Every finding on record at Avante Home Health Care, Inc

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey conducted on 1/18/24 to 1/21/24. Complaint number: 103099 Representing the California Department of Public Health: Surveyor ID #22303, Health Facilities Evaluator Nurse Surveyor ID #44916, Health Facilities Evaluator Nurse Unduplicated Census: 167 Active Census- 46 Sample Size: 7 Home Visits: 3 The Inspection was limited to the specific for the complaint investigated and does not represent the findings of a full inspection of the facility. The following Conditions of Participation were not met: 418.55 Condition of participation: Comprehensive patient assessments 484.65 Condition of Participation: QAPI: Develop/Implement/Evaluation/Maintain Program 484.105 Condition of Participation: Organization/Administration of Services 484.110 Condition of Participation: Clinical Records

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Comprehensive Assessment of Patients as follows: 1. The Home Health Agency (HHA) failed to submit a completed documentation of the comprehensive assessment in a timely manner for seven out of seven sampled Patients (Patient 1, 2, 3, 4, 5, 6, and 7) 2. the Home Health Agency (HHA) failed to assess the patient's continuing need for skilled nursing services for three of seven sampled patients (Patients 1,2 and 3). (Refer to G522). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated (in a way that is decided and controlled by law) compliance with the Federal Regulations for Comprehensive Assessment of Patients to ensure the provision of quality health care services in a safe manner.

Completion of the comprehensive assessment CFR(s): 484.55(b) Standard: Completion of the comprehensive assessment. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure to complete documentation of the comprehensive assessment for seven out of seven sampled Patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7). This deficient practice had the potential for Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7 not to received quality care and services to meet their care goals. d. A review of Patient 4’s patient profile (face sheet) indicated start of care (SOC) date of 10/13/2023, with primary diagnosis of Type 2 Diabetes (a condition that happens because of a problem in the way the body regulates and uses sugar as a fuel) and long term use of oral hypoglycemics (medications taken to lower blood sugar). Skilled Nurse (SN) visit frequency of twice a week for two weeks and once a week for 7 weeks. e. A review of Patient 5's face sheet indicated an SOC date of 11/23/2024 with a medical diagnosis of Type 2 diabetes and long term use of insulin (a hormone that regulates the amount of glucose in the body) with a certification period reviewed 1/22/2024 to 3/21/2024. SN visit frequency of twice a week for two weeks and once a week for 7 weeks. f. A review of Patient 6's face sheet indicated an SOC date of 12/6/2023 with a medical diagnosis of unilateral (one side of the body) left knee osteoarthritis (inflammation of the joints) with a certification period reviewed 12/6/2023 to 2/3/2024. SN visit frequency of twice a week for two weeks and once a week for 7 weeks. Physical Therapy (PT) Evaluation and set up treatment plan. g. A review of Patient 7's face sheet indicated an SOC date of 11/30/2023 with a medical diagnosis of intervertebral disc degeneration (the wear and tear of lumbar intervertebral disc, and it is mainly occurring at the (lumbar region which comprises of 6 parts) L3-L4 and L4-S1 vertebrae- bones protecting the spinal cord) with a certification period reviewed 11/30/2023 to 1/28/2024. SN visit frequency of once a week for one week, twice a week for two weeks and once a week for six weeks. PT evaluation and set up plan of treatment During a concurrent interview and record review on 1/26/2024 at 2:25 p.m., of Patient 4, 5, 6 and 7's EMR- Electronic Medical Record (a computer system that helps healthcare providers manage patient medical records and automate clinical workflows) with the Administrator (Admin). Admin, stated that all skilled nurses documentation were missing from the EMR. Admin stated that the agency utilizes both electronic and paper charting. When asked if he has the paper nurses notes in the office, Admin stated that the nurses had not submitted their notes. When asked about how he knew in the EMR that there are no notes submitted by the nurses, Admin answered that in the column beside the visit date, there should be a note sign attached. If there is no note sign attached, there are no notes submitted by the nurse. During an interview on 1/27/2024 at 2:30 p.m., with Licensed Vocational Nurse 1 (LVN 1) stated that she uses paper for her notes. LVN 1 confirmed that she still has 7 clinical notes that was not submitted to the office. LVN 1 stated that she usually submits her notes every two weeks. LVN 1 stated moving forward she will try to send her notes electronically and submit it timely. During an interview on 1/28/2024 at 12:25 p.m., with the Director of Nursing (DON), DON stated that we have to follow up with the nurses to give their notes back to the agency or use the EMR. DON agreed that the outcome for not submitting notes in a timely manner resulted in no coordination between the staff and the agency, no updated plan of care for each patients and interdisciplinary team (IDT- a group of professionals that brings together knowledge from different health care disciplines to help people receive the care they need)/case summaries were not updated, QAPI(Quality Assurance and Performance Improvement (QAPI) is a data driven and proactive approach to quality improvement used to ensure services are meeting quality standards and assuring care reaches a certain level) will not be resolved, our doctor is not notified of the current conditions of our patients and medications and the plan of care will not be updated with the current condition of the patients. A review of the agency’s undated policy titled “Content of the Clinical Record”, indicated that a clinical record will be maintained for each patient receiving care. The clinical record will contain sufficient information to identify the patient, describe the patient's problems and needs, justify care, accurately document care provided and results in detail, and facilitate continuity of care among organization and contract personnel. Staff notes will be submitted within 7 days of the clinical visit date with the patient. This pertains to the registered nurse (RN), LVN, Hospice aide (HA) Medical Social Worker (MSW), Chaplain, Volunteers and Therapy. a. A review of Patient 1's clinical record indicated a start of care (SOC) date of 10/4/23, with diagnosis that included osteoarthritis( occurs when flexible tissue at the ends of bones wears down). During a review of Patient 1's Plan of Care (POC) from 10/4/23 to 12/2/23, the POC indicated an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for seven weeks for assessment of all body system and medication compliance. The POC indicated the discharge planning was to discharge Patient 1 when medical condition was stable and the patient no longer needed skilled care. A further review of Patient 1's clinical record indicated there were no clinical notes and updated case summaries found in the electronic medical record. b. A review of Patient 2's clinical record indicated a start of care (SOC) date of 10/22/23, with diagnosis that included diabetes mellitus (a group of diseases that results in too much sugar in the blood). During a review of Patient 2's plan of care (POC) from 10/22/23 to 12/20/23, the POC indicated an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for seven weeks, for assessment of all body system and medication compliance. The plan of care indicated the discharge planning was to discharge Patient 2 when the patient’s medical condition was stable, and the patient no longer needed skilled care. A further review of Patient 2's clinical record indicated there were no clinical notes and updated case summaries found in the electronic medical record. c. A review of Patient 3's clinical record indicated a start of care (SOC) date of 10/18/23, with diagnosis that included hypertension (a condition in which the force of the blood against the artery walls too high). During a review of Patient 3's plan of care (POC) from 10/18/23 to 12/16/23, the POC indicated an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for seven weeks, for assessment of all body system and medication compliance. The plan of care indicated the discharge planning was to discharge Patient 2 when the patient’s medical condition was stable, and the patient no longer needed skilled care. A further review of Patient 3's clinical record indicated there were no clinical notes and updated case summaries found in the electronic medical record.

Eligibility for Medicare home health benefit CFR(s): 484.55(b)(2) Except as provided in paragraph (b)(3) of this section, a registered nurse must complete the comprehensive assessment and for Medicare patients, determine eligibility for the Medicare home health benefit, including homebound status. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to assess the patient's continuing need for skilled nursing services for three of seven sampled patients (Patients 1, Patient 2, and Patient 3). This deficient practice had the potential for Patients 1, Patient 2, and Patient 3 to receive unnecessary continuous home health services. a. A review of Patient 1's Patient Information indicated a start of care (SOC) date of 10/4/2023, with diagnosis that included osteoarthritis (occurs when flexible tissue at the ends of bones wears down). During a review of Patient 1's Plan of Care (POC) from 10/4/2023 to 12/2/2023, the POC indicated an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for seven weeks for assessment of all body system and medication compliance. The POC indicated the discharge planning was to discharge Patient 1 when medical condition was stable and the patient no longer needed skilled care. During a review of Patient 1’s initial comprehensive nursing assessment for recertification (OASIS- to determine the need for nursing services) dated 10/4/2023, the OASIS indicated Patient 1 had aching pain on the lower back and bilateral knees with the pain level 4 (mild to moderate) on a pain scale from zero (no pain) to ten (worse pain) less than daily. The OASIS indicated Patient 1's pain relieved with medication, heat, and rest. b. A review of Patient 2's Patient Information indicated a start of care (SOC) date of 10/22/2023, with diagnosis that included diabetes mellitus (a group of diseases that results in too much sugar in the blood). During a review of Patient 2's plan of care (POC) from 10/22/2023 to 12/20/2023, the POC indicated an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for seven weeks, for assessment of all body system and medication compliance. The plan of care indicated the discharge planning was to discharge Patient 2 when the patient’s medical condition was stable, and the patient no longer needed skilled care. During a review of Patient 2’s initial comprehensive nursing assessment for recertification (OASIS- to determine the need for nursing services) dated 10/22/2023, the OASIS indicated Patient 2 had aching pain on the lower back and bilateral knees with the pain level 4 (mild to moderate) on a pain scale from zero (no pain) to ten (worse pain) less than daily. The OASIS indicated Patient 2's pain relieved with medication, heat, and rest. During an observation on 1/27/2024, at 1 p.m., at Patient 2’s home, Patient 2 was alert, oriented, walking on steady gait without using any assistive device and who opened their entrance door to let us in. During an interview on 1/27/2024, at 1:20 p.m., with Patient 2, Patient 2 stated takes his own medications and would check his blood pressure readings which were in normal ranges. c. A review of Patient 3's Patient Information indicated a start of care (SOC) date of 10/18/2023, with diagnosis that included hypertension (a condition in which the force of the blood against the artery walls too high). During a review of Patient 3's plan of care (POC) from 10/18/2023 to 12/16/2023, the POC indicated an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for seven weeks, for assessment of all body system and medication compliance. The plan of care indicated the discharge planning was to discharge Patient 2 when the patient’s medical condition was stable, and the patient no longer needed skilled care. During a review of Patient 3’s initial comprehensive nursing assessment for recertification (OASIS- to determine the need for nursing services) dated 10/18/2023, the OASIS indicated Patient 3 had aching pain on the lower back with the pain level 5 (mild to moderate) on a pain scale from zero (no pain) to ten (worse pain) less than daily. The OASIS indicated Patient 3's pain relieved with medication, heat, and rest. During an interview on 1/28/2024, at 12:30 p.m., with the Director of Patient Care Services (DPCS), DPCS stated Patients 1, Patient 2, and Patient 3, were not in compliance with their medication regimen, so the agency decided to re-certify them for another 60 days for continuous SN (skilled nurse) monitoring and patient teaching. A review of the agency's policy titled "Discharge Criteria and Process" indicated services will be terminated when the goals of home health have been attained or are no longer attainable.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on interview and record review, The home health agency (HHA) failed to ensure the agency’s licensed personnel implemented, monitored, documented and followed standard policy and procedure for diabetic management. This deficient practice had the potential for adverse reactions, medication errors and ineffective insulin administration. Based on interview and record review, the home health agency (HHA) failed to: 1). Ensure licensed personnel coordinated and provided education to caregiver regarding labeling and calibration of diabetic supplies, for one of one sampled patient, Patient 5. 2). Ensure licensed nurses’ visit notes were readily available in patient’s clinical record. This deficient practice had the potential for the care and services needed by the patient will not be properly coordinated with the home health agency and the patient and family caregiver. A review of Patient 5’s clinical record titled, “Home Health Certification and Plan of Care (POC)”, with the certification period from 1/22/2024 to 3/21/2024, indicated a start of care (SOC) date on 11/23/2023, with diagnosis that included type 2 diabetes (abnormal blood sugar) with hyperglycemia (high blood sugar). Skilled nurse (SN) visits for twice a week for 2 weeks and once a week for 7 weeks. SN to perform every visit: vital signs: temperature/heart rate/respiratory rate/blood pressure, auscultate (listen to) lung sounds for any abnormalities, SN may monitor blood sugar level using aseptic (clean) technique, proper rotation of puncture sites using patient's glucometer machine, with proper disposal of sharps and contaminated materials and accurate documentation of blood sugar test results, if patient caregiver (PCG) is not available or per patient/PCG request, SN to perform diabetic foot exam and care upon every visit. SN may prepare and administer Novolog (rapid acting insulin) as needed per medical doctor (MD) order, if PCG is not available or per patient/PCG request. SN to assess the administration of Novolog by PCG to determine if proper technique is utilized and the correct dose of medication was drawn up. Patient's caregiver is confident, capable and competent in monitoring patient's blood sugar levels once daily and as needed, diabetic foot exam/care, and administer Novolog (SQ (subcutaneously- under the skin) injection daily, using aseptic technique and proper sharps disposal as validated by SN at SOC assessment. SN to notify MD of any signs/symptoms of infection, oxygen saturation less than 92%;Blood sugar greater than 350 or less than 60 ;pain level greater than 6/10 and or not relieved by prescribed medication; Pulse greater than 100 beats/min ,less than 60 beats/min ;systolic BP greater than 160 mm/hg ,less than 90 mm/Hg ;Diastolic BP greater than 90 mm/HG ,less than 60 mm/Hg ,Temperature greater than 100 degrees Fahrenheit(F-unit of temperature)) and less than 95 F orally; Respirations greater than 24 or less than 14 ; patient injury or falls, sudden change in mental status; severe shortness of breath (SOB) ;chest pain and any other abnormal findings. A televisit (visit via phone) was conducted on 1/27/2024 at 4:30 p.m., with Patient 5 and family member (FM) 1. FM 1 stated Patient 5 does not speak or understand english and will translate for her. FM 1 stated that she (Patient 5) received nurse visits 2-3 times per week. FM 1 also stated that caregivers alternate checking the patient’s blood sugar 2-3 times per week with a blood sugar ranges 300 to less than 200. FM 1 stated that the patient used her Novolog insulin pen frequently and is now on her fourth pen. When asked if the licensed staff who visited Patient 5 educated them (Patient 5 and FM1) to write a date and time the insulin was opened, FM 1 stated "No". When asked if the nurse checked Patient 5’s insulin box, FM1 stated “No." FM 1 stated he did not know the insulin was only good for 28 days. When asked if they (Patient 5 and FM1) know how to calibrate the patient’s glucometer, FM 1 stated, "I do not know." During a concurrent interview and record review on 1/26/2024 at 2:25 p.m., of Patient 5's Electronic Medical Record (EMR, computerized medical records), with the Administrator (Admin), the Admin, stated that all skilled nurses’ documentation were missing from the EMR. Admin stated that the agency utilizes both electronic and paper charting. When asked if he has the paper nurses’ notes in the office, Admin stated that the nurses had not submitted their notes. During an interview on 1/28/2024 at 12:25 p.m., with the Director of Nursing (DON), DON stated that we have to follow up with the nurses to give their notes back to the agency or use the EMR. DON stated, if nurses’ notes were not submitted timely, there will be no work coordination between the staff and the agency. The DON stated, plan of care for each patients will not be updated and the interdisciplinary group (IDT, group of healthcare professionals working together to provide residents with the care they need) case summaries will not be updated, QAPI (Quality Assurance and Performance Improvement (QAPI), a data driven approach to quality improvement used to ensure services are meeting quality standards and assuring care reaches a certain level) will not be resolved, doctors will not be notified of the current conditions of our patients and medications and the plan of care will not be updated with the current condition of the patients. A review of the HHA's undated policy and procedure (P&P) titled, " Coordination of Care with Contracts/Agreements," indicated the home health agency will maintain professional responsibility for all services provided. The P&P indicated, the home health program will retain responsibility for evaluating services, maintaining professional management responsibility, and ensuring continuity of care in all settings through its performance improvement program and/or corporate compliance program. All care provided will be in accordance with the home health plan of care and documented in the clinical record.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure the Condition of Participation for Quality Assessment and Performance Improvement were met as follows: 1). The HHA failed to provide documented evidence of an ongoing Quality Assessment and Performance Improvement [QAPI-a data driven and proactive approach to quality improvement. It combines two approaches - Quality Assurance (QA) and Performance Improvement (PI)] program. This deficient practice resulted to the failure of the agency's compliance to deliver statutorily mandated compliance with the Federal regulations for QAPI program to ensure highest quality of care was provided to patients assessed to receive the home health benefits. (Refer to G642) 2). The HHA failed to monitor, provide solutions, and implement compliance for the timely submission of nurses’ patients visit notes and documentation for seven of 7 patients, Patients 1, 2, 3, 4, 5, 6 and 7. This failure had the potential to result in the agency's inability to obtain patient concerns and needs and can affect the quality of care provided to all the patients under the agency’s care. (Refer to G648) The cumulative effects of these systemic practices resulted in HHA failure to deliver statutorily mandated compliance with the Federal regulations for QAPI program to ensure highest quality of care was provided to patients, evaluate negative patient care outcomes and resolving critical issues such as coordination of care, timely submission of documentations and understanding policies and procedures that govern the agency's operations.

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 home health agency (HHA) failed to provide documented evidence of an ongoing Quality Assessment and Performance Improvement [QAPI-a data driven and proactive approach to quality improvement. It combines two approaches - Quality Assurance (QA) and Performance Improvement (PI)] program. This deficient practice resulted to the failure of the agency's compliance to deliver statutorily mandated compliance with the Federal regulations for QAPI program to ensure highest quality of care was provided to patients assessed to receive the home health benefits. During a record review of the Quality Assessment and Performance Improvement (QAPI) program on 1/28/2024, at 12:45 p.m., indicated the QAPI program for 2022-2023 revealed that the agency was conducting an audit for the following listed for the first, second, third and fourth quarters. Clinical record Review/QAPI review falls/Incident Reports Infections (Patient and Employee) Patient/Staff satisfaction Patient/Staff Complaints Hospitalization Hand Hygiene Pain management effectiveness Medication Errors/Adverse events Plan of Care Compliance PT/OT/ST/MSW therapy Hand Hygiene Compliance Influenzas/COVID Vaccine Compliance Emergency Plans and Drills During an interview on 1/28/2024 at 12:50 p.m., with the Administrator (Admin), the Admin could not provide evidence that QAPI meetings were conducted, data were collected, and any documentations regarding QAPI. The Admin stated QAPI should have been reviewed quarterly and annually per their policy. A review of the HHA's policy and procedure (P&P), titled "Quality Outcomes /Performance," indicated that the purpose of the home health QAPI Plan is to provide a strategy for a systematic organization-wide implementation of quality assessment and performance improvement activities. This will ensure that the organization is providing appropriate, high-value, effective and efficient services in accordance with its mission and current standards of practice. A review of the HHA's undated P&P titled, "QAPI Coordinator: DPCS (Director of Patient Care Services); QAPI Group: DPCS, CEO (Chief Executive Officer), Office manager", indicated the home health agency will evaluate process and look for improvement opportunities and new projects quarterly.

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to monitor, provide solutions, and implement compliance for the timely submission of nurses’ patients visit notes and documentation for seven of 7 patients, Patients 1, 2, 3, 4, 5, 6 and 7. This failure had the potential to result in the agency's inability to obtain patient concerns and needs and can affect the quality of care provided to all the patients under the agency’s care. During a concurrent interview and record review on 1/26/2024 at 2:25 p.m., of Patients 1, 2, 3, 4, 5, 6 and 7's EMR, with the Admin, the Admin, stated that all skilled nurses’ documentation were missing from the EMR. The Admin stated that the agency utilizes both electronic and paper charting. When asked if he has the paper nurses’ notes in the office, the Admin stated that the nurses had not submitted their notes. When asked about how he (Admin) knew there were no visit notes submitted by the nurses at the EMR, Admin answered that in the column beside the visit date, there should have been an attached note signed. If there was no attached note signed, the nurses had not submitted their notes. During an interview on 1/27/2024 at 2:30 p.m., with Licensed Vocational Nurse 1 (LVN 1) stated that she used paper charting for her visit notes. LVN 1 stated she has 7 clinical notes that were not submitted to the HHA. LVN 1 stated she submits her visit notes every two weeks. During an interview on 1/28/2024 at 12:25 p.m., with the Director of Nursing (DON), DON stated we need to follow up with the nurses to ensure visit notes are submitted to the HHA timely or use the EMR. The DON stated the outcome for not submitting notes in a timely manner could result in needed care and services by the patient will not be coordination between the staff and the HHA. The DON stated the plan of care for each patient will not be updated, and interdisciplinary team (IDT- a group of professionals that brings together knowledge from different health care disciplines to help people receive the care they need) case summaries will not be updated, QAPI (Quality Assurance and Performance Improvement) concerns will not be resolved, doctors will not be notified of patients’ current conditions, medications and the plan of care will not be updated with the current condition of the patients.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure the Condition of Participation for Organization and Administration of Services were met as follows: 1.The Home Health Agency (HHA) failed to provide documented evidence that the Governing body (assumes full legal authority and responsibility for the management of the hospice, the provision of all hospice services, its fiscal operations [activities to manage funds], and continuous quality assessment and performance improvement) conducted meetings on a regular basis. (Refer to G942). 2. The HHA failed to ensure to update and implement a written and individualized plan of care (POC, a form where person's health conditions, specific care needs, and current treatments will be summarized. The care plan should outline what needs to be done to manage patient's care needs. It will also help to organize and prioritize caregiving activities) for seven out of seven sampled patients (Patients 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7). (Refer to G968). The cumulative effects of these deficient practices had the potential to result in a delay or lack of coordination of delivery of care and services for patients admitted in the home health service.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume 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. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to provide documented evidence that the Governing body (assumes full legal authority and responsibility for the management of the hospice, the provision of all hospice services, its fiscal operations [activities to manage funds], and continuous quality assessment and performance improvement) conducted meetings on a regular basis. This deficient practice had the potential to affect quality of patient care and services. During the complaint validation survey from 1/26/2024 to 1/28/2024, a request was made to the Administrator to provide Governing body meetings. On 1/28/2024, during a review of the "Governing Body - Minutes of Governing Body Meeting" dated 12/28/2022, indicated the agency conducted the meeting and the following topics were discussed: Reviewing and Approving Org (Organizational) Chart (a visual representation of agency's structure that shows roles, responsibilities, and relationships within organization) and PAC members. Reviewing and Approving Policy and Procedure for 2023. Reviewing and Approving 3 Year Budget and Expenditure - 2023, 2024, 2025. Reviewing and Approving annual Evaluation tool. Reviewing and Approving Infection Control Plan and Analysis Risk COVID 19 (an infectious disease caused by the SARS-CoV-2 virus) Training and review of process for pandemic. Reviewing and Approving Emergency Management & Hazardous vulnerability. Reviewing and Approving Fall Program. Reviewing and Approving Ethics committee and reporting protocol. Reviewing and Approving CDC (Centers for Disease Control and Prevention) hand hygiene goals for 100 % (percent) compliance. Reviewing and Approving CDC instructions for prevention and goals for COVID 19. Reviewing and Approving QAPI (Quality Assurance and Performance Improvement, a program aim to improve quality of patient care) (Pl) program, including patient safety and infection control management. P/Ps will be done and annual evaluation of the program for improvement. QAPI will be done on a quarterly basis. Director of Patient Care Services (DPCS) is in charge of QAPI. Infection control plan is integral part of the QAPI Program. Patient and employee safety program will include: development, maintenance and evaluation of patient safety program. Approving business hours: Monday to Friday, 10:00 am - 5:00 pm. During an interview and concurrent record review on 1/28/2024 at 12:53 p.m. with Administrator, the Administrator presented Governing Body meeting dated 12/28/2022 that showed the annual budget plans and general and administrative expenses for 12 months ending in 12/2023 and 12/2024. There were no signatures of the members of the Governing body who attended the indicated meeting. During a concurrent interview with the Administrator (ADM), the ADM stated that the members of the governing body where him and his wife who owned the agency. ADM further stated that if the document is not signed, it did not happen. The ADM stated they do yearly meeting for Governing body and quarterly with QAPI. The facility was not able to provide Governing body meeting minutes for the year of 2023. A review of the HHA's policy titled "Governing Body" revised 11/2020, indicated the Governing Body will assume full legal authority, responsibility, decision-making, and accountability for the overall management and operations, the provision of services, fiscal operations, human resource management, review of the organization's budget and operational plans, and its quality assessment and performance improvement (QAPI) program. The policy further indicated the Governing Body of the agency will serve as the governing authority for the home care program, which will function according to agency bylaws. The policy indicated Governing Body members will be selected based upon their industry experience, expertise, and professional relationships. The policy indicated the Governing Body will establish operational and human resources policies that are consistent with the organization's mission and approve new or revised policies as needed. The policy further indicated the Governing Body will appoint a Governing Body committee to work with Senior Leadership and the Performance Improvement Committee to review and develop policies and procedures consistent with the organization's mission; annually review and revise policies and procedures; prepare an annual evaluation of the agency in relation to its mission; and assist in identifying goals and measuring accomplishments of the organization's operations. The policy indicated the Governing body will evaluate the organization's performance on a regular bases. The policy further indicated all actions taken by the Governing Body will be documented in meeting minutes, which will be retained by the organization for a minimum of five (5) years. Minutes will minimally include attendance records, summaries of agenda items and action taken, and motions documented as stated and acted upon. Minutes will be distributed per organization policy.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure to update and implement a written and individualized plan of care (POC, a form where person's health conditions, specific care needs, and current treatments will be summarized. The care plan should outline what needs to be done to manage patient's care needs. It will also help to organize and prioritize caregiving activities. An updated plan of care must reflect current information from the patient's updated comprehensive assessment, from clinical notes, and case summary/IDG [Interdisciplinary group] notes) for seven out of seven sampled patients (Patients 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7). This deficient practice resulted in patients not receiving the quality of care and services identified in the POC. d. A review of Patient 4’s patient profile (face sheet) indicated start of care (SOC) date of 10/13/2023, with primary diagnosis of Type 2 Diabetes (a condition that happens because of a problem in the way the body regulates and uses sugar as a fuel) and long term use of oral hypoglycemics (medications taken to lower blood sugar). Skilled Nurse (SN) visit frequency of twice a week for two weeks and once a week for 7 weeks. There were no clinical notes and updated case summaries found in the electronic medical record. e. A review of Patient 5's face sheet indicated an SOC date of 11/23/2024 with a medical diagnosis of Type 2 diabetes and long term use of insulin (a hormone that regulates the amount of glucose in the body) with a certification period reviewed 1/22/2024 to 3/21/2024. SN visit frequency of twice a week for two weeks and once a week for 7 weeks. There were no clinical notes and updated case summaries found in the electronic medical record. f. A review of Patient 6's face sheet indicated an SOC date of 12/6/2023 with a medical diagnosis of unilateral (one side of the body) left knee osteoarthritis (inflammation of the joints) with a certification period reviewed 12/6/2023 to 2/3/2024. SN visit frequency of twice a week for two weeks and once a week for 7 weeks. Physical Therapy (PT) Evaluation and set up treatment plan. There were no clinical notes and updated case summaries found in the electronic medical record g. A review of Patient 7's face sheet indicated an SOC date of 11/30/2023 with a medical diagnosis of intervertebral disc degeneration (the wear and tear of lumbar intervertebral disc, and it is mainly occurring at the (lumbar region which comprises of 6 parts) L3-L4 and L4-S1 vertebrae- bones protecting the spinal cord) with a certification period reviewed 11/30/2023 to 1/28/2024. SN visit frequency of once a week for one week, twice a week for two weeks and once a week for six weeks. PT evaluation and set up plan of treatment. There were no clinical notes and updated case summaries found in the electronic medical record During a concurrent interview and record review on 1/26/2024 at 2:25 p.m., of Patient 4, 5, 6 and 7's EMR- Electronic Medical Record (a computer system that helps healthcare providers manage patient medical records and automate clinical workflows) with the Administrator (Admin). Admin, stated that all skilled nurses documentation were missing from the EMR. Admin stated that the agency utilizes both electronic and paper charting. When asked if he has the paper nurses notes in the office, Admin stated that the nurses had not submitted their notes. When asked about how he knew in the EMR that there are no notes submitted by the nurses, Admin answered that in the column beside the visit date, there should be a note sign attached. If there is no note sign attached, there are no notes submitted by the nurse. During an interview on 1/27/2024 at 2:30 p.m., with Licensed Vocational Nurse 1 (LVN 1) stated that she uses paper for her notes. LVN 1 confirmed that she still has 7 clinical notes that was not submitted to the office. LVN 1 stated that she usually submits her notes every two weeks. LVN 1 stated moving forward she will try to send her notes electronically and submit it timely. During an interview on 1/28/2024 at 12:25 p.m., with the Director of Nursing (DON), DON stated that we have to follow up with the nurses to give their notes back to the agency or use the EMR. DON agreed that the outcome for not submitting notes in a timely manner resulted in no coordination between the staff and the agency, no updated plan of care for each patients and interdisciplinary team (IDT- a group of professionals that brings together knowledge from different health care disciplines to help people receive the care they need)/case summaries were not updated, QAPI(Quality Assurance and Performance Improvement (QAPI) is a data driven and proactive approach to quality improvement used to ensure services are meeting quality standards and assuring care reaches a certain level) will not be resolved, our doctor is not notified of the current conditions of our patients and medications and the plan of care will not be updated with the current condition of the patients. A review of the HHA's document titled "Care planning" indicated to plan and provide individualized plan of care and or services appropriate to the goals and needs of the patients serviced by the agency. An individualized plan of care is developed by agency licensed staff for each patient based upon assessment that reflects the patient's identified problems and needs, consistent with physician and licensed independent practitioners’ orders or prescriptions in accordance with applicable laws and regulations. Interventions, including teaching and training guidelines, are appropriate to the scope of practice of the individual developing and or updating the plan of care and consistent with relevant clinical practice guidelines. The plan of care interventions to address the identified patient needs. Measurable patient outcomes, the plan of care is reviewed, updated and or modified at east every 2 weeks and more often as necessary. A review of the HHA's document titled "Initial and Comprehensive assessments" indicated that A plan of care will be developed from the information gathered during the initial and comprehensive assessment. The patient's physician ( or other authorized licensed independent practitioner) is consulted for approval if additions or modifications to the plan of care are required after the assessment is completed. a. A review of Patient 1's clinical record indicated a start of care (SOC) date of 10/4/23, with diagnosis that included osteoarthritis( occurs when flexible tissue at the ends of bones wears down). During a review of Patient 1's Plan of Care (POC) from 10/4/23 to 12/2/23, the POC indicated an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for seven weeks for assessment of all body system and medication compliance. The POC indicated the discharge planning was to discharge Patient 1 when medical condition was stable and the patient no longer needed skilled care. A further review of Patient 1's clinical record indicated there were no clinical notes and updated case summaries found in the electronic medical record. b. A review of Patient 2's clinical record indicated a start of care (SOC) date of 10/22/23, with diagnosis that included diabetes mellitus (a group of diseases that results in too much sugar in the blood). During a review of Patient 2's plan of care (POC) from 10/22/23 to 12/20/23, the POC indicated an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for seven weeks, for assessment of all body system and medication compliance. The plan of care indicated the discharge planning was to discharge Patient 2 when the patient’s medical condition was stable, and the patient no longer needed skilled care. A further review of Patient 2's clinical record indicated there were no clinical notes and updated case summaries found in the electronic medical record. c. A review of Patient 3's clinical record indicated a start of care (SOC) date of 10/18/23, with diagnosis that included hypertension (a condition in which the force of the blood against the artery walls too high). During a review of Patient 3's plan of care (POC) from 10/18/23 to 12/16/23, the POC indicated an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for seven weeks, for assessment of all body system and medication compliance. The plan of care indicated the discharge planning was to discharge Patient 2 when the patient’s medical condition was stable, and the patient no longer needed skilled care. A further review of Patient 3's clinical record indicated there were no clinical notes and updated case summaries found in the electronic medical record.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home.) failed to ensure the Condition of Participation (conditions that health care organizations must meet to begin and continue participating in the Medicare [a federal health insurance for people 65 or older, and some people under 65 with certain disabilities or conditions] program) regarding clinical records was met as follows. The HHA failed to ensure clinical records reflected the care and services for seven of seven sample patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7). This deficient practice resulted in incomplete clinical records and had the potential for Patient 1, Patient 2, Patient 3, Patient 4, Patient 5,Patient 6 and Patient 7 not receiving the necessary care/services.(Refer to G1012). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated (in a way that is decided and controlled by law) compliance with the Federal Regulations for Comprehensive Assessment of Patients to ensure the provision of quality health care services.

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, home health agency (HHA) failed to ensure clinical records reflected the care and services for seven of seven sample patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7). This deficient practice resulted in incomplete clinical records and had the potential for Patient 1, Patient 2, Patient 3, Patient 4, Patient 5,Patient 6 and Patient 7 not receiving the necessary care and services. d. A review of Patient 4’s patient profile (face sheet) indicated start of care (SOC) date of 10/13/2023, with primary diagnosis of Type 2 Diabetes (a condition that happens because of a problem in the way the body regulates and uses sugar as a fuel) and long term use of oral hypoglycemics (medications taken to lower blood sugar). Skilled Nurse (SN) visit frequency of twice a week for two weeks and once a week for 7 weeks. e. A review of Patient 5's face sheet indicated an SOC date of 11/23/2024 with a medical diagnosis of Type 2 diabetes and long term use of insulin (a hormone that regulates the amount of glucose in the body) with a certification period reviewed 1/22/2024 to 3/21/2024. SN visit frequency of twice a week for two weeks and once a week for 7 weeks. f. A review of Patient 6's face sheet indicated an SOC date of 12/6/2023 with a medical diagnosis of unilateral (one side of the body) left knee osteoarthritis (inflammation of the joints) with a certification period reviewed 12/6/2023 to 2/3/2024. SN visit frequency of twice a week for two weeks and once a week for 7 weeks. Physical Therapy (PT) Evaluation and set up treatment plan. g. A review of Patient 7's face sheet indicated an SOC date of 11/30/2023 with a medical diagnosis of intervertebral disc degeneration (the wear and tear of lumbar intervertebral disc, and it is mainly occurring at the (lumbar region which comprises of 6 parts) L3-L4 and L4-S1 vertebrae- bones protecting the spinal cord) with a certification period reviewed 11/30/2023 to 1/28/2024. SN visit frequency of once a week for one week, twice a week for two weeks and once a week for six weeks. PT evaluation and set up plan of treatment During a concurrent interview and record review on 1/26/2024 at 2:25 p.m., of Patient 4, 5, 6 and 7's EMR- Electronic Medical Record (a computer system that helps healthcare providers manage patient medical records and automate clinical workflows) with the Administrator (Admin). Admin, stated that all skilled nurses documentation were missing from the EMR. Admin stated that the agency utilizes both electronic and paper charting. When asked if he has the paper nurses notes in the office, Admin stated that the nurses had not submitted their notes. When asked about how he knew in the EMR that there are no notes submitted by the nurses, Admin answered that in the column beside the visit date, there should be a note sign attached. If there is no note sign attached, there are no notes submitted by the nurse. During an interview on 1/27/2024 at 2:30 p.m., with Licensed Vocational Nurse 1 (LVN 1) stated that she uses paper for her notes. LVN 1 confirmed that she still has 7 clinical notes that was not submitted to the office. LVN 1 stated that she usually submits her notes every two weeks. LVN 1 stated moving forward she will try to send her notes electronically and submit it timely. During an interview on 1/28/2024 at 12:25 p.m., with the Director of Nursing (DON), DON stated that we have to follow up with the nurses to give their notes back to the agency or use the EMR. DON agreed that the outcome for not submitting notes in a timely manner resulted in no coordination between the staff and the agency, no updated plan of care for each patients and interdisciplinary team (IDT- a group of professionals that brings together knowledge from different health care disciplines to help people receive the care they need)/case summaries were not updated, QAPI(Quality Assurance and Performance Improvement (QAPI) is a data driven and proactive approach to quality improvement used to ensure services are meeting quality standards and assuring care reaches a certain level) will not be resolved, our doctor is not notified of the current conditions of our patients and medications and the plan of care will not be updated with the current condition of the patients. A review of the HHA's undated document titled " Initial and Comprehensive Assessment" indicated The initial assessment and comprehensive assessment must be conducted by a registered nurse unless rehabilitation therapy (physical therapy, occupational therapy or speech language pathology) is the only requested service for that patient. In those cases, the appropriate rehabilitation therapist (physical therapist, occupational therapist or speech therapist) may conduct the initial assessment and the comprehensive assessment. For Medicare patients, an occupational therapist may complete the initial assessment when occupation therapy is ordered with another qualifying rehabilitation therapy service (speech language pathology or physical therapy) that establishes program eligibility (including homebound status).The comprehensive assessment for each patient must be completed in its entirety by a single clinician. During the initial and comprehensive patient assessment, all baseline data to be used in measuring the patient's progress towards goals and other relevant information will be documented in the patient's clinical record, including at least the following information, if applicable. A review of the HHA's undated document titled "Ongoing Assessments" indicated The scope and intensity of ongoing assessments will be determined by the patient's diagnoses, condition, desire for care, response to previous care, and the care setting. During each home visit the appropriate clinician will re-evaluate the patient according to the problems identified during the initial visit and thereafter. Documentation in the clinical record should support the assessment as well as the actions taken in response. Three (3) weeks prior to the recertification date, the Clinical Supervisor or designee will alert the clinical personnel regarding the need for a review and update of the plan of care and possible recertification. a. A review of Patient 1's clinical record indicated a start of care (SOC) date of 10/4/23, with diagnosis that included osteoarthritis( occurs when flexible tissue at the ends of bones wears down). During a review of Patient 1's Plan of Care (POC) from 10/4/23 to 12/2/23, the POC indicated an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for seven weeks for assessment of all body system and medication compliance. The POC indicated the discharge planning was to discharge Patient 1 when medical condition was stable and the patient no longer needed skilled care. A further review of Patient 1's clinical record indicated there were no clinical notes and updated case summaries found in the electronic medical record. b. A review of Patient 2's clinical record indicated a start of care (SOC) date of 10/22/23, with diagnosis that included diabetes mellitus (a group of diseases that results in too much sugar in the blood). During a review of Patient 2's plan of care (POC) from 10/22/23 to 12/20/23, the POC indicated an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for seven weeks, for assessment of all body system and medication compliance. The plan of care indicated the discharge planning was to discharge Patient 2 when the patient’s medical condition was stable, and the patient no longer needed skilled care. A further review of Patient 2's clinical record indicated there were no clinical notes and updated case summaries found in the electronic medical record. c. A review of Patient 3's clinical record indicated a start of care (SOC) date of 10/18/23, with diagnosis that included hypertension (a condition in which the force of the blood against the artery walls too high). During a review of Patient 3's plan of care (POC) from 10/18/23 to 12/16/23, the POC indicated an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for seven weeks, for assessment of all body system and medication compliance. The plan of care indicated the discharge planning was to discharge Patient 2 when the patient’s medical condition was stable, and the patient no longer needed skilled care. A further review of Patient 3's clinical record indicated there were no clinical notes and updated case summaries found in the electronic medical record.