Lourdes at Home Chha

“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.”

“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.”

“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.”

“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.”

“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.”

“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.”