Every finding on record at Lourdes at Home

This Statement of Deficiencies report is the result of an extended recertification survey conducted 10/23/24-10/25/24 and 10/28/24-11/01/24. The following information was reviewed on 10/22/24 during the pre-survey preparation: Participation in the required emergency drills and accuracy of contact information in the Health Commerce System. The following information was reviewed during the survey: the agency's emergency preparedness policies and procedures, emergency drills, communication plan, the emergency patient roster and current listing of agency staff (staff call-down list). An interview was conducted with the Director of Patient Services/Administrator. No deficiencies were cited.

The following statement of deficiencies represents the results of an extended recertification survey of Guthrie Lourdes at Home Certified Home Health Agency conducted 10/23/24-10/25/24 and 10/28/24-11/01/24 and included complaint investigation #107131. A standard re-certification survey was initiated on 10/23/2024. Deficient practices were identified within Level 1 standards in G 574 (Plan of Care) resulting in a partial extended survey. Significant findings were identified within conditions of participation 484.75 Skilled Professional Services that resulted in further expansion of the survey and review of all Conditions of Participation. The survey consisted of a review of 19 clinical records including 5 discharged patient records, 7 observational home visits and 11 personnel records for professional and paraprofessional personnel. The survey included a review of pertinent policies and procedures, Quality Improvement Meeting minutes for the past 12 months, agency’s Admission Packet, the Emergency Preparedness Plan, the Complaint Log, and 2 contracts. The patient census at the time of the survey was 399. Pre-survey activities consisted of review on 10/22/24 of the agency’s Health Commerce System account, Home Care Worker Registry, Criminal History Record Check, internet Quality Improvement System (iQIES) reports for the period 08/2023 to 07/2024, and the agency’s compliance with submissions of statistical reports. The Director of Patient Services/Administrator, Quality Manager/Clinical Manager, Rehabilitation Managers, and staff were interviewed. Findings were reviewed at the exit conference on 11/01/2024. The complaint was unsubstantiated. As a result of the extended survey, deficiencies were identified at condition level in CoP 484.75 Skilled Professional Services. The following deficiencies were identified as a result of the survey: Federal: G 572; Plan of Care; G 574; Plan of Care must include the following, G 580; only as ordered by a physician, G 590; Promptly alert relevant physician of changes, G 608; Coordinate Care Delivery; G 642; Program Scope, G 682; Infection Prevention; G 700; Skilled Professional Services; G 706 Interdisciplinary assessment of patients; G 714, Patient and Caregiver education, G 718; Communication with physicians, G 726; Nursing Services supervised by and RN, and G 798; Home Health Aides assignments and duties. No State deficiencies were cited

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on a review of clinical records and interviews with the Director of Patient Services/Administrator, Quality Manager/Clinical Manager, and Rehabilitation Managers, it was determined in 4 of 19 records, (patients #4, 10, 11 and, 13) the agency failed to provide services that were written in an individualized Plan of Care to address the total needs of the patients. Evidence as follows: 1. Patient #13 was admitted to the agency on 04/26/23 with diagnoses that included complication of internal fixation of bone, right lower leg, multiple fractures of right ribs, fall, type 2 diabetes, and severe persistent asthma. This patient was selected from the internet Quality Improvement and Evaluation System (iQIES) potentially avoidable events report dated 08/01/2023 through 07/31/2024 and was identified as having received emergent care for hyperglycemia. - On 10/18/23, the registered nurse visited the patient for a resumption of care following hospitalization for removal of right ankle hardware. The nurse documented the patient had previously developed osteomyelitis after a right ankle fracture that eventually required open reduction and internal fixation of the bones and, "discharge order calls for daily dressing changes." Further documentation included the nurse called the surgery office called and requested to decrease dressing change frequency from daily to 2 times weekly. The patient was unable to perform dressing changes independently and [caregiver] was unable to help. The surgeon's office approved the requested decrease but requested that the incision is monitored. The agency failed to develop a Plan of Care that followed the surgeon's original orders for daily dressing changes that resulted in a negative outcome to the patient's wound. On 10/28/24 at 12:00 p.m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager and Rehabilitation Managers who acknowledged the findings and offered no additional information. 2. Patient #4 was admitted to the agency on 06/26/24 with diagnoses that included type 2 diabetes, cellulitis of the left lower limb, right below the knee amputation, hypertensive heart disease, and heart failure. Wound Care Frequency The Plan of Care dated 06/26/24-08/24/24 included: - Wound care: left dorsal foot posterior area non-pressure wounds related to edema and atherosclerosis (2), one medial and one lateral, 2 times weekly and as needed for soilage. Cleanse with wound cleanser / apply Xeroform / cover with dry gauze / ABD (large, cushioned dressing pad) and secure with Kerlix and stockinette and mild compression Ace wrap by skilled nurse. On 08/30/24, the nurse contacted the provider to "update SN orders 1x/week," and sent an order for "SN: 1 x week for 2 weeks starting 09/01/24." The patient resided in an assisted living facility, had no caregiver available, and was unable to perform wound care independently. A signed order was returned for skilled nurse visits, "SN 1 x week for 2 weeks", however, the orders for wound care were not changed and remained 2 times weekly. During the weeks of 09/01/24 and 09/08/24 the nurse visited and performed wound care once each week on 09/03 and 09/12/24. On 09/12/24, the nurse visited after 9 days without wound care performed twice weekly and documented: possible cellulitis, LLE firm edema, +1 left ankle pitting edema and +2 calf edema. "Contacted physician to request increase in nursing to 2 times/week for wound care." On 10/31/24 at 4:00 p.m., the surveyor interviewed the Director of Patient Services who stated that visit frequency and wound care frequency are not interchangeable. The wound care order must be confirmed first and then the visit frequency. The nurse failed to provide wound care twice weekly per the Plan of Care / physician's orders that resulted in negative outcome to the patient’s wound. Edema Assessment/Wound Care The Plan of Care dated 06/26/24-08/24/24 included: Congestive Heart Failure: - assess edema at each visit - notify MD if edema increases by +1 (baseline 2+ at start of care) Wound Care Orders: - Left dorsal foot posterior area non-pressure wounds related to edema and atherosclerosis X 2, one medial and one lateral, 2 times weekly and as needed for soilage. Cleanse with wound cleanser / apply Xeroform / cover with dry gauze / ABD (large, cushioned dressing pad) and secure with Kerlix and stockinette and mild compression Ace wrap by skilled nurse. - Vascular: Educate patient / caregiver: Application of A-E (anti-embolic) stocking, on in a.m., off at HS (bedtime). On 07/09/24, the nurse visited and failed to assess and document edema.The surveyor reviewed a wound photo labeled left leg anterior medial that displayed marked imprints from Ace wrap and clothing and photo labeled left dorsal shows deep imprints into calf, size out of proportion to edematous foot. On 07/12/24, the nurse visited and failed to assess and document edema. On 07/18/24, the nurse visited and failed to assess and document edema.The surveyor reviewed a wound photo labeled left leg shows marked imprints from Ace wrap and dressing / clothing and disproportionate size of leg beneath Ace wrap (deep imprints) and size of foot below Ace wrap. On 07/25/24, the nurse failed to assess and document edema.The surveyor reviewed wound photos that displayed indentations in the side of left calf and around ankle. On 08/08/24, the nurse failed to assess and document edema.The surveyor reviewed wound photos that displayed indentations in the side of left inner calf and shin. On 08/19/24, the nurse visited and failed to document edema. The surveyor reviewed wound photos that displayed left calf duskiness with deep imprints from dressing/Ace wrap. The Plan of Care developed at the recertification visit dated 08/25-10/23/24 included: -Wound care: to left lower leg, anterior and posterior, any weeping ulcer, 2 X weekly and as needed for soilage. Cleanse with wound cleanser / apply Xeroform / cover with 4x4 gauze / ABD (large, cushioned dressing pad) / Kerlix / Ace. Wound care to be completed by skilled nurse. (Mild compression of the Ace wrap was omitted from the orders.) -Vascular: Educate patient / caregiver: Application of A-E (anti-embolic) stockings, on in a.m., off at HS (bedtime). Congestive Heart Failure: - assess edema at each visit - notify MD if edema increases by +1 (baseline 2+ at start of care) On 08/26/24 the nurse visited and failed to document edema. On 10/01/24 the nurse visited and failed to document edema. On 10/25/24, the surveyor conducted an observational home visit with the nurse. Upon removal of the Ace wrap and dressing the foot below the Ace wrap (midfoot to toes) was markedly edematous below the termination of the Ace wrap. On 10/28/24, the surveyor reviewed the agency policy, Edema Assessment revised 01/30/23 which included: - Edema will be monitored using the following scale. - Edema scale: Non-pitting edema (swelling with no indentation) 1+ (trace pitting; slight indentation; no perceptible swelling; rapid response) 2+ (mild pitting; indentation subsides rapidly - within 10-15 seconds) 3+ (moderate pitting; indentation remains for 1-2 minutes) 4+ (severe pitting indentation remains for greater than 2 minutes) At all visits the order for an anti-embolic stocking to the left calf was not addressed. The nurses failed to update the Plan of Care to remove or include anti-embolic stocking in the care of the edema and/or wound care. The nurses visited the patient 28 times between 06/24/24 and 10/25/24. At 8 visits the nurse failed to follow the Plan of Care and assess edema as ordered and, on 09/12/24, when the edema level rose from +1 to +2, the nurse failed to notify the physician when the edema level returned to +2. The nurses failed to contact the physician to report the negative effect of the Ace wrap and develop an alternate plan of care and to ensure the plan of care for edema assessment and reporting was followed. On 10/28/24 at 12:00 p.m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager and Rehabilitation Managers who acknowledged the findings and offered no additional information. 1. Patient #13 was admitted to the agency on 04/26/23 with diagnoses that included complication of internal fixation of the right lower leg bone, multiple fractures of right ribs, fall, type 2 diabetes, and severe persistent asthma. This patient was selected from the internet Quality Improvement and Evaluation System (iQIES) potentially avoidable events report dated 08/01/2023 through 07/31/2024 and was identified as having received emergent care for hyperglycemia. The patient was unable to perform dressing changes independently and [caregiver] was unable to help. Discharge orders included daily dressing changes. - On 10/18/23, the registered nurse visited the patient for a resumption of care following hospitalization for removal of right ankle hardware. The nurse documented the patient had previously developed osteomyelitis after a right ankle fracture that eventually required open reduction and internal fixation of the bones and, "discharge order calls for daily dressing changes." The nurse called the surgeon's office to request a decrease in wound care frequency and spoke to a nurse practitioner who agreed to decrease wound care frequency but requested "please monitor incisions." Orders were sent to primary care physician requesting visits 3 times/week for 2 weeks, then 1 time a week to end of certification period. The agency failed to develop a wound care plan that followed the surgeon's original orders for daily dressing changes. On 10/28/24, the surveyor reviewed the discharge summary/transfer note dated 12/16/23 which included the patient had been hospitalized with an admitting diagnosis osteomyelitis and was transferred to another hospital for further treatment. Discharge/transfer diagnosis osteomyelitis. On 10/28/24 at 12:00 p.m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager and Rehabilitation Managers who had no explanation for the agency's request to decrease visit and wound care frequency. They acknowledged the findings and offered no additional information. 2. Patient #4 was admitted to the agency on 06/26/24 with diagnoses that included type 2 diabetes, cellulitis of the left lower limb, right below the knee amputation, hypertensive heart disease, and heart failure. Wound Care Frequency The Plan of Care dated 08/25/24-10/23/24 included: - Wound care: left lower leg, any weeping ulcer, 2 times weekly and as needed for soilage. Cleanse with wound cleanser / apply Xeroform / cover with 4x4 gauze / ABD (large, cushioned dressing pad) /Kerlix / Ace. Wound care by skilled nurse. On 08/30/24, the nurse contacted the provider to "update SN orders 1x/week," and sent an order for "SN: 1 x week for 2 weeks starting 09/01/24." The patient resided in an assisted living facility, had no caregiver available, and was unable to perform wound care independently. A signed order was returned for skilled nurse visits, "SN 1 x week for 2 weeks", however, the orders for wound care were not changed and remained 2 times weekly. During the weeks of 09/01/24 and 09/08/24 the nurse visited and performed wound care once each week on 09/03 and 09/12/24. On 09/12/24, the nurse visited after 9 days without wound care performed twice weekly and documented: possible cellulitis, LLE firm edema, +1 left ankle pitting edema and +2 calf edema. "Contacted physician to request increase in nursing to 2 times/week for wound care." On 10/31/24 at 4:00 p.m., the surveyor interviewed the Director of Patient Services who stated that visit frequency and wound care frequency are not interchangeable. The wound care order must be confirmed first and then the visit frequency. The nurse failed to provide wound care twice weekly per the Plan of Care / physician's orders that likely resulted in a negative outcome to the patient’s wound. On 10/28/24 at 12:00 p.m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager and Rehabilitation Managers who acknowledged the findings and offered no additional information. 3. Patient #10 was admitted to the agency on 08/30/24 with diagnoses of chronic obstructive pulmonary disease, acute and chronic respiratory failure, pulmonary hypertension, heart failure, and hypertensive heart disease. Agency staff failed to follow the physician ordered Plan of Care as follows: The 08/30/24-10/28/24 Plan of Care included for the multidisciplinary team (which consisted of the skilled nurse, physical therapist, and respiratory therapist) to: - assess edema at each visit and notify the physician if edema increased by +1 - obtain weight at each visit and to notify the physician of a 2-pound weight gain or loss in 24 hours or a 5-pound weight gain or loss in one week Edema - On 09/04/24, 09/09/24, 09/11/24, 09/16/24, 09/19/24, 09/25/24, and 10/14/24 the physical therapist failed to assess if the patient had edema. - On 09/11/24, 09/17/24, 09/24/24, 10/01/24, and 10/07/24 the respiratory therapist failed to assess if the patient had edema. Weights - On 09/03/24 the licensed practical nurse failed to obtain the patient’s weight. - On 09/09/24, 09/11/24, 09/16/24, 09/19/24, 09/25/24, and 10/14/24 the physical therapist failed to obtain the patient’s weight. - On 09/11/24, 09/17/24, and 09/24/24 the respiratory therapist failed to obtain the patient’s weight. On 10/29/24 at 2:00 p.m. the findings were reviewed with the Director of Patient Services/Administrator and Office/Operations Manager who acknowledged the findings and offered no additional information. 4. Patient #11 was admitted to the agency on 06/27/24 for wound care to a stage 3 sacral pressure ulcer. Additional diagnoses included lower extremity lymphedema (swelling due to blocked lymphatic vessels), congestive heart failure, and Factor V Leiden (increased blood clotting). Agency staff failed to obtain weights per the physician ordered Plan of Care. The 06/27/24 and 08/26/24 Plan of Care included: - obtain weight at each visit and notify the physician of a 2-pound weight gain or loss in 24 hours or 5-pound weight gain or loss in one week - “baseline weight is ___per client 174lb declined weight at soc [start of care] visit” On 14 occasions (07/02, 07/05, 07/09, 07/12, 07/16, 07/19, 07/23, 07/26, 07/30, 08/30, 09/06, 09/25, 10/02, and 10/09/24), the nurse visited the patient and failed to obtain a weight or document a reason why the weight could not be obtained. On 10/29/24 at 2:00 p.m. the findings were reviewed with the Director of Patient Services/Administrator and Office/Operations Manager who acknowledged the findings and offered no additional information. Failure to provide physician ordered care likely contributed to negative outcomes for patients #4 and 13 and has the potential for poor patient outcomes and unmet patient needs for the agency's entire patient population.

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 a review of clinical records and interviews with the Director of Patient Services/Administrator, Quality Manager/Clinical Manager, and Rehabilitation Managers, it was determined in 7 of 19 records, (patients #1, 3, 5, 9, 11, 12, and 15) the agency failed to develop complete and accurate plans of care that were individualized to address the total needs of the patients. Evidence as follows: Patient #3 was admitted to the agency on 09/24/24 for wound care secondary to a left lower leg fasciotomy (surgery to release pressure) due to thrombectomy (blood clot removal). Edema On 09/24/24 the skilled nurse visited the patient for an initial assessment and indicated the patient had no edema (edema box not checked). At each visit from 09/25/24-10/11/24 (6 visits) and on 10/18/24 the skilled nurse checked the edema and non-pitting box within the assessment. The skilled nurse failed to communicate with the physician in order to update the plan of care to include orders to assess and monitor edema, including measurements and parameters for physician notification. Wound Care The 09/24/24 Plan of Care included the following wound care orders: - “Wound Vac: Negative pressure wound therapy to LLE [left lower extremity] surgical wound 3 x weekly and prn [as needed] leakage: Cleanse with NS [normal saline] or wound wash or water, apply skin prep to peri wound, apply black foam, drape and TRAC pad, connect to canister, continuous therapy at 125mm/Hg.” On 09/25/24 the skilled nurse visited the patient to perform wound care. The assessment included documentation on two separate wounds located on the left lower extremity. Per the 04/25/23 “Wound Care” policy, the wound care order obtained should include the type and location of each wound as well as the frequency of assessment. The Plan of Care failed: - to denote there were two separate surgical wounds to the left lower extremity and whether or not wound care would be the same for both wounds. Bathing The 09/24/24 Plan of Care included the patient may not bathe until approved by the provider from Vascular Surgery. The Plan of Care failed to define what bathing did or did not include (i.e. showering vs sponge bath vs not allowing left lower leg to get wet). On 10/28/24 at 12:00 p.m. the above findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager, and Rehabilitation Managers who acknowledged the findings and offered no additional information. Home Visit Patient #7 was admitted to the agency on 09/18/24 with diagnoses of bladder cancer, type II diabetes mellitus, hypertensive chronic kidney disease, and left sided weakness due to cerebral infarction (stroke). The 09/18/24-11/16/24 Plan of Care included: - “blood glucose is monitored via Dexcom CGM [continuous glucose monitor] managed by client and CG [caregiver] assist if needed.” - Humalog KwikiPen 100 unit/mL; 4-16 units subcutaneous 3 x per day before meals for diabetes, see sliding scale - DME (durable medical equipment): Dexcom On 09/18/24 the skilled nurse visited the patient for an initial assessment and documented the patient uses a Dexcom meter. On 09/23/24 the skilled nurse visited the patient and documented the patient “wears Dexcom 7 sensor: current reading 316, finger prick is actual 283.” On 10/25/24 at 9:30 a.m. the surveyor performed an observational home visit with the skilled nurse. During the visit the patient stated they use both the Dexcom and a glucometer to monitor blood sugar levels. After the skilled nurse left, the surveyor conducted an interview with the patient and the patient caregiver. The patient stated they have had diabetes for over 40 years. When asked about glucose monitoring, the patient again stated they use both the Dexcom and a glucometer to make sure they are getting accurate readings. When asked about education regarding the glucometer, the patient stated the nurse did check to make sure they were able to use the glucometer correctly. The Plan of Care failed to include how often or when the patient should check the Dexcom readings. The skilled nurse failed to update the Plan of Care to include: - the patient had a glucometer (DME) - how often or when the patient should use the glucometer On 10/28/24 at 12:00 p.m. the above findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager, and Rehabilitation Managers who acknowledged the findings and offered no additional information. Patient #11 was admitted to the agency on 06/27/24 for wound care to a stage 3 sacral pressure ulcer. Additional diagnoses included lower extremity lymphedema (swelling due to blocked lymphatic vessels), congestive heart failure, and Factor V Leiden (increased blood clotting). Clot Prevention The 06/25/24 referral included a physician visit note stating the patient had a hematoma of the left chest wall and their Eliquis (blood thinner) was on hold until an updated scan showed it was gone. On 06/27/24 the skilled nurse visited the patient for an initial assessment and documented “…eliquis is currently on hold so not currently on any high risk meds…” The skilled nurse failed to develop a plan of care for monitoring blood clot development due to patients’ history of Factor V Leiden and Eliquis being on hold. Lymphedema The 06/27/24-08/25/24 Plan of Care included: - assess edema at each visit and notify the physician if edema increases by +1 (using an edema scale from 0-4+) -“baseline edema is none RLE [right lower extremity] at soc [start of care] and chronic lymphedema LLE [left lower extremity]” On 07/02/24 the skilled nurse visited the patient and documented via checkbox “Non-pitting” (edema) and typed in for location “LLE [left lower extremity] lymphedema. On 07/09/24 the skilled nurse visited the patient and documented via checkbox “Edema”, “Pedal R [right] L [left], “Dependent”, “Non-pitting”, and typed in for location “BLE [bilateral lower extremities], left larger.” The 01/30/24 “Edema Assessment” policy states edema will be monitored using an edema scale ranging from non-pitting to 4+ or leg measurements. However, unlike the edema scale, leg measurements are not a standard component of the assessment and will be done at the request of the physician or at the discretion of the clinician. The skilled nurse failed to communicate with the physician to develop and update the Plan of Care to include: - an alternate method to accurately assess the patient’s edema/lymphedema (the edema scale within the plan of care did not allow for the skilled nurse to determine if changes had occurred) - measurement parameters for physician notification Compression Wraps On 08/30/24 the skilled nurse visited the patient and documented the patient agreed to start wrapping their legs after application of lotion. The skilled nurse failed to update the Plan of Care to include: - compression wraps, including instructions for use On 10/11/24 the physical therapist visited the patient and developed a care plan that included: - compression bandages to the bilateral lower extremities as tolerated and as appropriate according to patient’s clinical presentation The physical therapists plan of care for compression bandages failed to include: - what area of the lower extremities should be wrapped - what type of wrap should be used - when to apply/remove wraps - how often wraps should be used - who should apply the wraps On 10/29/24 at 2:00 p.m. the above findings were reviewed with the Director of Patient Services/Administrator and Office/Operations Manager who acknowledged the findings and offered no additional information. 1. Patient #15 was admitted to the agency on 03/27/24 with diagnoses that included Lewy body dementia, Parkinson’s disease, and cellulitis on right hand due to a dog bite. This patient was selected from the Internet Quality Improvement and Evaluation System (iQies) potentially avoidable events report dated 08/01/2023 through 07/31/2024 for an increase in the number of pressure ulcers during the home care episode. The 05/26/24-07/24/24 Plan of Care included the following orders: - clotrimazole (anti-fungal) 1% external 1 application twice a day for fungal infection (start date 05/06/24) - may shower if right hand dressing covering covered with resistant dressing (start date 03/27/24) The plan of care failed to include: - the location the anti-fungal topical application was to be applied - bathing considerations for the buttock and heel wounds On 10/29/24 at 2 p. m., the findings were reviewed with the Director of Patient Services and the Office Manager who acknowledged the findings and offered no additional information. Home visit 2. Patient #5 was admitted to the agency on 06/29/23 with diagnoses that included Type 2 diabetes, a diabetic ulcer to the left foot, osteomyelitis, and history of non-compliance. The 08/22/24 - 10/20/24 Plan of Care included the following orders: - HVPC (high voltage pulsed current) to left plantar ulcer to therapeutic level for 60 minutes (start effective date 07/24/24) - patient may not bathe until approved by MD (start effective date 12/22/23) On 10/25/24, the surveyor made an observational home visit with the physical therapy assistant (PTA) who administered the HVPC treatment to the wound. During the visit, the PTA reported: - the HVPC treatment was administered at the highest level and patient reported that they tolerated this well - the length of the HVPC treatment varied based on whether the patient had an appointment with the podiatrist that week. If the patient had podiatry appointment and only received 2 physical therapy/physical therapy assistant visits in a week, the patient received the HVPC treatment for 60 minutes each visit but if the patient did not have a podiatry appointment and had 3 PT/PTA visits that week, the HVPC treatment for 45 minutes each visit. The plan of care failed to: - include level of the HVPC treatment was to be administered at or duration of each treatment - provide bathing instructions On 10/28/24 at 12 p. m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager/Clinical Manager, and the Rehabilitation Managers. 3. Patient #12 was admitted to the agency on 02/27/24 with diagnoses that included urinary tract infection, spinal muscular atrophy, severe protein-calorie malnutrition, and hypertensive chronic kidney disease. On 02/27/24 the registered nurse visited the patient to complete the admission assessment and documented the following: - patient has suprapubic catheter present and patient intermittently drains every 2 – 4 hours during waking hours and uses drainage bag while sleeping (neither assessment nor plan of care specified how the intermittent draining was managed such as clamping or another method) On 10/29/24 the surveyor inquired if clamping was being used for the intermittent draining but no further information was provided. The 02/27/24-04/26/24 Plan of Care included the following orders: - sodium chloride 0.45% intravenous 1000ml as needed daily over 4 hours for signs and symptoms of dehydration - insert indwelling suprapubic catheter 14 French with 10 mL balloon, foley to be changed every 3 weeks and as needed for leakage/dislodgement to be completed by skilled nurse. Change bag every 4 weeks. The plan of care failed to include: - order for intermittent draining of suprapubic catheter - order for care to suprapubic insertion site - clarify who was to determine the need for as needed sodium chloride infusion or how that determination was to be made The agency failed to evaluate the utilization of the as needed sodium chloride intravenous 1000 mL on subsequent nursing visits. On 10/29/24 at 2 p. m. the findings were reviewed with the Director of Patient Services/Administrator and Office Manager who acknowledged the findings and offered no additional information. 1. Patient #12 was admitted to the agency on 02/27/24 with diagnoses that included urinary tract infection, spinal muscular atrophy, severe protein-calorie malnutrition, and hypertensive chronic kidney disease. On 02/27/24 the registered nurse visited the patient to complete the admission assessment and documented the following: - patient has suprapubic catheter present and patient intermittently drains every 2 – 4 hours during waking hours and uses drainage bag while sleeping (neither assessment nor plan of care specified how the intermittent draining was managed such as clamping or another method) On 10/29/24 the surveyor interviewed the Director of Patient Services if clamping was being used for the intermittent draining, but no further information was provided. The 02/27/24-04/26/24 Plan of Care included the following orders: - sodium chloride 0.45% intravenous 1000ml as needed daily over 4 hours for signs and symptoms of dehydration - insert indwelling suprapubic catheter 14 French with 10 mL balloon, foley to be changed every 3 weeks and as needed for leakage/dislodgement to be completed by skilled nurse. Change bag every 4 weeks. The Plan of Care failed to include: - order for intermittent draining of suprapubic catheter - order for care to suprapubic insertion site - who was to determine the need for as needed sodium chloride infusion or how that determination was to be made The agency failed to evaluate the utilization of the as needed sodium chloride intravenous 1000 mL on subsequent nursing visits. On 10/29/24 at 2 p. m. the findings were reviewed with the Director of Patient Services/Administrator and Office Manager who acknowledged the findings and offered no additional information. 2. Patient #3 was admitted to the agency on 09/24/24 for wound care secondary to a left lower leg fasciotomy (surgery to release pressure) due to thrombectomy (blood clot removal). Edema On 09/24/24 the skilled nurse visited the patient for an initial assessment and indicated the patient had no edema (edema box not checked). At each visit from 09/25/24-10/11/24 (6 visits) and on 10/18/24 the skilled nurse checked the "edema" and "non-pitting" boxes within the assessment. The skilled nurse failed to communicate with the physician to update the plan of care to include orders to assess and monitor edema, including measurements and parameters for physician notification. Wound Care The 09/24/24 Plan of Care included the following wound care orders: - “Wound Vac: Negative pressure wound therapy to LLE [left lower extremity] surgical wound 3 x weekly and prn [as needed] leakage: Cleanse with NS [normal saline] or wound wash or water, apply skin prep to peri wound, apply black foam, drape and TRAC pad, connect to canister, continuous therapy at 125mm/Hg.” On 09/25/24 the skilled nurse visited the patient to perform wound care. The assessment included documentation on two separate wounds located on the left lower extremity. Per the 04/25/23 “Wound Care” policy, the wound care order obtained should include the type and location of each wound as well as the frequency of assessment. The Plan of Care failed to denote there were two separate surgical wounds to the left lower extremity and whether or not wound care would be the same for both wounds. Bathing The 09/24/24 Plan of Care included the patient may not bathe until approved by the provider from Vascular Surgery. The Plan of Care failed to define what bathing did or did not include (i.e. showering vs sponge bath vs not allowing left lower leg to get wet). On 10/28/24 at 12:00 p.m. the above findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager, and Rehabilitation Managers who acknowledged the findings and offered no additional information. 3. Patient #11 was admitted to the agency on 06/27/24 for wound care to a stage 3 sacral pressure ulcer. Additional diagnoses included lower extremity lymphedema (swelling due to blocked lymphatic vessels), congestive heart failure, and Factor V Leiden (increased blood clotting). Clot Prevention The 06/25/24 referral included a physician visit note stating the patient had a hematoma of the left chest wall and their Eliquis (blood thinner) was on hold until an updated scan showed it was gone. On 06/27/24 the skilled nurse visited the patient for an initial assessment and documented “…eliquis is currently on hold so not currently on any high risk meds…” The skilled nurse failed to develop a plan of care for monitoring blood clot development due to patient's history of Factor V Leiden and Eliquis being on hold. Lymphedema The 06/27/24-08/25/24 Plan of Care included: - assess edema at each visit and notify the physician if edema increases by +1 (using an edema scale from 0-4+) -“baseline edema is none RLE [right lower extremity] at soc [start of care] and chronic lymphedema LLE [left lower extremity]” On 07/02/24 the skilled nurse visited the patient and documented via checkbox “Non-pitting” (edema) and typed in for location “LLE [left lower extremity] lymphedema. On 07/09/24 the skilled nurse visited the patient and documented via checkbox “Edema”, “Pedal R [right] L [left], “Dependent”, “Non-pitting”, and typed in for location “BLE [bilateral lower extremities], left larger.” The 01/30/24 “Edema Assessment” policy states edema will be monitored using an edema scale ranging from non-pitting to 4+ or leg measurements. However, unlike the edema scale, leg measurements are not a standard component of the assessment and will be done at the request of the physician or at the discretion of the clinician. The skilled nurse failed to communicate with the physician to develop and update the Plan of Care to include: - an alternate method to accurately assess the patient’s edema/lymphedema (the edema scale within the plan of care did not allow for the skilled nurse to determine if changes had occurred) - measurement parameters for physician notification Compression Wraps On 08/30/24 the skilled nurse visited the patient and documented the patient agreed to start wrapping their legs after application of lotion. The skilled nurse failed to update the Plan of Care to include: - compression wraps, including instructions for use On 10/11/24 the physical therapist visited the patient and developed a care plan that included: - compression bandages to the bilateral lower extremities as tolerated and as appropriate according to patient’s clinical presentation The physical therapists plan of care for compression bandages failed to include: - what area of the lower extremities should be wrapped - what type of wrap should be used - when to apply/remove wraps - how often wraps should be used - who should apply the wraps Home Visit 4. Patient #2 was admitted to the agency on 8/16/24 with diagnoses that include spinal muscular atrophy, Farber disease, seizures, and g-tube dependency, and tracheostomy. On 10/10/24 during the recertification visit, the skilled nurse documented that the skin under the tracheostomy ties was red. They also documented that the left side of the tracheostomy had a 2-inch skin tear, and the right side was red, raw and blanchable. The caregiver applied Citicaid AF barrier cream and a 2x2 Meplilex (cushioned) bandaged over the left side area. The summary stated that the caregiver was to continue to do so twice a day and as needed with site care. On 10/25/24, the surveyor conducted an observational home visit with the skilled nurse. During the home visit, the surveyor observed the skilled nurse cutting a hole in the Meplilex and applying it around the tracheostomy tube to cover both sides, after applying the barrier cream. The Plan of Care for both 08/16/24 to 10/14/24 and 10/15/24 to 12/13/24 did not include orders for wound care around the tracheostomy. On 10/28/24 at 12:00 p.m., the findings were reviewed with the Vice President, Director of Patient Services, Quality Manager and Rehabilitation Managers who acknowledged the findings and offered no additional information. 5. Patient #9 was admitted to the agency on 06/03/24 with diagnoses of Multiple Sclerosis, a stage 4 pressure injury on their buttocks, a colostomy, and neuromuscular dysfunction of the bladder. The 10/01/24 to 11/29/24 Plan of Care included an order to insert a indwelling suprapubic catheter every 2 weeks. The order documented “Foley to be changed every 2 weeks and prn [as needed]”. The order did not specify the suprapubic catheter was to be changed every 2 weeks and only referred to the Foley catheter. The order did not include any instructions on site care for the suprapubic catheter or if the catheter required a dressing. On 10/29/24 at 2:00 p.m. the findings were reviewed with the Director of Patient Services/Administrator and Office/Operations Manager who acknowledged the findings and offered no additional information. On 10/29/24 at 2:00 p.m. the above findings were reviewed with the Director of Patient Services/Administrator and Office/Operations Manager who acknowledged the findings and offered no additional information. Home Visit 6. Patient #7 was admitted to the agency on 09/18/24 with diagnoses of bladder cancer, type II diabetes mellitus, hypertensive chronic kidney disease, and left sided weakness due to cerebral infarction (stroke). The 09/18/24-11/16/24 Plan of Care included: - “blood glucose is monitored via Dexcom CGM [continuous glucose monitor] managed by client and CG [caregiver] assist if needed.” - Humalog Kwikpen 100 unit/mL; 4-16 units subcutaneous 3 x per day before meals for diabetes, see sliding scale - DME (durable medical equipment): Dexcom On 09/18/24 the skilled nurse visited the patient for an initial assessment and documented the patient uses a Dexcom meter. On 09/23/24 the skilled nurse visited the patient and documented the patient “wears Dexcom 7 sensor: current reading 316, finger prick is actual 283.” On 10/25/24 at 9:30 a.m. the surveyor performed an observational home visit with the skilled nurse. During the visit the patient stated they use both the Dexcom and a glucometer to monitor blood sugar levels. After the skilled nurse left, the surveyor conducted an interview with the patient and the patient caregiver. The patient stated they have had diabetes for over 40 years. When asked about glucose monitoring, the patient again stated they use both the Dexcom and a glucometer to make sure they are getting accurate readings. When asked about education regarding the glucometer, the patient stated the nurse did check to make sure they were able to use the glucometer correctly. The Plan of Care failed to include how often or when the patient should check the Dexcom readings. The skilled nurse failed to update the Plan of Care to include: - the patient had a glucometer (DME) - how often or when the patient should use the glucometer On 10/28/24 at 12:00 p.m. the above findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager, and Rehabilitation Managers who acknowledged the findings and offered no additional information. 7. Patient #15 was admitted to the agency on 03/27/24 with diagnoses that included Lewy body dementia, Parkinson’s disease, and cellulitis on right hand due to a dog bite. This patient was selected from the Internet Quality Improvement and Evaluation System (iQies) potentially avoidable events report dated 08/01/2023 through 07/31/2024 for an increase in the number of pressure ulcers during the home care episode. The 05/26/24-07/24/24 Plan of Care included the following orders: - clotrimazole (anti-fungal) 1% external 1 application twice a day for fungal infection (start date 05/06/24) - may shower if right hand dressing covering is covered with resistant dressing (start date 03/27/24) The plan of care failed to include: - the location the anti-fungal topical application was to be applied - bathing considerations for the buttock and heel wounds On 10/29/24 at 2 p. m., the findings were reviewed with the Director of Patient Services/Administrator and the Office Manager who acknowledged the findings and offered no additional information. Home visit 8. Patient #5 was admitted to the agency on 06/29/23 with diagnoses that included type 2 diabetes, a diabetic ulcer to the left foot, osteomyelitis, and history of non-compliance. The 08/22/24 - 10/20/24 Plan of Care included the following orders: - HVPC (high voltage pulsed current) to left plantar ulcer to therapeutic level for 60 minutes (start effective date 07/24/24) - patient may not bathe until approved by MD (start effective date 12/22/23) On 10/25/24, the surveyor made an observational home visit with the physical therapy assistant (PTA) who administered the HVPC treatment to the wound. During the visit, the PTA reported: - the HVPC treatment was administered at the highest level and patient reported that they tolerated this well - the length of the HVPC treatment varied based on whether the patient had an appointment with the podiatrist that week. If the patient had podiatry appointment and only received 2 physical therapy/physical therapy assistant visits in a week, the patient received the HVPC treatment for 60 minutes each visit but if the patient did not have a podiatry appointment and had 3 PT/PTA visits that week, the HVPC treatment for 45 minutes each visit. The Plan of Care failed to: - include level of the HVPC treatment was to be administered at or duration of each treatment - provide bathing instructions On 10/28/24 at 12 p. m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager/Clinical Manager, and the Rehabilitation Managers. Home Visit 9. Patient #1 was admitted to the agency on 05/03/24 with diagnoses including type 2 diabetes with foot ulcer, non- pressure ulcer of right heel and midfoot and chronic osteomyelitis of the right foot. The patient had a verbal order dated 05/10/24 for “high voltage pulsed current electric stimulation to be applied to wound for 60 minute treatment session. Simulation intensity to set at sensory level per patient.” The order did not contain a frequency for how often this treatment should be applied. The order also did not specify the criteria to judge the correct level and instead instructs the level to be “per patient”. The order did not specify how to tell if the level is too high or too low. Medications The patient's current medication profile, printed by the surveyor on 10/25/24, included the following medications: - hydrocodone 5 mg – acetaminophen 325 mg 1 tablet as needed every 6 hours with a maximum daily dose of 8 tablets - lactobacillus rhamnosus (GG) (Culturelle) capsule 1 capsule daily The surveyor performed a home visit with the skilled nurse on 10/25/24 at 9:30 a.m.. During the home visit, the skilled nurse provided the patient with a list of current medications. They stated the list was updated at the last visit. At the home visit, the surveyor went over the patient’s medications and compared it to the medication profile. The patient stated they were no longer taking the hydrocodone 5 mg – acetaminophen 325 mg or the lactobacillus rhamnosus (GG) (Culturelle). The skilled nurse failed to identify the patient was no longer taking multiple medications and provided them with an incorrect list of medications. On 10/28/24 at 12:00 p.m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager, and Rehabilitation Managers who acknowledged the findings and offered no additional information.

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 a review of patient records and interviews with the Director of Patient Services/Administrator, Quality Manager/Clinical Manager and Rehabilitation Managers, it was determined in 3 of 19 records (patients #2, 7, and 10), the agency failed to perform care in accordance with the orders of a physician or allowed practitioner that establishes and periodically reviews the plan of care. Evidence as follows: 1.Patient #7 was admitted to the agency on 09/18/24 with diagnoses of bladder cancer, type II diabetes mellitus, hypertensive chronic kidney disease, and left sided weakness due to cerebral infarction (stroke). On 09/30/24 and 10/04/24 the skilled nurse visited the patient and documented they provided education to the patient on keeping a blood pressure log. On 10/11/24 the skilled nurse visited the patient and documented the patient was taking their blood pressure as recommended and it had been occasionally high during that week. The skilled nurse failed to update the Plan of Care to include blood pressure monitoring including: - when/how often the patient should check their blood pressure - parameters in which to call the physician to report On 10/28/24 at 12:00 p.m. the above findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager, and Rehabilitation Managers who acknowledged the findings and offered no additional information. Patient #10 was admitted to the agency on 08/30/24 with diagnoses of chronic obstructive pulmonary disease, acute and chronic respiratory failure, pulmonary hypertension, heart failure, and hypertensive heart disease. The 08/30/24-10/28/24 Plan of Care included to educate the patient/caregiver on use of Acapella (handheld vibratory device to help loosen secretions in the lungs). The Plan of Care failed to include an order for use of the Acapella including the frequency and indication. On 10/29/24 at 2:00 p.m. the findings were reviewed with the Director of Patient Services/Administrator and Office/Operations Manager who acknowledged the findings and offered no additional information. Failure to provide care not outlined in the physician's orders has the potential for unmet patient needs and negative outcomes for the patient population. Home Visit 1. Patient #2 was admitted to the agency on 8/16/24 with diagnoses that include spinal muscular atrophy, Farber disease (a progressive genetic disorder), seizures, and g-tube dependency, and tracheostomy. On 10/10/24 during the recertification visit, the skilled nurse documented that the skin under the tracheostomy ties was red. They also documented that the left side of the tracheostomy had a 2-inch skin tear, and the right side was red, raw, and blanchable. The caregiver applied Critic-Aid AF barrier cream and a 2x2 Mepilex (cushioned) bandage over the left side area. The summary stated that the caregiver was to continue to do so twice a day and as needed with site care. On 10/25/24, the surveyor conducted an observational home visit with the skilled nurse. During the home visit, the surveyor observed the skilled nurse cutting a hole in the Mepilex and applying it around the tracheostomy tube to cover both sides, after applying the barrier cream. The Plan of Care for both 08/16/24 to 10/14/24 and 10/15/24 to 12/13/24 did not include orders for wound care around the tracheostomy. - On 10/28/24 at 12:00 p.m., the findings were reviewed with the Vice President, Director of Patient Services, Quality Manager and Rehabilitation Managers who acknowledged the findings and offered no additional information. 2. Patient #10 was admitted to the agency on 08/30/24 with diagnoses of chronic obstructive pulmonary disease, acute and chronic respiratory failure, pulmonary hypertension, heart failure, and hypertensive heart disease. The 08/30/24-10/28/24 Plan of Care included to educate the patient/caregiver on use of Acapella (handheld vibratory device to help loosen secretions in the lungs). The Plan of Care failed to include an order for use of the Acapella including the frequency and indication. On 10/29/24 at 2:00 p.m. the findings were reviewed with the Director of Patient Services/Administrator and Office/Operations Manager who acknowledged the findings and offered no additional information. 3 .Patient #7 was admitted to the agency on 09/18/24 with diagnoses of bladder cancer, type II diabetes mellitus, hypertensive chronic kidney disease, and left sided weakness due to cerebral infarction (stroke). - On 09/30/24 and 10/04/24 the skilled nurse visited the patient and documented they provided education to the patient on keeping a blood pressure log. - On 10/11/24 the skilled nurse visited the patient and documented the patient was taking their blood pressure as recommended and it had been occasionally high during that week. The skilled nurse failed to update the Plan of Care to include blood pressure monitoring including: - when/how often the patient should check their blood pressure - parameters in which to call the physician to report On 10/28/24 at 12:00 p.m. the above findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager, and Rehabilitation Managers who acknowledged the findings and offered no additional information. Failure to provide care not outlined in the physician's orders has the potential for unmet patient needs and negative outcomes for the patient population.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on a review of clinical records, policies and procedures and interviews with the Director of Patient Services/Administrator, Quality Manager/Clinical Manager, and Rehabilitation Managers it was determined for 2 of 19 records (Patients #10 and 11) the Skilled Nurse failed to communicate with the physician when changes in the patient's condition occurred. Evidence as follows: Patient #11 was admitted to the agency on 06/27/24 for wound care to a stage 3 sacral pressure ulcer. Additional diagnoses include lower extremity lymphedema (swelling due to blocked lymphatic vessels), congestive heart failure, and Factor V Leiden (increased blood clotting). The skilled nurses failed to notify the physician of changes in the patient's condition as follows: Wound The 06/27/24-08/25/24 and 08/26/24-10/24/24 Plan of Care included to assess the patient’s wound. On 07/16/24 the licensed practical nurse documented wound drainage was serosanguineous (blood and serum). On 07/19/24 the registered nurse documented the wound had purulent (puss) drainage. - The registered nurse failed to notify the physician the wound drainage worsened. On 07/23/24 the registered nurse documented the wound drainage was serosanguineous. On 07/26/24 the registered nurse documented the wound had purulent drainage. - The registered nurse failed to notify the physician the wound drainage worsened. On 07/30/24 the registered nurse documented the wound had purulent drainage. - The registered nurse failed to notify the physician the wound continued to have purulent drainage. On 08/06/24 the licensed practical nurse documented wound undermining was 1 cm. On 08/13/24 the licensed practical nurse documented wound undermining was 2.8 cm. - The licensed practical nurse failed to notify the physician and case manager the undermining increased by 1.8 cm. On 09/03/24 the licensed practical nurse documented wound drainage had no odor and the wound bed was pink. On 09/06/24 the registered nurse documented the wound drainage had a foul odor and the wound bed was macerated. - The registered nurse failed to notify the physician the drainage odor and wound bed had changed. On 09/09/24 the registered nurse documented the wound drainage had a foul odor and the wound bed was macerated. - The registered nurse failed to notify the physician the wound still was not showing signs of improvement. On 09/11/24 and 09/13/24 the registered nurse documented the wound bed was still macerated but the wound drainage no longer had a foul odor. - The registered nurse failed to notify the physician that even though the drainage no longer had a foul odor, the wound bed was not improving. On 09/16/24 the licensed practical nurse documented the wound bed was still macerated but the wound drainage no longer had a foul odor. - The licensed practical nurse failed to notify the physician and case manager that even though the drainage no longer had a foul odor, the wound bed was not improving. On 09/18/24 the registered nurse documented the wound had purulent drainage with a foul odor and the wound bed was macerated. - The registered nurse failed to notify the physician the wound drainage again had purulent foul-smelling drainage and continued to be macerated. On 09/25/24 the licensed practical nurse documented wound drainage was serosanguineous and the wound bed was pink. On 09/27/24 the registered nurse documented the wound had purulent drainage and the wound bed was macerated. - The registered nurse failed to notify the physician the wound had worsened. Lymphedema The 06/27/24 Plan of Care included: - assess edema at each visit and notify the physician if edema increases by +1 On 06/27/24, 07/02/24, and 07/05/24 the skilled nurse documented the patient had no edema/lymphedema to the right lower extremity. On 07/09/24 the skilled nurse documented the patient had bilateral lower extremity edema/lymphedema, left side larger. On 08/20/24 the skilled nurse documented the patient had no edema/lymphedema to the right lower extremity. On 08/22/24 the skilled nurse documented the patient had bilateral lower extremity edema/lymphedema. - The skilled nurse failed to notify the physician of the new edema/lymphedema to the right lower extremity. Weights The 06/27/24 and 08/26/24 Plan of Care included: - obtain weight at each visit and notify the physician of a 2-pound weight gain or loss in 24 hours or 5 pound weight gain or loss in one week - “baseline weight is ___per client 174lb declined weight at soc [start of care] visit” On 08/02/24 the registered nurse documented the patient’s weight as 204 which will be used as a baseline weight. - The skilled nurse failed to notify the physician this was the first obtained weight since the start of care and was a 30-pound increase from the stated weight of the patient on 06/27/24. 2.Patient #10 was admitted to the agency on 08/30/24 with diagnoses of chronic obstructive pulmonary disease, acute and chronic respiratory failure, pulmonary hypertension, heart failure, and hypertensive heart disease. The skilled nurse failed to notify the physician of increased edema and weight per the Plan of Care. Edema The 08/30/24-10/28/24 Plan of Care included: - assess edema at each visit and notify the physician if edema increased by +1 - “baseline edema is none” On 09/06/24 the licensed practical nurse documented no edema. On 09/09/24 the registered nurse documented +1 edema to the bilateral ankles. On 09/18/24 the licensed practical nurse documented no edema. On 09/24/24 the registered nurse documented +1 edema to the bilateral ankles. - On both occasions of increased edema as noted above the registered nurse failed to notify the physician. Weights The 08/30/24-10/28/24 Plan of Care included: - obtain weight at each visit and to notify the physician of a 2-pound weight gain or loss in 24 hours or a 5-pound weight gain or loss in one week - “baseline weight is __need to obtain baseline weight at next SNV [skilled nurse visit]” On 09/06/24 the licensed practical nurse documented the patient’s weight as 124 pounds. On 09/09/24 the registered nurse documented the patient’s weight as 130 pounds (6-pound weight gain between visits). On 09/18/24 the licensed practical nurse documented the patient’s weight as 125 pounds. On 09/24/24 the registered nurse documented the patient’s weight as 131.8 pounds (6.8-pound weight gain between visits). - On both occasions of increased weight as noted above the registered nurse failed to notify the physician. On 10/29/24 at 2:00 p.m. the above findings were reviewed with the Director of Patient Services/Administrator and Office/Operations Manager who acknowledged the findings and offered no additional information. On 10/29/24 at 2:00 p.m. the above findings were reviewed with the Director of Patient Services/Administrator and Office/Operations Manager who acknowledged the findings and offered no additional information. Failure to ensure the physician is notified regarding changes in the patient's condition has the potential for unmet patient needs.

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 a review of patient records and interviews with the Director of Patient Services/Administrator, Quality Manager/Clinical Manager and Rehabilitation Managers, it was determined in 1 of 19 records, (patient #1), the agency failed to ensure care was coordinated to meet the patient's needs. Evidence as follows: Home Visit Patient #4 was admitted to the agency on 06/26/24 with diagnoses that included type 2 diabetes, cellulitis of the left lower limb, right below the knee amputation, hypertensive heart, disease and heart failure. The agency's Plan of Care dated 08/25/24-10/23/24 included orders for: - assessment and wound care to the left lower leg by skilled nursing 2 times weekly - "Bathe: may shower if LLE dressing covered with water resistant dressing." - Vascular: Educate patient / caregiver: Application of A-E (anti-embolic) stockings, on in a.m., off at HS (bedtime). The patient resided in an assisted living facility and was unable to perform wound care independently. The agency nurse was the only person able to change the dressing 2 times weekly. On 07/23/24, the skilled nurse visited the patient and documented, "patient reports [they] have not taken a shower in a while in which RN encouraged patient to shower to stay clean and prevent any skin breakdown and infection." There was no evidence the nurse coordinated with the facilty staff to determine if the patient had a plan for bathing with the leg dressing in place. On 10/25/24 at 9:15 a.m., the surveyor conducted an observational home visit with the licensed practical nurse. During the visit the patient stated, "I haven't showered in 2 months." After the nurse visit, the surveyor remained and interviewed the patient. The patient stated they did miss showering and was capable of independent showering with the shower chair in the bathroom. The patient denied being provided instructions to cover the dressing for showers. The surveyor obtained the patient's aide care plan and medication administration record from the assisted living facility staff. The aide care plan for bathing included: - 1 time weekly on Friday - evening shift shower on Fridays The aide care plan failed to include: - instructions for bathing, including how to manage the dressing according to the Plan of Care with a waterproof dressing on the left lower extremity - instructions to assist patient to apply an anti-embolic stocking to the left leg in the a.m., and remove at bedtime or to temporarily hold the stocking due to the dressing On 11/01/24 at 10:45 a.m., the surveyor interviewed the case manager via phone regarding the plan for bathing the patient at the assisted living facility and the order to bathe with a waterproof dressing. The nurse expressed uncertainty how the patient currently bathed, stated the patient could be "resistant," but they would certainly discuss the issue with the facility nurse to develop a plan as soon as possible. The nurse failed to coordinate with the caregivers to develop a plan to ensure a plan for bathing. On 10/28/24 at 12:00 p.m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager and Rehabilitation Managers who acknowledged the findings and offered no additional information. Failure of the agency to coordinate care with the patient and all caregivers has the potential for unmet patient needs.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on a review of the agency's Quality Assessment Performance Improvement Program, meeting minutes for the past year, and interviews with the Director of Patient Services/Administrator and Quality Manager/Clinical Manager, it was determined that the scope of the program was inadequate to identify, analyze and track quality indicators necessary to assess the agency processes of care, services and operations. Evidence as follows: Based on a review of the agency’s Quality Assessment Performance Improvement Program, (QAPI) meeting minutes, interviews with the Director of Patient Services/Administrator and Clinical Manager/Quality Manager, it was determined that the scope of the program was inadequate to identify patient care issues which contributed to the extended survey. Evidence as follows: The QAPI Meeting minutes dated 02/22, 06/13, 07/25, 08/29, and 09/26/24 included audit results for multiple focused audits including: - diabetes - central line monitoring - drug regimen review - congestive heart failure - pain monitoring - wound assessment Wound assessment audits Wound assessment audit identified the percentage of wound patients in which: - wound measurements and photos were obtained weekly - wound care was performed as ordered - clinician provided education related to signs and symptoms of infection The July 2024 QAPI meeting minutes reported wound assessment audit results and “all measures look great and are in good standing.” The wound assessment audit failed to identify: - wounds were not being routinely assessed per policy by a registered nurse - wounds were not being assessed by a registered nurse following wound deterioration - licensed practical nurses were not routinely supervised by registered nurses per policy The QAPI reports failed to include summaries or analysis of the findings for: - comprehensive audits - rehospitalization audits - infection control including catheter-associated urinary tract infections On 10/29/24 at 12:45 p.m., the Quality Director/Clinical Manager was interviewed and reported: - Approximately 20 comprehensive audits were conducted monthly, and issues related to incomplete plan of care, goals that were not updated, and missing documentation were identified. - Audits for patients with an unplanned hospitalization are not routinely conducted. - Infection control is tracked by running a report in the electronic medical record and relies on clinicians to fill out a form when they are notified a patient was diagnosed with an infection. Failure to identify systemic issues within clinical records and potentially avoidable events contributed to negative outcomes and / or patient hospitalizations for patients 5, 9, 13, and 15.

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on a review of the agency’s Quality Assessment Performance Improvement Program and meeting minutes (02/22, 06/13, 07/25, 08/29, and 09/26/24), and interviews with the Director of Patient Services and Clinical Manager/Quality Manager, it was determined that the agency failed to track all adverse events, analyze their causes, and implement preventative actions, which contributed to the extended, condition level survey. Evidence as follows: The Quality Assessment Performance Improvement report failed to include summaries or analysis of all potentially avoidable event audits. On 10/28/24 at 1 p.m., during record review, the surveyor requested the potentially avoidable event audits conducted for patients #13 and #15. On 10/30/24 at 8:30 a. m., the Director of Patient Services/Administrator provided the surveyor the potentially avoidable event audit for patient #15 but reported that they were unable to locate the potentially avoidable audit for patient #13. The 05/2024 potentially avoidable event audit for patient #15 was due to the increase in pressure ulcers, and identified: - incomplete registered nurse assessment at the start of care - delayed registered nurse case manager visit following the start of care - the increase in pressure ulcers was preventable The potentially avoidable event audit failed to identify: - wounds were not being routinely assessed per policy by a registered nurse - wounds were not being assessed by a registered nurse following wound deterioration - licensed practical nurses were not routinely supervised by registered nurses per policy The potentially avoidable event audit for patient # 15 in May 2024 reflected the increase in pressure ulcers was avoidable and findings were reported to QAPI. The QAPI meeting minutes report “[Quality Manager/Clinical Manager name] presented the SHP Potentially Avoidable Events for the last 12 months” without a summary or analysis of the audit findings. On 10/29/24 at 12:45 p.m., the Quality Director/Clinical Manager was interviewed and reported: - issues related to excessive number of licensed practical nurse visits were identified in December 2023 - the agency implemented changes aimed to increase the number of registered nurses to visit patients, such as sending 2 managers back into the field, however, those nurses have since left the agency - schedulers were instructed to prioritize scheduling for case managers visits to occur within 7 days following the start of care, however, no education was done with schedulers about the scheduling of licensed practical nurse visits during the rest of the certification period Failure of the agency to track all adverse events, analyze their causes, and implement preventative actions have the potential to place patients at risk for negative outcomes.

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 7 observational home visits, review of agency policies and procedures, and interviews with the Director of Patient Services/Administrator, Quality Manager/Ckinical Manager and Rehabilitation Clinical Managers, it was determined during 1 of 7 visits (patients #1), the skilled nurse failed to follow accepted standards of infection control practices. Evidence as follows: Patient #1 was admitted to the agency on 05/03/24 with type 2 diabetes with foot ulcer, non- pressure ulcers of the right heel, and midfoot, chronic osteomyelits of the right foot. On 10/25/24 at 11:00 a.m., the surveyor conducted an observational home visit with the registered nurse and Clinical Manager. Upon entering the patient's home and care area, the nurse placed the supply bag directly onto the floor. The Clinical Manager stepped over to the bag and placed a barrier between the bag and the floor. On 10/28/24, the surveyor reviewed the agency's "Bag Technique" policy, revised 08/01/24 which included, "The shoulder strap supply bag is preferably placed on a clean, hard surface in the patient's home and always on a paper barrier." The nurse failed to ensure the principles of infection control and agency policy were followed when the bag was placed directly on the floor without a barrier. On 10/28/24 at 12:00 p.m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager and Rehabilitation Managers who acknowledged the findings and offered no additional information.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on reviews of clinical records, policies and procedures, interviews with agency staff including the Director of Patient Services/Administrator, Quality Manager/Clinical Manager and Rehabilitation Managers, it was determined that skilled professional services were not provided to all patients of the agency as evidenced by the failure to ensure: - that the home health agency ensured a registered nurse assessed and supervised the care provided by licensed practical nurses (see G 726) - patients were assessed by all disciplines (see G 706) - communication was completed with the physician (see G 718) - patients and caregivers were educated (see G 714) - rehabilitation assistants care was supervised by the appropriate physical or occupational therapist (see G 728) The cumulative effect of the systemic issues identified in Skilled Professional Services has been identified through lack of : - registered nurse assessment - multidisciplinary assessment - communication with all providers - coordination These resulted in negative outcomes for patients #1, 5,13, and 15, and the potential for negative outcomes for the agency patient population.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on a review of clinical records and interviews with the Director of Patient Services/Administrator, Quality Manager/Clinical Manager, and Rehabilitation Managers, it was determined in 1 of 19 records, (patient #16) the agency failed to provide ongoing interdisciplinary assessment to meet the needs of the patients. Evidence as follows: 1. Patient #16 was admitted to the agency on 03/07/24 with diagnoses that included essential tremor, radiculopathy, urinary tract infection, and spinal stenosis. This patient was selected from the internet Quality Improvement and Evaluation System (iQies) potentially avoidable events report dated 08/01/2023 through 07/31/2024 for development of urinary tract infection. The 03/07/24 – 05/05/24 Plan of Care included only orders for rehabilitation services including physical therapy/physical therapy assistant and occupational therapy. On 03/07/24 the Physical Therapist visited the patient for the admission assessment and documented the patient: - received home care services from the agency earlier this year, however, the patient only received 2 visits prior to being admitted to the hospital on 02/11/24 due to profound weakness and a urinary tract infection. - had generalized weakness, impaired balance, decreased endurance, deconditioning, and high risk for falls - needed assistance to dress, shower, toilet transfer, and toileting hygiene There was no evidence the physical therapist: - assessed genitourinary status - provided teaching on urinary tract infection prevention On 03/25/24, the Occupational Therapist visited the patient to conduct an evaluation and documented patient: - required supervision for shower safety but was toileting independently - reported difficulty with feeding themself due to hand tremors There was no evidence the occupational therapist: - assessed genitourinary status - provided teaching on urinary tract infection prevention The patient was seen by the physical therapist or physical therapy assistant on 03/07, 03/13, 03/15, 03/19, 03/21, 03/26, 03/28, 04/02, and 04/04/24 and occupational therapy on 03/25, 04/01, and 04/04/24 for routine rehabilitation visits. On 04/09/24, the physical therapy assistant visited the patient for a routine visit and documented the patient was placed on an antibiotic last week to treat a urinary tract infection and this caused a flare up of the patient’s irritable bowel syndrome The patient contacted the physician prior to the physical therapy assistant visit. The physician returned the call during the visit and directed the patient to: - stop taking the antibiotic - take “pepto,” which the patient reported they were unable to tolerate - visit the walk-in clinic if the problems persisted past Friday There was no evidence the physical therapy assistant notified the physical therapist or the occupational therapist. On 04/10/24, the occupational therapist visited the patient for a routine visit and documented the patient: - completed a course of antibiotic therapy for urinary tract infection and, contradictorily, the patient stopped antibiotic due to diarrhea as instructed by physician since the last visit - had a general aching in their abdomen since the diarrhea - felt overall slightly weaker due to the antibiotic and lack of appetite, but was able to maintain independent with bathing, dressing, and toileting. The patient was discharged from the agency to outpatient rehabilitation services the following week on 04/12/24. There was no evidence throughout the home care episode that the physical or occupational therapist: - assessed the patient’s genitourinary status - taught urinary tract infection prevention measures prior to or following the urinary tract infection diagnosis. On 10/28/24 at 12 p. m., the findings were reviewed with the Vice President, the Director of Patient Services/Administrator, Quality Manager/Clinical Manager, and the Rehabilitation Managers. On 10/29/24 at 1:20 p. m., the Director of Patient Services/Administrator confirmed there was no care coordination between the physical therapist, occupational therapist, or physician.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on a review of clinical records and interviews with the Director of Patient Services/Administrator, Quality Manager/Clinical Manager, and Rehabilitation Managers, it was determined in 4 of 19 records, (patients #3, 7, 9, and 10) the agency failed to educate patients and caregivers. Evidence as follows: 4. Patient #9 was admitted to the agency on 06/03/24 with diagnoses of Multiple Sclerosis, a stage 4 pressure injury on their buttocks, a colostomy, and neuromuscular dysfunction of the bladder. According to the Plan of Care dated 08/02/24-9/30/24, the client would require wound care 2 times per week, with the caregiver providing wound care the other day. There was also an order for the caregiver to perform wound care in the absence of a nurse when competence was verified and documented. The Plan of Care documented the “patient/caregiver will demonstrate independence with wound care by ___”. There was no evidence of documentation the caregiver ever demonstrated wound care. According to the care coordination note regarding the case on 09/27/24, the caregiver had complained about the wound care orders. This was resolved by having a PTWC specialist (Physical Therapist Wound Care) evaluate and make suggestions for a new wound dressing. The 09/20/24 visit note shows that the Physical Therapist Wound Care specialist visited the patient with the skilled nurse to provide wound care and suggestions. The wound care order was changed, and the Physical Therapist Wound Care specialist was to contact the doctor and update the plan of care. They had planned on the caregiver being present for the visit, but they were not there. Written instructions were left for the caregiver along with a request for them to be present at the next visit. At the next visit on 09/25/24, the caregiver to be present was again not present. The skilled nurse left a request with the patient the caregiver call with any questions or concerns. The caregiver was never educated in person regarding wound care orders and never demonstrated they were able to perform the wound care as ordered. On 10/29/24 at 2:00 p.m. the findings were reviewed with the Director of Patient Services/Administrator and Office/Operations Manager who acknowledged the findings and offered no additional information. 1.Patient #3 was admitted to the agency on 09/24/24 for wound care secondary to a left lower leg fasciotomy (surgery to release pressure) due to thrombectomy (blood clot removal). On 10/01/24 the skilled nurse documented they spoke with the patient who informed them that their wound vac and been removed and they now had new wound care orders. The 10/02/24 new wound care orders included: - cleanse area with normal saline, apply Xeroform, gauze, and wrap with kerlix and an ace bandage - skilled nurse to perform 3 x week and as needed for drainage - educate caregiver wound care to complete as needed On 10/02/24 the skilled nurse visited the patient and documented “educated CG [caregiver] on wound care-to complete PRN [as needed].” The skilled nurse failed to include what specifically the caregiver was educated on in regards to wound care including if the patient caregiver was able to perform a return demonstration or verbalize the new wound care orders. On 10/28/24 at 12:00 p.m. the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager, and Rehabilitation Managers who acknowledged the findings and offered no additional information. 2.Patient #7 was admitted to the agency on 09/18/24 with diagnoses of bladder cancer, type II diabetes, hypertensive chronic kidney disease, and left sided weakness due to cerebral infarction (stroke). On 10/11/24 the skilled nurse visited the patient and documented the patient was taking their blood pressure as recommended and it had been occasionally high during that week (blood pressure readings not documented), but average systolic (top number of a blood pressure) was 130. There was no evidence the skilled nurse assessed the ability of the patient/caregiver to check their blood pressure or provide education on what parameters should be reported to the agency and/or physician. On 10/28/24 at 12:00 p.m. the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager, and Rehabilitation Managers who acknowledged the findings and offered no additional information. 3.Patient #10 was admitted to the agency on 08/30/24 with diagnoses of chronic obstructive pulmonary disease, acute and chronic respiratory failure, pulmonary hypertension, heart failure, and hypertensive heart disease. The 08/29/24 hospital discharge instructions included: - cardiac diet (low sodium) and fluid restriction ( The 08/30/24-10/28/24 Plan of Care included: - cardiac diet with 1500mL fluid restriction daily - educate patient/caregiver on diet/hydration to promote proper management of disease process There was no evidence the skilled nurse assessed the patient’s knowledge of or provided education regarding fluid restrictions, including how to measure and track the amount of fluid the patient consumes throughout the day. On 10/29/24 at 2:00 p.m. the findings were reviewed with the Director of Patient Services/Administrator and Office/Operations Manager who acknowledged the findings and offered no additional information.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on a review of patient records and interviews with the Director of Patient Services/Administrator, Quality Manager/Clinical Manager and Rehabilitation Managers, it was determined in 2 of 19 records, (patients 3 and 4), the agency failed to communicate with the patient's health care provider related to the current plan of care. Evidence as follows: Patient #4 was admitted to the agency on 06/26/24 with diagnoses that included type 2 diabetes, cellulitis of the left lower limb, right below the knee amputation, hypertensive heart disease, and heart failure. The Plan of Care dated 06/26/24-08/24/24 included: Wound care: to left dorsal foot posterior area non-pressure wounds related to edema and atherosclerosis X 2, one medial and one lateral, 2 X weekly and as needed for soilage. Cleanse with wound cleanser / apply Xeroform / cover with dry gauze / ABD (large, cushioned dressing pad) and secure with Kerlix and stockinette and mild compression Ace wrap by skilled nurse. Vascular: Educate patient / caregiver: Application of A-E (anti-embolic) stockings, on in a.m., off at HS (bedtime). Congestive Heart Failure: - assess edema at each visit - notify MD if edema increases by +1 (baseline 2+ at start of care) On 06/24/24 the skilled nurse visited for the initial assessment and documented a 2+ edema level. On 06/28/24, the nurse visited and erroneously documented - dependent pedal edema to the right and left foot (patient has no right foot) - "BLE firm edema" (bilateral lower extremities) The 07/02/24 visit note included: - +1 ankle and calf edema (new edema level identified) Wound photo labeled left leg dorsal showed marked elastic indentation distal from the wound to the ankle. On 07/09/24, the nurse visited and failed to assess and document edema. Wound photo labeled left leg anterior medial showed marked imprints from Ace wrap and clothing, and photo labeled left dorsal showed deep imprints on calf, size of calf out of proportion to edematous foot. On 07/23/24 the nurse failed to assess and document edema. Wound photo showed imprints from Ace wrap. On 07/25/24 the nurse failed to assess and document edema. On 07/30/24, the nurse documented: - +1 pitting edema to right ankle On 08/05/24, the nurse documented: - left pedal edema - +1 left ankle and calf edema Wound photos showed indentations in the side of left calf and around ankle. On 08/08/24, the nurse failed to assess and document edema. Wound photos showed indentations in the side of left inner calf and shin. On 08/19/24, the nurse visited and failed to document edema. Wound photos showed left calf that appears dusky with deep imprints from dressing/Ace wrap. On 08/21/24 the nurse visited for recertification and documented LLE firm edema. The Plan of Care developed at the recertification visit dated 08/25-10/23/24 included: Wound care: to left lower leg, anterior and posterior, any weeping ulcer, 2 X weekly and as needed for soilage. Cleanse with wound cleanser / apply Xeroform / cover with 4x4 gauze / ABD (large, cushioned dressing pad) / Kerlix / Ace. Wound care to be completed by skilled nurse. Vascular: Educate patient / caregiver: Application of A-E (anti-embolic) stockings, on in a.m., off at HS (bedtime). Congestive Heart Failure: - assess edema at each visit - notify MD if edema increases by +1 (baseline 2+ at start of care) On 09/12/24 the nurse documented: - LLE firm edema - +1 left ankle pitting edema and +2 calf edema - contacted physician to request increase in nursing to 2 times/week for wound care and possible cellulitis. On 09/18, 09/20, 09/24, and 09/27/24, the nurse documented: - left dependent pedal edema - left ankle and calf 2+ edema Wound photo showed redness and indentation around calf. On 10/01/24 the nurse visited and failed to document edema. Wound photos showed marked indentations with blanched area. On 10/04 and 10/08/24, the nurse assessed and documented: - left dependent pedal edema - left ankle and calf 2+ edema The surveyor reviewed the wound photo which displays indentation around calf. On 10/11/24, the nurse assessed and documented: - left dependent pedal edema - left ankle and calf 1+ edema On 10/14/24, the nurse assessed and documented: - no edema Wound photos showed marked indentations surrounding calf. On 10/25/24, the surveyor conducted an observational home visit with the nurse. Upon removal of the Ace wrap and dressing, the foot below the Ace wrap was edematous with deep indentations on the calf. The agency failed to ensure all physicians and other health care practitioners involved in the Plan of Care communicated to discuss: - the negative effects of the Ace wrap level of compression, order for A-E stockings that had been omitted in lieu of the Ace wrap - increase in edema from 1+ to 2+ on 0-9/12/24 The Clinical Manager and Quality Team failed to review the visit notes and photographs to ensure the plan of care for edema reporting was followed, and to address the negative effects of excess prolonged compression in a circulatory compromised patient. On 10/28/24 at 12:00 p.m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager and Rehabilitation Managers who acknowledged the findings and offered no additional information. Home Visit Patient #1 was admitted to the agency on 05/03/24 with diagnoses including type 2 diabetes with foot ulcer, non- pressure ulcer of right heel and midfoot with necrosis of bone. The patient’s 09/06/24 Plan of Care included to notify the physician of blood glucose less than 70 or greater than 350. During the home visit, the patient told the skilled nurse their blood sugar the day before had been 67. The skilled nurse asked the patient if they re-checked their blood sugar that day, which they said they had and it went up after they ate. The skilled nurse reminded the patient they should be calling the doctor if their blood sugar is below 70. The skilled nurse failed to call and inform the physician the patient had a blood glucose below 70. On 10/28/24 at 12:00 p.m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager and Rehabilitation Managers who acknowledged the findings and offered no additional information. Patient #3 was admitted to the agency on 09/24/24 for wound care secondary to a left lower leg fasciotomy (surgery to release pressure) due to thrombectomy (blood clot removal). The 09/24/24-11/22/24 Plan of Care included an order for: - gabapentin 300mg; 2 caps daily at bedtime for nerve pain- wound care 3 x per week On 10/18/24, 10/21/24, and 10/23/24 the skilled nurse visited the patient and documented the patient was taking the gabapentin an hour before the visit because it helped with the pain and discomfort of the wound care. There was no evidence the skilled nurse notified the physician the patient was taking the gabapentin differently than how it was ordered and to determine if a change in the plan of care was needed. On 10/28/24 at 12:00 p.m. the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager, and Rehabilitation Managers who acknowledged the findings and offered no additional information. Patient #10 was admitted to the agency on 08/30/24 with diagnoses of chronic obstructive pulmonary disease, acute and chronic respiratory failure, pulmonary hypertension, heart failure, and hypertensive heart disease. The 08/30/24-10/28/24 Plan of Care included for the multidisciplinary team which consisted of the skilled nurse, physical therapist, and respiratory therapist, to perform:Edema - edema assessment at each visit and to notify the physician if edema increased by +1 - “baseline edema is none” Weights - weight checks at each visit and to notify the physician of a 2 pound weight gain or loss in 24 hours or a 5 pound weight gain or loss in one week - “baseline weight is __need to obtain baseline weight at next SNV [skilled nurse visit]” The skilled professionals failed to notify the physician for:Edema - +1 increase between the 09/06/24 (no edema) and 09/09/24 nursing visit (+1 edema) - +1 increase between the 09/18/24 (no edema) and the 09/24/24 nursing visit (+1 edema) - 09/04/24, 09/09/24, 09/11/24, 09/16/24, 09/19/24, 09/25/24, and 10/14/24 edema not assessed by physical therapist - 09/11/24, 09/17/24, 09/24/24, 10/01/24, and 10/07/24 edema not assessed by respiratory therapist Weights - 08/30/24 (start of care visit) no weight obtained, patient refused per skilled nurse - 09/03/24 no weight obtained by skilled nurse - 6 pound increase between the 09/06/24 (124 pounds) and 09/09/24 (130 pounds) nursing visits - 6.8 pound increase between the 09/18/24 (125 pounds) and the 09/24/24 (131.8 pounds) pounds nursing visits - 5.4 pound increase between the 10/01/24 (124.8 pounds) and the 10/11/24 (130.2 pounds) respiratory visits - 09/09/24, 09/11/24, 09/16/24, 09/19/24, 09/25/24, and 10/14/24 no weight obtained by physical therapist - 09/11/24, 09/17/24, and 09/24/24 no weight obtained by the respiratory therapist On 10/29/24 at 2:00 p.m. the above findings were reviewed with the Director of Patient Services/Administrator and Office/Operations Manager who acknowledged the findings and offered no additional information. Patient #11 was admitted to the agency on 06/27/24 for wound care to a stage 3 sacral pressure ulcer. Additional diagnoses include lower extremity lymphedema (swelling due to blocked lymphatic vessels), congestive heart failure, and Factor V Leiden (increased blood clotting). Wound CareThe 06/27/24-08/25/24 and 08/26/24-10/24/24 Plan of Care included to assess the patient’s wound. The skilled nurse failed to notify the physician after the following wound assessments documented a negative change: - 07/19/24 the wound had purulent (puss) drainage, the previous visit (07/16/24) drainage was serosanguineous (blood and serum) - 07/26/24 the wound had purulent drainage, the previous visit (07/23/24) drainage was serosanguineous - 07/30/24 the wound still had purulent drainage - +1.8 cm increase in undermining from 08/06/24 (1 cm) to 08/13/24 (2.8 cm) - 09/06/24 the wound drainage had a foul odor and the wound bed was macerated, the previous visit (09/03/24) drainage had no odor and the wound bed was pink - 09/09/24 the wound drainage still had a foul odor and the wound bed was still macerated - 09/11/24, 09/13/24, 09/16/24 the wound bed was still macerated but the wound drainage no longer had a foul odor - 09/18/24 the wound had purulent drainage which had a foul odor and the wound bed was macerated - 09/27/24 the wound had purulent drainage and the wound bed was macerated, the previous visit (09/25/24) the drainage was serosanguineous and the wound bed was pink Lymphedema The 06/27/24 Plan of Care included: - assess edema at each visit and notify the physician if edema increases by +1 On 06/27/24, 07/02/24, and 07/05/24 the skilled nurse documented the patient had no edema/lymphedema to the right lower extremity. On 07/09/24 the skilled nurse documented the patient had bilateral lower extremity edema/lymphedema, left side larger. On 08/20/24 the skilled nurse documented the patient had no edema/lymphedema to the right lower extremity. On 08/22/24 the skilled nurse documented the patient had bilateral lower extremity edema/lymphedema. The skilled nurse failed to notify the physician of the new edema/lymphedema to the right lower extremity. WeightsThe 06/27/24 and 08/26/24 Plan of Care included: - obtain weight at each visit and notify the physician of a 2 pound weight gain or loss in 24 hours or 5 pound weight gain or loss in one week - “baseline weight is ___per client 174lb declined weight at soc [start of care] visit” The skilled nurse failed to notify the physician for: - 09/02/24, 07/05/24, 07/09/24, 07/12/24, 07/16/24, 07/19/24, 07/23/24, 07/26/24, and 07/30/24 no weight obtained by skilled nurse - 08/02/24 weight documented as 204 which will be used as a baseline weight - 08/30/24, 09/06/24, 09/25/24, 10/02/24, and 10/09/24 no weight documented by skilled nurse On 10/29/24 at 2:00 p.m. the findings were reviewed with the Director of Patient Services/Administrator and Office/Operations Manager who acknowledged the findings and offered no additional information.

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on a review of patient records and interviews with the Director of Patient Services/Administrator, Quality Manager/Clinical Manager and Rehabilitation Managers, it was determined in 4 of 19 records (patients #5, 9, 13, and 15), the agency failed to supervise, monitor, and evaluate the provision of treatment by the Licensed Practical Nurses. Evidence as follows: 1. Patient #15 was admitted to the agency on 03/27/24 with diagnoses that included Lewy body dementia, Parkinson’s disease, and cellulitis on right hand due to a dog bite. This patient was selected from the internet Quality Improvement and Evaluation System (iQies) potentially avoidable events report dated 08/01/2023 through 07/31/2024 for an increase in the number of pressure ulcers during the home care episode. Licensed Practical Nurse Visits On 03/27/24 the registered nurse visited for the start of care assessment and documented the patient: - had a traumatic wound on the right hand from a dog bite - was at risk for pressure ulcers but did not have any pressure ulcers - caregiver demonstrated wound care The 03/27/24 – 05/25/24 Plan of Care included the following orders: - wound care to right hand trauma wound from dog bite 2 times a day – soak in warm water with antibacterial soap for 5-10 minutes and then rinse and pat dry, xeroform to wound bed, rolled gauze, ace wrap by caregiver with skilled nurse oversight (start date 03/27/24) - nursing frequency 1 time per week for 4 weeks and then every other week until the end of the 60-day certification period (start date 03/27/24) On 04/02/24, a licensed practical nurse (LPN) visited patient for the weekly visit and documented: - opened blister on left heel, without drainage or signs and symptoms of infection; caregiver was keeping this wound covered but did not document what caregiver used to cover the dressing - physician and case manager were notified On 04/09/24, an LPN visited the patient for the weekly visit and documented: - the patient had a new stage 2 pressure ulcer to the heel that was covered in lint from sock and pet hair - physician and caregiver managed notified of the changes and nurse requested orders for new wound care and increased nursing frequency The agency failed to send a registered nurse to assess the new wound or evaluate the plan of care. The licensed practical nurse visits were made on the following days: 04/11, 04/15, 04/17, and 04/19/24 On 04/22/24, 13 days after the new wound was identified and over 3 weeks since the last RN visit, the RN visited and documented: - the left heel pressure ulcer measured 4.8 cm length, 5.5 cm width, and 0.3 cm depth with macerated wound edges, wound was unstageable due to presence of slough and eschar (necrotic tissue) partially covering the wound base. On 04/26/24 an LPN visited the patient and identified a new pressure ulcer on the buttocks On 04/29/24 an RN visited for wound assessment and documented: - buttocks wound described as excoriation - left heel pressure ulcer measured at 4.5 cm length, 5.5 cm wide, and 0.3 cm deep The licensed practical nurses visited on the following days: 05/01, 05/03, 05/06, 05/08, 05/10, 05/13, 05/17, and 05/20/24 On 05/24/24, 4 weeks after the previous registered nurse visit, the RN visited the patient for the recertification visit and documented the following: - buttock excoriation measured at 10 cm length, 14 cm wide, and 0.1 cm depth - left heel pressure ulcer measured at 3.5 cm, 4.5 cm, and 0.5 depth On 06/10/24, the RN visited the patient and decreased frequency to once a week due to decreasing wound measurements. Wound measurements included: - heel wound 2 cm length, 3.5 cm width, and 1 cm depth - buttocks red and excoriated (no measurements documented) On 06/21/24, the next visit was made by an LPN (11 days after the previous visit) who documented: - heel wound 3 cm length, 3 cm width, and 0.1 cm depth - buttocks pressure ulcer 2 cm length, 3 cm width, and 0 cm depth with wound base covered in black necrotic tissue On 06/24/24, the RN visited for wound assessment and maintained the weekly nursing visit schedule. The patient was discharged to hospice on 07/08/24 with 2 pressure ulcers. As identified in New York Education Law, section 6902 of Article 139, Licensed Practical Nurses in New York State do not have assessment privileges; they may not interpret patient clinical data or act independently on such data; they may not triage; they may not create, initiate, or alter nursing care goals or establish nursing care plans. Licensed Practical Nurses function by law in a dependent role at the direction of the RN or other select authorized health care providers. Performing nursing assessments and corresponding progress notes are non-permissible tasks. The Agency Policy, “Role of the Licensed Practical Nurse” dated 06/06/22, revised and effective 09/04/24 included, "LPNs may not see a [Agency Name] more than 2 consecutive weeks without a RN case/clinical manager visit." The agency failed to schedule a RN for wound assessment following a change in condition or schedule RN visits as per their policy. On 10/29/24 at 2 p. m., the findings were reviewed with the Director of Patient Services and the Office Manager who acknowledged the findings and offered no additional information. 2. Patient #5 was admitted to the agency on 06/29/23 with diagnoses that included Type 2 diabetes, a diabetic ulcer to the left foot, osteomyelitis, and history of non-compliance. The 04/24/24-06/22/24 Plan of Care included the following orders: - wound care to the left foot surgical wound 3 times per week: clean with normal saline, betadine to edges of wound, acticoat 3 flex to wound base cover with hydrofera blue then drawtex, 4 x 4 gauze pad, abdominal pad, kerlex wrap, and Ace bandage to be completed by home care nurse or wound care center (start effective date 03/06/24) - nursing frequency of 2 times a week for 9 weeks with 3 as needed visits for falls, symptoms, or infection (start date 04/24/24 and end date 06/22/24) On 05/03/24 the registered nurse (RN) visited the patient for wound assessment and documented: - left lateral foot wound base 70% pink healthy tissue, 10% tannish slough (necrotic tissue), 20% yellow connective tissue with intact periwound without discoloration and moderate amount serosanguinous drainage at site. The LPNs visited and provided wound care on the following days: 05/08/24 (bloody drainage, MD notified & new wound care ordered) 05/10/24 (surrounding area macerated) 05/15/24 05/17/24 05/22/24 (wound edges white/hard, patient did not go to WCC as scheduled earlier this week & CM notified) 05/24/24 (surrounding white, slight callous and macerated; case manager notified) On 05/28/24 the patient was admitted to the hospital for treatment of an infection of the left foot diabetic ulcer requiring antibiotic therapy after presenting to the Emergency Room following a fall on the patio where the patient remained for 12 hours prior to activation of emergency management services. From 05/03 through 05/24/24, the RN failed to visit and assess the patient’s wound status and evaluate the plan of care prior to the patient’s re-admission to the hospital. The Agency Policy, “Role of the Licensed Practical Nurse” dated 06/06/22, revised and effective 09/04/24 included, "LPNs may not see a [Agency Name] more than 2 consecutive weeks without a RN case/clinical manager visit." On 10/28/24 at 12 p. m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager/Clinical Manager, and the Rehabilitation Managers. On 10/30/24 at XX:XX AM/PM, the additional findings related to scheduling of LPN visits were reviewed with (ADD TITLES HERE). 1. Patient #13 was admitted to the agency on 04/26/23 with diagnoses that included complication of internal fixation of bone, right lower leg, multiple fractures of right ribs, fall, Type 2 diabetes, and severe persistent asthma. This patient was selected from the internet Quality Improvement and Evaluation System (iQIES) potentially avoidable events report dated 08/01/2023 through 07/31/2024 and was identified as having received emergent care for hyperglycemia. Licensed Practical Nurse Visits - On 10/18/23, the registered nurse visited the patient for a resumption of care assessment following hospitalization for removal of right ankle hardware. The nurse the patient had previously developed osteomyelitis after a right ankle fracture that eventually required open reduction and internal fixation of the bones. - On 10/20/23, the registered nurse documented the dressing was soiled and ragged. The dressing was removed and assessed. Sutures were intact, however there was "scant drainage at the base of the medial suture line." - On 10/23/23, the registered nurse documented "requires continued education for co-morbidities. Pt requires 2x weekly wound care," and documented scant serosanguinous drainage to the wound. - On 10/25/23, a licensed practical nurse visited the patient and documented to the incision size and appearance, "clean, dry edges well approximated." - On 10/27/23, a licensed practical nurse visited and documented, "wound edges well approximated, no signs of infection." - On 10/30/23, a licensed practical nurse visited and documented, "dressing removed from right foot. Small amount of bloody drainage on ace wrap at lateral ankle. Upon removal, sutures remain in place at all 4 areas on right foot. Incision on right plantar foot is macerated and white. Upon cleaning, yellow purulent drainage noted from wound. Surgeon's office and case manager notified." - On 11/01/23, a licensed practical nurse visited and documented, "continues to have small amount of drainage, less maceration." - On 11/03/23, a licensed practical nurse visited and documented; sutures removed yesterday from right foot incisions. Edges well approximated, no drainage noted. - On 11/06/23, a licensed practical nurse visited and documented wound care completed, wound beds on right foot pink with a small amount of serosanguinous drainage. Case manager updated. - On 11/09/23, a licensed practical nurse visited and documented, wound measurements, surgical wound right heel, L 1cm x W 0.1cm x D 1 cm, wound care to right foot, small open area bottom of right foot. Despite the surgeon’s agreement to decrease the amount of dressing changes and visits if the incisions were monitored, 7 licensed practical nurse visits (22 days) occurred without wound assessment to monitor the incision between the RN assessment visit on 10/20/23 and the resumption of care RN visit 11/13/23. As identified in New York Education Law, section 6902 of Article 139, Licensed Practical Nurses in New York State do not have assessment privileges; they may not interpret patient clinical data or act independently on such data; they may not triage; they may not create, initiate, or alter nursing care goals or establish nursing care plans. Licensed Practical Nurses function by law in a dependent role at the direction of the RN or other select authorized health care providers. Performing nursing assessments and corresponding progress notes are non-permissible tasks. On 11/13/23, the nurse visited for a resumption of care after the patient was hospitalized with diagnosis of pancreatitis. Documentation included: - "pt's ankle wounds are healed well" - wound grid #1 - right heel surgical wound, open. Wound #1 L 1.0cm x W 0.1cm x D 0cm - narrative note, crack in bottom of R heel draining scant serous fluid. Cleansed and dry sterile dressing applied - SN service for dressing change 2x/week starting 11/15/23 - supervision visit for licensed practical nurse - On 11/16/24, a licensed practical nurse visited and documented right heel surgical wound pink with no drainage. Case manager updated. - On 11/20/23, a licensed practical nurse visited and documented, wound care completed, right plantar foot pink with small amount serosanguinous drainage. L 0.3cm x W 1cm x D 0.1cm. Pt going out of town for Thanksgiving. - On 11/27/23, a licensed practical nurse visited and documented, Wound #1 L 0.5cm x W 1cm x D 0cm, scant serosanguinous drainage. Wound #2 identified, another surgical wound opened; L 0.5cm x W 2 cm x D 0cm. Scant serosanguinous drainage. Wound on Right plantar foot red with a small amount serosanguinous drainage noted. Wound on Right ankle pink with a scant amount serous drainage. - On 11/29/23 the licensed practical nurse visited and documented, wound #1 L 1cm x W 0.4cm x D 0.5cm. Wound #2 not noted. Patient called this morning and stated dressing leaking. Upon removal of sock from R foot, moderate bloody drainage noted to be soaking through ace wrap. Dressing removed moderate bloody drainage noted along lateral aspect of foot. No open area noted at lateral aspect of foot. Pt does have open area on heel. While cleaning wound, did expel bloody drainage from wound opening. Wound had tunneling at 2-4 o'clock, position 2 cm. Called surgeon's office, requested orders to increase visits to 3xs/wk. and an order for iodoform packing strip in wound. Case manager updated on visit. - On 12/02/23 the licensed practical nurse visited and documented, blood sugar 386, rechecked during visit, reading HI. Range 200s-HI. Nurse walked into patient's new apartment; patient stated not feeling well. Heart rate 120s, hands shaky. Patient has no insulin in apartment at this time, says its at the old apartment and hasn't taken any since yesterday. Patient's [relative] says right foot is very swollen and is worried. Dressing removed; ankle is very swollen with drainage from small hole in ankle. None from heel wound. Ankle redressed. Patient sent via ambulance for emergent care. Surgeon and case manager notified. 7 visits (19 days) occurred between the RN visit on 11/13/23 and the patient’s emergent transfer to the hospital on 12/02/23 without wound assessment. It was discovered the patient again had osteomyelitis. The agency failed to ensure a registered nurse assessed the newly identified open area, wound #2 and assess (monitor) the incisions. The Agency Policy, Role of the Licensed Practical Nurse dated 06/06/22, revised and effective 09/04/24 included, "LPNs may not see a [Agency Name] more than 2 consecutive weeks without a RN case/clinical manager visit." The agency failed to ensure the patient was assessed by a registered nurse, and that licensed practical nurses were periodically supervised by a registered professional nurse. On 10/28/24 at 12:00 p.m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager and Rehabilitation Managers who acknowledged the findings and offered no additional information. 2. Patient #15 was admitted to the agency on 03/27/24 with diagnoses that included Lewy body dementia, Parkinson’s disease, and cellulitis on right hand due to a dog bite. This patient was selected from the internet Quality Improvement and Evaluation System (iQies) potentially avoidable events report dated 08/01/2023 through 07/31/2024 for an increase in the number of pressure ulcers during the home care episode. Licensed Practical Nurse Visits On 03/27/24 the registered nurse visited for the start of care assessment and documented the patient: - had a traumatic wound on the right hand from a dog bite - was at risk for pressure ulcers but did not have any pressure ulcers - had a caregiver who demonstrated wound care The 03/27/24 – 05/25/24 Plan of Care included the following orders: - wound care to right hand trauma wound from dog bite 2 times a day – soak in warm water with antibacterial soap for 5-10 minutes and then rinse and pat dry, xeroform to wound bed, rolled gauze, ace wrap by caregiver with skilled nurse oversight (start date 03/27/24) - nursing frequency 1 time per week for 4 weeks and then every other week until the end of the 60-day certification period (start date 03/27/24) On 04/02/24, a licensed practical nurse (LPN) visited patient for the weekly visit and documented: - opened blister on left heel, without drainage or signs and symptoms of infection; caregiver was keeping this wound covered (did not document what caregiver used to cover the dressing) - physician and case manager were notified On 04/09/24, an LPN visited the patient for the weekly visit and documented: - the patient had a new stage 2 pressure ulcer to the heel that was covered in lint from sock and pet hair - physician and case manager notified of the changes and nurse requested orders for new wound care and increased nursing frequency The agency failed to send a registered nurse to assess the new wound or evaluate the plan of care. The licensed practical nurse visits were made on the following days: 04/11, 04/15, 04/17, and 04/19/24 On 04/22/24, 13 days after the new wound was identified and over 3 weeks since the last RN visit, the RN visited and documented: - the left heel pressure ulcer measured 4.8 cm length, 5.5 cm width, and 0.3 cm depth with macerated wound edges, wound was unstageable due to presence of slough and eschar (necrotic tissue) partially covering the wound base. On 04/26/24 an LPN visited the patient and identified a new pressure ulcer on the buttocks On 04/29/24 an RN visited for wound assessment and documented: - buttocks wound described as excoriation - left heel pressure ulcer measured at 4.5 cm length, 5.5 cm wide, and 0.3 cm deep The licensed practical nurses visited on the following days: 05/01, 05/03, 05/06, 05/08, 05/10, 05/13, 05/17, and 05/20/24 On 05/24/24, 4 weeks after the previous registered nurse visit, the RN visited the patient for the recertification visit and documented the following: - buttock excoriation measured at 10 cm length, 14 cm wide, and 0.1 cm depth - left heel pressure ulcer measured at 3.5 cm, 4.5 cm, and 0.5 depth On 06/10/24, the RN visited the patient and decreased frequency to once a week due to decreasing wound measurements. Wound measurements included: - heel wound 2 cm length, 3.5 cm width, and 1 cm depth - buttocks red and excoriated (no measurements documented) On 06/21/24, the next visit was made by an LPN (11 days after the previous visit) who documented: - heel wound 3 cm length, 3 cm width, and 0.1 cm depth - buttocks pressure ulcer 2 cm length, 3 cm width, and 0 cm depth with wound base covered in black necrotic tissue On 06/24/24, the RN visited for wound assessment and maintained the weekly nursing visit schedule. The patient was discharged to hospice on 07/08/24 with 2 pressure ulcers. The Agency Policy, “Role of the Licensed Practical Nurse” dated 06/06/22, revised and effective 09/04/24 included, "LPNs may not see a [Agency Name] more than 2 consecutive weeks without a RN case/clinical manager visit." The agency failed to schedule a RN for wound assessment following a change in condition or schedule RN visits as per their policy. On 10/29/24 at 2 p. m., the findings were reviewed with the Director of Patient Services and the Office Manager who acknowledged the findings and offered no additional information. 3. Patient #5 was admitted to the agency on 06/29/23 with diagnoses that included Type 2 diabetes, a diabetic ulcer to the left foot, osteomyelitis, and history of non-compliance. The 04/24/24-06/22/24 Plan of Care included the following orders: - wound care to the left foot surgical wound 3 times per week: clean with normal saline, betadine to edges of wound, acticoat 3 flex to wound base cover with hydrofera blue then drawtex, 4 x 4 gauze pad, abdominal pad, kerlex wrap, and Ace bandage to be completed by home care nurse or wound care center (start effective date 03/06/24) - nursing frequency of 2 times a week for 9 weeks with 3 as needed visits for falls, symptoms, or infection (start date 04/24/24 and end date 06/22/24) On 05/03/24 the registered nurse (RN) visited the patient for wound assessment and documented: - left lateral foot wound base 70% pink healthy tissue, 10% tannish slough (necrotic tissue), 20% yellow connective tissue with intact periwound without discoloration and moderate amount serosanguinous drainage at site. The LPNs visited and provided wound care on the following days: 05/08/24 (bloody drainage, MD notified & new wound care ordered) 05/10/24 (surrounding area macerated) 05/15/24 05/17/24 05/22/24 (wound edges white/hard, patient did not go to WCC as scheduled earlier this week & CM notified) 05/24/24 (surrounding white, slight callous and macerated; case manager notified) On 05/28/24 the patient was admitted to the hospital for treatment of an infection of the left foot diabetic ulcer requiring antibiotic therapy after presenting to the Emergency Room following a fall on the patio where the patient remained for 12 hours prior to activation of emergency management services. From 05/03 through 05/24/24, the RN failed to visit and assess the patient’s wound status and evaluate the plan of care prior to the patient’s re-admission to the hospital. The Agency Policy, “Role of the Licensed Practical Nurse” dated 06/06/22, revised and effective 09/04/24 included, "LPNs may not see a [Agency Name] more than 2 consecutive weeks without a RN case/clinical manager visit." On 10/28/24 at 12 p. m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager/Clinical Manager, and the Rehabilitation Managers. On 10/30/24 at XX:XX AM/PM, the additional findings related to scheduling of LPN visits were reviewed with (ADD TITLES HERE). 4. Patient #9 was admitted to the agency on 06/03/24 with diagnoses of Multiple Sclerosis, a stage 4 pressure injury on their buttocks, a colostomy, and neuromuscular dysfunction of the bladder. The 10/01/24 to 11/29/24 Plan of Care included an order for - “Nursing Assessment Including: vital signs, cardio-respiratory, neuro, gastrointestinal, genitourinary, skin integrity, functional/ADL status, nutrition, hydration, mental status, psychosocial, home safety, fall risk, pain management, medication management”. - There was also an order for wound care to the right buttock stage 4 pressure injury 3 times per week. On 10/02/24, 10/04/24, 10/09/24, and 10/11/24, the Licensed Practical Nurse visited to perform wound care. On 10/11/24, the wound measured 9 cm x 12 cm x 0.2 cm. On 10/16/24 a registered nurse assessed the wound. It measured 9 cm x 15 cm x 0 cm and had moderate purulent drainage and a foul order. The patient also had a slight temperature of 99.7 degrees Fahrenheit. The skilled nurse called the primary doctor to report their finding concerning the wound. The registered nurse also suggested the patient may need to go to the emergency room to get antibiotics, which the patient refused. On 10/17/24, the primary doctor returned the nurse's phone call and stated they would call the patient with further instructions. On 10/18/24, a chat communication note documented the patient was inpatient due to the pressure ulcer of the buttocks. On 10/29/24 at 2:00 p.m. the findings were reviewed with the Director of Patient Services/Administrator and Office/Operations Manager who acknowledged the findings and offered no additional information. 1. Patient #13 was admitted to the agency on 04/26/23 with diagnoses that included complication of internal fixation of bone, right lower leg, multiple fractures of right ribs, fall, Type 2 diabetes, and severe persistent asthma. This patient was selected from the internet Quality Improvement and Evaluation System (iQIES) potentially avoidable events report dated 08/01/2023 through 07/31/2024 and was identified as having received emergent care for hyperglycemia. Licensed Practical Nurse Visits - On 10/18/23, the registered nurse visited the patient for a resumption of care assessment following hospitalization for removal of right ankle hardware. The nurse documented the patient had previously developed osteomyelitis after a right ankle fracture that eventually required open reduction and internal fixation of the bones. - On 10/20/23, the registered nurse documented the dressing was soiled and ragged. The dressing was removed and assessed. Sutures were intact, however there was "scant drainage at the base of the medial suture line." - On 10/23/23, the registered nurse documented "requires continued education for co-morbidities. Pt requires 2x weekly wound care," and documented scant serosanguinous drainage to the wound. - On 10/25/23, a licensed practical nurse visited the patient and documented to the incision size and appearance, "clean, dry edges well approximated." - On 10/27/23, a licensed practical nurse visited and documented, "wound edges well approximated, no signs of infection." - On 10/30/23, a licensed practical nurse visited and documented, "dressing removed from right foot. Small amount of bloody drainage on ace wrap at lateral ankle. Upon removal, sutures remain in place at all 4 areas on right foot. Incision on right plantar foot is macerated and white. Upon cleaning, yellow purulent drainage noted from wound. Surgeon's office and case manager notified." - On 11/01/23, a licensed practical nurse visited and documented, "continues to have small amount of drainage, less maceration." - On 11/03/23, a licensed practical nurse visited and documented; sutures removed yesterday from right foot incisions. Edges well approximated, no drainage noted. - On 11/06/23, a licensed practical nurse visited and documented wound care completed, wound beds on right foot pink with a small amount of serosanguinous drainage. Case manager updated. - On 11/09/23, a licensed practical nurse visited and documented, wound measurements, surgical wound right heel, L 1cm x W 0.1cm x D 1 cm, wound care to right foot, small open area bottom of right foot. On 11/13/23, the nurse visited for a resumption of care after the patient was hospitalized with diagnosis of pancreatitis. Documentation included: - "pt's ankle wounds are healed well" - wound grid #1 - right heel surgical wound, open. Wound #1 L 1.0cm x W 0.1cm x D 0cm - narrative note, crack in bottom of R heel draining scant serous fluid. Cleansed and dry sterile dressing applied - SN service for dressing change 2x/week starting 11/15/23 - supervision visit for licensed practical nurse - On 11/16/24, a licensed practical nurse visited and documented right heel surgical wound pink with no drainage. Case manager updated. - On 11/20/23, a licensed practical nurse visited and documented, wound care completed, right plantar foot pink with small amount serosanguinous drainage. L 0.3cm x W 1cm x D 0.1cm. Pt going out of town for Thanksgiving. - On 11/27/23, a licensed practical nurse visited and documented, Wound #1 L 0.5cm x W 1cm x D 0cm, scant serosanguinous drainage. Wound #2 identified, another surgical wound opened; L 0.5cm x W 2 cm x D 0cm. Scant serosanguinous drainage. Wound on Right plantar foot red with a small amount serosanguinous drainage noted. Wound on Right ankle pink with a scant amount serous drainage. - On 11/29/23 the licensed practical nurse visited and documented, wound #1 L 1cm x W 0.4cm x D 0.5cm. Wound #2 not noted. Patient called this morning and stated dressing leaking. Upon removal of sock from R foot, moderate bloody drainage noted to be soaking through ace wrap. Dressing removed moderate bloody drainage noted along lateral aspect of foot. No open area noted at lateral aspect of foot. Pt does have open area on heel. While cleaning wound, did expel bloody drainage from wound opening. Wound had tunneling at 2-4 o'clock, position 2 cm. Called surgeon's office, requested orders to increase visits to 3xs/wk. and an order for iodoform packing strip in wound. Case manager updated on visit. - On 12/02/23 the licensed practical nurse visited and documented, blood sugar 386, rechecked during visit, reading HI. Range 200s-HI. Nurse walked into patient's new apartment; patient stated not feeling well. Heart rate 120s, hands shaky. Patient has no insulin in apartment at this time, says its at the old apartment and hasn't taken any since yesterday. Patient's [relative] says right foot is very swollen and is worried. Dressing removed; ankle is very swollen with drainage from small hole in ankle. None from heel wound. Ankle redressed. Patient sent via ambulance for emergent care. Surgeon and case manager notified. Despite the surgeon’s agreement to decrease the amount of dressing changes and visits if the incisions were monitored, 7 licensed practical nurse visits (22 days) occurred without wound assessment to monitor the incision between the RN assessment visit on 10/20/23 and the resumption of care RN visit 11/13/23, and 7 visits (19 days) occurred between the RN visit on 11/13/23 and the patient’s emergent transfer to the hospital on 12/02/23. It was discovered the patient again had osteomyelitis. The agency failed to ensure a registered nurse assessed the newly identified open area, wound #2 and assess (monitor) the incisions. As identified in New York Education Law, section 6902 of Article 139, Licensed Practical Nurses in New York State do not have assessment privileges; they may not interpret patient clinical data or act independently on such data; they may not triage; they may not create, initiate, or alter nursing care goals or establish nursing care plans. Licensed Practical Nurses function by law in a dependent role at the direction of the RN or other select authorized health care providers. Performing nursing assessments and corresponding progress notes are non-permissible tasks. The Agency Policy, Role of the Licensed Practical Nurse dated 06/06/22, revised and effective 09/04/24 included, "LPNs may not see a [Agency Name] more than 2 consecutive weeks without a RN case/clinical manager visit." The agency failed to ensure the patient was assessed by a registered nurse, and that licensed practical nurses were periodically supervised by a registered professional nurse. On 10/28/24 at 12:00 p.m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager and Rehabilitation Managers who acknowledged the findings and offered no additional information. 2. Patient #15 was admitted to the agency on 03/27/24 with diagnoses that included Lewy body dementia, Parkinson’s disease, and cellulitis on right hand due to a dog bite. This patient was selected from the internet Quality Improvement and Evaluation System (iQies) potentially avoidable events report dated 08/01/2023 through 07/31/2024 for an increase in the number of pressure ulcers during the home care episode. Licensed Practical Nurse Visits On 03/27/24 the registered nurse visited for the start of care assessment and documented the patient: - had a traumatic wound on the right hand from a dog bite - was at risk for pressure ulcers but did not have any pressure ulcers - had a caregiver who demonstrated wound care The 03/27/24 – 05/25/24 Plan of Care included the following orders: - wound care to right hand trauma wound from dog bite 2 times a day – soak in warm water with antibacterial soap for 5-10 minutes and then rinse and pat dry, xeroform to wound bed, rolled gauze, ace wrap by caregiver with skilled nurse oversight (start date 03/27/24) - nursing frequency 1 time per week for 4 weeks and then every other week until the end of the 60-day certification period (start date 03/27/24) On 04/02/24, a licensed practical nurse (LPN) visited patient for the weekly visit and documented: - opened blister on left heel, without drainage or signs and symptoms of infection; caregiver was keeping this wound covered (did not document what caregiver used to cover the dressing) - physician and case manager were notified On 04/09/24, an LPN visited the patient for the weekly visit and documented: - the patient had a new stage 2 pressure ulcer to the heel that was covered in lint from sock and pet hair - physician and case manager notified of the changes and nurse requested orders for new wound care and increased nursing frequency The agency failed to send a registered nurse to assess the new wound or evaluate the plan of care. The licensed practical nurse visits were made on the following days: 04/11, 04/15, 04/17, and 04/19/24 On 04/22/24, 13 days after the new wound was identified and over 3 weeks since the last RN visit, the RN visited and documented: - the left heel pressure ulcer measured 4.8 cm length, 5.5 cm width, and 0.3 cm depth with macerated wound edges, wound was unstageable due to presence of slough and eschar (necrotic tissue) partially covering the wound base. On 04/26/24 an LPN visited the patient and identified a new pressure ulcer on the buttocks On 04/29/24 an RN visited for wound assessment and documented: - buttocks wound described as excoriation - left heel pressure ulcer measured at 4.5 cm length, 5.5 cm wide, and 0.3 cm deep The licensed practical nurses visited on the following days: 05/01, 05/03, 05/06, 05/08, 05/10, 05/13, 05/17, and 05/20/24 On 05/24/24, 4 weeks after the previous registered nurse visit, the RN visited the patient for the recertification visit and documented the following: - buttock excoriation measured at 10 cm length, 14 cm wide, and 0.1 cm depth - left heel pressure ulcer measured at 3.5 cm, 4.5 cm, and 0.5 depth On 06/10/24, the RN visited the patient and decreased frequency to once a week due to decreasing wound measurements. Wound measurements included: - heel wound 2 cm length, 3.5 cm width, and 1 cm depth - buttocks red and excoriated (no measurements documented) On 06/21/24, the next visit was made by an LPN (11 days after the previous visit) who documented: - heel wound 3 cm length, 3 cm width, and 0.1 cm depth - buttocks pressure ulcer 2 cm length, 3 cm width, and 0 cm depth with wound base covered in black necrotic tissue On 06/24/24, the RN visited for wound assessment and maintained the weekly nursing visit schedule. The patient was discharged to hospice on 07/08/24 with 2 pressure ulcers. The Agency Policy, “Role of the Licensed Practical Nurse” dated 06/06/22, revised and effective 09/04/24 included, "LPNs may not see a [Agency Name] more than 2 consecutive weeks without a RN case/clinical manager visit." The agency failed to schedule a RN for wound assessment following a change in condition or schedule RN visits as per their policy. On 10/29/24 at 2 p. m., the findings were reviewed with the Director of Patient Services and the Office Manager who acknowledged the findings and offered no additional information. 3. Patient #5 was admitted to the agency on 06/29/23 with diagnoses that included Type 2 diabetes, a diabetic ulcer to the left foot, osteomyelitis, and history of non-compliance. The 04/24/24-06/22/24 Plan of Care included the following orders: - wound care to the left foot surgical wound 3 times per week: clean with normal saline, betadine to edges of wound, acticoat 3 flex to wound base cover with hydrofera blue then drawtex, 4 x 4 gauze pad, abdominal pad, kerlex wrap, and Ace bandage to be completed by home care nurse or wound care center (start effective date 03/06/24) - nursing frequency of 2 times a week for 9 weeks with 3 as needed visits for falls, symptoms, or infection (start date 04/24/24 and end date 06/22/24) On 05/03/24 the registered nurse (RN) visited the patient for wound assessment and documented: - left lateral foot wound base 70% pink healthy tissue, 10% tannish slough (necrotic tissue), 20% yellow connective tissue with intact periwound without discoloration and moderate amount serosanguinous drainage at site. The LPNs visited and provided wound care on the following days: 05/08/24 (bloody drainage, MD notified & new wound care ordered) 05/10/24 (surrounding area macerated) 05/15/24 05/17/24 05/22/24 (wound edges white/hard, patient did not go to WCC as scheduled earlier this week & CM notified) 05/24/24 (surrounding white, slight callous and macerated; case manager notified) On 05/28/24 the patient was admitted to the hospital for treatment of an infection of the left foot diabetic ulcer requiring antibiotic therapy after presenting to the Emergency Room following a fall on the patio where the patient remained for 12 hours prior to activation of emergency management services. From 05/03 through 05/24/24, the RN failed to visit and assess the patient’s wound status and evaluate the plan of care prior to the patient’s re-admission to the hospital. The Agency Policy, “Role of the Licensed Practical Nurse” dated 06/06/22, revised and effective 09/04/24 included, "LPNs may not see a [Agency Name] more than 2 consecutive weeks without a RN case/clinical manager visit." On 10/28/24 at 12 p. m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager/Clinical Manager, and the Rehabilitation Managers. On 10/30/24 at XX:XX AM/PM, the additional findings related to scheduling of LPN visits were reviewed with (ADD TITLES HERE). 4. Patient #9 was admitted to the agency on 06/03/24 with diagnoses of multiple sclerosis, a stage 4 pressure injury on their buttocks, a colostomy, and neuromuscular dysfunction of the bladder. The 10/01/24 to 11/29/24 Plan of Care included an order for - “Nursing Assessment Including: vital signs, cardio-respiratory, neuro, gastrointestinal, genitourinary, skin integrity, functional/ADL status, nutrition, hydration, mental status, psychosocial, home safety, fall risk, pain management, medication management”. - There was also an order for wound care to the right buttock stage 4 pressure injury 3 times per week. On 10/02/24, 10/04/24, 10/09/24, and 10/11/24, the Licensed Practical Nurse visited to perform wound care. On 10/11/24, the wound measured 9 cm x 12 cm x 0.2 cm. On 10/16/24 a registered nurse assessed the wound. It measured 9 cm x 15 cm x 0 cm and had moderate purulent drainage and a foul order. The patient also had a slight temperature of 99.7 degrees Fahrenheit. The registered nurse called the primary doctor to report their finding concerning the wound. The registered nurse also suggested the patient may need to go to the emergency room to get antibiotics, which the patient refused. On 10/17/24, the primary doctor returned the nurse's phone call and stated they would call the patient with further instructions. On 10/18/24, a chat communication note documented the patient was inpatient due to the pressure ulcer of the buttocks. On 10/29/24 at 2:00 p.m. the findings were reviewed with the Director of Patient Services/Administrator and Office/Operations Manager who acknowledged the findings and offered no additional information. Failure to of the agency staff to ensure a registered nurse performs comprehensive assessment and supervises licensed practical nurses has resulted in unmet patient needs and negative outcomes for patients #9, 5, 13, and 15, and potential for negative outcomes in the patient population.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on review of clinical records, and interviews with the Director of Patient Services/Administrator, Quality Manager/Clinical manager, and Rehabilitation Managers, it was determined in 3 of 4 of records for patients receiving home health aide services (patients #2, 6, and 12) the skilled nurse failed to develop complete and accurate aide written instructions. Evidence as follows: 1. Patient #12 was admitted to the agency on 02/27/24 with diagnoses that included urinary tract infection, spinal muscular atrophy, severe protein-calorie malnutrition, and hypertensive chronic kidney disease. The 02/27/24-04/26/24 Plan of Care included an order for home health aide 2 times a week for 8 weeks starting 03/03/24. The 02/28/24 Home Health Aide Plan of Care included: - the patient had a suprapubic catheter and ileostomy - order to shower using shower chair at each visit The Home Health Aide Plan of Care failed to include: - instructions on showering with suprapubic catheter and ileostomy On 10/29/24 at 2 p. m., the findings were reviewed with the Director of Patient Services and Office Manager who acknowledged the findings and offered no additional information. 2. Patient # 6 was admitted to the agency on 08/06/24 with diagnoses that included prostate cancer, benign prostatic hyperplasia, hypertension, and chronic kidney disease. The 10/01/24 Home Health Aide Plan of Care included the following to be done at each visit: - bath in chair - complete bed bath - shower using a shower chair - report foley (an internal catheter used to drain bladder) dislodgement, leaking, no output - external catheter care - take temperature - obtain date of last bowel movement - pain rating The Care Plan failed to: - instruct the aide on when the patient should be bathed in chair, in bed, or in the shower - provide clear information on type of catheter (indwelling versus external) On 10/28/24 at 12 p. m., the findings were reviewed with the Vice President, Director of Patient Services/Administrator, Quality Manager/Clinical Manager, and the Rehabilitation Managers who acknowledged the findings and offered no additional information. Patient #2 was admitted to the agency on 8/16/24 with diagnoses that include spinal muscular atrophy, Farber disease, seizures, and g-tube dependency, and tracheostomy. On 10/10/24 the skilled nurse visited the patient for recertification. The nurse contacted the pediatric physician to obtain orders for home health aide services twice a week. The 10/10/24 Home Health Aide Care Plan had the following checked for bathing: - bed: bed bath or Rifton hygiene chair - shower The aide Care Plan failed to: - specify the frequency bathing should be completed - specify when the patient should receive a bed bath versus a bath in the hygiene chair versus a shower The supervising nurse failed to provide clear instructions to the aide on when and how the patient should be bathed. On 10/28/24 at 12:00 p.m., the findings were reviewed with the Vice President, Director of Patient Services, Quality Manager and Rehabilitation Managers who acknowledged the findings and offered no additional information.

This Statement of Deficiencies report is the result of an extended recertification survey conducted 11/30/21 - 01/04/22. The following information was reviewed during the survey: the agency's emergency preparedness policies and procedures, emergency drills, communication plan, the emergency patient roster and current listing of agency staff. Interviews were conducted with the Administrator, Director of Patient Services and Safety Coordinator. No deficiencies were cited.

The following statement of deficiencies represents the results of an extended recertification survey of Lourdes at Home Certified Home Health Agency conducted on 11/30/21 to 01/04/22. Patient Census as of 11/30/21 was 398. A standard re-certification survey of the Certified Home Health Agency (CHHA) was initiated on 11/30/21. Deficiencies were identified within Level 1 standards in 484.55 Comprehensive Assessments of Patients and 484.60 Plan of Care, as a result the survey was expanded to partial extended. On 12/03/21, significant findings were identified within the Conditions of Participation 484.55 Comprehensive Assessments of Patients and 484.60 Plan of Care, resulting in further expansion of the survey and review of related Conditions of Participation including 484.65 Quality Assessment Performance Improvement (QAPI), 484.70 Infection Control, and 414.102 Emergency Preparedness. The survey consisted of a review of 20 clinical records including 5 discharge records, 14 personnel records for professional and paraprofessional personnel, one contract staff, and 7 observational home visits. The survey included a review of pertinent policies and procedures, Quality Improvement and Governing Body meeting minutes for the past 12 months, the agency's Admission Packet, Emergency Preparedness Plan, and Complaint and On-Call logs. Pre-survey activities completed on 11/24/21 included review of the agency's Health Commerce System account, Home Care Worker Registry, Criminal History Record Check, and Internet Quality Improvement and Evaluation System (iQIES) reports for the period 08/2020 to 07/2021, and the agency's compliance with submission of statistical reports and emergency drills. The Administrator, Director of Patient Services, Safety Coordinator, Director of Quality, Home Care Manager, and agency staff were interviewed throughout the survey. Findings were reviewed at the exit conference on 01/04/22. As a result of the extended survey, deficiencies were identified at condition level in: 484.55 Comprehensive Assessment of Patients 484.60 Care Planning, Coordination, Quality of Care 484.65 Quality Assessment/Performance Improvement Federal deficiencies cited: G 526 Content of the Comprehensive Assessment; G 536 A review of all current medications; G 548 Within 48 hours of patient’s return; G 574 Plan of care must include the following; G 578 Conformance with physician’s orders; G 590 Promptly alert relevant physician of changes; G 606 Integrate all services; G 642 Program scope; G 654 Track adverse patient events; G 682 Prevention; G 798 Home Health Aide assignment and duties. State deficiency: J 1276 Governing authority.

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 Administrator, Director of Patient Services, Safety Coordinator, Director of Quality and Home Care Manager, it was determined this condition was not met as evidenced by: Failure to ensure comprehensive assessments were complete and accurately identified the current and ongoing needs of the patient. See G 526. Failure to ensure comprehensive medication reviews were conducted. See G 536. Failure to ensure timely assessment of patient's needs at the resumption of care. See G 548. The cumulative effect of these systemic issues related to the performance of comprehensive assessments resulted in potentially life-threatening consequences for Patient # 3, and the potential for negative outcomes for the agency's patient population.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on a review of clinical records, and interviews with the Administrator, Director of Patient Services (DPS), Safety Coordinator, Director of Quality, Home Care Manager and agency staff it was determined for 8 of 18 records (Patients # 1, 3, 4, 7, 10, 12, 15, and 18), the agency failed to ensure comprehensive assessments were of sufficient scope to ensure all patient needs were identified. Evidence was as follows: Patient #1 was admitted to the agency on 04/29/21 with diagnoses of Parkinson’s disease, dysphagia, anxiety, depression, sleep apnea, and urinary retention. The 04/22/21 physician referral noted the patient used a thickener for issues with swallowing liquids, and the patient had been very depressed due to rapid worsening of condition. The patient was noted to have urinary incontinence and retention and was performing catheterizations up to 3 times daily. A 04/23/21 sleep specialist note revealed the patient had used continuous positive airway pressure (CPAP) for many years and had recently complained of episodes of stridor both during the day and at night. The plan was to switch to bi-level positive airway pressure (BiPAP) and possibly a non-invasive ventilator (Trilogy) device due to the neuromuscular disorder. On 04/29/21 the physical therapist (PT) performed the initial assessment and failed to assess the following: - the PT documented the patient was incontinent of urine and failed to assess the use or presence of a catheter. - the PT failed to assess respiratory status including types of respiratory treatments in use including BiPap. - the PT failed to assess the patient's diet modifications in use such as thickener. On 12/06/21 at 3:00 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. Patient #7 was admitted to the agency on 10/20/21 with diagnoses of stage 3 pressure ulcer to the upper back, history of fractured hip, atrial fibrillation, and severe aortic stenosis. The 10/18/21 provider note identified the patient as having edema to lower extremities and recommended support stockings, the caregiver was using barrier cream for chafing in the perineal area. An attached message identified the family as limited in knowledge and using a mechanical (Hoyer) lift they did not feel very confident with. On 10/20/21 the registered nurse (RN) documented in the start of care assessment the patient had a stage 3 pressure ulcer to the upper back measuring 3.4cm long x2.5cm wide x0.2cm depth. The patient was incontinent and used depends. There was no assessment use of the barrier cream for redness of the peri-area related to incontinence. The RN documented the patient had no edema at the time of the assessment, but by the end of the day feet and ankles had some swelling. There was no assessment of the use of support stockings. The RN documented the presence of the Hoyer lift and wheelchair, however there was no assessment of the caregiver ability to transfer the patient using the Hoyer. On 12/06/21 at 3:00 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. Patient # 10 was admitted to the agency on 09/22/21 with diagnoses of stroke with hemiparesis, brain tumor, epilepsy, dysphagia, and lupus. The 08/26/21 referral revealed the patient had history of seizures which were hard to control with Phenobarbital 97.2 mg at bedtime and 64.8 each morning with instructions to never change the medication. On 09/22/21 the physical therapist (PT) performed the start of care assessment and failed to assess seizure history including the date of the last seizure and type of seizures. The history of seizures was not selected in the assessment. On 12/06/21 at 3:00 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. Patient #12 was admitted to the agency on 11/17/21 with diagnoses gastrointestinal bleeding, recent urinary tract infection, juvenile rheumatoid arthritis, Crohn’s disease, irritable bowel disease, malabsorption with use of total parenteral nutrition, history of bowel and liver transplant and neurogenic bladder. On 11/17/21 the RN performed the start of care assessment and documented the patient had chronic daily generalized pain at a level of 5 on a scale of 1 to 10, relieved with medications and relaxation. The medication list included Gabapentin 300 mg three times daily, Tylenol 650 mg every 4 hours as needed for pain to not exceed 3 grams per day, and hydromorphone 8 mg as needed for pain maximum daily dose 48 mg. The RN failed to assess what medications the patient was taking for pain and the frequency of medication use. The RN documented a Foley catheter instead of a suprapubic catheter and failed to assess the suprapubic site including site care and if there was a dressing to the area. The RN documented the patient had a Hickman catheter to the R chest and failed to assess the site including the presence of a dressing to the area. On 12/06/21 at 3:00 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. Failure to ensure comprehensive assessments are complete and accurately reflect the patient's status resulted in negative outcomes for Patients # and the potential for negative outcomes for the agency patient population. Patient # 18 was admitted to the agency on 11/10/21 with a primary diagnosis of Type 2 Diabetes Mellitus with other specified complications and secondary diagnoses of acute osteomyelitis of the right ankle and foot; chronic ulcer of the right heel and mid foot with necrosis of the bone; essential hypertension; left below the knee amputation; surgical amputation of toes of the right foot. On 11/10/21 the Registered Nurse (RN) visited the patient and completed the comprehensive assessment. The RN identified the patient lived alone, had a peripherally inserted central catheter (PICC) for intravenous (IV) antibiotics; two wounds on the right lower limb requiring a negative pressure vacuum assisted closure dressing (wound VAC); used daily long-acting insulin subcutaneous and short acting insulin based on blood glucose readings 3 times a day. The RN failed to perform a complete assessment of the following: PICC/IV ANTIBIOTICS The RN documented the PICC dressing had not been changed since the physician office visit completed on 11/04/21. The RN documented the patient had a double lumen PICC, and to see summary (narrative note) for details of the assessment. The summary failed to include: - an assessment of the insertion site - details of how loose the dressing was that the nurse documented she had to tape the edges down because there were no dressing supplies. - documentation of an arm circumference - measurement of the external length of the catheter - documentation the vancomycin continuous infusion was attached to one of the lumens - observation of the patient’s nephew performing infusion therapy using proper infection control techniques. MEDICATION REVIEW - the RN documented the patient had no issues found during medication review. However, the patient did not have medication bottles available for review. - the nurse documented the patient only takes oral medication if administered by another person, but failed to identify how the patient obtains his medications twice a day. - the nurse documented "patient unable to take injectable medications", however documented in the narrative summary that the patient verbalized how to administer insulin. It was unclear which assessment was accurate. The RN failed to identify if the patient’s long acting and short acting insulin vials or pens were at the patient’s home or at the nephew’s home with the other medications. The patient received 1-2 nursing visits a week between 11/10/21 and 12/08/21. The RN failed to document how the patient obtained his medications or if the medication bottles were returned to his home; observe the patient draw up and administer insulin and failed to observe the nephew administer the IV antibiotics using proper infection control technique. On 12/08/21 at 9:15 am, the surveyor reviewed the record with the CEO, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. Patient # 15 was admitted to the agency on 05/06/21 with diagnoses of type II diabetes with long-term insulin use, hip fracture following a hip replacement, metabolic encephalopathy, and hypertension. The admission registered nurse failed to ensure the assessment was comprehensive and met the patient’s needs. DIABETES The admission nurse visited 05/06/21 for the start of care assessment and documented the patient had type II diabetes requiring insulin and reported a fasting blood sugar of 78. The questions within the assessment form regarding the patient and caregiver's blood glucose testing and insulin administration independence were blank. The Plan of Care had the following entry under the heading Multidisciplinary: "pt/dtr demonstrated independence with glucometer 05/06/21". There was no glucose result from this demonstration or explanation that it was a demonstration without an actual test. The admission nurse failed to assess the patient and caregiver's ability to draw up and administer insulin. SKIN The admission nurse identified both buttocks were red and had a rash, noting the physician's discharge note included the patient had a fungal rash on the buttocks. The admission nurse also documented Miconazole cream was provided. There is no evidence the patient or caregiver was instructed on care for the rash or directions for use of Miconazole as this medication was not on the list of medications at discharge. On 12/08/21 at 10:00 AM, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator, and Home Care Manager. They acknowledged the findings and provided no additional information. Patient # 3 was admitted to the agency 10/26/21 with diagnoses of type 2 diabetes with foot ulcer, osteomyelitis, cellulitis, hypertension and acute kidney failure. Failure to ensure comprehensive assessments resulted in the patient’s uncontrolled blood glucose levels, likely inhibited wound healing, and had the potential for severe consequences including diabetic ketoacidosis and death. DIABETES/DIABETIC MANAGEMENT The 10/26/21 plan of care (POC) included Basaglar (long-acting insulin) 12 units daily, and an incomplete order for Admelog (fast-acting insulin) maximum daily dose (MDD) 66 units 3 times per day diabetes before meals. On 10/26/21 the admission registered nurse documented in the initial comprehensive assessment no issues were identified during drug regimen review. The RN failed to identify there were no instructions / sliding scale for Admelog, thus erroneously assessed the patient: -was independent with medication management and blood glucose monitoring -was able to independently take injectable medication; correct medication(s), proper dosage(s) at the correct times On 10/29/21 and 11/01/21 the registered nurse (RN) visited the patient and failed to assess the patient’s blood glucose or knowledge of diabetes management including use of insulin. On 11/03/21 the RN visited the patient and documented the patient’s pulse was 109, he reported diarrhea, and earlier that day his BG was “high” and he gave himself 20 units of Admelog. The RN had the patient test during the visit, BG was still “high,” and contacted the physician’s office who advised the patient should go to the Emergency Department (ED). The patient refused to go to the ED but said he would consider going later if BG did not decrease. The RN failed to: - assess the patient’s knowledge of blood glucose levels and diabetes management - assess the patient's knowledge and use of insulin - determine whether 20 units of Admelog was the correct dose to administer - review the patient’s medications and identify the Admelog lacked sliding scale instructions for administration - communicate assessment findings with the patient’s registered nurse case manager (RNCM) or agency nursing supervisor - complete a follow-up assessment until the next scheduled visit on 11/05/21 On 11/05/21 the RN visited the patient and documented the patient’s pulse was 105, BG was 380 and he had watery diarrhea 3 times per day for several days. On 11/08/21 the RN visited the patient and documented the patient’s pulse was 110, BG earlier that day was “high”, continued to have loose stools and vomited earlier that day. BG rechecked during visit was 143. On 11/12/21 the RN visited and documented the patient’s pulse was 109, BG was 300 with range of 140-300, continued to have loose stools, did not take Basaglar the prior evening. On 11/15/21 the RN visited the patient 1:07-2:45 pm and documented the patient’s BG was 385, no recent range was documented, the patient still had loose stools/diarrhea. On 11/17/21 the patient’s RN Case Manager (CM) visited the patient for the first time. The CM documented the patient’s BG was 175 with a range of 175-“high.” On 11/22/21 at 3:18 p.m. office administrative staff documented labs faxed to endocrinology office for BG 455, last week 509, PCP also notified. On 11/22/21 at 6:59 p.m. the RNCM documented she notified the patient of elevated BG of 455, patient stated he rechecked this evening, BG was 353 and he was asymptomatic of hyperglycemia. Stated he is used to it running high in the 300s and feels ill if it is lower than 200. On each of the dates noted above the agency nurses failed to: - assess the patient’s knowledge of blood glucose levels and diabetes management - assess whether the patient was administering the correct dose of insulin and identify there were no instructions for administration of Admelog - assess / identify the patient’s pulse and BG were outside of parameters and required physician notification On 12/03/21 at 12:30 p.m. the surveyor interviewed the RN. The RN stated she was so focused on the wound vac and IV antibiotics that she did not realize until after the second visit she should be checking blood glucoses. She said on 11/02/21, when the patient’s blood glucose was high, and he reported taking 20 units of Admelog, she presumed that was the correct dose and did not know if he had an actual sliding scale. When asked about other occurrences of high blood glucose not being reported to the physician, she stated she had “Obviously done a disservice to this man…. I missed the most important thing which is his insulin.” PAIN The 10/26/21 POC included the following: -Oxycodone-acetaminophen 10-325 mg, 2 tablets every 6 hours as needed for pain MDD 4 tablets -Pregabalin (Lyrica) 150 mg three times per day -Notify MD if reported pain is above 8 On 10/26/21 the admission RN documented the patient had no pain. On 10/29/21 the RN documented the patient had dull/cramping/shooting pain in lower back, caused by “wound” (no lower back wounds were identified). The RN failed to assess the pain level and what relieved pain. 11/01, 11/03, 11/05, 11/12 and 11/15/21 the RN documented chronic lower back pain, rated 3-7, relieved by rest and medications. The RN failed to assess what medications were being taken, how often, and when last taken. On 11/29/21 the RN documented the patient reported sharp, throbbing, aching, shooting, pinching chronic lower back pain rated 10 on a scale of 1-10, relieved with rest and relaxation, not being addressed with medication appropriately and upcoming pain management appointment on 12/06/21. The RN failed to assess what medications were being taken, how often, and when last taken; and failed to identify pain greater than 8 required physician notification. WOUND On 10/26/21 the admission RN documented the patient had 2 wounds: - wound # 1 left dorsal foot, stage 3 pressure ulcer injury - wound # 2 left lateral foot, surgical wound On 11/01/21 the RN documented: -wound # 1 right dorsal foot diabetic ulcer 3 cm L x 3.1 cm W x 0.1 cm D -wound # 2 right lateral foot diabetic ulcer 2.5 cm L x 4 cm W x 0.5 cm D On 11/3 and 11/05 the RN documented wound care was provided to left dorsal and lateral diabetic ulcers, no measurements were obtained. On 11/08/21 the RN documented wound care was provided to left dorsal diabetic ulcer and left lateral surgical wound; and noted undermining 1-3 on lateral wound, no measurements were obtained. On 11/12/21 the RN visited and documented wound care was provided to left dorsal and lateral diabetic ulcers, dorsal wound appeared to have a blood blister, no measurements were obtained. On 11/15/21 the RN visited and documented that left foot lateral surgical wound was macerated, wound vac not applied as tape would not stick, no measurements were obtained. On 11/17/21 the RNCM visited and documented a black area on back of left heel that patient stated it “he doesn’t know what it’s from,” could be from splint rubbing: -wound # 1 left dorsal foot diabetic ulcer 3 cm L x 3 cm W x 0.1 cm D -wound # 2 left lateral foot surgical wound 3 cm L x 4 cm W x 0.4 cm D -wound # 3 left heel unstageable pressure injury 2 cm x 2 cm, no depth measurement The RNCM documented next scheduled podiatry visit was 11/18/21 and failed to communicate with the podiatrist’s office regarding assessment findings. The agency “Wound Care” policy dated 03/2020 stated “wound measurements are to be completed weekly or sooner if the wound has deteriorated.” From 11/01/21 – 11/17/21: - the RN failed to assess wound measurements weekly and when blood blister, maceration and undermining developed - assessment of location and type of wounds was inconsistent / incorrect PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) The 10/26/21 plan of care included measure arm circumference 3 inches above PICC insertion site every week and as needed for swelling, redness, pain. On 11/01/21 the RN documented circumference of 24 (cm). On 11/08/21 the RN documented circumference of 27 (cm). On 11/15/21 no arm circumference was documented. On 11/22/21 the RNCM documented an arm circumference of 26 cm. On 11/29/21 the PICC was discontinued. On 12/03/21 the surveyor interviewed the RN who stated she must have made an error in one of the measurements as based on visualizing the arm there was not a 3 cm increase. On 12/06/21 at 1:15 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and stated that on 12/03/21 they spoke with the physician to obtain appropriate insulin orders, and over the weekend the patient was visited twice daily to assess and provide education. HV Patient # 4 was admitted to the agency 10/01/21 with diagnoses of surgical amputation of right toes, type 2 diabetes, hypertension and anemia. History included left leg below the knee amputation. The agency nurses failed to perform a comprehensive of the patient’s wounds as follows: On 10/01/21 the admission registered nurse documented 2 wounds in the initial assessment: - wound # 1, right lateral foot (RLF) surgical wound, with wound vac dressing, 4.5 cm length (L) x 2.5 cm width (W) x 0.4 cm depth (D) - surgical wound on right lower extremity (RLE) closed with staples The admission nurse failed to assess measurements of, or number of staples present on, RLE wound; documented dry gauze and kerlix wrap to RLE surgical incision from bypass surgery redressed at visit, client stated his ex-wife comes by each evening and assists him with this. There was no evidence the agency nurses ever assessed the caregiver’s ability to perform wound care. The 10/01/21 agency plan of care included: - # 1 wound care to RLE surgical incision three times weekly. Assess incision, cover with gauze/ABD secure with Kerlix, by agency or caregiver. - Negative pressure wound therapy to right lateral foot surgical wound three times weekly and as needed (PRN) soilage leakage. The assessment identified wound # 1 as the right lateral foot wound, but the POC identified wound # 1 as the right lower extremity wound. On 10/04/21 the registered nurse (RN) visited the patient and documented: - wound # 1, right lateral foot surgical wound (with wound vac) - wound # 2, right medial foot surgical wound with sutures - wound # 3, right lower extremity ankle to groin surgical wound with staples The RN documented wound care provided and all dressings changed per MD orders, though orders were for 2 wounds only, and assessment did not numerically align with orders. On 10/06/21 the the licensed practical nurse (LPN) visited and documented: - wound # 1 right leg surgical wound - wound # 2 right foot pinky toe surgical wound (with wound vac) - wound care was completed per MD orders On 10/08/21 the registered nurse case manager (RNCM) visited and documented: -wound # 1 RLF surgical wound, (wound vac), 5.1 cm L x 2.0 cm W x 0.3 cm D -(unnumbered) closed RLE surgical wound with sutures and staples The narrative note stated wound care was performed per orders. On 10/11/21 the licensed practical nurse (LPN) documented care provided to wound # 1 left foot surgical wound (wound vac); the narrative note documented “wound care done per MD orders.” Wound measurements were incomplete and there was no documentation of any other wound(s). On 10/13/21 the LPN documented care provided to wound # 1 RLF surgical wound (wound vac) and wound # 2 right leg inner thigh mid-calf surgical wound. The LPN documented 10/12 staples were removed from upper right leg at surgical appointment, every other staple left in calf due to redness and discharge noted at appointment. On 10/15/21 the LPN documented care provided to wound # 1 left foot surgical wound (wound vac); the narrative note documented “wound care done per MD orders.” Wound measurements were incomplete and there was no documentation of any other wound(s). On 10/18/21 the registered nurse case (RNCM) visited and documented full assessment not performed due to patient having podiatry appointment that day and wound care performed there. No wound assessment was completed. On 10/20/21 the LPN documented care provided to wound # 1 RLF surgical wound (wound vac); the narrative note documented “wound care provided as MD ordered.” Wound measurements were incomplete and there was no documentation of any other wound(s). On 10/22/21 the LPN documented care provided to wound # 1 RLF surgical wound (wound vac): and noted a closed right calf surgical wound with staples. The narrative note documented wound care done per MD orders. On 10/25/21 the LPN documented care provided to: -wound # 1 RLF surgical wound (wound vac), incomplete wound measurements present -wound # 2 right inner calf surgical wound with purulent small drainage -wound # 3 right foot arch surgical wound with purulent scant drainage The narrative note documented wound care done per MD orders. On 10/27/21 the LPN documented care provided to: -wound # 1 RLF surgical wound (wound vac), 4.8 cm L x 1.8 cm W x 0.3 -wound # 2 right foot wound, 2 stiches in place, purulent scant drainage On 10/29/21 the LPN documented care provided to: -wound # 1 RLF surgical wound (wound vac), -wound # 2 right foot wound, 2 stiches in place, purulent scant drainage On 11/01/21 the LPN documented care provided to wound # 1 RLF surgical wound (wound vac). The narrative note documented wound care done per MD orders, right foot wound noted to have scant drainage. On 11/03/21 the RNCM visited and documented: -wound # 1 RLF surgical wound, (wound vac), 5.5 cm L x 1.5 cm W x 0.2 cm D -(unnumbered) closed RLE surgical wound with sutures clean and intact From 10/08/21 to 11/03/21 the LPN visited to provide wound care on 9 occasions, sometimes documented on only 1 wound but up to 3 wounds, was not consistent in type and location of wounds, and on 2 occasions erroneously documented wound was on left foot. For almost 3 weeks, 10/08/21 to 10/27/21, no complete wound measurements were obtained. For almost 4 weeks, from 10/08/21 to 11/03/21, no registered nurse assessed the patient’s wounds. Review of agency “Wound Care” policy dated 03/2020 revealed: - orders will be obtained for the type and location of each wound and frequency of assessment - location of wound is to be described with an anatomical location and if the patient has multiple wounds each wound is assigned a number - wound numbering must remain consistent on the assessment and physician orders On 12/02/21 at 10:30 a.m. the surveyor completed an observational home visit with the RNCM. Following the visit, the surveyor interviewed the patient regarding his wounds. He stated that at the time of admission he had one wound from amputation of his right 5th toe, and a surgical incision from ankle to groin from bypass surgery. The surveyor asked about the ankle to groin incision and he said there were staples present that were removed in stages, as some sections of the incision around his foot and calf were not healing as well as others. Initially a dressing was from ankle to groin, but later only on his calf and foot; sometimes he performed those dressing changes, sometimes his ex-wife assisted, and sometimes the agency nurse completed them. On 12/06/21 at 3 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. The CEO stated LPNs are allowed to obtain wound measurements; and agency expectation is the RN will complete wound assessment at least every 2 weeks. They acknowledged the findings and provided no additional information.

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 observation, record review, and interviews with the Administrator, Director of Patient Services (DPS), Safety Coordinator, Home Care Manager, and agency staff, it was determined in 3 of 17 records (Patient # 3, 4, and 6), agency staff failed to perform complete and accurate medication reviews. Evidence was as follows: HV Patient # 3 was admitted to the agency 10/26/21 with diagnoses of type 2 diabetes with foot ulcer, osteomyelitis, cellulitis, hypertension and acute kidney failure. Failure to perform a comprehensive review of all patient medications resulted in the patient’s uncontrolled blood glucose levels, likely inhibited wound healing, and had the potential for severe consequences including diabetic ketoacidosis and death. DIABETES Hospital discharge instructions included: -Admelog SoloStar (fast-acting insulin) inject subcutaneously 3 times per day per prescribers’ instructions maximum of 66 units per day -Basaglar KwikPen (long-acting insulin) 12 units subcutaneously once daily in the evening The 10/26/21 agency plan of care included the following incomplete/incorrect medication orders: -Admelog SoloStar (fast-acting insulin) subcutaneous (injection) maximum daily dose (MDD) 66 units 3 times per day diabetes before meals -Basaglar KwikPen (long-acting insulin) 12 units subcutaneously daily The Admelog order lacked sliding scale instructions (number of units to administer based on blood glucose reading) for administration. The Basaglar instructions lacked evening administration and the dose was inconsistent with what the patient reported taking (see observational home visit notes below). On 10/26/21 the admission registered nurse (RN) visited the patient for an initial assessment, documented no issues were identified during drug regimen review, and failed to recognize there were no instructions / sliding scale for Admelog. On 11/02/21, lab results from 11/01/21 included a blood glucose (BG) of 554. An office RN contacted the patient and had him test during the phone call, the BG was 302, the office nurse documented the patient verbalized understanding of his sliding scale although no sliding scale was ordered. On 11/03/21 the RN visited the patient and documented earlier that day his BG was “high” and he gave himself 20 units of Admelog. The RN failed to review the patient’s medications, recognize the Admelog lacked sliding scale instructions for administration, and determine whether 20 units of Admelog was the correct dose to administer. On 11/05, 11/08, 11/12, 11/15, and 11/22/21 the RN and Registered Nurse Case Manager (RNCM), in response to elevated blood glucose levels, documented educating the patient on checking BG and taking insulin and failed to review medications and recognize there were no instructions for Admelog dosage. On 12/02/21 the surveyor completed an observational visit with the RN. At the visit the patient reported prior to visit BG was 420. The RN failed to review whether / how much Admelog the patient had taken and if it was in accordance with any instructions / sliding scale. Following the visit, the surveyor interviewed the patient regarding his insulin. The patient reported he took 10, rather than 12, units of Basaglar at nighttime and had been doing so since his admission to the agency. The surveyor asked the patient if he had written sliding scale / instructions for use of Admelog, he said they “might be in a box somewhere.” When asked if he knew the sliding scale instructions he said if blood glucose was 150-200 he would take 2 units, 201-250= 4 units, 251-300 = 6 units; then said “no, that’s not right, because it goes up by 2 and if it’s over 320 I take 20 units.” The patient then stated that it goes down 4 from 20 and if BG was under 200, he would take 12 units, between 200 and 320 he would take 16 units. Shortly thereafter the patient reported he would take 4-6 units if under 200. When the surveyor asked how he kept track he stated he would ask his mother as she has the same sliding scale. PAIN Hospital discharge instructions included acetaminophen-oxycodone 325 mg-10 mg 2 tablets by mouth every 6 hours as needed for 3 days. The agency POC included the following pain medications: -Oxycodone-acetaminophen 10-325 mg, 2 tablets every 6 hours as needed for pain MDD 4 tablets -Pregabalin (Lyrica) 150 mg three times per day During the observational home visit the RN reviewed the patient’s medication bottles; no oxycodone-acetaminophen, or Lyrica, were present. The patient reported he had no pain medications, that his Lyrica ran out, and that he was not prescribed oxycodone since leaving the hospital. A prescription bottle of etodolac 200 mg twice daily as needed for pain, filled 10/23/21, was present. The patient reported he didn’t take it as it did not help pain. On 12/06/21 at 1:15 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and stated that on 12/03/21 they spoke with the physician and obtained appropriate insulin orders, including a sliding scale, and other medications were reconciled. Patient # 4 was admitted to the agency 10/01/21 with diagnoses of surgical amputation, type 2 diabetes, hypertension and anemia. The skilled nurse (RN) failed to perform a comprehensive review of the patient's medications as follows: DIABETES On 10/01/21 the admission RN visited the patient and documented client demonstrated correct use of glucometer / follows sliding scale and sets insulin pen to scale in home and safely administers insulin. The 10/01/21 agency POC / medication orders included Novolog FlexPen (fast-acting insulin) 4 – 24 units 3 times per day before meals for diabetes – see sliding scale. The RN failed to identify the plan of care / medication orders lacked a sliding scale. PAIN The medication orders included the following pain medications: -Gabapentin 600 mg 3 times daily -Cyclobenzaprine 10 mg as needed daily for pain -Oxycodone 5 mg every 4 hours PRN pain MDD 6 -Acetaminophen 325 mg 2 tabs every 4 hours as needed (PRN) for pain, maximum daily dose (MDD) 3000 mg On 11/10/21 the RN visited and documented the patient had chronic pain to right lower extremity (RLE) wounds rated # 7 on a scale of 0-10. On 11/12/21 the RN visited and documented the patient had chronic pain to RLE wounds rated # 8 on a scale of 0-10. On each occasion noted above the RN documented the patient was using (unspecified amount of) ibuprofen approximately 2 x per day, and that medication regimen was unchanged. The RN failed to assess use of pain medications as ordered, identify the POC did not include ibuprofen, and communicate with the physician to develop an appropriate pain management plan. On 12/06/21 at 3 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. HV Patient #6 was admitted to the agency on 10/12/21 with diagnoses of type II diabetes with foot ulcer, cellulitis of the left lower limb, sepsis, osteomyelitis, heart disease, and orthostatic hypotension (positional low blood pressure). The registered nurse (RN) failed to perform a comprehensive review of the patient's medications as follows: Blood Pressure The 10/12/21 admission registered nurse (ARN) noted, "midodrine increased to 10mg 3 x's daily from 5mg, but this was also not called into the pharmacy and spouse is giving 2 tabs of the 5mg currently but will need new script soon". On 12/02/21, almost 2 months later during the observational home visit, the registered nurse case manager (RNCM) and spouse identified there was no midodrine in the home. Neither could recall the purpose of the medication but thought it might have been for hyperbaric chamber-induced anxiety that was never needed. At the conclusion of the visit, the spouse recalled the medication had been started for low blood pressure when the patient had weakness and episodes of near fainting. She reported, "the doctor said it was ok to take with the high blood pressure medication and should be taken when the blood pressure was below 100". The blood pressure on the day of the visit was 92/54 and at the visit prior on 11/24/21, 98/62. The RNCM failed to identify the medication and notify the physician for refill or further orders. On 12/06/21 at 1:15 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator, and Home Care Manager. They acknowledged the findings and provided no additional information. Patient # 9 was admitted to the agency on 10/21/21 with diagnoses of Covid-19, pneumonia due to coronavirus disease, hypertensive heart disease with heart failure, rheumatic disorders of both mitral and tricuspid valves, atrial fibrillation, rheumatoid arthritis, osteoarthritis, and osteoporosis. The registered nurse (RN) failed to perform a complete and accurate medication review as follows: Anxiety On 11/10/21, the RN visited for a resumption of care assessment visit after the patient had been hospitalized. At the visit prior to hospitalization, the patient had requested Xanax (alprazolam) for anxiety. Alprazolam 0.25mg tablets were started during the hospitalization and were included in the discharge instructions "these are your medications to take at home. order sent to your pharmacy." The RN noted discrepancies in the medication reconciliation, and medication change orders were noted on the updated Plan of Care dated 11/10/21. Alprazolam was not included. On 12/06/21 at 1:15 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator, and Home Care Manager. They acknowledged the findings and provided no additional information. Failure to perform complete and accurate medication reviews could lead to patients potentially taking medications inconsistent with the physician's intentions and possible negative patient outcomes.

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on a review of clinical records, and interviews with the Administrator, Director of Patient Services (DPS), Safety Coordinator, Director of Quality, Home Care Manager, and agency staff, it was determined in 2 out of 3 records (Patients # 4 and 9), the agency failed to conduct an assessment visit within 48 hours of return home from a hospital stay. This was evidenced by: HV Patient # 4 was admitted to the agency 10/01/21 with diagnoses of surgical amputation, type 2 diabetes, hypertension and anemia. On 11/15/21 the patient was hospitalized with osteomyelitis; he was discharged from the hospital on intravenous antibiotics on 11/24/21. The registered nurse failed to visit the patient to update the comprehensive assessment and plan of care until 11/27/21. On 11/22/21 at 11:10 a.m. an office support staff person documented in the inter-office communication notes the patient was inpatient since 11/15/21, will continue to monitor. The medical record included a fax from an infusion pharmacy date and time stamped 11/24/21 2:18 p.m. that stated the patient would be discharged to home that date with the following medications: -Normal saline flush. Flush IV with 10 ml before and after each dose and as needed for line maintenance. -Heparin 10 units/ml 5 ml flush. Flush IV with 5 ml after final saline flush and as needed for line maintenance. -Ertapenem 1 gm IV every 24 hours via gravity. -Vancomycin 1250 mg IV every 12 hours via IV home pump. On 11/26/21 at 08:15 a.m. the office support staff person documented the patient was discharged to home at 4:53 p.m. on 11/24/21, will be a resumption of care (ROC). On 11/27/21 at 11:20 a.m. the registered nurse (RN) completed the resumption of care visit. On 12/02/21 at 10:30 a.m. the surveyor completed an observational visit with the RN. Following the visit, the surveyor interviewed the patient regarding how and when he was educated to administer IV antibiotics. The patient stated that while in the hospital he spoke to a representative from the infusion company who reviewed the procedure, that night a representative dropped off the medications and supplies, and the next morning he spoke over the telephone to the infusion company representative who guided him through the process. On 12/02/21 at 2:10 p.m. the surveyor interviewed the office support person regarding the process of hospital discharge and agency resumption of care. She stated she had live access to the hospital system and checked each day to see which patients were discharged. When asked whether she checked for discharges between her 11/22 and 11/26/21 entries in the inter-office communication notes, she stated she was off during that time frame, but other office staff should have been checking. On 12/06/21 at 3 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. Failure to assess the patients' needs within 48 hours of inpatient discharge has the potential for unmet patient needs and negative outcomes for the agency patient population. Patient # 9 was admitted to the agency on 10/21/21 with diagnoses of Covid-19, pneumonia due to coronavirus disease, hypertensive heart disease with heart failure, rheumatic disorders of both mitral and tricuspid valves, atrial fibrillation, rheumatoid arthritis, osteoarthritis, and osteoporosis. On 10/29/21, the patient went to the emergency room with shortness of breath and remained hospitalized for 9 days with an acute exacerbation of congestive heart failure while recovering from Covid pneumonia. On 11/06/21, the patient was discharged and returned home with orders to resume home care with the agency, including nursing, physical and respiratory therapy. The resumption of care assessment was not completed until 11/10/21, 4 days after her return home. There was no explanation in the record for the delay. On 12/06/21 at 3 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator, and Home Care Manager. They acknowledged the findings and provided no additional information.

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 review and interviews with the Administrator, Director of Patient Services, Safety Coordinator, Director of Quality, Home Care Manager and agency staff, it was determined this condition was not met as evidenced by: - Failure to develop comprehensive plans of care which address each patient's individual needs. See G 574. - Failure to follow physician orders or contact physician when unable to comply. G 578. - Failure to promptly alert relevant physician of changes. G 590 - Failure to integrate all services. See G 606. The cumulative effect of the systemic issues identified in the failure to develop of comprehensive plans of care; coordinate care and services resulted the potential for significant negative outcome for patient # 3 related to uncontrolled blood glucose readings obtained but not reported to the physician, and a negative outcome for Patient # 17.

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 record reviews and interviews with the Administrator, Director of Patient Services (DPS), Safety Coordinator, Home Care Manager and agency staff, it was determined in 9 of 20 records (Patients # 1, 3, 4, 5, 6, 9, 11,12 and 17) agency staff failed to develop individualized plans of care that were complete, accurate, and addressed the total needs of the patient. This was evidenced by: 2. Patient # 17 was admitted to the agency on 01/22/21 with diagnoses of extensive deep vein thrombosis to the right lower extremity, pneumonia, pleural effusions, cirrhosis of the liver and history of pancreatic cancer. The record was selected from the Centers for Medicare and Medicaid services (CMS) potentially avoidable adverse event report 08/01/2020-07/31/2021 for increase in number of pressure ulcers and discharge to the community with unhealed stage II pressure ulcer. The 01/22/21 Plan of Care included incomplete orders for Novolog (short-acting insulin), directing to “see sliding scale”. The medication profile listed Novolog 0-2 units three times a day before meals with no details on the blood glucose measurements that would necessitate coverage. The Plan of Care was also incomplete listing unspecified diabetic supplies. On 12/06/21 at 3:00 pm the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. 4. Patient #1 was admitted to the agency on 04/29/21 with diagnoses of Parkinson’s disease, dysphagia, anxiety, depression, sleep apnea, and urinary retention. The 04/22/21 physician referral identified the patient was using a thickener for issues with swallowing liquids. The patient was noted to have urinary incontinence and retention and performed straight catheterization up to 3 times daily. The 04/23/21 sleep specialist note included continuous positive airway pressure (CPAP) use for many years with recent complaints of episodes of stridor both during the day and at night. The plan was to switch to bi-level positive airway pressure (BiPAP) and possibly a non-invasive ventilator (Trilogy) device due to the progressive neuromuscular disorder. The 04/29/21 Plan of Care was incomplete as follows: - The plan included Nectar Thick liquids as needed, however, did not specify how the need would be determined. - There were no orders for urinary catheterization. - The respiratory device was not included including when it was to be used. On 12/06/21 at 3:00 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. 5. Patient #12 was admitted to the agency on 11/17/21 with diagnoses of gastrointestinal bleeding, recent urinary tract infection, juvenile rheumatoid arthritis, Crohn’s disease, irritable bowel disease, malabsorption, history of bowel and liver transplant and neurogenic bladder. The patient received total parenteral nutrition (TPN). The 11/17/21 Plan of Care included a plan for an indwelling Foley catheter instead of a suprapubic catheter and failed to include site care, when to irrigate and type of fluid and amount for irrigation . The infusion orders were incomplete regarding site care, frequency, type and amount of fluid for flushing. On 12/06/21 at 3:00 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. Failure to ensure that comprehensive individualized plan of care is developed has the potential for unmet patient needs. HV 6. Patient #6 was admitted to the agency on 10/12/21 with diagnoses of type II diabetes with foot ulcer, cellulitis of the left lower limb, sepsis, osteomyelitis, heart disease, and orthostatic hypotension (positional low blood pressure). On 12/01/21, during the observational home visit, the patient, registered nurse case manager (RNCM), and spouse were reviewing the safety plan when he was alone in the home. The RNCM reminded the patient to wear the life alert alarm system around his neck and utilize it if necessary. The 10/12/21 Plan of Care failed to include the life alert alarm system. On 12/06/21 at 1:15 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator, and Home Care Manager. They acknowledged the findings and provided no additional information. HV 7. Patient #5 was admitted to the agency on 11/09/21. Diagnoses included gastrointestinal hemorrhage, acute embolism/ thrombus of deep veins of the upper extremity, iron deficiency anemia, compression fracture of the vertebrae, hypertension, and hypothyroidism. On 12/02/21, during the observational home visit, the physical therapist (PT) encouraged the patient to wear the "life alert" alarm call system and to utilize it if she had another fall. The patient "didn't want to be a bother". The PT reassured the patient a family would be contacted prior to an ambulance. The 11/09/21 Plan of Care was incomplete as it did not include the life alert alarm call system. On 12/06/21 at 1:15 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator, and Home Care Manager. They acknowledged the findings and provided no additional information. 1. Patient # 3 was admitted to the agency 10/26/21 with diagnoses of type 2 diabetes with foot ulcer, osteomyelitis, cellulitis, hypertension and acute kidney failure. The 10/26/21 agency plan of care (POC) was incomplete/inaccurate as follows: MEDICATIONS The 10/26/21 plan of care (POC) medication orders included Admelog SoloStar (fast-acting insulin) Subcutaneous MDD 66 units 3 times per day diabetes before meals. The Admelog order lacked sliding scale instructions for administration (number of units to administer based on blood glucose reading). The incomplete medication orders resulted in the patient’s uncontrolled blood glucose levels, likely inhibited wound healing, and had the potential for severe consequences including diabetic ketoacidosis and death. WOUND The POC included negative pressure wound therapy to left lateral foot 3 times weekly and as needed. On 11/15/21 the registered nurse (RN) visited the patient and documented that foot was macerated, wound vac not applied as tape would not stick, called podiatry to inform them of removal. On 11/16/21 the RN obtained an order to remove wound vac from left lateral wound and apply alternative dressing until after podiatry appointment 11/18/21. On 11/17/21 the patient’s Registered Nurse Case Manager (RNCM) visited the patient for the first time. The RNCM documented the patient had a black area / unstageable pressure injury that measured 2 cm x 2 cm on the back of his left heel. The RNCM placed an ABD pad covered with kerlix and ace and encouraged the patient to keep pressure off. The RNCM documented patient to see podiatry 11/18 and will have assessed at that time, will follow-up for any new orders. The RNCM failed to communicate with the podiatrist regarding the newly developed heel wound to obtain wound care orders / update the plan of care. On 11/22/21 the RNCM visited the patient and documented the patient stated podiatrist aware of right heel wound and next appointment 11/24/21. The RNCM documented wound care was provided to wounds per “interventions section” and failed to communicate with the podiatrist to update the plan of care for the lateral foot and heel wounds. On 11/30/21 the RN documented the physician was contacted to verify wound care on the lateral and heel wounds, the POC was updated 12/02/21. For approximately 2 weeks the agency failed to update the POC to include wound care provided to lateral foot and heel wounds. PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) The 10/26/21 plan of care included measure arm circumference 3 inches above PICC insertion site every week and as needed for swelling, redness, pain. The plan of care failed to include: -measuring external catheter length for migration -measurement changes of circumference and external catheter to report to the physician Review of agency policy "Infusion Therapy and Central Venous Access Device (CVAD) Management," dated 12/2020, revealed the policy did not include measurment parameters to be reported to the physician. On 12/06/21 at 1:15 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. 3. Patient # 4 was admitted to the agency 10/01/21 with diagnoses of surgical amputation of right toes, type 2 diabetes, hypertension and anemia. History included left leg below the knee amputation. The agency plan of care was incomplete as follows: MEDICATIONS The 10/01/21 agency POC / medication orders included Novolog (fast-acting insulin) 4 – 24 units 3 times per day before meals for diabetes – see sliding scale. -The Novolog order lacked sliding scale instructions for administration (number of units to administer based on blood glucose reading). On 11/10/21 and 11/12/21 the RN visited and documented the patient had chronic pain to right lower extremity (RLE) wounds and was taking ibuprofen approximately 2 times daily. The POC did not include ibuprofen. WOUND CARE On 10/01/21 the admission RN documented in the initial assessment wound # 1 was a right lateral foot (RLF) surgical wound. The RN also documented a surgical wound on right lower extremity (RLE) closed with staples, dry gauze and kerlix wrap to RLE surgical stapled incision from bypass surgery redressed at visit, client states his ex-wife comes by each evening and assists him with this. The 10/01/21 agency plan of care included: - # 1 wound care to RLE surgical incision three times weekly. Assess incision, cover with gauze/ABD secure with Kerlix, by agency or caregiver. - Negative pressure wound therapy to right lateral foot surgical wound three times weekly and as needed (PRN) soilage leakage. The POC orders for wound care were incomplete / incorrect as follows: - RLE surgical incision failed to include instructions for cleansing - RLE surgical incision was identified in the POC as wound # 1; though in the assessment the right lateral foot wound was identified as wound # 1 - the orders failed to include frequency of agency RN assessment On 12/06/21 at 3 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review, observation, and interviews with the Administrator, Director of Patient Services (DPS), Safety Coordinator, Home Care Manager and agency staff, it was determined in 6 of 20 patient records (Patients # 1, 3, 4, 6, 8, and 15) the agency failed to provide services as ordered by the physician. Evidence was as follows: Patient #1 was admitted to the agency on 04/29/21 with diagnoses of Parkinson’s disease, dysphagia, anxiety, depression, sleep apnea, and urinary retention. The 11/01/21 plan of care included orders for home health aide (HHA) twice weekly for 9 weeks. There was only one HHA visit made and no documentation of notification of the physician regarding the plan of care not being followed. The 11/01/21 plan of care also included nursing visits every two weeks for nine weeks. The RN visited on 11/01/21 and 11/16/21, there was a missed visit on 11/30/21, and no further visits in the record since then. On 12/06/21 at 3:00 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. Failure to provide care as outlined in the physician's orders has the potential for unmet patient needs and negative outcomes for the patient population. Patient # 11 was admitted to the agency on 10/13/21 with diagnoses of pulmonary embolism, muscle wasting and atrophy, protein-calorie malnutrition, heart disease, COPD, kidney disease, chronic back pain, and fractured vertebrae. Care was not provided as specified in the physician's orders during 11 of 11 visits as follows: The 10/13/21 agency Plan of Care (POC) included: notify MD of a 2 # weight gain or loss in 24 hours or 5 # weight gain or loss in one week.On 10/13/21 the admitting registered nurse visited for the assessment and documented "no functioning scales". No weight was obtained. On 10/18/21 and 10/21/21 the registered nurse (RN) documented a "patient-reported" weight of 84#. The next 8 visit notes, (10/31/21, 11/04/21, 11/08/21, 11/10/21, 11/15/21, 11/17/21, 11/22/21, and 11/29/21) included no weight. For all missed weight checks (11 of 11 visits), there was no evidence the patient's physician was notified of the agency's inability to obtain weight as ordered in the plan of care. On 12/06/21 at 3:00 PM, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator, and Home Care Manager. They acknowledged the findings and provided no additional information. Patient #6 was admitted to the agency on 10/12/21 with diagnoses of type II diabetes with foot ulcer, cellulitis of the left lower limb, sepsis, osteomyelitis, heart disease, and orthostatic hypotension (positional low blood pressure). Care was not provided as specified in the physician's orders as follows: The 10/13/21 agency Plan of Care (POC) included: Notify MD of Blood glucose less than 70 or greater than 350.On 10/15/21 the registered nurse (RN) visited and documented: "wife to call the doctor today due to high BG's, was in the 400's overnight."On 10/20/21 the RN visited and documented: blood glucose range of 177 - 458.There was no evidence the MD was notified of the elevated glucose levels. On 12/06/21 at 3:00 PM, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator, and Home Care Manager. They acknowledged the findings and provided no additional information. Patient # 15 was admitted to the agency on 05/06/21 with diagnoses of type II diabetes with long-term insulin use, hip fracture following a hip replacement, metabolic encephalopathy, and hypertension. The record was selected from the Centers for Medicare and Medicaid Services (CMS) potentially avoidable adverse event report 08/01/2020-07/31/2021 for urinary tract infections. Care was not provided as specified in the physician's orders as follows: The 05/06/21 agency Plan of Care (POC) included: Notify MD of Blood glucose less than 70 or greater than 350Test Blood glucose a minimum of 1 - 3 times per day.On 05/14/21 the registered nurse (RN) visited and documented the BS's range from 78 - 458. On 05/18/21 the licensed practical nurse (LPN) visited and documented "the patient has not been testing due to running out of strips." On 05/21/21 the RN visited and documented the BS was 459 last night. On 05/24/21 the RN visited and documented the patient had not tested yet today, they had been testing "here and there", and "testing less than daily". The RN's failed to notify the MD of the glucose levels over 350 and the LPN failed to notify the MD the patient was not testing the glucose at a minimum of daily. On 12/08/21 at 9:15 a.m., the surveyor reviewed the record with the CEO, Safety Coordinator, and Home Care Manager. They acknowledged the findings and provided no additional information. Patient # 3 was admitted to the agency 10/26/21 with diagnoses of type 2 diabetes with foot ulcer, osteomyelitis, cellulitis, hypertension and acute kidney failure. Failure to provide care as ordered by the physician resulted in the patient’s uncontrolled blood glucose levels and had the potential for severe consequences including diabetic ketoacidosis and death. The 10/26/21 plan of care included: - instruct the patient on daily glucose log including blood glucose levels and action taken in response to results - notify MD of blood glucose (BG) less than 70 or greater than 350 - notify MD of heart rate (HR) less than 60 or greater than 100 - notify MD if reported pain is above 8 On 10/29/21 and 11/01/21 the registered nurse (RN) visited the patient and failed to review the patient’s blood glucose levels. On 11/05/21 the RN visited the patient and documented the patient’s BG was 380 and HR 105. On 11/08/21 the RN visited the patient and documented the patient’s BG earlier that day was “high”, HR was 110. On 11/12/21 the RN visited the patient and documented the patient’s HR was 109. On 11/15/21 the RN visited the patient documented the patient’s BG was 385. On 11/17/21 the RN visited the patient patient’s BG was 175 with a range of 175-“high.” On 11/29/21 the RN documented the patient reported sharp, throbbing, aching, shooting, pinching chronic lower back pain rated 10 on a scale of 1-10. The each of the above occasions the RN failed to: - instruct the patient on daily glucose log including blood glucose levels and action taken in response to results - notify the physician of the elevated heart rates, blood glucose levels and severe pain. On 12/06/21 at 1:15 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. Patient # 4 was admitted to the agency 10/01/21 with diagnoses of surgical amputation of right toes, type 2 diabetes, hypertension and anemia. The RN failed to monitor and report the patient's blood glucose, heart rate and pain in accordance with the physician orders / plan of care (POC). DIABETES / BLOOD GLUCOSE The 10/01/21 agency POC included: Visits 5-8, review diabetes blood sugar log and patient / caregiver understanding -Visits 5-8 were completed by the licensed practical nurse (LPN) on 10/11/21, 10/13/21, 10/15/21 and 10/20/21. At each of those visits the LPN failed to review the patient’s current blood glucose and recent blood glucose range. VITAL SIGNS / HEART RATE The 10/01/21 agency POC included: Monitor vitals and 02 sat and notify MD of blood pressure less than 90/50 or greater than 160/90, heart rate less than 60 or greater than 100, temp greater than 100.5 and oxygen less than 90. The patient’s heart rate (HR) was elevated as follows: -10/08/21 - 102 -10/13/21 - 110 -10/15/21 - 102 -10/22/21 - 104 -10/25/21 - 102 -10/27/21 - 108 -10/29/21 - 112 -11/01/21 - 104 -11/03/21 - 104 -11/08/21 - 104 -11/15/21 - 106 The RN failed to notify the physician of the patient’s elevated HR. PAIN The 10/01/21 agency POC included: Assess and educate pain management, use of pain medications, PRN medications and use of non-drug pain relief techniques. Notify the physician if pain is reported above 7. -On 10/15 and 11/15/21 the LPN visited and failed to gather any data related to pain. -On 10/20, 10/25 and 11/8/21 the LPN indicated the patient had pain rated numerically but failed to provide the number the patient rated the pain. -On 11/12/21 the RN visited and documented the patient had chronic pain to RLE wounds rated # 8 on a scale of 0-10. The RN failed to notify the physician the patient reported a pain level of 8. On 12/06/21 at 1:15 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. Patient # 8 was admitted to the agency on 06/23/21 with diagnoses of pressure ulcer sacral region, multiple falls, chronic obstructive pulmonary disease, type 2 diabetes and hypertension. Care was not provided at the frequency specified in the physician's orders as follows: The 10/21/21 agency Plan of Care (POC) included aide services twice weekly. Review of the aide visit schedule and notes for a 6-week period from 10/21/21-12/03/21 revealed the agency only provided aide service for 5 out of 12 visits. For 4 of the 7 missed visits (10/29/21, 11/05/21, 11/30/21 and 12/03/21) there was no evidence the patient's physician was notified of the agency's inability to provide aide services as ordered in the plan of care. On 12/08/21 at 9:15 a.m., the surveyor reviewed the record with the CEO, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interviews with the Administrator, Director of Patient Services (DPS), Safety Coordinator, Home Care Manager, and agency staff, it was determined for 1 of 17 records (Patient # 3), the Skilled Nurse (SN) failed to consult with the physician when changes in the patient's condition occurred. This was evidenced by: Failure to ensure physician notification of changes in the patient's condition has resulted in negative outcomes for patients # and the potential for negative outcomes for the agency's patient population. HV Patient # 3 was admitted to the agency 10/26/21 with diagnoses of type 2 diabetes with foot ulcer, osteomyelitis, cellulitis, hypertension and acute kidney failure. The agency nurses failed to alert the physician of changes in the patient’s condition as follows: DIABETES / ELEVATED BLOOD GLUCOSE The 10/26/21 plan of care included: -Admelog SoloStar (fast-acting insulin) subcutaneous (injection) maximum daily dose (MDD) 66 units 3 times per day diabetes before meals (incomplete instructions for administration, see G 536) -Basaglar KwikPen (long-acting insulin) 12 units subcutaneously daily -monitor blood glucose (BG) a minimum of 4 times daily -notify MD of blood glucose less than 70 or greater than 350 On 11/05/21 the registered nurse (RN) visited the patient and documented the patient’s BG was 380 and he had watery diarrhea 3 times per day for several days. On 11/08/21 the RN visited the patient and documented the patient’s BG earlier that day was “high”, continued to have loose stools and vomited earlier that day. BG rechecked during visit was 143. On 11/12/21 the RN visited and documented the patient’s BG was 300 with range of 140-300, continued to have loose stools, did not take insulin glargine the prior evening. On 11/15/21 the RN visited the patient 1:07-2:45 pm and documented the patient’s BG was 385, no recent range was documented, the patient still had loose stools/diarrhea. On each occasion noted above (11/5, 11/8, 11/12 and 11/15/21), the RN failed to notify the primary care physician (PCP) and/or endocrinologist of the patient’s elevated blood glucose, diarrhea, vomiting, missed medication, and there were no instructions for administration of insulin lispro. On 11/15/21 at 5:33 pm an office / on-call RN documented in an inter-office communication note the lab called with a critical glucose level of 509. The RN called the patient to recheck BG which was 336, and called the PCP office and left a message. The RN documented there was no on-call provider. The RN failed to follow-up with the PCP or contact the endocrinology office where the patient had an upcoming appointment. On 11/17/21 the patient’s RN case manager (CM) visited the patient for the first time and documented the patient’s BG was 175 with a range of 175-“high.” The RNCM failed to notify the physician of BG outside of parameters. WOUND On 10/26/21, during the initial comprehensive assessment, the admission RN documented the patient had 2 wounds: - wound # 1 left dorsal foot - wound # 2 left lateral foot On 11/08/21 the RN visited and documented undermining was present on lateral wound. On 11/12/21 the RN visited and documented the dorsal wound appeared to have a blood blister. On 11/17/21 the RNCM visited and documented a 2 cm x 2 cm black area / unstageable pressure injury on back of left heel. On each of the 3 above noted occasions, the RN and RNCM failed to inform the podiatrist of change in wound status to determine if any change to the POC was indicated. PAIN The agency POC included the following: -Oxycodone-acetaminophen 10-325 mg, 2 tablets every 6 hours as needed for pain MDD 4 tablets -Pregabalin (Lyrica) 150 mg three times per day -Notify MD if reported pain is above 8 On 11/29/21 the RN documented the patient reported sharp, throbbing, aching, shooting, pinching chronic lower back pain rated 10 on a scale of 1-10, relieved with rest and relaxation, not being addressed with medication appropriately and upcoming pain management appointment on 12/06/21. The RN failed to notify the physician of pain greater than 8 to develop an appropriate pain management plan. On 12/02/21 the surveyor completed an observational visit with the RN. During the observational home visit the patient reported he had no pain medications, that his Lyrica ran out, and that he was not prescribed oxycodone since leaving the hospital. On 12/06/21 at 1:15 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on a review of clinical records, and interviews with the Administrator, Director of Patient Services (DPS), Safety Coordinator, Home Care Manager, and agency staff, it was determined in 6 of 20 records (Patients # 3, 7, 10, 11, 17 and 19) the agency failed to ensure: - significant information is consistently being exchanged between individuals responsible for developing and implementing the plan of care - the registered nurses (RNs) and physical therapist (PTs) have a clear understanding of the role of the case manager. - the clinical managers understand their responsibility to ensure all clinicians are implementing the plan of care and communicating with each other. This was evidenced by: Patient # 11 was admitted to the agency on 10/13/21 with diagnoses of pulmonary embolism, muscle wasting and atrophy, protein-calorie malnutrition, heart disease, COPD, kidney disease, chronic back pain, and fractured vertebrae. The agency failed to coordinate care to ensure all of the patient's needs were met as follows: NUTRITION On 10/13/21 the admitting registered nurse (RN) visited for the assessment and documented the patient didn't have much of an appetite which was her norm. The patient's weight was not obtained. The hospital discharge summary included the patient has been nauseous and not eating lately. Referring diagnoses included muscle wasting and atrophy and protein-calorie malnutrition. The admitting RN also completed the Nutritional screening within the assessment, and obtained a score of 6, and prompts "high risk, potential referral to a dietician, MSW, and physician". A physician's note in the medical record dated 09/10/21 indicates the patient "suffers from severe caloric malnutrition with a BMI of 19. I recommended starting Remeron as an appetite stimulant which she is agreeable to". There was no evidence the admitting RN discussed the need for a registered dietician referral or if a visit was offered. On 10/25/21 the registered nurse (RN) made a referral to the social worker for "community resources, possibly assisted living. The patient has no support system at home." Physical Therapy The Physical therapy assistant visited the patient on 10/20/21 and documented the patient was sent to the Emergency room during the visit due to pain 10/10, headache, and high blood pressure. On 11/16/21 the physical therapist (PT) documented a lapse in PT services due to PT not being made aware the patient had returned home from the hospital. The patient returned home from the hospital on 10/20/21. The PT documented the patient returned to her prior level and was discharged. The registered nurse case manager failed to coordinate with physical therapy to ensure physical therapy services resumed. On 12/06/21 at 3:00 PM the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator, and Home Care Manager. They acknowledged the findings and provided no additional information. Patient # 3 was admitted to the agency 10/26/21 with diagnoses of type 2 diabetes with foot ulcer, osteomyelitis, cellulitis, hypertension and acute kidney failure. Failure to coordinate care to identify and ensure all patient needs were met resulted in the patient’s uncontrolled blood glucose levels, likely inhibited wound healing, and had the potential for severe consequences including diabetic ketoacidosis and death. The 10/26/21 agency plan of care included Admelog SoloStar (fast-acting insulin) subcutaneous (injection) maximum daily dose (MDD) 66 units 3 times per day diabetes before meals The Admelog order lacked sliding scale instructions (number of units to administer based on blood glucose reading) for administration. On multiple occasions (11/03, 11/05, 11/08, 11/15 and 11/17/21) the registered nurse (RN) visited the patient and documented the patient had diarrhea, vomiting and elevated blood glucose that required sliding scale insulin coverage. The RN failed to communicate with the physician to obtain sliding scale instructions, and failed to communicate / coordinate with the registered nurse case manager (RNCM) or nursing supervisor to address the patient’s ongoing symptoms and uncontrolled blood glucose. On 11/16/21 a “case review note” entered in the inter-office communications by the Supervising OT stated: “Patient being seen for wounds on foot; yesterday skin was macerated. MD recommended keeping wound vac off until visit Thursday. Patient’s blood sugar was 500 yesterday. Patient won’t go to ED and misses appointments for doctors.” The note failed to identify who was present at the case review. The care team failed to: - identify cause for elevated blood glucose(s) - coordinate care with patient’s primary care physician and / or endocrinologist - identify cause for missed appointments - discuss the need for medical social worker (MSW) service The patient’s RNCM failed to visit the patient until 11/17/21, more than 3 weeks after the patient was admitted to the agency. On 12/03/21 at 12:30 p.m. the surveyor interviewed the RN. The RN stated she was “obviously failing miserably,” but that she did contact the PCP and endocrinologist that day and spoke with a caseworker who can help the patient schedule and attend appointments. On 12/06/21 at 1:15 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and the CEO stated the management team met on 12/03/21, contacted the physician for sliding scale insulin and other medication orders, and came up with a plan to visit the patient twice daily over the weekend, then daily during the week, to ensure the patient was medically stable and needs were being met. 1. Patient # 17 was admitted to the agency on 01/22/21 with diagnoses of extensive deep vein thrombosis to the right lower extremity, pneumonia, pleural effusions, cirrhosis of the liver and history of pancreatic cancer. The physical therapist (PT) failed to coordinate care to ensure diabetes and skin were monitored leading to inadequate prevention and delayed treatment of pressure ulcers. The record was selected from the Centers for Medicare and Medicaid services (CMS) potentially avoidable adverse event report 08/01/2020-07/31/2021 for increase in number of pressure ulcers and discharge to the community with unhealed stage II pressure ulcer. On 01/22/21 the PT performed the start of care assessment which was incomplete regarding diabetic and skin assessments. The PT documented the physician was contacted regarding medications and the patient was not taking Tresiba long-acting insulin. The PT failed to coordinate to ensure a nursing assessment was arranged to assess and instruct regarding diabetic and skin status and ensure medication regimen was followed. The 01/22/21 Plan of Care included Novolog (short-acting insulin) “see sliding scale”. Tresiba (long-acting insulin) 10 units daily. The medication profile listed Novolog 0-2 units three times a day before meals with no details on the blood glucose (BG) measurements that would necessitate coverage. The PT failed to coordinate to ensure the plan was complete. During subsequent visits, the PT and PT assistant (PTA) documented incomplete information regarding blood glucose readings and if the patient was taking insulin, and documented pain to lower extremities as follows: - On 02/03/21 the PT documented pain in the lower extremities at a level of 3 on a scale of 1-10 which came and went and varied in intensity and BG’s “really high this AM" so the PT did not want to push the patient too hard. Reported to physician to call patient with direction. No changes to medications since SOC and “skin is intact at this time”. There was no documentation of whether the patient was taking ordered insulin or coordination with the physician instead of leaving it up to the patient. - On 02/05/21 the PTA documented a BG of 335 was reported by the patient with no further information regarding time and trends and whether the patient was taking insulin. - On 02/09/21 the PTA documented a BG of 235 and on 02/11/21 281 reported by the patient with no further information on time and ongoing trends. - On 02/16/21 the PT visited the patient no BG documented. - On 02/19/21 the PTA documented educating the patient on importance of skin inspection to reduce the risk of infection. The PTA performed skin inspection due to complaint of open wound and discovered a wound across the right heel, the patient had not been covering it but stated keeping an eye on it. The PTA called the provider and set up an appointment for the same day. There was no documentation of BG level. There was no evidence the sliding scale was clarified until 02/19/21 medication clarification to provider for 0 units for BG 0-199, and 2 units for BG 200-300. - On 02/22/21 the PT visited for an evaluation and documented BG 89 reported by patient with no further readings, time, or trends. The PT documented the patient's BG seems to be better under control, however it was never clear if the patient had started to take Tresiba after admission. - On 02/24/21 the PT documented in a communication note the patient had a large wound on the bottom of the right foot and the physician was called for skilled nursing visits. The physician wanted to see the patient prior to giving orders. - On 02/25/21 the PTA notified the PT the BG level was 20 and paramedics were at the home when the PTA arrived. The BG was 321 actual during the visit. The PT documented the MD was notified. The PTA documented the patient did not go to the appointment scheduled for 02/19/21. On 03/01/21 the registered nurse (RN) visited the patient and documented three wounds. Right heel 2.5x9.5x0.1, Left heel 0.7x1.2x0.1 and L posterior ankle 0.2x2x0.1. The BG level was reported as 282 by the patient and range of 100-300 per the patient. The RN documented the patient was taking Tresiba 6 units at bedtime, and the RN would call for verification. The 03/03/21 Emergency Medicine provider note revealed the patient was sent from the physician office reporting of a wound to the right heel since hospitalization in January, the wound never fully healed, had gotten worse recently, and the patient was struggling to walk during physical therapy, was sent to his PCP who told him to go to the hospital. The patient reported he had been caring for the wound and keeping it clean. The patient also had a wound to the left heel that developed over the last few days. The patient had pain when trying to bear weight. The podiatrist documented an unstageable pressure ulcer to the posterior heel with overlying black eschar, as well as left heel and left ankle fissures. On 12/06/21 at 3:00 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. HV Patient #7 was admitted to the agency on 10/20/21 with diagnoses of stage 3 pressure ulcer to the upper back, history of fractured hip, atrial fibrillation, and severe aortic stenosis. The agency failed to coordinate to ensure a new order for wound care was communicated to nursing staff and implemented. The 11/24/21 physician communication included a new order for wound care to a red area on the coccyx twice weekly and as needed for soiling or dislodgement. Ordered care included cleansing the area with wound cleanser or soap and water, applying skin prep and a foam pad with border. On 11/29/21 the RN visited the patient and there was no documentation of wound care or assessment of the new wound to the coccyx. On 12/02/21 at 9:15 am, the surveyor conducted an observational home visit with the RN who performed a urinary catheterization to obtain a urine sample and wound care to the upper back wound. The RN did not provide wound care to the coccyx. On 12/02/21 at 1:45 pm, the surveyor interviewed the RN who stated the caregiver had been applying barrier cream to the area and the RN was not aware of the wound or the orders for wound care to the area. The RN stated it may have come from the doctor and not communicated to the RN. On 12/06/21 at 3:00 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. Patient # 10 was admitted to the agency on 09/22/21 with diagnoses of stroke with hemiparesis, brain tumor, epilepsy, dysphagia, and lupus. The agency failed to coordinate to offer or provide medical social worker (MSW) service to address expressed family concerns. On 09/22/21 the physical therapist (PT) performed the start of care assessment and documented the spouse had concerns over patient safety due to impaired decision making and was concerned the patient would fall when no one was present. The PT suggested the use of cameras and recruitment of family/friends to assist. The spouse reported feeling overwhelmed due to the lack of family support. There was no evidence the care team discussed the need of MSW referral or a visit was offered. On 12/06/21 at 3:00 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. Patient # 19 was admitted to the agency on 10/05/21 with diagnoses of COVID-19, asthma, chronic pain, type 2 diabetes, and lupus. Per the 10/01/21 discharge summary, the patient had been on prednisone (steroid) during hospitalization, and was being discharged on 20 mg per day. The patient was on a sliding scale insulin for hyperglycemia during admission and was to follow up with primary care provider to monitor glucose and consider starting medications as necessary. The 10/01/21 discharge instructions directed the patient to check blood glucose levels before meals and at bedtime, keep a log of readings to bring to provider visits, and call provider for blood glucose levels less than 100 or greater than 200. The instructions also directed the patient to measure weight daily and call provider if gain of 2 or more pounds per day. On 10/05/21 the PT visited the patient for the start of care assessment and documented the patient had a diagnosis of diabetes, however, there was no documentation of blood glucose monitoring or equipment or coordination with the physician or team to clarify diabetes monitoring orders and facilitate obtaining needed equipment. The 10/05/21 Plan of Care included diabetic precautions, however, there were no orders for monitoring blood glucose and weight. On 10/11/21 registered dietician (RD) visited the patient and documented “the patient had just found out she has diabetes and does not yet have a glucometer”. The RD educated the patient on the importance of using the meter faithfully once she obtained it. There was no evidence the team discussed the issue and coordinated a plan to assist the patient with obtaining a monitor and providing education regarding diabetes and blood glucose monitoring. On 10/26/21 the RN visited the patient due to reports of abnormal vital signs flagging for possible sepsis. The RN failed to address diabetic status. On 11/17/21 the respiratory therapist documented asking nursing about "drawing blood work specifically Hgb A1c on client awaiting a response for a call to the physician if yes". The record did not contain any further communication regarding diabetes. On 12/08/21 at 9:15 am, the surveyor reviewed the record with the CEO, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. Failure to ensure that care is coordinated, and agency staff understand the role of case management resulted in negative outcomes for patients # 17 and the potential for negative outcomes for the agency patient population.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on review of the agency's Quality Assurance and Performance Improvement (QAPI) Program, review of the agency's policies and procedures and interviews with the Administrator, Director of Patient Services, Safety Coordinator, Director of Quality, Home Care Manager and agency staff, it was determined the Governing Authority failed to ensure an agency-wide data driven QAPI program was in place to identify systemic issues in patient care. The agency failed to: -ensure the scope of the QAPI program clearly analyzed, and tracked quality indicators, including adverse patient events, and other aspects of performance to enable assessment of processes of care, services, and operations. See G642 - ensure adverse patient events were tracked, analyzed, and preventative actions implemented aimed at improving performance to ensure that the improvements are sustained. See G 654 The cumulative effect of these systemic practices resulted in the agency's inability to ensure the provision of quality health care and self-identify areas in need of improvement which has the potential to result in negative outcomes for the entire patient population and adversely affect organizational operations.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on review of Quality Assessment/Performance Improvement (QAPI) program, meeting minutes, policies and procedures and interviews with the Administrator, Director of Patient Services and Safety Coordinator, it was determined the scope of the program was inadequate to identify, analyze and track quality indicators necessary to assess the agency's processes of care, services and operations. Evidence was as follows: On 11/30/21 the surveyor requested the Quality Assurance/Process Improvement (QAPI) plan, policies and procedures, QAPI meeting minutes and reports for the last 12 months. The QAPI Program failed to address the scope of the program as follows: - the QAPI committee failed to identify and address all areas identified as less than 79 % compliant, - failed to develop and implement appropriate action plans for non-compliant areas identified below 79%, - failed to review track adverse outcomes to determine if changes in agency programs and processes were necessary. Between January and November 2021, the QAPI committee met 6 times (01/29/21, 03/05/21, 05/28/21, 06/29/21, 08/31/21, 10/05/21). The meeting minutes included a report of the findings from the external auditor that included 7 areas with low compliance rates. The areas included but were not limited to: - medication profile signed at beginning of week; - weight and edema assessed, parameters, MD notified; - MD notified if orders not followed; - wound assessment is complete (including weekly measurements and documented); - diabetic patient's glucose readings are documented and include whether reading is reported or actual, fasting or post- prandial. The 08/2020 QAPI Program policy and procedure, meeting minutes identified areas monitored by an external auditor. Diabetic monitoring The outside auditor submitted data for Diabetic patient’s glucose documentation including timing. Compliance with this measure ranged from 25 % February 2021 and 29% August 2021 to 83% as the highest in July of 2021. During the 10/05/21 meeting there was discussion regarding sending out diabetic education in November and possible outreach to the auditor to determine if data for individual clinicians could be obtained. There was no immediate investigation and correction of ongoing issues with assessment of diabetic status leading to deficiencies found in this report. See G 526, G 536, G 574, G 578, G 590, and G 606. Weight and Edema monitoring The outside auditor submitted data for weight and edema assessed, parameters, MD notified. Compliance with this measure ranged from 0% for June, July and September 2021, 25% for April and May 2021, only one month at 100% August 2021. There was no immediate investigation and correction of ongoing issue leading to deficiencies found in this report. See G 578 and G 606. Following orders The outside auditor submitted data for MD notified if orders not followed. Compliance with this measure ranged from 44% in February and July 2021 to 67% in April and May 2021. There was no immediate investigation and correction of ongoing issues leading to deficiencies found in this report. See G 578 and G 606. Wound assessment The outside auditor submitted data for Wound assessment is complete. Compliance with this measure ranged from 23% in April and May 2021 to 89% in July 2021. There was no immediate investigation and correction of ongoing issues leading to deficiencies found in this report. See G 526. On 12/15/21 at 12:30 PM the surveyor interviewed the DPS and Safety Coordinator. They stated both were new to their positions and were aware of problems with consistent auditing and the need for correction of current issues. Failure to implement effective measures to improve care may prevent the agency correction of substandard areas of care and lead to adverse patient outcomes.

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on review of 5 closed records (Patients # 13-17), review of the agency's Quality Assessment Performance Improvement (QAPI) Program, and interviews with the Administrator, Director of Patient Services, Safety Coordinator and Director of Quality, it was determined that the agency failed to adequately review records of patients with adverse events, analyze their causes and implement preventive actions and failed to identify deficient practice for 2 of 5 records (Patients # 15 and 17). Evidence was as follows: 1. Patient # 17 was admitted to the agency on 01/22/21 with diagnoses of extensive deep vein thrombosis to the right lower extremity, pneumonia, pleural effusions, cirrhosis of the liver and history of pancreatic cancer. The record was selected from the Centers for Medicare and Medicaid services (CMS) potentially avoidable adverse event report 08/01/2020-07/31/2021 for increase in number of pressure ulcers and discharge to the community with unhealed stage II pressure ulcer. Significant issues were found with coordination of services to ensure wounds were identified and timely treatment initiated leading to a deterioration in skin status and to ensure the patient had the correct medications and doses to treat diabetes. See G 606. Deficiencies were also identified with the Plan of Care including a nonspecific sliding scale for short-acting insulin, lack of a plan for ongoing diabetic assessment, and unspecified diabetic supplies. The patient experienced fluctuations in blood sugars which may have been prevented with a clear plan for assessment and treatment. See G 574 2. Patient #15 was admitted to the agency on with diagnoses of type 2 diabetes with long-term insulin use, hip fracture around a prosthesis, metabolic encephalopathy and hypertension. The record was selected from the Centers for Medicare and Medicaid services (CMS) potentially avoidable adverse event report 08/01/2020-07/31/2021 for development of urinary tract infection. Deficiencies were identified with following the Plan of Care for blood sugars as ordered and failing to notify the physician when readings were out of parameters. See G 578 On 12/15/21 at 12:30 PM the surveyor interviewed the DPS and Safety Coordinator. They stated they were both new to the agency and were not given access to the iQIES website and were unaware of Potentially Avoidable Events reports and therefore had not reviewed patient records for adverse events. They had contacted a previous employee who stated they had been on hold. Failure to identify deficient practices after review of potentially avoidable events resulted in negative outcomes for the agency patient population.

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 observational home visits, review of agency policies and procedures and interviews with the Administrator, Director of Patient Services (DPS), Safety Coordinator, Home Care Manager, and agency staff, it was determined during 3 of 5 home visits (Patients # 2, 3 and 6), the nurse failed to follow accepted standards of infection control practices. Evidence was as follows: Failure to follow accepted standards of practice, and agency policy and procedure has the potential for unmet patient needs and possible negative patient outcomes. HV Patient #2 was admitted to the agency on 07/01/20 with diagnoses of cutaneous abscess of buttocks, cystostomy with a suprapubic catheter, urinary catheter, vesico-intestinal fistula, ileostomy, COPD, chronic kidney disease, and osteoarthritis. On 12/01/21 the surveyor conducted an observational home visit with the licensed practical nurse (LPN), observed wound care and suprapubic site care with dressing change. The agency plan of care included the following wound care to the right upper buttock, perineal tunneling abscess 3 x's per week, PRN for soilage dislodgement: Cleanse with mild soap and water, pat dry, apply Aquacel AG rope, cover with gentle foam border, skin prep peri-wound, and buttocks. The LPN removed and discarded the soiled dressing. Without changing the gloves, the LPN then cleansed the wound as ordered with gauze soaked with soap and water. The LPN failed to remove the soiled gloves, perform hand hygiene, and don clean gloves prior to cleaning the wound after handling the soiled dressing. A review of agency policy “Wound Care” dated 03/2020 revealed the policy did not address avoiding cross-contamination of wounds or when to change gloves. On 12/06/21 at 1:15 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator, and Home Care Manager. They acknowledged the findings and provided no additional information. HV Patient #6 was admitted to the agency on 10/12/21 with diagnoses that included type II diabetes with foot ulcer, cellulitis of the left lower limb, sepsis, osteomyelitis, heart disease, and orthostatic hypotension (positional low blood pressure). On 12/02/21 the surveyor conducted an observational home visit with the registered nurse case manager (RNCM) and observed wound care. The agency plan of care included the following wound care to the left foot, chronic ulceration daily, and PRN soilage: paint with betadine and cover with dry gauze and secure with Kerlix. During the procedure, the RNCM placed the old dressing and all other waste in the living room wastebasket. At the completion of the visit, the RNCM left the waste in the basket and departed. A review of agency policies “Wound Care” dated 03/2020, and “Identification, Handling and Disposal of Hazardous Waste” dated 08/2020, revealed neither policy addressed proper disposal of soiled dressings. Leaving hazardous biological waste has the potential for the spread of infection. On 12/06/21 at 1:15 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator, and Home Care Manager. They acknowledged the findings and provided no additional information. HV Patient # 3 was admitted to the agency 10/26/21 with diagnoses of type 2 diabetes with foot ulcer, osteomyelitis, cellulitis, hypertension and acute kidney failure. The agency plan of care included the following wound care to left dorsal foot, left lateral foot and left heel: Cleanse with saline, cover with adaptic, sterile 4 x 4 gauze, secure with tape or foam border dressing. On 12/02/21 at 4:45 p.m. the surveyor completed an observational visit with the SN and observed the following: The SN removed the soiled dressing, carried it in the kitchen and disposed of in the kitchen garbage can. The SN cleansed the wounds with gauze and normal saline, when finished the SN removed her soiled gloves and placed the soiled gloves and gauze on the carpeted floor. After donning new gloves, the SN applied adaptic to each of 3 wounds, covered with gauze, and began to wrap with kerlix. The patient asked about applying an ABD pad; the SN paused the dressing change to look in the supplies, and the adaptic and gauze fell off the wounds. The SN discarded the 3 pieces of gauze along with those previously discarded on the carpeted floor, and placed the adaptic on a clean field, one on top of each other. The SN proceeded with the dressing change, reusing the adaptic, thus potentially cross contaminating the wounds. After completing the dressing change the SN took the pile of gloves and gauze from the floor to the kitchen and disposed of in the trash can. Following the visit, the surveyor observed the trash can to be unlined, with a paper bag that came approximately 1/2-2/3 of the way up and was full to the top of the paper bag. Review of agency policies “Wound Care” dated 03/2020, and “Identification, Handling and Disposal of Hazardous Waste” dated 08/2020, revealed neither policy addressed avoiding cross contamination of wounds or proper disposal of soiled dressings. On 12/06/21 at 1:15 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on review of clinical records for patients receiving home health aide (HHA) service and interviews with the Administrator, Direction of Patient Services (DPS), Safety Coordinator, Home Care Manager and agency staff, evidence was lacking in 3 of 5 records (Patients # 1, 7 and 8), that agency staff developed complete and accurate aide written instructions. Evidence was as follows: Patient #1 was admitted to the agency on 04/29/21 with diagnoses of Parkinson’s disease, dysphagia, anxiety, depression, sleep apnea, and urinary retention. The 11/01/21 Plan of Care included home health aide (HHA) services twice weekly for 9 weeks. On 11/01/21 the registered nurse (RN) performed a start of care assessment due to a change in insurance coverage and currently had a mechanical lift (Hoyer) in the home. The 11/16/21 HHA care plan failed to include the Hoyer lift and the patient’s transfer status. On 12/06/21 at 3:00 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. Patient #7 was admitted to the agency on 10/20/21 with diagnoses of stage 3 pressure ulcer to the upper back, history of fractured hip, atrial fibrillation, and severe aortic stenosis. The 10/20/21 Plan of Care included HHA services two times a week for 8 weeks. On 10/20/21 the RN documented in the start of care assessment the patient had a stage 3 pressure ulcer to the upper back measuring 3.4cm long x2.5cm wide x0.2cm depth. The patient was incontinent and used depends. The RN documented the patient had no edema at the time of the assessment, but by the end of the day feet and ankles had some swelling. The 10/20/21 Plan of Care included support hose on in the am and off in the pm. The 11/11/21 home health aide care plan failed to include instructions regarding the support hose and instructions regarding management of incontinence. On 12/06/21 at 3:00 pm, the surveyor reviewed the record with the CEO, DPS, Director of Quality, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information. Failure to ensure that home health aide care plans are complete has the potential for unmet patient needs. Patient # 8 was admitted to the agency on 06/23/21 with diagnoses of pressure ulcer sacral region, multiple falls, chronic obstructive pulmonary disease, type 2 diabetes and hypertension. The 06/23/21 agency Plan of Care (POC) included aide services 3 times weekly. On 06/23/21 the skilled nurse (SN) visited the patient for an initial comprehensive assessment and documented the patient was incontinent of urine. On 08/20/21 and 10/20/21 the SN visited the patient to complete recertification assessments and documented the patient was incontinent of urine and stool. On 07/12/21 the physical therapist (PT) visited the patient and documented the patient had a personal emergency response system (PERS) that she was not wearing. Aide care plans dated 07/02/21, 08/20/21 and 10/20/21 failed to include: -instructions for managing incontinence / use of incontinence products -ensuring/reminding patient to wear PERS unit On 12/08/21 at 9:15 a.m., the surveyor reviewed the record with the CEO, Safety Coordinator and Home Care Manager. They acknowledged the findings and provided no additional information.

This Statement of Deficiencies Report is the result of a complaint survey (Complaint # NY00270617), conducted from 01/29/21 to 02/09/21. The survey included reviews of 3 medical records; complaint log; on-call logs; pertinent policies and procedures and .interviews with the Director of Patient Services (DPS), Nurse Manager (NM), Skilled Nurse (SN), and Authorization Specialist (AS). On 02/09/21 the clinical record findings were reviewed with the discussed the DPS and the NM. The allegation was substantiated. The following Federal Standard Level deficiencies were cited: G 484 Patients Rights; G 526 Comprehensive Assessment.

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on a review of 3 patient records, the agency's complaint log, and interviews with the Director of Patient Services (DPS) Nurse Managers (NM), and Skilled Nurse (SN), it was determined the agency failed to identify concerns voiced regarding patient care, investigate the concerns, and develop a plan to resolve the concerns. Evidence was as follows: 1. Patient # 1 was admitted to the agency on 10/09/20 with diagnoses of sepsis, pressure ulcers, and multiple sclerosis. The patient was initially receiving Skilled Nurse (SN) visits twice weekly for wound care and Foley catheter care. On 10/17/20, the (SN) visited and asked the patient if she had someone help her take sponge baths. The patient informed the SN that she did not. The SN told the patient she would get an order for a home health aide (HHA) and social work (MSW) services for rides to medical appointments. The SN obtained a physician's order for HHA services twice a week. On 012/11/21 the physicians orders for HHA services were decreased 1 time per week, and with no explanation, the HHA services were decreased even further to 1 HHA visit every 2 weeks. On 01/26/21, the SN documented a call received from a community nurse regarding the patient's urine appearing milky with sediment in the tubing of the catheter. On 01/29/21, the surveyor interviewed the community nurse who called to report the concern regarding the catheter. The community nurse informed the surveyor that when she spoke to the SN, she voiced her concerns about the patient's unkempt appearance, that her clothing was soiled, saturated in urine, appeared that they weren't changed in days, as well as the catheter issues. On 01/29/21, the surveyor requested the complaint log, there was no section for 2021. The DPS provided a summary of 1 complaint in process for 2021 and not yet in the log, and was regarding this patient. On 02/03/21, the surveyor interviewed the SN regarding the 01/26/21 note from the community nurse who reported the catheter issues. The SN stated that she called the urologist's office, obtained an order for a urine culture and sensitivity based on the call. The surveyor asked the SN if any other issues were reported during this call, the SN stated she couldn't. The surveyor asked about concerns regarding the patient's appearance and hygiene, the SN said "oh yes, she did mention that." The SN further explained the patient could not bathe herself and was dependent on her family, whom she did not like to bother. The SN continued that the patient's children worked and went to school, and her husband was very busy. The SN explained that the HHA visits and the SN visits were decreased to every other week due to the patient's insurance insurance restrictions, therefore, she was only bathed every 2 weeks. The surveyor asked the SN if she reported the caller's concerns or visited the patient to assess her physical condition, or discussed the concerns with her supervisor, the SN stated, "I think I told the nurse manager." On 02/03/21, the surveyor interviewed the Nurse Manager (NM), who reported that he had never been told about this phone call. The SN failed to recognize that the concerns voiced regarding the patient's condition required an investigation, and development of a plan to resolve the issues. Failure to document, investigate, and resolve complaints has the potential for unmet patient needs and possible agency-wide negative patient outcomes.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on a review of clinical records and interviews with the Director of Patient Services (DPS), Nurse Manager (NM), and Skilled Nurse (SN), it was determined in 2 of 3 records, the agency failed to ensure assessments were of sufficient scope to ensure all patient needs were identified. 1. Patient # 1 was admitted to the agency on 10/09/20 with diagnoses of sepsis, pressure ulcers, and multiple sclerosis. The skilled nurse (SN) failed to perform a complete and accurate comprehensive assessment of the patient's needs. On 10/09/20, the SN visited the patient and documented in the comprehensive initial assessment the patient had 2 pressure ulcers. The SN performed wound assessment, dressing change and obtained the following wound care orders: - stage 3 pressure ulcer of the ischium: cleanse with water, pat dry and use Hydrofiber Ag to the wound base, cover with foam border twice weekly and as needed (PRN) for soilage by Lourdes at Home (LAH) - newly epithelialized wound to coccyx: cleanse with warm water, pat dry, and cover with foam border pad once weekly and PRN for dislodgement by LAH. The 10/09/20 Home Health Certification and Plan of Care included SN visits twice weekly for 8 weeks and 3 PRN visits for increased wound drainage and if the dressing becomes dislodged. The 12/08/20 Home Health Certification and Plan of Care included the following dressing change orders: - stage 3 pressure ulcer of the ischium: cleanse with water, pat dry and use Hydrofiber Ag to the wound base, cover with foam border twice weekly and as needed (PRN) for soilage by Lourdes at Home (LAH) - 2 coccyx wounds: cleanse with warm water, pat dry, and cover with foam border pad once weekly and PRN for dislodgement by LAH and primary caregiver (PCG). On 12/11/20, the SN obtained an order to decrease the SN visits to one visit per week. The SN failed to determine who would perform wound care when the the SN wasn't available and failed to assess the competency of that individual. On 01/11/21, the SN obtained another physician's order to decrease SN visits to once every other week. During visits conducted between 12/11/20 and 01/11/21, the SN failed to provide wound care teaching, or assess the competency of the individual or individuals responsible to provide wound care twice a week. On 02/03/21, the surveyor interviewed the patient and asked who was providing wound care to when the SN decreased the frequency of visits. The patient stated that no one in her family was taught to perform wound care, in fact she recently asked the SN why she was receiving so many gauze pads. The SN stated that the gauze was supposed to be used to cleanse the wounds with water and pat dry. The patient informed the SN that her daughter was placing the dry gauze under the foam dressings which was not part of the wound care orders. Foley Catheter On 10/09/21, the SN visited the patient and documented the patient the presence of an indwelling urinary catheter inserted in the emergency room due to inability to void. On 10/27/20, the SN obtained catheter irrigation orders: - irrigate indwelling catheter with 30-60 ml of sterile water as needed for blockage/leakage by SN or caregiver. The SN failed to identify the person responsible for catheter irrigation and failed to assess competency of the person responsible to irrigate the catheter. On 02/03/21, the surveyor interviewed the SN and asked who she instructed in catheter irrigation, and where it would be documented. The SN stated that she never met the patient's children as they were in either in school or working. The SN stated she attempted to talk the son through the procedure over the phone without success. Although the SN informed the surveyor during the 02/03/21 interview that the SN and HHA visits were decreased due to insurance coverage, the SN failed to ensure the patient's needs were met by the patient's family; that the family was competent in wound care and catheter care and irrigation. On 02/09/21, the record was reviewed with the DPS, NM's, and Supervising Nurses. They acknowledged the findings and provided no additional information. 2. Patient #3 was admitted to the agency on 01/06/21 with diagnoses of complicated migraine, type 2 diabetes, and asthma. The physical therapist (PT) identified during the initial assessment that the patient did not have a primary caregiver and could not take injectable medications for diabetes. The PT documented the patient uses the following injectable medication: Lispro 14 units, 3 times per day (rapid-acting insulin), Levemir 36 units at bedtime (long-acting insulin), and Dulaglutide 1 syringe weekly (stimulates pancreatic insulin release), and reported a blood glucose of 152. The PT obtained an order for SN assessment for diabetic education and respiratory evaluation at the initial visit. The SN failed to visit the patient until 01/11/21, five days later to assess the patient's ability to administer anti-diabetic medications and manage diabetes. The SN failed to assess: - if the patient has a glucometer and test strips - competency using the glucometer - patients ability to self-administer insulin - knowledge of diabetic management including reporting parameters, and signs and symptoms of high and low blood sugar symptoms. On 02/09/21, the record was reviewed with the DPS, NM's, and Supervising Nurses, they acknowledged the findings. Failure to ensure comprehensive assessments are complete and accurately reflect the patient's status has the potential for negative outcomes for the agency patient population.