Every finding on record at Innovative Senior Care Home Health of Charlotte LLC

An onsite. unannounced recertification survey was conducted 6/9/25-6/11/25. No deficiencies to the Emergency Preparedness Plan were identified.

An onsite, unannounced recertification survey was conducted 6/9/25-6/11/25. Standard level deficiencies to the Medicare CoP were identified.

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 agency policy, direct observation, clinical record review, patient/caregiver interviews, and staff interviews the Plan of Care [POC] failed to included all the medications/correct medications the patient was taking for 5 of 7 patients who recieved home visits [#6, 11, 12, 7 and 8]; and the POC failed to include any vital sign parameters for 1 of 5 discharged records [# 5]. The findings included: 4. Patient # 7 had a start of care date of 5/24/25 with an admitting diagnosis of emphysema [a form of COPD [chronic obstructive pulmonary disease] characterized by damage to the tiny air sacs in the lungs, making it harder to breathe]. Review of the Plan of Care [POC] for the certification period 5/24/25-7/22/25 included orders for SN [skilled nursing] 1 time a week for 2 weeks, 2 times a week for 2 weeks, 1 time a week for 6 weeks and “...Skilled nurse to instruct on new and changed medications...” On 6/10/25 at approximately 12:30 pm a joint visit was made with RN # 18. During the visit a medication review was conducted using a medication profile provided by the agency. The following discrepancies were noted: Oxygen 2 liters continuously via nasal canula was listed on the medication profile with a date of 6/9/25. During an interview with patient # 7 he reported, “I haven’t used the oxygen unless I felt short of breath. I never did use it 100% of the time.” Oxycodone [pain medication] 5 mg – take 1 tablet by mouth every 4 hours as needed for pain level 4-6 or continuous pain level of 3-4. During the interview with the patient he reported he no longer uses the oxycodone. “I probably only took those pills for the first day or two after I came home.” Aspirin [anti-inflammatory medication] 81 mg daily was not listed on the medication profile. The patient reports taking this medication for “a long time”. During an interview with the director on 6/11/25 at approximately 11 am, the director confirmed the POC did not include all the correct/current medications. 5. Patient # 8 had a start of care 2/22/25 with an admitting diagnosis of type 2 diabetes mellitus with diabetic chronic kidney disease. Review of the Resumption of Care [comprehensive assessment completed after in-patient stay] Plan of Care [POC] for the certification period 5/7/25-6/21/25 included orders for SN [skilled nursing] 1 time a week for 7 weeks. On 6/10/25 at 9:45 am a joint visit was conducted with RN # 5. During the visit a medication review was conducted using a medication profile provided by the agency. The following discrepancies were noted: The medication profile included losartan [blood pressure medication] 100 mg each day. The patient had prepackaged medications in the home. RN # 5 advised the patient’s daughter used the prepackaged medications to prefill the medication planner. The prepackaged losartan was 50 mg daily. The patient had paroxetine [anti-depressant] 20 mg daily in the prepackaged medications and aspirin [anti-inflammatory] 81 mg daily in the prepackaged medications. During an interview with the patient, the patient advised she used the medications which were prepackaged. During an interview with the agency director on 6/11/25 at 11 am, the director confirmed the POC did not include all the correct/current medications. 6. Patient # 5 had a start of care date of 3/14/24 with an admitting diagnosis of type 2 diabetes mellitus with diabetic chronic kidney disease. Review of the Plan of Care [POC] for the certification period 5/13/24-7/11/24 included orders for PT [physical therapy] 1 time a week for 6 weeks and OT [occupational therapy] 1 time a week for 1 week, 2 times a week for 1 week, 1 time a week for 4 weeks. Review of the patient’s expressed goals on the plan of care revealed “Right shoulder to stop hurting and blood sugar fairly stable, blood pressure down.” The POC did not include any vital sign/pain/blood sugar parameters. During an interview with the agency director on 6/11/25 at 2 pm, the director confirmed the POC should have included certain parameters. A policy, Monitoring Medications, (revised 07/1/2024), was presented by the agency director on 6/11/2025 at 11:55 am. The policy stated, “...all clinicians will participate in medication review and reconciliation throughout the episode.” A policy, Plan of Care (POC)(4/1/25), was provided by the agency director on 6/11/25, at 8:49 am. The Policy stated, “...The POC includes medications and treatments...” 1. Patient #6 was admitted on 5/5/2025 with a diagnosis of type 2 diabetes (adult onset) with foot ulcer (a pressure wound on foot that is common with diabetes). The plan of care for 5/5/2025-7/3/2025 included orders for SN (skilled nursing) 2 times a week for 1 week, 3 times a week for 7 weeks, 2 times a week for 1 week. During a home visit on 6/9/2025 at approximately 9:30 am with registered nurse (RN) #7, a medication review was conducted using a medication list provided by the agency and the following discrepancy was noted: Gabapentin (used to treat nerve pain) was listed on the medication list as 400 mg 3 times a day, the prescription bottle directions read 800mg 2 times a day and the patient revealed that he took this medication as prescribed on bottle. During an interview on 6/9/2025 at 12:45 pm, when asked “how often do you do a complete medication review?” RN #7 stated that she checks the meds at each visit and RN #7 confirmed that the medications on the plan of care were incorrect. 2. Patient #11 was admitted on 5/22/2025 with a diagnosis of chronic right heart failure (the right side of the heart does not pump effectively, leading to a buildup of fluid and pressure). The plan of care for 5/22/2025 - 7/20/2025 included orders for PT (physical therapy) 1 time a week for 1 week, 2 times a week for 2 weeks, and 1 time a week for 4 weeks. During a home visit on 6/10/2025 at approximately 2:00 pm with PT #9, a medication review was conducted using a medication list provided by the agency and the following discrepancies were noted: The medication list did not include Tylenol (used for pain or fever) 500mg 2 tablets every 6 hours as needed for pain. Lasix (used to treat fluid retention) 40mg was listed on the medication list as 2 times a week as needed. The prescription bottle directions read daily as needed. The patient stated he took Lasix daily. Gabapentin (used to treat nerve pain) was listed on the medication list as 300 mg 3 times a day, the prescription bottle directions read 3 times a day as needed, and the patient stated he took 2 tabs at bedtime and sometimes another tab during the night. Pramipexole (used to treat restless legs) 0.5mg was listed on the medication list as 1 tablet daily. The prescription bottle directions read 2 tablets as needed at bedtime. May take up to 4 tablets daily. The patient revealed that he took 2 tablets at about 8:30pm and then he took another tablet when he was going to sleep, and sometimes another tablet during the night if his “legs are jumping”. During an interview on 6/10/2025 at 2:32 pm, when asked “how often do you do a complete medication review?” PT #9 stated,“I do a med review each visit”. PT #9 confirmed that the medications on the plan of care were incorrect. 3. Patient #12 was admitted on 4/14/2025 with a diagnosis of pressure ulcer right heel stage 3 (a wound caused by pressure that extends through the full thickness of the skin and into the fat layer). The plan of care for 4/14/2025-6/12/2025 included orders for SN (skilled nursing) 3 times a week for 6 weeks, 2 times a week for 1 week, 3 times a week for 1 week, and 2 times a week for 1 week. During a home visit on 6/11/2025 at approximately 9:30 am with registered nurse (RN) #16, a medication review was conducted using a medication list provided by the agency and the following discrepancy was noted: Gabapentin (used to treat nerve pain) was listed on the medication list as 600 mg 2 times a day, the prescription bottle directions read 4 times a day as needed, and the patient revealed that she took this medication as prescribed on bottle. During an interview on 6/11/2025 at 9:42 am, when asked “how often do you do a complete medication review?” RN #16 stated, “I check the meds each visit” and RN #16 confirmed that the medications on the plan of care were incorrect.

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 agency policy, clinical record review, and staff interviews, the agency failed to obtain a physician's order for a urine specimen obtained via in and out catheterization for 1 of 1 patients with an indwelling catheter [#15]; and failed to obtain a physician's order to increase the bulb size of an indwelling catheter for 1 of 1 patients with an indwelling catheter [#15 ]; and failed to change an dwelling catheter in four weeks for 1 of 1 patients with an indwelling catheter [#15 ]. The findings included: The policy, Physician Orders [10/1/ 23], was received on 6/11/25 at 9:49 am from the director. The policy stated...” No medications, treatments...studies...will be administered without the order of a qualified physician...” 1A. Patient # 15 had a start of care date of 2/12/25. Review of the Plan of Care [POC] for the certification period 4/13/25-6/11/25 included a diagnosis of hypo-osmolality [low blood osmolality- the concentration of dissolved substances in the blood is low and is usually caused by an excess of water relative to sodium] and hyponatremia [low sodium in the blood] and encounter for fitting and adjustment of urinary device. Further review of the POC revealed orders for SN [skilled nursing] visits 2 times a week for 3 weeks, 1 time a week for 6 weeks and “...Clinician to obtain urine and test via reagent strip. If results are positive, urine to be sent to lab for UA [urinalysis]...” Review of the clinical record revealed RN # 17 conducted a visit on 4/14/25 and documented, “...16-french foley catheter inserted...Upon insertion urine specimen was collected and given to ________ [ALF name] staff for UTI [urinary tract infection] testing. There was no evidence that the RN followed the physician’s order related to testing via reagent strip. During an interview with the agency director on 6/11/25 at 2 pm, the director confirmed the RN failed to follow the physician’s order related to testing urine via reagent strip and did not obtain an order for an urine specimen obtained by in and out catheterization. 1B. Patient # 15 had a start of care date of 2/12/25. Review of the Plan of Care [POC] for the certification period 4/13/25-6/11/25 included a diagnosis of hypo-osmolality [low blood osmolality- the concentration of dissolved substances in the blood is low and is usually caused by an excess of water relative to sodium] and hyponatremia [low sodium in the blood] and encounter for fitting and adjustment of urinary device. Further review of the POC revealed orders for SN [skilled nursing] visits 2 times a week for 3 weeks, 1 time a week for 6 weeks and “...Skilled nurse for insertion of 16 fr [French] 10 cc balloon indwelling catheter....” Review of the clinical record revealed RN # 17 conducted a visit on 4/14/25 and documented, “...16 french foley catheter inserted...with 30-cc balloon...” Further review revealed no evidence that the RN obtained an order for a 30-cc balloon. During an interview with the agency director on 6/11/25 at 2 pm, during the interview the director confirmed the physician’s order was for a 10-cc balloon. 1C. Patient # 15 had a start of care date of 2/12/25. Review of the Plan of Care [POC] for the certification period 4/13/25-6/11/25 included a diagnosis of hypo-osmolality [low blood osmolality- the concentration of dissolved substances in the blood is low and is usually caused by an excess of water relative to sodium] and hyponatremia [low sodium in the blood] and encounter for fitting and adjustment of urinary device. Further review of the POC revealed orders for SN [skilled nursing] visits 2 times a week for 3 weeks, 1 time a week for 6 weeks and “...Skilled nurse for insertion of 16 fr [French] 10 cc balloon indwelling catheter...change every 4 weeks and PRN [as needed]. Review of the clinical record revealed RN # 17 changed the foley catheter on 4/14/25. RN # 17 conducted a routine visit on 5/15/25 and documented, “Patient has indwelling foley catheter...catheter will be changed next visit...” Further review of the clinical record revealed RN # 17 changed the foley catheter during the 5/23/25 visit. During an interview with the agency director on 6/11/25 at 2 pm, the director confirmed the foley should have been changed on 5/12/25.

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 agency policy, clinical record review, and staff interviews, the agency failed to notify the physician of changes in patient condition for 3 out of 12 patients current on service [#12, #16, #17]. The findings included: 2. Patient # 16 had a Start of Care date of 4/17/25 with an admitting diagnosis of multiple fracture of ribs, right side. Review of the Plan of Care for the certification period 4/17/25-6/15/25 revealed supplemental orders dated 4/20/25 for SN [skilled nursing] 3 times a week for 1 week, 2 times a week for 3 weeks, 1 time a week for 4 weeks. Review of the clinical record revealed LPN # 1 conducted a routine visit on 5/14/25 and documented the following information, “...SN reviewed change to magnesium with Pt [patient] and caregiver [wife]. Pt was taking one tablet. Instructions are to take 2 tabs daily...” Review of the clinical record revealed no evidence that LPN # 1 notified the physician that the patient was taking the wrong dose of medication. During an interview with the agency director on 6/11/25 at approximately 2 pm, the director confirmed the physician should have been notified. 3. Patient 17 had a Start of Care [SOC] date of 5/13/25 with admitting diagnoses of encounter for change or removal of surgical wound dressing, and malignant neoplasm [cancer] of right main bronchus [lung]. Review of the Plan of Care [POC] for the certification period 5/13/25-7/11/25 included orders for SN [skilled nursing] 4 times a week for 1 week, 3 times a week for 3 weeks, 2 times a week for 4 weeks, 1 time a week for 1 week; PT [physical therapy] 1 time a week for 1 week, 2 times a week for 2 weeks, 1 time a week for 4 weeks; OT [occupational therapy] 1 time a week for 4 weeks and “...When vital signs are obtained licensed professional to report vital signs falling outside the following established parameters...systolic [top number of blood pressure] less than 90 or greater than 150, diastolic [bottom number of blood pressure] less than 60 or greater than 110, pain level greater than 7...” Review of the clinical record revealed OT # 8 documented a blood pressure of 92/42 on 5/14/25. There was no evidence that the physician was notified. RN # 18 documented a visit on 5/31/25 and recorded a pain level of 10. There was no evidence that the physician was notified of the pain level. A policy, Coordination of Care, From Admit Through Discharge (revised 9/1/2024), received from the agency director on 6/11/2025 at 8:49 am states “At admission, throughout care, and at discharge, coordination of services is promoted through routine communication with the patient’s physician…when changes occur in the patient’s condition or response to treatment…” 1. Patient #12 was admitted on 4/14/2025 with a diagnosis of pressure ulcer right heel stage 3 (a wound caused by pressure that extends through the full thickness of the skin and into the fat layer). The plan of care for 4/14/2025-6/12/2025 included orders for SN (skilled nursing) 3 times a week for 6 weeks, 2 times a week for 1 week, 3 times a week for 1 week, and 2 times a week for 1 week. Review of the clinical record revealed that on the 5/27/2025 nursing visit, the patient’s right heel wound was measured at 0.6 x 2 x 0.2 by RN #16. On the 6/2/2025 nursing visit, the right heel wound was measured at 1.2 x 1.9 x 0.2 by RN #16. There was no documentation that the physician had been notified of the increase in wound size. During an interview with the agency director on 6/11/25 at approximately 1:30 pm, the director confirmed that no documentation was in the record that the physician was notified.

Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This STANDARD is not met as evidenced by: Based on agency policy, clincal record review, and staff interviews the SN [skilled nurse] failed to obtain PICC [peripherally inserted central catheter, is a long, thin tube inserted into a vein and guided to a central vein in the chest, allowing for long-term access to the bloodstream] line measurements for 1 of 1 patient with a PICC line [#13]. The findings included: The policy, Dressing Change Procedure for Central Venous, Midline and Peripherally Inserted Central Catheters [10/1/16], was provided by the agency director on 6/11/25 at 11:55 am. The policy stated, “...Inspect catheter, catheter exit site...Obtain upper arm circumference (approximately 5 cm above exit site) ...Measure external length of catheter from the insertion site to the catheter hub...” Patient # 13 had a start of care date [SOC] of 4/15/25 with admitting diagnoses of type 2 diabetes mellitus with foot ulcer and encounter for adjustment and management of VAD [vascular access device is a medical device that provides access to the bloodstream, allowing for repeated or long-term infusion of medications, fluids, or blood products, or for blood sampling]. The Plan of Care [POC] for the certification period 4/15/25-6/13/25 included orders for SN [skilled nursing] 3 times a week for 1 week and “...Skilled nurse to perform site care for infusion access device PICC [peripherally inserted central catheter, is a long, thin tube inserted into a vein and guided to a central vein in the chest, allowing for long-term access to the bloodstream] to RUE [right upper extremity] with transparent dressing changes a week [sic] and PRN...” Review of the clinical record revealed RN # 14 completed the SOC assessment on 4/15/25. Review of RN # 14’s documentation revealed the OASIS [Outcome and Assessment Information Set- It is a standardized data set used by home health agencies to collect and report information about their patients, including their clinical conditions, functional status, and other relevant details] question “does the patient have infusion access” was answered No. Further review of the documentation on 4/15/25 revealed no assessment/measurement of the PICC line site. Further review of the clinical record revealed RN #16 conducted a visit on 4/16/25 and documented, “PICC line dressing intact...” There was no evidence that the PICC line or arm circumference was measured. The patient received 12 nursing visits from SOC until the PICC line was discontinued and removed on 5/23/25. There was no evidence of PICC line/arm circumferences in 12 of 12 SN visits. During an interview with the director on 6/11/25 at approximately 2 pm, the director confirmed the PICC line/arm circumference should have been measured weekly with dressing changes.

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on agency policy, clinical record review, and staff interviews, the skilled nurse failed to include specific items on the Plan of Care related to caring for 1 of 1 patient with a PleurX drainage system [a type of indwelling catheter used to drain excess fluid from the chest or abdomen] [#17]. The findings included: A policy, Plan of Care (POC) [4/1/25] was provided by the agency director on 6/11/25, at 8:49 am. The Policy stated, “...Each patient has an individualized Plan of Care developed in consultation with the patient, physician...that integrates comprehensive assessment findings to address patient problems, needs...” Patient # 17 had a Start of Care date of 5/13/25 with admitting diagnoses of encounter for change or removal of surgical wound dressing, and malignant neoplasm [cancer] of right main bronchus [lung]. Review of the Plan of Care [POC] for the certification period 5/13/25-7/11/25 included orders for SN [skilled nursing] 4 times a week for 1 week, 3 times a week for 3 weeks, 2 times a week for 4 weeks, 1 time a week for 1 week and “Skilled nurse may perform up to 3 PRN [as needed] visits for...need for additional pleurx catheter drainage...” Review of the clinical summary found on the POC revealed the following documentation by RN # 5, “SOC [start of care] clinical summary- The patient was recently hospitalized Dx [diagnoses] of lung cancer with metastatic disease. He was dc’d [discharged] 5/9/25. The patient’s primary focus of care is pleurx cath [PleurX drainage system is a type of indwelling catheter used to drain excess fluid from the chest or abdomen] drainage and teaching...”Further review of the POC revealed no specific physician’s order related to drainage of the PleurX , no order related to PleurX drainage dressing changes, and no specific order related to the amount of fluid that could safely be removed each time. During an interview with the agency director on 6/11/25 at approximately 3 pm, the director confirmed the POC should have included specific orders related to the PleurX drainage system.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on clinical record review and staff interviews, the skilled nurse failed to document information related to the drainage [amount of drainage/appearance of drainage] obtained when accessing a PleurX [type of indwelling catheter used to drain excess fluid from the chest or abdomen] for 1 of 1 patient with a PleurX [#17]. The findings included: Patient #17 had a Start of Care [SOC] date of 5/13/25 with admitting diagnoses of encounter for change or removal of surgical wound dressing, and malignant neoplasm [cancer] of right main bronchus [lung]. Review of the Plan of Care [POC] for the certification period 5/13/25-7/11/25 included orders for SN [skilled nursing] 4 times a week for 1 week, 3 times a week for 3 weeks, 2 times a week for 4 weeks, 1 time a week for 1 week and “Skilled nurse may perform up to 3 PRN [as needed] visits for...need for additional pleurx [sic] catheter drainage [PleurX drainage system is a type of indwelling catheter used to drain excess fluid from the chest or abdomen]...” Review of the clinical record revealed RN # 5 conducted the SOC visit on 5/13/25. Review of the documentation revealed the amount of drainage/appearance of drainage was not documented. RN # 16 conducted a routine visit on 6/2/25. There was no documentation of the amount of drainage removed by the PleurX and the appearance of the drainage. During an interview with the agency director on 6/11/25 at approximately 2 pm, the director confirmed she would expect to see the amount of drainage/appearance documented each time the PleurX was drained.

An unannounced on-site recertification survey was conducted 6/13/22-6/15/22. No deficiencies to the Emergency Preparedness Plan were identified.

An unannounced on-site recertification survey was conducted 6/13/22-6/15/22. Standard level deficiencies to the Medicare CoP were identified.

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 agency policy, clinical record review and staff interviews the agency failed to provide SN [skilled nursing] services [frequency] in accordance with the Plan of Care [POC] for 1 of 14 active records [# 19 ]. The findings included: Patient # 19 had a Start of Care [SOC] date of 4/15/55 and an admitting diagnosis of Unspecified Open Wound to Right Hip. A review of the Plan of Care [POC] for the certification period 4/15/22 to 6/13/22 included orders for SN [skilled nurse] 1 time a week for 3 weeks, 2 times a week for 6 weeks. A review of the clinical record revealed only 1 SN visit was made the week of 5/8/22 and the week of 5/15/22. Further review of the clinical record revealed no evidence as to why the visits were not made or any evidence the physician was notified of the missed visits. An interview was conducted with RN # 12 on 6/15/22 at approximately 12:45 pm. During the interview the RN confirmed the SN visits were not completed in accordance with the POC.

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 agency policy, clinical record review and staff interviews the agency failed to include all components to the Plan of Care [POC] for 2 of 19 records reviewed[#3, 16]. The findings included: The policy, Plan of Care [revised date 12/02/21], was provided by RN # 12 on 6/14/22 at approximately 1:15 pm. The policy stated, “The POC includes…functional limitations and activities permitted, nutritional requirements, medications and treatments…” 1A. Patient # 3 had a Start of Care [SOC] date of 5/19/22 and admitting diagnoses of Malignant Neoplasm of Pharynx, Other Complications of skin Graft, Disruption of External Operation Wound and Encounter for Adjustment and Management of VAD [vascular access device]. A review pf the Plan of Care [POC] revealed the following information “Nutritional Requirements: PEG [percutaneous endoscopic gastrostomy] FEEDINGS” . The POC did not include the type of feedings or the amount to be fed. An interview was conducted with RN # 5 on 6/15/22 at approximately 10 am. During the interview the RN stated, “I had the information in my notes, I just didn’t put it on the 485. The patient was getting Glycernia [sic] 2 cartons 3 times a day.” During an interview with the executive director on 6/15/22 at approximately 2:30 pm, the director stated, “I would expect to see the type and amount of feedings on the POC.” 1B. Patient # 3 had a Start of Care [SOC] date of 5/19/22 and admitting diagnoses of Malignant Neoplasm of Pharynx, Other Complications of skin Graft, Disruption of External Operation Wound and Encounter for Adjustment and Management of VAD [vascular access device]. A review pf the Plan of Care [POC] included orders for SN [skilled nursing] 1 time a week for 9 weeks and “Skilled nurse to perform site care for PICC [peripherally inserted central catheter] line to rt [right] upper arm with dressing changes weekly…”A review of the clinical record revealed a referral dated 5/18/22. The referral included an order to “Arrange for home infusion therapy…Infuse Cefazolin 2 grams every 8 hours for 6 weeks”. A review of the POC did not include Cefazolin as a current medication. An interview was conducted with RN # 5 [RN who completed the admission visit] on 6/15/22 at 10 am. During the interview the RN confirmed the patient had Cefazolin ordered at the time he was discharged from the hospital. The RN also confirmed the patient was flushing with 3 ml of Heparin and 10 ml of normal saline each day. The Heparin nor the Normal Saline were included on the POC. During an interview with the Executive Director on 6/15/22 at approximately 2:30 pm. The Director confirmed the Cefazolin, the Heparin and the Normal Saline should have been included on the POC. 2. Patient # 16 had a Start of Care [SOC] date of 2/28/22 and admitting diagnoses of Pressure Ulcer Right Heel, Stage 4 and Diabetes Mellitus. A review of the Plan of Care [POC] for the certification period 2/28/22 to 4/28/22 revealed the following documentation “Activities Permitted: Wheelchair”. Further review of the clinical record revealed referral information dated 2/25/22 from _______[name of facility]. A review of the referral information revealed the following directions,”…Must Maintain Non-Weight Bearing to Left Lower Extremity per Podiatry…” An interview was conducted with RN # 12 on 6/15/22 at approximately 2 pm. During the interview RN # 12 confirmed the POC should have reflected the non-weight bearing status.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on agency policy, clinical record review and staff interviews the agency failed to follow the Plan of Care [POC] related to wound care for 2 of 11 records with a wound [#4, 5]; notifying the physician when vital signs were out of the given parameters for 1 of 5 discharged records [#12]; related to weight bearing restrictions for 1 of 8 patients receiving physical therapy [#11]. The findings included: 4. Patient #11 was admitted to the agency on 05/15/22 with diagnoses including left humerus (upper arm bone) fracture, Alzheimer’s disease, and hypertensive chronic kidney disease. Plan of Care from 05/15/22 to 07/13/22 revealed orders for physical therapy 1 time per week for 1 week, 2 times per week for 4 weeks, 1 time per week for 2 weeks, and 1 time every 2 weeks for 2 weeks. Employee #11, the admitting physical therapist, conducted the initial assessment on 05/15/22. This visit note revealed, “…Unable to locate any ortho (orthopedic) follow up with [name of physician] in patient’s chart to find the weight bearing status for LT UE (left upper extremity)/shoulder-will follow up with [name of assisted living facility director]…” Employee #16, a physical therapist, conducted a visit on 05/26/22. This visit note revealed, “Patient seen today for transfer training, gait training, and bilateral upper extremity and lower extremity strengthening…” In an interview on 06/15/22 at 10:15 AM, Employee #11 stated, “June 8th was the day that I got the confirmation from [the orthopedic physician] that she was weight bearing as tolerated…” and confirmed that clinicians should not have been performing exercises to Patient #11’s left upper extremity prior to 06/08/22. In an interview on 06/15/22 at 11:00 AM, Employee #16 stated that Patient #11 performed, “…a couple of gentle range of motion exercises of the upper extremity…bilaterally…My recollection is that she was able to weight bear as tolerated to both right and left upper extremity…” Employee #16 did not have access to Patient #11’s clinical record at the time of interview. The policy, Plan of Care [revised date 12/01/21], was provided by RN # 12 on 6/14/22 at approximately 1:15 pm. The policy stated, “Each patient has an individualized Plan of Care [POC] developed in consultation with the patient, physician or authorized practitioner, and staff that integrates comprehensive assessment findings to address patient problems, needs and goals…” 1. Patient # 4 had a Start of Care [SOC] date of 5/9/22 and admitting diagnoses of Pressure Ulcer of Left Buttock, Stage 2 and Type 2 Diabetes Mellitus with Hyperglycemia. A review of the Plan of Care [POC] for the certification period 5/9/22 to 7/7/22 included orders for SN [skilled nursing] 2 times a week for 1 week, 1 time a week for 1 week, 2 times a week for 1 week, 1 time a week for 1 week, 2 times a week for 5 weeks and “Skilled nurse to perform/instruct/reinforce patient/caregiver procedure [sic]of wound care to left buttocks…” A supplemental order was written on 5/10/22 to “Clean wound with mild soap and water or wound cleanser, pat dry, apply Medi-honey and cover with foam dressing 2 times per week…” A review of the clinical record revealed LPN # 3 made a routine visit on 5/12/22 and documented the following information, “…No wound care supplies on hand today. Patient has buttocks area including wound well covered with barrier cream…Barrier cream left in place due to no supplies…” Further review of the clinical record revealed no evidence the LPN notified the physician the wound care was no preformed in accordance with the POC. LPN # 3 was not available for interview. An interview was conducted with RN # 12 on 6/15/22 at approximately 12:30 pm. During the interview the RN confirmed wound care was not done in accordance with the POC. 2. Patient # 5 had a Start of Care [SOC] date of 5/5/22 and an admitting diagnosis of Unspecified Open Wound of Right Breast. A review of the Plan of Care [POC] for the certification period 5/5/22 to 7/3/22 included orders for SN [skilled nursing] 1 time a week for 1 week, 3 times a week for 8 weeks, 2 PRN [as needed] for wound complications and “Skilled nurse to perform patient procedure of wound care to right breast Monday, Wednesday, and Friday. Cleanse with normal saline or Antasept. Apply silver alginate to wound bed…” A review of the clinical record revealed RN # 2 documented on 5/9/22 [Monday] “Patient’s dressing changed by caregiver; no visit needed…” An interview was conducted with RN # 12 on 6/15/22 at approximately 2 pm. During the interview the RN confirmed the wound care was not completed in accordance with the POC. 3. Patient # 12 had a Start of Care [SOC] date of 4/29/21 and admitting diagnoses of Laceration without Foreign Body, Left Lower Leg, Chronic Obstructive Pulmonary Disease [COPD] and Essential Hypertension. A review of the Plan of Care [POC] for the certification period 10/26/21 to 12/24/21 included orders for SN [skilled nursing] 1 time a week for 1 week, 2 times a week for 1 week, 1 time a week for 5 weeks and “Licensed professional to report resting vital signs falling outside the following established parameters…pain greater than 6…” A review of the clinical record revealed LPN # 7 conducted routine visits on 10/29/21 and 11/3/21. A review of the visit note documentation dated 10/29/21 and 11/3/21 revealed a pain rating of 7 in the ribs. Further review of the visit note documentation revealed no evidence the LPN notified the physician of the pain level falling outside the given parameters. LPN # 7 was not available for an interview. An interview was conducted with RN # 12 on 6/15/22 at approximately 2 pm. During the interview the RN confirmed there was no evidence the LPN notified the physician of the pain level in accordance with the Plan of Care

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 agency policy, clinical record review and staff interviews the agency failed to communicate with the physician when a patient had indications of self-inflicted wounds for 1 of 1 record reviewed [#5]; changes in a wound status/new areas of breakdown for 2 of 10 records with a wound [#9, 19]. Findings include: The policy, “Coordination of Care [revised date of 8/1/19] was provided by RN # 12 on 6/14/22 at approximately 1:15 pm. The policy stated, “ …Coordination of care with physician…When changes occur in the patient’s condition or response to treatment…Coordination of care among disciplines…All clinicians will report within 1 business day to the Patient Care Manager or Clinical Manager …Significant changes in the patient’s condition ” 1. Patient # 5 had a Start of Care [SOC] date of 5/5/22 and admitting diagnoses of Unspecified Open Wound of Right Breast and Unspecified Intellectual Disabilities. A review of the Plan of Care [POC] for the certification period 5/5/22 to 7/3/22 included orders for SN [skilled nursing] 1 time a week for 1 week, 3 times a week for 8 weeks and “Skilled nurse to perform patient procedure of wound care to right breast Monday, Wednesday and Friday. Cleanse with normal saline or anasept. Apply silver alginate to wound bed…” A review of the clinical record revealed RN # 2 made a routine visit on 5/16/22 for wound care. Further review of the clinical record revealed the following documentation by RN # 2, “Patient seen for wound care. Appears to have behavioral issues including history of self-inflicted wounds caused by picking at self.” During an interview with RN # 2 on 6/15/22 at approximately 930 am, the RN stated, “No, I didn’t notify the physician of my findings…I would think he would already know.” 2. Patient # 9 had a Start of Care [SOC] date of 4/29/22 and an admitting diagnosis of Hypertensive Heart and Chronic Kidney Disease with Heart Failure and Stage 1-4 Unspecified Chronic Kidney Disease. A review of the Plan of Care [POC] for the certification period 4/29/22 to 6/27/22 included orders for SN [skilled nursing] 1 time a week for 1 week, 2 times a week for 8 weeks and “Skilled nurse to perform wound care to RLE [right lower extremity] open blister wound. Cleanse with wound cleanser. Apply calcium alginate silver. Cover with foam adhesive…” A review of the SN visit note dated 5/12/22 and completed by RN # 5 revealed the following documentation, “…Pt [patient] does have 2 intact blisters on both inner LLE [left lower extremity] will continue to monitor both.” There is no evidence the RN contacted the physician related to the new blisters. An interview was conducted with RN # 5 on 6/15/22 at approximately 10:30 am. During the interview the RN stated, “I thought I notified the physician. If I did it will be in the chart.” An interview was conducted with RN # 12 on 6/15/22 at approximately 1 pm. During the interview the RN stated, “I can’t find any documentation where the physician was notified of the blisters.” Further review of the clinical record revealed RN # 2 made a routine visit on 5/23/22. A review of the SN visit note revealed RN # 2 documented the following information, “…New blister measuring 4x2 cm filled with serous liquid intact to LLE [left lower extremity].” There was no evidence the RN notified the physician of her findings. An interview was conducted with RN # 2 on 6/15/22 at approximately 9:30 am. During the interview the RN stated, “I don’t recall if I called the physician. That information doesn’t ring a bell.” An interview was conducted with RN # 12 on 6/15/22 at approximately 1 pm. During the interview, RN # 12 confirmed there was no evidence the physician was notified of RN # 2’s findings. 3. Patient # 19 had a Start of Care [SOC] date of 4/15/22 and an admitting diagnosis of Unspecified Open Wound to Right Hip. A review of the Plan of Care [POC] for the certification period 4/15/22 to 6/13/22 included orders for SN [skilled nurse] 1 time a week for 3 weeks, 2 times a week for 6 weeks and “Skilled nurse to perform procedure of wound care to rt [right hip]…Cleanse with NS [normal saline] or soap and water. Apply Alginate AG. Cover with foam adhesive…” LPN # 6 completed a routine visit on 6/4/22. A review of the visit documentation revealed the following information, “…Odor from wound. SN will discuss possible new wound care orders with ______ [name] RN from _______ [agency name] HH [home health]…” Further review of the clinical record revealed no evidence the LPN had notified the physician of her findings. LPN # 6 was not available for interview. An interview was conducted with RN # 12 on 6/15/22 at approximately 1:30 pm. During the interview the RN confirmed the LPN did not notify the RN or the MD of the change in the wound .

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 observation during a virtual visit and staff interview the registered nurse failed to change gloves/perform hand hygiene after cleaning a wound and before obtaining clean 4x4's from a pack of clean 4x4's for 1 of 5 virtual visits [#16]. The findings included: Patient #16 had a Start of Care 02/28/2022. The Plan of Care (POC) for the certification period of 04/29/2022 to 06/27/2022 included diagnoses of Pressure ulcer of right heel, stage 4; type 2 diabetes mellitus with diabetic chronic kidney disease. Services provided included skilled nurse (SN) 1 time per week for 1 week, 3 times per week for 1 week, 1 time per week for 1 week, 3 times per week for 5 weeks, 6 times per week for 1 week and 1 time per week for 1 week. The wound care order is: “Skilled nurse to cleanse wound to right heel with wound cleanser, prepare periwound area with skin prep, allow to dry. Fill entire area with black foam sponge. Cover with transparent drape and apply tubing. Apply negative pressure device at 125mm/hg (millimeter of mercury/ unit of pressure) (continuous). Dressing to be changed 3x per week…” A virtual home visit was conducted with SN #2 on 06/14/2022 at 10:30 am. During the dressing change SN #2 was observed reaching into a sleeve of clean 4x4’s with the same gloved hand as she had cleaned the wound without changing gloves. This resulted in cross contamination of the clean 4x4’s. Employee #12, clinical manager, was onsite with SN#2 during the home visit. An interview with employee #12, clinical manager, on 06/15/2022 at approximately 3:00 pm confirmed having witnessed the nurse causing cross contamination.

Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This STANDARD is not met as evidenced by: Based on clinical record review and staff interview, the agency failed to assess and provide nursing services as ordered for 1 of 1 record with a delay in skilled nursing Start of Care. Findings include: Patient #18 had a Start of Care [SOC] date of 05/06/2022 and an admitting diagnosis of acute on chronic Congestive Heart Failure. A review of the referral for home health services dated 5/3/22 revealed the physician ordered Physical therapy [ PT], Occupational therapy [OT] and Skilled nursing [SN]. The Plan of Care [ POC] for the certification period 05/06/2022 to 07/04/2022 included orders for SN 2 times per week for 1 week; 1 time per week for 1 week; 2 times per week for 3 weeks. Further review of the clinical record revealed a supplementary order was written on 5/13/22. The order stated, “…HHSN [home health skilled nursing] to eval [evaluate] and treat large R [right] lower leg skin tear x 2 Q [every] 3 day drsg [dressing] changes with Xeroform dressing, ABD pad, Kerlix and tape. SN PRN [as needed] change if bloody or soiled.” A second supplementary order for wound care was obtained on 5/20/22. The order stated, “…SN to A/M [sic] wound to right 2 opened area trauma wound lowe [sic] leg. Cleanse with wound cleanser or NS [normal saline] pat dry xeroform abd kerflix [sic] secure with tape twice weekly x 4 weeks 2 PRN complications…” Further review of the clinical record revealed the initial nursing evaluation on 5/25/22 approximately 22 days after the referral was received and 5 days after the last order for wound care was received]. There was no evidence the nurse conducted an initial evaluation as indicated in the referral, provided visits per the POC, or provided nursing or wound care per the 5/13/22 and 5/20/22 physician orders until 5/25/22. An interview with the clinical manager on 06/15/2022 at 1:59 pm confirmed orders were not followed.

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 policy review, clinical record review and staff interview, the agency failed to follow up timely with the physician regarding a new onset of urinary burning with odor for 1 of 19 clinical records reviewed (#2), failed to notify the physician that the patient was not weighing herself and/or did not have a scale for 1 of 19 clinical records reviewed (#2), and failed to notify the physician regarding a significant change in wound status (#8) for 1 of 11 patients with wounds . Findings include: Policy 2.1.017 titled Coordination of Care, From Admit Through Discharge was received from the agency director on 06/14/22 at 1:15 PM. This policy revealed, “The agency provides care and services within an integrated continuum of care system. This is accomplished by…identifying patient needs through assessment and communication with other health care providers…coordinating patient care among various disciplines to ensure that services are continuous and coordinated from admission through discharge…In the event that a physician cannot be reached to communicate the status of a patient the following will occur…Medical Director and/or Supervisor will be contacted for assistance with contacting physician…Patients with critical needs as determined by the clinician will be advised to seek emergency medical treatment” 1a. Patient #2 was admitted to the agency on 5/21/22 with diagnoses including sepsis (systemic infection), toxic gastroenteritis (inflammation of stomach due to infection), toxic colitis (inflammation of the colon due to infection), colon cancer, heart failure, atrial fibrillation (abnormal heart rhythm), personal history of urinary tract infections, and chronic kidney disease. Plan of Care from 05/21/22 to 07/19/22 revealed orders for skilled nursing 1 time per week for 9 weeks, physical therapy 1 time per week for 1 week, 2 times per week for 4 weeks, and 1 time per week for 3 weeks effective 05/22/22, occupational therapy 1 time per week for 7 weeks effective 05/22/22. Orders of discipline and treatments included, “…skilled nurse to provide instructions related to heart failure including but not limited to definition of heart failure, measures to prevent heart failure, signs and symptoms of heart failure, measures to manage heart failure…skilled nurse to evaluate patient and develop plan of care (POC) in coordination with physician…” On 06/01/22, Employee #8, a registered nurse, conducted a skilled nursing visit. This visit note revealed, “Pt (patient) has urinary burning, states has odor to urine. Called [name of physician] requested order for UA (urinalysis). Awaiting response…” On 06/05/22 at 2:21 PM, Employee #8 entered a coordination that stated, “Received call Friday from PCP (primary care physician) office that regarding [sic] signs and symptoms of UTI (urinary tract infection), patient needed to see urology. SN (skilled nurse) called patient daughter [sic] and notified her of the same she agreed to make appt (appointment)…” There was no evidence in the clinical record regarding follow up with the primary care physician between the 06/01/22 skilled nursing visit and the 06/05/22 coordination note. In an interview on 06/15/22 at 2:25 PM, Employee #13, the agency director, was asked what the expectation of follow up would be in this situation and stated, “She (Employee #8) should follow up the next day or if it’s the weekend, the next business day…” Employee #8 was not available for interview at the time of survey. 1b. Patient #2s Plan of Care from 05/21/22 to 07/19/22 revealed orders for skilled nursing 1 time per week for 9 weeks. Ordered interventions included, “…skilled nurse to provide instructions related to heart failure including but not limited to definition of heart failure, measures to prevent heart failure, signs and symptoms of heart failure, measures to manage heart failure…skilled nurse to evaluate patient and develop plan of care (POC) in coordination with physician…” Employee #5, a registered nurse, conducted the OASIS (Outcome and Assessment Information Set) admission visit on 05/21/22. This visit note revealed a documented weight of 162 pounds and non-pitting edema of the left lower extremity. Employee #5 conducted a skilled nursing visit on 05/27/22. This visit note revealed documented skilled interventions provided including, “5. Instruct Patient/Caregiver on the importance of daily weights to detect fluid retention. Details/Comments: Patient/caregiver repeats instructions completely and accurately on teaching/training provided about weighing.” Employee #8 conducted a skilled nursing visit on 06/01/22. During this visit, Employee #8 documented Patient #2’s weight as 167 pounds, a 5-pound increase since the admission visit. This visit note also revealed “…Instructed on CHF (congestive heart failure) mgmt. (management) & the need to get digital scales in the home & begin recording daily wt. Instructed on s/s of heart failure and angina and the causes of heart problems.” There was no evidence of a documented weight after the 06/01/22 skilled nursing visit and no documentation that the physician was notified that Patient #2 was not obtaining daily weights as a measure to manage heart failure. In an interview on 06/15/22 at 2:25 PM, Employee #13, the agency director, confirmed that there was no evidence that the physician was notified that Patient #2 was not obtaining daily weights and stated if a scale is not available, “…we can do measurements of the calf/ankle area, assess & monitor if there is edema, educate on low sodium diet, baked foods versus fried, etc…” Employee #8 was not available for interview at the time of survey. 2. Patient #8 was admitted to the agency on 12/17/20 with diagnoses including Stage 2 pressure ulcer of the left ankle, chronic kidney disease, hypertension, Type 2 diabetes, and Alzheimer’s. Plan of Care from 04/16/21 to 06/14/21 revealed orders for skilled nursing 1 time per week for 4 weeks. Employee #9, a registered nurse, conducted a skilled nursing visit on 05/14/21. Patient #8’s left ankle wound was measured 0.3 centimeters length x 0.3 centimeters width x 0.1 centimeters depth. There was no evidence of bleeding. Pain was documented at 4 on a 0 to 10 scale. Employee #10, a licensed practical nurse, conducted a skilled nursing visit on 05/18/21. There were no documented wound measurements at the time of this visit. The wound was noted with a small amount of bleeding when the bandage was removed. Pain noted while cleaning the wound. Employee #10 conducted a skilled nursing visit on 05/25/21. Patient #8’s left ankle wound measured 0.8 centimeters length x 0.5 centimeters width x 0.2 centimeters depth. There was documented swelling to the left leg, knee, and ankle and noted as “tender”. This visit note also revealed, “Pain noted during treatment with facial expression & groaning. Called [physician name] to get an order for a new treatment. Message left.” On 06/03/21, Employee #9 documented a coordination note that revealed, “SN called to set up visit and PCG (patient’s caregiver) requested to be discharged from agency stating the patient will be going to see her provider soon and will no longer need the HHS (home health services). SN called and left message notifying MD of PNT/PCG (patient and patient’s caregiver) request for discharge…skilled nurse to discharge patient from agency per patient/caregiver request. MD made aware.” Employee #9 conducted the agency discharge on 06/06/21. There was no evidence of any contact further contact with the physician between the initial call on 05/25/21 and the notification of request for discharge on 06/03/21. In an interview on 06/15/22, Employee #13, the agency director, confirmed that there was no evidence in the clinical record that a clinician spoke to the physician regarding the change in Patient #8’s wound.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on clinical record review and staff interviews the clinical record failed to include a transfer summary for 1 of 5 discharged records [#5]. The findings included: Patient # 5 had a Start of Care [SOC] date of 5/5/22 and an admitting diagnosis of Unspecified Open Wound of Right Breast. A review of the Plan of Care [POC] for the certification period 5/5/22 to 7/3/22 included orders for SN [skilled nursing] 1 time a week for 1 week, 3 times a week for 8 weeks, 2 PRN [as needed] for wound complications. A review of the clinical record revealed the patient was discharged on 5/26/22 with her wound care to be managed by the wound clinic. Further review of the clinical record revealed no discharge summary was completed until 6/16/22. During an interview with RN # 12 on 6/15/22 at approximately 1 pm. The RN stated, “I just completed the discharge summary this morning.”