Brio Home Health Services, Inc.

“Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This Standard is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure essential clinical documents were provided for two of 10 sampled patients (Patient 1 and 2), when Patient 1 and 2’s home clinical record booklet did not contain their current plan of care (POC- a guide that lists their medical and emotional needs, including treatments, medications, and personal wishes, to ensure their care), including their most current Medication Profile (MP-a current list of all medications prescribed for a specific patient), while Patients 1 and 2 were receiving home health services. This failure had the potential to result in poor care coordination, unmanaged symptoms, and medication errors, placing Patients 1 and 2 at risk for unmet health goals and delays in timely clinicals interventions. Findings: 1. A review of Patient 1’s face sheet (a document that gives a summary of patient’s information), indicated a start of care date of April 7, 2026, with a certification period (a specific timeframe during which a patient is eligible to receive home health services) from June 6, 2026, to August 4, 2026. Patient 1 had diagnoses which included displaced subtrochanteric fracture of the left femur (left thigh bone is broken in the upper region or just below the hip joint, and the broken ends have shifted out of their normal alignment) and age-related osteoporosis (a condition where bones become weak, thin, and brittle as people grow older). During a concurrent interview and record review, on June 17, 2026, at 9:30 AM, with Certified Home Health Aid (CHHA), in the presence of Patient 1, in Patient 1’s home, the clinical record booklet and the surrounding area were reviewed. Patient 1’s current POC, including the most recent MP, were not found in the booklet or anywhere in the house. Both CHHA and Patient 1 confirmed that these essential documents were not available. 2. A review of Patient 2’s face sheet indicated a start-of-care date of April 13, 2026, with a certification period from June 12, 2026, to August 10, 2026. Patient 2 had diagnoses which included hypothyroidism (a condition where a small gland in the neck doesn’t make enough thyroid hormone (body’s chemical that controls your body’s metabolism) and glaucoma (diseases that cause eye pressure to increase). During a concurrent interview and record review, on June 17, 2026, at 10:45 AM, with License Vocational Nurse (LVN), in the presence of Patient 2, in Patient 2’s home, the clinical record booklet and the surrounding area were reviewed. Patient 2’s current POC, including the most recent MP, were not found in the booklet or anywhere in the house. Both LVN and Patient 2 confirmed that these essential documents were not available. During an interview on June 19, 2026, at 2:15 PM, with the Director of Patient Care Services (DPCS)/Administrator (Admin), the DPCS/Admin stated that the visiting nurse and the case manager were responsible to ensure the current POC including the most recent MP, and other essential documents must be at the patient’s location and to be easily accessible. The DPCS/Admin further stated, maintaining an up-to-date POC and MP was crucial for effective care coordination, proper medication management, and timely clinical responses. The DPCS/Admin further stated that it is also to ensure patients receive all services outlined in the POC. During a concurrent interview and record review on June 19, 2026, at 2:30 PM, with the DPCS/Admin, the agency’s policy and procedure (P&P) titled, “Physician Plan of Care Orders,” revised January 15, 2026, was reviewed. The P&P indicated, “Policy. The [Named of the home health agency] certification and Plan of Treatment (CMS 485) is an individualized plan for care and treatment based on the comprehensive assessment of the patient by the RN [Registered Nurse] Case Manager and signed by the patient’s physician, osteopathy, or podiatrist. A written process for assessment and the development of the plan of care shall be established. Additional orders are obtained throughout the episode of care based on patient’s needs. Frequency of the review of the plan of care occurs minimally at recertification and with a resumption of care. The agency shall communicate and integrate orders from all physicians involved and issuing orders in the plan of care. All orders shall be received in HIPPA [Health Insurance Portability and Accountability Act—a law that designed to protect sensitive patient’s health information] compliance… Purpose… 4. To assure coordination of all services and interventions are communication to all physicians involved and issuing orders for the home health plan of care. 5. To ensure drugs, services, and treatments are administered only as ordered by a physician… 1. The agency will provide services, during each episode, consistent with the plan of care. The attending physician will review the plan as the patient’s condition warrants, but at least every 60 days. 2. At the time of recertification, a written summary of the patient’s current comprehensive assessment and progress to the measurable outcomes and goals and the services being provided are submitted with the new plan of care for review and approval by the physician. …”. The DPCS/Admin stated the agency did not follow the policy.”

“Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA’s quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This Standard is not met as evidenced by: Based on interview and record review, the agency failed to implement an infection control surveillance system (an ongoing, systematic collection and analysis of health data to monitor infectious diseases), when the agency’s infection prevention and control program (a set of practices and policies intended to prevent and reduce the spread of infections in healthcare settings) did not have the required comprehensive analysis of collected data. This failure had the potential to place patients at risk for infection in a universe of 90 patients from failure to identify infection risks, trends, patterns, or root causes necessary in developing an infection prevention strategy to improve care practices and control infections and transmission of communicable diseases. Findings: A review of the agency’s “Infection Control” binder, for the year 2025- 2026, was conducted. There was no documented evidence to show risk analysis that had been initiated using surveillance data collected to develop a system for identifying root causes, patterns, or trends in the agency’s infection control program from June 15, 2025, through June 15, 2026. During an interview on June 19, 2026, at 11:30 AM, with the Director of Patient Care Services (DPCS)/Administrator (Admin), the DPCS/Admin stated, “the agency previously had on a Quality Assurance [QA- ensures all infection‑control practices follow required laws, regulations, and agency policies] person to handle infection control duties, but that person had become too busy to continue the work prompting me [DPCS/Admin] to assume responsibility for infection control”. The DPCS/Admin further stated that that she was unaware of the requirement for analysis of data collected is part of the surveillance system by the agency as part of infection control regulations for identifying trends and preventing infections. During a concurrent interview and record review, on June 19, 2026, at 11:45 AM, with the DPCS/Admin, the agency’s policy and procedure (P&P) titled, “Infection Control/Exposure Plan”, revised January 15, 2026, was reviewed. The P&P indicated, “… POLICY. The [Named of the Home Health AgencyeH] maintains policies and procedures for the service of patients with infectious and/or contagious diseases and for infection control ... PURPOSE. 1. To protect individuals from transmission of communicable/infectious diseases through infection control measures. 2. To maintain written policies and procedures based on infection control practices related to the services provided. These policies and procedures will be reviewed at least annually for required and /or appropriate revisions. 4. To maintain a surveillance system to track the occurrences and transmission of infections related to the services provided with reporting of data quarterly. 5. To comply with current applicable local, CALIFORNIA, and regulatory body regulations,... Procedure. a. The Infection Control Plan with accepted practices of prevention and control: i. Prevention: the agency will follow accepted precautions to prevent the transmission of infections and communicable disease. ii. Control: the agency maintains an agency-wide program is in place for surveillance, identification, prevention, control, and investigation of infectious and communicable diseases. The program is an integral part of the QAPI program. Iii . A plan occurs for the appropriate actions that are expected to result in improvement and disease prevention.…” The DPCS/Admin admitted that surveillance data analysis should be started, regularly reviewed, and monitored to spot trends and prevent infections as required by agency policy. The DPCS/Admin further stated the agency did not follow this policy.”

“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 interview and record review, the agency failed to ensure medication reconciliation (process to compare current medication order with what home medications patients are taking) was conducted for two of four sampled patients (Patients 1 and 4) when Patient 1 and 4’s Medication Profile (MP) did not accurately reflect the patients’ current medication regimen. These failures had the potential to cause ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy placing Patients 1 and 4’s health and safety at risk. Findings: 1. A review of Patient 1’s face sheet (a document that gives a summary of patient’s information), indicated a start of care date of April 7, 2026, with a certification period (a specific timeframe during which a patient is eligible to receive home health services) from June 6, 2026, to August 4, 2026. Patient 1 had diagnoses which included displaced subtrochanteric fracture of the left femur (left thigh bone is broken in the upper region or just below the hip joint, and the broken ends have shifted out of their normal alignment) and age-related osteoporosis (a condition where bones become weak, thin, and brittle as people grow older). During a home visit observation on June 17, 2026, at 9:40 AM, with Certified Home Health Aid (CHHA), in the presence of Patient 1, an observation of Patient 1’s actual medication bottles, which were available in the home, were compared with Patient 1’s most current MP. During a concurrent observation and interview on June 17, 2026, at 9:45 AM, with CHHA and Patient 1, CHHA checked a bottle of omeprazole (an over‑the‑counter medication that reduces the amount of acid the stomach produces) 20 milligrams (mg-a unit of measurement). CHHA and Patient 1 reviewed Patient 1’s MP and confirmed that the order for “omeprazole 20 mg” was not listed on Patient 1’s MP. Patient 1 stated, “I have been taking this medication [omeprazole 20 mg] for about 2 months now, including this morning [June 17, 2026], and my doctor is aware of it.” During a continued concurrent observation and interview on June 17, 2026, at 9:50 AM, with CHHA and Patient 1, CHHA checked a bottle of memantine hydrochloride (Namenda -a prescription medication primarily used to treat moderate to severe dementia—loss of memory, language, problem‑solving, and other thinking abilities) with the label as 28 mg, taken as one capsule daily. CHHA reviewed Patient 1’s MP and confirmed the discrepancy, the MP listed an order indicated “namenda 2 mg tablet, take one time daily,” which did not match the medication bottle in the home. Patient 1 stated, “I have been taking memantine hydrochloride 28 mg, one capsule every morning for years since 2000, including this morning [June 17, 2026], and my doctor is aware of it.” During a continued concurrent observation and interview on June 17, 2026, at 9:55 AM, with CHHA and Patient 1, CHHA checked a bottle of potassium (a prescription mineral and electrolyte supplement that the body needs to function correctly) 20 milliequivalents (mEq-a unit of measurement), with the label as taken as one tablet by mouth daily. CHHA reviewed Patient 1’s MP and confirmed that the order for “potassium 20 mEq, take one tablet by mouth daily” was not listed on Patient 1’s MP. Patient 1 stated, “I have been taking potassium 20 mEq, one tablet every morning for years since 2000, including this morning [June 17, 2026], and my doctor is aware of it.” 2. A review of Patient 4’s face sheet, indicated a start of care date of June 5, 2026, with a certification period from June 5, 2026, to August 3, 2026. Patient 4 had diagnoses which included atrial fibrillation (an irregular and often very rapid heart rhythm), hypertension (high blood pressure), and type 2 diabetes mellitus (when the body cannot use insulin or a hormone that turns food into energy and manages your blood sugar level correctly and sugar builds up in the blood). During a home visit observation on June 17, 2026, at 2:35 PM, with Physical Therapist (PT), in the presence of Patient 4 and Patient 4’s care giver, an observation of Patient 4’s actual medications, which were available in the home, were compared with Patient 4’s most current MP. During a concurrent observation and interview on June 17, 2026, at 2:40 PM, with PT and Patient 4’s caregiver, PT checked a bubble pack card (pre‑sorted pouches that organize pills by day and time) of diltiazem (a prescription medication used to treat high blood pressure and angina [chest pain]) 60 mg, with the label as taken as one tablet by mouth before meals and at bedtime (total of four times a day). PT reviewed Patient 4’s MP and confirmed the discrepancy, indicating that the MP listed an order for, “diltiazem 30 mg, take 1 tablet daily at bedtime,” which did not match the medication available in the home. Patient 4’s caregiver stated that she had been giving Patient 4 diltiazem 60 mg four times daily, before every meal (breakfast, lunch, and dinner) and before bedtime (total of four times a day), since two weeks ago after Patient 4 was discharged from the hospital, including this morning (June 17, 2026), and that her doctor was aware of it. During a continued concurrent observation and interview on June 17, 2026, at 2:45 PM, with PT and Patient 4’s caregiver, PT checked a bubble pack card of metformin (a prescription medication used to treat type 2 diabetes by lowering blood sugar levels) 500 mg, with the label as taken as one tablet by mouth two times a day with meals. PT reviewed Patient 4’s MP and confirmed the discrepancy, indicating that the MP listed an order for “metformin 500 mg, take 1 tablet daily,” which did not match the medication available in the home. Patient 4’s caregiver stated that she had been giving Patient 4 metformin 500 mg two times daily since two weeks ago after Patient 4 was discharged from the hospital, including this morning (June 17, 2026), and that the doctor was aware of it. During an interview on June 19, 2026, at 1:45 PM, with the Director of Patient Care Services (DPCS)/Administrator (Admin), the DPCS/Admin stated the expectation for nurses and staff was to perform medication reconciliation according to the agency’s policy. The DPCS/Admin further stated medication reconciliation should be conducted at each visit and that the medication profile must be updated if there are any changes. During a concurrent interview and record review on June 19, 2026, at 1:50 PM, with the DPCS/Admin, the agency’s policy and procedure (P&P) titled, “Medication Administration,” revised January 15, 2026, was reviewed. The P&P indicated, “Policy. The administration of medications will be performed only in accordance with verbal or written orders from the patient’s physician following an admission comprehensive assessment for patient history of medications, as well as physical, psychosocial factors that could impact medication effectiveness… Purpose. To ensure personnel are providing medication administration under appropriate direction and in accordance with standards of practice and medication management protocols. Procedure… 4. The nurse will routinely monitor all medications to determine their action, special precautions, patient’s response, side effects, allergies, and contraindications. 5. RN Case Manager will complete a medication profile for each patient at the time of admission and update with patient on each visit, including new or discontinued medications. a. The profile will include the name of the drug, date ordered, dose, route, frequency, duration of therapy, if appropriate, purpose or effect, side effects, and contraindications. b. The profile will include over-the-counter drugs, nutritional supplements, herbal remedies, vitamins and minerals…” The DPCS/Admin stated that the agency’s policy was not being followed.”