Willow Hospice LLC

“It is required that the hospice develops and maintains an emergency preparedness (EP) plan that is reviewed and updated at least every two (2) years. This standard was not met as evidenced by document review and interview. A review of the agency’s Emergency Plan (effective 2020 - 2023) revealed that the agency did not ensure that the plan was reviewed and updated at least every two years. The Emergency Plan and Checklist and Hazard Vulnerability Analysis was dated 8/1/2020. The Continuity of Business Operations was dated 7/13/2020. The documentation for the Emergency Plan Activation for the COVID-19 Pandemic and evaluation was dated 7/13/2020. There was no documented evidence of any review or update to the Emergency Plan since 2020. During an interview and joint document review with the Administrator/Director of Nursing on 12/29/2023, it was confirmed that the only documentation in the Emergency Plan binder was from 2020. The Administrator could produce any further documentation by the end of the site visit.”

“It is required that the hospice providing care in the patient’s home conducts exercises to test the emergency preparedness plan annually. If the organization experiences a natural or man-made emergency that requires activation of the emergency plan, the organization is exempt from engaging in its next required full-scale community-based exercise or individual, facility-based functional exercise following the onset of the emergency event. This exercise may include but is not limited to a second full-scale exercise that is community-based or a facility-based functional exercise, a mock disaster drill, or a tabletop exercise or workshop that is led by a facilitator that includes a group discussion using a narrated, clinically relevant emergency scenario and a set of problem statements, directed messages, or prepared questions designed to challenge the emergency plan. This standard was not met as evidenced by document review and interview. A review of the agency’s Emergency Plan (effective 2020 - 2023) revealed that the agency did not ensure that the plan included documentation to meet the required annual testing requirements. There was documentation on 7/13/2020 of implementing and evaluating the agency’s Emergency Plan for the COVID-19 Pandemic response. No other exercises or real-life incidents were documented after 7/13/2020 to review and test the effectiveness of the agency’s plan. During an interview and joint document review on 12/29/2023 of the hospice’s Emergency Plan with the Administrator/Director of Nursing it was confirmed that the only documented implementation of the Emergency Plan was on 7/13/2020. There was no documentation of any other events or testing/drills documented. Additionally, the Administrator stated that the plan had been activated since July 2020 but could not produce the required documentation before the end of the site visit.”

“It is required that the hospice measures, analyzes, and tracks quality indicators of performance that enable the assessment of processes of care, hospice services, operations, and adverse events. This standard was not met as evidenced by document review and interview. Agency policy: Quality Assessment Performance Improvement Program (QAPI.5) dated 10/1/2021 read in part the purpose was “To develop, implement, evaluate, and maintain an effective outgoing, Hospice-wide, data-driven Quality Assessment Performance Improvement (QAPI) Program as defined in the QAPI Plan. Definition: ‘Quality Indicator’ means a specific, valid, and reliable measure of access, care outcomes, or satisfaction, or measure of a process of care... Measure, analyze, and track quality indicators, including adverse patient events, surveillance, identification, prevention, control, and investigation of infections and communicable diseases, and other aspects of performance that enable the Hospice to assess processes of care, Hospice services, and operations. Program data: Use quality indicator data, including patient care and other relevant data, in the design of the program. Use the data collected to monitor the effectiveness and safety of services and quality of care and identify opportunities and priorities for improvement... Agency policy: Designing Processes/Programs (QAPI.10) 10/1/2021 included in part that “Hospice leaders will consider the following when identifying potential new process needs: hospice strategic plan, customer survey results, patient complaints, adverse events, staff survey results, industry trends, performance indicators, hospice function/processes...” Agency Policy: Performance Improvement Process: Data Collection (QAPI.15) dated 10/1/2021 stated in part that “The Hospice will collect and measure data to monitor effectiveness and safety of services and quality of care, identify opportunities for improvement, and monitor performance of areas targeted for study and to determine effectiveness of change...The data will be collected and forwarded to the Quality Assessment Performance Improvement (QAPI) committee...”; QAPI.15- dated 4/14/2023 read in part that, “The QAPI Committee will use the following measures as appropriate for the scope of services provided by the Hospice. An analysis of a representative sample of services furnished to patients contained in both active and closed records - to include a determination that services have been performed as outlined in the individualized service plan, care plan, or Plan of Care...” Agency Policy: Performance Improvement Process: Data Aggregation and Analysis (QAPI.20) dated 10/1/2021, included in part that “The Hospice will implement a systematic process to analyze collected data on an on-going basis by a ... QAPI Committee...The collected measurement data will be reviewed for the purpose of comparing the process and outcomes over time for trend analysis, including routine data collected, comparing/benchmarking data to databases or other organizations .....All assessment, comparison, and recommendation activities will be documented...” Agency Policy: Performance Improvement Process: Improved Performance (QAPI.25) dated 10/1/2021 read in part that “...When developing improvement activities, the Hospice will consider the expected impact of the improvement, the expectation level for the improvement activity and the measures/data needed to evaluate the effectiveness of the improvement activities...The Hospice will document what PIPs are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects...Data will be collected to assess if improvement occurred as a result of the strategy for change.” A review of the agency’s QAPI documentation (effective 2020 - 2023) revealed that the agency did not ensure that the hospice included any data in the QAPI Program documentation or the QAPI Meeting/Minutes to enable the agency to measure, analyze, or track any areas of the hospice’s processes, operations, or documentation. The hospice’s QAPI documentation included the QAPI Plan outline and three QAPI Reports/Meetings; The March 2023 QAPI Report/Meeting included only “The QAPI Committee recommends the following interventions: Formulate QAPI Plan and Guidelines. Resources: CMS Guidelines and Hospice Consultant. Process Improvement Plan: review CMS Guidelines for required QAPI plan, place QAPI plan in manual/writing, present plan to the QAPI Committee, make changes as needed ...”; The July 2023 QAPI Report/Meeting consisted of “The QAPI Committee recommends the following interventions: Review and approve the QAPI Plan and Guidelines. Resources: CMS Guidelines and Hospice Consultant. Process Improvement Plan: approval of the QAPI Plan/Guidelines, establish QAPI Committee DON, RN representative, Medical Director, Chaplain, and Social Worker, and plan first meeting date to evaluate HIS data (bi-annually and PRN). The QAPI Committee is in agreement to the above plan...”; The November 2023 QAPI Report/Meeting included, “The QAPI Committee recommends the following interventions: monthly compliance with OIG (Office of the Inspector General) audits. Resources: (OIG website). Process Improvement Plan: audits required monthly on all patient care employees; the Alternate Administrator will second verify reports. Follow-up Goal: will monitor until 100% compliance is reached. The QAPI Committee is in agreement to above plan and will reconvene to review or PRN if no improvement is found in auditing. Goal: 100% compliance on audit reports monthly. The QAPI Committee is in agreement to above plan and will reconvene....” There was no documented evidence of analysis, tracking, trending, or benchmarking of data in the QAPI Program documentation. During an interview and joint document review with the Administrator/Director of Nursing on 12/29/2023, it was confirmed that the QAPI Plan and the three documented QAPI Reports/Meetings were the extent of the hospice’s QAPI documentation. There was no audit data presented or any additional documentation provided prior to the end of the site visit. A review of the agency’s QAPI documentation (effective 2020 - 2023) revealed that the agency did not ensure that the hospice included any data in the QAPI Program documentation or the QAPI Meeting/Minutes to enable the agency to measure, analyze, or track any areas of the hospice’s processes, operations, or documentation. The hospice’s QAPI documentation included the QAPI Plan outline and three QAPI Reports/Meetings in the evidence below. The March 2023 QAPI Report/Meeting included only “The QAPI Committee recommends the following interventions: Formulate QAPI Plan and Guidelines. Resources: CMS Guidelines and Hospice ConsultLink. Process Improvement Plan: review CMS Guidelines for required QAPI plan, place QAPI plan in manual/writing, present plan to the QAPI Committee, make changes as needed ...” The July 2023 QAPI Report/Meeting consisted of “The QAPI Committee recommends the following interventions: Review and approve the QAPI Plan and Guidelines. Resources: CMS Guidelines and Hospice ConsultLink. Process Improvement Plan: approval of the QAPI Plan/Guidelines, establish QAPI Committee DON, RN representative, Medical Director, Chaplain, and Social Worker, and plan first meeting date to evaluate HIS data (bi-annually and PRN). The QAPI Committee is in agreement to the above plan...” The November 2023 QAPI Report/Meeting included, “The QAPI Committee recommends the following interventions: monthly compliance with OIG (Office of the Inspector General) audits. Resources: (OIG website). Process Improvement Plan: audits required monthly on all patient care employees; the Alternate Administrator will second verify reports. Follow-up Goal: will monitor until 100% compliance is reached. The QAPI Committee is in agreement to above plan and will reconvene to review or PRN if no improvement found in auditing. Goal: 100% compliance on audit reports monthly. The QAPI Committee is in agreement to above plan and will reconvene....” No analysis, tracking, trending, or benchmarking of data was presented in the QAPI Program documentation. The first patient was admitted on 4/27/2023, six months prior to the site visit. No analysis, tracking, trending, or benchmarking of data was presented in the QAPI Program documentation.”

“It is required that the hospice uses quality indicator data, including patient care data and other relevant data, in the QAPI program. This standard was not met as evidenced by document review and interview. Agency Policy: Quality Assessment Performance Improvement Program (QAPI.5) dated 10/1/2021 included in part that the purpose of the hospice’s QAPI program was “To develop, implement, evaluate, and maintain an effective outgoing, Hospice-wide, data-driven Quality Assessment Performance Improvement (QAPI) Program as defined in the QAPI Plan. Definition: ‘Quality Indicator’ means a specific, valid, and reliable measure of access, care outcomes, or satisfaction, or measure of a process of care. ... including adverse patient events, surveillance, identification, prevention, control, and investigation of infections and communicable disease, and other aspects of performance that enable the Hospice to assess processes of care. Use quality indicator data, including patient care and other relevant data, in the design of the program. Use the data collected to monitor the effectiveness and safety of services and quality of care and identify opportunities and priorities for improvement...Performance improvement activities will track processes of care hospice services, operations, and adverse patient events, analyze their causes, and implement preventative actions and mechanisms that include feedback and learning throughout the Hospice...” A review of the agency’s QAPI documentation dated, March 2023, July 2023, and November 2023, revealed that the agency did not ensure that the hospice included any objective data quality indicator data in the QAPI documentation/QAPI Meeting Minutes. There was no documentation or reporting of any data related to clinical record audits, personnel file audits, adverse event tracking, complaint tracking, satisfaction survey data, or infection control reporting. During an interview and joint document review with the Administrator/Director of Nursing on 12/29/2023, it was confirmed that the QAPI Plan and the three documented QAPI Reports/Meetings were the extent of the hospice’s QAPI documentation. There was no audit data presented. No additional documentation was provided prior to the end of the site visit. A review of the agency’s QAPI documentation revealed that the agency did not ensure that the hospice included any objective data quality indicator data in the QAPI documentation/QAPI Meeting Minutes. The hospice’s QAPI documentation included the QAPI Plan outline and three QAPI Reports/Meetings in the evidence below. The March 2023 QAPI Report/Meeting included only “The QAPI Committee recommends the following interventions: Formulate QAPI Plan and Guidelines. Resources: CMS Guidelines and Hospice ConsultLink. Process Improvement Plan: review CMS Guidelines for required QAPI plan, place QAPI plan in manual/writing, present plan to the QAPI Committee, make changes as needed ...” The July 2023 QAPI Report/Meeting consisted of “The QAPI Committee recommends the following interventions: Review and approve the QAPI Plan and Guidelines. Resources: CMS Guidelines and Hospice ConsultLink. Process Improvement Plan: approval of the QAPI Plan/Guidelines, establish QAPI Committee DON, RN representative, Medical Director, Chaplain, and Social Worker, and plan first meeting date to evaluate HIS data (bi-annually and PRN). The QAPI Committee is in agreement to the above plan...” The November 2023 QAPI Report/Meeting included, “The QAPI Committee recommends the following interventions: monthly compliance with OIG (Office of the Inspector General) audits. Resources: (OIG website). Process Improvement Plan: audits required monthly on all patient care employees; the Alternate Administrator will second verify reports. Follow-up Goal: will monitor until 100% compliance is reached. The QAPI Committee is in agreement to above plan and will reconvene to review or PRN if no improvement found in auditing. Goal: 100% compliance on audit reports monthly. The QAPI Committee is in agreement to above plan and will reconvene....” There was no documentation or reporting of any data related to clinical record audits, personnel file audits, adverse event tracking, complaint tracking, satisfaction survey data, or infection control reporting. No data collection at all was documented or reported. The first patient was admitted on 4/27/2023, six months before the site visit.”

“It is required that licensed professionals participate in hospice-sponsored in-service training. This standard was not met as evidenced by document review, interview, and personnel record review. In 2 of 2 (100%) personnel records reviewed revealed that the agency did not ensure that both the Administrator and the Alternate Administrator completed and documented the state-mandated administrator continuing education hours for each year. Agency policy: “Agency In-Services - Addendum” (HR.65-[state]) dated 9/1/2023 stated in part that “The Hospice Administrator and Alternate Administrator must complete 12 clock hours of continuing education within each 12 months period beginning with the date of designation...Documentation of Administrator and Alternate Administrator continuing education must be on file at the hospice and contain the name of the class or workshop, the topics covered, and the hours and dates of training...” Personnel Record 1: The Administrator/Director of Nursing date of hire was 2/20/2020. A review of personnel record revealed there was no documented evidence for state-required administrator continuing education hours for the years 2021 and 2022. Personnel Record 2: The Alternate Administrator/Alternate Director of Nursing date of hire was 9/28/2020. A review of personnel record revealed there was no documented evidence for state-required administrator continuing education hours for the year 2022. During an interview and joint personnel record review with the Administrator/Director of Nursing on 12/29/2023, the Administrator stated that both the Administrator and Alternate Administrator had completed the continuing education hours, but the documentation for the Alternate Administrator for 2022 and for the Administrator 2021 and 2022 could not be located. Further, the Administrator added that the individual who was helping with the personnel files believed that the old continuing education certificates could be removed and replaced with the most current documentation. No further documentation was produced prior to the end of the site visit.”

“It is required that the hospice assesses the skills and competencies of all individuals providing care, including volunteers providing services and, as necessary, provides in-service training and education programs where required. This standard was not met as evidenced by document review, interview, and personnel record review. In 5 of 5 (100%) personnel files reviewed revealed that the agency did not ensure that yearly skills competencies were completed per policy for patient care staff. Agency policy: Staff Competency (HR.10) dated 10/1/2021 included in part that “...The Hospice will provide for competency by qualified individuals on hire and annually to assess direct care staff’s basic skill levels for all staff providing care, including paraprofessionals and professionals.” Personnel Record 1: The Administrator/Director of Nursing/RNCM, with a hire date of 2/20/2020, had an initial Registered Nurse Competency completed on hire on 9/28/2020. There was no documentation of Annual RN Competencies for 2023. Personnel Record 2: The Alternate Administrator/Alternate Director of Nursing, with a hire date of 9/28/2020, had an initial Registered Nurse Competency completed on 9/29/2020. There was no documented evidence for an annual competency for 2023. Personnel Record 3: The Medical Social Worker with the hire date of hire of 9/11/2020 had an initial Hospice Social Worker Competency completed on 9/11/2020. There was no documented evidence for an annual competency for 2023. Personnel Record 4: The Chaplain/Bereavement Coordinator, with the hire date of 9/10/2020, had an initial Chaplain/Bereavement Counselor Competency completed on 9/10/2020. There was no documented evidence for an annual competency for 2023. Personnel Record 5: The LVN with the hire date of 10/9/2020 had an Initial LVN Competency completed on 10/9/2020. There was no documented evidence for an annual competency for 2023. It was confirmed on 12/29/2023 during an interview and joint personnel record review with the Administrator/Director of Nursing that documentation of these competencies was missing from the employee personnel files. No further employee competency documentation was produced prior to the end of the site visit.”

“It is required that the hospice obtains a criminal background check on all hospice employees who have direct patient contact or access to patient records. Criminal background checks are obtained in accordance with state requirements. This standard was not met as evidenced by document review, interview, and personnel record review. In 6 of 6 (100%) personnel records reviewed revealed the agency did not ensure the appropriate Office of Inspector General (OIG) were performed upon hire and monthly thereafter nor had the agency ensured that all employees had documented Employee Misconduct Registry checks upon hire and annually thereafter as stated in agency policies and addendums. Agency policy: Background Checks – (HR.115) dated 10/1/2021 stated in part that “The Hospice will perform background checks for verification of employability, in compliance with applicable federal, state, and local laws, on staff who have direct contact with patients and/or access to patient records. Staff will not have direct contact with patients or access to records until the Hospice has obtained the results of the criminal history record information and has verified employability. Employment will be contingent on passing the criminal history check and registry searches, as appropriate. The Hospice will maintain documentation to demonstrate that the criminal history check was conducted. In addition to the initial verification of employability, the Hospice will search the NAR and the EMR registries annually to determine if an employee is listed on either registry as unemployable...”; “All hospice employees, contractors, and volunteers who have direct access to patients or access to records will have an OIG exclusion list check prior to hire and monthly thereafter. Documentation will be maintained to verify compliance with the search and reporting requirements. At minimum, documentation will include: date of the federal and state, if required database searches, first and last names and date of birth of all hospice employees and contractors subject to the search requirements, whether or not the employee/contractor appeared in the federal/state databases...” Agency policy: Background Checks – Addendum (HR.115-[state]) dated 4/14/2023 read in part that “In addition to the initial verification of employability, the Hospice will search the NAR and EMR registries annually to determine if an employee is listed on either registry as unemployable. The Hospice must not hire or continue to employ a person listed in the NAR or EMR as unemployable. The Hospice will maintain a copy of the results of the EMR and NAR search results in the individual’s personnel file…If the Hospice employs a person pending a criminal history check, the Hospice will ensure that the person has no direct contact with a patient until the Hospice obtains the person’s criminal history record information and verifies the person’s employability under HSC, Section 250.006 as stated above, in Procedure I.A.10.a. Contract 3: The agency’s contract for PT/OT/ST services did not include the required contract language that any provider providing services to the agency’s hospice patients or any contracted provider with access to the hospice’s patient clinical information was required to perform a criminal background check. Personnel Record 1: The Administrator/Director of Nursing had a date of hire of 2/20/2020. A review of the personnel record revealed that the Office of Inspector General Exclusion List (OIG) check upon hire and the monthly checks for March through December 2020 and all of 2021 and 2022 was not in the personnel record in accordance with agency policy. Only three out of twelve months were documented for 2023. The personnel record was missing the initial Employee Misconduct Registry (EMR) upon hire for 2020 and the annual 2021 and 2022 documentation. Personnel Record 2: The Alternate Administrator/Alternate Director of Nursing had a date of hire of 9/28/2020. A review of the personnel record revealed that the OIG Exclusion List check upon hire and the monthly checks for March through December 2020 and all of 2021 and 2022 was not in the personnel record in accordance with agency policy. Only three out of twelve months were documented for 2023. The personnel record was missing the initial EMR check upon hire for 2020 and the annual 2021 and 2022 documentation. Personnel Record 3: The Social Worker had a date of hire of 9/11/2020. A review of the personnel record revealed that the personnel record was missing the annual EMR check for 2021 and 2022. The OIG Exclusion List check upon hire check was missing in accordance with agency policy from the personnel record and the monthly checks for March through December 2020 and all of 2021 and 2022. Three out of twelve months were documented for 2023. Personnel Record 4: The Chaplain/Bereavement Coordinator had a date of hire of 9/10/2020. A review of the personnel record revealed that the personnel record was missing the annual EMR check for 2021 and 2022. The personnel record was missing the OIG Exclusion List check upon hire and the monthly checks for March through December 2020 and all of 2021 and 2022. Three out of twelve months were documented for 2023. Personnel Record 5: The LVN had a date of hare of 10/9/2020. A review of the personnel record revealed that the personnel record was missing the initial EMR check upon hire for 2020 and the annual 2021 and 2022 documentation. The OIG Exclusion List check upon hire was missing from the personnel record and the monthly checks for March through December 2020 and all of 2021 and 2022. Three out of twelve months were documented for 2023. Personnel Record 6: The Hospice Medical Director had a hire date of 8/29/2020. A review of the personnel record revealed that the OIG Exclusion List checks upon hire was missing from the personnel record and the monthly checks for March through December 2020 and all of 2021 and 2022. Three out of twelve months were documented for 2023. During an interview ad joint personnel record and contract review with the Administrator/Director of Nursing on 12/29/2023, the Administrator/Director of Nursing was confirmed that the hospice had not performed the monthly Office of Inspector General (OIG) exclusions check or the annual Employee Misconduct Registry documents. The December 2023 QAPI Meeting Minutes identified an issue with the monthly OIG checks, but there was minimal time to determine the effectiveness of the actions to indicate improvement or sustainability. Additionally, during a joint contract review and interview with the Administrator/Director of Nursing on 12/29/2023, it was confirmed that the contract did not contain the requirement that the PT/OT/ST providers have a criminal background check performed.”