Every finding on record at Suncrest Home Health Services Inc

The following reflects the findings of the California Department of Public Health during a recertification survey conducted May 16, 2022 through May 19, 2022 Representing the Department: Surveyors: 35183, 44841, 45013 Census: 237 Unduplicated Admissions: 1093 Home Visits with record reviews: 7 Record Reviews without home visits: 12 Sample Size: 19 The condition of participation was met.

The following reflects the findings of the California Department of Public Health during a recertification survey conducted May 16, 2022 through May 19, 2022 Representing the Department: Surveyors: 35183, 44841, 45013 Census: 237 Unduplicated Admissions: 1093 Home Visits with record reviews: 7 Record Reviews without home visits: 12 Sample Size: 19 The following condition of participation was not met: G 640 484.65 Quality assessment/performance improvement

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure a medication reconciliation was conducted at the initial and recertification visit for two of 17 sampled patients (Patients 3 and 4) when: 1. For Patient 3: one medication the patient was taking were not indicated on the Medication Profile (MP-a current list of all medications prescribed for a specific patient). 2. For Patient 4: two medications the patient was taking were not indicated on the Medication Profile (MP-a current list of all medications prescribed for a specific patient). This failure had the potential to cause ineffective drug therapy, significant side effects and noncompliance with drug therapy. Findings: A review of Patient 3’s face sheet (a document that gives a summary of patient’s information) and plan of care (a document that provides direction of type of nursing care a patient needs), undated, indicated a start of care date of February 3, 2022, with a certification period of April 4, 2022, to June 2, 2022. Patient 3 had a primary diagnosis pressure ulcer to right buttock stage 2 (when a pressure ulcer breaks the skin, causing severe pain). During a home visit on May 17, 2022, at 1:00 PM with a Certified Home Health Aid (CHHA) and in the presence of Patient 3 and Patient 3’s daughter [name of Patient 3’s daughter], an observation of Patient 3’s actual medication bottles available in the home were compared with Patient 3’s most current Medication Profile (MP). During a concurrent observation and interview on May 17, 2022, at 1:00 PM, with Patient 3’s daughter [name of Patient 3’s daughter] checked a bottle of Norvasc (=amlodipine besylate tablets are a prescription medicine to treat high blood pressure) 10 mg (milligram-a unit of measure) by mouth daily. Patient’s 3’s MP had no indication of the order for Norvasc 10 mg by mouth daily. Patient 3’s daughter [name of Patient 3’s daughter] verified Patient 3’s bottle of Norvasc 10 mg had not been recorded on the MP. Patient 3’s daughter [name of Patient 3’s daughter] stated “I picked this medication from pharmacy couple months ago, back in February this year.” During a concurrent observation and interview on May 17, 2022, at 1:10 PM, with Patient 3’s daughter [name of Patient 3’s daughter] verified medication filled date as February 6, 2022, and She stated “yes, that’s the day I picked up the medication from pharmacy.” During concurrent record review and interview on May 18, 2022, at 3:00 PM, of Patient 3’s current MP, the Admin/DPCS agreed that Patient 3’s current MP did not include Norvasc. The Admin/DPCS stated the agency process is the admitting nurse should check if medications to verify if the medications needed to be continued or discontinued with the physician and should be done at each visit if MP needs to be updated for any changes. During a concurrent record review and interview with Admin/DCPS on May 18, 2022, at 3:10 PM, of the agency’s policy and procedure (P&P) entitled “Medication Reconciliation” revised October 2017, the P&P indicated “Medications order while the patient is receiving care will be compared to the medication list/profile. The medication list/profile will be updated with each new or changed medication. The patient’s medication list in the home will also be updated.”. The Admin/DPCS stated “that’s how is supposed to be, I will educate my nurses again”. A review of Patient 4’s face sheet (a document that gives a summary of patient’s information) and plan of care (a document that provides direction of type of nursing care a patient needs), undated, indicated a start of care date of April 30, 2022 with a certification period of April 30, 2022 to June 1, 2022. Patient 4 had a primary diagnosis of encounter for surgical aftercare. During a home visit on May 17, 2022, at 2:30 PM with a Licensed Vocational Nurse (LVN 1) and in the presence of Patient 4 and Patient 4’s spouse, an observation of Patient 4’s actual medication bottles available in the home were compared with Patient 4’s most current Medication Profile (MP). During a concurrent observation and interview on May 17, 2022, at 2:30 PM, with LVN 1, LVN 1 checked a bottle of Plavix (a blood-thinning medication) 75 mg (milligram-a unit of measure) by mouth at bedtime and a bottle of Aspirin (ASA - a blood-thinning medication) 81 mg by mouth daily. Patient’s 4’s MP had no indication of the order for Plavix 75 mg by mouth at bedtime or ASA 81 mg by mouth daily. LVN 1 verified Patient 4’s bottle of Plavix 75 mg and bottle of ASA 81 mg had not been recorded on the MP. LVN 1 stated “that’s weird, I always ask them if they have any new medications or changes every visit.” During an interview on May 17, 2022, at 2:30 PM, with Patient 4, Patient 4 stated that he had on Plavix and ASA for “years” long before being admitted to home health services in April 2022. During an interview on May 18, 2022, at 10:40 AM, with Administrator/Director of Patient Care Services (Admin/DPCS), the Admin/DPCS stated that Patient 4’s current medication profile did not include Plavix and ASA. Admin/DPCS stated that the expectations of the admitting nurse/staff was to perform medication reconciliation (process of identifying the most accurate list of all medications the patient is taking) per agency policy. The Admin/DPCS stated that the admitting nurse should check if medications were old or new and to verify if the medications needed to be continued or discontinued with the physician. The Admin/DPCS further stated that the same should be done at each visit and the medication profile needs to be updated if there are any changes. During a review of the agency’s policy and procedure (P&P) entitled “Medication Profile” revised October 2017, the P&P indicated, “The admitting RN (registered nurse), PT (physical therapist), or SLP (speech language pathologist) checks all medications a patient may be taking and documents on the medication profile. The nurse or therapist will add all new/changed medications(s) to the medication profile. All prescribed medications, over-the-counter (OTC) medications and home remedies will be documented on the medication profile…The medication profile will be reviewed every home visit and updated as changes occur.” During a review of the agency’s policy and procedure (P&P) entitled “Medication Reconciliation” revised October 2017, the P&P indicated, “At time of admission, the admitting RN, PT, or SLP will create and document a complete list of medication that the patient is taking at home, including dose, strength, route, and frequency. Any discrepancies will be reconciled by an RN with the patient’s physician. Medications order while the patient is receiving care will be compared to the medication list/profile. The medication list/profile will be updated with each new or changed medication. The patient’s medication list in the home will also be updated.”

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on interview, and record review, the agency failed to ensure the one of 17 sampled patients (Patient 13’s) individualized plan of care contained all medications and treatments. This failure had the potential to cause Patient 13 to not receive the needed care and services. A review of Patient 13’s plan of care (a document that identifies the patient’s needs and care), dated November 30, 2021, indicated a start of care date of November 30, 2021, with a certification period of November 30, 2021, to January 28, 2022. There were no medications listed under item 10 on the Patient 13’s plan of care. During a review of the agency’s policy and procedure (P&P) entitled “Plan of Care – CMS #485 and Physician Orders” revised October 2017, indicated: “The individualized plan of care must include the following: All medications and treatments.” During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on May 16, 2022, at 2:50 PM, the Admin/DPCS stated Patient 13’s plan of care was incomplete for the medication section and verified that the medications were supposed to be listed on the plan of care per agency’s policy.

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 measure and analyze quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) in order to assess the agency’s processes of care, services, and operations, from January 1, 2021, to May 17, 2022, in a universe of 237 patients. (Refer to G 642) 2. Based on interview and record review, the agency failed to use quality indicator (a measurable element of the agency’s practice that can be used to assess the quality of care provided) data from OASIS (Outcome and Assessment Information Set) to monitor the quality of the agency’s services. In addition, the agency’s Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program’s data collection, from January 1, 2021, to May 17, 2022, in a universe of 237 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, 2021, to May 17, 2022 in a universe of 237 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, 2021, to May 17, 2022, in a universe of 237 patients when: a. The QAPI program failed to measure and analyze quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) from January 1, 2021, to May 17, 2022, in order to assess the agency’s processes of care, services, and operations. (Refer to G 660) b. The QAPI program failed to use quality indicator (a measurable element of the agency’s practice that can be used to assess the quality of care provided) data from January 1, 2021, to May 17, 2022, from OASIS (Outcome and Assessment Information Set) to monitor the quality of the agency’s services. In addition, the agency’s Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program’s data collection. (Refer to G 660) c. The QAPI program failed to conduct and document performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) from January 1, 2021, to May 17, 2022, the agency had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved. (Refer to G 660) The cumulative effect of these systemic practices resulted in the potential to cause problems in health outcomes, patient safety and quality of care, to go unrecognized and unaddressed. And the potential for the agency to provide inferior care and services to its patients.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to measure and analyze quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) in order to assess the agency’s processes of care, services, and operations, from January 1, 2021, to May 17, 2022, in a universe of 237 patients. This failure had the potential to cause problems in health outcomes, patient safety and quality of care, to go unrecognized and unaddressed. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2021 to 2022, was conducted from January 1, 2021, to May 17, 2022. The QAPI binder contained data collection on the following quality indicators: a. patient falls b. patient grievances c. patient infections d. patient re-hospitalizations The QAPI binder did not contain documented evidence to show the collected data had been assembled and analyzed, from January 1, 2021, to May 17, 2022. There was no documented evidence to show statistical techniques such as controls charts (a graph used to study how a process changes over time), histograms (a graphical representation that organizes a group of data points into user-specified ranges), bar graphs (a chart that plots data using rectangular bars or columns) or pareto charts (a chart that contains both bars and a line graph, where individual values are represented in descending order by bars, and the cumulative total is represented by the line) had been used to analyze the collected data. The QAPI binder did not contain documented evidence to show the agency had developed mechanisms such as thresholds (a value), setting upper and lower control limits (identifies what value is acceptable), percentages (numbers that summarize data), ratios (the relationship in quantity, amount, or size between two or more things) or performance goals in order to identify levels, patterns or trends in the agency’s provision of care from January 1, 2021, to May 17, 2022. A review of the patient fall data collected from July 2021 to March 2022 was conducted. The data indicated Patient 19 suffered the following falls: a. September 3, 2021 b. November 19, 2021 c. December 22, 2021 d. December 31, 2021 e. March 7, 2022 There was no documented evidence to show the agency had identified Patient 19’s fall pattern. There was no documented evidence to show the agency had triggered Patient 19 for further investigation to improve Patient 19’s safety. During an interview with an Office Manager (OM) and a QAPI Coordinator (QAPI Coord) on May 17, 2022, at 3 PM, the QAPI Coord stated she was hired by the agency on December 1, 2021, and was responsible for the QAPI Program from that point forward. The OM stated she had been responsible for the QAPI Program before December 1, 2021. The QAPI Coord stated the quality indicator data had not been measured or analyzed from January 1, 2021, to May 17, 2022. The QAPI Coord stated Patient 19’s fall pattern had not been identified. The OM stated the quality indicator data had not been measured or analyzed from January 1, 2021, to May 17, 2022. The OM stated Patient 19’s fall pattern had not been identified. A review of the agency’s policy and procedure titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” dated October 2017, indicated the following: Aggregation [to gather together] and Analysis: 1. The QAPI committee will compile and analyze collected data 2. Statistical techniques will be utilized, as appropriate, to compile and analyze data. Such statistical techniques include: control charts, histograms, bar graphs and pareto charts. Such techniques help to focus the Agency’s attention and resources on those processes and outcomes for which more intensive analysis will be most beneficial. … Performance Expectation: 1. For each process identified to be improved, mechanisms to identify levels, patterns or trends in that process that will trigger further evaluation of the process will be identified. Performance expectation to trigger further evaluations may include, but are not limited to: Thresholds Setting upper and lower control limits Percentages Ratios Setting performance goals for further evaluation Identification of patterns/trends. Sample size will be determined for each Quality Assessment and Performance indicator to adequately represent the indicator.”

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to use quality indicator (a measurable element of the agency’s practice that can be used to assess the quality of care provided) data from OASIS (Outcome and Assessment Information Set) to monitor the quality of the agency’s services. In addition, the agency’s Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program’s data collection, from January 1, 2021, to May 17, 2022, in a universe of 237 patients. This failure had the potential for the agency to miss statistically significant data from OASIS reports and fail to identify patient population trends. In addition, the GB may miss an opportunity to correct ineffective data collection. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2021 to 2022, was conducted from January 1, 2021, to May 17, 2022. The QAPI binder contained data collection on the following quality indicators: a. patient falls b. patient grievances c. patient infections d. patient re-hospitalizations The QAPI binder did not contain documented evidence to show a quality indicator had been chosen January 1, 2021, to May 17, 2022, for the following OASIS reports from January 1, 2021, to May 17, 2022: a. Home Health Compare (a report on home health agency performance and patient satisfaction) b. Outcome-Bases Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing. (a report on incidence rates for 12 infrequently occurring untoward events. These potentially avoidable events reflect a serious health problem or decline in health status for an individual patient that potentially could have been avoided) c. Outcome-Based Quality Improvement (OBQI) Outcome Report (statistics from the agency’s OASIS reporting for use in the agency’s QAPI program) d. Patient/Agency Characteristics Report (presents a "snapshot" of agency patient characteristics) e. Submission Statistics by Agency Report (OASIS submissions made by or on behalf of an agency during a specified period of time) f. Error Summary Report by Home Health Agency (summarizes the errors an agency encountered in OASIS submissions during a specified period of time) During an interview with an Office Manager (OM) and a QAPI Coordinator (QAPI Coord) on May 18, 2022, at 2:20 PM, the QAPI Coord stated she was hired by the agency on December 1, 2021, and was responsible for the QAPI Program from that point forward. The OM stated she had been responsible for the QAPI Program before December 1, 2021. The OM stated a quality indicator had not been chosen from the OASIS reports from January 1, 2021, to May 17, 2022, because she had been unaware of the requirement. The QAPI Coord stated a quality indicator had not been chosen from the OASIS reports from January 1, 2021, to May 17, 2022, because she had been unaware of the requirement. A review of the agency’s policy and procedure titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” dated October 2017, indicated the following: Data Collection: … 5. Sources of information from which data may be collected include (but are not limited to): Measures derived from OASIS data … Use of OASIS Data: 1. The Home Health Agency utilizes the following OASIS reports: Home Health Compare Outcome-Bases Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing Outcome-Based Quality Improvement (OBQI) Outcome Report Patient/Agency Characteristics Report Submission Statistics by Agency Report Error Summary Report by Home Health Agency 2. Quality Assessment and Performance Improvement (QAPI) activities include obtaining and systematically analyzing OASIS reports to: Collect and trend data to monitor performance Recognize statistically significant data Identify patient population trends Establish criteria for focused review Identify and reduce risk Investigate factors that contribute to potentially avoidable events Determine staff education that can promote improved outcomes Use evidence-based practices in quality assessment and performance improvement initiatives.” 2. A review of the agency's "Governing Body Minutes," binder, undated, was conducted from January 1, 2021, to May 17, 2022. There was no documented evidence to show the Governing Body (GB) approved the frequency and detail of the QAPI program’s data collection. There was no documented evidence to show the QAPI Committee had provided the detail and frequency of data collection to the GB for review and approval. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS), Office Manager (OM) and QAPI Coordinator (QAPI Coord) on May 18, 2022, at 2:40 PM, the QAPI Coord stated she had not provided the GB the frequency and detail of the QAPI program’s data collection from January 1, 2021, to May 17, 2022. The Admin/DPCS and OM stated they were members 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, 2021, to May 17, 2022. A review of the agency’s policy and procedure titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” dated October 2017, indicated, “Program Scope: …5. The frequency and detail of the data collection must be approved by the Governing Body.”

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, 2021, to May 17, 2022, in a universe of 237 patients. This failure had the potential to cause problems in health outcomes, patient safety and quality of care to go unaddressed and continue. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2021 to 2022, was conducted from January 1, 2021, to May 17, 2022. There was no documented evidence to show performance improvement projects had been initiated, were in process or had been completed for the 17 months (January 1, 2021, to May 17, 2022) reviewed. During an interview with an Office Manager (OM) and a QAPI Coordinator (QAPI Coord) on May 17, 2022, at 3:45 PM, the QAPI Coord stated she was hired by the agency on December 1, 2021, and was responsible for the QAPI Program from that point forward. The OM stated she had been responsible for the QAPI Program before December 1, 2021. The OM stated no PIPs had been initiated from January 1, 2021, through December 1, 2021. The QAPI Coord stated no PIPs had been initiated from December 1, 2021, through May 17, 2022. The QAPI Coord and the OM stated they had not followed the agency’s QAPI Plan. A review of the agency’s policy and procedure titled “Sample Quality Assessment and Performance Improvement (QAPI) Plan,” dated revised November 2021, indicated, “Objectives: …To conduct Performance Improvement Projects aimed at performance improvement and to track performance to ensure that it is sustained.” A review of the agency’s policy and procedure titled “Improving Organizational Performance,” dated revised November 2021, indicated the following: “Procedure: … 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, 2021, to May 17, 2022, in a universe of 237 patients when: 1. The QAPI program failed to measure and analyze quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) from January 1, 2021, to May 17, 2022, in order to assess the agency’s processes of care, services, and operations. 2. The QAPI program failed to use quality indicator (a measurable element of the agency’s practice that can be used to assess the quality of care provided) data from OASIS (Outcome and Assessment Information Set) to monitor the quality of the agency’s services from January 1, 2021, to May 17, 2022. In addition, the agency’s Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program’s data collection from January 1, 2021, to May 17, 2022. 3. The QAPI program failed to conduct and document performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) from January 1, 2021, to May 17, 2022, the agency had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved. This failure had the potential to cause the agency to provide inferior care and services to its patients. 1. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2021 to 2022, was conducted from January 1, 2021, to May 17, 2022. The QAPI binder contained data collection on the following quality indicators: a. patient falls b. patient grievances c. patient infections d. patient re-hospitalizations The QAPI binder did not contain documented evidence to show the collected data had been assembled and analyzed from January 1, 2021, to May 17, 2022. There was no documented evidence to show statistical techniques such as controls charts (a graph used to study how a process changes over time), histograms (a graphical representation that organizes a group of data points into user-specified ranges), bar graphs (a chart that plots data using rectangular bars or columns) or pareto charts (a chart that contains both bars and a line graph, where individual values are represented in descending order by bars, and the cumulative total is represented by the line) had been used to analyze the collected data. The QAPI binder did not contain documented evidence to show the agency had developed mechanisms such as thresholds (a value), setting upper and lower control limits (identifies what value is acceptable), percentages (numbers that summarize data), ratios (the relationship in quantity, amount, or size between two or more things) or performance goals from January 1, 2021, to May 17, 2022, in order to identify levels, patterns or trends in the agency’s provision of care. A review of the patient fall data collected from July 2021 to March 2022 was conducted. The data indicated Patient 19 suffered the following falls: a. September 3, 2021 b. November 19, 2021 c. December 22, 2021 d. December 31, 2021 e. March 7, 2022 There was no documented evidence to show the agency had identified Patient 19’s fall pattern. There was no documented evidence to show the agency had triggered Patient 19 for further investigation to improve Patient 19’s safety. During an interview with an Office Manager (OM) and a QAPI Coordinator (QAPI Coord) on May 17, 2022, at 3 PM, the QAPI Coord stated she was hired by the agency on December 1, 2021, and was responsible for the QAPI Program from that point forward. The OM stated she had been responsible for the QAPI Program before December 1, 2021. The QAPI Coord stated the quality indicator data had not been measured or analyzed from January 1, 2021, to May 17, 2022. The QAPI Coord stated Patient 19’s fall pattern had not been identified. The OM stated the quality indicator data had not been measured or analyzed from January 1, 2021, to May 17, 2022. The OM stated Patient 19’s fall pattern had not been identified. A review of the agency’s policy and procedure titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” dated October 2017, indicated the following: Aggregation [to gather together] and Analysis: 1. The QAPI committee will compile and analyze collected data 2. Statistical techniques will be utilized, as appropriate, to compile and analyze data. Such statistical techniques include: control charts, histograms, bar graphs and pareto charts. Such techniques help to focus the Agency’s attention and resources on those processes and outcomes for which more intensive analysis will be most beneficial. … Performance Expectation: 1. For each process identified to be improved, mechanisms to identify levels, patterns or trends in that process that will trigger further evaluation of the process will be identified. Performance expectation to trigger further evaluations may include, but are not limited to: Thresholds Setting upper and lower control limits Percentages Ratios Setting performance goals for further evaluation Identification of patterns/trends. Sample size will be determined for each Quality Assessment and Performance indicator to adequately represent the indicator.” 2a. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2021 to 2022, was conducted from January 1, 2021, to May 17, 2022. The QAPI binder contained data collection on the following quality indicators: a. patient falls b. patient grievances c. patient infections d. patient re-hospitalizations The QAPI binder did not contain documented evidence to show a quality indicator had been chosen from the following OASIS reports from January 1, 2021, to May 17, 2022: a. Home Health Compare (a report on home health agency performance and patient satisfaction) b. Outcome-Bases Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing. (a report on incidence rates for 12 infrequently occurring untoward events. These potentially avoidable events reflect a serious health problem or decline in health status for an individual patient that potentially could have been avoided) c. Outcome-Based Quality Improvement (OBQI) Outcome Report (statistics from the agency’s OASIS reporting for use in the agency’s QAPI program) d. Patient/Agency Characteristics Report (presents a "snapshot" of agency patient characteristics) e. Submission Statistics by Agency Report (OASIS submissions made by or on behalf of an agency during a specified period of time) f. Error Summary Report by Home Health Agency (summarizes the errors an agency encountered in OASIS submissions during a specified period of time) During an interview with an Office Manager (OM) and a QAPI Coordinator (QAPI Coord) on May 18, 2022, at 2:20 PM, the QAPI Coord stated she was hired by the agency on December 1, 2021, and was responsible for the QAPI Program from that point forward. The OM stated she had been responsible for the QAPI Program before December 1, 2021. The OM stated a quality indicator had not been chosen from the OASIS reports from January 1, 2021, to May 17, 2022, because she had been unaware of the requirement. The QAPI Coord stated a quality indicator had not been chosen from the OASIS reports from January 1, 2021, to May 17, 2022, because she had been unaware of the requirement. A review of the agency’s policy and procedure titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” dated October 2017, indicated the following: Data Collection: … 5. Sources of information from which data may be collected include (but are not limited to): Measures derived from OASIS data … Use of OASIS Data: 1. The Home Health Agency utilizes the following OASIS reports: Home Health Compare Outcome-Bases Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing Outcome-Based Quality Improvement (OBQI) Outcome Report Patient/Agency Characteristics Report Submission Statistics by Agency Report Error Summary Report by Home Health Agency 2. Quality Assessment and Performance Improvement (QAPI) activities include obtaining and systematically analyzing OASIS reports to: Collect and trend data to monitor performance Recognize statistically significant data Identify patient population trends Establish criteria for focused review Identify and reduce risk Investigate factors that contribute to potentially avoidable events Determine staff education that can promote improved outcomes Use evidence-based practices in quality assessment and performance improvement initiatives.” 2b. A review of the agency's "Governing Body Minutes," binder, undated, was conducted from January 1, 2021, to May 17, 2022. There was no documented evidence to show the Governing Body (GB) approved the frequency and detail of the QAPI program’s data collection. There was no documented evidence to show the QAPI Committee had provided the detail and frequency of data collection from January 1, 2021, to May 17, 2022, to the GB for review and approval. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS), Office Manager (OM) and QAPI Coordinator (QAPI Coord) on May 18, 2022, at 2:40 PM, the QAPI Coord stated she had not provided the GB the frequency and detail of the QAPI program’s data collection from January 1, 2021, to May 17, 2022. The Admin/DPCS and OM stated they were members 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, 2021, to May 17, 2022. A review of the agency’s policy and procedure titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” dated October 2017, indicated, “Program Scope: …5. The frequency and detail of the data collection must be approved by the Governing Body.” 3. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2021 to 2022, was conducted from January 1, 2021, to May 17, 2022. There was no documented evidence to show performance improvement projects had been initiated, were in process or had been completed for the 17 months (from January 1, 2021, to May 17, 2022) reviewed. During an interview with an Office Manager (OM) and a QAPI Coordinator (QAPI Coord) on May 17, 2022, at 3:45 PM, the QAPI Coord stated she was hired by the agency on December 1, 2021, and was responsible for the QAPI Program from that point forward. The OM stated she had been responsible for the QAPI Program before December 1, 2021. The OM stated no PIPs had been initiated from January 1, 2021, through December 1, 2021. The QAPI Coord stated no PIPs had been initiated from December 1, 2021, through May 17, 2022. The QAPI Coord and the OM stated they had not followed the agency’s QAPI Plan. A review of the agency’s policy and procedure titled “Sample Quality Assessment and Performance Improvement (QAPI) Plan,” dated revised November 2021, indicated, “Objectives: …To conduct Performance Improvement Projects aimed at performance improvement and to track performance to ensure that it is sustained.” A review of the agency’s policy and procedure titled “Improving Organizational Performance,” dated revised November 2021, indicated the following: “Procedure: … 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.” A review of the agency's "Governing Body Minutes," binder, undated, was conducted from January 1, 2021, to May 17, 2022. There was no documented evidence to show the Governing Body (GB) had received a written report from the QAPI Coordinator that included a summary of all activities included as part of the QAPI Plan. There was no documented evidence to show the QAPI Coordinator had provided the detail and frequency of data collection to the GB for review and approval. There was no documented evidence to show the GB approved the frequency and detail of the QAPI program’s data collection. The was no documented evidence to show the GB identified the QAPI committee’s failure to measure and analyze data, chose a quality indicator from OASIS reports or conduct performance improvement projects. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS), Office Manager (OM) and a QAPI Coordinator (QAPI Coord) on May 18, 2022, at 3 PM, the QAPI Coord stated she had not provided the GB a written report that included a summary of all activities included as part of the QAPI Plan or provided the detail and frequency of data collection from January 1, 2021, to May 17, 2022, to the GB for review and approval. The Admin/DPCS and OM stated they were both members of the GB. The Admin/DPCS and OM stated the GB had not identified the QAPI committee’s failure to measure and analyze data, chose a quality indicator from OASIS reports or conduct performance improvement projects from January 1, 2021, to May 17, 2022. The Admin/DPCS stated the GB had not approved the frequency and detail of the QAPI program’s data collection from January 1, 2021, to May 17, 2022. A review of the agency’s policy and procedure titled “Improving Organizational Performance,” dated revised November 2021, indicated the following: “Policy: … The Governing Body is responsible for ensuring that the performance improvement program is defined, implemented and maintained, and is evaluated annually. Procedure: 1. Senior management with Governing Body oversight will: … D. Adopt a structured framework for performance improvement. … 9. Quality indicators 10. Data collection and analysis … E. Identify and set specific outcomes for measurable improvement and acceptable limits for findings. 1. At least one important aspect related to care must be monitored through use of OASIS data. … 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. A review of the agency’s policy and procedure titled “Sample Quality Assessment and Performance Improvement (QAPI) Plan,” dated revised November 2021, indicated the following: “Assignment of Responsibility: … 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 all regulatory requirements … Responsibilities of QAPI Committee: … Under the direction of the QAPI Coordinator, the committee issues a quarterly report summarizing QAPI activities and results of actions taken. The report is submitted to the Governing Body and appropriate managers and staff.”

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on interview, and record review the agency failed to ensure COVID-19 (an infectious disease caused by the SARS-CoV-2 virus) un-vaccinated staff followed additional transmission-based precautions (precautions used to help stop the spread of germs from one person to another) as indicated in the agency’s “COVID-19 Vaccination,” policy, dated, April 25, 2022, in a universe of 237 patients. This failure had the potential to cause the spread of the COVID-19 virus to the agency’s patients. During an interview with a Physical Therapy Assistant (PTA 1) on May 17, 2022, at 11:01 AM, PTA 1 stated she had received a non-medical exemption to the COVID 19 vaccination. PTA 1 stated she wore a surgical mask when she saw the agency's patients and tested once per week. PTA 1 stated the agency told her to wear a surgical mask and test once per week when seeing their patients due to her un-vaccinated status. Record review indicated PTA 1 last saw the agency’s patient on April 28, 2022. During an interview with a Registered Physical Therapist (RPT 1) on May 18, 2022, at 9:30 AM, RPT 1 stated she was un-vaccinated and received a non-medical exemption. RPT 1 stated she sometimes wore an N 95 (a particulate-filtering facepiece respirator that filters at least 95 percent of airborne particles) mask and sometimes wore a surgical mask when seeing the agency's patients. RPT 1 stated she wore whichever mask was available to her at the time of the visit. Record review indicated RPT 1 last saw the agency’s patient on May 9, 2022. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) and the Office Manager (OM) on May 18, 2022, at 10:48 AM, the OM stated she was responsible for the staff COVID-19 vaccination program. The OM stated she emailed the information on the mandated vaccination requirements, and the form to request an exemption to all the agency staff including contracted staff. The OM stated, “I called and told them [PTA 1 and RPT 1] they need to wear an N 95 mask when seeing our patients and I told them about the weekly testing due to not being vaccinated.” The Admin/DPCS stated he did not do teaching with the contracted staff on the COVID vaccination requirements. The Admin/DPCS and OM stated un-vaccinated staff were to wear an N 95 mask when seeing their patients, not surgical masks. The Admin/DPCS and OM stated PTA 1 and RPT 1 did not follow the agency's policy and procedure as instructed in the agency's email. A review of the agency’s policy and procedure titled “COVID-19 Vaccination,” dated April 25, 2022, indicated the following: “Accommodations for Unvaccinated Staff with a Qualifying Exemption/Contingency Plan: Staff who are not yet fully vaccinated, or who have been granted an exemption or accommodation as authorized by law, or who have a temporary delay, must adhere to additional precautions. The actions or job modifications that may be implemented to support risk reduction of COVID-19 transmission include, but are not limited to: … Requiring staff who have not completed their primary vaccination series to use a NIOSH [National Institute for Occupational Safety and Health]-approved N 95 or equivalent or higher-level respirator for source control, regardless of whether they are providing direct care to or otherwise interacting with patients.”

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure registered nursing staff signed and certified accuracy for OASIS nursing assessments (Outcome and Assessment Information Set: a patient-specific, standardized assessment used in home health care to plan care, determine reimbursement, and measure quality) for five of 17 sampled patients (Patients 13, 14, 15, 16, and 17). This failure caused Patients 13, 14, 15, 16, and 17’s clinical record to contain nursing assessments that no one verified to be true and correct. Findings: 1.A review of Patient 13’s admission OASIS assessment dated November 30, 2021, indicated a blank area for the signature and date in the section that read “I have personally reviewed all of the above information and hereby, certify, affirm, and declare that the above information is complete, true, accurate, and complete.” A review of Patient 13’s discharge OASIS assessment dated December 18, 2021, indicated a blank area for the signature and date in the section that read “I have personally reviewed all of the above information and hereby, certify, affirm, and declare that the above information is complete, true, accurate, and complete.” 2.A review of Patient 14’s admission OASIS assessment dated March 15, 2022, indicated a blank area for the signature and date in the section that read “I have personally reviewed all of the above information and hereby, certify, affirm, and declare that the above information is complete, true, accurate, and complete.” A review of Patient 14’s discharge OASIS assessment dated March 31, 2022, indicated a blank area for the signature and date in the section that read “I have personally reviewed all of the above information and hereby, certify, affirm, and declare that the above information is complete, true, accurate, and complete.” During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on May 9, 2022, at 3:00 PM, the Admin/DPCS stated the admission and discharge OASIS assessments for Patient’s 13 & 14 should have been signed by the Registered Nurse (RN) and it was not. The Admin/DPCS stated the RN should have signed and dated the assessment before submitting it in the electronic clinical record and did not. The Admin/DPCS verified that it is the agency’s policy and procedure (P&P) to verify accuracy and completion of OASIS forms with signature and date. 3. A review of Patient 15’s admission OASIS assessment dated December 14, 2021, indicated a blank area for the signature and date in the section that read “I have personally reviewed all of the above information and hereby, certify, affirm, and declare that the above information is complete, true, accurate, and complete.” A review of Patient 15’s discharge OASIS assessment dated February 2, 2022, indicated a blank area for the signature and date in the section that read “I have personally reviewed all of the above information and hereby, certify, affirm, and declare that the above information is complete, true, accurate, and complete.” 4. A review of Patient 16’s admission OASIS assessment dated February 3, 2022, indicated a blank area for the signature and date in the section that read “I have personally reviewed all of the above information and hereby, certify, affirm, and declare that the above information is complete, true, accurate, and complete.” A review of Patient 16’s transfer to in patient facility OASIS assessment dated February 13, 2022, indicated a blank area for the signature and date in the section that read “I have personally reviewed all of the above information and hereby, certify, affirm, and declare that the above information is complete, true, accurate, and complete.” 5. A review of Patient 17’s admission OASIS assessment dated December 22, 2021, indicated a blank area for the signature and date in the section that read “I have personally reviewed all of the above information and hereby, certify, affirm, and declare that the above information is complete, true, accurate, and complete.” A review of Patient 17’s recertification OASIS assessment dated February 16, 2022, indicated a blank area for the signature and date in the section that read “I have personally reviewed all of the above information and hereby, certify, affirm, and declare that the above information is complete, true, accurate, and complete.” A review of Patient 17’s discharge OASIS assessment dated March 7, 2022, indicated a blank area for the signature and date in the section that read “I have personally reviewed all of the above information and hereby, certify, affirm, and declare that the above information is complete, true, accurate, and complete.” During a concurrent record review and interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on May 9, 2022, at 3:00 PM, the Admin/DPCS verify Patient 15’s admission and discharge OASIS Patient 16’s admission and transfer to inpatient OASIS Patient 17’s admission, recertification and discharge OASIS was not signed by the Registered Nurse (RN). The Admin/DPCS stated the RN should have signed and dated the assessment before submitting it in the electronic clinical record and did not. The Admin/DPCS verified that it is the agency’s P&P to verify accuracy and completion of OASIS forms with signature and date. During a review of the agency’s P&P entitled “Reporting of OASIS Information” revised October 2017, the P&P indicated: “Agency staff will ensure that the accuracy of OASIS date reflects the patient’s status at time of assessment and data collection.” During a review of the agency’s P&P entitled “Medical Record Entries and Authentication” revised October 2017, the P&P indicated: “All medical record entries will be dated and authenticated. If automated clinical record system is used, authentication includes a signature and title, or secured computer entry by a unique identifier of a primary author who has reviewed and approved the entry, in accordance with state law.”