Kaizen Home Care, Inc.

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to include objectively measurable goals in the Plan of Care to determine the patient’s progress towards obtaining the goals in 2 of 7 records (P-6, P-7) reviewed. Findings included: Patient #6’s (P-6) start of Care (SOC) was dated 5/22/2025. The Plan of Care (POC) for the certification period 5/22/25 through 7/20/25 identified diagnoses of Hypertensive Heart Disease with Heart Failure, Atrial Fibrillation (A-fib), Headache, Congestive Heart Failure (CHF), Hypothyroidism, Macular Degeneration, Bilateral Osteoarthritis of the knee, and History of falling. The patient was receiving Skilled Nursing services once a week for 3 weeks. Upon review of the Plan of Care, it was noted the goals on the Plan of Care were not objectively measurable to determine the patient’s progress towards obtaining the goals. Examples included: “Facility Staff will demonstrate compliance with prescribed treatment regimen regarding heart failure including adherence to cardiac regimen/program within 3 weeks; Facility staff will verbally encourage proper use of assistive devices within 3 weeks; Occupational therapy evaluation will be performed and a plan of care to increase functional independence with ADLs (Activities of Daily Living) and IADL (Instrumental Activities of Daily Living) will be established and countersigned by physician. These goals are not objectively measurable to determine the patient’s progress towards obtaining the goals. Patient #7’s (P-7) The Start of Care was dated 5/21/2025. The Plan of Care for the certification period 5/21/2025 to 7/19/2025 identified diagnoses of Chronic Diastolic (congestive) Heart Failure (CHF), Chronic Obstructive Pulmonary Disease (COPD), Pain in left thigh, Unsteadiness on feet, Amyloidosis, Chronic Kidney Disease (Stage 3), amnesia, Atherosclerotic Heart Disease of Native Coronary Artery (CAD), and Peripheral Vascular Disease (PVD). The patient was receiving Physical Therapy Services 2 times a week for 6 weeks. Upon review of the Plan of Care, it was noted the goals on the Plan of Care were not objectively measurable to determine the patient’s progress towards obtaining the goals. Examples included: “Patient with goal to climb up and down steps with and without assistive device in order to access ambulation within the home; Patient will be from falls/injury during this episode of care (sic); Patient will demonstrate understanding of individual emergency preparedness plan within 3 weeks.” These goals are not objectively measurable to determine the patient’s progress towards obtaining the goals.”

“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 conduct a patient-specific, comprehensive assessment that accurately reflected the patient’s current health status leading to home care needs in 1 (P-3) of 7 records reviewed, resulting in incomplete clinical information to aid in determining the needs of the patient. Findings included: A review of the agency policy on 6/25/25 titled “Initial Assessments/Comprehensive Assessments” (Revised January 2020). The policy states, “8. The Initial Comprehensive Assessment also includes: - Relevant diagnoses and current health status, including all active health and medical problems… - Physical assessment/review of systems and pertinent physical findings…” Patient #1’s (P-1) Start of Care (SOC) was dated 11/12/24. The Plan of Care (POC) identified diagnoses of Hypertension, Alzheimer’s and Falls. During record review on 6/25/25, it was noted that the “Principal Diagnosis” listed on the POC stated, “Hypertension.” The comprehensive assessment completed on 11/12/24 by the registered nurse (RN) stated, “Primary Diagnosis: Essential (primary) hypertension. Severity: 03. Visit Narrative: P-1 is a 94yo female who resides with her sone who is her pcg (paid care giver). P-1 has a hx (history) of dementia, neck pain, falls, CKD (Chronic Kidney Disease) stage 3, she was previously on blood pressure meds but no longer is on those meds…” According CMS OASIS (Outcome and Assessment Information Set) a severity level of 03 states, “Symptoms poorly controlled, patient needs frequent adjustment in treatment and dose monitoring.” The agency failed to accurately document the patient’s Hypertension diagnosis. The Clinical Manager/Alt-Administrator (CM-1) reviewed and acknowledged the findings listed above in an interview on 6/27/25 at 11:20 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 record review and interview, the agency failed to ensure the comprehensive assessment included a review of all medications the patient was currently taking to identify significant drug interactions in 2 (P-3 and P-4) of 7 records reviewed potentially resulting in unidentified harmful medication side effects or interactions. Findings include: The agency policy titled “Initial Assessment/Comprehensive Assessment”, revised January 2020, was reviewed on 6/27/25. On page 3., it stated: “Each patient’s comprehensive assessment includes a review of all medications the patient is currently taking… The Agency nurse must consider and document each medication that the patient is taking to identify… Significant drug interactions… Concerns identified by clinician during medication review must be reported to physician.” Patient #4 (P-4): This 82-year-old was admitted to the agency on 11/22/24 with diagnoses including a pressure ulcer of the left buttocks and heart failure. The medical record was reviewed on 6/25/25. During review, it was noted that the RN completed the comprehensive start of care assessment on 11/22/24 and included documentation that 12 medications were reviewed and reconciled, and that no medication issues were found. Additionally, during record review, the “Drug-Drug Interactions” report which was manually populated by the agency’s EMR (electronic medical record) system was reviewed on 6/25/25. The report identified 3 major drug-drug interactions and 15 moderate drug-drug interactions between P-4’s medications. There was no documentation in the medical record that the RN identified, considered, or notified the physician for any of the drug interactions reported by the agency EMR system. The Clinical Manager (CM-1) reviewed the finding on 6/27/25 at 10:30 a.m. during an interview. CM-1 was also the RN who completed the comprehensive start of care for P-4. CM-1 acknowledged that the drug-drug interactions should have been identified and documented. Patient #3’s (P-3) Start of Care (SOC) was dated 5/30/25. The Plan of Care (POC) identified diagnoses of Right Foot Wound, Cellulitis and Diabetes Type 2. During record review on 6/26/25, section M2001 of the Comprehensive Assessment dated 5/30/25 and completed by the RN, documented “Yes - Issues found during review.” Additionally, the RN documented “Yes” under “M2003 Medication Follow-up: Did the agency contact a physician by midnight of the next calendar day and complete prescribed/recommended actions in response to the identified potential clinically significant medication issues?” A drug-drug interaction report completed on 6/26/25 and documented 2 major drug interactions between Lisinopril & Spironolactone-HCTZ and Xarelto & Aspirin. The Clinical Manager/Alt-Administrator (CM-1) was questioned when the drug-drug interactions were faxed to the physician and stated, “They were faxed on 6/5/25.” The agency failed to timely coordinate with the physician to complete an accurate medication profile. The Clinical Manager/Alt-Administrator (CM-1) reviewed and acknowledged the findings listed above in an interview on 6/27/25 at 11:10 am.”

“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 clinical notes were accurate for 1 (P-3) of 7 records reviewed, resulting in the potential to negatively affect the health and well-being of these patients. Findings include: A review of the agency policy on 6/25/25 titled “Medical Record Content” (Revised March 2018). The policy states, “The agency will provide an accurate and current medical record for every patient seen by the Agency. Procedure: 1. 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...” Patient #3’s (P-3) Start of Care (SOC) was dated 5/30/25. The Plan of Care (POC) identified diagnoses of Right Foot Wound, Cellulitis and Diabetes Type 2. During record review on 6/26/25, it was noted that the registered nurse (RN) completed a comprehensive assessment on 5/30/25 and stated, “Visit Narrative: …P-3 has diabetes and checks his blood sugars daily. P-3 check today and was 204…” The POC stated, “Orders for Discipline and Treatment: SN (Skilled Nurse) Frequency: 1w1 (1 time a week for 1 week), 2w2, 1w6 … SN to instruct patient on self-management program to include, disease process, who to contact if signs and symptoms persist or worsen as well as dietary measures, medication management, foot care precautions, blood sugar monitoring…” The SN failed to document blood sugar readings for 5 of 5 visits after the comprehensive assessment: 6/3/25, 6/6/25, 6/10/25, 6/13/25 and 6/28/25. Additionally, the RN documented the same visit note for 6/10/25, 6/13/25 and 6/18/25 stating, “…He states diabetes in stable for him. RN felt BS (blood sugars) are slightly high. Instructed on diabetic diet. Pt (patient) states he is eating and drinking well. Pt states his sister is still sick and she could not be here. He plans to see Dr. next week.” [SIC] The agency failed to accurately document within the electronic medical record. The Clinical Manager/Alt-Administrator (CM-1) reviewed and acknowledged the findings listed above in an interview on 6/27/25 at 11:00 am.”