Every finding on record at Brio Home Health Services,Inc.

The following reflects the findings of the California Department of Public Health during an Emergency Preparedness survey conducted June 16, 2026, through June 19, 2026. Census: 90. Unduplicated Admissions: 338. Home Visits with record reviews: 4. Record Reviews without home visits: 6. Sample Size: 10. All the Emergency Preparedness Condition of Participations are met.

The following reflects the findings of the California Department of Public Health during a recertification survey conducted June 16, 2026, through June 19, 2026. Census: 90. Unduplicated Admissions: 338. Home Visits with record reviews: 4. Record Reviews without home visits: 6. Sample Size: 10. Three deficiencies were issued during a recertification survey.

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.

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.

The following reflects the findings of the California Department of Public Health during an Emergency Preparedness survey conducted May 22, 2023, through May 25, 2023. Representing the Department: Surveyors: 35183, 46119, 45431 Census: 53 Unduplicated Admissions: 357 Home Visits with record reviews: 4 Record Reviews without home visits: 6 Sample Size: 10 No deficiencies were issued for Emergency Preparedness for Brio Home Health Services.

AMENDED The following reflects the findings of the California Department of Public Health during a recertification survey conducted May 22, 2023, through May 25, 2023. Representing the Department: Surveyors: 35183, 46119, 45431 Census: 53 Unduplicated Admissions: 357 Home Visits with record reviews: 4 Record Reviews without home visits: 6 Sample Size: 10 All conditions of participation were met.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on interview, and record review, the agency failed to ensure the patients' initial assessment was completed within 48 hours of the physician's referral date or on the physician-ordered start of care date for six of 10 sampled patients (Patients 2, 5, 7, 8, 9, and 10). This failure had the potential to cause a delay in the determination of Patients 2, 5, 7, 8, 9, and 10’s immediate care and support needs. 1. A review of Patient 2’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of April 24, 2023, with a certification period of April 24, 2023, to June 22, 2023. Patient 2 had diagnoses that included a pressure ulcer (wound caused by prolonged pressure) stage three (depth of pressure ulcer indicating exposed muscle) of the sacral (at the bottom of the spine, above the buttocks) region. A review of Patient 2’s referral order dated April 19, 2023, indicated, “For Home Health PT [Physical Therapy] Eval and Treat...” A review of Patient 2’s initial assessment dated April 24, 2023, indicated the initial assessment had been conducted on April 24, 2023. (The initial assessment had been completed five days after the physician’s referral order) During a concurrent interview and record review with the Administrator/Director of Patient Care Services (Admin/DPCS) on May 25, 2023, at 11:27 AM, Patient 2’s clinical record was reviewed. The Admin/DPCS verified Patient 2 did not have an initial assessment within 48 hours of the referral to the agency and should have. 2. A review of Patient 5’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of April 5, 2023, with a certification period of April 5, 2023, to June 3, 2023. Patient 5 had diagnoses that included benign prostatic hyperplasia (prostate gland enlargement causing urination difficulty). A review of Patient 5’s referral order dated April 2, 2023, indicated, “ Order Details: …For Home Health PT [Physical Therapy] Eval [evaluation] and Treat-Home Health OT [Occupational Therapy] Evaluate and Treat-RN [Registered Nurse] for Urinary Catheter [a tube inserted into the bladder to allow urine to drain from the bladder into a bag]. Care, …” A review of Patient 5’s initial assessment dated April 5, 2023, indicated the initial assessment had been conducted on April 5, 2023. (The initial assessment had been completed three days after the physician’s referral order.) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on May 23, 2023, at 11:26 AM, the Admin/DPCS verified Patient 5 had not received his initial assessment within 48 hours of the referral order. The Admin/DPCS stated she was unaware a physician’s order was required if the agency was unable to conduct a patient’s initial assessment within 48 hours of the physician’s referral order. 3. A review of Patient 7’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of April 17, 2023, with a certification period of April 17, 2023, to June 15, 2023. Patient 7 had diagnoses that included hypertensive heart disease (heart disease caused by high blood pressure). A review of Patient 7’s referral order dated April 13, 2023, indicated, “ Reason for Referral: Please obtain PT [Physical Therapy]/OT [Occupational Therapy] and RN [Registered Nurse] visit.” A review of Patient 7’s initial assessment dated April 17, 2023, indicated the initial assessment had been conducted on April 17, 2023. (The initial assessment had been completed four days after the physician’s referral order.) During an interview with a Clinical Manager (CM) on May 23, 2023, at 4:27 PM, the CM verified Patient 7 had not received the initial assessment within 48 hours of the referral order. The CM stated she was unaware a physician’s order was required if the agency was unable to conduct a patient’s initial assessment within 48 hours of the physician’s referral order. 4. A review of Patient 8’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of December 19, 2022, with a certification period of December 19, 2022, to February 16, 2023. Patient 8 had diagnoses that included hypertension (high blood pressure). A review of Patient 8’s referral order dated December 8, 2022, indicated, “... to D/C [discharge] home 12/16/22 [December 16, 2022] with home health pt [Physical Therapy]/ot [Occupational Therapy] …” A review of Patient 8’s initial assessment dated December 19, 2022, indicated the initial assessment had been conducted on December 19, 2022. (The initial assessment had been completed three days after the physician’s ordered start date.) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on May 22, 2023, at 2:04 PM, the Admin/DPCS verified Patient 8 had not received the initial assessment on the physician’s ordered start date. The Admin/DPCS stated she was unaware a physician’s order was required if the agency was unable to conduct a patient’s initial assessment on the physician’s ordered start date. 5. A review of Patient 9’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of January 2, 2023, with a certification period of January 2, 2023, to May 2, 2023. Patient 9 had diagnoses that included heart failure (a condition where the heart does not pump enough blood for the body's needs). A review of Patient 9’s referral order dated December 30, 2022, indicated, “ …For Home Health PT [Physical Therapy] Eval [evaluation] and Treat, …Instructions Home health RN [Registered Nurse] for safety eval and medication management.” A review of Patient 9’s initial assessment dated January 2, 2023, indicated the initial assessment had been conducted on January 2, 2023. (The initial assessment had been completed three days after the physician’s referral order.) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on May 22, 2023, at 3:59 PM, the Admin/DPCS verified Patient 9 had not received the initial assessment within 48 hours of the referral order. The Admin/DPCS stated she was unaware a physician’s order was required if the agency was unable to conduct a patient’s initial assessment within 48 hours of the physician’s referral order. 6. A review of Patient 10’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of February 24, 2023, with a certification period of February 24, 2023, to April 24, 2023. Patient 10 had diagnoses that included hepatic encephalopathy (the loss of brain function when a damaged liver does not remove toxins from the blood). A review of Patient 10’s referral order dated February 21, 2023, indicated, “Referred to Specialty: Home Health Services … Disciplines Requested: Nursing, Disciplines Requested: Physical Therapy, Disciplines Requested: Occupational Therapy, Services to Provide: Home Safety Evaluation, Services to Provide: Evaluate and Treat Visits per week: 3, For how many weeks: 54 … Start of Care: Within 1 [one] Day [February 22, 2023] … ” A review of Patient 10’s initial assessment dated February 24, 2023, indicated the initial assessment had been conducted on February 24, 2023. (The initial assessment had been completed two days after the physician’s ordered start date.) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on May 23, 2023, at 9:35 AM, the Admin/DPCS verified Patient 10 had not received the initial assessment on the physician’s ordered start date. The Admin/DPCS stated she was unaware a physician’s order was required if the agency was unable to conduct a patient’s initial assessment on the physician’s ordered start date. A review of the agency’s policy and procedure titled, “Initial Assessments/Comprehensive Assessments,” dated January 2020, indicated, “ … In instances where the patient requests a delay in the start of care date, the Agency will need to contact the physician to request a change in the start of care date and such change will be documented in the medical record. A RN [Registered Nurse], PT [Physical Therapist] or SLP [Speech Language Pathologist] must conduct the initial assessment visit within 48 hours of referral, within 48 hours of the patient's return home or on the physician-ordered start of care date. The initial assessment visit is conducted to determine the immediate care and support needs of the patient. In the absence of a physician-specified start of care date, the initial assessment visit is conducted within 48 hours of the referral. If the physician specified a start of care date, this supersedes the 48-hour time frame. …”

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 interview, and record review, the agency failed to ensure an individualized plan of care was reviewed, approved, and signed by a physician within 30 working days of the patients' start of care for two of 10 sampled patients (Patients 5 and 6). This failure caused the agency to provide care that was not care planned or reviewed and approved by a physician. 1. A review of Patient 5’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of April 5, 2023, with a certification period of April 5, 2023, to June 3, 2023. Patient 5 had diagnoses that included benign prostatic hyperplasia (prostate gland enlargement causing urination difficulty). A review of Patient 5’s plan of care/physician’s order dated April 5, 2023, to June 3, 2023, was conducted on May 23, 2023. There was no documented evidence to show the physician had reviewed and signed the plan of care. (Thirty-four working days had passed without a physician’s review and signature). During an interview with a Clinical Manager (CM) on May 23, 2023, at 2:21 PM, the CM verified Patient 5’s plan of care not been reviewed, approved, and signed by a physician within 30 working days. The CM stated Patient 5’s plan of care should have been signed by May 17, 2023 and had not. 2. A review of Patient 6’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of April 1, 2023, with a certification period of April 1, 2023, to May 30, 2023. Patient 6 had diagnoses that included acute respiratory failure (sudden impairment of oxygen exchange between the lungs and the blood). A review of Patient 6’s plan of care/physician’s order dated April 1, 2023, to May 30, 2023, was conducted on May 23, 2023. There was no documented evidence to show the physician had reviewed and signed the plan of care. (Thirty-seven working days had passed without a physician’s review and signature). During an interview with a Clinical Manager (CM) on May 23, 2023, at 3:24 PM, the CM verified Patient 6’s plan of care not been reviewed, approved, and signed by a physician within 30 working days. The CM stated Patient 6’s plan of care should have been signed by May 12, 2023 and had not. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on May 24, 2023, at 9:15 AM, the Admin/DPCS verified Patient 5 and 6’s plans of care had not been reviewed and signed by the physician within 30 working days. The Admin/DPCS stated the agency’s policy and procedure titled “Plan of Care - CMS #485 and Physician Orders,” dated March 2019, did not indicate a time frame for the physician’s review and signature on the patients’ plans of care. The Admin/DPCS stated the agency followed the time frame indicated in Title 22: § 74697. Plan of Treatment; Plan of Care; Plan for Personal Care Services, which indicated 30 working days. A review of Title 22: § 74697. Plan of Treatment; Plan of Care; Plan for Personal Care Services, indicated, “(a) A written plan of treatment (or plan of care for home health agencies participating in the Medicare and/or Medi-Cal program) shall be established for each patient whose care requires medical orders. A plan of treatment or plan or care for patients requiring medical orders shall be: (1) Approved and signed within 30 working days by the attending physician, dentist, podiatrist. or other licensed and legally authorized practitioner within his or her scope of practice.” A review of the agency’s policy and procedure titled, “Plan of Care - CMS #485 and Physician Orders,” dated March 2019, indicated, “…The total Plan of Care will be reviewed and signed by the attending physician …”

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on interview, and record review, the agency failed to obtain a physician’s order to discontinue Physical Therapy (PT) and Occupational Therapy (OT) services for one of 10 sampled patients (Patient 5). This failure had the potential to cause Patient 5 not to receive needed PT and OT services. A review of Patient 5’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of April 5, 2023, with a certification period of April 5, 2023, to June 3, 2023. Patient 5 had diagnoses that included benign prostatic hyperplasia (prostate gland enlargement causing urination difficulty). A review of Patient 5’s referral order dated April 2, 2023, indicated, “...Order Details: ...For Home Health PT [Physical Therapy] Eval [evaluation] and Treat-Home Health OT [Occupational Therapy] Evaluate and Treat-RN [Registered Nurse] for Urinary Catheter [a tube inserted into the bladder to allow urine to drain from the bladder into a bag]. Care, ...” A review of Patient 5’s PT and OT evaluations was conducted from April 5, 2023, to May 23, 2023, was conducted. There was no documented evidence to show Patient 5 had received a PT and OT evaluation. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on May 23, 2023, at 12:29 PM, the Admin/DPCS stated Patient 5 had refused the PT and OT services. The Admin/DPCS stated Patient 5’s physician should have been contacted for an order to discontinue the PT and OT services and had not. A review of the agency’s policy and procedure titled, “Plan of Care - CMS #485 and Physician Orders,” dated March 2019, indicated, “...Care and services provided will be provided according to physician orders. Orders are current and updated. ...”

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on interview, and record review, the agency failed to measure and analyze quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) in order to assess the agency’s processes of care, services, and operations, from January 1, 2022, to December 31, 2022, in a universe of 53 patients. This failure had the potential to cause problems in health outcomes, patient safety and quality of care, to go unrecognized and unaddressed. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2022, was conducted from January 1, 2022, to December 31, 2022. The QAPI binder indicated the following quality indicators: a. Clinical record review b. Customer satisfaction survey c. Falls d. Patient infections The QAPI binder did not contain documented evidence to show data had been assembled and analyzed, from January 1, 2022, to December 31, 2022. There was no documented evidence to show statistical techniques such as controls charts (a graph used to study how a process changes over time), histograms (a graphical representation that organizes a group of data points into user-specified ranges), bar graphs (a chart that plots data using rectangular bars or columns) or pareto charts (a chart that contains both bars and a line graph, where individual values are represented in descending order by bars, and the cumulative total is represented by the line) had been used to analyze the collected data. The QAPI binder did not contain documented evidence to show the agency had developed mechanisms such as thresholds (a value), setting upper and lower control limits (identifies what value is acceptable), percentages (numbers that summarize data), ratios (the relationship in quantity, amount, or size between two or more things) or performance goals in order to identify levels, patterns or trends in the agency’s provision of care from January 1, 2022, to December 31, 2022. During a concurrent record review and interview, on May 25, 2023, at 9:12 AM, with the Administrator/Director of Patient Care Services (Admin/DPCS) and the QAPI Coordinator (QAPI Coord), the contents of the QAPI binder were reviewed. The Admin/DPCS stated she was responsible for the QAPI Program. The QAPI Coord stated she and the QAPI Committee had not analyzed the data collected from the quality indicators. The QAPI Coord stated no action plans had been developed for problem areas. The Admin/DPCS stated the agency’s policy and procedure titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” dated March 2019, was not followed. A review of the agency’s policy and procedure titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” dated March 2019, indicated, “AGGREGATION AND ANALYSIS: 1. The QAPI committee will compile and analyze collected data. 2. Statistical techniques will be utilized, as appropriate, to compile and analyze data. Such statistical techniques include control charts, histograms, bar graphs and Pareto charts. Such techniques help to focus the Agency's attention and resources on those processes and outcomes for which more intensive analysis will be most beneficial. Such assessment is initiated by: comparison internally (levels, trends, patterns), with others (references databases), with standards, with practice guidelines, with best practices (industry leaders). … PERFORMANCE EXPECTATION: 1. For each process identified to be improved, mechanisms to identify levels, patterns or trends in that process that will trigger further evaluation of the process will be identified. Performance expectations to trigger further evaluations may include, but are not limited to thresholds, setting upper and lower control limits, percentages, ratios, setting performance goals for further evaluation, identification of patterns/trends. Sample size will be determined for each Quality Assessment and Performance Improvement indicator to adequately represent the indicator. 2. For each established indicator to be improved, the performance expectation will be determined. The frequency of data collection and analysis will be specified for each indicator. The QAPI Committee, and/or those involved in patient care will analyze the data collected to pursue opportunities for improvement and identify important problems. 3. A summary of data collection, analysis, recommendations for improvement and report of cumulative findings will be prepared by the QAPI Committee. The reports are forwarded to the Governing Body. Failure to achieve expected levels of performance will be documented and an explanation delineated to identify opportunities for improvement. …”

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on interview, and record review, the agency failed to use quality indicator (a measurable element of the agency’s practice that can be used to assess the quality of care provided) data from OASIS (Outcome and Assessment Information Set) to monitor the quality of the agency’s services. In addition, the agency’s Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program’s data collection, from January 1, 2022, to December 31, 2022, in a universe of 53 patients. This failure had the potential for the agency to miss statistically significant data from OASIS reports and fail to identify patient population trends. 1. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2022, was conducted from January 1, 2022, to December 31, 2022. The QAPI binder indicated the following quality indicators: a. Clinical record review b. Customer satisfaction survey c. Falls d. Patient infections The QAPI binder did not contain documented evidence to show a quality indicator had been chosen for the time period of: January 1, 2022, to December 31, 2022, from the following OASIS reports: a. Home Health Compare (a report on home health agency performance and patient satisfaction) b. Outcome-Bases Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing. (a report on incidence rates for 12 infrequently occurring untoward events. These potentially avoidable events reflect a serious health problem or decline in health status for an individual patient that potentially could have been avoided) c. Outcome-Based Quality Improvement (OBQI) Outcome Report (statistics from the agency’s OASIS reporting for use in the agency’s QAPI program) d. Patient/Agency Characteristics Report (presents a "snapshot" of agency patient characteristics) e. Submission Statistics by Agency Report (OASIS submissions made by or on behalf of an agency during a specified period of time) f. Error Summary Report by Home Health Agency (summarizes the errors an agency encountered in OASIS submissions during a specified period of time) During a concurrent record review and interview, on May 25, 2023, at 10:10 AM, with the Administrator/Director of Patient Care Services (Admin/DPCS) and the QAPI Coordinator (QAPI Coord), the contents of the QAPI binder were reviewed. The Admin/DPCS stated she was responsible for the QAPI Program. The QAPI Coord stated she and the QAPI Committee had not chosen a quality indicator from the OASIS reports. The Admin/DPCS stated the agency’s policy and procedure titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” dated March 2019, was not followed. A review of the agency’s policy and procedure titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” dated March 2019, indicated, “…USE OF OASIS DATA: 1. The Home Health Agency utilizes the following OASIS reports: Home Health Compare, Outcome-Bases Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing, Outcome-Based Quality Improvement (OBQI) Outcome Report, Patient/Agency Characteristics Report, Submission Statistics by Agency Report, Error Summary Report by Home Health Agency. 2. Quality Assessment and Performance Improvement (QAPI) activities include obtaining and systematically analyzing OASIS reports to: collect and trend data to monitor performance, recognize statistically significant data, identify patient population trends, establish criteria for focused review, identify and reduce risk, investigate factors that contribute to potentially avoidable events, Determine staff education that can promote improved outcomes, use evidence-based practices in quality assessment and performance improvement initiatives. …”

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on interview, and record review, the agency failed to conduct and document performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the agency had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved, from January 1, 2022, to December 31, 2022, in a universe of 53 patients. This failure had the potential to cause problems in health outcomes, patient safety and quality of care to go unaddressed and continue. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2022, was conducted from January 1, 2022, to December 31, 2022. There was no documented evidence to show performance improvement projects had been initiated, were in process or had been completed for the 12 months (January 1, 2022, to December 31, 2022) reviewed. During a concurrent record review and interview, on May 25, 2023, at 11:35 AM, with the Administrator/Director of Patient Care Services (Admin/DPCS) and the QAPI Coordinator (QAPI Coord), the contents of the QAPI binder were reviewed. The Admin/DPCS stated she was responsible for the QAPI program. The QAPI Coord stated a PIP had not been conducted for the year 2022. The Admin/DPCS stated the agency’s policy and procedure titled “Performance Improvement Projects,” dated March 2018, was not followed. A review of the agency’s policy and procedure titled “Performance Improvement Projects,” dated March 2018, indicated, “POLICY: The Agency will conduct performance improvement projects. … PROCEDURE: 1. The number and scope of distinct improvement projects conducted annually will reflect the scope, complexity and past performance of the Agency's services and operations. 2. The Agency will document the quality improvement projects undertaken, the reasons for conducting these projects and the measurable progress achieved on these projects. 3. The Agency should have one performance improvement project either in development, ongoing or completed each calendar year. 4. The Agency decides, based on the QAPI program activities and data, what projects are indicated and the priority of the projects.”

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on interview, and record review, the agency’s Governing Body (GB) failed to provide oversight for its Quality Assessment and Performance Improvement (QAPI) Program from January 1, 2022, to December 31, 2022, in a universe of 53 patients when: 1. The QAPI program failed to measure and analyze quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) in order to assess the agency’s processes of care, services, and operations, from January 1, 2022, to December 31, 2022. 2. The QAPI program failed to use quality indicator (a measurable element of the agency’s practice that can be used to assess the quality of care provided) data from OASIS (Outcome and Assessment Information Set) to monitor the quality of the agency’s services. In addition, the agency’s Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program’s data collection, from January 1, 2022, to December 31, 2022. 3. The QAPI program failed to conduct and document performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the agency had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved, from January 1, 2022, to December 31, 2022. This failure had the potential to cause the agency to provide inferior care and services to its patients. 1. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2022, was conducted from January 1, 2022, to December 31, 2022. The QAPI binder indicated the following quality indicators: a. Clinical record review b. Customer satisfaction survey c. Falls d. Patient infections The QAPI binder did not contain documented evidence to show data had been assembled and analyzed, from January 1, 2022, to December 31, 2022. There was no documented evidence to show statistical techniques such as controls charts (a graph used to study how a process changes over time), histograms (a graphical representation that organizes a group of data points into user-specified ranges), bar graphs (a chart that plots data using rectangular bars or columns) or pareto charts (a chart that contains both bars and a line graph, where individual values are represented in descending order by bars, and the cumulative total is represented by the line) had been used to analyze the collected data. The QAPI binder did not contain documented evidence to show the agency had developed mechanisms such as thresholds (a value), setting upper and lower control limits (identifies what value is acceptable), percentages (numbers that summarize data), ratios (the relationship in quantity, amount, or size between two or more things) or performance goals in order to identify levels, patterns or trends in the agency’s provision of care from January 1, 2022, to December 31, 2022. During a concurrent record review and interview, on May 25, 2023, at 9:12 AM, with the Administrator/Director of Patient Care Services (Admin/DPCS) and the QAPI Coordinator (QAPI Coord), the contents of the QAPI binder were reviewed. The Admin/DPCS stated she was responsible for the QAPI Program. The QAPI Coord stated she and the QAPI Committee had not analyzed the data collected from the quality indicators. The QAPI Coord stated no action plans had been developed for problem areas. The Admin/DPCS stated the agency’s policy and procedure titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” dated March 2019, was not followed. A review of the agency’s policy and procedure titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” dated March 2019, indicated, “AGGREGATION AND ANALYSIS: 1. The QAPI committee will compile and analyze collected data. 2. Statistical techniques will be utilized, as appropriate, to compile and analyze data. Such statistical techniques include control charts, histograms, bar graphs and Pareto charts. Such techniques help to focus the Agency's attention and resources on those processes and outcomes for which more intensive analysis will be most beneficial. Such assessment is initiated by: comparison internally (levels, trends, patterns), with others (references databases), with standards, with practice guidelines, with best practices (industry leaders). … PERFORMANCE EXPECTATION: 1. For each process identified to be improved, mechanisms to identify levels, patterns or trends in that process that will trigger further evaluation of the process will be identified. Performance expectations to trigger further evaluations may include, but are not limited to thresholds, setting upper and lower control limits, percentages, ratios, setting performance goals for further evaluation, identification of patterns/trends. Sample size will be determined for each Quality Assessment and Performance Improvement indicator to adequately represent the indicator. 2. For each established indicator to be improved, the performance expectation will be determined. The frequency of data collection and analysis will be specified for each indicator. The QAPI Committee, and/or those involved in patient care will analyze the data collected to pursue opportunities for improvement and identify important problems. 3. A summary of data collection, analysis, recommendations for improvement and report of cumulative findings will be prepared by the QAPI Committee. The reports are forwarded to the Governing Body. Failure to achieve expected levels of performance will be documented and an explanation delineated to identify opportunities for improvement. …” 2a. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2022, was conducted from January 1, 2022, to December 31, 2022. The QAPI binder indicated the following quality indicators: a. Clinical record review b. Customer satisfaction survey c. Falls d. Patient infections The QAPI binder did not contain documented evidence to show a quality indicator had been chosen for the time period of: January 1, 2022, to December 31, 2022, from the following OASIS reports: a. Home Health Compare (a report on home health agency performance and patient satisfaction) b. Outcome-Bases Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing. (a report on incidence rates for 12 infrequently occurring untoward events. These potentially avoidable events reflect a serious health problem or decline in health status for an individual patient that potentially could have been avoided) c. Outcome-Based Quality Improvement (OBQI) Outcome Report (statistics from the agency’s OASIS reporting for use in the agency’s QAPI program) d. Patient/Agency Characteristics Report (presents a "snapshot" of agency patient characteristics) e. Submission Statistics by Agency Report (OASIS submissions made by or on behalf of an agency during a specified period of time) f. Error Summary Report by Home Health Agency (summarizes the errors an agency encountered in OASIS submissions during a specified period of time) During a concurrent record review and interview, on May 25, 2023, at 10:10 AM, with the Administrator/Director of Patient Care Services (Admin/DPCS) and the QAPI Coordinator (QAPI Coord), the contents of the QAPI binder were reviewed. The Admin/DPCS stated she was responsible for the QAPI Program. The QAPI Coord stated she and the QAPI Committee had not chosen a quality indicator from the OASIS reports. The Admin/DPCS stated the agency’s policy and procedure titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” dated March 2019, was not followed. A review of the agency’s policy and procedure titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” dated March 2019, indicated, “…USE OF OASIS DATA: 1. The Home Health Agency utilizes the following OASIS reports: Home Health Compare, Outcome-Bases Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing, Outcome-Based Quality Improvement (OBQI) Outcome Report, Patient/Agency Characteristics Report, Submission Statistics by Agency Report, Error Summary Report by Home Health Agency. 2. Quality Assessment and Performance Improvement (QAPI) activities include obtaining and systematically analyzing OASIS reports to: collect and trend data to monitor performance, recognize statistically significant data, identify patient population trends, establish criteria for focused review, identify and reduce risk, investigate factors that contribute to potentially avoidable events, Determine staff education that can promote improved outcomes, use evidence-based practices in quality assessment and performance improvement initiatives. …” 2b. A review of the agency's "Governing Body Minutes," binder, dated 2022, was conducted from January 1, 2022, to December 31, 2022. There was no documented evidence to show the Governing Body (GB) approved the frequency and detail of the QAPI program’s data collection. There was no documented evidence to show the QAPI Committee had provided the detail and frequency of data collection to the GB for review and approval. During an interview with the Director of Patient Care Services (DPCS), on May 25, 2023, at 10:56 AM, the Admin/DPCS stated she was a member of the GB. The Admin/DPCS stated the QAPI Coord had not provided the GB with the frequency and detail of the QAPI program’s data collection from January 1, 2022, to December 31, 2022. The Admin/DPCS stated the GB had not approved the frequency and detail of data collection for the QAPI program from January 1, 2022, to December 31, 2022. A review of the agency’s policy and procedure titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” dated March 2019, indicated, “…PROGRAM SCOPE: … 5. The frequency and detail of the data collection must be approved by the Governing Body.” 3. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2022, was conducted from January 1, 2022, to December 31, 2022. There was no documented evidence to show performance improvement projects had been initiated, were in process or had been completed for the 12 months (January 1, 2022, to December 31, 2022) reviewed. During a concurrent record review and interview, on May 25, 2023, at 11:35 AM, with the Administrator/Director of Patient Care Services (Admin/DPCS) and the QAPI Coordinator (QAPI Coord), the contents of the QAPI binder were reviewed. The Admin/DPCS stated she was responsible for the QAPI program. The QAPI Coord stated a PIP had not been conducted for the year 2022. The Admin/DPCS stated the agency’s policy and procedure titled “Performance Improvement Projects,” dated March 2018, was not followed. A review of the agency’s policy and procedure titled “Performance Improvement Projects,” dated March 2018, indicated, “POLICY: The Agency will conduct performance improvement projects. … PROCEDURE: 1. The number and scope of distinct improvement projects conducted annually will reflect the scope, complexity and past performance of the Agency's services and operations. 2. The Agency will document the quality improvement projects undertaken, the reasons for conducting these projects and the measurable progress achieved on these projects. 3. The Agency should have one performance improvement project either in development, ongoing or completed each calendar year. 4. The Agency decides, based on the QAPI program activities and data, what projects are indicated and the priority of the projects.” A review of the agency's "Governing Body Minutes," binder, dated 2022, was conducted from January 1, 2022, to December 31, 2022. There was no documented evidence to show the Governing Body (GB) had received a written report from the QAPI Coordinator that included a summary of all activities included as part of the QAPI Plan. There was no documented evidence to show the QAPI Coordinator had provided the detail and frequency of data collection to the GB for review and approval. There was no documented evidence to show the GB approved the frequency and detail of the QAPI program’s data collection. The was no documented evidence to show the GB identified the QAPI committee’s failure to measure and analyze data, chose a quality indicator from OASIS reports or conduct performance improvement projects. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) and QAPI Coordinator (QAPI Coord) on May 25, 2023, at 11:35 AM, the QAPI Coord stated she had not provided the GB a written report that included a summary of all activities included as part of the QAPI Plan or provided the detail and frequency of data collection from January 1, 2022, to December 31, 2022, to the GB for review and approval. The Admin/DPCS stated she was a member of the GB. The Admin/DPCS stated the GB had not identified the QAPI committee’s failure to measure and analyze data, chose a quality indicator from OASIS reports or conduct performance improvement projects from January 1, 2022, to December 31, 2022. The Admin/DPCS stated the GB had not approved the frequency and detail of the QAPI program’s data collection from January 1, 2022, to December 31, 2022. A review of the agency’s policy and procedure titled, “Governing Body,” dated March 2018, indicated, “POLICY: The Governing Body (or designated persons so functioning) assumes full legal authority and responsibility for the Agency's overall management and operation, the provision of all home health services, fiscal operations, review of the Agency's budget and its operational plans and its quality assessment and performance improvement program. PURPOSE: To ensure lines of authority are established and to ensure appropriate quality services are provided to patients. RESPONSIBILITIES: … 3. The Governing Body is responsible for assuring: That an ongoing program for Quality Assessment/Performance Improvement and patient safety is defined, implemented and maintained, That the Agency-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated for effectiveness, That clear expectations for patient safety are established, implemented and maintained, That any findings of fraud or waste are appropriately addressed.”

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 interview, and record review, the agency failed to ensure the clinical record contained required items for one of 10 sampled patients (Patients 6) when three skilled nursing visit notes were not submitted on the Monday of the following week by 5:00 PM as indicated in the agency's policy and procedure titled, "Timely Submission of Patient Documentation," dated October 2017. This failure had the potential to cause clinicians reviewing the clinical record to make assessments and decisions based on incomplete and outdated information. A review of Patient 6’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of April 1, 2023, with a certification period of April 1, 2023, to May 30, 2023. Patient 6 had diagnoses that included acute respiratory failure (sudden impairment of oxygen exchange between the lungs and the blood). A review of Patient 6’s plan of care/physician’s order dated April 1, 2023, to May 30, 2023, indicated the skilled nurse (SN- a Registered Nurse-RN or a Licensed Vocational Nurse-LVN) was to make visits to Patient 6, one time a week for one week, two times a week for three weeks, and one time a week for five weeks. A review of Patient 6’s scheduling calendar indicated the SN was scheduled to visit Patient 6 on the following dates: April 1, 4, 7, 11, 14, 18, 22, and 26, 2023, May 5, 10, and 17, 2023. A review of Patient 6’s SN visit notes was conducted on May 23, 2023. There was no documented evidence to show SN visit notes for the following dates: a. April 26, 2023, (the clinical note was due to be in the electronic medical record on May 1, 2023) b. May 10, 2023, (the clinical note was due to be in the electronic medical record on May 14, 2023) c. May 17, 2023, (the clinical note was due to be in the electronic medical record on May 22, 2023) During an interview with a Clinical Manager (CM) on May 23, 2023, at 3:41 PM, the CM stated the SN visit for April 26, 2023, was made and the note was due on May 1, 2023, and it was not submitted. The CM stated the SN visit for May 10, 2023, was made and the note was due on May 14, 2023, and it was not submitted. The CM stated the SN visit for May 17, 2023, was made and the note was due on May 22, 2023, and it was not submitted. The CM stated the SN did not follow the agency’s policy and procedure titled “Timely Submission of Patient Documentation,” dated October 2017. A review of the agency’s policy and procedure titled “Timely Submission of Patient Documentation,” dated October 2017, indicated, “POLICY: The Agency will ensure the timely and proper submission of patient documentation. … PROCEDURE: … 5. Itineraries, with all visit reports attached, must be submitted every Monday of the following week by 5:00 pm. Unless Monday is a holiday, then it is due the next day also by 5:00 pm. …”