Safe Hands Home Health Care

“Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient’s eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse (RN) conducted an initial assessment visit within 48 hours of referral, the patient’s return home, or physician ordered start of care date in 2 (P-1 and P-6) of 10 sample records reviewed resulting in a delay in determining the patient’s immediate care and support needs (See G514); failed to ensure the comprehensive assessment accurately reflected the patient’s current health status in 4 (P-3, P-4, P-5, and P-6) of 10 sampled records reviewed resulting in incomplete clinical information for determining the needs of the patient (See G528); and failed to ensure the comprehensive assessment accurately reflected medications the patient was currently taking in 4 (P-1, P-2, P-7, and P-8) of 10 sample records reviewed resulting in the agency being unaware of medications taken by the patient and the potential for harmful medication effects and poor patient outcomes (See G536). The cumulative effects of this systemic problem resulted in the Home Health Agency’s inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR 484.55 Comprehensive Assessment of Patients.”

“Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This Element is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the rights of the patient regarding participation in, being informed about, and consenting, or refusing care furnished by the agency in 1 (P-1) of 4 patient’s in which a joint visit occurred, resulting in the patient’s preference not being respected. Findings include: P-1: This 58-year-old was admitted to the agency on 8/22/24 with diagnoses including right sided paralysis after a stroke; chronic kidney disease; and type 2 Diabetes. On 8/26/24 at 3:50 p.m., a joint home visit was made with the registered nurse (RN). Upon entry and introduction, P-1 began immediately questioning the RN to why the RN was not contacting him regarding visits. The RN stated that she (the RN) had tried calling him but when she was not able to get through, she called his mother to set up a time for the visit. It was noted that P-1’s mother did not reside in the same home. P-1 stated that he was fully capable of making his own decisions for the visit schedule and that his mom did not update him on any care decisions made with the agency. P-1 discussed this issue for several minutes and reiterated the point over again. P-1 stated that his son could help him with the phone when needed. It was noted that one of P-1’s sons (appearing as a young adult), was in the home at the time of the visit and assisting P-1 with all needs requested. During record review on 8/27/24, it was noted that the RN completed the Comprehensive Assessment on 8/22/24 and documented that P-1 was alert and oriented x 4 (person; place; time; and situation), able to focus and shift attention, comprehends and recalls task directions independently and without cues; and demonstrated necessary skills to self-manage disease process. It was also noted that P-1 signed consents for home health care. During review of the Plan of Care, the following was documented in the section “Advance Directives”, “This patient does not have an advanced care plan or a surrogate decision maker and is not able to provide legal documentation for the home health medical record.” Finally, during review of the referral documentation and progress notes sent by the rehab facility and signed by the physician on 8/1/24, the following was documented: “Advanced Directive: Patient deemed competent to make medical decisions.” There was no documentation in the medical record that the mother was either appointed by P-1 or had any legal authority to make decisions on the part of P-1 regarding visits or care provided by the agency. These findings were reviewed and acknowledged during interview on 8/29/24 at 12:30 p.m. with the Assistant Administrator (Staff A); the Director of Operations (Staff B); and the Clinical Manager (Staff C).”

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse (RN) conducted an initial assessment visit within 48 hours of referral, the patient’s return home, or physician ordered start of care date in 2 (P-1, 6) of 10 sample records reviewed resulting in a delay in determining the patient’s immediate care and support needs, and the potential for poor patient outcomes. Findings include: Agency policy titled “Initial Assessments/Comprehensive Assessments”, revised October 2017, was reviewed on 8/28/24. On page 2., it stated “5. Initial Assessment and Time Frame: A RN, PT or SLP must conduct the initial assessment visit within 48 hours of referral, within 48 hours of the patient’s return home or on the physician-ordered start of care date.” P-1: This 58-year-old was admitted to the agency on 8/22/24 with diagnoses including right sided paralysis after stroke; chronic kidney disease; and type 2 Diabetes. The medical record was reviewed on 8/27/24. During review, it was noted the signed physician referral was dated 8/1/24. It was also noted that P-1 would be discharging from a skilled care rehab, but the date of discharge was unclear from the rehab paperwork. The last progress note from the skilled rehab was dated 8/1/24. The comprehensive assessment was completed by the RN on 8/22/24 (21 days later than the dated referral). During interview on 8/29/24 at 12:30 p.m. with the Assistant Administrator (Staff A), query was made to which day P-1 discharged from the skilled rehab as this was not able to be determined from information in the medical record. Staff A reviewed a texting system that the agency used (not part of the medical record) in which staff would communicate with one another. Staff A stated that it appeared P-1 was discharged on 8/8/24 (14 days prior to the start of care) and that staff sent messages regarding attempts to contact P-1 using this system however, there was no reflection of these attempts in the medical record and no follow up with the referring physician regarding the delay in start of care. The agency failed to conduct the initial assessment within 48 hours of the patient’s return home. P-6: This 77-year-old patient was admitted to this agency on 7/24/24 with the diagnoses of type II diabetes, atrial fibrillation, and congestive heart failure. During record review on 8/28/24, it was noted the initial referral for services was written on 7/19/24. Upon further review of the record, it was determined the initial assessment visit was completed by the registered nurse on 7/24/24 – 5 days after the referral was written. The Administrator (Staff A) was queried regarding the late start during an interview on 8/29/24 at 11:30 AM. Staff A was able to show staff communication regarding issues scheduling this patient, however, he was unable to provide evidence the physician was notified to request a change in the start of care date. Staff A reported the physician on this case is an attending physician and is “impossible to find.” Staff A acknowledged the findings.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient’s current health status in 4 (P-3, P-4, P-5, and P-6) of 10 sampled records reviewed resulting in incomplete clinical information for determining the needs of the patient and the potential for poor patient outcomes. Findings include: P-3: This 71-year-old was admitted to the agency on 5/9/24 with diagnoses including type 2 Diabetes; ulcers to both left and right feet; high blood pressure. The medical record was reviewed on 8/28/24. The comprehensive assessment was completed and signed by the RN on 5/9/24 and included a primary diagnosis of type 2 diabetes with foot ulcer. In the section “Endocrine”, the RN marked the box “No problems identified” and included a comment “Patient denies to check blood sugar” [sic]. Diabetes was not marked as an endocrine issue in the section, and no assessment information was obtained regarding the diagnosis (blood sugar ranges; diabetic care; or diabetic management options). It was unclear what the patient’s current health status was relating to the primary diagnosis of type 2 Diabetes. This finding was reviewed and acknowledged during interview on 8/29/24 at 12:30 p.m. with the Assistant Administrator (Staff A); the Director of Operations (Staff B); and the Clinical Manager (Staff C). **Policy titled “Initial Assessments/Comprehensive Assessments” (revised October 2017) stated, “8. The Initial Comprehensive Assessment also includes:….Drug allergies…..Psychosocial status, functional and cognitive status.” P-4: This 70-year-old patient was admitted to this agency on 7/13/24 with the diagnoses of surgical aftercare following surgery for a cystectomy (removal of the bladder) as the result of a malignant neoplasm of the bladder (bladder cancer). During record review on 8/26/24, it was noted the handwritten Medication Profile completed by the nurse during the comprehensive assessment on 7/13/24 identified morphine and codeine as allergies for this patient. During further review of the record, it was noted the plan of care (dated 7/13/24) reported “NKA” (No known allergies to Food/Drugs/Latex/Environment). Additionally, review of the medical history sent from the doctor, it was noted the patient also has allergies to Keflex and sulfadiazine. During an interview on 8/29/24 at 11:30 AM, the Administrator (Staff A) was queried regarding the findings above. Staff A stated he was not sure why it was reported the patient had no known allergies, when it was clear the nurse identified them during the evaluation. Staff A acknowledged the findings. P-5: This 85-year-old patient was admitted to this agency on 5/22/24 with the diagnoses of a stage 2 pressure ulcer on the left hip, hypertensive heart and chronic kidney disease with heart failure, and unspecified chronic kidney disease. During record review on 8/28/24, it was noted the Outcome and Assessment Information Set (OASIS) dated 5/22/24 noted under “Section GG: Prior Functioning: Everyday Activities” on the Outcome and Assessment Information Set (OASIS) dated 5/22/24 that the patient was “Dependent” (fully reliant on the assistance of others) for all self-care. Upon further review of the OASIS, it was determined discharge goals were set for “independent” in eating and oral hygiene and “partial/moderate assistance” for all other self-care activities. This information is conflicting and does not paint a clear picture of the patient’s current or previous function. P-6: This 77-year-old patient was admitted to this agency on 7/24/24 with the diagnoses of type II diabetes, atrial fibrillation, and congestive heart failure. During record review on 8/28/24, it was noted the OASIS dated 7/24/24 reported the patient “Needed Some Help” for self-care, indoor mobility, stairs, and functional cognition under “Section GG: Prior Functioning: Everyday Activities.” Goals were set on the OASIS under “Section GG: Self-Care” and “Mobility” that patient would require “Partial/moderate assistance” for all activities at discharge – including high-level activities such as walking 150 feet, going up and down 12 stairs, and picking items up off the floor. Additionally, the physical therapy evaluation dated 7/25/24 reported under “Prior Level of Function” that the patient was “Dependent on caregiver for all activities.” The physical therapy evaluation also reported the “Patient is non ambulatory. Patient is bed bound” and “Transfers not applicable as patient is bed bound.” The information is conflicting and does not provide a clear picture of the patient’s current or potential status. Findings were reviewed with and acknowledged by the Administrator (Staff A) during an interview on 8/29/24 at 11:30 AM.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the comprehensive assessment accurately reflected medications the patient was currently taking in 4 (P-1, P-2, P-7, and P-8) of 10 sample records reviewed resulting in the agency being unaware of medications taken by the patient and the potential for harmful medication effects. Findings include: P-1: This 58-year-old was admitted to the agency on 8/22/24 with diagnoses including right sided paralysis after stroke; chronic kidney disease; and type 2 Diabetes. On 8/26/24 at 3:50 p.m., a joint home visit was made with the registered nurse (RN). During the visit, P-1’s blood sugar (BS) was tested using an in-home glucometer and found to be 325 milligrams/deciliter (mg/dL) which is a high reading. The RN questioned the patient regarding the finding. P-1 reported that he had been taking his insulin but had recently eaten. The RN questioned him about the insulin and stated that P-1 had not previously reported taking insulin. The RN called P-1’s physician during the visit to verify that the patient should be taking insulin and received verbal instruction for current orders. It was noted that P-1 had both Humalog (short acting insulin-lispro) and Lantus (long-action insulin-glargine) in the home (stored in the refrigerator) and had been using them with help from his son. It was unclear how much insulin P-1 had been using. The in-home written patient medication log from the agency start of care visit did not have either insulin preparations listed at the start of the visit. The medical record was reviewed on 8/27/24 and contained the physician progress notes attached from the skilled rehab facility that P-1 was discharged from. The latest physician progress note dated 8/1/24 (same day as signed referral) stated “Impression and plan… #4 type 2 diabetes continue current glycemic control with long-action insulin glargine and SGLT2 inhibitor dapagliflozin” [sic]. The comprehensive assessment was completed and signed by the RN on 8/22/24. It was noted in the section “Admission Summary/F2F Addendum”, the following was documented, “Son in home assisting with medication and insulin”. In the section “Endocrine”, insulin was not selected as one of the “Diabetic Management Options”. During review of the plan of care (POC) dated 8/22/24, no insulin (short or long acting) was noted on the list of medications until after the home visit on 8/27/24. Dapagliflozin (oral diabetes medication) was listed. During interview on 8/29/24 at 12:30 p.m. with the Assistant Administrator (Staff A) and the Clinical Manager (Staff C), this finding was reviewed. Staff A stated that the RN was not notified by the patient at the start of care (SOC) visit and Staff C stated that the skilled rehab always has insulin orders. When queried to why the referral information with medications was not reviewed and reconciled with the patient/physician at the SOC, no explanation was able to be given. The agency failed to ensure the comprehensive assessment included an accurate reflection of the medications taken by the patient. P-2: This 79-year-old was admitted to the agency on 4/3/24 with diagnoses including pressure ulcer of the left ankle (unstageable); Multiple Sclerosis; and high blood pressure. On 8/27/24 at 11:35 a.m., a joint home visit was conducted with the home health aide. During the visit, interview was conducted with P-2’s wife (caregiver) regarding the admission packet and medication list. It was noted that a written list of medications was in the home and signed by the nurse on 4/3/24 and included the following medications: 1. Gemtesa 75 milligrams (mg) daily (for urinary retention) 2. Metoprolol Succinate 100 mg daily (for high blood pressure) 3. Losartan Potassium 100 mg daily (for high blood pressure) 4. Methocarbamol 500 mg two times daily (muscle relaxer) 5. Lyrica 25 mg two times daily (treatment of nerve pain). P-2’s wife was queried to whether the list reflected P-2’s current medication list. P-2’s wife stated that P-2 was not taking all the medications on the list and brought out the following 2 medications in their prescription bottles from the pharmacy and 1 store bought supplement: 1. Metoprolol Succinate ER 50 mg – instructions on the bottle stated “take one tablet… daily” 2. Losartan Potassium 25 mg- instructions on the bottle stated “take one tablet… daily” 3. One A Day Men’s 50+ Multivitamin/Multimineral Supplement bought from store P-2’s wife stated that P-2 was only taking the 3 medications (above) as instructed per the bottle, not what was written in the home medication log. P-2’s wife also stated that she purchased the One A Day supplement recently and gave it once daily because he had run out of prescribed vitamin D. The medical record was reviewed on 8/28/24. The comprehensive recertification assessment was completed by an RN on 7/29/24 and documented in the section “Visit Interventions” that a medication review was completed and noted there were medication discrepancies but did not indicate what discrepancies were identified. During review of the POC for the certification period of 8/1/24- 9/29/24, it was noted that the medications listed included all the medications and dosages written in the home medication log, and included an additional medication, Vitamin D 125 micrograms once daily (not on the home medication log). On 8/29/24 at 12:30 p.m., this finding was reviewed with Staff A and Staff C. When queried which medications and dosages the patient should be taking, Staff A and Staff C were unable to give an answer. P-7: The Start of Care (SOC) was dated 7/25/24. The Plan of Care (POC) identified diagnoses of Cervicalgia, Spinal Stenosis, Muscle Weakness and Diabetes Type 2. During record review on 8/27/24, it was noted that the medication profile dated 7/25/24 states, “Insulin Lispro 100 unit/ML 8 units three times per day subcutaneous.” During a joint home visit on 8/27/24, the patient was questioned on Insulin Lispro dosage and stated, “I take 12 units three times per day.” When questioned for how long she has been taking the 12 units, she replied, “I have been taking that dose for years.” The patient is taking a total of 12 units of Insulin Lispro 100 unit/ML extra each day than what is list on the medication profile. The agency failed to have an accurate medication profile. P-8: The Start of Care (SOC) was dated 7/15/24. The Plan of Care (POC) identified diagnoses of Parkinson’s, Diabetes Type 2 and Falls. During record review on 8/27/24, it was noted that the Physical Therapist completed an evaluation assessment on 7/18/24 and documented, “Dependence on supplemental oxygen.” Additionally, the Skilled Nursing visit completed on 7/24/24 stated, “Respiratory: Oxygen use, intermittent. LPM (Liters Per Minute) 2. Intermittent Via Options: Nasal Cannula.” The medication profile completed on 7/15/24 failed to include Oxygen. These findings were reviewed with and acknowledged by the Staff A (Assistant Administrator) and Staff B (Director of Operations) and Staff C (Clinical Manager) during an interview on 8/29/24 at 9:50 am.”

“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 record review and interview, it was determined that the agency failed to ensure the Plan of Care included objectively measurable and individualized goals in 5 (P-4, 5, 8, 9, 10) of 10 records reviewed; patient specific and individualized orders based on referral and assessment of needs in 1 (P-10) of 10 records reviewed; and safety precautions in 3 (P-4, 5, 8) of 10 records reviewed, resulting in a potential for failure to measure progress toward achievement of desired outcomes. Findings include: **Agency Policy: “Plan of Care – CMS #485 and Physician Orders,” (Revised October 2017). The policy states, “4. The individualized plan of care must include the following: Safety measures to protect against injury. Patient-specific interventions and education, measurable outcomes and goals identified by the Agency and the patient.” P-8: The Start of Care (SOC) was dated 7/15/24. The Plan of Care (POC) identified diagnoses of Parkinson’s, Diabetes Type 2 and Falls. During record review on 8/27/24, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patient/Caregiver will be able to verbalize signs and symptoms of cardiac complications, when to call physician, nurse or 911 by 8/10/24.” Additionally, another goal stated, “Patient/Caregiver will verbalize understanding and demonstrate compliance with prescribed care to improve health status and minimize long-term debilitating diabetes complications by 8/10/24.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. Additionally, it was discovered that no weight parameters to notify the physician and oxygen precautions were documented on the POC. P-9: The Start of Care (SOC) was dated 4/27/24. The Plan of Care (POC) identified diagnoses of Chronic Kidney Disease and Congestive Heart Failure. During record review on 8/28/24, it was noted that the goals within the POC were not measurable. For example, one goal stated, “SN (Skilled Nurse) to instruct patient on nonpharmacologic pain relief measures, including relaxation techniques, massage, stretching, positioning, and/or hot/cold packs by 5 weeks.” Additionally, another goal stated, “Patient will have no acute care hospitalizations, ER visits nor readmissions during this episode of care.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. P-10: The Start of Care (SOC) was dated 8/1/23. The Plan of Care (POC) identified diagnoses of Stage 4 Pressure Ulcer and Prostate Cancer. During record review on 8/28/24, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patient/Caregiver will demonstrate ability to effectively manage medication regimen by the end of the episode.” Additionally, another goal stated, “Patient will manage improvement of symptoms regarding hydronephrosis by dc.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. These findings were reviewed with and acknowledged by the Staff A (Assistant Administrator) and Staff B (Director of Operations) and Staff C (Clinical Manager) during an interview on 8/29/24 at 10:30 am. P-4: This 70-year-old patient was admitted to this agency on 7/13/24 with the diagnoses of surgical aftercare following surgery for a cystectomy (removal of the bladder) as the result of a malignant neoplasm of the bladder (bladder cancer). During record review on 8/26/24, the following examples of skilled nursing goals were noted on the plan of care: “Patient will return to stable cardiovascular status regarding HTN, Hyperlipidemia and verbalized improvement to symptoms by dc.” “Patient/Caregiver will be able to demonstrate management of urinary device and signs/symptoms to report by dc.” These goals are vague, not measurable, and not patient specific. Additionally, it was noted the physical therapy evaluation dated 7/15/24 identified the patient had “moderate pain” to her stomach, right shoulder, and low back radiating to her right leg. Upon review of the physical therapy goals, it was noted there was no goal set to monitor/manage pain. P-5: This 85-year-old patient was admitted to this agency on 5/22/24 with the diagnoses of a stage 2 pressure ulcer on the left hip, hypertensive heart and chronic kidney disease with heart failure, and unspecified chronic kidney disease. During record review on 8/27/24, the following examples of skilled nursing goals were noted on the plan of care: “Patient will return to stable genitourinary status regarding overreactive bladder and verbalize improvement to symptoms by the end of care.” “Patient/Caregiver will demonstrate competence with self-management of HTN, Heart failure, as evidenced by adherence to medication regimen, ability to identify s/s necessitating contact with medical professionals, diet regimen guidelines, activity compliance and symptom management by end of care.” “Patient will have promotion of healing and restoration of skin integrity without complication by end of care.” These goals are vague, not measurable, and not patient specific. Findings were reviewed with and acknowledged by the Administrator (Staff A) and Director of Nursing (Staff C) during an interview on 8/29/24 at 11:15 AM.”

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physician was promptly alerted to changes in the patient’s needs which suggested outcomes were not being met and the plan of care should be altered in 1 (P-2) of 10 sample records reviewed resulting in unmet patient needs and pain for this patient. Findings include: P-2: This 79-year-old was admitted to the agency on 4/3/24 with diagnoses including pressure ulcer of the left ankle (unstageable); Multiple Sclerosis; and high blood pressure. The medical record was reviewed on 8/28/24. During review of the plan of care for the certification period of 8/1/24- 9/29/24, the following orders and treatments were listed: Notify physician of pain level greater than 6/10 (using a 0-10 scale where 0 is no pain and 10 is the worst pain); Skilled nursing to assess joint pain/swelling, and signs or symptoms of complications related to decreased mobility. During review of the nursing notes, the following were noted: On the nursing visit note dated 8/3/24, the nurse documented in the “Visit Narrative” that the patient was lying in bed upon arrival and grimacing in pain, expressed pain during care, and documented the patient’s current pain level as a 3/10 and was a 3/10 throughout the past week. On 8/7/24, the nurse documented in the visit note under “Visit Narrative” that the doctor was notified regarding increased pain and that follow up was needed. The pain level was documented as currently at a 4/10 but in the past week was a 7/10. There was no follow up noted in the medical record. On 8/14/24, the nurse documented in the “Visit Narrative” that the patient was having pain during care and encouraged the caregiver to provide pain medication. The pain level was documented as currently 4/10 and over the week 8/10. It was unclear what pain medication the nurse was encouraging. No new orders or follow up with the physician was documented. On 8/21/24, the nurse documented in the “Visit Narrative” that the physician was notified of pain which was currently a 4/10 but an 8/10 throughout the past week, but there was “no response” and the nurse documented will “follow up”. No follow up was entered into the medical record as of the date of review (8/28/24). On 8/27/24 at 11:35 a.m., a joint home visit was conducted with the home health aide. It was noted that P-2 had pain during care as evidenced by grimace, moaning, and guarding of the right arm. During the visit, interview was conducted with P-2’s wife (caregiver) regarding the medication list. P-2 did not have medications in the home for pain. These findings were reviewed and acknowledged during interview on 8/29/24 at 12:30 p.m. with the Assistant Administrator (Staff A); the Director of Operations (Staff B); and the Clinical Manager (Staff C).”

“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 record review and interview, the agency failed to ensure skilled professionals performed complete on-going assessments of the patient’s health status and needs in 2 (P-4, 6) of 10 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: P-4: This 70-year-old patient was admitted to this agency on 7/13/24 with the diagnoses of surgical aftercare following surgery for a cystectomy (removal of the bladder) as the result of a malignant neoplasm of the bladder (bladder cancer). During record review on 8/26/24, it was noted the social work evaluation dated 7/16/24 stated “Pt is requesting adequate DME (durable medical equipment), and additional in home assistance.” It also stated, “Pt needs DME….” And “Will follow up with office regarding DME….”. There is no indication of what DME the patient is in need of or of any follow-up provided by the social worker. During an interview on 8/29/24 at 11:30 AM, the Administrator (Staff A) and Director of Operations (Staff B) were asked if they could identify what DME needs the patient had based on the social work evaluation. Staff B stated she assumed it was in reference to the wound care supplies that patient needed (and received) based on previous notes, however, she was unable to determine this from the social work note. Staff A also acknowledged that wound care supplies would not be considered DME, therefore the record continues to be unclear. There have been no follow-up visits or notes from the social worker. Staff A acknowledged the findings. Additionally, it was noted on the physical therapy note dated 7/18/24 stated, “Client reported that her Urologist sent her to the ER yesterday 07/17/24, she came home the same day. Client stated that she took her pain medication about an hour ago however she is feeling dizzy and nauseated at this time.” [sic] There was no additional information regarding the reason for the visit to the emergency room or any further assessment to determine if the patient is safe to continue with therapy that day. The physical therapist failed to provide ongoing assessment of this patient following the emergency room visit. Findings were reviewed with and acknowledged by the Administrator (Staff A) during an interview on 8/29/24 at 11:30 AM. P-6: P-6: This 77-year-old patient was admitted to this agency on 7/24/24 with the diagnoses of type II diabetes, atrial fibrillation, and congestive heart failure. During record review on 8/28/24, it was noted the Outcome and Assessment Information Set (OASIS) reported, “Caregivers are burnt out at the GH (group home) where patient resides” regarding caregiver availability to assist patient with managing his diabetes. There was no evidence of any follow-up or communication with a social worker regarding other resources for this patient and his caregivers. Findings were reviewed with and acknowledged by the Administrator (Staff A) during an interview on 8/29/2at 11:30 AM.”

“Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure that skilled services were administered in accordance with the physician’s orders and the Plan of Care in 4 (P-4, 5, 6, 9, 10) of 10 sampled patients reviewed for skilled services, resulting in the potential for decline in physical functioning, unidentified health concerns and unmet care needs. Findings include: **Agency Policy: “Plan of Care – CMS #485 and Physician Orders” (Revised October 2017) states, “Procedure: 20. Care and services provided will be provided according to physician orders. Orders are current and updated. 21. Drug, services and treatments are administered by staff only as ordered by physician.” P-9: The Start of Care (SOC) was dated 4/27/24. The Plan of Care (POC) identified diagnoses of Chronic Kidney Disease and Congestive Heart Failure. During record review on 8/28/24, it was noted that the POC dated 4/27/24 ordered “MSW (Medical Social Worker) Frequency: Eval.” The MSW evaluation dated 5/14/24 was l7 days from the Skilled Nurse comprehensive assessment dated 4/27/24. Staff A was questioned on 8/29/24 and stated, “Our expectation is that the MSW would complete the evaluation by day 5.” P-10: The Start of Care (SOC) was dated 8/1/23. The Plan of Care (POC) identified diagnoses of Stage 4 Pressure Ulcer and Prostate Cancer. During record review on 8/28/24, an order was noted stating, “Wound Care Plan Overview…Order Valid From: Mon 19 Aug 2024…Addition Instructions: --Order: cbc (complete blood count), esr (erythrocyte sedimentation rate), crp (c-reactive protein test), cmp (comprehensive metabolic panel) …” The record failed to document completion of the ordered labs. These findings were reviewed with and acknowledged by the Staff A (Assistant Administrator) and Staff B (Director of Operations) and Staff C (Clinical Manager) during an interview on 8/29/24 at 10:10 am. P-4: This 70-year-old patient was admitted to this agency on 7/13/24 with the diagnoses of surgical aftercare following surgery for a cystectomy (removal of the bladder) as the result of a malignant neoplasm of the bladder (bladder cancer). During record review on 8/26/24, it was determined the referral dated 7/8/24 requested services from skilled nursing, physical therapy, and occupational therapy upon the patient’s discharge from the hospital on 7/11/24. Upon further review of the record, it was determined there was no occupational therapy evaluation completed. During an interview on 8/29/24 at 11:30 AM, the Administrator (Staff A) was asked why an occupational therapy evaluation was not completed. Staff A stated the nurse who completes the start of care determines if services are needed. Staff A was able to show a communication checklist completed by the nurse at the start of care that stated occupational therapy services were not needed, however, there was no evidence this was communicated with the physician. Staff A acknowledged the findings. P-5: This 85-year-old patient was admitted to this agency on 5/22/24 with the diagnoses of a stage 2 pressure ulcer on the left hip, hypertensive heart and chronic kidney disease with heart failure, and unspecified chronic kidney disease. During record review on 8/27/24, it was determined home health aide services were ordered on the plan of care dated 5/22/24 for 2 times a week for 8 weeks. During further review of the record, it was noted the home health aide visits on 7/9/24 and 7/11/24 were cancelled by the home health aide due to a personal emergency. There was no indication of an attempt to reschedule these visits with another aide or that the doctor was contacted regarding new orders to approve the temporary change in frequency. The Administrator (Staff A) was queried regarding the above findings during an interview on 8/29/24 at 11:30 AM. Staff A was unable to provide evidence of an attempt to reschedule the visits or evidence of communication with the physician. Staff A acknowledged the findings. P-6: This 77-year-old patient was admitted to this agency on 7/24/24 with the diagnoses of type II diabetes, atrial fibrillation, and congestive heart failure. During record review on 8/28/24, it was determined the referral dated 7/19/24 requested services from skilled nursing, social work, physical therapy, and occupational therapy. Upon further review of the record, it was determined there was no occupational therapy or social work evaluation completed. During an interview on 8/29/24 at 11:30 AM, the Administrator (Staff A) was asked why an evaluation was not done by occupational therapy or social work. Staff A stated the nurse who completes the start of care determines if services are needed. Staff A was able to show a communication checklist completed by the nurse that stated occupational therapy and social work services were not needed based on the patient’s current and prior function, however, there was no evidence this was communicated with the physician. Staff A stated the physician on this case is an attending physician at the hospital and is “impossible to find” for any signatures so the agency often has to find another physician to sign. Staff A acknowledged the findings and agreed there should be communication with whichever physician took over the case. Additionally, it was noted the plan of care for P-6 dated 7/24/24 stated under orders and interventions for “SN (skilled nurse) to perform complete physical assessments each visit with emphasis on type 2 DM (diabetes mellitus).” There were also orders to report fasting blood sugars greater than 180 and less than 70 and random blood sugars greater than 200 and less than 70 to the physician. Upon further review of the record, it was noted the Outcome and Assessment Information Set (OASIS) dated 7/24/24 stated the patient’s normal blood sugar ranges were 70 to 100 fasting and 80 to 110 random, according to the caregiver. It was also noted that the patient’s caregiver is the one who takes the patient’s blood sugar. On the skilled nursing note dated 7/29/24, it was again noted the patient’s caregiver takes the patient’s blood sugar, however, there was no mention of the patient’s most recent reading. On 8/5/24, the skilled nursing note reported, “Nurse attempted to collect blood sugar, but there’s no glucometer in home.” It was also noted “…no glucometer in home, office notified to order….Will follow-up.” There was no evidence of an order written after this visit to get a glucometer for this patient. There was no mention of the patient’s most recent reading from the caregiver. On 8/14/24, the skilled nursing note reported, “patient does not have a glucometer at home.” On 8/20/24, the skilled nursing note again stated the patient’s caregiver takes the patient’s blood sugar. However, there was no mention of the patient’s most recent blood sugar reading from the caregiver or any mention of the follow-up for getting the patient a glucometer. Based on the above documentation, it is unclear who is checking the patient’s blood sugar and how. It is also unclear how the nurse is monitoring the patient’s diabetes, which is his primary diagnosis, if there are no blood sugar readings. The Administrator (Staff A), the Director of Operations (Staff B), and Director of Nursing (Staff C) were queried regarding the above findings during an interview on 8/29/24 at 11:30 AM. Staff B was able to locate an order for the glucometer written on 8/21/24 (16 days after it was initially noted the patient did not have one), however, she was unable to locate any information regarding the delay in the order or any follow-up done by the nurse as to whether a glucometer was obtained. Staff A stated that there are often difficulties working with the staff at the group home and that may be why the nurse did not get any blood sugar reading from the caregiver, however, he was unable to locate any documented evidence of this. Staff B was asked what the expectation is for a nurse to monitor blood sugar for a patient with the primary diagnosis of diabetes. Staff B stated it is expected that the nurse gets a recent reading from the caregiver if unable to collect it at the visit. Staff A acknowledged the findings.”

“Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Home Health Aide provided care in accordance with the plan of care for 1 (P-8) of 4 patients in which Home Health Aide services were provided, resulting in the potential for patients to receive sub-standard services from the agency. P-8: The Start of Care (SOC) was dated 7/15/24. The Plan of Care (POC) identified diagnoses of Parkinson’s, Diabetes Type 2 and Falls. The Home Heath Aide (HHa) care plan dated 7/15/24 noted “Plan Details: Vital Signs: Blank under QV (Every visit), QW (Every week) and N/A (Not Applicable). On 7/22/24, the HHa documented “Vital Signs: BP (Blood Pressure) 141/55, HR (Heart Rate) 78, Temp 97.0, Resp 24.” The HHa provided services that were not ordered on the care plan which could result in potential poor patient outcomes. This finding was reviewed with and acknowledged by the Staff A (Assistant Administrator) and Staff B (Director of Operations) and Staff C (Clinical Manager) during an interview on 8/29/24 at 9:30 am.”

“If concern identified, direct observation CFR(s): 484.80(h)(1)(ii) If an area of concern in aide services is noted by the supervising registered nurse or other appropriate skilled professional, then the supervising individual must make an on-site visit to the location where the patient is receiving care in order to observe and assess the aide while he or she is performing care. This Element is not met as evidenced by: See: (Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24) Based on record review and interview, the agency failed to ensure the registered nurse (RN) completed onsite supervisory assessments of home health aide services in 2 (P-2 and P10) of 4 sample records reviewed in which home health aide services were used, resulting in lack of interaction between the RN and the patient (or caregiver) and inability of the agency to know if the home health aide was properly following the plan of care. Findings include: P-10: The Start of Care (SOC) was dated 8/1/23. The Plan of Care (POC) identified diagnoses of Stage 4 Pressure Ulcer and Prostate Cancer. The Registered Nurse (RN) completed a supervisory visit on 8/20/24. During record review on 8/28/24, it was noted that the RN documented a supervisory visit, but no visit was scheduled or completed by the RN that day. The agency failed to follow policy and complete an onsite supervisory visit. This finding was reviewed with and acknowledged by the Staff A (Assistant Administrator) and Staff B (Director of Operations) and Staff C (Clinical Manager) during an interview on 8/29/24 at 9:40 am. P-2: This 79-year-old was admitted to the agency on 4/3/24 with diagnoses including pressure ulcer of the left ankle (unstageable); Multiple Sclerosis; and high blood pressure. The medical record was reviewed on 8/28/24. During review of the plan of care for the certification period of 8/1/24- 9/29/24, it was noted that home health aide services were ordered 2 times per week for 7 weeks. During review of the scheduled visits, it was noted that the home health aide attended the visits as scheduled from 8/1/24- 8/27/24, and there were 2 supervisory visit notes documented by an RN during that period. The supervisory visit notes were signed by the RN on 8/11/24 and 8/24/24 and included the following information: The aide maintained open communication with the patient/caregiver; arrived as scheduled to visits; followed the plan of care; demonstrated competency with tasks; informed the supervisor of client’s needs; complies with infection control; and honors client’s rights. There were no RN visits documented concurrently with the supervisory visit notes; no aide was identified by name on either note; and there were no comments of who provided details for the evaluation (patient/caregiver) in either note. These findings were reviewed and acknowledged during interview on 8/29/24 at 12:30 p.m. with the Assistant Administrator (Staff A); the Director of Operations (Staff B); and the Clinical Manager (Staff C).”

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained completed assessments and visit notes for 4 (P-7, 8, 9, 10) of 10 records reviewed, resulting in a lack of information for the physician and all agency staff caring for the patient. Findings include: P-7: The Start of Care (SOC) was dated 7/25/24. The Plan of Care (POC) identified diagnoses of Cervicalgia, Spinal Stenosis, Muscle Weakness and Diabetes Type 2. During record review on 8/27/24, it was noted that the Physical Therapist completed the comprehensive assessment on 7/25/24. Under the “Endocrine” section of the comprehensive assessment, it stated, “Diabetes: Blood Sugars Performed By: Patient. Patient’s Blood Sugar Status Unknown (no glucometer, paper logs, visit reports, nor patient ability to report). Blood Sugars Status Unknown Reason: Client does not check blood sugar at home.” During a joint visit on 8/27/24, the patient was questioned regarding blood sugars and stated, “I check my blood sugars every day.” The agency failed to accurately document the comprehensive assessment. P-8: The Start of Care (SOC) was dated 7/15/24. The Plan of Care (POC) identified diagnoses of Parkinson’s, Diabetes Type 2 and Falls. During record review on 8/27/24, it was noted that the Registered Nurse (RN) completed a comprehensive assessment on 7/15/24. Under the “Respiratory Status” section of the comprehensive assessment, it was noted the “Oxygen use, intermittent and Oxygen use, continuous” boxes were unchecked. Additionally, under the “Supply Manager/DME section of the comprehensive assessment, it was noted that “Oxygen” was uncheck. The POC completed on 7/15/24 stated, “Homebound Narrative: Patient is exhibiting a considerable and a taxing effort to leave home due to …O2 (Oxygen) dependence…” The agency failed to accurately document the comprehensive assessment. P-9: The Start of Care (SOC) was dated 4/27/24. The Plan of Care (POC) identified diagnoses of Chronic Kidney Disease and Congestive Heart Failure. During record review on 8/28/24, it was noted that the POC stated, “Notify physician of vital sign parameters out of range: … Fasting blood sugar greater than (>) 180 or less than () 200 or less than ( P-10: The Start of Care (SOC) was dated 8/1/23. The Plan of Care (POC) identified diagnoses of Stage 4 Pressure Ulcer and Prostate Cancer. During record review on 8/28/24, it was noted that the POC stated, “Notify physician of vital sign parameters out of range: … Fasting blood sugar greater than (>) 180 or less than () 200 or less than ( These findings were reviewed with and acknowledged by the Staff A (Assistant Administrator) and Staff B (Director of Operations) and Staff C (Clinical Manager) during an interview on 8/29/24 at 10:00 am.”

“Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained all interventions, treatments, and services in 1 (P-5) of 10 records reviewed, resulting in an incomplete and inaccurate medical record. Findings include: P-5: This 85-year-old patient was admitted to this agency on 5/22/24 with the diagnoses of a stage 2 pressure ulcer on the left hip, hypertensive heart and chronic kidney disease with heart failure, and unspecified chronic kidney disease. During record review on 8/27/24, it was noted the speech therapy discharge note dated 6/8/24 stated a written HEP (home exercise program) was given to the patient. Upon further review of the record, there was no evidence of an HEP given to the patient. During an interview on 8/29/24 at 11:15 AM, the Administrator (Staff A) was asked to provide evidence of the HEP mentioned above. Staff A stated the staff sometimes scans an attachment to the medical record, however, he was unable to find one for this patient. Staff A acknowledged the findings.”

“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 record review and interview, the Agency failed to ensure a discharge summary was complete, provided the patient’s current health status at the time of discharge, progress toward goals, and forwarded to the physician within 5 days of discharge in 1 (P-9) of 3 closed records, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: P-9: The Start of Care (SOC) was dated 4/27/24. The Plan of Care (POC) identified diagnoses of Chronic Kidney Disease and Congestive Heart Failure. During record review on 8/28/24, it was noted that the agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient’s discharge. Additionally, it was noted that the Skilled Nursing discharge dated 5/25/24 stated, “Care Summary: (Care Given, Progress, Regress Including Therapies): Patient has progress well, goals met.” (SIC) The discharge summary failed to detail the course of care provided, responses to treatment, any potential continuing needs, and failed to document the patient’s health status at the time of discharge in measurable terms. These findings were reviewed with and acknowledged by the Staff A (Assistant Administrator) and Staff B (Director of Operations) and Staff C (Clinical Manager) during an interview on 8/29/24 at 9:30 am.”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on document review and interview, it was determined that the agency failed to ensure the LPN #1 (licensed practical nurse) provided wound care only as ordered by the physician in 1 (P-1) of 4 records reviewed with wound care out of a total of 10 records reviewed (See G 580); failed to ensure the patient’s Plan of Care (POC) was updated and revised as required in a time of health status decline for 1 (P-1) 1 of record reviewed with a change in wound status and severe UTI (urinary tract infection) symptoms, from a total sample of 10 records reviewed (See G 588); failed ensure the physician was notified of changes in the patient’s condition in 1 (P-1) of 1 records reviewed with significant changes in condition, out of a total of 10 records (See G 590); and failed to ensure services were integrated to assure the identification of patient needs and proper coordination of care with other disciplines in 1 (Patient #10) of 10 records reviewed (See G 606). The cumulative effect of these systemic problems resulted in the agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.60 Care Planning, Coordination, Quality of Care.”

“Contents of clinical record CFR(s): 484.110(a) Standard: Contents of clinical record. The record must include: This Standard is not met as evidenced by: Based on record review and interview, it was determined the agency failed to ensure the clinical record was accurate and individualized to the patient during the time(s) when health care was provided in 1 (P-1) out of a total sample of 10 records reviewed, resulting in unrecognized increased medical needs of the patient at the time of discharge from skilled nursing services. Findings include: P-1: The patient was admitted to the agency on 12/21/2023 with diagnoses which included diabetes-type 1, urosepsis (UTI (urinary tract infection) spreading into the blood stream), cardiomyopathy, and hypertension. On 2/6/24, review of the P-1’s Plan of Care (POC) ordered a Skilled Nursing (SN) visit frequency of 1W6 (once per week times 6 weeks) with RN #1 providing supervision over an LPN (licensed practical nurse, LPN #1) who conducted clinical assessments and performed interventions and treatments to P-1. Additional review found the lone visit performed by the RN #1 on 1/23/24, had copied and pasted previous documentation from LPN #1 as their own assessment and findings that same day. Further, evidence was found the LPN #1 also copied and pasted her own documentation from earlier visits to represent current findings in the clinical record. Examples are as follow word for word: (1 of 1 LPN #1 visit notes): On 12/28/23, the “Integumentary (skin)” section documented, “No problems identified” followed by, “Healed wound on coccyx between buttocks, No measurement today. No drainage, no foul odor. Patient encouraged to keep area dry to prevent opening.” (2 of 2 LPN #1 visit notes): On 1/2/24, the “Integumentary” section documented, “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager).” (SIC) (3 of 3 LPN #1 visit notes): On 1/9/24, the “Integumentary” section documented, “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM. Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained.” (SIC) The above text has a perfect match when compared to the 1/2/24 visit note in 386 out of 386 characters from “Patient ...RNCM.” The “Genitourinary” (referencing urinary elimination) section documented, “Patient states that she continues to having burning, frequency and she states” It feels like I’m on fire down there”. She states that this has worsened the last few days. She states she needs antibiotics. Patient was in tears upon arrival states she can not take the burning during urination any longer. She is requesting to see the physician. She states she is afraid of sepsis. Info forward to RNCM. Author offered option to go seek emergency treatment. Patient declined r/t immobility and transportation.” (SIC) (4 of 4 LPN #1 visit notes): On 1/19/24 the “Integumentary” documented “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM. Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained. Patient wounds are open and some odor. Patient states it is so painful she can not sleep. No orders in IW. Info fwd to o call who states she has to be seen.” (SIC) The “Genitourinary” section documented, “Patient states that she continues to having burning, frequency and she states” It feels like I’m on fire down there”. She states that this has worsened the last few days. She states she needs antibiotics. Patient was in tears upon arrival states she can not take the burning during urination any longer. She is requesting to see the physician. She states she is afraid of sepsis. Info forward to RNCM. Author offered option to go seek emergency treatment. Patient declined r/t immobility and transportation.” (SIC) The above text has an exact match when compared to the 1/9/24 visit note under “Integumentary” in 599 out of 599 characters from “Patient ...obtained.” In addition, the “Genitourinary” section had an exact match in 507 out of 507 characters from “Patient ...transportation.” This visit patient complains of Symptoms of UTI that was first reported on 12/28 with no medication or treatment and worsening symptoms. MD on call (physician) notified, also RNCM contacted while at patients home with family. No answer. On call (physician) states patient needs to be seen before they can prescribe something. Family notified.” (SIC) (1 of 1 RN #1 visit notes): On 1/23/24 the RN #1 documented under “Integumentary” the following “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM. Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained.” (SIC) Under the “Genitourinary” section, the RN documented, “Patient states that she continues to having burning, frequency and she states” It feels like I’m on fire down there”. She states that this has worsened the last few days. She states she needs antibiotics. Patient was in tears upon arrival states she can not take the burning during urination any longer. She is requesting to see the physician. She states she is afraid of sepsis. Info forward to RNCM. Author offered option to go seek emergency treatment. Patient declined r/t immobility and transportation.” (SIC/end of note) The above RN #1 visit note documentation matches the 1/19/24 LPN #1 visit note, “Integumentary” in 599 out of 599 characters from “Patient ...obtained.” and another exact match under the “Genitourinary” section of 507 out of 507 characters from “Patient ...transportation.” This represents 2 of 2 sections of clinical assessment, each occurring on different dates, a total of 1,106 out of 1,106 characters. (1 of 1 Discharge Summary by RN #1): On 1/23/24 the RN documented: “Reason for D/C: Goals Met.” No documentation was found in the clinical record which explained why both RN #1 and LPN #1 had copied and pasted previous clinical findings to represent current findings. No evidence was found in the record of a physician response to the above findings. No evidence was found concerning further communication amongst the health care team for additional orders regarding assessments, interventions, and treatments to help meet P-1’s significant medical needs at the time before being discharged. These findings were reviewed and acknowledged by the agency’s Chief Executive Officer (Staff A) and Clinical Manager (Staff B). Both were verbally and visibly upset at the findings and would launch an investigation as soon as possible. The agency failed to review and maintain a clinical record that represented the needs of the patient have been met prior to discharge from services and failed to follow the agency’s policy as referenced below. Agency Policy: “Medical Record Content” Reference HH5-1A.01 (Undated) stated, “The Agency will initiate and maintain an individual and accurate medical record for each patient receiving care in compliance with all federal/state laws and regulations. Initial and ongoing assessments, including comprehensive assessment and all assessments of the most recent home health admission. A statement of any change in patient’s condition. A statement of the conclusions or impressions drawn from the assessment data. Patient’s response to care/services. Coordination of care activities...””

“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 record review and interview, it was determined that the agency failed to ensure the LPN (licensed practical nurse) provided wound care only as ordered by the physician in 1 (P-1) of 4 records reviewed with wound care, out of a total sample of 10 records reviewed, resulting in deteriorating wound status and unmet patient needs. Findings include: P-1: The patient was admitted to the agency on 12/21/2023 with diagnoses which included diabetes-type 1, urosepsis (UTI (urinary tract infection) spreading into the blood stream), cardiomyopathy, and hypertension. On 2/6/24, review of the P-1’s Plan of Care (POC) revealed no wound care orders, treatments, or interventions throughout the certification period (12/21/23 to 2/18/24). Skilled Nursing (SN) had an ordered visit frequency of 1W6 (once per week times 6 weeks). The hospital referral and initial start of care (SOC) assessment performed by SN documented no problems identified concerning wound care. However, visit notes from the LPN (licensed practical nurse, LPN #1) and RN #1 revealed the following documentation on: (1 of 1 LPN #1 visit notes): On 12/28/23 under “Integumentary (skin)” stated “No problems identified” followed by, “Healed wound on coccyx between buttocks, No measurement today. No drainage, no foul odor. Patient encouraged to keep area dry to prevent opening.” (2 of 2 LPN #1 visit notes): On 1/2/24 under “Integumentary” stated “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager).” (SIC) (3 of 3 LPN #1 visit notes): On 1/9/24 under “Integumentary” stated “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager). Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained.” (SIC) (4 of 4 LPN #1 visit notes): On 1/19/24 under “Integumentary” stated “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager). Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained. Patient wounds are open and some odor. Patient states it is so painful she can not sleep. No orders in IW. Info fwd to o call who states she has to be seen.” (SIC) (1 of 1 RN #1 Supervisory Visit notes): On 1/19/24 the RN #1 supervisory notes documented: “5. Informs supervisor of client’s needs and changes in the patient’s condition as required: Yes, ...8. Changes made to client plan of care: No, ...11. Is the patient receiving wound care services: No, ...” (1 of 1 RN #1 visit notes): On 1/23/24 under “Integumentary” stated “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM. Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained.” (SIC) (1 of 1 Discharge Summary by RN #1): On 1/23/24 the RN #1 documented: “Reason for D/C: Goals Met.” No documentation was evidenced in the RN Discharge Summary that P-1 had an open wound and “some odor” (indicating infection).” No communication notes were evidenced in the medical record which alerted the physician to obtain orders to implement treatments/interventions to meet P-1’s escalating wound care needs. After reviewing the above information, a phone interview was conducted with P-1 on 2/6/24 at 1:06 PM. to ascertain any interventions the LPN #1 may have performed from 1/2/24 through 1/19/24 without any physician orders. P-1 was noted to be happy with the care she received from the LPN #1 and her interventions helped. When asked what interventions were provided, P-1 replied, “She washed and dried the wound, then applied barrier cream.” Per interview, the LPN #1 went outside the scope of practice and provided interventions/treatments without a physician’s order. These findings were reviewed and acknowledged by the agency’s Chief Executive Officer (Staff A) and Clinical Manager (Staff B) on 2/6/24 at 2:50 PM. Both agreed that the LPN #1 should have never given any advice or interventions without prior written orders from the physician. The agency failed to obtain physician orders to ensure services were provided as ordered, failed to ensure supervision was provided by the RN #1 over the LPN #1 in determining if all interventions and treatments were furnished in accordance with physician orders, and failed to follow the agency’s policies as referenced below. Agency Policy: “Nursing Services” No. 9.16.1 (Revised February 2021) stated, “Nursing care will be provided in accordance with the patient’s plan of care...” Agency Policy: “Reassessments/Update of the Comprehensive Assessment” No. 9.7.1 (Revised February 2021) stated, “Staff will additionally reassess each patient with each home visit on an ongoing basis to evaluate current problems and needs as well as to adjust the care provided.””

“Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient’s Plan of Care (POC) was updated and revised as required in a time of health status decline for 1 (P-1) 1 of record reviewed with a change in wound status and severe UTI (urinary tract infection) symptoms, from a total sample of 10 records reviewed, resulting in unmet patient care needs and the potential for poor clinical outcomes. Findings include: P-1: The patient was admitted to the agency on 12/21/2023 with diagnoses which included diabetes-type 1, urosepsis (UTI (urinary tract infection) spreading into the blood stream), cardiomyopathy, and hypertension. On 2/6/24, review of the P-1’s Plan of Care (POC) ordered a Skilled Nursing (SN) visit frequency of 1W6 (once per week times 6 weeks) with RN #1 providing supervision over LPN #1 (licensed practical nurse) who conducted clinical assessments and performed interventions and treatments to P-1. Additional review found SN/RN #1 failed to communicate multiple SCIC (significant change in condition) to the physician in order to revise the POC for P-1. Details concerning P-1’s SCIC are as follow: (1 of 1 LPN #1 visit notes): On 12/28/23, the “Integumentary (skin)” section documented, “No problems identified” followed by, “Healed wound on coccyx between buttocks, No measurement today. No drainage, no foul odor. Patient encouraged to keep area dry to prevent opening.” (2 of 2 LPN #1 visit notes): On 1/2/24, the “Integumentary” section documented, “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager).” (SIC) (3 of 3 LPN #1 visit notes): On 1/9/24, the “Integumentary” section documented, “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager). Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained.” (SIC) The “Genitourinary” (referencing urinary elimination) section documented, “Patient states that she continues to having burning, frequency and she states” It feels like I’m on fire down there”. She states that this has worsened the last few days. She states she needs antibiotics. Patient was in tears upon arrival states she can not take the burning during urination any longer. She is requesting to see the physician. She states she is afraid of sepsis. Info forward to RNCM. Author (LPN #1) offered option to go seek emergency treatment. Patient declined r/t immobility and transportation.” (SIC) (4 of 4 LPN #1 visit notes): On 1/19/24 the “Integumentary” documented “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager). Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained. Patient wounds are open and some odor. Patient states it is so painful she can not sleep. No orders in IW. Info fwd to o call who states she has to be seen.” (SIC) The “Genitourinary” section documented, “Patient states that she continues to having burning, frequency and she states” It feels like I’m on fire down there”. She states that this has worsened the last few days. She states she needs antibiotics. Patient was in tears upon arrival states she can not take the burning during urination any longer. She is requesting to see the physician. She states she is afraid of sepsis. Info forward to RNCM. Author (LPN #1) offered option to go seek emergency treatment. Patient declined r/t immobility and transportation. This visit patient complains of Symptoms of UTI that was first reported on 12/28 with no medication or treatment and worsening symptoms. MD on call (Physician) notified also RNCM contacted while at patients home with family. No answer. On call states patient needs to be seen before they can prescribe something. Family notified.” (SIC) (1 of 1 RN #1 visit notes): On 1/23/24, RN #1 documented under “Integumentary” the following “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM. Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained.” (SIC) Under the “Genitourinary” section, RN #1 documented, “Patient states that she continues to having burning, frequency and she states” It feels like I’m on fire down there”. She states that this has worsened the last few days. She states she needs antibiotics. Patient was in tears upon arrival states she can not take the burning during urination any longer. She is requesting to see the physician. She states she is afraid of sepsis. Info forward to RNCM. Author (LPN #1) offered option to go seek emergency treatment. Patient declined r/t immobility and transportation.” (SIC/end of note) (1 of 1 Discharge Summary by RN #1): On 1/23/24, RN #1 documented: “Reason for D/C: Goals Met.” No documentation was found in the clinical record that P-1’s POC had been revised to address and implement interventions and treatment to prevent further decline in the patient’s health status before discharging the patient from SN services. These findings were reviewed and acknowledged by the agency’s Chief Executive Officer (Staff A) and Clinical Manager (Staff B) on 2/6/24 at 3:00 PM. Both stated an internal investigation would take place as soon as possible. The agency failed to review and maintain a clinical record that represented the needs of the patient have been met prior to discharge from services and failed to follow the agency’s policy as referenced below. Agency Policy: “Plan of Care - CMS #485 and Physician Orders” (undated) stated, “Skilled nursing and other home health services will be in accordance with a Plan of Care based on the patient’s diagnosis and assessment of immediate and long-range needs and resources. Care and services provided will be provided according to physician orders. Orders are current and updated. Changes in the patient’s condition that require a change in the Plan of Care must be documented in the patient’s clinical record.””

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physician was notified of changes in the patient’s condition in 1 (P-1) of 1 record reviewed with SCIC (significant change in condition) concerning wound and UTI (urinary tract infection) from a total sample of 10 records reviewed, resulting in a poor patient outcome. Findings include: P-1: The patient was admitted to the agency on 12/21/2023 with diagnoses which included diabetes-type 1, urosepsis (UTI (urinary tract infection) spreading into the blood stream), cardiomyopathy, and hypertension. On 2/6/24, review of the P-1’s Plan of Care (POC) ordered a Skilled Nursing (SN) visit frequency of 1W6 (once per week times 6 weeks) with RN#1 providing supervision over LPN #1 (licensed practical nurse) who conducted clinical assessments and performed interventions and treatments to P-1. Additional record review found the agency failed to ensure supervisory RN#1 had notified the physician to address P-1’s immediate medical concerns and declining health status. Details are as follow: (1 of 1 LPN #1 visit notes): On 12/28/23, the “Integumentary (skin)” section documented, “No problems identified” followed by, “Healed wound on coccyx between buttocks, No measurement today. No drainage, no foul odor. Patient encouraged to keep area dry to prevent opening.” (2 of 2 LPN #1 visit notes): On 1/2/24, the “Integumentary” section documented, “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager).” (SIC) (3 of 3 LPN #1 visit notes): On 1/9/24, the “Integumentary” section documented, “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager). Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained.” (SIC) The “Genitourinary” (referencing urinary elimination) section documented, “Patient states that she continues to having burning, frequency and she states” It feels like I’m on fire down there”. She states that this has worsened the last few days. She states she needs antibiotics. Patient was in tears upon arrival states she can not take the burning during urination any longer. She is requesting to see the physician. She states she is afraid of sepsis. Info forward to RNCM. Author (LPN #1) offered option to go seek emergency treatment. Patient declined r/t immobility and transportation.” (SIC) (4 of 4 LPN #1 visit notes): On 1/19/24 the “Integumentary” documented “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager). Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained. Patient wounds are open and some odor. Patient states it is so painful she can not sleep. No orders in IW. Info fwd to o call who states she has to be seen.” (SIC) The “Genitourinary” section documented, “Patient states that she continues to having burning, frequency and she states” It feels like I’m on fire down there”. She states that this has worsened the last few days. She states she needs antibiotics. Patient was in tears upon arrival states she can not take the burning during urination any longer. She is requesting to see the physician. She states she is afraid of sepsis. Info forward to RNCM. Author offered option to go seek emergency treatment. Patient declined r/t immobility and transportation. This visit patient complains of Symptoms of UTI that was first reported on 12/28 with no medication or treatment and worsening symptoms. MD on call (Physician) notified also RNCM contacted while at patients home with family. No answer. On call states patient needs to be seen before they can prescribe something. Family notified.” (SIC) (1 of 1 RN #1 visit notes): On 1/23/24 the RN documented under “Integumentary” the following “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM. Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained.” (SIC) Under the “Genitourinary” section, the RN documented, “Patient states that she continues to having burning, frequency and she states” It feels like I’m on fire down there”. She states that this has worsened the last few days. She states she needs antibiotics. Patient was in tears upon arrival states she can not take the burning during urination any longer. She is requesting to see the physician. She states she is afraid of sepsis. Info forward to RNCM. Author (LPN #1) offered option to go seek emergency treatment. Patient declined r/t immobility and transportation.” (SIC/end of note) (1 of 1 Discharge Summary by RN #1): On 1/23/24, RN #1 documented: “Reason for D/C: Goals Met.” No evidence was found in the clinical record that LPN #1, RN #1, and Physician had communicated with one another to the point orders were obtained for additional assessments, interventions, and treatments to help meet P-1’s significant medical needs at the time before being discharged. These findings were reviewed and acknowledged by the agency’s Chief Executive Officer (Staff A) and Clinical Manager (Staff B) during an interview on 2/6/24 at 3:20 PM. The agency failed to ensure supervisory RN #1 on the case for P-1 had notified the physician to address P-1’s medical concerns and declining health status.”

“Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure services were integrated to assure the identification of patient needs and proper coordination of care with other disciplines in 2 (P-1, P-10) of 10 records reviewed out of a total sample of 10 records, resulting in the potential for unmet care needs. Findings include: P-1: The patient was admitted to the agency on 12/21/2023 with diagnoses which included diabetes-type 1, urosepsis (UTI (urinary tract infection) spreading into the blood stream), cardiomyopathy, and hypertension. On 2/6/24, review of the P-1’s Plan of Care (POC) ordered a Skilled Nursing (SN) visit frequency of 1W6 (once per week times 6 weeks) with an RN providing supervision over an LPN (licensed practical nurse) who conducted clinical assessments and performed interventions and treatments to P-1. Additional record review found the agency failed to ensure the supervisory RN and LPN integrated services to meet P-1’s immediate medical concerns and declining health status. Details are as follow: (1 of 1 LPN visit notes): On 12/28/23, the “Integumentary (skin)” section documented, “No problems identified” followed by, “Healed wound on coccyx between buttocks, No measurement today. No drainage, no foul odor. Patient encouraged to keep area dry to prevent opening.” (2 of 2 LPN visit notes): On 1/2/24, the “Integumentary” section documented, “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager).” (SIC) (3 of 3 LPN visit notes): On 1/9/24, the “Integumentary” section documented, “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager). Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained.” (SIC) The “Genitourinary” (referencing urinary elimination) section documented, “Patient states that she continues to having burning, frequency and she states” It feels like I’m on fire down there”. She states that this has worsened the last few days. She states she needs antibiotics. Patient was in tears upon arrival states she can not take the burning during urination any longer. She is requesting to see the physician. She states she is afraid of sepsis. Info forward to RNCM. Author offered option to go seek emergency treatment. Patient declined r/t immobility and transportation.” (SIC) (4 of 4 LPN visit notes): On 1/19/24 the “Integumentary” documented “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager). Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained. Patient wounds are open and some odor. Patient states it is so painful she can not sleep. No orders in IW. Info fwd to o call who states she has to be seen.” (SIC) The “Genitourinary” section documented, “Patient states that she continues to having burning, frequency and she states” It feels like I’m on fire down there”. She states that this has worsened the last few days. She states she needs antibiotics. Patient was in tears upon arrival states she can not take the burning during urination any longer. She is requesting to see the physician. She states she is afraid of sepsis. Info forward to RNCM. Author offered option to go seek emergency treatment. Patient declined r/t immobility and transportation. This visit patient complains of Symptoms of UTI that was first reported on 12/28 with no medication or treatment and worsening symptoms. MD on call Woodruff notified also RNCM contacted while at patients home with family. No answer. On call states patient needs to be seen before they can prescribe something. Familynotified.” (SIC) (1 of 1 RN visit notes): On 1/23/24 the RN documented under “Integumentary” the following “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM. Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained.” (SIC) Under the “Genitourinary” section, the RN documented, “Patient states that she continues to having burning, frequency and she states” It feels like I’m on fire down there”. She states that this has worsened the last few days. She states she needs antibiotics. Patient was in tears upon arrival states she can not take the burning during urination any longer. She is requesting to see the physician. She states she is afraid of sepsis. Info forward to RNCM. Author offered option to go seek emergency treatment. Patient declined r/t immobility and transportation.” (SIC/end of note) (1 of 1 Discharge Summary by RN): On 1/23/24 the RN documented: “Reason for D/C: Goals Met.” No evidence was found in the medical record that the LPN, RN, and Physician had communicated with one another to the point orders were obtained for additional assessments, interventions, and treatments to help meet P-1’s significant medical needs at the time before being discharged. These findings were reviewed and acknowledged by the agency’s Chief Executive Officer (Staff A) and Clinical Manager (Staff B) during an interview on 2/6/24 at 3:20 PM. The failure to integrate all services (LPN, RN, and Physician) appropriately resulted in P-1’s medical needs concerning wounds, and severe pain associated with an UTI, were not met prior to being discharged from SN services. P-10 was admitted to this home care agency on 2/1/24 with the primary diagnosis of multiple stage 4 pressure ulcers on his buttocks and sacral region. According to the plan of care (dated 2/1/24), it was noted the licensed practical nurse (LPN) was ordered to do the wound care on this patient 3 times a week for 8 weeks. Upon further review of the plan of care, it was noted there were no orders on how to care for the wound. According to the schedule, it was noted the LPN was scheduled to see the patient for wound care on 2/3/24. This visit was missed due to the patient not being home, however, Staff A was asked how the LPN (who must follow orders from the registered nurse) would have known how to treat the wounds. Staff A reported the agency sends the wound information to an outside program that generates treatment recommendations from a physician, and that is what the LPN would follow. Staff A was unable to find evidence of this recommendation in the record or evidence the information had been sent out for treatment recommendation. Staff A was asked again how the LPN would have known what to do if that form was not in the record. He reported it is often written in the plan of care, but acknowledged the plan of care for this patient did not include any orders for wound care. Staff A then stated the nurse who did the evaluation could call the LPN with instructions, however, he was unable to provide written evidence of this happening. Staff A admitted he is not sure how the LPN would have known what to do in this case and agreed that care was not properly coordinated between the registered nurse and the LPN. Staff A acknowledged the findings during an interview on 2/5/24 at 1400.”

“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 record review and interview, the agency failed to ensure the RN (registered nurse) supervised the care provided by the LPN (licensed practical nurse) in 1 (P-1) of 1 record reviewed in which LPN services were provided from a total sample of 10 records reviewed, resulting in a lack of clinical supervision, and unmet patient needs during a state of declining health status. Findings include: P-1: The patient was admitted to the agency on 12/21/2023 with diagnoses which included diabetes-type 1, urosepsis (UTI (urinary tract infection) spreading into the blood stream), cardiomyopathy, and hypertension. On 2/6/24, review of the P-1’s Plan of Care (POC) ordered a Skilled Nursing (SN) visit frequency of 1W6 (once per week times 6 weeks) with an RN #1 providing supervision over an LPN (licensed practical nurse, LPN #1) who conducted clinical assessments and performed interventions and treatments to P-1. Additional review found the RN #1 failed to supervise and communicate with the LPN #1 and physician concerning multiple SCIC (significant change in condition) noted below which were clearly documented in the LPN’s home visit notes. Details are as follow: (1 of 1 LPN #1 visit notes): On 12/28/23, the “Integumentary (skin)” section documented, “No problems identified” followed by, “Healed wound on coccyx between buttocks, No measurement today. No drainage, no foul odor. Patient encouraged to keep area dry to prevent opening.” (2 of 2 LPN #1 visit notes): On 1/2/24, the “Integumentary” section documented, “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager).” (SIC) (3 of 3 LPN #1 visit notes): On 1/9/24, the “Integumentary” section documented, “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager). Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained.” (SIC) The “Genitourinary” (referencing urinary elimination) section documented, “Patient states that she continues to having burning, frequency and she states” It feels like I’m on fire down there”. She states that this has worsened the last few days. She states she needs antibiotics. Patient was in tears upon arrival states she can not take the burning during urination any longer. She is requesting to see the physician. She states she is afraid of sepsis. Info forward to RNCM. Author offered option to go seek emergency treatment. Patient declined r/t immobility and transportation.” (SIC) (4 of 4 LPN #1 visit notes): On 1/19/24 the “Integumentary” documented “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM (registered nurse case manager). Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained. Patient wounds are open and some odor. Patient states it is so painful she can not sleep. No orders in IW. Info fwd to o call who states she has to be seen.” (SIC) The “Genitourinary” section documented, “Patient states that she continues to having burning, frequency and she states” It feels like I’m on fire down there”. She states that this has worsened the last few days. She states she needs antibiotics. Patient was in tears upon arrival states she can not take the burning during urination any longer. She is requesting to see the physician. She states she is afraid of sepsis. Info forward to RNCM. Author offered option to go seek emergency treatment. Patient declined r/t immobility and transportation. This visit patient complains of Symptoms of UTI that was first reported on 12/28 with no medication or treatment and worsening symptoms. MD on call Woodruff notified also RNCM contacted while at patients home with family. No answer. On call states patient needs to be seen before they can prescribe something. Family notified.” (SIC) (1 of 1 RN #1 Supervisory Visit notes): On 1/19/24 the RN #1 supervisory notes documented: “5. Informs supervisor of client’s needs and changes in the patient’s condition as required: Yes, ...8. Changes made to client plan of care: No, ...11. Is the patient receiving wound care services: No, ...” (1 of 1 RN #1 visit notes): On 1/23/24 the RN documented under “Integumentary” the following “No problems identified” followed by, “Patient states that she has had several episodes of incontinence and was unable to make it to the bathroom. She states her buttocks hurt and the pain was a ten now a 7. Patient has wound to the buttocks that was moist and yellowish and color no foul odor no drainage. The wound is now open. Patient encouraged to reposition and keep the area dry to prevent opening. Info forward to RNCM. Patient states that someone contacted her regarding a visit to look at wound. Patient was instructed to stay off area as much as possible and keep dry. RNCM contacted so that wound care orders could be obtained.” (SIC) Under the “Genitourinary” section, the RN documented, “Patient states that she continues to having burning, frequency and she states” It feels like I’m on fire down there”. She states that this has worsened the last few days. She states she needs antibiotics. Patient was in tears upon arrival states she can not take the burning during urination any longer. She is requesting to see the physician. She states she is afraid of sepsis. Info forward to RNCM. Author offered option to go seek emergency treatment. Patient declined r/t immobility and transportation.” (SIC/end of note) (1 of 1 Discharge Summary by RN #1): On 1/23/24 the RN documented: “Reason for D/C: Goals Met.” No evidence was found which explained how under No. 5 within the RN Supervisory Note, that the RN could document the client’s needs and changes in the condition have appropriately been met given the documented evidence above. These findings were reviewed and acknowledged by the agency’s Chief Executive Officer (Staff A) and Clinical Manager (Staff B). Both stated this was unacceptable and would launch an investigation as soon as possible. The agency failed to ensure the RN #1 provided oversight over the LPN #1 and supervised the safety and well-being of P-1 as stipulated by the agency’s policy referenced below. Agency Policy: “Nursing Services” No.9.16.1 (Revised February 2021) stated, “Nursing care will be provided in accordance with the patient’s plan of care, under the supervision of a registered nurse. Professional nursing service will be provided by a registered nurse and include: 1) Initial and ongoing assessments of the patient’s needs... at appropriate time points... 6) Preparing clinical and progress notes... 7) Coordination of Services... 10) Evaluating the effectiveness and outcomes of care.””