John Paul Home Health Care

“Supervise skilled professional assistants CFR(s): 484.75(c) Standard: Supervision of skilled professional assistants. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse supervised the care of the licensed practical nurse for 1 (P-1) of 17 records reviewed, resulting in a lack of oversight regarding the services provided by the licensed practical nurse. Findings include: During the entrance conference on 10/7/24 at 9:15 a.m., the clinical manager (CM-B) stated that licensed practical nurses (LPN) are supervised by a registered nurse (RN) every 30 days, and this is documented as a supervisory visit in the skilled nursing visit notes. P-1: This 69-year-old patient was admitted to home care on 5/3/24 with diagnoses of chronic venous hypertension with ulcers and diabetes. During record review on 10/7/24, it was noted that the plan of care ordered skilled nursing visits once a week for one week, then three times a week for seven weeks. The LPN provided 10 of the 16 nursing visits from 5/8/24 to 6/26/24. There was no documented evidence of supervision by the RN. This finding was reviewed and acknowledged by the clinical manager (CM-B) during an interview on 10/10/24 at 10:40 a.m.”

“Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse prepared an aide care plan that contained patient information and instructions for 2 (P-2, 3) of 8 records reviewed in which aide services were provided, resulting in the potential for unsafe, substandard care, and unmet care needs. Findings include: Agency Policy C-751 – Home Health Aide Care Plan. A complete and appropriate Home Health Aide Care Plan, identifying the specific duties to be performed by the home health aide, shall be developed by a Registered Nurse or Therapist. P-2: This 65-year-old patient was admitted to home care on 6/24/24 with diagnoses of hypertensive heart disease with heart failure, acute systolic heart failure, and diabetes. During record review on 10/7/24, it was noted that the patient wears a life vest, a wearable defibrillator for patients at risk of sudden cardiac death. The addendum to the home health aide care plan states, “she wears a life vest.” The care plan failed to include instructions for removal and bathing. P-3: This 83-year-old patient was admitted to home care on 9/26/24, with diagnoses of venous ulcer, diabetes, and chronic kidney disease. During record review on 10/8/24, it was noted that the aide care plan failed to include that the patient receives hemodialysis three times per week or instructions for the patient’s AV fistula, a surgically created connection between an artery and a vein that allows for hemodialysis access. These findings were reviewed and acknowledged by the clinical manager (CM-B) during an interview on 10/10/24 at 10:40 a.m.”

“Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure that clinical records were safeguarded against loss or unauthorized use for 2 of 17 records reviewed (P-4, 11), resulting in the potential compromise of protected health information. Findings include: P-11: The Start of Care (SOC) was dated 9/25/24. The Plan of Care (POC) identified diagnoses of Left Below the Knee Amputation, Diabetes Type 2 and Hypertension. During record review on 10/7/24, it was noted that the Electronic Medical Record (EMR) contained a signed consent, patient individualized emergency plan and patient plan of care for the wrong patient, one whom had a SOC date of 8/26/24. This finding was reviewed with and acknowledged by CM-B (Clinical Manager) during an interview on 10/10/24 at 9:25 am. Agency Policy C-610 – Consent for Filming or Recording (no date). When a client is to be filmed or recorded for any purpose, the client will be required to give informed consent. P-4: This 76-year-old patient was admitted to home care on 6/4/24 with diagnoses of venous insufficiency and wound to the right lower extremity. During home visit observation with the registered nurse (RN) on 10/8/24 at 2:30 p.m., the RN was observed capturing a photo of the patient’s wound on her personal cell phone. After the visit at 3:20 p.m., the RN was queried on the process of obtaining images. The RN confirmed that she uses her personal cell phone to take the pictures then emails the images to the agency, using her agency email address, to be uploaded into the chart. The clinical manager (CM-B) was queried on the use of personal devices to obtain images of patient wounds during an interview on 10/10/24 at 10:40 a.m. CM-B stated that the agency does not supply tablets to staff and that staff use their own personal devices. CM-B stated the agency does not have a policy for security and privacy for use of electronic devices or personal cell phone use. The agency failed to protect personal health information for this patient.”

“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 record review and interview, the agency failed to ensure that 1 (P-10) of 17 records reviewed were included in their overall planning of care including informing the patient/caregiver in advance of which services would be provided and disciplines that will furnish care, resulting in a lack of inclusion in planning, lack of informed consent and unmet care needs. Findings include: P-10: The Start of Care (SOC) was dated 9/6/24. The Plan of Care (POC) identified diagnoses of Bilateral Knee Osteoarthritis, Hypertension and Diabetes Type 2. During record review on 10/8/24, it was noted that the referral stated, “Requesting home RN (Registered Nurse) + PT (Physical Therapy) … Aide (Home Health Aide) is also requested”. The consent signed by the patient on 9/6/24 and the comprehensive assessment completed by the RN on 9/6/24 were blank under the Home Health Aide (HHA) section and there was no documentation of the patient refusing HHA. Additionally, the consent stated, “Occupational Therapy (OT): Eval/Treat.” There was no documented evidence that OT has competed an Eval/Treat. The agency failed to provide services as ordered and consented to. These findings were reviewed with and acknowledged by CM-B (Clinical Manager) and during an interview on 10/10/24 at 9:50 am.”

“5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was completed within 5 calendar days of the start of care in 2 (P-4, 7) of 17 records reviewed, resulting in a delay in determining the immediate care and support needs for this patient. Findings include: Agency Policy C-145 – Comprehensive Client Assessment (revised 12/22). A thorough, well-organized, comprehensive and accurate assessment, consistent with the client’s immediate needs will be completed for all clients in a timely manner, but no later than five (5) calendar days after the start of care. P-4: This 76-year-old patient was admitted to home care on 6/4/24 with diagnoses of venous insufficiency and wound to the right lower extremity. During record review on 10/8/24, it was noted that the referral for home care, dated 5/17/24, ordered skilled nursing, home health aide, occupational therapy, and physical therapy (PT). PT evaluated the patient on 6/11/24, 7 days after the start of care. There was no evidence the physician was notified. This finding was reviewed and acknowledged by the clinical manager (CM-B) during an interview on 10/10/24 at 10:40 a.m. P-7: This 42-year-old patient was admitted to home care on 7/29/24 with diagnoses of a malignant neoplasm of the right male breast (breast cancer) and secondary malignant neoplasms (cancerous tumors) of the bone, digestive system, and lungs. During record review on 10/9/24, it was noted the plan of care dated 7/29/24 ordered the following services: skilled nursing, physical therapy, occupational therapy, speech therapy, social work, and dietician. Upon further review of the record, it was determined the dietician evaluated the patient on 8/8/24 – 10 days after the start of care. Additionally, the occupational therapist evaluated the patient on 8/9/24 – 11 days after the start of care. There was no documentation of the reason for the delay in care or that the physician was notified. Findings were reviewed with and acknowledged by the Clinical Manager (CM-B) during an interview on 10/10/24 at 12:15 PM.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum, the following information: (1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient’s current health status at the time of admission to for 5 (P-1, 5, 6, 7, 12) of 17 records reviewed, resulting in incomplete clinical information to aide in determining the needs of these patients to assist in developing the plan of care. Findings include: *Agency Policy – Wound Care Policy (revision 10/8/21). At admission full skin assessment is to be completed with the consent of the patient/caregiver. Wounds present at the SOC (start of care) will be documented in the SOC Oasis. P-1: This 69-year-old patient was admitted to home care on 5/3/24 with diagnoses of chronic venous hypertension with ulcers and diabetes. During record review on 10/7/24, it was noted that the start of care assessment, completed by the registered nurse on 5/3/24, indicated the patient had venous ulcers on the left lateral leg and the right lower leg. The status of the wound was documented as “open” but failed to include wound measurements. The comprehensive assessment failed to accurately reflect the patient’s health status to assist in developing the patient’s plan of care and to monitor potential worsening or improvement of wounds. This finding was reviewed and acknowledged by the clinical manager (CM-B) during an interview on 10/10/24 at 10:40 a.m. P-5: This 91-year-old patient was admitted to home care on 4/30/24 with diagnoses of type 2 diabetes with diabetic neuropathy, and right hip pain. During record review on 10/8/24, it was noted the Outcome and Assessment Information Set (OASIS) dated 4/30/24 indicated the patient was diabetic and insulin dependent. Upon further review of the endocrine system evaluation on the OASIS, the following was noted: “Is patient independently able to draw up the correct dose of insulin? No” “Is patient able to properly administer own insulin? No” “Is patient taking oral hypoglycemic agent? No” “Is patient independent with glucometer use? No” “Is caregiver able to correctly draw up and administer insulin? No” “Is caregiver independent with glucometer use? No” During a joint home visit with P-5 and the physical therapist (PT-D) on 10/8/24 at 2:00 PM, the patient’s daughter was interviewed regarding how P-5 managed his diabetes at home. The patient’s daughter reported she, her mother (the patient’s wife), and the patient are all able to test his blood sugar and administer the insulin as needed. She stated P-5 has been a diabetic for over 30 years and they have done very well with managing his blood sugar and medication. Upon review of the patient’s medication in the home (and comparison to the record), it was also determined the patient is taking Glucotrol daily, which is an oral hypoglycemic. The information is conflicting and does not provide a clear picture of the patient’s current or potential status. P-6: This 74-year-old patient was admitted to home care on 9/19/24 with diagnoses of hypertensive heart and kidney disease, congestive heart failure, and chronic kidney disease. During record review on 10/8/24, it was noted the mobility section on the OASIS reported the following activities were “Not attempted due to medical conditions or safety concerns.”: “roll left and right...sit to lying….lying to sitting on side of bed...sit to stand…chair/bed-to-chair transfer...walk 10 feet.” Upon further review of the record, it was noted the Musculoskeletal section on the OASIS indicated the patient was “able to bear weight and pivot during the transfer process but unable to transfer self.” It also indicated the patient was “able to walk only with the supervision or assistance of another person at all times.” The information is conflicting and does not provide a clear picture of the patient’s current or potential status. P-7: This 42-year-old patient was admitted to home care on 7/29/24 with diagnoses of a malignant neoplasm of the right male breast (breast cancer) and secondary malignant neoplasms (cancerous tumors) of the bone, digestive system and lungs. During record review on 10/9/24, it was noted the endocrine section on the OASIS dated 7/29/24 indicated the patient was not taking any oral hypoglycemic agents for his diabetes. Additionally, it was noted the patient “has a history of diabetes and is not on any medication.” Upon review of the OASIS for the recertification dated 9/26/24, it was noted under the endocrine section that the patient was still not taking any oral hypoglycemic agents for his diabetes. However, in the comments section it stated, “Patient and caregiver states he has a history of Diabetes currently on oral agent (refer to med profile).” [sic] Upon review of the diagnosis section on the recertification OASIS, it was noted the patient had “Long term (current) use of oral hypoglycemic drugs.” The medication profile section indicated this medication was Metformin and was taken daily. The information is conflicting and does not provide a clear picture of the patient’s current or potential status. P-12: This 80-year-old patient was admitted to home care on 8/29/24 with diagnoses of venous insufficiency, pressure ulcers, and type 2 diabetes. During record review on 10/9/24, it was determined that no initial blood sugar measurements were taken to determine the patient’s baseline to assist in developing an appropriate plan of care. As a result, the patient’s status regarding her diabetic management is unclear in the comprehensive assessment. Findings were reviewed with and acknowledged by the Clinical Manager (CM-B) during an interview on 10/9/24 at 2:40 PM. P-5: This 91-year-old patient was admitted to home care on 4/30/24 with diagnoses of type 2 diabetes with diabetic neuropathy, and right hip pain. During record review on 10/8/24, it was noted the Outcome and Assessment Information Set (OASIS) dated 4/30/24 indicated the patient was diabetic and insulin dependent. Upon further review of the endocrine system evaluation on the OASIS, the following was noted: “Is patient independently able to draw up the correct dose of insulin? No” “Is patient able to properly administer own insulin? No” “Is patient taking oral hypoglycemic agent? No” “Is patient independent with glucometer use? No” “Is caregiver able to correctly draw up and administer insulin? No” “Is caregiver independent with glucometer use? No” During a joint home visit with P-5 and the physical therapist (PT-D) on 10/8/24 at 2:00 PM, the patient’s daughter was interviewed regarding how P-5 managed his diabetes at home. The patient’s daughter reported she, her mother (the patient’s wife), and the patient are all able to test his blood sugar and administer the insulin as needed. She stated P-5 has been a diabetic for over 30 years and they have done very well with managing his blood sugar and medication. Upon review of the patient’s medication in the home (and comparison to the record), it was also determined the patient is taking Glucotrol daily, which is an oral hypoglycemic. The information is conflicting and does not provide a clear picture of the patient’s current or potential status. P-6: This 74-year-old patient was admitted to home care on 9/19/24 with diagnoses of hypertensive heart and kidney disease, congestive heart failure, and chronic kidney disease. During record review on 10/8/24, it was noted the mobility section on the OASIS reported the following activities were “Not attempted due to medical conditions or safety concerns.”: “roll left and right...sit to lying….lying to sitting on side of bed...sit to stand…chair/bed-to-chair transfer...walk 10 feet.” Upon further review of the record, it was noted the Musculoskeletal section on the OASIS indicated the patient was “able to bear weight and pivot during the transfer process but unable to transfer self.” It also indicated the patient was “able to walk only with the supervision or assistance of another person at all times.” The information is conflicting and does not provide a clear picture of the patient’s current or potential status. P-7: This 42-year-old patient was admitted to home care on 7/29/24 with diagnoses of a malignant neoplasm of the right male breast (breast cancer) and secondary malignant neoplasms (cancerous tumors) of the bone, digestive system and lungs. During record review on 10/9/24, it was noted the endocrine section on the OASIS dated 7/29/24 indicated the patient was not taking any oral hypoglycemic agents for his diabetes. Additionally, it was noted the patient “has a history of diabetes and is not on any medication.” Upon review of the OASIS for the recertification dated 9/26/24, it was noted under the endocrine section that the patient was still not taking any oral hypoglycemic agents for his diabetes. However, in the comments section it stated, “Patient and caregiver states he has a history of Diabetes currently on oral agent (refer to med profile).” [sic] Upon review of the diagnosis section on the recertification OASIS, it was noted the patient had “Long term (current) use of oral hypoglycemic drugs.” The medication profile section indicated this medication was Metformin and was taken daily. The information is conflicting and does not provide a clear picture of the patient’s current or potential status. P-12: This 80-year-old patient was admitted to home care on 8/29/24 with diagnoses of venous insufficiency, pressure ulcers, and type 2 diabetes. During record review on 10/9/24, it was determined that no initial blood sugar measurements were taken to determine the patient’s baseline to assist in developing an appropriate plan of care. As a result, the patient’s status regarding her diabetic management is unclear in the comprehensive assessment. Findings were reviewed with and acknowledged by the Clinical Manager (CM-B) during an interview on 10/9/24 at 2:40 PM. *Agency Policy – Wound Care Policy (revision 10/8/21). At admission full skin assessment is to be completed with the consent of the patient/caregiver. Wounds present at the SOC (start of care) will be documented in the SOC Oasis. P-1: This 69-year-old patient was admitted to home care on 5/3/24 with diagnoses of chronic venous hypertension with ulcers and diabetes. During record review on 10/7/24, it was noted that the start of care assessment, completed by the registered nurse on 5/3/24, indicated the patient had venous ulcers on the left lateral leg and the right lower leg. The status of the wound was documented as “open” but failed to include wound measurements. The comprehensive assessment failed to accurately reflect the patient’s health status to assist in developing the patient’s plan of care and to monitor potential worsening or improvement of wounds. This finding was reviewed and acknowledged by the clinical manager (CM-B) during an interview on 10/10/24 at 10:40 a.m.”

“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 record review and interview, the agency failed to ensure the comprehensive assessment included a review of all medications to identify any potential adverse effects, drug reactions, duplicate drug therapy, or interactions for 8 of 17 (P-1, 3, 4, 5, 7, 9, 13, 15) records reviewed, resulting in the potential for harmful medication effects for these patients. Findings include: **Agency Procedure: “Effective 3/1/2024. Medication Reconciliation of Therapy Oasis tasks…Reconciliation will be run in the EMR (Electronic Medical Record). All interactions and notification letter will be faxed to the patient’s managing physician. Fax confirmation will be attached to the medication reconciliation task under the miscellaneous tab.” P-9: The Start of Care (SOC) was dated 8/2/24. The Plan of Care (POC) identified diagnoses of Parkinson’s, Hypertension and Diabetes Type 2. During record review on 10/7/24, it was noted that the Physical Therapist completed the comprehensive assessment on 8/2/24. A medication interaction report was generated by RN-C (Registered Nurse/Clinical Manager) on 10/9/24. The interaction report indicates duplicate drug therapy consisting of: Metoprolol Tartrate, Amlodipine Besylate and Hydrochlorothiazide. Additionally, a drug-drug “Review Suggested” was noted between Amlodipine Besylate and Simvastatin. The EMR failed to contain all interactions and a notification letter under the miscellaneous tab per procedure and there was no documentation to indicate the physician was notified of the interactions. This finding was reviewed with and acknowledged by CM-B (Clinical Manager) during an interview on 10/10/24 at 9:45 am. P-13: This patient was admitted to home care on 9/14/24 with diagnoses of a right cerebrovascular accident (stroke), left sided weakness, and difficulty walking. The comprehensive assessment was completed by the registered nurse on 9/14/24. The 10/8/24 review of the comprehensive assessment indicates for (M2001) drug regimen review that issues were found during the review and that the physician was contacted. There was no indication of the issues found during the drug review or that the physician was informed of the issues that were found. The nurse documents that report was given to John Paul Home Health Care intake coordinator and nursing director. A medication interaction report was generated by RN-C (registered nurse/clinical manager) on 10/9/24. The interaction report indicates duplicate drug therapy consisting of: Amlodipine Besylate + Diltiazem HCI ER (both are calcium channel blockers) and Carvedilol (beta blocker) + Amlodipine Besylate. There was no documentation to indicate the physician was notified of the duplicate drug therapies. The findings were reviewed with and acknowledged by CM-B (clinical manager) during an interview on 10/10/24 at 11:15 a.m. The agency failed to follow its own policy titled, Medication Profile C-700 (no date) which states, the clinician shall promptly report any identified problems to the physician/allowed non-physician practitioner. P-15: This patient was admitted to home care on 9/19/24 with diagnoses of increased gastrin secretion, non-ST elevation myocardial infarction (NSTEMI), and acute respiratory failure with hypoxia. The comprehensive assessment was completed by the registered nurse on 9/19/24. The 10/7/24 review of the comprehensive assessment indicates for (M2001) drug regimen review that no issues were found during the review. A medication interaction report was generated by RN-C (registered nurse/clinical manager) on 10/9/24. The interaction report indicates duplicate drug therapy consisting of: Metoprolol Tartrate + Amlodipine Besylate (both are used to lower blood pressure) and Senna leaves oral + Senna S oral tablet (laxatives). There was no documentation to indicate the physician was notified of the duplicate drug therapies. Agency Policy C-700 – Medication Profile (dated 3/1/24) states, “the clinician shall promptly report any identified problems to the physician/allowed non-physician practitioner (NPP).” P-1: This 69-year-old patient was admitted to home care on 5/3/24 with diagnoses of chronic venous hypertension with ulcers and diabetes. During record review on 10/7/24, it was noted that the start of care assessment, completed by the registered nurse on 5/3/24, indicated that no issues were found during drug regimen review (M2001). The record failed to include a medication profile at admission. In addition, a medication interaction report was generated by the clinical manager (RN-C) on 10/9/24, indicated two drug allergy checks for Tylenol + red dye and tramadol + hydrocodone as well as three “review suggested” drug-to-drug interactions for doxycycline + ferrous fumarate, levothyroxine + ferrous fumarate, and rivaroxaban + carvedilol. There was no evidence the physician was notified. P-3: This 83-year-old patient was admitted to home care on 9/26/24, with diagnoses of venous ulcer, diabetes, and chronic kidney disease. During record review on 10/8/24, it was noted that the start of care assessment, completed by the registered nurse on 9/26/24, indicated that no issues were found during drug regimen review (M2001). A medication interaction report was generated by the clinical manager (RN-C) on 10/9/24, indicated “review suggested” drug-to-drug interaction for metoprolol + amiodarone and duplicate therapy for metoprolol/hydralazine/bumetanide. There was no evidence the physician was notified. P-4: This 76-year-old patient was admitted to home care on 6/4/24 with diagnoses of venous insufficiency and wound to the right lower extremity. During record review on 10/8/24, it was noted that the start of care assessment, completed by the registered nurse on 6/4/24, indicated that no issues were found during drug regimen review (M2001). A medication interaction report was generated by the clinical manager (RN-C) on 10/9/24, indicated “review suggested” drug-to-drug interaction for ibuprofen and Eliquis (a blood thinner), as well as duplicate therapy for metoprolol/losartan. There was no evidence the physician was notified. These findings were reviewed and acknowledged by the clinical manager (CM-B) during an interview on 10/10/24 at 10:40 a.m. **Policy titled “Medication Profile” (revised 3/1/24) stated the following: “1. At the time of admission, the admission professional shall check all medications a client may be taking to identify possible ineffective drug therapy or adverse reaction, significant side effects, drug allergies, and contraindicated medication…”, “2. The Nurse/Therapist shall record on the Medication Profile all prescribed and over-the-counter (OTC) medications the client is currently taking.”, and “All interactions and notification letter will be faxed to the patient’s managing physician. Fax confirmation will be attached to the medication reconciliation task under the miscellaneous tab.” P-5: This 91-year-old patient was admitted to home care on 4/30/24 with diagnoses of type 2 diabetes with diabetic neuropathy, and right hip pain. During record review on 10/8/24, it was noted there was no initial medication profile review in the record to check for medication discrepancies. Additionally, during a joint home visit with P-5 and the physical therapist (PT-D) on 10/8/24 at 2:00 PM, the medications in the home were reviewed with the patient’s daughter and compared with the current list on the plan of care. According to the most recent plan of care dated 8/28/24, P-5 was taking “Lantus Subcutaneous 100 UNIT/ML 1 ml inject 10 units subcutaneous every day.” However, during the interview with the patient’s daughter, it was determined the patient has never taken Lantus. The patient’s daughter stated the patient takes Humalog using a “KwikPen” (prefilled syringe). She stated he only takes it as needed when his blood sugar is high. Humalog was not listed on the patient’s medication profile. PT-D was made aware of the findings at the time of discovery. P-7: This 42-year-old patient was admitted to home care on 7/29/24 with diagnoses of a malignant neoplasm of the right male breast (breast cancer) and secondary malignant neoplasms (cancerous tumors) of the bone, digestive system, and lungs. During record review on 10/9/24, it was noted the skilled nursing visit dated 9/12/24 stated the oncologist started the patient on the following medications: dexamethasone, capecitabine, and tukysa. There was no evidence a medication interaction report was run to check for any discrepancies or concerns. On the skilled nursing daily note dated 9/20/24, it was noted the medication mirtazapine was added. There was no evidence a medication interaction report was run to check for any discrepancies or concerns. Additionally, upon review of the plan of care dated 9/27/24 following the addition of these 4 medications, it was noted that none of them had been added to the updated plan of care. The Clinical Manager (CM-B) was interviewed on 10/10/24 at 12:15 PM regarding the expectation of when medications should be reconciled. CM-B reported medications should be reviewed and reconciled at the comprehensive assessment, after updates to the comprehensive assessment, and after any new medication is added. CM-B acknowledged the findings.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure a plan of care was developed for 1 of 17 (P-13) records reviewed and failed to ensure the plan of care included parameters to notify the physician, allergies, interventions, measurable goals and wound care for 9 of 17 (P-2, 5, 6, 8, 11, 12, 14, 16, 17) records reviewed, resulting in no assurance patients are receiving care and services specific to their individual needs. Findings include: P-13: This 80-year-old patient was admitted to home care on 9/14/24 with diagnoses of a right cerebrovascular accident (stroke), left sided weakness, and difficulty walking. The patient was receiving skilled nursing, physical therapy, occupational therapy, and social work services. The comprehensive assessment was completed by the registered nurse on 9/14/24. During record review on 10/8/24, it was noted that there was no plan of care for review. An interview was conducted with the clinical manager (CM-B) on 10/8/24 at 12:05 p.m. CM-B explained that the care plan is out for coding, and they have 30-days to complete the plan of care due to coding. CM-B was asked how staff are providing care without a plan of care. CM-B replied that it’s definitely been a problem they are working on. The agency failed to follow its own policy titled, Plan of Care C-580 (no date), which states the plan of care is developed within five (5) working days. Another policy titled, Care Plans C-660 (no date) states that each client will have a care plan on file that is in the patient’s chart within seven (7) days of the initial visit. P-14: This patient had surgery for a right total knee replacement on 9/30/24. Home care services began on 10/2/24. The patient was receiving physical therapy (PT) services. The comprehensive assessment completed by the PT on 10/2/24 noted that the patient rated his right knee pain at 10/10 that was sharp, aching, and constant. The 10/2/24 plan of care failed to include parameters to notify the physician regarding the patient’s pain and failed to include goals or outcomes related to the patient’s pain. The finding was reviewed with CM-B (clinical manager) during an interview on 10/10/24 at 11:15 a.m. CM-B responded that there should be a reportable pain parameter on the plan of care. P-16: This patient was admitted to home care on 12/2/23 with diagnoses of dislocation of left humerus (upper arm), type 2 diabetes, and high blood pressure. The patient received skilled nursing, physical therapy, and occupational therapy services. The occupational therapy evaluation on 12/6/23 noted that the patient rated his left shoulder pain at 8 on a scale of 0 (low) to 10 (high). The 12/2/23 plan of care failed to include parameters to notify the physician regarding the patient’s pain. P-17: This 85-year-old patient was admitted to home care on 3/724 with diagnoses of encounter for attention to gastrostomy, left lung cancer, bladder cancer, and pressure ulcers to the left buttock and sacrum. The patient had a nasogastric tube sewed to the septum of her nose to receive nutrition. The patient received skilled nursing, physical therapy, occupational therapy, and aide services. The registered nurse completed a comprehensive assessment on this patient on 3/7/24. The nurse documented on the assessment that the patient/caregiver verbalized understanding to report to the physician regarding a pain level greater than 7. The 3/7/24 plan of care failed to include parameters to notify the physician regarding the patient’s pain. Agency Policy C-145 – Comprehensive Client Assessment (revised 12/22). The client’s strengths, goals, and care preferences, including information that may be used to demonstrate the client’s progress toward achievement of the goals identified by the client and the measurable outcomes identified by the agency. P-2: This 65-year-old patient was admitted to home care on 6/24/24 with diagnoses of hypertensive heart disease with heart failure, acute systolic heart failure, and diabetes. During record review on 10/7/24, it was noted that the plan of care failed to include measurable nursing goals that are individualized to address patient needs. For example, one goal stated, “patient will verbalize understanding of proper use of pain medication.” There was no evidence of how this goal could be objectively measured to determine progress toward meeting the goal. Another goal stated, “patient will be free from signs and symptoms of hypo/hyperglycemia during the episode” as well as parameters for fasting and random glucose monitoring. During the second certification period (starting 8/23/24), nursing made eight patient visits; one of the eight nursing visits included documentation of the patient’s blood sugar level. This finding was reviewed and acknowledged by the clinical manager (CM-B) during an interview on 10/10/24 at 10:40 a.m. **Agency Policy: “Care Plans, C-660,” (Undated). The policy states, “1. Following the initial assessment, a Care Plan shall be developed with the client and/or caregiver. The interventions shall correspond to the problems identified, services needed and the client goals for the episode of care.” P-8: The Start of Care (SOC) was dated 4/27/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure, Diabetes Type 2 and Transient Ischemic Attack. The referral dated 4/25/24 documented the following allergy: Losartan. The POC dated 4/27/24 failed to document the allergy to Losartan. The agency failed to document and accurately assess the patient’s allergy. During record review on 10/7/24, it was documented that the patient was a diabetic and there were no diabetic parameters to notify the physician of blood sugar irregularities. The POC failed to contain the blood sugar parameters to notify the physician. P-11: The Start of Care (SOC) was dated 9/25/24. The Plan of Care (POC) identified diagnoses of Left Below the Knee Amputation, Diabetes Type 2 and Hypertension. The POC dated 9/25/24 stated, “Allergies: NKA (No Known Allergies).” The referral dated 9/18/24 documented the following allergy: Bactrim. The agency failed to document and accurately assess the patient’s allergy. Additionally, The POC dated 9/25/24 stated, “Orders and Treatments: …Patient’s left leg wrapped in dressing, next visit, SN (Skilled Nurse) will assess and will change dressing as per physician’s order…” The following SN visit was completed on 9/28/24 and stated, “Wounds Addressed on this Visit: Wound 1 – Location: Left BKA (Below the Knee Amputation) … Treatment: Surgical wound cleanse with wound cleanser, patted dry, applied xeroform, 4x4 wrapped with kerlix… Additional information: 37 staples in place.” The Electronic Medical Record (EMR) contained no evidence of a wound care order or physician’s order regarding wound care. The agency failed to document the wound care order from the physician. These findings were reviewed with and acknowledged by CM-B (Clinical Manager) and during an interview on 10/10/24 at 10:30 am. P-5: This 91-year-old patient was admitted to home care on 4/30/24 with the diagnoses of type 2 diabetes with diabetic neuropathy, and right hip pain. During record review on 10/8/24, it was noted the plan of care failed to include individualized, measurable goals to address patient needs. For example, one goal stated, “Patient will demonstrate improved TUG (timed up and go) score to improve mobility.” Another goal stated, “Patient will demonstrate improved endurance with activity.” There was no objective information to assess the patient’s progress towards meeting these goals. It was also noted the evaluation completed by the physical therapist on 4/30/24 indicated the patient had pain in his right hip at a 5/10 intensity. There were no goals written related to the patient’s pain levels. There were also no parameters for pain to report to the physician. Upon further review of the record, it was noted the plan of care also failed to include interventions for diabetes – the patient’s primary diagnosis. Additionally, the plan of care failed to include blood sugar parameters to report to the physician. P-6: This 74-year-old patient was admitted to home care on 9/19/24 with the diagnoses of hypertensive heart and kidney disease, congestive heart failure (CHF), and chronic kidney disease. During record review on 10/8/24, it was noted the plan of care failed to include individualized, measurable goals to address patient needs. For example, one goal stated, “Patient’s respiratory rate will remain within established parameters during the episode. There was no objective information specific to this patient to measure the patient’s progress towards meeting this goal. Upon further review of the record, it was noted the Outcome and Assessment Information Set (OASIS) indicated a weight was not obtained due to the patient being too unsafe to stand on a scale. Instead, circumferential measurements of bilateral lower extremities were included to evaluate the patient’s edema related to her CHF. However, it was determined the plan of care failed to include parameters for edema to be reported to the physician. P-12: This 80-year-old patient was admitted to home care on 8/29/24 with the diagnoses of venous insufficiency, pressure ulcers, and type 2 diabetes. During record review on 10/9/24, it was noted the plan of care dated 8/29/24 ordered skilled nursing services for 1 time a week for 1 week, 2 times a week for 3 weeks, and 1 time a week for 4 weeks. The plan of care also included an intervention for wound care to be changed “daily and as needed.” Review of the daily skilled nursing visit notes dated 9/3/24, 9/5/24, 9/8/24, 9/12/24/ 9/17/24/ 9/19/24, 9/24/24, and 10/1/24 indicated, “Pt unable to do wound care and has no one in the home who can provide the wound care at this time.”. The agency failed to ensure the interventions corresponded to the problems identified in the initial assessment to meet the needs of the patient. Findings were reviewed with and acknowledged by the Clinical Manager (CM-B) during an interview on 10/10/24 at 2:40 PM.”

“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 findings that fell outside the parameters ordered in the patient’s plan of care in 1 of 17 (P-15) records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-15: This patient was admitted to home care on 9/19/24 with diagnoses of increased gastrin secretion, non-ST elevation myocardial infarction (NSTEMI), and acute respiratory failure with hypoxia. The 9/19/24 plan of care orders the physician to be notified of systolic blood pressure (BP) greater than 160 and to be notified of diastolic BP greater than 90. On 9/24/24 the occupational therapist (OT) documented the patient’s BP at 152/100 and 162/104. The OT documented that the case manager was notified of the high BP and to follow up the next day. There was no documented follow-up on 9/25/24. On 9/26/24, the OT documented the patient’s BP at 152/102 and 146/102. The OT documented that the case manager was notified of the high BP and to follow up the next day. There was no documented follow-up on 9/27/24. The next visit was 5 days later on 10/1/24. The OT documented the patient’s BP at 140/98 and 148/102 and the patient stating that her head hurts. The OT documented that the case manager was notified of the high BP and to follow up the next day. There was no documented follow-up on 10/2/24. On 10/3/24, the OT documented the patient’s BP at 180/110 and 164/114 and patient stating that her head hurts. The OT documented that the case manager was notified of the high BP and to follow up the next day. There was no documented follow-up on 10/4/24. The OT failed to notify the physician of elevated BP readings that fell outside the parameters ordered by the physician on 9/24/24, 9/26/24, 10/1/24, and 10/3/24. The findings were reviewed with CM-B (clinical manager) during an interview on 10/10/24 at 11:15 a.m. CM-B responded that the physician should have been notified.”

“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 document review and interview, it was determined that the agency failed to ensure ongoing communication between Skilled Nursing and Home Health Aide in 1 (P-8) of 17 records reviewed, which resulted in the potential for unidentified patient needs. Findings include: **Agency Policy: “Clinical Documentation, C-680,” (Undated). The policy states, “Purpose: To ensure that there is an accurate record of the services provided, client response and ongoing need for care. Special Instructions: 3. Additional information that is pertinent to the client’s care or condition may be documented on the Progress Note or Flow Sheet.” P-8: The Start of Care (SOC) was dated 4/27/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure, Diabetes Type 2 and Transient Ischemic Attack. During record review on 10/7/24, it was noted that the Home Health Aide (HHA) on 5/3/24 documented, “Skin Condition: Patient has a lot of breakdown and small open wound under the belly flap area…Nurse notified…” On 5/7/24 the HHA documented, “Patient still has skin breakdown on lower back on both sides, rash under belly has cleared.” The following Skilled Nursing (SN) visit dated 5/10/24 stated, “Skin: Warm, Dry, Turgor: Decreased.” The agency failed to document skin breakdown that was communicated to the SN. This finding was reviewed with and acknowledged by CM-B (Clinical Manager) during an interview on 10/10/24 at 9:30 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 all services were provided as ordered by the physician or allowed practitioner as indicated in the plan of care in 1 (P-5) of 17 records reviewed, resulting in the potential for poor patient outcomes and unmet care needs. Findings include: P-5: This 91-year-old patient was admitted to home care on 4/30/24 with diagnoses of type 2 diabetes with diabetic neuropathy, and right hip pain. During record review on 10/8/24, it was noted the plan of care dated 4/30/24 ordered physical therapy services 1 time a 1 for 1 week and 2 times a week for 4 weeks. Upon further review of the record, it was determined the patient was seen 1 time a week for the first week as ordered, however, he was only seen 1 time a week for the next 4 weeks due to doctor’s appointments. During an interview on 10/10/24 at 12:15 PM, the Clinical Manager (CM-B) was asked about the expectation for rescheduling missed visits. CM-B stated the expectation is to try to reschedule any missed visits during that week to meet the frequency ordered on the plan of care. If the visit cannot be rescheduled for any reason, the expectation is to contact the doctor and send new orders if the ordered frequency cannot be met. CM-B acknowledged the findings at the time of the interview.”

“Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record was complete and included detailed notes for 4 (P-1, 2, 3, 10) of 17 records reviewed, resulting in lack of continuity of care and undocumented health concerns. Findings include: P-1: This 69-year-old patient was admitted to home care on 5/3/24 with diagnoses of chronic venous hypertension with ulcers and diabetes. During record review on 10/7/24, it was noted that the licensed practical nurse (LPN) visits on 5/16/24, 5/21/24, and 6/26/24 failed to include a documented blood sugar. It was also noted that the start of care listed legal blindness as a current diagnosis, however 12 of the 16 nursing visits indicate “vision within normal limits.” Additionally, 10 of the 16 nursing visits failed to include wound measurements. P-2: This 65-year-old patient was admitted to home care on 6/24/24 with diagnoses of hypertensive heart disease with heart failure, acute systolic heart failure, and diabetes. During record review on 10/7/24, it was noted that the plan of care ordered skilled nursing twice a week for eight weeks. The plan of care ordered nursing to instruct patient on daily weight self-monitoring program and to report weight gain of 3 pounds in one day or 7 pounds in one week to monitor potential worsening of congestive heart failure. During the second certification period (starting 8/23/24), nursing made eight patient visits; none of these nursing visits included documentation of the patient’s weight. On 9/4/24, the physical therapist documented “feet swelling up lately,” on 9/9/24, “continues to have swelling in feet,” on 9/11/24, “legs feel heavy with swelling,” and on 9/19/24, “swelling down after doctor increased dose of water pill.” On all eight nursing visits, the nurse documented “bilateral lower edema.” The record failed to include edema measurements such as +1/+2 or leg/ankle circumference measurements to monitor potential worsening of heart failure. In addition, the plan of care contained parameters for reporting blood sugar while one of the eight nursing visits (9/25/24) included a documented blood sugar level. P-3: This 83-year-old patient was admitted to home care on 9/26/24, with diagnoses of venous ulcer, diabetes, and chronic kidney disease. During record review on 10/8/24, it was noted that the skilled nursing visit on 10/1/24 failed to include a documented blood pressure or blood sugar. These findings were reviewed and acknowledged by the clinical manager (CM-B) during an interview on 10/10/24 at 10:40 a.m. For P-3, the CM-B stated the chart has not been through quality assurance yet and will be sent back to the nurse to complete. **Agency Policy: “Clinical Documentation, C-680,” (Undated). The policy states, “Purpose: To ensure that there is an accurate record of the services provided, client response and ongoing need for care.” P-10: The Start of Care (SOC) was dated 9/6/24. The Plan of Care (POC) identified diagnoses of Bilateral Knee Osteoarthritis, Hypertension and Diabetes Type 2. During record review on 10/8/24, it was noted that the Physical Therapist (PT) completed an evaluation on 9/10/24 with an ordered frequency of 2w1 (2 times a week for 1 week). The PT documented evaluation trunk strength as 2/5 for right and left, and 2-/5 strength for hip and knee right and left. The PT discharge was completed 2 days later, on 9/12/24, the PT documented trunk, hip and knee strength as 3/5 for right and left. The “National Library of Medicine: Muscle Strength Grading” states, “The most commonly accepted method of evaluating muscle strength is the Medical Research Council Manual Muscle Testing scale. This method involves testing key muscles from the upper and lower extremities against the examiner’s resistance and grading the patient’s strength on a 0 to 5 scale accordingly: … 2 - Muscle activation with gravity eliminated, achieving full range of motion. 3 - Muscle activation against gravity, full range of motion.” Additionally, the PT documented at discharge on 9/12/24, “Care Summary: …Patient has shown significant improvement in terms of muscle strength to lower extremities…Patient required verbal and physical assistance to maintain mid line balance while functional activities due to lower extremities weakness…” The PT failed to accurately document the patients response to services provided. This finding was reviewed with and acknowledged by CM-B (Clinical Manager) during an interview on 10/10/24 at 9:25 am.”

“Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physical therapist communicated with the physician regarding pain for 1 of 2 (P-14) post-operative records reviewed, resulting in a lack of physician involvement in directing the appropriate care for this patient, and failed to ensure skilled nursing communicated assessment findings with the physician for 3 (P-1, 3, 7) of 17 records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-14: This patient had surgery for a right total knee replacement on 9/30/24. Home care services began on 10/2/24. The patient was receiving physical therapy (PT) services. The comprehensive assessment completed by the PT on 10/2/24 noted that the patient rated his right knee pain at 10/10 that was sharp, aching, and constant. During record review on 10/8/24, it was noted that the PT failed to document communication with the physician regarding the patient’s constant high pain experience on 10/2/24. The finding was reviewed with CM-B (clinical manager) during an interview on 10/10/24 at 11:15 a.m. CM-B responded that the physician should have been notified. P-1: This 69-year-old patient was admitted to home care on 5/3/24 with diagnoses of chronic venous hypertension with ulcers and diabetes. During record review on 10/7/24, it was noted that the plan of care ordered nursing to report fasting blood sugar levels greater than 180 or less than 70 and random blood sugar levels greater than 250 or less than 70. During the licensed practical nurse (LPN) visit on 5/11/24, the LPN documented the blood sugar as 53 and on 5/15/24 as 63. There was no evidence the physician was notified, if the patient was experiencing hypoglycemic symptoms, or if the blood sugar level had been repeated. P-3: This 83-year-old patient was admitted to home care on 9/26/24, with diagnoses of venous ulcer, diabetes, and chronic kidney disease. During record review on 10/8/24, it was noted that the plan of care ordered nursing to report systolic blood pressure greater than 160 or less than 90. During the registered nurse visit on 10/3/24, the nurse documented the blood pressure as 167/77. There was no evidence the physician was notified. These findings were reviewed and acknowledged by the clinical manager (CM-B) during an interview on 10/10/24 at 10:40 a.m. P-7: This 42-year-old patient was admitted to home care on 7/29/24 with diagnoses of a malignant neoplasm of the right male breast (breast cancer) and secondary malignant neoplasms (cancerous tumors) of the bone, digestive system and lungs. During record review on 10/9/24, it was noted the plan of care dated 7/29/24 stated to notify the physician if “patient experiences….pain level greater than 7, pain medications not effective…”. Upon further review of the record, it was determined the Outcome and Assessment and Information Set (OASIS) dated 7/29/24 indicated the patient had a pain level of 10/10 and “minimal relief obtained” from the pain medication. There was no evidence of the physician being notified. Additionally, the OASIS for the recertification dated 9/26/24 also indicated a pain level of 10/10 and “minimal relief obtained” from the pain medication. There was no evidence the physician was notified. Findings were reviewed with and acknowledged by the Clinical Manager (CM-B) during an interview on 10/10/24 at 12:15 PM.”

“Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient’s plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure they adequately documented on-site supervisory visit to the patient’s home to supervise the services that were provided by the home health aide for 2 (P-2, 8) of 8 records reviewed in which aide services had been provided, from a total sample of 17 records reviewed, resulting in a lack of oversight of aide care and services. Findings include: **Agency Policy: “Home Health Aide Supervision, C-340,” (Undated). The policy states, “3. Supervisory visits of Home Health Aides shall be according to the following frequency: a. When skilled services are being provided to a client, a Registered Nurse/Therapist must make a supervisory visit to the client’s residence no less frequently than every 14 days...” P-8: The Start of Care (SOC) was dated 4/27/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure, Diabetes Type 2 and Transient Ischemic Attack. The Registered Nurse (RN) completed a supervisory visit on 5/9/24. During record review on 10/7/24, 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 CM-B (Clinical Manager) during an interview on 10/10/24 at 9:35 am. P-2: This 65-year-old patient was admitted to home care on 6/24/24 with diagnoses of hypertensive heart disease with heart failure, acute systolic heart failure, and diabetes. During record review on 10/7/24, it was noted that the plan of care ordered home health aide services twice a week for eight weeks. The registered nurse completed an aide supervisory visit on 9/17/24, with the next supervisory visit due on 10/1/24. There was no evidence this visit was completed. This finding was reviewed and acknowledged by the clinical manager (CM-B) during an interview on 10/10/24 at 10:40 a.m.”

“HH aide supervision elements CFR(s): 484.80(h)(4)(i-vi) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements: (i) Following the patient’s plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional; (ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family; (iii) Demonstrating competency with assigned tasks; (iv) Complying with infection prevention and control policies and procedures; (v) Reporting changes in the patient’s condition; and (vi) Honoring patient rights. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure home health aide services were provided as ordered in 1 (P-1) of 8 records reviewed with aide services, resulting in the potential for unmet care needs. Findings include: P-1: This 69-year-old patient was admitted to home care on 5/3/24 with diagnoses of chronic venous hypertension with ulcers and diabetes. During record review on 10/7/24, it was noted that the plan of care ordered home health aide services twice a week for eight weeks. The aide documented missed visits on 5/7/24, 5/14/24, 6/18/24, and 6/25/24. There was no evidence the aide notified the registered nurse of the missed visits. This finding was reviewed and acknowledged by the clinical manager (CM-B) during an interview on 10/10/24 at 10:40 a.m. CM-B stated, “the (nursing) supervisor must be notified of every missed visit.””

“Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure clinical manager oversight of coordinating patient care services and personnel for 1 (P-1) of 17 records reviewed, resulting in the potential for inappropriate care. Findings include: P-1: This 69-year-old patient was admitted to home care on 5/3/24 with diagnoses of chronic venous hypertension with ulcers and diabetes and was discharged from agency services on 9/27/24. During record review on 10/7/24, it was noted that the patient received a home health aide visit on 9/28/24, the day after discharge. This finding was reviewed and acknowledged by the clinical manager (CM-B) during an interview on 10/10/24 at 10:40 a.m.”

“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 observation, record review and interview, the agency failed to ensure clinical notes were accurate for 5 of 17 (P-2, 5, 7, 10, 11) records reviewed, resulting in the potential to negatively affect the health and well-being of these patients. Findings include: **Agency Policy: “Clinical Documentation, C-680,” (Undated). The policy states, “Purpose: To ensure that there is an accurate record of the services provided, client response and ongoing need for care.” **Agency Policy: “Wound Care,” (Revised 10/8/21). The policy states, “3. A. Weekly assessment is to be completed and documented on the visit note.” P-10: The Start of Care (SOC) was dated 9/6/24. The Plan of Care (POC) identified diagnoses of Bilateral Knee Osteoarthritis, Hypertension and Diabetes Type 2. During record review on 10/8/24, it was noted that the Skilled Nurse (SN) documented on 9/14/24, “Skilled Intervention: Assessment / Instruction / Performance: T (Taught) / I (Instructed) related s (signs) / s (symptoms) of infection…pain at tube insertion site…” There is no documented evidence the patient has tube, the agency failed to accurately document within the clinical notes. P-11: The Start of Care (SOC) was dated 9/25/24. The Plan of Care (POC) identified diagnoses of Left Below the Knee Amputation, Diabetes Type 2 and Hypertension. During record review on 10/7/24, it was noted that the POC ordered SN at a frequency of 2w2 (2 times a week for 2 weeks), 1w5. The SN documented a wound assessment on 9/28/24 stating, “Wound 1 – Location: Left BKA (Below the Knee Amputation) … Size: Length: 20cm, Width: 0cm, Depth: 0cm…Wound Edges: Attached, Drainage: None, Odor: None…” The SN completed two visits the following week on 10/2/24 and 10/5/24. The was no documented evidence that wound measurements were completed, the SN failed to follow the wound care policy and document weekly wound measurements. These findings were reviewed with and acknowledged by CM-B (Clinical Manager) and during an interview on 10/10/24 at 10:05 am. Agency Policy-C-680 – Clinical Documentation (no date). Documentation of services ordered on the plan of care will be completed the day service is rendered and incorporated into the clinical record within seven days after the care has been provided. P-2: This 65-year-old patient was admitted to home care on 6/24/24 with diagnoses of hypertensive heart disease with heart failure, acute systolic heart failure, and diabetes. During record review on 10/7/24, it was noted that the plan of care ordered physical therapy once a week for one week, then twice a week for five weeks. Physical therapy visits from 10/1/24 and 10/3/24 were blank. The clinical manager (CM-B) was queried on the expectation for completion of visit notes during an interview on 10/10/24 at 10:40 a.m., and replied, “staff has 7 days to complete documentation, these visits are late. We print late reports daily and notify the staff.” P-5: This 91-year-old patient was admitted to home care on 4/30/24 with diagnoses of type 2 diabetes with diabetic neuropathy, and right hip pain. During record review on 10/8/24, the certification period from 8/28/24 to 10/26/24 was reviewed. Upon review of the physical therapy notes, it was noted that all 11 physical therapy notes in this certification period stated, “HEP (home exercise program) sheet provided”. Upon further review of the record, there was no evidence of a HEP sheet provided or what exercises the patient was instructed to do. Therefore, this record is missing information on treatments provided to this patient. P-7: This 42-year-old patient was admitted to home care on 7/29/24 with diagnoses of a malignant neoplasm of the right male breast (breast cancer) and secondary malignant neoplasms (cancerous tumors) of the bone, digestive system and lungs. During record review on 10/9/24, it was noted the physical therapy evaluation dated 8/1/24 stated “HEP was provided to the patient and was instructed to follow daily.” There was no evidence of the HEP provided or what exercises the patient was instructed to do. Therefore, this record is missing information on treatments provided to this patient. Findings were reviewed with and acknowledged by the Clinical Manager (CM-B) during an interview on 10/10/24 at 12:15 PM.”

“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 sent to the physician within 5 business days of the patient’s discharge for 4 of 5 (P-1, 8, 9, 16) records reviewed in which the patient was discharged from the agency, resulting in the physician not having knowledge of the patient’s health status at the time of discharge and a summary of the care received which has the potential to negatively affect all patients discharged in the past twelve months. Findings include: **Agency Policy: “Client Discharge Process, C-500,” (Undated). The policy states, “E. A completed discharge summary will be sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the client after discharge within 5 business days of the client’s discharge.” P-8: The Start of Care (SOC) was dated 4/27/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure, Diabetes Type 2 and Transient Ischemic Attack. During record review on 10/7/24, it was noted that the Skilled Nurse (SN) completed a discharge on 8/22/24. The Electronic Medical Record (EMR) contained no evidence that the discharge summary was sent to the physician within 5 business days of the patient’s discharge. P-9: The Start of Care (SOC) was dated 8/2/24. The Plan of Care (POC) identified diagnoses of Parkinson’s, Hypertension and Diabetes Type 2. During record review on 10/7/24, it was noted that the Physical Therapist (PT) completed a discharge on 9/13/24. The EMR contained no evidence that the discharge summary was sent to the physician within 5 business days of the patient’s discharge. These findings were reviewed with and acknowledged by CM-B (Clinical Manager) and during an interview on 10/10/24 at 10:25 am. P-16: This patient was admitted to home care on 12/2/23 with diagnoses of dislocation of left humerus (upper arm), type 2 diabetes, and high blood pressure. The patient received skilled nursing, physical therapy, and occupational therapy services. The patient was discharged from agency services by the physical therapist on 1/25/24. During record review on 10/7/24, it was noted that there was no discharge summary for review and no evidence that a discharge summary was sent to the physician within 5 business days of discharge. The finding was reviewed with CM-B (clinical manager) during an interview on 10/10/24 at 11:15 a.m. CM-B reviewed the medical record and explained that no discharge summary had been created and no discharge summary was sent to the physician. P-1: This 69-year-old patient was admitted to home care on 5/3/24 with diagnoses of chronic venous hypertension with ulcers and diabetes. During record review on 10/7/24, it was noted that the patient was discharged from agency services on 9/27/24. There was no evidence that a detailed discharge summary report was sent to the physician within 5 days of the patient’s discharge. This finding was reviewed and acknowledged by the clinical manager (CM-B) during an interview on 10/10/24 at 10:40 a.m.”

“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, the agency failed to ensure the plan of care included medical social work services for 1 of 1 (P-1) records reviewed with an identified need for social work services, resulting in a lack of community resource information for this patient. Findings include: P-1: This 78-year-old patient was admitted to home care services on 12/8/23 with diagnoses of venous insufficiency and bilateral lower extremity non-pressure chronic ulcers. The medical record was reviewed on 7/31/24. The comprehensive assessment conducted by the nurse on 12/8/23 indicates the patient has a need for community resource information to manage care, community resources for transportation, and that the agency coordinator was notified. The plan of care failed to include an assessment/evaluation by medical social work services (MSW). The findings were reviewed with Staff-A (clinical manager) during an interview on 7/31/24 at 2:40 p.m. Staff-A reviewed the medical record and replied that MSW services were offered to the patient on 5/17/24, however the patient declined the services.”

“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 significant changes in the condition of the patient’s wounds for 1 of 3 (P-1) records reviewed with wound care, resulting in the potential for a poor patient outcome: Findings include: P-1: This 78-year-old patient was admitted to home care services on 12/8/23 with diagnoses of venous insufficiency and bilateral lower extremity non-pressure chronic ulcers. During record review on 7/31/24, it was noted that Staff-B (licensed practical nurse) documented the following on 6/4/24, 6/7/24, and 6/11/24: wounds #1, 2, 4, 5 were closed and that wound #3 was open 2 cm length x 1.5 cm length x 0.2 cm depth with small serous drainage and no odor. On 6/15/24 Staff-B documented that wound #3 was open and had improved slightly 1.8 x 1.5 x 0.2 with small serous drainage and no odor. Wounds #2 and #4 had changes. Staff-B documented that wound #2 was closed with large serous drainage and strong odor and that wound #4 was closed (?) with measurements of 2.7 x 2 with large serous drainage and strong odor. It was unclear how wound #2 could be closed with large drainage and odor. It was unclear how wound #4 could be documented as closed with measurements of 2.7 x 2 cm with large serous drainage and odor. During an interview on 7/31/24 at 11:05 a.m., Staff-B explained that he remembered only one open wound at the time of the visit on 6/15/24 and was unaware of documenting the strong wound odor. The documentation on 6/15/24 does not conform with Staff-B’s recollection. Staff-B arrived for a visit on 6/18/24 and the patient declined wound care. There was no documented evidence that the physician was notified of the significant change in the status of the patient’s wounds as documented on 6/15/24. The finding was reviewed with Staff-A (clinical manager) during an interview on 7/31/24 at 2:40 p.m. Staff-A reviewed the findings and pointed out that wounds #2 and #4 were documented as closed and that the wound measurements, drainage, and odor may have been carried forward from a previous assessment.”