Sima Corporate Group

“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: The agency failed to ensure that the Condition of Participation: G 640 484.65 Quality assessment and performance improvement (QAPI) was in compliance as follows: 1. Based on interview and record review, the agency failed to ensure the Quality Assessment and Performance Improvement (QAPI) program resulted in measurable improvement of patient health outcomes, patient safety, and quality of care, in a universe of seven patients. (Refer to G 642) 2. Based on interview, and record review, 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, 2023, to January 10, 2024, in a universe of seven patients. (Refer to G 644) 3. 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, 2023, to January 10, 2024, in a universe of seven patients. (Refer to G 658) 4. 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, 2023, to January 10, 2024, in a universe of seven patients when: a. The agency failed to ensure the Quality Assessment and Performance Improvement (QAPI) program resulted in measurable improvement of patient health outcomes, patient safety, and quality of care. (Refer to G 660) b. 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, 2023, to January 10, 2024. (Refer to G 660) c. 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, 2023, to January 10, 2024. (Refer to G 660) The cumulative effect of these systemic practices resulted in the GB to miss opportunities to correct ineffective data collection and analysis, leading to the potential for poorer patient outcomes, increased risk of adverse events, and a negative impact on reputation due to the inability to proactively identify and address systemic problems affecting patient care quality.”

“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 ensure the Quality Assessment and Performance Improvement (QAPI) program resulted in measurable improvement of patient health outcomes, patient safety, and quality of care, in a universe of seven patients. This failure had the potential to cause poorer patient outcomes, increased risk of adverse events, and a negative impact on reputation due to the inability to proactively identify and address systemic problems affecting patient care quality. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2023, to January 10, 2024. The binder contained quarterly reports dated First Quarter (January, February, and March) 2023, Second Quarter (April, May, and June) 2023, Third Quarter (July, August, and September) 2023, Fourth Quarter (October, November, and December) 2023, and First Quarter 2024. Each of the quarterly reports indicated the same quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) and the measurement of each quality indicator indicated zero problems (accept re-hospitalization) with no need for improvement. First Quarter 2023-Quality Indicators: Patient Infections: number of occurrences—zero, need for action--none. Employee Infections: number of occurrences—zero, need for action--none. Falls: number of occurrences—zero, need for action--none. Medication Errors: number of occurrences—zero, need for action--none. Adverse Drug Reactions (a harmful, unintended result caused by taking medication): number of occurrences—zero, need for action--none. Sentinel Events (a patient safety event that results in death, permanent harm, or severe temporary harm): number of occurrences—zero, need for action--none. Patient Grievances (complaint): number of occurrences—zero, need for action--none. Abuse and Neglect: number of occurrences—zero, need for action--none. Hospitalization (when a patient is readmitted to a hospital after being discharged for the same or related care): number of occurrences—zero, need for action--none. Unusual Occurrence (an event or condition that could or has put the safety, health, or well-being of a patient in jeopardy): number of occurrences—zero, need for action--none. Other Incident Report (a document that records an unexpected event that occurs in a healthcare facility, such as an accident, error, or near miss): number of occurrences—zero, need for action--none. Second Quarter 2023-Quality Indicators: Patient Infections: number of occurrences—zero, need for action--none. Employee Infections: number of occurrences—zero, need for action--none. Falls: number of occurrences—zero, need for action--none. Medication Errors: number of occurrences—zero, need for action--none. Adverse Drug Reactions: number of occurrences—zero, need for action--none. Sentinel Events: number of occurrences—zero, need for action--none. Patient Grievances: number of occurrences—zero, need for action--none. Abuse and Neglect: number of occurrences—zero, need for action--none. Hospitalization: number of occurrences—one, there was no documented evidence to show an action had been taken. Unusual Occurrence: number of occurrences—zero, need for action--none. Other Incident Report: number of occurrences—zero, need for action--none. Third Quarter 2023-Quality Indicators: Patient Infections: number of occurrences—zero, need for action--none. Employee Infections: number of occurrences—zero, need for action--none. Falls: number of occurrences—zero, need for action--none. Medication Errors: number of occurrences—zero, need for action--none. Adverse Drug Reactions: number of occurrences—zero, need for action--none. Sentinel Events: number of occurrences—zero, need for action--none. Patient Grievances: number of occurrences—zero, need for action--none. Abuse and Neglect: number of occurrences—zero, need for action--none. Hospitalization: number of occurrences—one, there was no documented evidence to show an action had been taken. Unusual Occurrence: number of occurrences—zero, need for action--none. Other Incident Report: number of occurrences—zero, need for action--none. Fourth Quarter 2023-Quality Indicators: Patient Infections: number of occurrences—zero, need for action--none. Employee Infections: number of occurrences—zero, need for action--none. Falls: number of occurrences—zero, need for action--none. Medication Errors: number of occurrences—zero, need for action--none. Adverse Drug Reactions: number of occurrences—zero, need for action--none. Sentinel Events: number of occurrences—zero, need for action--none. Patient Grievances: number of occurrences—zero, need for action--none. Abuse and Neglect: number of occurrences—zero, need for action--none. Hospitalization: number of occurrences—zero, need for action--none. Unusual Occurrence: number of occurrences—zero, need for action--none. Other Incident Report: number of occurrences—zero, need for action--none. First Quarter 2024-Quality Indicators: Patient Infections: number of occurrences—zero, need for action--none. Employee Infections: number of occurrences—zero, need for action--none. Falls: number of occurrences—zero, need for action--none. Medication Errors: number of occurrences—zero, need for action--none. Adverse Drug Reactions: number of occurrences—zero, need for action--none. Sentinel Events: number of occurrences—zero, need for action--none. Patient Grievances: number of occurrences—zero, need for action--none. Abuse and Neglect: number of occurrences—zero, need for action--none. Hospitalization: number of occurrences—zero, need for action--none. Unusual Occurrence: number of occurrences—zero, need for action--none. Other Incident Report: number of occurrences—zero, need for action--none. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2023, to January 10, 2024. The binder contained data collection for clinical chart audits (a systematic review and evaluation of a patient’s medical records (electronic or paper) to assess the quality, accuracy, and completeness of documentation, care delivery, and whether healthcare practices align with established standards, ultimately aiming to identify areas for improvement in patient care). Each clinical chart audit looked for compliance with the same quality indicators and the measurement of compliance with each quality indicator indicated 100 percent compliance. Clinical Chart Audits, data collection completed January 10, 2023, April 10, 2023, July 10, 2023, October 9, 2023, and January 10, 2024. Quality indicator measured: Care plan is based on RN (Registered Nurse) initial assessment: 100 percent compliant—no need for action. All identified patient care issues are addressed in the plan of care: 100 percent compliant—no need for action. Clinical documentation follows the plan of care: 100 percent compliant—no need for action. Goals are individualized and have measurable time frames: 100 percent compliant—no need for action. Plan of care is signed by MD (Medical Doctor): 100 percent compliant—no need for action. Patient/PCG involved with POC (Plan of Care): 100 percent compliant—no need for action. Plan of Care includes plan for hospitalization and emergent care: 100 percent compliant—no need for action. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2023, to January 10, 2024. The binder contained QAPI Committee Meeting Minutes dated January 10, 2023, April 10, 2023, July 10, 2023, October 9, 2023, and January 10, 2024. There was no documented evidence to show the committee discussed or considered adding to or changing the quality indicators in order to identify areas to improve patient health outcomes, patient safety, or quality of care. During a concurrent record review and interview, on November 21, 2024, at 11:35 AM, with the Administrator/Director of Patient Care Services (Admin/DPCS) the contents of the QAPI binder were reviewed. The Admin/DPCS stated she fulfilled the role of QAPI Coordinator and was responsible for the QAPI Program. The Admin/DPCS stated she could not show the agency had accomplished measurable improvement in patient health outcomes, patient safety, or quality of care from January 1, 2023, to January 10, 2024. The Admin/DPCS stated she had relied on the guidance from a nurse consultant and had not known the QAPI Program was ineffective. The Admin/DPCS stated she had reached out to the nurse consultant but had been unable to reach her. The Admin/DPCS stated she had failed to follow the agency’s QAPI Program requirements. A review of the agency’s policy and procedure titled “Improving Organizational Performance,” dated April 2020, indicated, “PURPOSE: To establish patient outcomes as the primary focus of the organization’s performance improvement activities. To improve organizational performance by focusing on high risk, high volume, and problem-prone areas. POLICY: Senior management as designated by the Governing Body will have the responsibility of quality management: to guide the organization’s efforts in improving organizational performance; to define expectations of the performance improvement activities; and to generate the plan and processes the organization will utilize to assess, improve and maintain quality of care and service including appropriateness and effectiveness of patient services. Performance improvement results will be utilized to address problem issues, improve the quality of care and patient safety, and will be incorporated into program planning and process design and modifications...PROCEDURE: 1. Senior management with Governing Body oversight will: A. Participate in educational activities to increase their level of understanding and ability to implement performance improvement activities. The educational activities may include seminars, consultations, periodicals, and review of available information from other organizations (benchmarking). B. Set expectations for performance improvement and manage processes to improve organization performance. C. Focus on high risk, high volume, and problem-prone areas. Consider incidence, prevalence, and severity of problems in those areas and lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. D. Adopt a structured framework for performance improvement. The problem-solving approach will stress the interrelationship of quality services provided, management activities, and sound business practices as applicable to the organization’s: 1. Mission/philosophy 2. Culture 3. Strategic objectives 4. Resources 5. Operational components/responsibilities (financial, clinical/service, and personnel) 6. Practice Standards 7. Activities related to patient care and patient safety focusing on high risk, high volume and problem prone areas 8. Clinical/service skills and competencies of personnel 9. Quality indicators 10. Data collection and analysis 11. Frequency of activities. E. Identify and set specific outcomes for measurable improvement and acceptable limits for findings. …””

“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’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, 2023, to January 10, 2024, in a universe of seven patients. This failure caused the GB to miss opportunities to correct ineffective data collection and analysis, leading to the potential for poorer patient outcomes, increased risk of adverse events, and a negative impact on reputation due to the inability to proactively identify and address systemic problems affecting patient care quality. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2023, to January 10, 2024. The binder contained quarterly reports dated First Quarter 2023, Second Quarter 2023, Third Quarter 2023, Fourth Quarter 2023, and First Quarter 2024. Each of the quarterly reports indicated the same quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) and the measurement of each quality indicator indicated zero problems (accept re-hospitalization) with no need for improvement. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2023, to January 10, 2024. The binder contained data collection for clinical chart audits (a systematic review and evaluation of a patient’s medical records (electronic or paper) to assess the quality, accuracy, and completeness of documentation, care delivery, and whether healthcare practices align with established standards, ultimately aiming to identify areas for improvement in patient care). Each clinical chart audit looked for compliance with the same quality indicators and the measurement of compliance with each quality indicator indicated 100 percent compliance. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2023, to January 10, 2024. The binder contained QAPI Committee Meeting Minutes dated January 10, 2023, April 10, 2023, July 10, 2023, October 9, 2023, and January 10, 2024. There was no documented evidence to show the committee discussed or considered adding to or changing the quality indicators in order to identify areas to improve patient health outcomes, patient safety, or quality of care. A review of the agency’s “Governing Body Minutes,” binder, undated, was conducted from January 1, 2023, to January 10, 2024. 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 a concurrent record review and interview, on November 21, 2024, at 12:21 PM, with the Administrator/Director of Patient Care Services (Admin/DPCS) the “Governing Body Minutes,” from January 1, 2023, to January 10, 2024, were reviewed. the Admin/DPCS stated she was a member of the Governing Body (GB) and the GB had not approved the frequency and detail of data collection for the QAPI program from January 1, 2023, to January 10, 2024. The Admin/DPCS stated the QAPI Committee had not provided the frequency and detail of data collection to the GB for review and approval. In addition, the GB and QAPI Committee had failed to follow the agency’s QAPI Program requirements. A review of the agency’s policy and procedure titled “Sample Quality Assessment and Performance Improvement (QAPI) Plan,” dated April 2020, indicated, “Evaluation of the QAPI Plan: A formal evaluation of all QAPI activities will occur annually. A written report will be completed by the QAPI Coordinator. After review by the directors of each department, the report will be presented to the Governing Body. The report will include a summary of all activities included as part of the QAPI Plan. The Governing Body will measure the effectiveness of the QAPI Plan based on the established objectives. The Governing Body will provide input into the identification and prioritization of future improvement activities.””

“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, 2023, to January 10, 2024, in a universe of seven 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, undated, was conducted from January 1, 2023, to January 10, 2024. There was no documented evidence to show performance improvement projects had been initiated, were in process or had been completed for the 13 months (January 1, 2023, to January 10, 2024) reviewed. During a concurrent record review and interview, on November 21, 2024, at 12:35 PM, with the Administrator/Director of Patient Care Services (Admin/DPCS) the contents of the QAPI binder were reviewed. The Admin/DPCS stated she fulfilled the role of QAPI Coordinator and was responsible for the QAPI Program. The Admin/DPCS stated a PIP had not been initiated or conducted from January 1, 2023, to January 10, 2024, because she had relied on the assistance from a nurse consultant who had not mentioned the requirement. The Admin/DPCS stated she had reached out to the nurse consultant but had been unable to reach her. The Admin/DPCS stated she had failed to follow the agency’s QAPI Program requirements. A review of the agency’s policy and procedure titled “Improving Organizational Performance,” dated April 2020, indicated, “PROCEDURE: 1. Senior management with Governing Body oversight will: … G. Ensure that the organization adheres to the CMS Conditions of Participation for Quality Assessment and Performance Improvement (QAPI) standards. H. Ensure that performance improvement projects are conducted that reflect the following standards: 1. The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the organization’s services and operations. 2. The organization must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these 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, 2023, to January 10, 2024, in a universe of seven patients when: 1. The agency failed to ensure the Quality Assessment and Performance Improvement (QAPI) program resulted in measurable improvement of patient health outcomes, patient safety, and quality of care. 2. 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, 2023, to January 10, 2024. 3. 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, 2023, to January 10, 2024. This failure caused the GB to miss opportunities to correct ineffective data collection and analysis, leading to the potential for poorer patient outcomes, increased risk of adverse events, and a negative impact on reputation due to the inability to proactively identify and address systemic problems affecting patient care quality. 1. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2023, to January 10, 2024. The binder contained quarterly reports dated First Quarter (January, February, and March) 2023, Second Quarter (April, May, and June) 2023, Third Quarter (July, August, and September) 2023, Fourth Quarter (October, November, and December) 2023, and First Quarter 2024. Each of the quarterly reports indicated the same quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) and the measurement of each quality indicator indicated zero problems (accept re-hospitalization) with no need for improvement. First Quarter 2023-Quality Indicators: Patient Infections: number of occurrences—zero, need for action--none. Employee Infections: number of occurrences—zero, need for action--none. Falls: number of occurrences—zero, need for action--none. Medication Errors: number of occurrences—zero, need for action--none. Adverse Drug Reactions (a harmful, unintended result caused by taking medication): number of occurrences—zero, need for action--none. Sentinel Events (a patient safety event that results in death, permanent harm, or severe temporary harm): number of occurrences—zero, need for action--none. Patient Grievances (complaint): number of occurrences—zero, need for action--none. Abuse and Neglect: number of occurrences—zero, need for action--none. Hospitalization (when a patient is readmitted to a hospital after being discharged for the same or related care): number of occurrences—zero, need for action--none. Unusual Occurrence (an event or condition that could or has put the safety, health, or well-being of a patient in jeopardy): number of occurrences—zero, need for action--none. Other Incident Report (a document that records an unexpected event that occurs in a healthcare facility, such as an accident, error, or near miss): number of occurrences—zero, need for action--none. Second Quarter 2023-Quality Indicators: Patient Infections: number of occurrences—zero, need for action--none. Employee Infections: number of occurrences—zero, need for action--none. Falls: number of occurrences—zero, need for action--none. Medication Errors: number of occurrences—zero, need for action--none. Adverse Drug Reactions: number of occurrences—zero, need for action--none. Sentinel Events: number of occurrences—zero, need for action--none. Patient Grievances: number of occurrences—zero, need for action--none. Abuse and Neglect: number of occurrences—zero, need for action--none. Hospitalization: number of occurrences—one, there was no documented evidence to show an action had been taken. Unusual Occurrence: number of occurrences—zero, need for action--none. Other Incident Report: number of occurrences—zero, need for action--none. Third Quarter 2023-Quality Indicators: Patient Infections: number of occurrences—zero, need for action--none. Employee Infections: number of occurrences—zero, need for action--none. Falls: number of occurrences—zero, need for action--none. Medication Errors: number of occurrences—zero, need for action--none. Adverse Drug Reactions: number of occurrences—zero, need for action--none. Sentinel Events: number of occurrences—zero, need for action--none. Patient Grievances: number of occurrences—zero, need for action--none. Abuse and Neglect: number of occurrences—zero, need for action--none. Hospitalization: number of occurrences—one, there was no documented evidence to show an action had been taken. Unusual Occurrence: number of occurrences—zero, need for action--none. Other Incident Report: number of occurrences—zero, need for action--none. Fourth Quarter 2023-Quality Indicators: Patient Infections: number of occurrences—zero, need for action--none. Employee Infections: number of occurrences—zero, need for action--none. Falls: number of occurrences—zero, need for action--none. Medication Errors: number of occurrences—zero, need for action--none. Adverse Drug Reactions: number of occurrences—zero, need for action--none. Sentinel Events: number of occurrences—zero, need for action--none. Patient Grievances: number of occurrences—zero, need for action--none. Abuse and Neglect: number of occurrences—zero, need for action--none. Hospitalization: number of occurrences—zero, need for action--none. Unusual Occurrence: number of occurrences—zero, need for action--none. Other Incident Report: number of occurrences—zero, need for action--none. First Quarter 2024-Quality Indicators: Patient Infections: number of occurrences—zero, need for action--none. Employee Infections: number of occurrences—zero, need for action--none. Falls: number of occurrences—zero, need for action--none. Medication Errors: number of occurrences—zero, need for action--none. Adverse Drug Reactions: number of occurrences—zero, need for action--none. Sentinel Events: number of occurrences—zero, need for action--none. Patient Grievances: number of occurrences—zero, need for action--none. Abuse and Neglect: number of occurrences—zero, need for action--none. Hospitalization: number of occurrences—zero, need for action--none. Unusual Occurrence: number of occurrences—zero, need for action--none. Other Incident Report: number of occurrences—zero, need for action--none. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2023, to January 10, 2024. The binder contained data collection for clinical chart audits (a systematic review and evaluation of a patient’s medical records (electronic or paper) to assess the quality, accuracy, and completeness of documentation, care delivery, and whether healthcare practices align with established standards, ultimately aiming to identify areas for improvement in patient care). Each clinical chart audit looked for compliance with the same quality indicators and the measurement of compliance with each quality indicator indicated 100 percent compliance. Clinical Chart Audits, data collection completed January 10, 2023, April 10, 2023, July 10, 2023, October 9, 2023, and January 10, 2024. Quality indicator measured: Care plan is based on RN (Registered Nurse) initial assessment: 100 percent compliant—no need for action. All identified patient care issues are addressed in the plan of care: 100 percent compliant—no need for action. Clinical documentation follows the plan of care: 100 percent compliant—no need for action. Goals are individualized and have measurable time frames: 100 percent compliant—no need for action. Plan of care is signed by MD (Medical Doctor): 100 percent compliant—no need for action. Patient/PCG involved with POC (Plan of Care): 100 percent compliant—no need for action. Plan of Care includes plan for hospitalization and emergent care: 100 percent compliant—no need for action. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2023, to January 10, 2024. The binder contained QAPI Committee Meeting Minutes dated January 10, 2023, April 10, 2023, July 10, 2023, October 9, 2023, and January 10, 2024. There was no documented evidence to show the committee discussed or considered adding to or changing the quality indicators in order to identify areas to improve patient health outcomes, patient safety, or quality of care. During a concurrent record review and interview, on November 21, 2024, at 11:35 AM, with the Administrator/Director of Patient Care Services (Admin/DPCS) the contents of the QAPI binder were reviewed. The Admin/DPCS stated she fulfilled the role of QAPI Coordinator and was responsible for the QAPI Program. The Admin/DPCS stated she could not show the agency had accomplished measurable improvement in patient health outcomes, patient safety, or quality of care from January 1, 2023, to January 10, 2024. The Admin/DPCS stated she had relied on the guidance from a nurse consultant and had not known the QAPI Program was ineffective. The Admin/DPCS stated she had reached out to the nurse consultant but had been unable to reach her. The Admin/DPCS stated she had failed to follow the agency’s QAPI Program requirements. A review of the agency’s policy and procedure titled “Improving Organizational Performance,” dated April 2020, indicated, “PURPOSE: To establish patient outcomes as the primary focus of the organization’s performance improvement activities. To improve organizational performance by focusing on high risk, high volume, and problem-prone areas. POLICY: Senior management as designated by the Governing Body will have the responsibility of quality management: to guide the organization’s efforts in improving organizational performance; to define expectations of the performance improvement activities; and to generate the plan and processes the organization will utilize to assess, improve and maintain quality of care and service including appropriateness and effectiveness of patient services. Performance improvement results will be utilized to address problem issues, improve the quality of care and patient safety, and will be incorporated into program planning and process design and modifications...PROCEDURE: 1. Senior management with Governing Body oversight will: A. Participate in educational activities to increase their level of understanding and ability to implement performance improvement activities. The educational activities may include seminars, consultations, periodicals, and review of available information from other organizations (benchmarking). B. Set expectations for performance improvement and manage processes to improve organization performance. C. Focus on high risk, high volume, and problem-prone areas. Consider incidence, prevalence, and severity of problems in those areas and lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. D. Adopt a structured framework for performance improvement. The problem-solving approach will stress the interrelationship of quality services provided, management activities, and sound business practices as applicable to the organization’s: 1. Mission/philosophy 2. Culture 3. Strategic objectives 4. Resources 5. Operational components/responsibilities (financial, clinical/service, and personnel) 6. Practice Standards 7. Activities related to patient care and patient safety focusing on high risk, high volume and problem prone areas 8. Clinical/service skills and competencies of personnel 9. Quality indicators 10. Data collection and analysis 11. Frequency of activities. E. Identify and set specific outcomes for measurable improvement and acceptable limits for findings. …” 2. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2023, to January 10, 2024. The binder contained quarterly reports dated First Quarter 2023, Second Quarter 2023, Third Quarter 2023, Fourth Quarter 2023, and First Quarter 2024. Each of the quarterly reports indicated the same quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) and the measurement of each quality indicator indicated zero problems (accept re-hospitalization) with no need for improvement. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2023, to January 10, 2024. The binder contained data collection for clinical chart audits (a systematic review and evaluation of a patient’s medical records (electronic or paper) to assess the quality, accuracy, and completeness of documentation, care delivery, and whether healthcare practices align with established standards, ultimately aiming to identify areas for improvement in patient care). Each clinical chart audit looked for compliance with the same quality indicators and the measurement of compliance with each quality indicator indicated 100 percent compliance. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2023, to January 10, 2024. The binder contained QAPI Committee Meeting Minutes dated January 10, 2023, April 10, 2023, July 10, 2023, October 9, 2023, and January 10, 2024. There was no documented evidence to show the committee discussed or considered adding to or changing the quality indicators in order to identify areas to improve patient health outcomes, patient safety, or quality of care. A review of the agency’s “Governing Body Minutes,” binder, undated, was conducted from January 1, 2023, to January 10, 2024. 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 a concurrent record review and interview, on November 21, 2024, at 12:21 PM, with the Administrator/Director of Patient Care Services (Admin/DPCS) the “Governing Body Minutes,” from January 1, 2023, to January 10, 2024, were reviewed. the Admin/DPCS stated she was a member of the Governing Body (GB) and the GB had not approved the frequency and detail of data collection for the QAPI program from January 1, 2023, to January 10, 2024. The Admin/DPCS stated the QAPI Committee had not provided the frequency and detail of data collection to the GB for review and approval. In addition, the GB and QAPI Committee had failed to follow the agency’s QAPI Program requirements. A review of the agency’s policy and procedure titled “Sample Quality Assessment and Performance Improvement (QAPI) Plan,” dated April 2020, indicated, “Evaluation of the QAPI Plan: A formal evaluation of all QAPI activities will occur annually. A written report will be completed by the QAPI Coordinator. After review by the directors of each department, the report will be presented to the Governing Body. The report will include a summary of all activities included as part of the QAPI Plan. The Governing Body will measure the effectiveness of the QAPI Plan based on the established objectives. The Governing Body will provide input into the identification and prioritization of future improvement activities.” 3. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2023, to January 10, 2024. There was no documented evidence to show performance improvement projects had been initiated, were in process or had been completed for the 13 months (January 1, 2023, to January 10, 2024) reviewed. During a concurrent record review and interview, on November 21, 2024, at 12:35 PM, with the Administrator/Director of Patient Care Services (Admin/DPCS) the contents of the QAPI binder were reviewed. The Admin/DPCS stated she fulfilled the role of QAPI Coordinator and was responsible for the QAPI Program. The Admin/DPCS stated a PIP had not been initiated or conducted from January 1, 2023, to January 10, 2024, because she had relied on the assistance from a nurse consultant who had not mentioned the requirement. The Admin/DPCS stated she had reached out to the nurse consultant but had been unable to reach her. The Admin/DPCS stated she had failed to follow the agency’s QAPI Program requirements. A review of the agency’s policy and procedure titled “Improving Organizational Performance,” dated April 2020, indicated, “PROCEDURE: 1. Senior management with Governing Body oversight will: … G. Ensure that the organization adheres to the CMS Conditions of Participation for Quality Assessment and Performance Improvement (QAPI) standards. H. Ensure that performance improvement projects are conducted that reflect the following standards: 1. The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the organization’s services and operations. 2. The organization must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. …” During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS), on November 21, 2024, at 12:35 PM, the Admin/DPCS stated she was a member of the GB and the GB had not identified the QAPI program’s failure to show measurable improvement of patient health outcomes, patient safety, and quality of care, or the GB’s failure to approve the frequency and detail of the QAPI program’s data collection, or the failure of the QAPI Committee to conduct and document performance improvement projects. The Admin/DPCS stated the GB had not provided oversight for the agency’s QAPI Program. A review of the agency’s policy and procedure titled “Improving Organizational Performance,” dated April 2020, indicated, “POLICY: … The Governing Body is responsible for ensuring that the performance improvement program is defined, implemented and maintained, and is evaluated annually.” A review of the agency’s policy and procedure titled “Sample Quality Assessment and Performance Improvement (QAPI) Plan,” dated April 2020, indicated, “Assignment of Responsibility: … The following summary of responsibilities provides a framework for the process of quality assessment and performance improvement. The Governing Body is ultimately responsible for the QAPI Plan and for ensuring: That the QAPI Plan is ongoing, implemented and maintained. That implemented QAPI activities address the appropriate priorities for the improved quality of care and patient safety. Clear expectations for patient safety are met. That all QAPI actions/changes are evaluated for effectiveness. The QAPI Plan meets regulatory requirements.””

“Information to patient CFR(s): 484.50(a)(1) Provide the patient and the patient’s legal representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to the patient: This Element is not met as evidenced by: Based on interview, and record review, the agency failed to ensure the patients’ designated health care agents were identified, contacted, informed of home health services and patients’ rights, and allowed to consent or reject home health services and treatments for two of seven sampled patients (Patients 2 and 3). This failure had the potential to cause Patients 2 and 3 to suffer violations of patients’ rights and to receive unwanted, unnecessary or harmful treatments and services. 1. A review of Patient 2’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of November 6, 2024, with a certification period of November 6, 2024, to January 4, 2025. Patient 2 had diagnoses that included bipolar disorder (a mental illness that causes extreme mood swings, shifts in energy, activity levels, and thinking). A review of Patient 2’s attending physician’s history and physical (H&P) dated October 31, 2024, the H&P indicated, “CHIEF COMPLAINT/HISTORY OF PRESENT ILLNESS: The patient is a 66-year-old Caucasian male with a past medical history of … bipolar disorder, lack of coordination, … history of … cerebral infarction [stroke], cognitive communication deficit [a communication difficulty due to problems with thinking, learning, remembering, and making decisions], … He resides at [name of board and care facility] …. His sister, [name of sister], who can be reached at [phone number of sister], visits him regularly and takes him to his medical appointments. The patient is alert and oriented to person and place but not fully oriented to time or situation. He is non-ambulatory and wheelchair-bound, requiring assistance with all activities of daily living, including bathing, feeding, and transferring. … He is frequently confused and forgetful. Due to cognitive and physical limitations, the patient is unable to provide his own medical history; information was gathered from his caregiver and medical records. … REVIEW OF SYSTEM/PHYSICAL EXAMINATION: … NEUROLOGIC: Alert and forgetful, confused. … The skilled and other medically necessary services above are required due to: … Confusion/disorientation due to bipolar, cognitive communication deficit, compromised mental status due to bipolar, cognitive communication deficit, … Homebound Assessment: … Patient is homebound and in need of skilled services due to poor ambulation and generalized weakness, and requires considerable taxing effort, confusion, or impaired mental status that restrict functional abilities outside of the home, … Care plan: … 3. DEMENTIA [a chronic condition that causes a decline in mental functioning, such as thinking, remembering, and reasoning, to the point that it interferes with daily life]/COGNITIVE DEFICIT: Frequently orient the client to reality and surroundings. Allow the client to have familiar objects around him or her; use other items, such as a clock, a calendar, and daily schedules, to assist in maintaining reality orientation. Ensure the home environment is safe and free from hazards such as sharp objects, slippery floors, and obstacles. Establish a consistent daily routine with regular mealtimes, medication schedules, and activities. Ensure the person with dementia receives a balanced diet with plenty of fluids. Monitor for signs of dehydration or malnutrition and address any issues promptly. 4. BIPOLAR DISORDER: Educate on compliance of prescribed medication, assess the client’s cognitive function, including attention, memory, and decision-making skills, provide structured solitary activities with the assistance of a nurse or aide, encourage the client to communicate openly about their feelings and concerns, and provide a nonjudgmental and supportive environment. …” Patient 2’s attending physician did not make themselves available for interview. A review of Patient 2’s “Patient Consent and Admission Service Agreement,” dated November 6, 2024, (the process in which a health care provider educates a patient about the risks, benefits, and alternatives of the suggested medical care) and “Client’s [Patient’s] Rights and Responsibilities,” dated November 6, 2024 (a document that provides patients with information on how they can reasonably expect to be treated during their home health care) was conducted. The documents indicated Patient 2’s signature. During an interview with Patient 2’s sister on November 20, 2024, at 3:02 PM, Patient 2’s sister stated she had not been contacted by the home health agency and did not know Patient 2 was receiving home health services. Patient 2’s sister stated her brother had multiple strokes and “wasn’t himself anymore.” Patient 2’s sister stated she managed her brother’s life now because “he just couldn’t,” and he should not have been asked to sign any documents. Patient 2’s sister stated the home health agency should have contacted her to discuss home health services and she would have reviewed and signed the necessary documents. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on November 20, 2024, at 3:25 PM, the Admin/DPCS verified Patient 2’s designated health care agent was not identified, contacted, informed of home health services and patients’ rights or allowed to consent or reject home health services and treatments. The Admin/DPCS verified Patient 2 had signed the “Patient Consent and Admission Service Agreement,” dated November 6, 2024, and “Client’s [Patient’s] Rights and Responsibilities,” dated November 6, 2024, and should not have. 2. A review of Patient 3’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of November 6, 2024, with a certification period of November 6, 2024, to January 4, 2025. Patient 3 had diagnoses that included bipolar disorder (a mental illness that causes extreme mood swings, shifts in energy, activity levels, and thinking), and dementia (a chronic condition that causes a decline in mental functioning, such as thinking, remembering, and reasoning, to the point that it interferes with daily life). A review of Patient 3’s attending physician’s history and physical dated October 31, 2024, the H&P indicated, “CHIEF COMPLAINT/HISTORY OF PRESENT ILLNESS: The patient is a 73-year-old African American male with a past medical history of bipolar disorder, dementia, … He is currently a resident at [name of board and care facility]. The patient’s power of attorney is his niece, [name of niece], who can be reached at [niece’s phone number]. He is alert and oriented to person and place but not fully oriented to time or situation, and he appears without any distress. Due to cognitive limitations, the patient is unable to provide his medical history; information was obtained from his caregiver and medical records. … His niece usually is the one who takes him to his medical appointments. … MENTAL STATUS: Confused … The skilled and other medically necessary services above are required due to: unable to safely leave home without maximum assistance and/or effort due to bipolar, dementia, confused, difficult and taxing effort to leave home due to bipolar, dementia, confused, confusion/disorientation due to bipolar, dementia, confused, compromised mental status due to bipolar, dementia, confused, impaired ability or unsafe to drive due to bipolar, dementia, confused. … Homebound Assessment: Patient is homebound and in need of skilled services due to poor ambulation and generalized weakness, and requires considerable taxing effort, confusion, or impaired mental status that restrict functional abilities outside of the home. … Care plan … 1. BIPOLAR DISORDER: Educate on compliance of prescribed medication, assess the client’s cognitive function, including attention, memory, and decision-making skills, provide structured solitary activities with the assistance of a nurse or aide, encourage the client to communicate openly about their feelings and concerns, and provide a nonjudgmental and supportive environment. … 5. DEMENTIA: Frequently orient the client to reality and surroundings, allow the client to have familiar objects around him or her; use other items, such as a clock, a calendar, and daily schedules, to assist in maintaining reality orientation, ensure the home environment is safe and free from hazards such as sharp objects, slippery floors, and obstacles, establish a consistent daily routine with regular mealtimes, medication schedules, and activities, ensure the person with dementia receives a balanced diet with plenty of fluids, monitor for signs of dehydration or malnutrition and address any issues promptly. …” Patient 3’s attending physician did not make themselves available for interview. A review of Patient 3’s “Patient Consent and Admission Service Agreement,” dated November 6, 2024, (the process in which a health care provider educates a patient about the risks, benefits, and alternatives of the suggested medical care) and “Client’s [Patient’s] Rights and Responsibilities,” dated November 6, 2024 (a document that provides patients with information on how they can reasonably expect to be treated during their home health care) was conducted. The documents indicated Patient 3’s signature. Patient 3’s niece was unavailable for interview. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on November 20, 2024, at 3:25 PM, the Admin/DPCS verified Patient 3’s designated health care agent was not identified, contacted, informed of home health services and patients’ rights or allowed to consent or reject home health services and treatments. The Admin/DPCS verified Patient 3 had signed the “Patient Consent and Admission Service Agreement,” dated November 6, 2024, and “Client’s [Patient’s] Rights and Responsibilities,” dated November 6, 2024, and should not have. A review of the agency’s policy and procedure (P&P) titled “Informed Consent/Refusal of Treatment,” dated April 2020, the P&P indicated, “PURPOSE: To obtain written consent for care during the admission process and to communicate the organization’s process for informing patients and family/caregivers regarding services as well as involving patients in the care/service planning process. POLICY: Upon admission and throughout the course of care/service, the patient and family/caregiver will be: 1. Given information, in an understandable language, to make informed decisions regarding the care/service being provided. 2. Encouraged to participate in the care/service planning process, including planning for transfer, referral, and discharge. 3. Allowed to refuse all or part of his/her care/service to the extent permitted by law; the expected consequences of such actions must be explained. A. Specific consent for recording, photographing, or filming care, treatment, or services will be obtained as needed. … B. … informs patients of their right to confirm the license status of their physical therapist and provides information regarding the licensing board. Patients or patient representatives are required to sign and date an acknowledgement confirming receipt of the form. Completed acknowledgements must be retained in the patient’s medical record. … 4. During the admission visit, the patient or authorized representative will sign the organization’s written consent for care/service. …” A review of the agency’s policy and procedure titled, “Patient Bill of Rights,” dated April 2020, the P&P indicated, “PURPOSE: To encourage awareness of patient rights and provide guidelines to assist patients in making decisions regarding care and for active participation in care planning. POLICY: Each patient will be an active, informed participant in his/her plan of care. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. If a state court has not adjudged a patient to lack legal capacity to make health care decisions as defined by state law, the patient may designate someone to act as his/her representative to exercise the patient’s rights. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. … 8. When the patient’s representative signs the Patient Bill of Rights form, an explanation of that relationship must be documented and kept on file in the clinical record. … 10. The family or guardian may exercise the patient’s rights when a patient is incompetent or a minor. …””

“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 three of seven sampled patients (Patients 1, 4, and 5). This failure had the potential to cause a delay in the determination of Patients 1, 4, and 5’s immediate care and support needs. 1. A review of Patient 1’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of November 10, 2024, with a certification period of November 10, 2024, to January 8, 2025. Patient 1 had diagnoses that included osteoarthritis of the knee (a type of arthritis that occurs when flexible tissue at the ends of bones wears down). A review of Patient 1’s referral order dated November 4, 2024, indicated a request for home health services. A review of Patient 1’s initial assessment dated November 10, 2024, indicated the initial assessment had been conducted on November 10, 2024. (The initial assessment had been completed six days after the physician’s referral order) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on November 19, 2024, at 12:21 PM, the Admin/DPCS stated the referral order from the referring physician was dated November 4, 2024, and the agency needed to admit Patient 1 within 48 hours which would be no later than November 6, 2024, but had not. 2. A review of Patient 4’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of November 13, 2024, with a certification period of November 13, 2024, to January 11, 2025. Patient 4 had diagnoses that included low back pain. A review of Patient 4’s referral order dated October 31, 2024, indicated a request for home health services. A review of Patient 4’s initial assessment dated November 13, 2024, indicated the initial assessment had been conducted on November 13, 2024. (The initial assessment had been completed 13 days after the physician’s referral order) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on November 21, 2024, at 9:51 AM, the Admin/DPCS stated the referral order from the referring physician was dated October 31, 2024, and the agency needed to admit Patient 4 within 48 hours which would be no later than November 2, 2024, but had not. 3. A review of Patient 5’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of October 26, 2024, with a certification period of October 26, 2024, to December 24, 2024. Patient 5 had diagnoses that included a surgical amputation (the action of surgically cutting off a limb) of the left leg below the knee. A review of Patient 5’s referral order dated October 8, 2024, indicated a request for home health services. A review of Patient 5’s initial assessment dated October 26, 2024, indicated the initial assessment had been conducted on October 26, 2024. (The initial assessment had been completed 18 days after the physician’s referral order) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on November 21, 2024, at 11 AM, the Admin/DPCS stated the referral order from the referring physician was dated October 8, 2024, and the agency needed to admit Patient 5 within 48 hours which would be no later than October 10, 2024, but had not. A review of the agency’s policy and procedure (P&P) titled “Initial and Comprehensive Assessment,” dated April 2020, the P&P indicated, “PURPOSE: To provide guidelines for the initial assessment of patients admitted to service and for completing the plan of care. POLICY: An initial patient assessment will be performed and documented in the patient’s clinical record by a registered nurse, physical therapist, or speech therapist. The initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of the patient’s return home, on the start of care date ordered by the physician (or other authorized licensed independent practitioner), or at the patient/family request with the approval of the physician (or [another] authorized licensed independent practitioner). …””

“5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care. This Element is not met as evidenced by: Based on interview and record review, the agency failed to ensure the comprehensive assessment (a detailed evaluation of a patient’s health status that includes physical, mental, and social factors) was completed within five calendar days of the Start of Care (SOC) or physician’s ordered start date for two of seven sampled patients (Patients 4 and 5) when: 1. For Patient 4, the Physical Therapy (PT) evaluation was conducted on November 20, 2024, seven days after the SOC. 2. For Patient 5, the Physical Therapy (PT) evaluation was conducted on November 4, 2024, nine days after the SOC. These failures caused Patients 4 and 5 to suffer a delay in receiving physical therapy services and potentially prolonging the patients’ recovery. 1. A review of Patient 4’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of November 13, 2024, with a certification period of November 13, 2024, to January 11, 2025. Patient 4 had diagnoses that included low back pain. A review of Patient 4’s initial assessment dated November 13, 2024, indicated the initial assessment had been conducted on November 13, 2024. A review of Patient 4’s PT evaluations was conducted. Patient 4’s PT evaluation dated November 20, 2024, indicated the PT evaluation had been conducted on November 20, 2024. During a concurrent interview and record review with the Administrator/Director of Patient Care Services (Admin/DPCS) on November 21, 2024, at 9:51 AM, Patient 4’s nursing assessments and PT evaluations were reviewed. The Admin/DPCS verified Patient 4 had received a PT evaluation on November 20, 2024, seven days after the SOC. 2. A review of Patient 5’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of October 26, 2024, with a certification period of October 26, 2024, to December 24, 2024. Patient 5 had diagnoses that included a surgical amputation (the action of surgically cutting off a limb) of the left leg below the knee. A review of Patient 5’s initial assessment dated October 26, 2024, indicated the initial assessment had been conducted on October 26, 2024. A review of Patient 5’s PT evaluations was conducted. Patient 5’s PT evaluation dated November 4, 2024, indicated the PT evaluation had been conducted on November 4, 2024. During a concurrent interview and record review with the Administrator/Director of Patient Care Services (Admin/DPCS) on November 21, 2024, at 11 AM, Patient 5’s nursing assessments and PT evaluations were reviewed. The Admin/DPCS verified Patient 5 had received a PT evaluation on November 4, 2024, nine days after the SOC. The Admin/DPCS stated the PT had informed the agency Patient 5 had not made himself available for the October 31, 2024, appointment (within the five-day window) but the agency had not informed Patient 5’s attending physician or surgeon that Patient 5’s PT evaluation was being delayed due to Patient 5’s uncooperative behavior. A review of the agency’s policy and procedure titled “Initial and Comprehensive Assessment,” dated April 2020, indicated, “PURPOSE: To provide guidelines for the initial assessment of patients admitted to service and for completing the plan of care. POLICY: … A comprehensive patient assessment will be completed within five (5) calendar days of the patient’s start of care. …””

“Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This Element is not met as evidenced by: Based on interview and record review, the agency failed to ensure a Registered Nurse (RN) provided supervision of care provided by a Licensed Vocational Nurse (LVN) for one of seven sampled patients (Patient 6). This failure had the potential to cause substandard LVN care practices to go unrecognized. A review of Patient 6’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of September 2, 2024, with a certification period of September 2, 2024, to October 31, 2024. Patient 6 had diagnoses that included spondylosis (a condition in which there is abnormal wear on the cartilage and bones of the lower back). A review of Patient 6’s care plan dated September 2, 2024, to October 31, 2024, indicated the skilled nurse (SN- a Registered Nurse-RN or a Licensed Vocational Nurse-LVN) was to make visits to Patient 6, every other week for five weeks. A review of Patient 6’s LVN visit notes indicated visits were made on September 17, 2024 and October 2, 2024. A review of Patient 6’s RN visit notes from September 2, 2024, to October 31, 2024, was conducted. There was no documented evidence to show an RN supervisory visit for the LVN had been conducted. During a concurrent interview and record review with the Administrator/ Director of Patient Care Services (Admin/DPCS) on November 18, 2024, at 3:37 PM, Patient 6’s LVN visit notes and RN visit notes for the certification period of September 2, 2024, to October 31, 2024, were reviewed. The Admin/DPCS stated the LVN had not received a supervisory visit every 30 days as indicated in the agency’s policy and procedure titled “Responsibilities/Supervision of Clinical Services,” dated April 2019. A review of the agency’s policy and procedure titled “Responsibilities/Supervision of Clinical Services,” dated April 2019, indicated, “PURPOSE: To ensure a process is in place for the selection of a qualified individual for overseeing all clinical care and services. … 7. The Clinical Director will ensure that the following supervision is maintained within the organization: … D. Licensed practical/vocational nurse: 1. LPN/LVN will be supervised by a registered nurse at least every 30 days or as directed by the State Practice Act, whichever is more frequent. …””

“Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient’s discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This Element is not met as evidenced by: Based on interview and record review, the agency failed to ensure a discharge summary (a written document that details a patient’s home health encounter, including their diagnosis, treatment received, medications, test results, and discharge instructions, essentially providing a comprehensive overview of their medical experience to their primary care provider once they discharge from home health services) was completed and sent to the primary care practitioner within five business days of the patients’ discharge for two of seven sampled patients (Patients 6 and 7). This failure caused the patients’ attending physicians to be unaware of their patient’s response to the home health services received and the need of continuing medical services of their patients at discharge. 1. A review of Patient 6’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of September 2, 2024, with a certification period of September 2, 2024, to October 31, 2024. Patient 6 had diagnoses that included spondylosis (a condition in which there is abnormal wear on the cartilage and bones of the lower back). A review of Patient 6’s discharge order, dated October 30, 2024, indicated, “Discharge patient from home health services.” A review of Patient 6’s discharge assessment dated October 30, 2024, was conducted. There was not documented evidence to show a discharge summary had been completed and sent to Patient 6’s attending physician. During an interview with the Administrator/Director of Paint Care Services (Admin/DPCS) on November 18, 2024, at 2:49 PM, the Admin/DPCS stated there was no documented evidence to show a discharge summary had been completed and sent to the attending physician. The Admin/DPCS stated the discharging Registered Nurse (RN) should have completed a discharge summary, provided discharge teaching to the patient and/or primary caregiver and sent the discharge summary to the attending physician and did not. 2. A review of Patient 7’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of July 19, 2024, with a certification period of July 19, 2024, to September 16, 2024. Patient 7 had diagnoses that included hypertension (high blood pressure). A review of Patient 7’s discharge order, dated September 13, 2024, indicated, “Discharge patient from home health services.” A review of Patient 7’s discharge summary dated September 13, 2024, was conducted. The electronic clinical charting system indicated the discharge summary was incomplete and pending, the discharge summary did not contain a signature from Patient 7’s attending physician and there was no indication the discharge summary had been sent to Patient 7’s attending physician. During an interview with the Administrator/Director of Paint Care Services (Admin/DPCS) on November 19, 2024, at 10:16 AM, the Admin/DPCS verified the electronic clinical charting system indicated the discharge summary was incomplete and pending. The Admin/DPCS stated there was no documented evidence to show a discharge summary had been completed and sent to the attending physician. The Admin/DPCS stated the discharging Registered Nurse (RN) should have completed the discharge summary and sent the discharge summary to the attending physician and did not. A review of the agency’s policy and procedure titled, “Discharge Summary,” dated April 2020, indicated, “PURPOSE: To define the requirements for documentation of discontinuation of a service and when patients are discharged from the organization. POLICY: Each patient discharged from a service and/or from the organization will have a written discharge summary completed and filed in the clinical record. PROCEDURE: 1. Each clinician who provides care will complete a discharge summary at the time his/her discipline is discharged, which may include as appropriate: A. Patient identifying information. B. Patient’s physician and phone number. C. The date of discharge, the date the physician and patient informed of discharge D. The reason for discharge. E. Diagnosis. F. The status of problems identified at admission and during the provision of care. G. The progress towards goals/desired outcomes. H. Treatment preferences. I. Medical status at discharge including continuing symptom management needs. J. The overall status of the patient. K. A summary of the care or services provided. L. Instructions given to patient or responsible party. 2. The discharge summary and other relevant clinical record documents will be completed and submitted within 72 hours of discharge from service. 3. A copy of the discharge summary and any necessary medical information will be provided to the patient’s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the organization within five (5) business days of the patient’s discharge. …””