Hilltop Healthcare, LLC

“Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure a clinical manager/RN was available during operating hours for one patient and all employees. Findings: On 07/18/25 at 8:15 a.m., an attempt was made by the surveyor to enter the agency for survey purposes. The surveyor observed the agency door was locked, there was no answer to multiple knocks on the door, and there were no agency personnel present on site. Continued observation showed no notice posted on the door or window that the agency location was temporarily closed during designated operating hours. At 8:30 a.m., the surveyor phoned the telephone number posted on the agency door. A telephone representative of the agency answered the telephone call and stated they were at the Poteau location (a separately licensed/certified home health agency, name with-held) and did not know why personnel were not answering the telephone at the agency’s location. The surveyor was placed on hold until the administrator for the agency answered the telephone call. The administrator was informed the surveyor had arrived at the location of the agency in Ada to conduct a follow up survey for the agency. The administrator of the agency stated: · She was the clinical manager/RN for the agency. · The assistant that is usually at the agency’s location was off today. · She would have someone from the Seminole agency (a separately licensed/certified home health agency, name with-held) come to the agency’s location to unlock the door, and she would fax the documentation related to the plan of correction from the 06/18/25 survey to the agency. At 8:45 a.m., the surveyor received a call from the administrator. The administrator stated no one at the Seminole agency had keys to enter the agency, she would come to the agency for survey, but it would take at least two hours to arrive from her work location in Poteau. At 11:45 a.m., the administrator of the agency arrived at the agency’s location. The administrator stated she did not have keys to open the door of the agency and requested the follow up survey be conducted in the empty foyer outside of the agency’s office door. A review of administrative records showed the plan of correction from the 06/18/25 survey had been completed. At 12:45 p.m., the administrator stated: · She was the clinical manager/RN in addition to being the administrator for the agency since April 2025. · The former clinical manager/RN left the agency in February 2024, and the agency has been looking for a replacement since that time. · The agency’s location should have personnel on-site during the designated office hours for the agency. The clinical manager/RN should be readily available for survey purposes.”

“Available during all operating hours CFR(s): 484.105(b)(3) The administrator or a pre-designated person is available during all operating hours. This Element is not met as evidenced by: Based on observation and interview, the agency failed to ensure an administrator or alternate administrator was available during all operating hours for one patient and all employees. Findings: On 07/18/25 at 8:15 a.m., an attempt was made by the surveyor to enter the agency for survey purposes. The surveyor observed the agency door was locked, there was no answer to multiple knocks on the door, and there were no agency personnel present on site. Continued observation showed there was no notice posted on the door or window that the agency location was temporarily closed during designated operating hours. At 8:30 a.m., the surveyor phoned the telephone number posted on the agency door. A telephone representative of the agency answered the telephone call and stated they were at the Poteau location (another separately licensed/certified home health agency, name with-held) and did not know why personnel were not answering the telephone at the agency’s location. The surveyor was placed on hold until the administrator for the agency answered the telephone call. The administrator was informed the surveyor had arrived at the location of the agency in Ada to conduct a follow up survey for the agency. The administrator of the agency stated the assistant that is usually at the agency’s location was off, they would have someone from the Seminole agency (A different separately licensed/certified home health agency, name with-held) come to the agency’s location to unlock the door, and they would fax the documentation related to the plan of correction from the 06/18/25 survey to the agency. At 8:45 a.m., a telephone call from the administrator was received. The administrator stated no one at the Seminole agency had keys to enter the agency and that they would come to the agency for survey, but it would take at least two hours to arrive from her work location in Poteau. At 11:45 a.m., the administrator of the agency arrived at the agency’s location. The administrator stated they did not have keys to open the door of the agency and requested the follow up survey be conducted in the empty foyer outside of the agency’s office door. A review of administrative records showed the plan of correction from the 06/18/25 survey had been completed. At 12:45 p.m., the administrator stated: · They were the administrator for the agency since April 2025. · The administrator of the agency died in December 2024. · The former alternate administrator left the agency in February 2024, and the agency has been looking for a replacement since that time. · The agency’s location should have personnel on-site during the designated office hours for the agency. · The administrator and/or an alternate administrator should be readily available for survey purposes.”

“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 interviews, the agency failed to ensure evidence of a patient centered QAPI Program in calendar years 2023 and 2024 for all patients and employees. The failed practice had the potential to place all patients and employees at risk for insufficient self-monitoring and efforts to improve care, services and operations. See tag G642. Based on record review and interviews, the agency failed to ensure utilization of QAPI quality indicator data in calendar years 2023 and 2024 for all patients and employees. The failed practice had the potential to place all 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 included self-monitoring efforts that identified and evaluated outcomes to improve care, services, and operations in calendar years 2023 and 2024 for all patients and employees. The failed practice had the potential to place all patients and employees at risk loss of opportunity to identify problems and loss of ability to correct problems that threaten the health and safety of all patients and staff. See tag #G646. Based on record review and interviews, the agency failed to ensure performance improvement projects for the agency in calendar years 2023 and 2024 included: 1. Goals 2. Collection, analysis and review of related data 3. Follow up monitoring and reporting for all patients and three employees. The failed practice had the potential to place the agency, its patients and all employees at risk for stagnated efforts for improvement because 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 conduction of a patient centered QAPI program in calendar years 2023 and 2024 for all patients and employees. The failed practice had the potential to place all patients and employees at risk for insufficient governing body oversite of agency services and operations. See Tag #G660. .”

“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 a governing body oversite of the agency: 1. Program evaluation and budget authorization for calendar year 2023. 2. Program evaluation, operating budget, and capital expenditure plan for calendar year 2024 for all patients and employees. The failed practice had the potential to impact on the care and services provided by the agency in the communities that it serves. See tag G942. Based on record review and interview, the agency failed to ensure a governing body appointment of the administrator for the agency from 02/11/24 to 04/12/25 for all patients and staff. The failed practice had the potential to effect day-to-day operational oversite responsibilities of the agency, impacting the services its patients received. See tag G946. Based on record review and interview, the agency governing body failed to ensure operational oversight of the agency by an administrator from 02/11/24 to 04/12/25 for all patients and all employees. The failed practice effected the agency’s ability to effectively operate and provide appropriate care and services to its patients and the community at large. See tag G948. Based on record review and interview, the agency failed to ensure governing body appointment of a supervising nurse for the agency for all patients and employees. The failed practice had the potential to effect the services provided by the agency and the subsequent care outcomes of its patients and to provide adequate clinical supervisory oversite of its staff. See tag G958. .”

“Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(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]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure an Emergency Preparedness Communication Plan included current employee contact information for the agency for two patients and three employees. Findings: A review of administrative records showed an Emergency Preparedness Communication Plan with former employee contact information and had no current employee contact information for the agency. On 06/18/25 at 12:50 p.m., Staff C stated the Emergency Preparedness Communication Plan was not updated to include contact information for current employees of the agency.”

“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 emergency preparedness disaster table-top exercises, drills, community drills or plan activation events were conducted from 05/15/23 to 12/31/23 and in calendar year 2024 for two patients and three employees. Findings: A review of emergency preparedness records showed no emergency preparedness disaster table-top exercises, drills, community drills or plan activation events were conducted from 05/15/23 to 12/31/23 and calendar year 2024. On 06/18/25 at 12:50 p.m., Staff A stated there were no table-top exercise, drill, community drill or plan activation event from 05/15/23 to 12/31/23 and calendar year 2024.”

“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 interviews, the agency failed to ensure evidence of a patient centered QAPI Program in calendar years 2023 and 2024 for all patients and employees. The failed practice had the potential to place all patients and employees at risk for insufficient self-monitoring and efforts to improve care, services and operations. Findings: A review of QAPI records showed no QAPI program improvement quarterly meeting activity, measurements, analysis, tracking or evaluation of data by the agency in calendar years 2023 and 2024. On 06/18/25 at 1:00 p.m., Staff C stated the agency did not meet quarterly and had no prepared quarterly reports of data during calendar years 2023 and 2024.”

“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 interviews, the agency failed to ensure utilization of QAPI quality indicator data in calendar years 2023 and 2024 for all patients and employees. The failed practice had the potential to place all patients at risk of repeated agency mishaps, ineffective management of care and poor quality of care. Findings: A review of QAPI records showed no quality indicator data collection sources were utilized in the analysis and reporting of data in the agency’s QAPI Program in calendar years 2023 and 2024. On 06/18/25 at 1:00 p.m., Staff C stated QAPI records didn’t document collection or analysis of quality indicator data sources in calendar years 2023 and 2024.”

“Program activities CFR(s): 484.65(c) (1) The HHA’s performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. 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 included self-monitoring efforts that identified and evaluated outcomes to improve care, services, and operations in calendar years 2023 and 2024 for all patients and employees. The failed practice had the potential to place all patients and employees at risk loss of opportunity to identify problems and loss of ability to correct problems that threaten the health and safety of all patients and staff. Findings: A review of QAPI records showed no patient centered QAPI Program activities that included self-monitoring efforts that identified and evaluated outcomes to improve care, services, and operations in calendar years 2023 and 2024. On 06/18/25 at 1:00 p.m., Staff C stated QAPI program records didn’t show self-monitoring activities that included identification and evaluation of outcomes for the agency in calendar years 2023 and 2024.”

“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 interviews, the agency failed to ensure performance improvement projects for the agency in calendar years 2023 and 2024 included: 1. Goals 2. Collection, analysis and review of related data 3. Follow up monitoring and reporting for all patients and three employees. The failed practice had the potential to place the agency, its patients and all employees at risk for stagnated efforts for improvement because of unidentified problematic clinical, administrative, infection control or personnel problems. Findings: A review of QAPI records showed no performance improvement project goals, collection, analysis and review of related data and follow up monitoring and reporting of the identified performance improvement project problem in calendar years 2023 and 2024. On 06/18/25 at 1:00 p.m., Staff C stated the agency didn’t show QAPI improvement project records which showed project goals, collection, analysis of the data and follow up monitoring and reporting of the identified performance improvement projects in 2023 and 2024.”

“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 conduction of a patient centered QAPI program in calendar years 2023 and 2024 for all patients and employees. The failed practice had the potential to place all patients and employees at risk for insufficient governing body oversite of agency services and operations. Findings: A review of governing body meeting minute records showed no governing body oversite in the conduction of a patient centered QAPI program for calendar year 2024. On 06/18/25 at 1:00 p.m., Staff A stated governing body meeting minute records did not show oversite in the conduction of the QAPI program for calendar year 2024.”

“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 infection control program surveillance data was included in QAPI program activities in calendar years 2023 and 2024 for all patients and employees. Findings: A review of QAPI records showed no infection control surveillance data in calendar years 2023 and 2024. On 06/18/25 at 1:00 p.m., Staff C stated infection surveillance data was not reported through the agency’s QAPI program in calendar years 2023 and 2024.”

“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 a governing body oversite of the agency and: 1. Program evaluation and budget authorization for calendar year 2023. 2. Program evaluation, operating budget, and capital expenditure plan for calendar year 2024 for all patients and employees. The failed practice had the potential to impact on the care and services provided by the agency in the communities that it serves. Findings: A review of governing body meeting showed no governing body oversite of the agency program evaluation and budget authorization for calendar year 2023 and program evaluation, operating budget, and capital expenditure plan for calendar year 2024. On 06/18/25 at 1:00 p.m., Staff C stated governing body meeting minutes didn’t document governing body oversite of the agency program evaluation and budget authorization for calendar year 2023 and program evaluation, operating budget, and capital expenditure plan for calendar year 2024.”

“Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body appointment of a supervising nurse for the agency for all patients and employees. The failed practice had the potential to effect the services provided by the agency and the subsequent care outcomes of its patients and to provide adequate clinical supervisory oversite of its staff. Findings: A review of governing body records showed no appointment of the supervising nurse for the agency from 02/11/24 to 04/12/25. On 06/18/25 at 1:00 a.m., Staff C stated: 1. The agency had no designated Director of Nursing from 02/11/24 to 04/12/25. 2. She was the Director of Nursing for the agency since 04/12/25.”

“HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator’s name, business address, and business phone number in order to receive complaints. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the administrator’s name and contact information was included in the admission packet information for two (Patients #1 and #2) of seven patients. Findings: A review of administrative records (start of care patient information packet) identified contact information for the prior administrator who left the agency on 02/11/24. On 06/18/25 at 12:20 p.m., Staff C reviewed the start of care patient information packet provided at a patient’s SOC and stated the contact information for the current administrator had not been updated.”

“HHA can no longer meet the patient’s needs CFR(s): 484.50(d)(1) The transfer or discharge is necessary for the patient’s welfare because the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the HHA can no longer meet the patient’s needs, based on the patient’s acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA’s capabilities; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure: 1. Notification to the physician the agency could no longer meet the patient’s needs prior to discharge for five (Patients #3, 4, 5, 6 and #7) of seven patients. 2. Arrange transfer of care to another care entity for five (Patients #3, 4, 5, 6 and #7) of seven patients. Findings: Patient #3 A review of administrative records showed the patient was discharged from the agency on 02/01/24 due to staffing changes in the agency (no RN/SN for the agency after 02/11/24). A review of a POC for 12/07/23 to 02/04/24 showed a SN visits for assessment, monitoring and teaching of health conditions, pain management and for SN to conduct foley catheter change 20 French/10 cubic centimeters every month and physical therapy for evaluation and treatment. The clinical record showed no communication or coordination of care with the ordering medical provider, to notify the patient was being discharged from home care services and showed no communication or coordination of care with any receiving provider to continue the patient’s care prior to the patient’s discharge from HHA services on 02/01/24. On 06/18/25 at 12:16 p.m., Staff C stated: 1. The SN did not communicate with the ordering medical provider that the patient was being discharged from the agency. 2. The agency showed no coordination of care with the receiving provider to continue the patient’s care prior to the patient’s discharge from HHA services on 02/01/24. Patient #4 A review of administrative records showed the patient was discharged from the agency on 02/01/24 due to staffing changes in the agency (no RN/SN for the agency after 02/11/24). A review of a POC for 12/21/23 to 02/18/24 showed SN visits for assessment, monitoring and teaching of health conditions and pain management. The clinical record showed no communication or coordination of care with the ordering medical provider, to notify the patient was being discharged from home care services and showed no communication or coordination of care with any receiving provider to continue the patient’s care prior to the patient’s discharge from HHA services on 02/01/24. On 06/18/25 at 12:25 p.m., Staff C stated: 1. The SN did not communicate with the ordering medical provider that the patient was being discharged from the agency. 2. The agency showed no coordination of care with the receiving provider to continue the patient’s care prior to the patient’s discharge from HHA services on 02/01/24. Patient #5 A review of administrative records showed the patient was discharged from the agency on 02/05/24 due to staffing changes in the agency (no RN/SN for the agency after 02/11/24). A review of a POC from 12/25/23 to 02/22/24 showed SN visits for assessment, monitoring and teaching of health conditions and pain management. The clinical record showed no communication or coordination of care with the ordering medical provider, to notify the patient was being discharged from home care services and showed no communication or coordination of care with any receiving provider to continue the patient’s care prior to the patient’s discharge from HHA services on 02/05/24. On 06/18/25 at 12:40 p.m., Staff C stated: 1. The SN did not communicate with the ordering medical provider that the patient was being discharged from the agency. 2. The agency showed no coordination of care with the receiving provider to continue the patient’s care prior to the patient’s discharge from HHA services on 02/01/25. Patient #6 A review of administrative records showed the patient was discharged from the agency on 02/06/24 due to staffing changes in the agency (no RN/SN for the agency after 02/11/24). A review of a POC from 12/29/23 to 02/26/24 showed SN visits for assessment, monitoring and teaching health conditions, pain and weight management. The clinical record showed no communication or coordination of care with the ordering medical provider, to notify the patient was being discharged from home care services and showed no communication or coordination of care with any receiving provider to continue the patient’s care prior to the patient’s discharge from HHA services on 02/06/24. On 06/18/25 at 12:45 p.m., Staff C stated: 1. The SN did not communicate with the ordering medical provider that the patient was being discharged from the agency. 2. The agency showed no coordination of care with the receiving provider to continue the patient’s care prior to the patient’s discharge from HHA services on 02/06/25. Patient #7 A review of administrative records showed the patient was discharged from the agency on 02/08/24 due to staffing changes in the agency (no RN/SN for the agency after 02/11/24). A review of a POC from 12/13/23 to 02/10/24 showed SN visits for assessment, monitoring and teaching health conditions; pain, fingerstick blood sugar and weight management. The clinical record showed no communication or coordination of care with the ordering medical provider, to notify the patient was being discharged from home care services and showed no communication or coordination of care with any receiving provider to continue the patient’s care prior to the patient’s discharge from HHA services on 02/08/24. On 06/18/25 at 12:50 p.m., Staff C stated: 1. The SN did not communicate with the ordering medical provider that the patient was being discharged from the agency. 2. The agency showed no coordination of care with the receiving provider to continue the patient’s care prior to the patient’s discharge from HHA services on 02/08/25.”

“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 an initial assessment was conducted within 48 hours of referral for one (Patients #2) of seven patients. Findings: Patient #2 A review of the clinical record showed the agency received referral information on 04/14/25 and the initial assessment occurred on 04/17/25. Clinical record documentation showed no patient refusal of initial assessment, no physician notification of a delay in initial assessment and no change in orders. On 06/18/25 at 12:20 p.m., Staff C stated the initial assessment should have been conducted within 48 hours of referral and any delay in the initial assessment should have been documented in clinical record.”

“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 individualized patient POC included pain reporting parameters for one (Patient #3) of seven patients. Findings: Patient #3 A review of the POC dated 12/07/23 to 02/04/24 showed orders for SN to conduct assessments, monitoring, intervention and teaching of patient health conditions and pain management every visit. SN visit notes showed SN visits were conducted on: · 12/11/23 with a pain level reported of 2 of 10 · 12/13/23 with a pain level reported of 7 of 10 · 12/18/23 with a pain level reported of 4 of 10 · 12/21/23 with a pain level reported of 2 of 10 · 12/26/23 with a pain level reported of 4 of 10 · 01/02/24 with a pain level reported of 9 of 10 · 01/08/24 with a pain level reported of 3 of 10 The SN visit notes showed no physician notifications and no change in orders. On 06/18/25 at 12:25 a.m., Staff C stated the POC should have included physician pain reporting parameters.”

“Communication with all physicians CFR(s): 484.60(d)(1) Standard: Coordination of Care. The HHA must: (1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure care was coordinated between the agency and physician for three (Patients #1, 2 and #7) of seven patients. Findings: Patient #1 A review of the POC dated 04/15/25 to 06/13/25 showed orders for a SN visit frequency one time a week for nine weeks, SN to assess/monitor/instruct health conditions, SN to report blood pressure greater than 160/90 and less than 90/60, and weight less than 144 pounds each visit. SN visit notes dated: · 04/23/25 showed a weight of 143 · 04/29/25 showed a BP of 151/96 · 05/13/25 showed a weight of 143 · 05/20/25 showed a BP of 108/91 and a weight of 143 · 05/27/25 showed a weight of 143 · 06/03/25 showed a weight of 143 · 06/03/25 showed a weight of 143 · 06/10/25 showed a BP of 164/104 and a weight of 143 Further review of SN visit notes showed “auto faxed to physician” and showed no follow up physician communications or coordination of care notes. On 06/18/25 at 12:16 p.m., Staff C stated the SN should have notified the physician that the patient’s weight and blood pressure continued to be out of the reporting parameters. Patient #2 A review of the POC dated 04/17/25 to 06/15/25 showed orders for a SN visit frequency of one time a week for nine weeks, SN to assess/monitor/instruct health conditions, SN to report pain level greater than 6 of 10. A review of SN notes showed: · 04/25/25 reported pain level of 8 of 10. · 04/29/25 a reported pain level of 7 of 10. · 05/06/25 a reported pain level of 7 of 10. · 05/13/25 a reported pain level of 10 of 10. · 05/20/25 a reported pain level of 7 of 10. · 05/30/25 a reported pain level of 10 of 10. · 06/03/25 a reported pain level of 7 of 10. · 06/09/25 a reported pain level of 10 of 10. Further review of SN visit notes showed “auto faxed to physician” and showed no follow up physician communications or coordination of care notes. On 06/18/25 at 12:20 p.m., Staff C stated the SN should have notified the physician that the patient’s pain continued to be outside of the reporting parameters. Patient #7 A review of the POC dated 12/13/23 to 02/10/24 showed orders for a SN visit frequency of one time a week for nine weeks, SN to assess/monitor/instruct health conditions and CHHA visit frequency of one time a week for one week, then two times a week for eight weeks. A review of clinical documentation showed: · 01/08/24 CHHA missed visit due to no answer at the door · 01/10/24 SN missed visit due to no answer at the door · 01/11/24 CHHA missed visit due to no answer at the door · 01/15/24 CHHA missed visit due to no answer at the door Further review of clinical documentation showed SN and CHHA visit notes documented “auto faxed to physician” and showed no follow up physician communications or coordination of care notes and no additional attempts to contact the patient. On 06/18/25 at 12:16 p.m., Staff C stated the SN should have notified the physician that the patient continued to have missed SN and CHHA visits from 01/08/24 to 01/11/24.”

“Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure: 1. PT conducted visits as ordered for one (Patient #3) of seven patients. 2. SN monitored the patient’s pain level and report levels outside of reporting parameters every visit as ordered for one (Patients #5) of seven patients. Findings: Patient #3 A review of the POC dated 12/07/23 to 02/04/24 showed orders for PT to evaluate and treat week of 12/07/23. A PT visit note dated 01/08/24 showed a PT evaluation was conducted with a PT frequency of two times a week for four weeks. The PT visit note showed no patient refusal of PT evaluation before 01/08/24, no physician notification and no changes in orders. A PT visit note dated 01/11/24 showed the visit was missed due to “other”. The missed visit note showed no attempts to reschedule the missed visit, no physician notification and no changes in orders. On 06/18/25 at 12:25 p.m., Staff C stated the PT evaluation and visits should have been conducted as ordered on the POC. Patient #5 A review of the POC dated 05/08/25 to 07/06/25 showed orders for SN to monitor the patient’s pain level every visit and report pain levels outside of the reported pain parameters of greater than 8 of 10. SN visit dated 01/23/24 the patient reported a pain level of 9 of 10 and on SN visit dated 02/01/24 the patient reported a pain level of 9 of 10. The SN visit notes showed no physician notification and no changes in orders. On 06/18/25 at 12:40 p.m., Staff C stated the SN should have reported the patient’s pain level as ordered on the POC at the time of the visits.”

“Participate in the HHA’s QAPI program; CFR(s): 484.75(b)(8) Participation in the HHA’s QAPI program; and This Element is not met as evidenced by: Based on a record review and interview, the agency failed to ensure multi-disciplined skilled professional staff were available to participate and provide input into the agency’s QAPI program for all patients and employees. Findings: A review of QAPI records showed no multi-disciplined skilled professional staff participation in QAPI activities in calendar years 2023 and 2024. On 06/18/25 at 1:00 p.m., Staff C stated QAPI records did not show multi-disciplined skilled professional staff participation in QAPI program activities.”

“Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient’s plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure certified home health aide supervisory visits were completed every 14 days in the patients home for two (Patients #6 and #7) of seven patients. Findings: Patient #6 A review of the POC dated 12/29/23 to 02/06/24 showed orders for showed a CHHA visit frequency of two times a week for eight weeks, then one time week for one week. A review of the clinical record showed CHHA supervisory visits were completed on 01/10/24 and 01/24/24 using a check mark format. The supervisory visit notes showed no home visits were conducted on 01/10/24 and 01/24/24 and showed no patient refusal of visits, no physician notification and no change in orders. On 06/18/25 at 12:45 p.m., Staff C stated the CHHA supervisory visit notes showed no in home CHHA supervisory visits were conducted. Patient #7 A review of the POC dated 12/13/23 to 02/10/24 showed orders for showed a CHHA visit frequency of two times a week for eight weeks, then one time week for one week. A review of the clinical record showed CHHA supervisory visits were completed on 12/13/23, 12/27/23, 01/10/24, 01/24/24 and 02/07/24 using a check mark format. The supervisory visit notes showed no home visits were conducted on 12/13/23, 12/27/23, 01/10/24, 01/24/24 and 02/07/24 and showed no patient refusal of visits, no physician notification and no change in orders. On 06/18/25 at 12:45 p.m., Staff C stated the CHHA supervisory visit notes showed no in home CHHA supervisory visits were conducted.”

“Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) Standard: Administrator. The administrator must: (i) Be appointed by and report to the governing body; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure a governing body appointment of the administrator for the agency from 02/11/24 to 04/12/25 for all patients and staff. The failed practice had the potential to effect day-to-day operational oversite responsibilities of the agency, impacting the services its patients received. Findings: A review of administrative governing body meeting minutes showed no appointment of the administrator for the agency from 02/11/24 to 04/12/25. On 06/18/25 at 1:00 p.m., Staff C stated: 1. She was the administrator for the agency since 04/12/25. 2. The prior administrator left the agency on 02/10/24.”

“Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This Element is not met as evidenced by: Based on record review and interview, the governing body failed to ensure operational oversight of the agency by an administrator from 02/11/24 to 04/12/25 for all patients and all employees. The failed practice effected the agency’s ability to effectively operate and provide appropriate care and services to its patients and the community at large. Findings: A review of administrative records showed no administrator was appointed or designated by the governing body from 02/11/24 to 04/12/25. On 06/18/23 at 1:00 p.m., Staff C stated there was no appointment or designation of ongoing day to day operational oversight for the agency by an administrator of agency from 02/11/24 to 04/12/25.”