Every finding on record at Emberton and Company Home Health, L.L.C.

The Oklahoma State Department of Health conducted an unannounced Medicare Emergency Preparedness Program survey at the agency on 01/31/24 to 01/31/24. Deficiencies were cited as a result of the Emergency Preparedness Program survey.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and 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 an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital 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. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and 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 an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop 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 an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and 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 an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and 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 an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator 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 an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and 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 an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and 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 an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and 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 an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure an emergency preparedness disaster tabletop exercises and drills were conducted for calendar years 2022 and 2023 for all patients and all current staff members. A review of the agency's disaster/emergency preparedness records showed no drill for the surveyed agency within the past two years. On 01/31/24 at 2:30 p.m., Staff A stated there was no documentation of an emergency preparedness disaster table-top exercises or drills for 2022 and 2023.

The Oklahoma State Department of Health conducted an unannounced Medicare re-certification survey at the agency on 01/31/24 to 01/31/24. An entrance conference was conducted with Staff A. The survey process was explained. Questions were answered. Staff A was identified as the contact person for administrative issues and clinical issues. Findings were discussed during an informal exit conference with Staff A. Condition level deficiencies were cited in the following areas: 484.65 Quality Assessment and Performance Improvement 484.105 Organization and Administration of Services 484.110 Clinical Records Glossary: HHA Home Health Agency PIP Performance Improvement Project Pt's Patients QAPI Quality Assurance and Performance Improvement

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure a patient centered QAPI Program for future patients and all current employees. This failed practice had the potential to place future potential patients and all current employees at risk for insufficient self-monitoring and efforts to improve care, services, and operations. See G642. Based on record review and interview, the agency failed to ensure utilization of QAPI data to improve program effectiveness, quality of patient care and overall program improvement for all future patients and current employees. This failed practice had the potential to place future patients at risk of repeated agency mishaps, ineffective management of care and poor quality of care. See G644. Based on record review and interview the agency failed to ensure conduction of patient centered QAPI Program activities for all future patients and all current employees. The failed practice had the potential to place future patients and all current employees at risk for poor quality of care due to missed opportunities by the agency to detect and correct problem areas. See G646. Based on record review and interview, the agency failed to ensure the initiation and review of a PIP through their QAPI Program for future patients and all current employees. This failed practice had the potential to place the agency, all future patients and all current employees at risk for stagnated efforts for improvement as a result of unidentified problematic clinical, administrative, infection control or personnel problems. See G658. Based on record review and interview the agency failed to ensure governing body oversite of the conduction of patient centered QAPI Program activities for future patients and all current employees. This failed practice had the potential to place all future patients and all current employees at risk for insufficient oversite of agency services, programs and operations and disregard for acceptable practices and policies and procedures. See G660 .

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 record review and interview, the agency failed to ensure evidence of a patient centered QAPI Program for future patients and current employees. This failed practice had the potential to place all future patients and current employees at risk for insufficient self-monitoring and efforts to improve care, services and operations. A review of administrative records showed no documentation of a QAPI program developed, implemented, or sustained for calendar year 2022 and 2023.On 01/31/24 at 2:50 p.m., Staff A stated: there was no QAPI program for 2022 and 2023 and he agency had no patient admissions since 2022.

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 record review and interview, the agency failed to ensure utilization of QAPI data to improve program effectiveness, quality of patient care and overall program improvement for all future patients and current employees. This failed practice had the potential to place future patients and current employees at risk of repeated agency mishaps, ineffective management of care and poor quality of care. A review of administrative records showed no data collection activities utilized in the agency's QAPI Program for calendar year of 2022 and 2023. On 01/31/24 at 2:50 p.m., Staff A stated there was no QAPI program data utilized for 2022 and 2023.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure conduction of patient centered QAPI Program activities for all future patients and current employees. The failed practice had the potential to place future patients and all current employees at risk for poor quality of care due to missed opportunities by the agency to detect and correct problem areas. A review of administrative records showed no ongoing QAPI program activities to improve the care, services, and operations of the agency for calendar years 2022 and 2023. On 01/31/24 at 2:50 p.m., Staff A stated there was no QAPI program activities developed for 2022 and 2023.

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 record review and interview, the agency failed to ensure the initiation and review of a PIP through their QAPI Program for future patients and current employees. This failed practice had the potential to place the agency, all future patients and current employees at risk for stagnated efforts for improvement as a result of unidentified problematic clinical, administrative, infection control, and personnel problems. A review of the agency's PIP project showed an in-service for documentation dated 01/15/2024. Further review showed no other initiation, review, data analysis, or status of PIPs for calendar years 2022 and 2023. On 01/31/24 at 2:55 p.m., Staff A stated there was no PIP project developed for 2022 and 2023.

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 record review and interview the agency failed to ensure governing body oversite of the conduction of patient centered QAPI Program activities for future patients and all current employees. This failed practice had the potential to place all future patients and all current employees at risk for insufficient oversite of agency services, programs and operations and disregard for acceptable practices and policies and procedures. A review of administrative records showed no governing body oversite of ongoing QAPI program activities and no quarterly QAPI meetings to improve the care, services, and operations of the agency for calendars 2022 and 2023. On 01/31/24 at 2:55 p.m., Staff A stated there was no QAPI program activities developed for 2022 and 2023 and no documentation of governing body oversite of QAPI program activities.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body oversite of a patient centered, data driven QAPI Program, and the program evaluation for calendar year 2022 and 2023 affecting all future patients and current staff. This failed practice had the potential to lead to failed agency processes and failure to identify agency and patient needs, potentially affecting the agency, its staff and all patients. (See G942) Based on record review and interview, the agency failed to ensure governing body oversite of an operating budget, capital expenditure plan, and allocation of resources activities for calendar year 2022 and 2023. The failed practice had the potential to prevent proper agency financial planning and addressing of operational needs, activities, and expenses during operation, potentially affecting the agency, its staff and all patients. (See G988) .

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body oversite of a patient centered, data driven QAPI Program, and the program evaluation for calendar year 2022 and 2023 affecting all future patients and current staff. This failed practice had the potential to lead to failed agency processes and failure to identify agency and patient needs, potentially affecting the agency, its staff and all patients. A review of governing body records showed the following: 1. Governing body minutes dated 03/08/22 showed no documentation a QAPI program, operating budget, capital expenditure plan, and allocation of resources activities or agency program evaluation. 2. Governing body minutes dated 07/21/22 showed no documentation a QAPI program, operating budget, capital expenditure plan, and allocation of resources activities or agency program evaluation. Additional requests for governing body minutes yielded no results. On 01/31/24 at 1:55 p.m., Staff A stated there were no documents which showed evidence of continuous, ongoing governing body oversite and responsibility for the agency.

Institutional planning CFR(s): 484.105(h) Standard: Institutional planning. The HHA, under the direction of the governing body, prepares an overall plan and a budget that includes an annual operating budget and capital expenditure plan. (1) Annual operating budget. There is an annual operating budget that includes all anticipated income and expenses related to items that would, under generally accepted accounting principles, be considered income and expense items. However, it is not required that there be prepared, in connection with any budget, an item by item identification of the components of each type of anticipated income or expense. (2) Capital expenditure plan. (i) There is a capital expenditure plan for at least a 3-year period, including the operating budget year. The plan includes and identifies in detail the anticipated sources of financing for, and the objectives of, each anticipated expenditure of more than $600,000 for items that would under generally accepted accounting principles, be considered capital items. In determining if a single capital expenditure exceeds $600,000, the cost of studies, surveys, designs, plans, working drawings, specifications, and other activities essential to the acquisition, improvement, modernization, expansion, or replacement of land, plant, building, and equipment are included. Expenditures directly or indirectly related to capital expenditures, such as grading, paving, broker commissions, taxes assessed during the construction period, and costs involved in demolishing or razing structures on land are also included. Transactions that are separated in time, but are components of an overall plan or patient care objective, are viewed in their entirety without regard to their timing. Other costs related to capital expenditures include title fees, permit and license fees, broker commissions, architect, legal, accounting, and appraisal fees; interest, finance, or carrying charges on bonds, notes and other costs incurred for borrowing funds. (ii) If the anticipated source of financing is, in any part, the anticipated payment from title V (Maternal and Child Health Services Block Grant) or title XVIII (Medicare) or title XIX (Medicaid) of the Social Security Act, the plan specifies the following: (A) Whether the proposed capital expenditure is required to conform, or is likely to be required to conform, to current standards, criteria, or plans developed in accordance with the Public Health Service Act or the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963. (B) Whether a capital expenditure proposal has been submitted to the designated planning agency for approval in accordance with section 1122 of the Act (42 U.S.C. 1320a-1) and implementing regulations. (C) Whether the designated planning agency has approved or disapproved the proposed capital expenditure if it was presented to that agency. (3) Preparation of plan and budget. The overall plan and budget is prepared under the direction of the governing body of the HHA by a committee consisting of representatives of the governing body, the administrative staff, and the medical staff (if any) of the HHA. (4) Annual review of plan and budget. The overall plan and budget is reviewed and updated at least annually by the committee referred to in paragraph (i)(3) of this section under the direction of the governing body of the HHA. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body oversite of an operating budget, capital expenditure plan, and allocation of resources activities for calendar year 2022 and 2023 for all future patients and agency staff. The failed practice had the potential to prevent proper agency financial planning and addressing of operational needs, activities, and expenses during operation, potentially affecting the agency, its staff and all patients. A review of governing body records showed the following: 1. Governing body minutes dated 03/08/22 showed no documentation a QAPI program, operating budget, capital expenditure plan, and allocation of resources activities or agency program evaluation. 2. Governing body minutes dated 07/21/22 showed no documentation a QAPI program, operating budget, capital expenditure plan, and allocation of resources activities or agency program evaluation. 3. Additional requests forgoverning body records yielded no results. On 01/31/24 at 1:55 p.m., Staff A stated there are no documents which showed evidence of continuous, ongoing governing body oversite and responsibility for the agency.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the retention of clinical records for (an unknown number) all previous patients. This failed practice resulted in an inability to access clinical records for an unknown number of previous clients as well as agency inability to maintain rosters of patients previously on service with the agency. (See G1026) Based on record review and interview, the agency failed to ensure the ability to retrieve patient records. This failed practice had the potential to place past clients at risk for: 1. inability to access records; 2. inability to access health care information; and 3. inability to dispute billed services. (See G1030) .

Retention of records CFR(s): 484.110(c)(1)(2) Standard: Retention of records. (1) Clinical records must be retained for 5 years after the discharge of the patient, unless state law stipulates a longer period of time. (2) The HHA's policies must provide for retention of clinical records even if it discontinues operation. When an HHA discontinues operation, it must inform the state agency where clinical records will be maintained. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the retention of clinical records for all previous patients. This failed practice resulted in an inability to access clinical records for an unknown number of previous clients as well as agency inability to maintain rosters of patients previously on service with the agency. A request for a patient roster for the past two years yielded no patient roster. A request for access to clinical records for the last two years yielded no access. On 01/31/24 at 11:32 a.m., Staff A stated: there was no patient clinical records to access because there had been no admissions since 2022 and there was no access to records for previous patients because they (the agency) no longer had an EMR with which to review those records.

Retrieval of records CFR(s): 484.110(e) Standard: Retrieval of clinical records. A patient's clinical record (whether hard copy or electronic form) must be made available to a patient, free of charge, upon request at the next home visit, or within 4 business days (whichever comes first). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the ability to retrieve patient records. This failed practice had the potential to place past clients at risk for: 1. inability to access records; 2. inability to access health care information; and 3. inability to dispute billed services. A request for a patient roster for the past two years yielded no patient roster. A request for access to clinical records for the last two years yielded no access. On 01/31/24 at 11:32 a.m., Staff A stated: there was no patient clinical records to access because there had been no admissions since 2022 and there was no access to records for previous patients because they no longer had an EMR with which to review those records.

The Oklahoma State Department of Health conducted an unannounced Medicare Emergency Preparedness Program survey at the agency on 03/23/21 to 03/24/21. Deficiencies were cited as a result of the Emergency Preparedness Program survey.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to develop and implement an agency emergency preparedness program for 81 patients and all staff members. Finding: A review of administrative records showed no documentation an emergency preparedness program was in place at the agency. On 03/23/21 at 10:00 a.m., Staff B stated the agency had a policy and procedure related to emergency preparedness but had no documentation of an emergency preparedness program was actively in place.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure development of a community-based risk assessment (All Hazards Risk Assessment) for 81 patients and all employees. Findings: A review of administrative records showed no documentation of a community-based risk assessment which addressed the agency, its patient population, or its employees. On 03/23/21 at 10:00 a.m., Staff A stated the agency had no emergency preparedness community-based risk assessment.

Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure an Emergency Preparedness Communication Plan which included required information related to all patients, staff members and resources of the agency. Findings: A review of administrative records showed no Emergency Preparedness Communication Plan. On 03/23/21 at 1:30 p.m., Staff A stated the agency did not have an Emergency Preparedness Communication Plan in place.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and 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 an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital 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. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and 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 an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop 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 an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and 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 an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and 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 an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator 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 an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and 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 an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and 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 an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and 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 an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure an emergency preparedness disaster table top exercises and drills were conducted for fiscal years 2019 and 2020 for 81 patients and all staff members. Findings: A review of administrative records related to emergency preparedness showed no agency disaster table top exercises, drills or participation in community based drills for calendar years 2019 and 2020. On 03/23/21 at 1:30 p.m., Staff A stated the agency had no documentation of emergency preparedness disaster table top exercises, drills or participation in community based drills for calendar years 2019 and 2020.

The Oklahoma State Department of Health conducted an unannounced Medicare re-certification survey at the agency on 03/23/21 through 03/24/21. An entrance conference was conducted with Staff A. The survey process was explained. Questions were answered. Staff A was identified as the contact person for administrative issues and Staff B was identified as the contact person for clinical issues. Findings were discussed during an informal exit conference with Staff A and B. Condition level deficiencies were cited in the following areas: 484.60 Care Planning, Coordination, Quality of Care 484.65 Quality Assessment/Performance Improvement 484.70 Infection Prevention and Control Glossary: HHA Home Health Agency OT Occupational Therapy PIP Performance Improvement Project POCs Plan of Care pt's Patients QAPI Quality Assurance and Performance Improvement SN Skilled Nurse ST Speech Therapy SOC Start of Care

Patient refuses services CFR(s): 484.50(d)(4) The patient refuses services, or elects to be transferred or discharged; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to: 1. educate the patient on potential health outcomes related to refusal of SN visits; and 2. notify the physician of the patient's continued refusal of SN visits for one (Patient #1) of seven patients. Findings: Patient #1 A review of a POC for 02/03/21 to 04/03/21 showed a SN visit frequency of one time a week for eight weeks. A review of visit notes showed missed SN visits on 02/13/21, 02/18/21, 02/27/21 and on 03/09/21. Documentation showed no communication or education attempts to the patient for potential health outcomes related to refusal of SN visits and no documentation to the physician of the patient's continued refusal of SN visits. On 03/23/21 at 1:00 p.m., Staff A stated there was no documentation of: 1. attempts to educate the patient of potential health outcomes related to refusal of SN visits: and 2. no physician notification of the patient's refusal of SN visits.

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 record review and interview, the agency failed to ensure a SOC assessment was conducted within 48 hours of referral for one (Patient #2) of seven patients. Findings: Patient #2 A review of the clinical record showed the agency received referral information on 02/03/21 and the SOC assessment occurred on 02/08/21. Documentation showed no patient refusal of SOC assessment, no physician notification of a delay in SOC and no change in orders. On 03/24/21 at 1:15 p.m., Staff B stated the SOC assessment should have been conducted by 02/05/21.

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 record review and interview, the agency failed to ensure medication embedded wound care supplies were included in the review of medications for potential/adverse effects, drug reactions, side effects, interactions and duplicate drug therapy for three (Pt's #5 and #7) of seven patients. Findings: Patient #5 A review of the plan of care dated 01/27/21 to 03/27/21 documented a principal diagnosis of Charcot's joint with pressure wound to right foot and ordered home health nursing to perform wound site care using Xeroform (a medication embedded dressing material with 3% Bismouth Tribromophenate) A review of the clinical record showed no documentation the Xeroform was added to the medication profile or reviewed for potential/adverse effects, drug reactions, side effects, interactions and duplicate drug therapy. Patient #7 A review of the plan of care dated 08/17/20 to 10/15/20 documented a principal diagnosis of chronic kidney disease, Stage 3-4 with a pressure wound to the right buttock and ordered home health nursing to perform wound site care using Aquacel Ag (a medication embedded dressing material.) A review of the clinical record showed no documentation the Aquacel Ag was added to the medication profile or reviewed for potential/adverse effects, drug reactions, side effects, interactions and duplicate drug therapy. On 03/24/21 at 1:40 p.m., Staff B stated the medicated dressing materials used on Pt's #5 and #7 should have been added to the medication profiles and reviewed for potential/adverse effects, drug reactions, side effects, interactions and duplicate drug therapy.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to ensure a discharge oasis assessment was completed for two (Pt's #2 and #4) of seven patients. Findings: Patient #2 A review of the clinical record showed a discharge oasis assessment dated 03/01/21 scheduled and not conducted. A communication note dated 02/23/21 documented the patient declined further services from the home health agency. Documentation showed no discharge visit completed, no communication to the physician the patient had declined further services from the home health agency and no changes in orders. Patient #4 A review of the clinical record showed occupational therapy and physical therapy discharge visits were conducted on 03/22/21. A communication note dated 03/20/21 documented the patient declined further services from the home health agency. Documentation showed no discharge oasis assessment completed, no communication to the physician the patient had declined further services from the home health agency and no changes in orders. On 03/24/21 at 1:25 p.m., Staff B stated discharge oasis assessments had not been conducted for Pt's #2 and #4.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on record review and interview the agency failed to ensure the individualized POCs included patient interventions and goals for four (Pt's #1, 2, 3 and #4) of seven patients. This failed practice had the potential to effect the health and health care outcomes of all 81 patients who required skilled care interventions and goals to improve their health status. See Tag #G574. Based on record review and interview the agency failed to ensure physician notification of: 1. refused/missed SN visits for three (#1, 2 and #5); 2. delayed OT evaluation for one (Patient #3) and; 3. report an elevated blood pressure for one (Patient #7) of seven patients. This failed practice had the potential to effect the health and health care outcomes of all 81 patients who did not receive physician ordered skilled services to improve their health status. See Tag #G578. Based on record review and interview the agency failed to notify the physician of patient refusal of care and imminent discharge from the HHA for two (Pt's #2 and #4) of seven patients. This failed practice had the potential to effect health care outcomes of all patients who were discharged from HHA services with no coordination of their care continuation needs between the HHA and the patients physicians. See Tag #G598.

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 record review and interview, the agency failed to ensure the individualized patient POCs included patient interventions and goals for four (Pt's #1, 2, 3 and #4) of seven patients. This failed practice had the potential to effect the health and health care outcomes of all 81 patients that required skilled care interventions to improve their health status. Findings: Patient #1 A review of a POC dated 02/08/21 to 04/08/21 documented a principal diagnosis of cerebral vascular accident with aphasia. Documentation showed no patient care interventions or goals. Patient #2 A review of a POC dated 02/08/21 to 04/08/21 documented a principal diagnosis of cervical disc disorder. Documentation showed no patient care interventions or goals. Patient #3 A review of a POC dated 02/09/21 to 04/09/21 documented a principal diagnosis of arthropathy right knee. Documentation showed no patient care interventions or goals. Patient #4 A review of a POC dated 02/24/21 to 04/24/21 documented a principal diagnosis of pneumothorax. Documentation showed no patient care interventions or goals. On 03/24/21 at 1:25 p.m., Staff B stated the POCs for Pt's #1, 2, 3 and #4 did not document required patient care interventions or goals.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to notify the physician of: 1. refused/missed SN vists for three (Pt's #1, 2 and #5); 2. delayed OT evaluation for one (Patient #3) and; 3. report an elevated blood pressure for one (Patient #7) of seven patients. This failed practice had the potential to effect the health and health care outcomes of all 81 patients that required skilled care interventions to improve their health status. Findings: Patient #1 A review of the POC dated 02/03/21 to 04/03/21 showed a SN frequency of one time a week for eight weeks. Documentation showed SN visits were refused/missed by the patient on 02/13/21, 02/18/21, 02/27/21 and on 03/09/21. Documentation showed no attempts to reschedule the refused/missed visits, no physician notification of the refused/missed visits and no change in orders. Patient #2 A review of the POC dated 02/08/21 to 04/08/21 showed a SN frequency of one time a week for nine weeks. Documentation showed SN visits were refused/missed by the patient on 02/15/21 and 02/24/21. Documentation showed no attempts to reschedule the refused/missed visits, no physician notification of the refused/missed visits and no change in orders. Patient #3 A review of the POC dated 02/09/21 to 04/09/21 showed a order for OT evaluation week of 02/09/21 to 02/02/13/21. Documentation showed an OT evaluation was conducted on 02/18/21. Documentation showed no patient/caregiver refusal of the OT evaluation, no physician notification of delay in OT evaluation and no change in orders. Patient #5 A review of the POC dated 01/27/21 to 03/27/21 showed a SN frequency of one time a week for one week, four times a week for one week and three times a week for one week. Documentation showed a SN visit was refused/missed by the patient on 01/29/21. Documentation showed no attempts to reschedule the refused/missed visit, no physician notification of the refused/missed visit and no change in orders. Patient #7 A review of the POC 08/17/20 to 10/15/20 documented a principal diagnosis of chronic kidney disease, stage 4 and showed a physician reporting parameter of systolic blood pressure greater than 180 and a diastolic blood pressure greater than 90. A nurse's note dated 10/06/20 showed a blood pressure of 158/100. Documentation showed no physician notification of the blood pressure reading. On 03/24/21 at 1:45 p.m, Staff B stated: 1. refused/missed SN visits for Pt's #1, 2 and #5 should have been reported to the physician and documented; 2. the physician should have been notified of the delayed OT evaluation for Patient #3 and a new order should have been entered into the patient's clinical record; and 3. the nurse should have notified the physician of the elevated blood pressure reading on Pt #7 during the home visit on 10/06/20.

Discharge plans communication CFR(s): 484.60(c)(3)(ii) (ii) Any revisions related to plans for the patient's discharge must be communicated to the patient, representative, caregiver, all physicians or allowed practitioner's issuing orders for the HHA plan of care, and 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 HHA (if any). This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to notify the physician of patient refusal of care and imminent discharge from the HHA for two (Pt's #2 and #4) of seven patients. This failed practice had the potential to effect the health and health care outcomes of all 81 patients that required skilled care interventions to improve their health status. Findings: Patient #2 A review of a clinical communication note dated 02/23/21 documented the patient declined further services from the home health agency. Documentation showed no discharge visit completed, no communication to the physician the patient had declined further services from the home health agency and no changes in orders. Patient #4 A review of a clinical communication note dated 03/20/21 documented the patient declined further services from the home health agency. Documentation showed no discharge visit completed, no communication to the physician the patient had declined further services from the home health agency and no changes in orders. On 03/24/21 at Staff B stated the physician should have been notified when Pt's #2 and #4 declined further services and visits to discharge Pt's #2 and #4 from agency services should have been conducted.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview the agency failed to ensure evidence of a patient centered QAPI Program for all patients and employees. This failed practice had the potential to place 81 patients and all employees at risk for insufficient self-monitoring and efforts to improve care, services and operations. See Tag #G642. Based on record review and interview, the agency failed to ensure utilization of QAPI data to improve program effectiveness, quality of patient care and overall program improvement for all patients and employees. This failed practice had the potential to place 81 patients at risk of repeated agency mishaps, ineffective management of care and poor quality of care. See Tag #G644. Based on record review and interview the agency failed to ensure conduction of patient centered QAPI Program activities for all patients and employees. The failed practice had the potential to place 81 patients and all employees at risk for insufficient self-monitoring and efforts to improve care, services and operations. See Tag #G646. Based on record review and interview the agency failed to ensure the initiation and review of a PIP through their QAPI Program for all patients and all employees. This failed practice had the potential to place the agency, 81 patients and all employees at risk for stagnated efforts for improvement as a result of unidentified problematic clinical, administrative, infection control or personnel problems. See Tag #G658. Based on record review and interview the agency failed to ensure governing body oversite of the conduction of patient centered QAPI Program activities for all patients and all employees. This failed practice had the potential to place 81 patients and all employees at risk for insufficient governing body oversite of agency services and operations. See Tag #G660.

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 record review and interview, the agency failed to ensure evidence of a patient centered QAPI Program for 81 patients and employees. This failed practice had the potential to place 81 patients and all employees at risk for insufficient self-monitoring and efforts to improve care, services and operations. Findings: A review of administrative records showed no ongoing patient centered QAPI program and no QAPI data collected, monitored or evaluated by the agency for calendar year's 2019 or 2020. On 03/23/21 at 11:30 p.m., Staff A stated there was no documentation which showed a QAPI program for calendar year's 2019 or 2020.

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 record review and interview, the agency failed to ensure utilization of QAPI data to improve program effectiveness, quality of patient care and overall program improvement for 81 patients and all employees. This failed practice had the potential to place 81 patients at risk of repeated agency mishaps, ineffective management of care and poor quality of care. Findings: A review of administrative records showed no data collection activities utilized in an agency QAPI Program for calendar year's 2019 and 2020. On 03/24/21 at 11:30 a.m., Staff A stated: 1. They had no analysis of data collected available that showed improved quality of patient care; and 2. Program improvement data was not available.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure conduction of patient centered QAPI Program activities for 81 patients and all employees. The failed practice had the potential to place 81 patients and all employees at risk for insufficient self-monitoring and efforts to improve care, services and operations. Findings: A review of administrative records showed no ongoing QAPI program activities to improve the care, services, and operations of the agency for calendar year's 2019 and 2020. On 03/24/21 at 11:30 a.m., Staff A stated they had no agency QAPI documentation which showed QAPI program 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 record review and interview, the agency failed to ensure the initiation and review of a PIP through their QAPI Program for 81 patients and all employees. This failed practice had the potential to place the agency, 81 patients and all employees at risk for stagnated efforts for improvement as a result of unidentified problematic clinical, administrative, infection control or personnel problems. Findings: A review of QAPI records showed no initiation, review, data analysis, or status of PIPs in calendar year's 2019 and 2020. On 03/24/21 at 9:30 a.m., Staff A stated the agency had no documentation which showed PIP activities for 2019 and 2020.

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 record review and interview the agency failed to ensure governing body oversite of the conduction of patient centered QAPI Program activities for 81 patients and all employees. This failed practice had the potential to place 81 patients and all employees at risk for insufficient governing body oversite of agency services and operations. Findings: A review of administrative records showed no governing body oversite of ongoing QAPI program activities, no patient record audits and no quarterly QAPI meetings to improve the care, services, and operations of the agency for calendar years 2019 and 2020. On 03/24/21 at 11:30 a.m., Staff A stated they had no documentation which showed governing body oversite of QAPI program activities for calendar years 2019 and 2020.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on record review and interview the agency failed to ensure: 1. a comprehensive infection control program for 81 patients and all employees; and 2. compliance with infection control surveillance activities after an incident of patient exposure to COVID-19 for eight (Pt's #8, 9, 10, 11, 12, 13, 14 and #15) of eight patients. This failed practiced placed the agency at risk for missed opportunities to identify and reduce the incidence and occurrence of infection throughout the agency and effect the health and well being of all patients and employees. See Tag #G684. Based on record review and interview, the agency failed to show infection control education was: 1) included in QAPI activities; 2) showed interventions to reduce future infections; and 3) provided and/or maintained for all patients and employees. This failed practiced placed the agency at risk for missed opportunities to identify and correct substandard practices and reduced opportunities to create learning throughout the agency for all patients and employees. See Tag #G686.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure: 1. a comprehensive infection control program for 81 patients and all employees; and 2. compliance with infection control surveillance activities after an incident of patient exposure to COVID-19 for eight (Pt's #8, 9, 10, 11, 12, 13, 14 and #15) of eight patients. This failed practiced placed the agency at risk for missed opportunities to identify and reduce the incidence and occurrence of infection throughout the agency and effect the health and well being of all patients and employees. Findings: A review of administrative records showed no comprehensive infection control program for the agency. A review of an administrative incident report log dated 12/01/20 documented eight patients were exposed to COVID-19. Documentation showed no infection control program surveillance reporting and no surveillance follow up activities for Pt's #8, 9, 10, 11, 12, 13, 14 and #15. Patient #8 A review of the clinical record showed no documentation of the patient being exposed to a person with an active COVID-19 infection. Documentation showed no communication with the patient of COVID-19 infection exposure, no physician notification of patient exposure to infection, no testing and no infection surveillance follow up activities. Patient #9 A review of the clinical record showed no documentation of the patient being exposed to a person with an active COVID-19 infection. Documentation showed no communication with the patient of COVID-19 infection exposure, no physician notification of patient exposure to infection, no testing and no infection surveillance follow up activities. Patient #10 A review of the clinical record showed no documentation of the patient being exposed to a person with an active COVID-19 infection. Documentation showed no communication with the patient of COVID-19 infection exposure, no physician notification of patient exposure to infection, no testing and no infection surveillance follow up activities. Patient #11 A review of the clinical record showed no documentation of the patient being exposed to a person with an active COVID-19 infection. Documentation showed no communication with the patient of COVID-19 infection exposure, no physician notification of patient exposure to infection, no testing and no infection surveillance follow up activities. Patient #12 A review of the clinical record showed no documentation of the patient being exposed to a person with an active COVID-19 infection. Documentation showed no communication with the patient of COVID-19 infection exposure, no physician notification of patient exposure to infection, no testing and no infection surveillance follow up activities. Patient #13 A review of the clinical record showed no documentation of the patient being exposed to a person with an active COVID-19 infection. Documentation showed no communication with the patient of COVID-19 infection exposure, no physician notification of patient exposure to infection, no testing and no infection surveillance follow up activities. Patient #14 A review of the clinical record showed no documentation of the patient being exposed to a person with an active COVID-19 infection. Documentation showed no communication with the patient of COVID-19 infection exposure, no physician notification of patient exposure to infection, no testing and no infection surveillance follow up activities. Patient #15 A review of the clinical record showed no documentation of the patient being exposed to a person with an active COVID-19 infection. Documentation showed no communication with the patient of COVID-19 infection exposure, no physician notification of patient exposure to infection, no testing and no infection surveillance follow up activities. Additional infection control surveillance documentation was requested and yielded no further reports. On 03/23/21 at 12:30 p.m., Staff A stated: 1. Pt's #8,9,10,11,12,13,14 and #15 were exposed to COVID-19 after being seen by an employee who later tested positive for COVID-19 infection. 2. Pt's #8,9,10,11,12,13,14 and #15 were informed of the exposure and all of them said they would get tested through their physicians. On 03/24/21 at 1:30 p.m., Staff B stated: 1. the agency had no infection surveillance program in place; 2. no infection surveillance activities were ongoing; and 3. Pt's #8,9,10,11,12,13,14 and #15 should have had documented infection control surveillance reporting and follow up activities.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to show infection control education was: 1) included in QAPI activities; 2) showed interventions to reduce future infections; and 3) provided and/or maintained for all patients and employees. This failed practiced placed the agency at risk for missed opportunities to identify and correct substandard practices and reduced opportunities to create learning throughout the agency for all patients and employees. Findings: A review of administrative records showed no documentation of infection control program education or learning activities provided by the agency. On 03/24/21 at 1:30 p.m., Staff B stated there was no documentation of infection control program education or learning activities provided by the agency.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure governing body oversite of: operating budget and allocation of resources for calendar years 2019 and 2020 for 81 patients and all staff. Findings: A review of administrative records showed no governing body over-site of the operating budget and allocation of resources for the agency in calendar years 2019 and 2020. On 03/24/21 at 9:00a.m., Staff A stated there was no documentation which showed evidence of governing body discussion of the operating budget or resource allocation needs for the agency for calendar years 2019 and 2020.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to ensure clinical records were complete for one (Patient #1) of seven patients. Findings: Patient #1 A review of the clinical record showed incomplete documentation (blank visit note designated as not started) of ST visits conducted on 03/10/21 and 03/16/21. On 03/24/21 at 1:00 p.m., Staff B stated ST visit notes should have been completed within 24 hours of when the visits were conducted.

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to ensure documentation of wound care interventions performed by the SN for two (Patient #5 and #7) of seven patients. Findings: Patient #5 A review of the clinical record showed physician orders for SN to perform wound care every visit. Documentation showed no wound care interventions performed by the SN on visit notes dated 02/03/21, 02/04/21, 02/06/21, 02/08/21, 02/10/21, 02/18/21, 02/20/21, 03/06/21, 03/12/21 and 03/16/21 and no physician communication or coordination note entries for the SN visit dates. Patient #7 A review of the clinical record showed physician orders for SN to perform wound care every visit. Documentation showed no wound care interventions performed by the SN on visit notes dated 10/08/20 and no physician communication or coordination note entries for the SN visit date. On 03/24/21 at 1:45 p.m., Staff B stated the SN visit notes on Pt's #5 and #7 did not document wound care interventions performed by the SN during the visits.