed the Physical Therapist documented the patient was moving to another area and would be starting outpatient physical therapy on 06/06/2023. Review of Visit Note dated 06/01/2023 revealed the Physical Therapist documented that the patient was discharged from the agency. There is no documentation that the physician was notified that the patient was discharged from the agency. Review of the clinical record from 05/17/2023 to 06/01/2023 lacks clear documentation that the physician was notified of the patient’s discharge from Nursing and Physical Therapy. Additionally, there is no documentation that the Skilled Nurse or Physical Therapist coordinated or communicated with each other regarding the patient’s discharge and completed a Discharge Summary that includes a full list of the patient’s current medications at discharge. During interview on 09/18/2024 at 10:22 AM, the Registered Nurse stated there should have been communication with the Physical Therapist and documentation of discharge coordination between the clinicians. Also, the discharge summary provided to the patient was not complete and should have included dose, form, route, quantity, frequency, and any pertinent instructions for all of the medications. During interview on 09/17/2024 at 11:17 AM, the Physical Therapist stated there should have been communication with the Registered Nurse and documentation of discharge coordination between the clinicians. Also, the discharge instructions did not include the name, dose, form, route, quantity, frequency, and any pertinent instructions for any of medications and it should have. During an interview on 09/18/2024 at 10:36 AM, the Clinical Director (Jamestown) stated that a Discharge Summary should have been sent to the physician by the last clinician involved in the patient’s care. The Clinical Director stated that the Clinical Director will look for a Discharge Summary. As of exit, no further information provided to refute the findings.”

“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 an observational home visit, review of clinical records and staff interviews for nine (9) of seventeen (17) patients (Patient #s: 2, 6, 9, 8, 10, 11, 13, 15, and 17) the agency failed to develop individualized plans of care that are complete and accurate and address the total needs of the patients. Failure to ensure that a comprehensive individualized plan of care is developed has the potential for unmet patient needs. Patient #9 - This 80-year-old patient with diagnoses that include benign prostatic hyperplasia with lower urinary tract symptoms, other obstructive and reflux uropathy, and hypo-osmolality and hyponatremia was admitted to the home care agency on 03/06/2023. Review of the Home Health Certification and Plan of Care for 03/06/2023 to 05/04/2023 revealed the patient is ordered metformin 1,000 milligram tablet twice a day by mouth for diabetes type II. A. Review of the Review of the Home Health Certification and Plan of Care for 03/06/2023 to 05/04/2023 lacks a diabetic diagnosis. During interview on 09/16/2024 at 11:51 AM, the Registered Nurse stated the coding team removed the diagnosis, this has been an on-going issue. The patient is diabetic but is non-compliant with blood glucose testing, the physician is aware. B. Review of the Review of the Home Health Certification and Plan of Care for 03/06/2023 to 05/04/2023 lacks orders for blood glucose testing. During interview on 09/16/2024 at 11:51 AM, the Registered Nurse stated the patient is diabetic but is non-compliant with blood glucose testing, the physician is aware. HV Patient #15 - This 78-year-old therapy-only patient with diagnoses that include encounter for surgical aftercare following surgery on circulatory system, bipolar disorder, and type II diabetes mellitus with diabetic neuropathy was admitted to the home care agency on 08/30/2024. A. Review of the Home Health Certification and Plan of Care for 08/30/2024 to 10/28/2024 revealed the order for insulin glargine 100 unit/milliliter subcutaneous pen 10 units at bedtime, however the plan of care lacks orders for blood glucose testing frequency, who is responsible, and diabetic supplies. During interview on 09/16/2024 at 01:18 PM, the Physical Therapist stated the patient does not check blood glucoses regularly. The orders for diabetic management were not included on the plan of care. B. During a home visit on 09/11/2024 at 09:30 AM, the patient’s wife stated the patient receives Skilled Nursing Services from another agency. Review of the Home Health Certification and Plan of Care for 08/30/2024 to 10/28/2024 lacks documentation stating the patient receives services from another agency. During interview on at 01:19 PM, the Physical Therapist stated he did not know to include services provided by another agency on the plan of care. Patient #2 – This 82-year-old patient with the diagnoses of type II diabetes mellitus without complications, chronic obstructive pulmonary disease, and acute and chronic respiratory failure with hypoxia was admitted to the home care agency on 08/27/2024. A. Review of the Registered Nurse Outcome and Assessment Information Set Note dated 08/27/2024 revealed the patient is using 2.5 (two and half) liters of oxygen via nasal cannula continuously. Review of the Home Health Certification and Plan of Care for 08/27/2024 to 10/25/2024 lacks an order for oxygen to include route and dose. During interview on 09/17/2024 at 12:48 PM, the Registered Nurse stated the patient does use oxygen but there is no order. Patient #6 – This 60-year-old patient with the diagnoses of multiple sclerosis, type II diabetes mellitus with hyperglycemia, and non-st elevation myocardial infarction was admitted to the home care agency on 11/29/2023. Review of the Home Health Certification and Plan of Care for 11/29/2023 to 01/27/2024 revealed the order for trulicity 4.5 milligrams/0.5 milliliters subcutaneous pen injector weekly per instructions. Review of the clinical record lacks instruction for administration of the trulicity. During interview on 09/16/2024 at 03:05 PM, the Patient Care Manager Home Health, Registered Nurse stated there is no order clarifying the use of trulicity. Review of the agency’s Elsevier Nasogastric (NG) Guidance (approved Clinical Skills Online program) dated 07/2024 revealed that the guidelines covered the following topics: administration of tube feeds, NG tube placement verification, NG tube insertion, administration of medications via the NG tube, NG tube removal, assessing for gastric aspirate (residuals), skin care, irrigation of the NG tube, and measuring external portion of NG tube for migration. Patient #8- This 65-year-old patient with diagnoses that include malignant neoplasm of unspecified part of right bronchus or lung, gastrostomy malfunction and gastrostomy infection was admitted to the home care agency on 12/22/2023 and discharged 03/06/2024. A.) Review of the Home Health Certification and Plan of Care for 12/22/2023 to 02/19/2024 revealed the following orders: “Skilled Nurse (SN) for instruction of gastrointestinal system including Corpak (type of Nasogastric tube), GI (gastrointestinal) hemorrhage, peritonitis due to dislodgment of existing [the patient did not have a PEG (percutaneous endoscopic gastrostomy) tube]. Corpak NG tube replaced on 11/22/2023. Patient to receive Osmolite 1.5 65 ml (milliliter) /hr (hour) via Kangaroo pump continuous with 90 ml water flush every 4 (four) hours. SN to instruct on new and changed medications, those with assessed knowledge deficit, high risk medications and any applicable drug interactions. SN to instruct/ supervise patient /caregiver on strict NPO (nothing by mouth) (for patient).” Review of the Home Health Certification and Plan of Care for 12/22/2023 to 02/19/2024 lacks orders for NG tube care that includes assessing NG tube placement, measuring the external portion of the NG tube, documentation of the size of the Corpak NG tube and documentation regarding when the NG tube is to be replaced. During interview on 09/23/2024 at 11:00 AM, the Clinical Director stated the Corpak NG tube does not require an assessment of residuals or the need to check for migration by measuring the external portion of the tube. During interview on 09/23/2024 at 11:19 AM, the Executive Director stated the agency has no protocol or policy to follow regarding the Corpak NG and orders for the Corpak NG should have been verified with the physician and included on the plan of care. B.) Review of the agency’s undated Elsevier Feeding Tube: Medication Administration (approved Clinical Skills Online program) provided to the surveyor on 09/20/2024 revealed the following protocols: - Flush the feeding tube with a minimum of 15 milliliter (ml) of purified water before and after the administration of medications. - Prepare medications for instillation into the feeding tube: a. Liquid: Measure the prescribed dose. b. Tablet: Crush the tablet using device to grind into a fine powder. Mix and dilute it in 30 to 60 ml of purified water. c. Capsule: Open the capsule or pierce the gelcap with a sterile needle and empty contents into 30 to 60 ml of purified water. - Place the patient in high fowlers position; - Check placement of the feeding tube; - Draw back on the syringe slowly and obtain a small volume of gastric contents, assess the appearance of gastric contents; - Administer liquid or dissolved medication by pouring it into syringe and flushing, give each medication separately and flush between medications with at least 15 ml of purified water. Review of the Home Health Certification and Plan of Care for 12/22/2023 to 02/19/2024 revealed the following orders: - SN to instruct/ supervise patient/caregiver on strict NPO. - SN to instruct on new and changed medications, those with assessed knowledge deficit, high risk medications and any applicable drug interactions. - Medications: methylprednisolone, metoprolol tartrate, oxycodone, pantoprazole, pregabalin, quetiapine and sulfamethoxazole-trimethoprim to be administered via nasogastric tube. Review of the Home Health Certification and Plan of Care for 12/22/2023 to 02/19/2024 lacks procedural orders for administration of medications via the NG tube (to include flushes before and after administration of medication, aspiration of gastric contents, checking placement, patient positioning, and preparation and administration of each medication). Additionally, the plan of care does not include orders to instruct the patient and caregiver on NG tube medication administration. During interview on 09/23 2024 at 11:03AM, the Clinical Director stated the RN was not available for interview. The Clinical Director acknowledged the plan of care for 12/22/2023 to 02/19/2024 lacks orders and directions for the administration of medications through the Corpak NG tube and orders to instruct the patient and caregiver in NG tube medication administration. During interview on 09/23/2024 at 11:19 AM, the Executive Director stated the agency has no protocol or policy to follow regarding the Corpak NG tube. Additionally, the Executive Director stated orders for the Corpak NG medication administration should have been verified with the physician and included on the plan of care. Patient #11 – This 32-year-old patient with diagnoses that include fracture closure of unspecified part of the left femur and anxiety was admitted to the home care agency on 08/04/2024. Review of the PT (Physical Therapy) OASIS (outcome and assessment information set) Admission Visit Note dated 08/04/2024 revealed the PT documented that the service of Occupational Therapy (OT) was required for this patient to assist with ADL (activities of daily living) training. Review of the Home Health Certification and Plan of Care for 08/04/2024 to 10/02/2024 revealed orders for Physical Therapy but lacks orders for Occupational Therapy to evaluate and treat the patient. During interview on 09/16/2024 at 02:13 PM, the PT stated the patient was assessed and required an OT evaluation, but the PT never obtained an order for OT or initiated an internal referral to initiate OT. The agency failed to develop individualized plans of care that are complete and accurate and address the total needs of the patients as evidenced by the following: HV Patient #13- This 66-year-old patient with diagnoses that include pressure ulcer of sacral region, stage two (2), moderate protein-calorie malnutrition and spastic hemiplegia affecting right dominant side was admitted to the home care agency on 08/29/2024. A. Review of the Registered Nurse Outcome and Assessment Information Set Note dated 08/29/2024 revealed the patient is noncompliant with glucose testing every other day. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 lacks a diagnosis for diabetes and orders for blood glucose testing frequency, who is responsible for managing blood sugars, and diabetic supplies. During interview on 09/16/2024 at 11:55 AM, the Registered Nurse stated the patient is diabetic, and that the diagnosis must have fallen off during “coding,” but should be on the plan of care. B. Review of the Registered Nurse Outcome and Assessment Information Set Note dated 08/29/2024 revealed the patient is a current heavy smoker of both cigarettes and marijuana. Additionally, the patient consumes alcohol daily. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 does not include information regarding the patient’s frequent tobacco, marijuana, and alcohol use. During a home visit observation on 09/10/2024 at 11:50 AM, the patient’s sister reported that that the patient still smokes both marijuana and cigarettes, but has decreased alcohol consumption, and instead of drinking two forty-ounce bottles of alcohol, the patient now consumes one forty-ounce bottle. The sister stated that the patient was homeless, but the sister took the patient in. The sister expressed concern that there were other siblings in the family that died as a result of substance use and the patient is spending all the patient’s income on alcohol, tobacco, and marijuana. The patient’s sister stated that the sister signed the patient’s power of attorney the previous day and the sister had been purchasing patient supplies using the sister’s own money. Review of the clinical record lacks documented evidence of a referral for social work to address the patient’s and the family’s needs. During interview on 09/16/2024 at 12:12 PM, the Registered Nurse stated that there was a discussion with the physician about the patient’s use of tobacco, marijuana, and alcohol, but it was not documented. Additionally, the diagnoses were not “coded” on the plan of care and there was not a referral made for social work, which should have been offered. C. Review of the Registered Nurse Outcome and Assessment Information Set Note dated 08/29/2024 revealed the following nutritional screen: - Major risk factors: decubitus/pressure ulcer stage two (II) or greater and diagnosis of malnutrition - Other risk factors: on a special diet and takes three (3) or more medications or over-the-counter medications per day - Total nutrition score: 16 - Based on the nutrition screen score, the nutritional risk, patient is at a high nutritional risk - Indicate at what nutritional risk level was presented for this patient: greater than seven (7) points or any identified major risk factor equals high risk - Plan for high-risk patients: may notify physician for further orders Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed a diagnosis of moderate protein-calorie malnutrition and an order for Ensure Original Liquid eight (8) milliliters oral daily supplement, not to replace meal. Review of the clinical record lacks documented evidence that the Skilled Nurse discussed the patient’s nutritional status and needs with the patient and/or requested a referral for nutritional services for this nutritional high-risk patient. During an interview on 09/16/2024 at 12:50 PM, the Registered Nurse stated there should have been a documented conversation about nutrition and a nutritional services referral should have been offered but was not. D. During a home visit observation on 09/10/2024 at 11:40 AM to observe the agency’s Registered Nurse, the aide in the home introduced self to surveyor and reported that the patient receives aide services through an agency not affiliated with the Certified Home Health Agency. The aide reported that the patient receives aide services three (3) times a week for a total of nine (9) hours a week. Additionally, during the visit, the patient’s sister reported that the patient requires additional aide hours and was going to contact the agency providing the aide services to discuss the need for more aide hours. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed there is no documentation in the plan of care to show that the patient receives aide services through another agency. During interview on 09/16/2024 at 12:21 PM, the Patient Care Manager of Home Health (Buffalo) stated that the agency and home health aide information should be included in the plan of care. Patient #10- This 80-year-old patient with diagnoses that include aftercare following joint replacement surgery, hypertensive chronic kidney disease with stage 1-4/unspecified chronic kidney and type two (2) diabetes mellitus with diabetic chronic kidney disease was admitted to the home care agency on 05/17/2023. A. Review of the Home Health Certification and Plan of Care for 05/17/2023 to 07/15/2023 revealed a diagnosis of Type two (2) diabetes mellitus with diabetic chronic kidney disease. Review of the Skilled Physical Therapy Outcome and Assessment Information Set Note dated 05/17/2023 revealed the Physical Therapist documented the following: - Does the patient have diabetes: Yes - Name of physician managing diabetes: [Physician’s name] - Has the patient had a hemoglobin A1c within the last three months: Yes- contact the physician managing diabetes to request a copy of results - Type of diabetes: type two (2) - Is the patient taking insulin or non-insulin anti-diabetic injection: yes - Who is providing the insulin/non-insulin anti-diabetic injections: patient - Can the patient manage insulin or non-insulin anti-diabetic dosage (draw up or use pen and self-inject): yes - Is diabetes due to an underlying cause or condition: unknown - Does patient have any of the following complications associated with diabetes: renal - Is the patient experiencing symptoms of low or high blood glucose: no - CBG results obtained by (CBG reference range 80-120 mg/dl): patient - Does patient demonstrate understanding and competency in CBG testing: yes Review of the Home Health Certification and Plan of Care for 05/17/2023 to 07/15/2023 revealed there is no order for diabetic testing supplies. During interview on 09/17/2024 at 10:49 AM, the Clinical Director (Jamestown) stated there should be an order for a glucometer and testing supplies and there is not. B. Review of the Skilled Physical Therapy Outcome and Assessment Information Set Note dated 05/17/2023 revealed the Physical Therapist documented the following: - Inadequate/no grab bars in bath/shower - Inadequate/no stair railings Review of the Home Health Certification and Plan of Care for 05/17/2023 to 07/15/2023 revealed the following DME and Supplies: - Briefs/bladder control pads - Cane - Quad cane - Shower/tub equipment - Walker rolling (four (4) wheeled) - Bedside commode - Walker rolling (two (2) wheeled only) - Dressing-surgical The clinical record lacks documentation that the Physical Therapist discussed the need for bath/shower grab bars and stair railings and evidence that the Physical Therapist obtained an order for the needed durable medical equipment. During interview on 09/17/2024 at 10:45 AM, the Physical Therapist stated there was a conversation to guide the patient to get equipment, but it was not documented, and orders were not obtained from the provider. C. Review of the Skilled Physical Therapy Outcome and Assessment Information Set Note dated 05/17/2023 revealed the following orders: physical therapy to provide/instruct/reinforce to patient/caregiver wound care to right knee, patient to leave island dressing on until 5/22/2023 then allowed to remove, cleanse with solution given from hospital, and redress with island dressing, and leave on until follow up orthopedic appointment. The clinical record lacks a complete order for wound care to include the name of the wound cleansing solution to be used. During interview on 09/17/2024 at 10:37 AM, the Physical Therapist stated being unable to recall whether the wound cleanser solution should have been included in the orders. As of exit, no additional evidence was provided to refute the findings. Patient #17- This 85-year-old Therapy Only patient with diagnoses that include alzheimer’s disease with late onset, essential (primary) hypertension, and anxiety disorder unspecified was admitted to the home care agency on 08/20/2024. Review of the Visit Note Report dated 08/20/2024 revealed the Physical Therapist documented the patient’s gastrointestinal assessment findings as “constipation.” Review of the Home Health Certification and Plan of Care for 08/20/2024 to 10/18/2024 revealed the following: if patient exhibits signs or symptoms of constipation, ensure patient is taking any prescribed medications for conditions if not already prescribed then instruct to initiate 17 grams of Miralax by mouth daily until normal bowel regime resumes and/or instruct patient to initiate 15 milligrams senna by mouth two times daily until normal bowel regime resumes. If normal bowel movements do not resume in two days, contact physician for additional orders. The order for Miralax is incomplete and does not include instructions regarding how to prepare the medication for administration. Additionally, the plan of care does not include an order for the Physical Therapist to provide instruction and education regarding the ordered medications, to include administration, side effects and concerns that need to be reported. During interview on 09/16/2024 at 11:20 AM, the Physical Therapist stated there is no order clarifying the use of medications for constipation because the Adult facility that the patient resides in would have a “standing order” for the medications. The Physical Therapist stated that the orders were discussed with the Licensed Practical Nurse at the facility because the patient is too confused to understand instructions. As of exit, no further information was provided to refute the findings.”

“All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This Element is not met as evidenced by: Based on review of clinical records and staff interviews for three (3) of seventeen (17) patients (Patient #s: 1, 10, and 13) the agency failed to ensure that all physician orders were included in the Plan of Care. Failure to ensure all orders are included in the Plan of Care has the potential for unmet patient needs. Patient #1- This 67-year-old therapy only patient with the diagnoses of hemiplegia following cerebral infarction affecting left nondominant side, type II diabetes mellitus without complications and unspecified atrial fibrillation was admitted to the home care agency on 08/24/2024. Review of the Home Health Certification and Plan of Care for 08/24/2024 to 10/22/2024 revealed the following orders: - alprazolam 0.5 milligrams every 8 hours as needed oral - aspirin 81 milligrams daily oral - clopidogrel 75 milligrams daily oral - colchicine 0.6 milligrams daily as needed oral - eliquis 5 milligrams twice daily oral - ergocalciferol (vitamin D2) 1250 micrograms once weekly oral - fenofibrate nano crystalized 145 milligrams daily oral - isosorbide mononitrate extended release 60 milligrams daily oral - lisinopril 30 milligrams daily oral - metformin 500 milligrams twice daily oral - metoprolol tartrate 25 milligrams twice daily oral A. Review of Visit Note Report dated 08/29/2024 revealed the Physical Therapist documented the following: Pain- When was patient’s last dose of pain medication- This morning, Tylenol. Patient states it is not very effective nor is the other pain medication. Review of the Home Health Certification and Plan of Care dated 08/24/2024 to 10/22/2024 lacks documented evidence of an order for Tylenol. During interview on 09/17/2024 at 11:39 AM, the Physical Therapist stated that the medication list was not reviewed for a Tylenol order, the Physical Therapist assumed that Tylenol was on the list. Furthermore at 11:39 AM, the Executive Director stated that there was no supplemental order for Tylenol. B. Review of Visit Note Report dated 08/29/2024 revealed the Physical Therapist documented the following: Therapeutic Subjective- Patient states that vitamin B12, vitamin D and a new blood thinner were started. A medication reconciliation was performed and all medications the patient claimed to be new are currently listed on the updated medication list as of start of care. No discrepancies found. Review of the clinical record revealed a supplemental physician order dated 09/09/2024 to add vitamin B12 Active 1000 micrograms (Chewable tablet) daily oral and to discontinue ergocalciferol (vitamin D2) 1250 micrograms once weekly oral. Review of the clinical record lacked an order for vitamin B12 until 09/09/2024. During interview on 09/17/2024 at 11:45 AM the Physical Therapist stated that during that visit the Physical Therapist reviewed the patient’s current medication list on the agency tablet and thought vitamin B12 was already on the plan of care. The agency failed to ensure all physician orders are included in the Plan of Care as evidenced by the following: Patient #10- This 80-year-old patient with diagnoses that include aftercare following joint replacement surgery, hypertensive chronic kidney disease with stage 1-4/unspecified chronic kidney and type two (2) diabetes mellitus with diabetic chronic kidney disease was admitted to the home care agency on 05/17/2023. A. Review of the Physical Therapy Visit Note Report dated 05/18/2023 revealed patient and daughter instructed in…using glucerna instead of boost. Review of the clinical record lacks orders for boost and glucerna. During an interview on 09/17/2024 at 11:31 AM, the Physical Therapist was unable to recall if there were orders for the nutritional supplements. As of exit, no further evidence was provided to refute the findings. B. Review of the Client Coordination Note Report dated 05/31/2024 revealed the Registered Nurse documented the patient has gotten the freestyle libre two (2) system, much education this date on application and use. Patient was able to apply sensor to arm independently. Review of the clinical record lacks an order for the freestyle libre two (2) system for blood sugar testing and replacement of sensors. During an interview on 09/18/2024 at 10:12 AM, the Registered Nurse stated orders were not obtained or documented in the clinical record for the freestyle libre two (2) testing system because the patient had it in the home. Patient #13- This 66-year-old patient with diagnoses that include pressure ulcer of sacral region, stage two (2), moderate protein-calorie malnutrition and spastic hemiplegia affecting right dominant side was admitted to the home care agency on 08/29/2024. Review of the Skilled Nurse Visit Note Report dated 09/10/2024 revealed the Skilled Nurse documented the following: - Does the patient have diabetes: yes - Is the patient taking insulin or non-insulin anti-diabetic injections: no - Continuous Blood Glucose (CBG) obtained by: caregiver- CBG results documented in vital sign section - Is caregiver competent in performing CBG testing: yes - Does caregiver check controls according to manufacturer guidelines: yes - Patient’s highest fasting blood glucose in last seven (7) days: n/a - Lower extremities assessment: yes - Describe lower extremities assessment findings: no findings - Indicate changes in equipment/equipment needs: n/a- no changes needed to equipment. Review of the clinical record lacks documented evidence of an order for diabetic testing supplies, diabetic management, and glucose testing. During an interview on 09/16/2024 at 11:57 AM, the Registered Nurse stated no order was obtained for diabetic testing, management and glucose testing.”

“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 an observational home visit, review of clinical records and interviews with agency staff for five (5) of seventeen (17) patients (Patient #’s: 4, 8, 9, 13, and 16), the agency failed to provide services in accordance with physician orders and the Plan of Care. Failure to ensure patient care is provided in accordance with physician orders and the Plan of Care has the potential for patients to receive poor care and for health care needs to go unmet. Patient #4 – This 96- year-old therapy-only patient with the diagnoses of unspecified dementia with mood disturbance and anxiety, vascular dementia with psychotic disturbances and anxiety, and major depressive disorder was admitted to the home care agency on 05/15/2024 and discharged on 09/06/2024. Review of the Home Health Certification and Plan of Care for 07/14/2024 to 09/11/2024 revealed “Physical Therapy to provide assessment and teaching of management of depression.” Review of the Physical Therapy Recertification with Skill Visit Note dated 07/11/2024 and Physical Therapy Visit Notes dated 07/15/2024, 07/23/2024, 07/29/2024, 08/07/2024, 08/13/2024, 08/19/2024, and 08/29/2024 lack documented evidence the Physical Therapist completed an assessment of the patient’s depression. During interview on 09/16/2024 at 01:50 PM, the Physical Therapist stated the recertification visits and revisits do not prompt an assessment of depression, but an assessment can be added in the narrative note and was not. Patient #9 - This 80-year-old patient with diagnoses that include benign prostatic hyperplasia with lower urinary tract symptoms, other obstructive and reflux uropathy, and hypo-osmolality and hyponatremia was admitted to the home care agency on 03/06/2023. Review of the Home Health Certification and Plan of Care for 03/06/2023 to 05/04/2023 revealed the order for Skilled Nursing once a week for eight (8) weeks and five (5) times a week for one (1) week. Review of the clinical record from 03/17/2023 to 03/23/2023 lacks documented evidence a Skilled Nursing visit occurred or documentation that the physician was notified of the missed visit. During interview on 09/16/2024 at 11:47AM, the Registered Nurse stated the patient was supposed to have a visit on 03/19/2024 but there is no note to explain why it was missed. Patient #8- This 65-year-old patient with diagnoses that include malignant neoplasm of unspecified part of right bronchus or lung, gastrostomy malfunction and gastrostomy infection was admitted to the home care agency on 12/22/2023 and discharged 03/06/2024. Review of the Home Health Certification and Plan of Care for 02/20/2024 to 04/19/2024 revealed an order for Skilled Nurse (SN) to obtain weight every visit and notify Registered Nurse (RN)/Physician of weight loss of 5 (five) pounds (lbs) within 2 (two) weeks. Review of the clinical record revealed the SN made visits on 02/21/2024, 02/28/2024 and 03/06/2024. Review of the SN Visit Notes dated 02/21/2024, 02/28/2024 and 03/06/2024 revealed the SN did not document that a weight was obtained, and no weight is recorded on those dates. During interview on 09/17/2024 at 04:05 PM, the RN stated being unable to recall why weights were not documented at the identified visits. Patient #16- This 70-year-old patient with the diagnoses of orthopedic aftercare following surgical amputation, type II diabetes mellitus, and unspecified atherosclerosis native arteries of the extremities, left leg was admitted to the home care agency on 08/21/2024. Review of the Home Health Certification and Plan of Care for 08/21/2024 to 10/19/2024 revealed the order for Skilled Nursing twice a week for one (1) week, three (3) times a week for eight (8) weeks and two (2) as needed visits for wound complications. Review of the clinical record from 08/21/2024 to 09/11/2024 lacks documented evidence a second Skilled Nursing visit occurred the week of 09/08/2024 to 09/14/2024 or documentation that the physician was notified of the missed visit. Review of the Client Episode Coordination Notes Report dated 09/09/2024 revealed a Missed Visit Notification for Physical Therapy due to the patient’s doctor appointment which included notification to the primary physician by fax on 09/09/2024. During interview on 09/16/2024 at 11:43 AM, the Registered Nurse stated that there should have been a Skilled Nursing visit scheduled for 09/09/2024 but the Registered Nurse was not sure if it was done. Furthermore, the Executive Director stated that the Skilled Nursing was missed on 09/09/2024 but there was a typo in the note. That it should be marked for Skilled Nursing instead of Physical Therapy, and the doctor was notified. The agency failed to provide services in accordance with physician orders and the Plan of Care as evidenced by: HV Patient #13- This 66-year-old patient with diagnoses that include pressure ulcer of sacral region, stage two (2), moderate protein-calorie malnutrition and spastic hemiplegia affecting right dominant side was admitted to the home care agency on 08/29/2024. A. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed the order for Skilled Nurse one (1) week one (1), two (2) week three (3), and two (2) as needed for wound complications. Review of the Missed Visit Notification dated 09/06/2024 revealed notification sent to provider via fax for missed physical therapy visit on 09/05/2024. Review of the Missed Visit Notification dated 09/09/2024 revealed notification sent to provider via fax for missed physical therapy visit on 09/06/2024. Review of the clinical record from 09/01/2024 to 09/07/2024 lacks documented evidence a Skilled Nursing visit occurred or documentation that the physician was notified of the missed skilled nursing visit. During interview on 09/16/2024 at 12:10 PM, the Executive Director (Buffalo) stated the missed visit notification to the provider was for the missed nursing visits and physical therapy was documented in error. B. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed the order for skilled nurse to perform/instruct patient/caregiver procedure of wound care to sacrum wound three times a week and as needed for soiled or dislodged, caregiver to perform on non-visit days. Cleanse with normal saline. Apply aquacel if draining. Cover with foam dressing using clean technique. Instruct patient/caregiver signs/symptoms of wound infection and proper disposal of dressings. During a home visit on 09/10/2024 at 12:10 PM, the surveyor observed patient with sacral wound open to air prior to registered nurse performing wound care. During wound care, registered nurse applied aquacel silver (ag) to wound bed after stating that the wound was open and draining. During interview on 09/16/2024 at 12:17 PM, the Registered Nurse stated aquacel was not used and should have been. There was not an order obtained for aquacel with silver before using it.”

“Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This Element is not met as evidenced by: Based on review of clinical records and interviews with agency staff for two (2) of seventeen (17) patients (Patient #’s 8 and 14), the agency failed to ensure the plan of care (POC) is reviewed and revised by the physician who is responsible for the plan of care and the agency as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days. 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 POC’s are reviewed and revised to reflect the patient’s current status as evidenced by the following: Patient #8- This 65-year-old patient with diagnoses that include malignant neoplasm of unspecified part of right bronchus or lung, gastrostomy malfunction and gastrostomy infection was admitted to the home care agency on 12/22/2023 and discharged 03/06/2024. A.) Review of the Home Health Certification and Plan of Care for 12/22/2023 to 02/19/2024 revealed the following orders: - Nutritional Requirements: Strict NPO (nothing by mouth), NG (nasogastric) tube feeds; and - Medications: methylprednisolone, metoprolol tartrate, oxycodone, pantoprazole, pregabalin, quetiapine and sulfamethoxazole-trimethoprim to be administered via nasogastric tube. Review of the Resumption of Care Physician Orders dated 01/22/2024 revealed a new order for miralax 17 gram oral powder packet, administer 1 (one) packet daily by oral route. The revised plan of care was not individualized to meet the patient’s NPO needs. During interview on 09/17/2024 at 03:35 PM, the Registered Nurse (RN) stated it was an oversight that the medication was ordered orally when the patient was NPO and all medications were to be administered via the NG tube. B.) Review of the SN Visit Note dated 02/06/2024 revealed the RN documented “the patient has a new mediport to left chest, incision is open to air and well approximated, no s/sx (signs or symptoms) of infection. Discussed care of site…Site care not performed.” Review of the Physician Order dated 02/06/2024 revealed the order for “To new medport (mediport) site: keep site clean and dry.” The order lacks specification of when the port was last accessed/flushed, when the port is next due to be accessed/flushed and the individual(s) responsible for accessing/flushing the port. It is unknown whether the agency was responsible for the port maintenance, or the physician. During interview on 09/17/2024 at 03:35 PM, the RN stated the patient’s Oncologist would be managing the mediport and performing all port care but the RN failed to document this. C.) Review of the Home Health Certification and Plan of Care for 02/20/2024 to 04/19/2024 revealed the following orders: - Nutritional Requirements: NPO, tube feedings. The plan of care states “He (patient) has an NG tube with continuous feedings managed by his wife.” - Medications: - bisadodyl 5 mg (milligram) tablet, 2 (two) tablets twice daily/PRN (as needed) for constipation by oral route; and - miralax 17 gram oral powder packet, 1 (one) packet daily by oral route. During interview on 09/17/2024 at 03:59 PM, the RN stated it was an oversight that the medications were ordered orally when the patient was NPO and all medications were to be administered via the NG tube. D.) Review of the agency’s Elsevier “Nasogastric (NG) Guidance” (approved Clinical Skills Online program) dated 07/2024 revealed that the guidelines covered the following topics: administration of tube feeds, NG tube placement verification, NG tube insertion, administration of medications via the NG tube, NG tube removal, assessing for gastric aspirate (residuals), skin care, irrigation of the NG tube, and measuring external portion of NG tube for migration. Review of the Home Health Certification and Plan of Care for 02/20/2024 to 04/19/2024 revealed the following orders: - SN to instruct on administration of nasogastric feedings, Osmolite 1.5, 65 ml per hour via pump. Instructions to include safety measures, care of equipment and preparation of feedings. Flush with 90 ml of water every 4 (four) hours. - SN to instruct on new and changed medications, those with assessed knowledge deficit, high risk medications and any applicable drug interactions. The plan of care states “Patient has an NG tube with continuous feedings managed by his wife.” - Nutritional Requirements: NPO, tube feedings. Review of the Home Health Certification and Plan of Care for 02/20/2024 to 04/19/2024 lacks orders for NG tube care that includes assessing NG tube placement, measuring the external portion of the NG tube, documentation of the size of the Corpak NG tube and documentation regarding when the NG tube is to be replaced. During interview on 09/23/2024 at 11:00 AM, the Clinical Director stated the Corpak NG tube does not require an assessment of residuals or the need to check for migration by measuring the external portion of the tube. During interview on 09/23/2024 at 11:19 AM, the Executive Director stated the agency has no protocol or policy to follow regarding the Corpak NG and orders for the Corpak NG should have been verified with the physician and included on the plan of care. E.) Review of the agency’s undated Elsevier “Feeding Tube: Medication Administration” (approved Clinical Skills Online program) provided to the surveyor on 09/20/2024 revealed the following protocols: - Flush the feeding tube with a minimum of 15 milliliter (ml) of purified water before and after the administration of medications. - Prepare medications for instillation into the feeding tube: a. Liquid: Measure the prescribed dose. b. Tablet: Crush the tablet using device to grind into a fine powder. Mix and dilute it in 30 to 60 ml of purified water. c. Capsule: Open the capsule or pierce the gelcap with a sterile needle and empty contents into 30 to 60 ml of purified water. - Place the patient in high fowlers position; - Check placement of the feeding tube; - Draw back on the syringe slowly and obtain a small volume of gastric contents, assess the appearance of gastric contents; - Administer liquid or dissolved medication by pouring it into syringe and flushing, give each medication separately and flush between medications with at least 15 ml of purified water. Review of the Home Health Certification and Plan of Care for 02/20/2024 to 04/19/2024 revealed the following orders: - SN to instruct on administration of nasogastric feedings, Osmolite 1.5, 65 ml per hour via pump. Instructions to include safety measures, care of equipment and preparation of feedings. Flush with 90 ml of water every 4 (four) hours. - SN to instruct on new and changed medications, those with assessed knowledge deficit, high risk medications and any applicable drug interactions. The plan of care states “Patient has an NG tube with continuous feedings managed by his wife.” - Nutritional Requirements: NPO, tube feedings. - Medications: methylprednisolone, metoprolol tartrate, oxycodone, pregabalin, quetiapine, sulfamethoxazole-trimethoprim, and tylenol all administered via nasogastric tube. Review of the Home Health Certification and Plan of Care for 02/20/2024 to 04/19/2024 lacks procedural orders for administration of medications via the NG tube (to include flushes before and after administration of medication, aspiration of gastric contents, checking placement, patient positioning, and preparation and administration of each medication). Additionally, the plan of care does not include orders to instruct the patient and caregiver on NG tube medication administration. During interview on 09/17/ 2024 at 04:02 PM, the RN stated being unaware the identified orders should have been included on the plan of care. The RN acknowledged a lack of experience working with NG tubes. During interview on 09/23/2024 at 11:19 AM, the Executive Director stated the agency has no protocol or policy to follow regarding the Corpak NG tube. Additionally, the Executive Director stated orders for the Corpak NG medication administration should have been verified with the physician and included on the plan of care. F.) Review of the Home Health Certification and Plan of Care for 02/20/2024 to 04/19/2024 revealed the patient has a mediport that is cared for by the patient’s oncologist and the agency may receive orders regarding the mediport from the oncologist. The plan of care does not include information regarding when the port was last accessed/flushed, when the mediport was due to be accessed/flushed and who was responsible for maintaining the mediport. During interview on 09/17/2024 at 4:04 PM, the RN stated all accessing/flushing was to be completed by the patient’s Oncologist but the RN failed to document this on the plan of care orders. Patient #14 – This 76-year-old patient with diagnoses that include non-pressure chronic ulcer of the left ankle and venous insufficiency was admitted to the home care agency on 08/29/2024. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed the following orders: - SN to instruct patient/ caregiver on edema, to include signs and symptoms to report and management. - SN to perform wound care to LLE (left lower extremity) BIW/PRN (twice weekly and as needed) for soiling- cleanse with NS (normal saline), apply calcium alginate AG (absorbent dressing with antibacterial silver) to open areas, wrap with Unna boot (compression dressing), secure with coban (self-adherent wrap) and tape. Review of the SN Visit Note dated 09/03/2024 revealed the SN documented the patient has comprecares (reusable compression garment) for bilateral lower extremities, but the patient is not applying them to the lower extremities. Additionally, the RN documented the patient was educated to use the comprecares to both lower extremities during waking hours to prevent the edema from returning. Review of the SN Visit Note dated 09/10/2024 revealed the RN documented the patient wears a tubigrip (multipurpose support bandage) and comprescares to the right lower extremity. Review of the clinical record lacks orders for comprecares and tubigrip to be applied to the patient’s right lower extremity and/or left lower extremity. During interview on 09/17/2024 at 12:05 PM, the RN that made the visit on 09/03/2024 stated the patient was not observed wearing tubigrip during the visit. Additionally, the RN did not obtain an order for the patient to wear comprecares to bilateral lower extremities as the patient was instructed to apply. During interview on 09/17/2024 at 01:20 PM, the RN that made the visit on 09/10/2024 stated the physician was not contacted and orders were not obtained regarding the patient wearing tubigrip and comprecares to the right lower extremity, as observed.”

“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 an observational home visit, review of clinical records and interview with agency staff for six (6) of seventeen (17) patients (Patient #s: 1, 8, 11, 13, 14, and 16), the agency staff failed to promptly alert the physician to any changes in the patient’s condition that suggests the need to alter the plan of care (POC). Failure to promptly notify the physician to any changes in the patient’s condition that suggests the plan of care should be altered has the potential to result in unmet patient needs and negative patient outcomes. Patient #1- This 67-year-old therapy only patient with the diagnoses of hemiplegia following cerebral infarction affecting left nondominant side, type II diabetes mellitus without complications and unspecified atrial fibrillation was admitted to the home care agency on 08/24/2024. Review of the Visit Note Report dated 08/29/2024 revealed the Physical Therapist documented the following: Pain- Does the patient have medications ordered for pain- Yes. When was the patient’s last dose of pain medication- This morning, Tylenol. Patient states it is not very effective nor is his other pain medication. Therapy Subjective- Patient states he has about 8-9/10 at rest (without facial grimace), and he doesn’t think either of his pain medications do much for him. Care Coordination- None. Review of the clinical record lacks documented evidence the physician was notified of the patient’s reports of ineffective pain medications. During interview on 09/17/2024 at 11:42 AM, the Physical Therapist stated that that the physician was not contacted because the patient’s pain was brought under control with stretching, and since the pain was relieved with stretching the Physical Therapist did not contact the physician. The Physical Therapist further stated that the physician probably should have been contacted but the Physical Therapist felt the pain was relieved during the visit. Patient #16- This 70-year-old patient with the diagnoses of orthopedic aftercare following surgical amputation, type II diabetes mellitus, and unspecified atherosclerosis native arteries of the extremities, left leg was admitted to the home care agency on 08/21/2024. Review of the Visit Note Report dated 08/24/2024, revealed the Licensed Practical Nurse documented the following: Vital Signs: Vital Sign Alert: Reading- 7, Upper Limit- 6, Physician Contacted: N, Comments- Constant pain. Pain: Does the patient report pain- Yes- patient reports pain, Indicate patient pain scale rating- 7, Indicate location- Left foot, Indicate quality of pain- shooting, Does pain interfere with patient’s activity- Yes, Explain what activities the pain interferes with and the frequency of the interference- walking, Indicate what relieves pain- pain is not relieved at an acceptable level, Describe actions taken to assist patient with pain relief- Pain medication and offloading. Care Coordination: Care Coordination with the Registered Nurse. Post Intervention Pain: Does the patient report pain- Yes- patient reports pain, Indicate patient pain scale rating- 7. Narrative- Patient complained of consistent pain but is taking prescribed pain medication. Patient was instructed to take prescribed pain medication as well as Tylenol in between pain medication doses to help with breakthrough pain. Vitals were obtained all within normal limits and documented in the vitals section. During interview on 09/18/2024 at 11:22 AM, the Executive Director stated the record was being looked at to see if the physician was called and the Executive Director will provide the documentation if found. As of exit, no further documentation was provided to refute the findings. The agency failed to ensure POC’s are reviewed and revised to reflect the patient’s current status as evidenced by the following: Review of the agency policy entitled “Pain Assessment” revised 02/01/2024 revealed “Clinicians assess pain at each comprehensive and subsequent skilled visit….A score of 7 (seven) or greater on any of the pain assessment tools is indicative of severe pain, which will require physician/ authorized practitioner notification and patient appropriate interventions.” Patient #8- This 65-year-old patient with diagnoses that include malignant neoplasm of unspecified part of right bronchus or lung, gastrostomy malfunction and gastrostomy infection was admitted to the home care agency on 12/22/2023 and discharged 03/06/2024. A.) Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission Visit Note dated 12/22/2023 revealed the RN documented the patient’s weight is 149 lbs (pounds) per “scales.” Additionally, the RN documented the patient is strict NPO (nothing by mouth), has a Corpak nasogastric (NG) feeding tube in place, receives continuous tube feedings, and is at a high nutritional risk, scoring 17 (greater than 7 is high risk) on the Total Nutrition Assessment Score. Review of the clinical record from 12/23/2023 to 01/21/2024 revealed that there is no weight documented and no evidence that the patient’s weight was obtained. Review of the RN Resumption of Care Visit Note dated 01/22/2024 revealed the RN documented the patient’s weight is 122 lbs per “scales.” Additionally, the RN documented the patient has new metastasis to the liver, has a NG tube in place, receives continuous tube feeds and is at a high nutritional risk, scoring 16 (greater than 7 is high risk) on the Total Nutrition Assessment Score. The RN documented “A message was left on secure nurse line with (attending physician’s) office, requesting call back.” Review of the clinical record from 01/22/2024 to 03/06/2024, when the patient was discharged, revealed there is no documented evidence that the RN notified the physician or followed up with the physician regarding the patient’s 27-pound weight loss from 12/22/2023 to 01/22/2023. Additionally, there is no documented evidence that a nutritional consult was considered for this high nutritional risk patient. During interview on 09/17/2024 at 03:20 PM, the RN stated being unable to recall if the physician was notified of the identified weight loss and acknowledged there is no documentation that the physician was notified of the weight loss. During interview on 09/17/2024 at 03:36 PM, the Clinical Director stated the agency should have requested a nutrition consult but believed the patient was assessed by a nutritionist at the inpatient facility that had discharged the patient. Additionally, the Clinical Director stated that the agency did not have documentation from the discharging facility to show that the patient was evaluated by a nutritionist after the 12/01/2023 Nutrition Initial Assessment Note provided by the facility. B.) Review of the Resumption of Care Physician Orders dated 01/22/2024 revealed the Skilled Nurse (SN) is to monitor pain and instruct patient regarding pharmacologic and non-pharmacologic pain control measures such as positioning. Patient prescribed the following pain medications: - Oxycodone 5 mg (milligram) tablet, 1 (one) every 4 (four) hours as needed for severe pain via nasogastric tube; and - Tylenol 325 mg tablet, 2 (two) tablets every 6 (six) hours for mild to moderate pain via nasogastric tube. Review of the RN Resumption of Care Visit Note dated 01/22/2024 revealed the RN documented the patient has having generalized pain rated as 8 on a 0-10 scale (0 being no pain and 10 being the worst pain experienced). The pain is described as aching and relieved with oxycodone. Additionally, the RN documented “A message was left on secure nurse line with (attending physician’s) office, requesting call back.” Review of the clinical record lacks documentation that the physician was notified of the patient’s severe pain or that the RN followed-up with the physician regarding the patient’s reported pain and need for appropriate pain management interventions. During interview on 09/17/2024 at 03:20 PM, the RN stated being unable to recall whether the physician was notified of the severe pain and did not recall whether any pain management interventions were put in place, because it is not documented. Review of the SN Visit Note dated 01/29/2024 revealed the RN documented the patient was having abdominal pain rated a 9 on a 0-10 scale, pain is aching and relieved with rest. Additionally, the RN documented “Discussed pain management and patient is looking for a pain management specialist. Writer to provide wife with phone numbers.” There is no documentation that the RN contacted the physician to notify the physician about the patient’s severe pain and need for appropriate pain management interventions. During interview on 09/17/2024 at 03:30 PM, the RN stated being unable to recall whether the physician was notified of the severe pain and did not recall whether any pain management interventions were put in place, because it is not documented. C.) Review of the Client Coordination Narrative Note dated 03/06/2024 revealed the note was written by the RN as a late note for a phone call that was received on 03/04/2024. The RN documented the following: “Spoke with wife this AM. Per wife, SPO2 (oxygen saturation) was 83% (percent) this AM. Requesting hospice consult. Writer called hospice to initiate and [Ruth] (office nurse) at (attending physician’s) office to discuss. Hospice consult will be completed.” Review of the clinical record lacks documentation that the RN notified the physician about the patient’s low oxygen saturations and need for appropriate interventions to include an order for supplemental oxygen. During interview on 09/17/2024 at 04:11 PM, the RN stated the spouse sat the patient up during the telephone call with the RN and the patient’s oxygen saturation level improved. The RN stated being unable to recall whether the low oxygen saturation was reported to the physician on 03/04/2024. Additionally, the RN stated that there is no documentation that the physician was notified about the patient’s low oxygen saturations, and improvement with repositioning. Patient #11 – This 32-year-old patient with diagnoses that include fracture closure of unspecified part of the left femur and anxiety was admitted to the home care agency on 08/04/2024. A.) Review of the Client Coordination Note dated 08/27/2024 revealed the Physical Therapy Assistant (PTA) documented the patient went to an urgent care for a sinus infection. Review of the Physical Therapy (PT) Routine Visit Note dated 08/27/2024 revealed the PTA documented the patient went to urgent care, was started on an antibiotic and a verbal order was completed for the new antibiotic. Additionally, the PTA reported communicating with the PT and Patient Case Manager regarding the urgent care visit. Review of the Physician Order dated 08/27/2024 revealed an order to the authorized practitioner for Cefdinir 250 mg (milligram) per 5 ml (milliliter), take 13 ml by mouth once a day for 10 (ten) days for a sinus infection. Review of the clinical record lacks documentation the authorized practitioner was contacted promptly and updated on the patient’s urgent care visit for a sinus infection and started on a new antibiotic. During interview on 09/16/2024 at 2:37 PM, the PTA stated the authorized practitioner was not called but was notified through the receipt of the Physician Order sent of the patient’s new sinus infection and starting a new antibiotic. B.) Review of the PT Routine Visit Note dated 09/10/2024 revealed the PTA documented the patient complained of left hip pain rated a 7 on a 0-10 scale (0 being no pain and 10 being the worst pain experienced). Additionally, the PTA documented the pain is aching, interfere’s with the patient’s activities and is relieved with immobility and relaxation techniques. Review of the clinical record lacks documented evidence the authorized practitioner was alerted of the patient’s severe pain identified at the 09/10/2024 visit. During interview on 09/16/2024 at 02:40 PM, the PTA stated the patient’s identified pain was reported to the authorized practitioner, but it failed to be documented in the patient’s record. Patient #14 – This 76-year-old patient with diagnoses that include non-pressure chronic ulcer of the left ankle and venous insufficiency was admitted to the home care agency on 08/29/2024. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed an order for SN to perform wound care to LLE (left lower extremity) BIW/PRN (twice weekly and as needed) for soiling- cleanse with NS (normal saline), apply calcium alginate AG (absorbent dressing with antibacterial silver) to open areas, wrap with Unna boot (compression dressing), secure with coban (self-adherent wrap) and tape. Review of the RN OASIS Admission Visit Note dated 08/29/2024 revealed the RN documented the following wound assessments: - Left lateral-distal pretibial non pressure chronic ulcer: length 6 cm (centimeter), width- 7cm and depth 0.1 cm, full thickness wound with large amounts of serosanguinous exudate. - Left achilles tendon non pressure chronic ulcer: length 5.2 cm, width 6.4 cm, depth 0.1 cm, full thickness wound with large amounts of serosanguinous exudate. Review of the SN Visit Note dated 09/03/2024 revealed the RN documented the following wound assessments: - Left lateral-distal pretibial non pressure chronic ulcer: Wound not assessed and wound care not provided due to wound being healed. - Left achilles tendon non pressure chronic ulcer: length 13 cm, width 17 cm, depth 0 cm, partial thickness wound with small amount of serosanguinous exudate. Review of the clinical record lacks documented evidence the physician was notified of the wound status changes identified on 09/03/2024. During interview on 09/17/2024 at 12:22 PM, the RN stated the physician was not notified of the wound changes identified in the 09/03/2024 visit. The agency failed to notify the physician to changes in the patient’s condition as evidenced by the following: HV Patient #13- This 66-year-old patient with diagnoses that include pressure ulcer of sacral region, stage two (2), moderate protein-calorie malnutrition and spastic hemiplegia affecting right dominant side was admitted to the home care agency on 08/29/2024. During home visit observation on 09/10/2024 at 11:45 AM, the patient’s sister reported the patient slid off of the commode and fell “the other day at five (5) in the morning” and was not able to recall who she called to let them know of the fall. Review of the clinical record lacks documented evidence the physician was notified of the patient’s fall. During interview on 09/16/2024 at 12:22 PM, the Registered Nurse stated inability to recall if the fall was reported to the physician. As of exit, no further information provided to refute the findings.”

“Communication with all physicians CFR(s): 484.60(d)(1) Standard: Coordination of Care. The HHA must: (1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This Element is not met as evidenced by: Based on review of clinical records, and interview with agency staff, for two (2) of seventeen (17) patients (Patient #’s 8, and 14), the agency failed to ensure clinicians communicate with all physicians involved in the patient’s care. Failure to communicate with all physicians involved in the plan of care has the potential for unmet patient needs and patient harm. The agency failed to ensure clinicians communicate with all physicians/authorized practitioners involved in the plan of care as evidenced by the following: Patient #8- This 65-year-old patient with diagnoses that include malignant neoplasm of unspecified part of right bronchus or lung, gastrostomy malfunction and gastrostomy infection was admitted to the home care agency on 12/22/2023 and discharged 03/06/2024. A.) Review of the Home Health Certification and Plan of Care for 02/20/2024 to 04/19/2024 revealed the patient has a mediport that is cared for by the patient’s oncologist (the oncologist is involved in the patient’s care in addition to the attending physician signing the plan of care) and the agency may receive orders regarding the mediport from the oncologist. The plan of care does not include information about the port to include when it was last accessed/flushed, when the mediport is due to be accessed/flushed and who is responsible for maintaining the mediport, i.e. the oncologist or the home care staff. Review of the clinical record lacks documentation of communication with the oncologist to determine and verify how the mediport will be cared for and maintained. During interview on 09/17/2024 at 04:04 PM, the Registered Nurse (RN) stated the patient’s oncologist was managing the mediport and the RN never contacted the oncologist to obtain the identified orders for the mediport. B.) Review of the Home Health Certification and Plan of Care from 02/20/2024 to 04/19/2024 revealed the patient has no advance directives in place. Additionally, the RN documented “patient has been on services following diagnosis of lung cancer. Patient now has mets (metastasis) to liver. Patient has extreme weakness and pain. He will be going for infusion of IVIG (intravenous immune globulin) awaiting insurance approval and the plan is to start palliative chemo….Patient continues to require services for skilled assessment and education related to chemotherapy…Palliative needs assessed and patient is not interested in hospice services at this time. He did have a palliative consult however…Mental status: Forgetful; Alert and Oriented x3 (to person, place and time)…When vital signs are obtained licensed professional to report vital signs falling outside the following established parameters…O2 Sat [oxygen saturation] Review of the SN (Skilled Nurse) Visit Note dated 03/06/2024 revealed the RN documented the patient was disoriented, an assessment of the non-verbal pain symptoms was conducted and the patient did not display vocal complaints, facial grimaces/ winces, bracing, restlessness, and rubbing. Additionally, the RN documented the patient’s pulse is 124 radial, oxygen saturation is 82 % (percent) on room air, lungs diminished throughout, dyspnea noted at rest, difficult to rouse and chest retractions are observed with breathing. There is no documentation the RN notified the physician of the patient’s status changes and initiated a transfer to the hospital for evaluation of the patient’s acute change in status for a patient with no advance directives in place. During interview on 09/12/2024 at 12:15 PM, the RN stated the attending physician’s office was contacted and the attending physician’s office and the RN were waiting to hear back from the oncologist regarding whether the patient was a candidate for further cancer treatment. The RN stated there is no documentation of this call to the attending physician’s office and the attending physician’s request to delay care until a determination of further treatment options was completed by the oncologist. Additionally, the RN stated the oncologist determined the patient was not a candidate for further cancer treatment and was transferred to hospice on 03/06/2024. The RN acknowledged there is no documentation of communication between the agency and the oncologist regarding the patient’s status and transitioning the patient to hospice. During interview on 09/17/2024 at 04:42 PM, the RN stated the patient’s spouse drove the patient to an appointment with the oncologist on 03/06/2024 after the RN’s assessment to determine if the patient was eligible for further cancer treatment. The RN stated the wife told the RN that the oncologist stated the patient was not a candidate for further cancer treatment but the RN did not speak with the oncologist directly. The RN acknowledged that there is no documentation of any communication occurring between the spouse, the oncologist, the attending physician and the hospice regarding transferring the patient to hospice. Patient #14 – This 76-year-old patient with diagnoses that include non-pressure chronic ulcer of the left ankle and venous insufficiency was admitted to the home care agency on 08/29/2024. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed an order for SN to perform wound care to LLE (left lower extremity) BIW/PRN (twice weekly and as needed) for soiling- cleanse with NS (normal saline), apply calcium alginate AG (absorbent dressing with antibacterial silver) to open areas, wrap with Unna boot (compression dressing), secure with coban (self-adherent wrap) and tape. Review of the SN Visit Note dated 09/06/2024 revealed the RN documented completing the following wound assessments: - Left lateral-distal pretibial non pressure chronic ulcer: measurements not due, partial thickness, granulation tissue intact with moderate amounts of serosanguinous exudate. - Left achilles tendon, non pressure chronic ulcer: measurements not due, partial thickness, granulation tissue intact, moderate amounts serosanguinous exudate. - Wound care completed to both areas of cleanse with NS, apply calcium alginate AG to open areas, wrap with Unna boot, secure with coban and tape. Review of the SN Visit Note dated 09/10/2024 revealed the RN documented completing the following wound assessments: - Left lateral-distal pretibial, non pressure chronic ulcer- inactivate wound, wound healed. - Left achilles tendon, non pressure chronic ulcer: inactivate wound, wound healed. - Left distal lower leg, superficial (new wound identified): length 1.5 cm (centimeter), width 1.5 cm, depth 0 cm, partial thickness, granulation tissue intact, no exudate. - Left ankle, superficial (new wound identified): length 1 cm, width 2 cm, depth 0 cm, partial thickness, granulation tissue intact, no exudate. - Wound care completed to both areas of cleanse with NS, apply calcium alginate AG to open areas, wrap with Unna boot, secure with coban and tape. Review of the clinical record lacks documentation of communication with the physician to report the left lateral-distal pretibial non pressure ulcer and the left achilles tendon non pressure ulcer are healed and wound care to both identified areas are discontinued. Review of the clinical record lacks documentation of communication with the physician to report the patient has two new open areas on the left lower extremity on the distal lower leg and the left ankle requiring wound care orders. During interview on 09/17/2024 at 01:15 PM, the RN stated the patient’s physician was not contacted to report the healing of the two identified wounds and the development of two additional wounds on the left lower extremity requiring continued wound care.”

“Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient’s needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This Element is not met as evidenced by: Based on an observational home visit, review of clinical records and interviews with agency staff for three (3) of seventeen (17) patients (Patients #s: 8, 10, and 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. The agency failed to coordinate care delivery and ensure patient needs are addressed as evidenced by the following: Review of the agency policy entitled “Coordination Of Care, From Admit Through Discharge” revised 09/01/2024 revealed “Coordination of care with physician/authorized practitioner occurs at admission, throughout care, and at discharge….Coordination of care among disciplines through care planning processes occurs from admission to discharge.” Patient #8- This 65-year-old patient with diagnoses that include malignant neoplasm of unspecified part of right bronchus or lung, gastrostomy malfunction and gastrostomy infection was admitted to the home care agency on 12/22/2023 and discharged 03/06/2024. Review of the Home Health Certification and Plan of Care for 12/22/2023 to 02/19/2024 reveled the patient is to receive Skilled Nursing (SN), PT (Physical Therapy), OT (Occupational Therapy) and ST (Speech Therapy) services. Review of the Client Coordination Team Case Conference Note dated 02/06/2024 revealed the Patient Care Manager documented that based on discussion the recommendation of the team, which included the SN, PT, OT, ST and MSW (Masters Social Worker)) is to recertify the patient and the anticipated disciplines recertifying the patient are: SN, PT, OT, and ST. Review of the Client Coordination Note dated 02/13/2024 revealed the ST documented the patient declined ST services for the remainder of the week due to not feeling well. Review of the Physician Order dated 02/16/2024 revealed the Patient Care Manager documented the patient declined therapy visits for the last 2 (two) weeks and will discontinue therapy for now. PT effective 02/11/2024- no visits requested/ scheduled, OT effective 02/11/2024- no visits requested/ scheduled. Review of the clinical record from 02/11/2024 to 03/06/2024 lacks documentation that the patient received Physical Therapy, Occupational Therapy and Speech Therapy services. Additionally, there is no documentation that the patient was discharged from Physical Therapy, Occupational Therapy and Speech Therapy services. Furthermore, there is no documentation that the Skilled Nurse or physician were notified. During interview on 09/17/2024 at 03:00 PM, the Speech Therapist stated the ST failed to follow-up with the patient after the patient refused visits the week of 02/13/2024. Additionally, the physician and Skilled Nurse were not notified. During interview on 09/17/2024 at 03:05 PM, the Physical Therapist stated there were no further attempts to see the patient after the refusal of services during the week of 02/11/2024 and both Physical Therapy and Occupational Therapy failed to notify the Skilled Nurse and physician of this. The agency failed to coordinate care as evidenced by the following: Patient #10- This 80-year-old patient with diagnoses that include aftercare following joint replacement surgery, hypertensive chronic kidney disease with stage 1-4/unspecified chronic kidney and type two (2) diabetes mellitus with diabetic chronic kidney disease was admitted to the home care agency on 05/17/2023. A. Review of the Physical Therapist Outcome and Assessment Information Set Note dated 05/17/2023 revealed the patient was instructed to go to [WCA] for doppler…patient instructed not to do CPM (continuous passive motion), or exercises until cleared of blood clot. Review of the Physical Therapist Visit Note Report dated 05/18/2023 revealed patient able to perform 10 reps, with assist of seated, supine, and standing isotonic LE strengthening exercises, CPM set up, daughter demonstrates independence. Review of the clinical record lacked documented evidence of coordination between the patient’s physician and the therapist to determine whether the patient could resume continuous passive motion exercises. During interview on 09/17/2024 at 10:42 AM, the Physical Therapist stated that the patient did not have a blood clot and was unable to recall if it was documented prior to resumption of CPM and exercises. B. Review of the Physical Therapist Outcome and Assessment Information Set Note dated 05/17/2023 revealed the Physical Therapist documented a plan to refer the patient to a provider for diabetes mellitus management. Review of the clinical record lacks documented evidence that the patient was referred to the planned provider for management of diabetes mellitus. During interview on 09/17/2024 at 10:54 AM, the Physical Therapist stated a referral was something that was talked about, but it was not completed before patient was discharged. C. Review of the Registered Nurse Discharge of Skilled Services (Not from Agency) Visit Note Report dated 05/31/2023 revealed patient was discharged from nursing services on 05/31/2023. Review of the Physical Therapist Discharge from Agency Visit Note dated 06/01/2023 revealed patient was discharged from physical therapy services and agency on 06/01/2023. Review of the clinical record lacks documented evidence of coordination between the Registered Nurse and the Physical Therapist regarding the discharge. During interview on 09/18/2024 at 10:25 AM, the Registered Nurse stated that there was a discussion with the Physical Therapist about the patient moving out of the area but, it was not documented and should have been. HV Patient #13- This 66-year-old patient with diagnoses that include pressure ulcer of sacral region, stage two (2), moderate protein-calorie malnutrition and spastic hemiplegia affecting right dominant side was admitted to the home care agency on 08/29/2024. Review of the Registered Nurse Outcome and Assessment Information Set Note dated 08/29/2024 revealed the patient receives aide services three (3) days a week. During a home visit observation on 09/10/2024 at 11:40 AM to observe the agency’s Skilled Nurse, a person who identified self as the patient’s aide who worked at another agency and provides aide services to the patient for three (3) hours a day, three (3) days a week for a total of nine (9) hours a week. Review of the clinical record lacked documentation regarding the agency that provides aide services or communication with the agency providing aide services. During interview on 09/16/2024 at 12:20 PM, the Registered Nurse stated the home health aide information was in a clinical note in the record, but the information was not clear and should have included information on the services and what agency was responsible for managing the aide services.”

“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 an observational home visit, review of clinical records and staff interview for six (6) of seventeen (17) patients (Patient #’s 6, 8, 10, 11, 13, and 17), the agency failed to ensure the patient/caregiver receives appropriate education and training regarding the care and services identified in the plan of care. Failure to provide appropriate education and training has the potential to result in the patient receiving inadequate care and could result in patient harm. Patient #6 – This 60-year-old patient with the diagnoses of multiple sclerosis, type II diabetes mellitus with hyperglycemia, and non-st elevation myocardial infarction was admitted to the home care agency on 11/29/2023. Review of the Home Health Certification and Plan of Care for 11/29/2023 to 01/27/2024 revealed “Skilled Nurse to instruct patient on blood glucose testing. Frequency for blood glucose testing: daily” and the following orders: - lantus solostar U-100 insulin 100 unit/milliliter 35 units at bedtime - trulicity 4.5 milligrams/0.5 milliliters weekly per instruction Review of the Registered Nurse Outcome and Assessment Information Set Note dated 11/29/2023 revealed the Registered Nurse documented “Patient reports she is missing glucometer and has for a while, writer informer primary care provider office and new glucometer was sent to pharmacy patient and caregiver educated to pick it up.” There is a lack of documented evidence the Registered Nurse observed a demonstration of the patient/caregiver obtaining a blood glucose or administrating insulin. Review of the clinical record lacks documented evidence the patient received appropriate education regarding obtaining a blood glucose and administering insulin. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to independently obtain a blood glucose or administer a subcutaneous diabetic medication. During interview on 09/16/2024 at 01:10 PM, the Patient Care Manager Home Health, Registered Nurse stated there is no documentation to state that a clinician educated the patient/caregiver on proper insulin administration. The agency failed to ensure the patient/caregiver receives appropriate education and training regarding the care and services identified in the plan of care as evidenced by the following: Patient #8- This 65-year-old patient with diagnoses that include malignant neoplasm of unspecified part of right bronchus or lung, gastrostomy malfunction and gastrostomy infection was admitted to the home care agency on 12/22/2023 and discharged 03/06/2024. Review of the agency’s undated Elsevier Feeding Tube: Medication Administration (approved Clinical Skills Online program) provided to the surveyor on 09/20/2024 revealed the following protocols for administration of medications through a feeding tube: - Flush the feeding tube with a minimum of 15 milliliter (ml) of purified water before and after the administration of medications. - Prepare medications for instillation into the feeding tube: a. Liquid: Measure the prescribed dose. b. Tablet: Crush the tablet using device to grind into a fine powder. Mix and dilute it in 30 to 60 ml of purified water. c. Capsule: Open the capsule or pierce the gelcap with a sterile needle and empty contents into 30 to 60 ml of purified water. - Place the patient in high fowlers position; - Check placement of the feeding tube; - Draw back on the syringe slowly and obtain a small volume of gastric contents, assess the appearance of gastric contents; - Administer liquid or dissolved medication by pouring it into syringe and flushing, give each medication separately and flush between medications with at least 15 ml of purified water. A.) Review of the Home Health Certification and Plan of Care for 12/22/2023 to 02/19/2024 revealed the following orders: - SN (Skilled Nurse) to instruct/ supervise patient/caregiver on strict NPO (nothing by mouth). - SN to instruct on new and changed medications, those with assessed knowledge deficit, high risk medications and any applicable drug interactions. - Medications: methylprednisolone, metoprolol tartrate, oxycodone, pantoprazole, pregabalin, quetiapine and sulfamethoxazole-trimethoprim to be administered via nasogastric (NG) tube. Review of the RN (Registered Nurse) OASIS (outcome and assessment information set) Admission Visit Note dated 12/22/2023 revealed the RN documented a medication review was performed, no issues were found during a drug regimen review, and the patient is compliant with all medications listed on the medication review. The assessment lacks documentation that the RN provided the patient/caregiver with education and training on medication preparation and administration of medications through the Corpak NG tube. Additionally, there is no documentation by the RN that the patient/caregiver demonstrated proficiency in medication administration and could independently and safely administer the medications. Furthermore, there is no documentation of an assessed knowledge deficit on the part of the patient/caregiver requiring further education and/or training. Review of the SN Visit Note dated 12/26/2023 (the visit following the patient’s admission) revealed the RN documented the patient is compliant with the medication regimen. There is no documented evidence the RN provided the patient/caregiver with education and training on medication preparation and administration of medications through the Corpak NG tube. Additionally, there is no documentation by the RN that the patient/caregiver demonstrated proficiency in medication administration and could independently and safely administer the medications. Furthermore, there is no documentation of an assessed knowledge deficit on the part of the patient/caregiver requiring further education and/or training. During interview on 09/23/2024 at 11:19 AM, the Clinical Director stated the RN that performed the 12/22/2023 and 12/26/2023 patient visits is unavailable for interview. The Clinical Director stated there is no documentation of the RN instructing and the patient/caregiver returning a demonstration of medication preparation and administration through the NG tube. The Clinical Director stated the instruction and demonstration of the patient’s medications through the NG tube should have been documented. B.) Review of the Home Health Certification and Plan of Care for 02/20/2024 to 04/18/2024 revealed the following orders: - SN to instruct on new and changed medications, those with assessed knowledge deficit, high risk medications and any applicable drug interactions. - Nutritional Requirements: NPO, tube feedings; - Medications: methylprednisolone, metoprolol tartrate, oxycodone, pregabalin, quetiapine, sulfamethoxazole-trimethoprim and tylenol are administered through the patient’s nasogastric tube. Additionally, the RN documented the patient has an NG tube with continuous tube feedings managed by the patient’s wife. Review of the RN Recert With Skill Visit Note dated 02/15/2024 revealed the RN documented a review of medications was performed and the patient is compliant with all medications listed on the medication record. There is no documented evidence the RN provided the patient/caregiver with education and training on medication preparation and administration of medications through the Corpak NG tube. Additionally, there is no documentation by the RN that the patient/caregiver demonstrated proficiency in medication administration and could independently and safely administer the medications. Furthermore, there is no documentation of an assessed knowledge deficit on the part of the patient/caregiver requiring further education and/or training. Review of the SN Visit Note dated 02/21/2024 revealed the RN documented the patient is compliant with the medication regime. There is no documented evidence the RN provided the patient/caregiver with education and training on medication preparation and administration of medications through the Corpak NG tube. Additionally, there is no documentation by the RN that the patient/caregiver demonstrated proficiency in medication administration and could independently and safely administer the medications. Furthermore, there is no documentation of an assessed knowledge deficit on the part of the patient/caregiver requiring further education and/or training. During interview on 09/20/2024 at 11:55 AM, the RN stated the patient’s spouse was observed administering the patient’s medications via the NG tube during the identified visits, but no instruction was provided or documented by the RN on the preparation and administration of the medications via the NG tube. Patient #11 – This 32-year-old patient with diagnoses that include fracture closure of unspecified part of the left femur and anxiety was admitted to the home care agency on 08/04/2024. Review of the Physician Order dated 08/29/2024 revealed the patient was started on cyclobenzaprine 10 mg (milligram) tablet, 1 (one) tablet by oral route at bedtime/PRN (as needed) for muscle spasms. Review of the PT (Physical Therapy) Visit Note dated 08/29/2024 revealed the PT documented the following: Medication Understanding Changes: - Cyclobenzaprine 10 mg tablet, 1 (one tablet)- Purpose: “Y (yes)”, Directions for Use : “Y (yes)”, Side effects/Interactions: “Y (yes).” Additionally, the PT documented not providing the following intervention: Instruct patient/caregiver on any new and changed medications, those with assess knowledge deficit, high risk medications and any drug/drug interactions. Exception code: “Not applicable to current visit.” The documentation does not specify who was instructed, and if there is an assessed knowledge deficit on the part of the patient/caregiver requiring further education and/or training. During interview on 09/16/2024 at 02:30 PM, the PT stated the patient/caregiver were instructed on the identified medication and believed documenting in the “Medication Understanding Changes” tab was sufficient to show the education provided. During interview on 09/16/2024 at 02:32 PM, the Clinical Director stated the PT should have completed the intervention regarding medication instruction in the identified visit when educating on the medication. The agency failed to ensure the patient/caregiver receives appropriate education regarding the care and services identified in the plan of care as evidenced by the following: HV Patient #13- This 66-year-old patient with diagnoses that include pressure ulcer of sacral region, stage two (2), moderate protein-calorie malnutrition and spastic hemiplegia affecting right dominant side was admitted to the home care agency on 08/29/2024. A. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed the order for the Skilled Nurse to perform/instruct patient/caregiver procedure of wound care to sacrum wound three times a week and as needed for soiled or dislodged, caregiver to perform on non-visit days. Cleanse with normal saline. Apply aquacel if draining. Cover with foam dressing using clean technique. Instruct patient/caregiver signs/symptoms of wound infection and proper disposal of dressings. During a home visit observation to observe the Skilled Nurse, on 09/10/2024 at 12:10 PM, the patient’s sacral wound was open to air and did not have a foam dressing on. Review of the clinical record lacks documented evidence that the patient/caregiver received appropriate education/training on management of the wound to include wound care per orders and infection prevention practices. During interview on 09/16/2024 at 12:55 PM, the Register Nurse stated there is no documentation that patient/caregiver was provided education for wound care, signs and symptoms of wound infection, and disposal of dressings. B. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed the order for patient/caregiver to be instructed in measures to improve home safety and reduce fall risk. Review of the Registered Nurse Outcome and Assessment Information Set Note dated 08/29/2024 revealed the following: - Was MAHC (Missouri Alliance for Home Care) 10 fall risk assessment completed: yes - Age 65+: yes - Diagnosis (three (3) or more co-existing): yes - Prior history of falls within three (3) months: yes - Incontinence: yes - Visual impairment: no - Impaired functional mobility: yes - Environmental hazards: yes - Polypharmacy (four (4) or more prescriptions-any type): yes - Pain affecting level of function: yes - Cognitive impairment: yes - According to MAHC 10 Fall Risk Assessment, this patient’s score is: 9 - Based on the score, the patient is: at risk for falling - Does the patient have a MAHC 10 score of eight (8) or greater: yes - Do you currently have a PERS (Personal Emergency Response System) unit: no - Do you agree to have a representative from medical guardian call to discuss PERS options: no During a home visit observation on 09/10/2024 at 11:45 AM, the patient’s sister reported the patient slid off of the commode and fell “the other day at five (5) in the morning.” The sister stated that the fall was reported, but the sister could not recall who the sister reported the fall to, and could not be certain that the agency was notified. Review of the clinical record lacks documented evidence that the patient/caregiver received education/training on home safety and fall reduction measures. During interview on 09/16/2024 at 12:22 PM, the Registered Nurse stated the patient is a fall risk, and education should have been provided and documented, but it was not. C. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed the order for the Skilled Nurse to instruct patient/caregiver on documenting health information in the healthcare journal. During a home visit observation on 09/10/2024 at 11:52 AM, the patient’s sister reported having difficulty keeping paperwork and medical information organized. The clinical record lacks documented evidence that the patient/caregiver received appropriate education on the documentation of health information in the healthcare journal. During interview on 09/16/2024 at 12:23 PM, the Registered Nurse stated that the patient/caregiver should have been provided with education on keeping a healthcare journal, and that information should have been documented in the patient’s record to include the patient/caregiver’s response to the education provided. Patient #10- This 80-year-old patient with diagnoses that include aftercare following joint replacement surgery, hypertensive chronic kidney disease with stage 1-4/unspecified chronic kidney and type two (2) diabetes mellitus with diabetic chronic kidney disease was admitted to the home care agency on 05/17/2023. Review of the Medication Interaction Note dated 05/19/2023 revealed the following: - aspirin 325 milligram tablet interacts with lisinopril 10 milligram tablet…education provided - aspirin 325 milligram tablet interacts with sertraline 25 milligram tablet…education provided - cyclobenzaprine 10 milligram tablet interacts with oxycodone 5 milligram tablet…education provided - cyclobenzaprine 10 milligram tablet interacts with sertraline 25 milligram tablet…education provided - lipitor 10 milligram tablet interacts with verapamil extended release (sustained release) 180 milligram tablet …education provided - oxycodone 5 milligram tablet interacts with verapamil extended release (sustained release) 180 milligram tablet…education provided - green tea (with metabolic enhancer blend) 250 microgram-775 milligram tablet interacts with Humalog kwikpen (units-100) insulin 100 unit/milliliter subcutaneous…education provided - green tea (with metabolic enhancer blend) 250 microgram-775 milligram tablet interacts with toujeo solostar units-300 insulin 300 unit/milliliter (1.5 milliliter) subcutaneous pen…education provided - green tea (with metabolic enhancer blend) 250 microgram-775 milligram tablet interacts with Trulicity 0.75 milligram/0.5 milliliter subcutaneous pen injector…education provided. Review of the clinical record revealed there is no documented evidence the Registered Nurse documented what education was provided regarding the drug to drug interactions and the patient’s understanding of the education provided. During interview on 09/17/2024 at 01:32 PM, the Registered Nurse stated inability to recall what education was provided to the patient or the patient’s response. Additionally, the Registered Nurse stated that the specifics of the education and patient’s response should have been documented. Patient #17- This 85-year-old Therapy Only patient with diagnoses that include alzheimer’s disease with late onset, essential (primary) hypertension, and anxiety disorder, unspecified was admitted to the home care agency on 08/20/2024. Review of the Home Health Certification and Plan of Care for 08/20/2024 to 10/18/2024 revealed the following diagnoses: Alzheimer’s Disease with late onset and problems related to health literacy. Review of the Physical Therapy Outcome and Assessment Information Set Note dated 08/20/2024 revealed the following goal was met: Patient/caregiver verbalizes understanding of safety threats and how to resolve them. Review of the clinical record revealed there is a lack of documented evidence that the patient/caregiver verbalized understanding of safety threats and how to resolve them. During interview on 09/16/2024 at 11:23 AM, the Physical Therapist stated the education was provided to the Licensed Practical Nurse at the Adult Home Facility where the patient lived, because the patient is too confused to understand and “I was not able to speak with the patient’s son.””

“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, agency policy and procedure, and interviews with staff, for eight (8) of seventeen (17) patients (Patient #’s: 1, 2, 7, 9, 13, 14, 16, and 17) the agency failed to prepare and document complete and accurate clinical notes. Failure to document complete and accurate clinical and progress notes has the potential for unmet patient needs. Patient #9 - This 80-year-old patient with diagnoses that include benign prostatic hyperplasia with lower urinary tract symptoms, other obstructive and reflux uropathy, and hypo-osmolality and hyponatremia was admitted to the home care agency on 03/06/2023. A. Review of the Home Health Certification and Plan of Care for 03/06/2023 to 05/04/2023 revealed “Skilled Nurse for insertion of 20 FR (twenty French) 10 cc (ten cubic centimeters) balloon indwelling catheter using aseptic technique.” Review of the Skilled Nursing Visit Notes dated 03/19/2023, 03/16/2023, 03/24/2023, 04/06/2023, and 04/13/2023 revealed the Licensed Practical Nurse documented the patient is using a 16 FR (sixteen French) catheter. During interview on 09/16/2024 at 11:46 AM, the Registered Nurse stated the Licensed Practical Nurse no longer works at the agency. It is unclear why the Licensed Practical Nurse documented the patient had a 16 FR (sixteen French) catheter; the patient was using 20 FR (sixteen French) catheters. B. Review of the Registered Nurse Visit and Supervisory Visit Notes dated 03/30/2023 and 04/19/2023 revealed the Registered Nurse documented “Patient seen for routine skilled nursing visit and wound care.” Review of the clinical record lacks documented evidence the patient has a wound. During interview on 09/16/2024 at 11:50 AM, the Registered Nurse stated the patient did have a wound at one time but continued to monitor the area. The patient did not have a wound or wound care at the time of the visits and that was documented incorrectly. Patient #2 – This 82-year-old patient with the diagnoses of type II diabetes mellitus without complications, chronic obstructive pulmonary disease, and acute and chronic respiratory failure with hypoxia was admitted to the home care agency on 08/27/2024. Review of the agency policy entitled “Home Health Aide Supervision” revised 06/01/2024 revealed “In home supervision is required during the initial visit by the aide or when there is a change in personnel.” Review of the Home Health and Plan of Care for 08/27/2024 to 10/25/2024 revealed orders for Home Health Aide effective 09/01/2024 one (1) time a week for three (3) weeks. Review of the Aide Visit Note dated 09/03/2024 revealed this was the first Home Health Aide service visit provided to the patient. Review of the Registered Nurse Visit with Supervision revealed the Registered Nurse documented the following: - Were supervisory functions performed? No. During interview on 09/17/2024 at 1:40 PM, the Registered Nurse stated the co-visit was done with the home health aide during the visit but incorrectly documented the supervisory visit as not done. The Registered Nurse will add an addendum. Patient #14 – This 76-year-old patient with diagnoses that include non-pressure chronic ulcer of the left ankle and venous insufficiency was admitted to the home care agency on 08/29/2024. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed the patient has the following active diagnoses: venous insufficiency (chronic peripheral), peripheral vascular disease, unspecified, non-pressure chronic ulcer of the left ankle, chronic obstructive pulmonary disease, unspecified atrial fibrillation, lymphedema, not elsewhere classified, hypertensive heart disease without heart failure, nicotine dependence, cigarettes, uncomplicated and long term current use of aspirin. Review of the SN (Skilled Nurse) Visit Note dated 09/10/2024 revealed the Registered Nurse (RN) documented the following endocrine assessment: - Does the patient have diabetes? “Yes;” - Is the patient taking insulin or non-insulin anti-diabetic injection? “No;” - CBG (capillary blood glucose) results obtained by: “N/A (not applicable);” - Explain not applicable CBG response: “Not ordered to check;” and - Patient’s highest fasting blood glucose in last 7 (seven) days: “Not ordered to check.” Review of the clinical record lacks documented evidence the patient has diabetes. During interview on 09/17/2024 at 01:10 PM, the RN stated the patient does not have diabetes and this was documented in error at the identified visit. Patient #1- This 67-year-old therapy only patient with the diagnoses of hemiplegia following cerebral infarction affecting left nondominant side, type II diabetes mellitus without complications and unspecified atrial fibrillation was admitted to the home care agency on 08/24/2024. A. Review of the Home Health Certification and Plan of Care for 08/24/2024 to 10/22/2024 revealed the Physical Therapist documented the following: Orders for Discipline and Treatments: DME (durable medical equipment) in use includes SPC, standard walker and electric scooter. It is unknown what is meant by SPC. During interview on 09/17/2024 at 01:40 PM the Physical Therapist stated that SPC is a single point cane that the patient had at home, and that the Physical Therapist should have written that. B. Review of the Visit Note Report dated 08/27/2024 revealed the Physical Therapist documented the following: Date of Last Bowel Movement: 08/28/2024. During interview on 09/17/2024 at 11:36 AM, the Physical Therapist stated that 08/28/2024 was a typo, it should not be a future date. C. Review of the Visit Note Reports for visit dates 08/27/2024, 08/29/2024, 09/02/2024, 09/05/2024, and 09/09/2024 revealed the Physical Therapist documented the following: 08/27/2024- Does the patient have a cardiac, pulmonary, or renal diagnosis? No. 08/29/2024- Does the patient have a cardiac, pulmonary, or renal diagnosis? Yes. 09/02/2024- Does the patient have a cardiac, pulmonary, or renal diagnosis? No. 09/05/2024- Does the patient have a cardiac, pulmonary, or renal diagnosis? No. 09/09/2024- Does the patient have a cardiac, pulmonary, or renal diagnosis? No. During interview on 09/17/2024 at 11:47 AM, the Physical Therapist stated that the documentation was probably a typo, and there are a lot of new yes/ no questions. The Physical Therapist stated that the Physical Therapist may have clicked the wrong one answer 08/29/2024. D. Review of the Home Health Certification and Plan of Care for 08/24/2024 to 10/22/2024 revealed an order for Colchicine 0.6 milligrams, orally, daily as needed for joint/ muscle pain. Review of the Visit Note Report dated 09/02/2024 revealed the Physical Therapist documented the following: Does patient have medications ordered for pain? No. During interview on 09/17/2024 at 11:48 AM, the Physical Therapist stated that the patient has a nerve pain medication and Tylenol ordered, and that the Physical Therapist likely clicked “no” instead of “yes” by mistake. Patient #16- This 70-year-old patient with the diagnoses of orthopedic aftercare following surgical amputation, type II diabetes mellitus, and unspecified atherosclerosis native arteries of the extremities, left leg was admitted to the home care agency on 08/21/2024. A. Review of the Home Health Certification and Plan of Care for 08/21/2024 to 10/19/2024 revealed the following orders: DME and Supplies: ABD pad; alcohol; daily living aids: DME- CBG (capillary blood glucose) monitoring supplies, rails/ grab bars, raised toilet seat, walker, wheelchair, Dressing- wound care; gauze, irrigation; saline, wound cleaner. Review of the Visit Note Report dated 08/23/2024 revealed the Physical Therapist documented the following: Equipment/ Supplies: Durable Medical Equipment Available: Rolling walker (2 wheeled only) Other: Indicate other DME available: Shower Chair, chair lift to second level to arrive on Tuesday. Assessment: Therapist instructed patient and caregiver in proper stand, pivot transfer from wheelchair to recliner. Indicate Therapy Plan: Physical Therapy Plan of Care to Address: transfer training, wheelchair mobility, strengthening bilateral lower extremities, balance and safety training. The information in the plan of care and the visit note are inconsistent. It is unclear whether the patient has a wheelchair in the home or just a rolling walker. During interview on 09/16/2024 at 10:49 AM, the Physical Therapist stated that the patient did have a wheelchair in the home. B. Review of the Visit Note Report dated 08/30/2024 revealed the Registered Nurse documented the following: Interventions Not Provided: 23. Instruct patient/ caregiver on the meaning of anticoagulant/ antiplatelet therapy and what is involved. Exemption code: client death. During interview on 09/16/2024 at 11:34 AM, the Registered Nurse stated the exemption code was just a typo, that the patient is alive and well. The Registered Nurse further stated that this was a mistake, and the Registered Nurse was likely trying to click on something else near that code. C. Review of Visit Note Report dated 08/30/2024 revealed the Registered Nurse documented the following: Assessment: Any recent falls? Yes- check for injury and complete fall notification coordination note. Narrative: “Fall 08/29/2024, upstairs hallway in the home, patient reported that the patient was trying to put on a shirt while standing and lost balance. Communication of fall reported to the physician, the patient was educated to slow slowly and intentionally to prevent further falls, reinforcement needed.” Review of Client Episode Coordination Notes Report dated 09/04/2024 revealed the Physical Therapist documented the following: Fall Notification: Note: Describe the fall event; Patient reports fall in the hallway upstairs on 09/02/2024, while attempting to get dressed. Patient was educated on the importance of getting dressed while seated for safety. Patient in agreement. Does the patient have any injuries; no injuries. Did the patient go to the Emergency Room, have follow up appointment with the physician, or have interventions due to the fall? No. Communication of the fall reported to the physician, the Physical Therapy Department Supervisor, and the Registered Nurse. During interview on 09/16/2024 at 10:55 AM, the Physical Therapist stated that the patient only had one (1) fall on 08/29/2024. The Physical Therapist further stated that at the Physical Therapist’s visit on 09/04/2024, the patient reported that the fall occurred on 09/02/2024 but was confused on the date. The Physical Therapist later found that the Registered Nurse documented the event on 08/30/2024, the Physical Therapist then confirmed there was only one (1) fall and should have updated the incorrect note but forgot to do it. Patient #7- This 87-year-old patient with the diagnoses of unspecified dementia of unspecified severity without behaviors, major depressive disorder and chronic atrial fibrillation was admitted to the home care agency on 02/09/2024. Review of the Visit Note Report dated 03/29/2024 revealed the Registered Nurse completed a discharge visit with the patient on 03/29/2024. Review of the clinical record lacks documented evidence of the Registered Nurse’s narrative note/ client coordination note for the discharge visit on 03/29/2024. During interview on 09/18/2024 at 11:28 AM, the Patient Care Manager of Home Health (Buffalo) stated that a narrative note for the visit on 03/29/2024 was not found in the record. The agency failed to prepare and document complete and accurate clinical notes as evidenced by the following: Patient #17- This 85-year-old Therapy Only patient with diagnoses that include alzheimer’s disease with late onset, essential (primary) hypertension, and anxiety disorder, unspecified was admitted to the home care agency on 08/20/2024. A. Review of the Physical Therapist Visit Note dated 08/29/2024 revealed the Physical Therapist documented that the patient has a normal pattern for bowel movements every two (2) to three (3) days. Review of the Physical Therapy Outcome and Assessment Information Set Note dated 08/20/2024 revealed the physical therapist documented gastrointestinal assessment findings: “constipation.” During interview on 09/16/2024 at 11:20 AM, the physical therapist was unable to verify that the patient has a diagnosis and/or history of constipation and stated that the patient had a bowel movement during the visit and constipation was selected in error. B. Review of the Occupational Therapy Visit Note Report dated 08/23/2024 revealed findings from auscultation of breath sounds listening to all anterior and posterior lobes: “ NT” During interview on 09/16/2024 at 03:06 PM, the Occupational Therapist stated the findings were documented in error and should have selected, N/A- therapist/therapist assistant practicing in the State of New York, instead of NT. C. Review of the Occupational Therapy Visit Note Report dated 08/23/2024 revealed the patient receives assistance from paid help. During interview on 09/16/2024 at 03:10 PM, the Patient Care Manager of Home Health (Buffalo), Registered Nurse stated the documentation should have been clearer and the therapist could have chosen a drop-down box to type in that the patient receives assistance from memory care staff instead of selecting paid help because the patient does not receive additional assistance from an outside source. D. Review of the Occupational Therapy Visit Note Report dated 08/23/2024 revealed the occupational therapist documented the following: “PLOF was SBA with basic activities of daily living, CGA.” During interview on 09/16/2024 at 03:10 PM, the Occupational Therapist stated that the abbreviations for PLOF, SBA, and CGA are for prior level of function, stand by assist and contact guard assist, respectively. Additionally, abbreviations should be only used when included in an agency policy. Patient #13- This 66-year-old patient with diagnoses that include pressure ulcer of sacral region, stage two (2), moderate protein-calorie malnutrition and spastic hemiplegia affecting right dominant side was admitted to the home care agency on 08/29/2024. A. Review of the Skilled Nurse Visit Note Report dated 09/10/2024 revealed the nurse documented the following: has the patient experienced unwanted weight gain/loss of more than two (2) pounds since the last visit or three (3) pounds in the last week: patient is bedbound/unable to stand for weight. Measurement obtained. During interview on 09/16/2024 at 12:51 PM, Patient Care Manager of Home Health (Buffalo) Registered Nurse (RN) stated that the RN documented in error as the patient is bedbound and the patient’s hospital bed does not include the ability to weigh the patient. B. Review of the Missed Visit Notification dated 09/09/2024 and 09/05/2024 revealed missed visits for Physical Therapy on 09/06/2024 and 09/05/2024, respectively. During interview on 09/16/2024 at 12:41 PM, the Patient Care Manager of Home Health (Buffalo), Registered Nurse stated that Physical Therapy was documented in error and should have been documented that the missed visits were RN visits. C. Review of the Client Coordination Note Report dated 08/29/2024 revealed the Patient Care Manager of Home Health (Buffalo), Registered Nurse documented the following: patient living and caregiver situation- lives alone. Review of the Registered Nurse Outcome and Assessment Information Set Note dated 08/29/2024 revealed the Registered Nurse documented that the patient lives with other person(s) in the home During interview on 09/16/2024 at 12:46 PM, the Patient Care Manager of Home Health (Buffalo), Registered Nurse stated that the patient lives with a sister and does not live alone.”

“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 five (5) of seventeen (17) patients (Patient #s:1, 8, 12, 14, and 16), the agency failed to follow agency policies and procedures, current clinical practice guidelines and accepted professional standards when providing services. Failure to follow agency policies and procedures and ensure compliance with accepted professional standards has the potential to result in unmet patient needs and inadequate care. HV Patient #12 - This 87-year-old therapy-only patient with diagnoses that include hemiplegia following cerebral infarction, dysphagia following cerebral infarction oropharyngeal phase and essential hypertension was admitted to the home care agency on 08/05/2024. Review of the Visit Notes Report dated 09/04/2024 and 09/06/2024 revealed the Physical Therapist was at the patient’s home for a visits on 09/04/2024 and 09/06/20204. The Physical Therapist electronically signed the documentation for the visit made on 09/04/20204 on 09/06/2024 and the visit that occurred on 09/06/2024 was electronically signed 09/08/2024 two (2) days after the visits occurred. Review of the clinical record lacked documented evidence the Physical Therapist completed synchronization of the assessment within twenty-four (24) hours from visit date. During interview on 09/18/2024 at 11:33AM, the Executive Director (Buffalo) acknowledged that the visits were not synchronized in a timely fashion but should have been. The agency failed to ensure compliance with accepted professional standards as evidenced by the following: Patient #8- This 65-year-old patient with diagnoses that include malignant neoplasm of unspecified part of right bronchus or lung, gastrostomy malfunction and gastrostomy infection was admitted to the home care agency on 12/22/2023 and discharged 03/06/2024. Review of the RN (Registered Nurse) Recert With Skill Visit Note dated 02/15/2024 revealed the RN electronically signed the documentation for this visit on 02/19/2024, four (4) days after the visit was conducted. During interview on 09/17/2024 at 03:49 PM, the RN stated being unable to recall why the documentation was not completed within twenty-four (24) hours. Patient #14 – This 76-year-old patient with diagnoses that include non-pressure chronic ulcer of the left ankle and venous insufficiency was admitted to the home care agency on 08/29/2024. Review of the agency’s undated Elsevier Unna boot Application (approved Clinical Skills Online program) provided to the surveyor on 09/11/2024 revealed the following protocols for Unna boot application: 1. Perform hand hygiene. Don appropriate personal protective equipment. 4. Explain the procedure to the patient, family and caregivers and ensure that the patient agrees to the treatment. 5. Verify the practitioner’s order and assess the patient for pain. 6. Prepare an area in a clean, convenient location and assemble the necessary supplies. 7. Position the patient with the affected leg(s) elevated and not in a dependent position. 10.. Assess the patient for contraindications to application of the Unna boot, such as decreased sensation in the leg(s), infection in the leg(s), or allergies to the ingredients in the Unna boot materials. 11. Assess for pedal pulse(s) to ensure adequate circulation. If no pulse is detected, notify the practitioner. 12. Use a handheld Doppler ultrasound and blood pressure cuff to compare ankle and brachial pressures. a. The ratio of the systolic pressure at the posterior tibial or dorsalis pedis artery divided by the brachial artery pressure should be equal to or greater than 1 (one). b. If the ration is 0.7 or less, significant arterial insufficiency is present and compression is contraindicated. 24. Perform Unna boot dressing changes per the practitioner’s orders…. Review of the Home Health Certification and Plan of Care for 08/29/2024 to 10/27/2024 revealed the following orders: - SN (Skilled Nurse) 2WK5 (two times weekly for five weeks), 1WK4 (one time weekly for four weeks); - SN to perform wound care to LLE (left lower extremity) BIW (twice weekly)/ PRN (and as needed) for soiling: Cleanse with NS (normal saline), apply Calcium Alginate AG (a highly absorptive dressing with broad antimicrobial silver properties); wrap with Unna boot, secure with coban (a self-adhering compression bandage) and tape. Review of the RN OASIS (outcome and assessment information set) Admission Visit Note dated 08/29/2024 revealed the RN documented performing wound care to the LLE of cleansing with NS, applying calcium Alginate AG to open areas, wrapping with Unna boot and securing with coban and tape, per orders. The assessment lacks documented evidence of obtaining the patient’s ankle and brachial pressures, prior to applying the Unna boot, to ensure the Unna boot is not contraindicated. Review of the SN Visit Notes dated 08/31/2024, 09/03/2024, 09/06/2024, and 09/10/2024 revealed the RN documented performing the following wound care to the LLE: cleansed with NS, applied calcium Alginate AG to open areas, wrapped with Unna boot and secured with coban and tape, per orders. The assessments lack documented evidence of obtaining the patient’s ankle and brachial pressures, prior to applying the Unna boot, to ensure the Unna boot is not contraindicated. During interview on 09/17/2024 at 12:37 PM, the Executive Director stated being under the belief that determination of ankle and brachial pressures prior to application of a compression dressing was only required for placement of Profore (a multi-layer compression bandage system) dressings. Additionally, the Executive Director stated clarification regarding which dressings require ankle and brachial pressure determinations prior to dressing application would be provided. No further documentation was provided. Review of the agency’s policy number 7.003 entitled “Home Care Record” revised 10/01/2023 revealed the following: “Clinical notes for all services the patient has received shall be: a. Turned into the agency in person or by fax, at least within two (2) days from visit. For Point of Care users, synchronization will occur within twenty- four (24) hours from visit.” Patient #16- This 70-year-old patient with the diagnoses of orthopedic aftercare following surgical amputation, type II diabetes mellitus, and unspecified atherosclerosis native arteries of the extremities, left leg was admitted to the home care agency on 08/21/2024. A. Review of the Visit Note Report dated 08/23/2024 revealed the Physical Therapist was at the patient’s home for a visit on 08/23/2024. The Physical Therapist electronically signed the documentation for this visit on 08/26/2024 (three (3) days after the visit date). During interview on 09/16/2024 at 10:51 AM, the Physical Therapist confirmed that the documentation was electronically signed on 08/26/2024 at 06:19 AM. Furthermore, the Physical Therapist stated that visit documentation should be completed within twenty- four (24) hours of the visit. B. Review of the Visit Note Report dated 08/24/2024 revealed the Licensed Practical Nurse was at the patient’s home for a visit on 08/24/2024. The Licensed Practical Nurse electronically signed the documentation for this visit on 09/02/2024 (nine (9) days after the visit date). During interview on 09/18/2024 at 11:19 AM, the Patient Care Manager of Home Health (Buffalo), Registered Nurse stated that the Licensed Practical Nurse electronically signed the documentation on 09/02/2024, well over twenty- four (24) hours, and it shouldn’t be that long. C. Review of the Visit Note Report dated 08/28/2024 revealed the Physical Therapist was at the patient’s home for a visit on 08/28/2024. The Physical Therapist electronically signed the documentation for this visit on 08/30/2024 (two (2) days after the visit date). During interview on 09/16/2024 at 10:52 AM, the Executive Director confirmed that the documentation was electronically signed on 08/30/2024 at 06:47 AM. Furthermore, at 10:53 AM, the Physical Therapist stated that it is expected that visit documentation should be completed within twenty-four (24) hours. D. Review of the Visit Note Report dated 09/02/2024 revealed the Registered Nurse was at the patient’s home for a visit on 09/02/2024. The Registered Nurse electronically signed the documentation for this visit on 09/05/2024 (three (3) days after the visit date). During interview on 09/16/2024 at 10:36 AM, the Registered Nurse stated that visit documentation is usually completed within twenty- four (24) hours, the Registered Nurse further stated that there was no other documentation as to why the note was completed late. E. Review of the Visit Note Report dated 09/06/2024 revealed the Registered Nurse was at the patient’s home for a visit on 09/06/2024. The Registered Nurse electronically signed the documentation for this visit on 09/08/2024 (two (2) days after the visit date). During interview on 09/16/2024 at 11:40 AM, the Executive Director confirmed that the documentation was electronically signed on 09/08/2024 at 09:04 PM. Furthermore, the Registered Nurse stated that Registered Nurse visit documentation should be completed within twenty- four (24) hours of the visit. Patient #1- This 67-year-old therapy only patient with the diagnoses of hemiplegia following cerebral infarction affecting left nondominant side, type II diabetes mellitus without complications and unspecified atrial fibrillation was admitted to the home care agency on 08/24/2024. Review of the Visit Note Report dated 09/05/2024 revealed the Physical Therapist was at the patient’s home for a visit on 09/05/2024. The Physical Therapist electronically signed the documentation for this visit on 09/08/2024 (three (3) days after the visit date). During interview on 09/17/2024 at 11:49 am, the Executive Director confirmed that the Physical Therapist’s documentation was electronically signed on 09/08/2024 at 08:05 PM. At 11:50 am, the Physical Therapist stated that agency expectation for documentation completion is generally not more than two (2) days, and the Physical Therapist usually completes documentation within twenty- four (24) hours, and the Physical Therapist was not sure what happened with this visit.”