Care in Action Home Healthcare Agency LLC

“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 a review of quality assessment performance improvement (QAPI) documents and an interview with the administrator, the home health agency (HHA) failed to select the indicators that it would utilize in its QAPI program based upon identified adverse or negative patient outcomes or agency processes that the HHA wished to monitor and measure (G642); failed to collect and use data to monitor the effectiveness and safety of services and quality of care, and identify opportunities for improvement (G644); failed to focus on high risk, high volume, or problem-prone areas, and consider the incidence, prevalence, and severity of problems in those areas (G646); failed to show evidence of tracking adverse patient events, analyzing their causes, and implementing preventive actions (G654); failed to show evidence of actions aimed at performance improvement, and after implementing those actions, measuring success and tracking performance to ensure that improvements are sustained (G656); failed to have one performance improvement project either in development, on-going or completed each calendar year in 2023, 2024 or 2025 (G658); and failed to assure that the governing body assumed overall responsibility for ensuring that the QAPI program reflected the complexity of the HHA and its services, involved all services (including those provided under contract or arrangement), focused on indicators related to improved outcomes, and took actions to address the HHA’s performance across the spectrum of care (G660). Findings include: This condition is not met as evidenced under the following standards which did not result in immediate jeopardy. This condition was not met based on non-compliance with the above standards: §484.65(a)(1)(2) Program Scope §484.65(b)(1)(2)(3) Program Data §484.65(c)(1) Program Activities §484.65(c)(2) Program Activities §484.65(c)(3) Program Activities §484.65(d)(1)(2) Performance Improvement Project §484.65(e)(1)(2)(3) Executive Responsibilities for QAPI”

“Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This Condition is not met as evidenced by: Based on a review of personnel files (PF), home health aide training documents, and an interview with the administrator, the home health agency (HHA) failed to ensure adherence to home health aide qualification (G754); failed to provide evidence of the content and duration of home health aide classroom and supervised practical training (G760); failed to maintain documentation that demonstrates that the requirements of the standard were met; (G766); and failed to provide a competency evaluation (G768) and documentation of a competency evaluation (772); and failed to conduct onsite supervisory visits every 14 days (G808). Findings include: This condition is not met as evidenced under the following standards which did not result in immediate jeopardy. This condition was not met based on non-compliance with the above standards: §484.80(a) Home Health Aide Qualifications §484.80(b)(1)(4) Content and Duration of Home Health Aide Classroom and Supervisory Practical Training §484.80(c) Competency Evaluation 484.80(c)(1)(2)(3) Competency Evaluation 484.80(c)(5) Documentation of Competency Evaluation 484.80(h)(1)(i) Onsite Supervisory Visit Every 14 days”

“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), §485.542(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 a review of the emergency preparedness program (EPP) documents and an interview with the administrator, the home health agency (HHA) failed to ensure that the EPP was based on and included a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. Findings include: A review of EPP program documents on July 1, 2025 at 1:00 PM found that the hazard vulnerability/risk assessment (HVA) was not completed. The HVA contained within the EPP program documents was blank and contained no information. An interview conducted with the administrator and director of clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”

“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 a review of the emergency preparedness program (EPP) documents and an interview with the administrator, the home health agency (HHA) failed to ensure that the EPP contained a communication process in the event of a disaster or need to activate the disaster/emergency plan. Findings include: A review of EPP program documents on July 1, 2025 at 1:00 PM found that the communication plan did not include any of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. An interview conducted with the administrator and director of clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”

“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 a review of the emergency preparedness program (EPP) documents and an interview with the administrator, the home health agency (HHA) failed to conduct exercises to test the emergency plan (EP) at least annually. Findings include: A review of EPP documents on July 1, 2025 at 1:00 PM found that there was no evidence that the HHA participated in a full-scale exercise that was community-based, or when a community-based exercise was not accessible, conducted an annual individual, facility-based functional exercise every 2 years; and conducted an additional exercise every 2 years, opposite the year the full-scale or functional exercise was conducted to include but not be limited to the following: 1) a second full-scale exercise that is community-based or an individual, facility-based functional exercise; or 2) a mock disaster drill; or 3) 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. There were no documented EP exercises in 2023 or 2024. An interview conducted with the administrator and director of clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”

“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 a review of quality assessment performance improvement documents and an interview with the administrator, the home health agency (HHA) failed to select the indicators that it would utilize in its QAPI program based upon identified adverse or negative patient outcomes or agency processes that the HHA wished to monitor and measure. Findings include: HHA Policy QAP-001.1 Quality Assessment and Performance Improvement (QAPI) Program reviewed on July 1, 2025 at 1:30 PM reads in part, “The Agency will develop, implement, maintain and evaluate a data-driven QAPI program, guided by established quality management principles, to enhance the quality of care, service, operations, and safety.” A review of QAPI materials on July 1, 2025 at approximately 1:30 PM consisted of a review of the QAPI Program Policy only. There was no evidence provided that the HHA selected and monitored quality indicators based upon agency processes that the HHA wished to monitor and measure, nor was there evidence that the HHA implemented a data-driven QAPI program. An interview held with the administrator and clinical director on July 1, 2025 starting at approximately 4:15 PM confirmed the above findings.”

“Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA’s governing body. This Standard is not met as evidenced by: Based on a review of quality assessment performance improvement documents and an interview with the administrator, the home health agency (HHA) failed to utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program and failed to collect data to monitor the effectiveness and safety of services and quality of care, identify opportunities for improvement, and ensure that the frequency and detail of the data collection was approved by the HHA’s governing body. Findings include: HHA Policy QAP-001.1 Quality Assessment and Performance Improvement (QAPI) Program reviewed on July 1, 2025 at 1:30 PM states in part, “The Agency’s QAPI program will utilize quality indicators to improve home health services. Indicators will be measurable, objective and quantitative measures of key system elements’ performance (i.e., visit frequency, compliance to physician orders, care coordinator documentation, medication reconciliation, patient satisfaction surveys, or other areas of care).” A review of QAPI materials on July 1, 2025 at approximately 1:30 PM consisted of a review of the QAPI Program Policy only. There was no evidence provided that the HHA used measurable, objective and quantitative quality indicators to improve home health services. The HHA had not selected nor monitored any data for its QAPI program. An interview conducted with the administrator and director of clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”

“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 a review of quality assessment performance improvement documents and an interview with the administrator, the home health agency (HHA) failed to provide evidence that the QAPI program focused on high risk, high volume, or problem-prone areas, and considered the incidence, prevalence, and severity of problems in those areas. Findings include: HHA Policy QAP-001.1 Quality Assessment and Performance Improvement (QAPI) Program reviewed on July 1, 2025 at approximately 1:30 PM reads in part, “The Agency’s QAPI program will include performance improvement activities that focus on high-risk, high-volume, or problem-prone areas, consider the incidence, prevalence and severity of problems in those areas, assess processes that involve risks, including infections and communicable disease, review variances, for example, incidents, accidents, complaints/grievances, and workers compensation claims, results in the immediate action of an identified problem posing a risk to the health and safety of patients, track adverse patient and personnel events, analyze their causes, and implement correction actions (such event will be reviewed at least quarterly to detect trends and create an action plan to decrease occurrences), act on corrective actions, measure success, and track performance to ensure improvements are sustained, include at least one important administrative function of the agency (i.e., monitoring the completion of performance evaluations, the number of in-service hours, or billing audits).” A review of QAPI materials on July 1, 2025 at approximately 1:30 PM consisted of a review of the QAPI Program Policy only. There was no evidence provided that the HHA identified, selected or monitored high-risk, high-volume or problem-prone areas, nor considered the incidence, prevalence and severity of problems in those areas. An interview conducted with the administrator and director of clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”

“Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This Standard is not met as evidenced by: Based on a review of quality assessment performance improvement documents and an interview with the administrator, the home health agency (HHA) failed to select the indicators that it would utilize in its QAPI program based upon identified adverse or negative patient outcomes or agency processes that the HHA wished to monitor and measure. Findings include: HHA Policy QAP-001.1 Quality Assessment and Performance Improvement (QAPI) Program reviewed on July 1, 2025 at 1:30 PM states in part, “The Agency’s QAPI program will utilize quality indicators to improve home health services. Indicators will be measurable, objective and quantitative measures of key system elements’ performance (i.e., visit frequency, compliance to physician orders, care coordinator documentation, medication reconciliation, patient satisfaction surveys, or other areas of care).” A review of QAPI materials on July 1, 2025 at approximately 1:30 PM consisted of a review of the QAPI Program Policy only. There was no evidence provided that the HHA used measurable, objective and quantitative quality indicators to improve home health services. The HHA had not selected nor monitored any data for its QAPI program. An interview conducted with the administrator and director of clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”

“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 a review of quality assessment performance improvement documents and an interview with the administrator, the home health agency (HHA), failed to have one performance improvement project either in development, on-going or completed each calendar year in 2023, 2024 or 2025. Findings include: HHA Policy QAP-001.1 Quality Assessment and Performance Improvement (QAPI) Program reviewed on July 1, 2025 at approximately 1:30 PM states in part, “The agency’s QAPI program will develop each performance improvement project using criteria to: describe the indicator(s) to be monitored/activities to be conducted, identify the frequency of activities, designate who is responsible for conducting the activities, describe the methods of data collection, note the acceptable limits for findings/thresholds, write a plan of correction when thresholds are not met, plan to re-evaluate findings that fail to meet acceptable limits, include other activities as required under state or federal law.” A review of QAPI materials on July 1, 2025 at approximately 1:30 PM consisted of a review of the QAPI Program Policy only. There was no evidence provided that the HHA identified and developed a performance improvement project in 2023, 2024 or 2025 (to date). An interview conducted with the administrator and director clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”

“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 a review of quality assessment performance improvement documents and an interview with the administrator, the home health agency (HHA) failed to assure that the governing body assumed overall responsibility for ensuring that the QAPI program reflected the complexity of the HHA and its services, involved all services (including those provided under contract or arrangement), focused on indicators related to improved outcomes, and took actions to address the HHA’s performance across the spectrum of care. Findings include: HHA Policy QAP-001.1 Quality Assessment and Performance Improvement (QAPI) Program reviewed on July 1, 2025 at approximately 1:30 PM reads in part, “The Governing Body will assume overall responsibility for creating, implementing, and supporting the QAPI program to ensure an ongoing program for quality improvement and patient safety is defined, implemented and maintained; its actions regarding involvement, oversight, and accountability for the QAPI program are documented in meeting minutes; QAPI efforts address priorities for improved quality of care and patient safety (all improvement actions will be evaluated for effectiveness): clear expectations for patient safety are established, implemented, and maintained; findings of fraud or waster are appropriate addressed. The Governing Body will approve the frequency and detail of the data collected for the QAPI program. It will ensure the program addresses priorities for improved patient outcomes, quality of care, and patient safety; involves all agency services; focuses on indicators related to improved outcomes, including emergent care service use, hospital admissions, and readmissions; reviews all variance, for example, infections and communicable disease; evaluates all improvement actions for effectiveness; sets, implements and maintains clear expectations for patient safety; takes actions that address the agency’s performance across the spectrum of care (including medical errors), addresses any findings of fraud or waster, has an evaluation of its performance improvement projects to ensure they reflect the scope, complexity and past performance of the agency’s services and operations; has evidence of QAPI activities as documented in the meeting minutes of each responsible party.” A review of QAPI materials on July 1, 2025 at approximately 1:30 PM consisted of a review of the QAPI Program Policy only. There were no materials provided by the HHA to show evidence of the Governing Boards involvement in QAPI activities. An interview conducted with the administrator and director clinical services on July 1, 2025 starting at 4;15 PM confirmed the above findings.”

“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 a review of quality assessment performance improvement documents and an interview with the administrator, the home health agency (HHA) failed to utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program and failed to collect data to monitor the effectiveness and safety of services and quality of care, identify opportunities for improvement, and ensure that the frequency and detail of the data collection was approved by the HHA’s governing body. Findings include: HHA Policy QAP-001.1 Quality Assessment and Performance Improvement (QAPI) Program reviewed on July 1, 2025 at 1:30 PM states in part, “The Agency’s QAPI program will utilize quality indicators to improve home health services. Indicators will be measurable, objective and quantitative measures of key system elements’ performance (i.e., visit frequency, compliance to physician orders, care coordinator documentation, medication reconciliation, patient satisfaction surveys, or other areas of care)....Utilize the following methods for collecting data: current documentation review (clinical records, incident reports, complaints, infection logs, patient satisfaction surveys, etc.); patient care; direct observation of clinical performance; operating systems; interview with staff and patients; chart audits, at least quarterly, to include active and closed patient records....Coordinate a program for surveillance/monitoring, identification, prevention, control, and investigation of infectious and communicable diseases, which is an integral component of the Agency’s QAPI program.” A review of QAPI materials on July 1, 2025 at approximately 1:30 PM consisted of a review of the QAPI Program Policy only. There was no evidence provided that the HHA used measurable, objective and quantitative quality indicators for the surveillance/monitoring, identification, prevention, control and investigation of infectious and communicable diseases. The HHA had not selected nor monitored any data for its infection control program. An interview conducted with the administrator and director of clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”

“Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide’s performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This Standard is not met as evidenced by: Based on a review of personnel files (PF) and an interview with the administrator, the agency failed to demonstrate the presence of: The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide’s performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation for one (1) of seven (7) files reviewed: PF# 5. Findings includes: A review of policies conducted on July 01, 2025 starting at 2:15 PM revealed following: A policy titled, “New Employee Orientation” Policy: PER-011.1 reads in part, “Procedure 1. New employee, including contract employees, will be required to attend the new-employee orientation…2. A new employee must attend orientation on the first day of employment or the first available date but prior to patient care. A policy titled, “Home Health Aide – PA” Policy: JD-009.1 reads in part, “Qualifications…2. Must be licensed, certified, or registered in accordance with applicable local, state and federal law and regulation. 3. Home Health Aide (HHA) education consisting of in-class hours, training, and hands-on demonstration specific to home health, meeting the 42 C.F.R. 484.36 and Condition of Participation 484.80 requirements for content and duration of HHA classroom and supervised practical training, and as identified in Pennsylvania 601.6. A review of personnel files (PF) was conducted on June 30, 2025 at approximately at 2:00 pm The date of hire (DOH) is indicated below. PF#5 DOH 05/07/2025 did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. File contained a competency exam dated for 5/7/2025 but Administrator could not provide any documentation of the seventy-five (75) hour training course An interview conducted with the administrator on July 1, 2025, at approximately 4:15 pm confirmed the above findings.”

“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 a review of clinical records (CR), home health agency (HHA) policy, and an interview with the administrator, the HHA failed to assure that an initial assessment was completed by the registered nurse (RN) within forty-eight (48) hours of the referral for three (3) of four (4) CR’s reviewed: CR#2, CR#3 and CR#4. Findings include: The HHA’s Policy Guidelines for Assessment PC-019.1 reviewed on June 30, 2025 at 3:00 PM states in part, “The initial assessment must be conducted: within (48) forty-eight hours of referral, within 48 (forty-eight) hours of a patient returning home, or on the physician/allowed practitioner order start of care date.” A review of CR’s was conducted on June 30, 2025 starting at approximately 10:10 AM through 4:00 PM. The start of care (SOC) and Home Health Certification Period (CP) are indicated below. CR#2 SOC 06/06/2025, CP 06/06/2025 to 08/04/2025 contained an OASIS (Outcome and Assessment Information Set) document completed on 06/08/2025 which noted that the date of referral was 06/2/2025. There was no specific SOC date ordered by the physician. The initial assessment was not completed by the RN until 06/08/2025, six (6) days after the referral. CR#3 SOC 05/05/2025, CP 05/05/2025 to 07/03/2025 contained an OASIS (Outcome and Assessment Information Set) document completed on 05/05/2025 which noted that the date of referral was 04/28/2025. There was no specific SOC date ordered by the physician. The initial assessment was not completed by the RN until 05/05/2025, seven (7) days after the referral. CR#4 SOC 03/27/2025, CP 03/27/2025 to 05/25/2025 contained an OASIS (Outcome and Assessment Information Set) document completed on 03/27/2025 which noted that the date of referral was 03/18/2025. There was no specific SOC date ordered by the physician. The initial assessment was not completed by the RN until 03/27/2025, nine (9) days after the referral. An interview conducted with the administrator and director of clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”

“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 a review of clinical records, home health agency (HHA) policies, home visit observation, and an interview with the administrator, the HHA failed to ensure that an accurate review of the current medications that the patient was using was conducted for two (2) of four (4) CR’s reviewed: CR#1 and CR#3. Findings include: The HHA’s Policy PC-019.1 Guidelines for Assessment reviewed on July 1, 2025 at 2:00 PM reads in part, “The comprehensive assessment must include, at a minimum, the following components....all medications, including prescription and nonprescription, will be reviewed and compiled into a medication profile for the patient, matching the assessment, POC (plan of care) and written information on the patient.” The HHA’s Policy PC-029.1 Medication Reconciliation reviewed on July 1, 2025 at 2:10 PM states in part, “To identify and address discrepancies in a patient’s medication regimen and help improve communication among healthcare team members and with patient regarding their medications...Medication reconciliation is comparing the patient’s medical record to an external list of medications obtained from the patient, hospital or other provider...the medication reconciliation process renders a list, or medication profile, that will be maintained and updated as changes occur. Copies will be retained in the patient’s home and clinical record....Clinicians will use the following medication reconciliation steps to determine the accuracy of the patient’s medication profile...look for any high-risk medications such as opioids, hypoglycemics, and anticoagulants....the clinician will contact the physician or allowed provider promptly regarding potential issues found during medication reconciliation, including but not limited to medication discrepancies, side effect, problems or reactions. Communication with the physician or allowed practitioner regarding medication issues will be documented in the clinical record...The clinician must provide the patient and caregiver with a current, written medication profile outlining medication instructions including but not limited to: medication name, dosage, route, frequency, classification, date prescribed or taken, date discontinued, drug or food allergies, medication that will be administered by the agency and/or personnel acting on behalf of the agency.” The HHA’s Registered Nurse Job Description Policy JD-007.3 reviewed on June 30, 2025 at 3:15 PM reads in part, “Implement care and services as ordered by the physician/provider.” A review of CR’s was conducted on June 30, 2025 starting at approximately 10:10 AM through 4:00 PM. The start of care (SOC) and Home Health Certification Period (CP) are indicated below. CR#1 SOC 06/23/2025, CP 06/23/2025 to 08/21/2025. The Home Health Certification and Plan of Care (POC) contained medication orders for Xarelto (a blood thinner) 20 mg (milligrams) 1 tablet with dinner by mouth, and Trazodone HCl (an antidepressant) 50 mg 1 tablet at bedtime by mouth. A review of the Medication Profile contained the following medications that were not documented on the POC: Haloperidol (an antipsychotic) 5 mg, two times daily by mouth, and Lexapro (an antidepressant/antianxiety) 10 mg daily by mouth. There were no additional physician orders found in the CR for the Haldol and Lexapro. The OASIS (Outcome and Assessment Information Set) completed on 06/23/2025 found that the section titled “Medication Status” did not note reconciliation of medications - the check off box indicating “Medications Reconciled” was not checked. The Drug Regimen Review on the OASIS noted “No issues found during review” despite the discrepant information between the POC and the medication profile. The section on the OASIS indicating Patient/Caregiver High Risk Drug Education for hypoglycemics, anticoagulants, etc. noted “N/A - patient not taking any high-risk drugs, though the patient was taking an anticoagulant. Further discrepant information was found as follows: The patient was discharged from the hospital on 06/23/2025 with a list of discharge medications to be taken after discharge. The discharge medication list noted that Trazodone 50 mg 1 tablet by mouth was to be taken at bedtime as needed for insomnia. The POC and the medication profile prepared for the patient by the HHA upon admission to the HHA on 06/23/2025 noted that Trazodone 50 mg 1 tablet by mouth was to be taken routinely (not as needed) at bedtime. The Visit Intervention Section on the OASIS noted that a complete medication review and medication reconciliation “due to noted discrepancies” was performed, but there were no orders to address and/or reconcile the various discrepancies noted on the POC versus the medication profile versus the discharge medication list, and to clarify and document if the Trazodone was intended to be taken routinely or as needed. CR#3 SOC 05/05/2025, CP 05/05/2025 to 07/03/2025. The Drug Regimen Review on the OASIS, completed on 05/05/2025, found that no medication issues were identified. The Visit Intervention Section on the OASIS noted that a complete medication review and medication reconciliation “due to noted discrepancies” was performed. The OASIS also noted that the patient is unable to take injectable medications unless administered by another person. A home visit was conducted on July 1, 2025 at approximately 11:35 AM. The patient is receiving his/her medications through a 3rd party pharmacy packaging company. The pharmacy prepares the medications in strip packaging with the date and time as to when the medication is to be taken by the patient. The pharmacy also provides a monthly medication administration record (MAR) which lists the medications, doses, and times of administration. A review of the pharmacy’s MAR for the time period 06/01/2025 to 06/30/2025 found that the patient is receiving Invega Sust Injection (used to treat schizophrenia) 150 milligrams (mg) per milliliter via an intramuscular injection every thirty (30) days and taking Depakote (used for psychiatric illness) one (1) tablet by mouth twice daily. Neither the Invega nor the Depakote were listed in the physician orders on the Home Health Certification and Plan of Care (POC) and there were no subsequent physician orders for these medications to be administered. Multi Vitamin 1 tablet daily by mouth was ordered on the POC. The order for the multi vitamin was not contained on the list of medications being provided by the 3rd party pharmacy. There was no documentation or communication regarding the status of the multi vitamin as to whether it was to be continued or discontinued. An interview conducted with the administrator and director clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on a review of clinical records (CR), home health agency (HHA) policy, home visit observation, and an interview with the administrator, the HHA failed to assure that medications and services provided to patients were ordered by a physician or allowed practitioner and documented in the CR. Two (2) of four (4) CR’s reviewed did not meet the requirement: CR#1 and CR#3. Findings include: The HHA’s Policy PC-009.1 Physician Or Allowed Practitioner’s Orders reviewed on July 1, 2025 at approximately 2:20 PM states in part, “The Agency must ensure that all prescription and nonprescription drugs, medications, devices, treatments, and services provided to clients are ordered by a physician or allowed practitioner.” The HHA’s Policy PC-029.1 Medication Reconciliation reviewed on July 1 at approximately 2:10 PM states in part, “To identify and address discrepancies in a patient’s medication regimen and help improve communication among healthcare team members and with patient regarding their medications...the clinician will contact the physician or allowed provider promptly regarding potential issues found during medication reconciliation, including but not limited to medication discrepancies, side effect, problems or reactions. Communication with the physician or allowed practitioner regarding medication issues will be documented in the clinical record.” The HHA’s Registered Nurse Job Description Policy JD-007.3 reviewed on June 30, 2025 at approximately 3:15 PM reads in part, “Implement care and services as ordered by the physician/provider.” A review of CR’s was conducted on June 30, 2025 starting at approximately 10:10 AM through 4:00 PM. The start of care (SOC) and Home Health Certification Period (CP) are indicated below. CR#1 SOC 06/23/2025, CP 06/23/2025 to 08/21/2025. The Home Health Certification and Plan of Care (POC) contained the following medication orders: Xarelto (a blood thinner) 20 mg (milligrams) 1 tablet with dinner by mouth, and Trazodone HCl (an antidepressant) 50 mg 1 tablet at bedtime by mouth. A review of the Medication Profile contained the following medications that were not documented on the POC: Haloperidol (an antipsychotic) 5 mg, two times daily by mouth, and Lexapro (an antidepressant/antianxiety) 10 mg daily by mouth. There were no additional physician orders found for the Haldol and Lexapro nor documented communication with the physician seeking clarification regarding the discrepancies. CR#3 SOC 05/05/2025, CP 05/05/2025 to 07/03/2025. A home visit was conducted on July 1, 2025 at approximately 11:35 AM. The patient is receiving his/her medications through a 3rd party pharmacy packaging company. The pharmacy prepares the medications in strip packaging with the date and time as to when the medication is to be taken by the patient. The pharmacy also provides a monthly medication administration record (MAR) which lists the medications, doses, and times of administration. A review of the MAR for the time period 06/01/2025 to 06/30/2025 found that the patient is receiving Invega Sust Injection (used to treat schizophrenia) 150 milligrams (mg) per milliliter via an intramuscular injection every thirty (30) days and taking Depakote (used for psychiatric illness) one (1) tablet by mouth twice daily. Neither the Invega nor the Depakote were listed in the physician orders on the Home Health Certification and Plan of Care (POC) and there were no subsequent physician orders for these medications to be administered, nor documented communication with the physician seeking clarification regarding the discrepancies. A review of the clinical record found that a home health aide (aide) care plan had been prepared by a registered nurse (RN) on 05/05/2025. During the home visit for CR#3 that was conducted on July 1, 2025 at 11:35, the RN stated that the patient is receiving services from an aide. The administrator, in an interview conducted on July 1, 2025 at approximately 12:25 PM, stated that the patient has been receiving aide services since 05/07/2025. A review of skilled nursing (SN) notes for 5/15, 5/20, 5/22, 5/27, 5/29, 6/3, 6/5, 6/10, 6/17, 6/19, 6/24, 6/26 stated “needs met by intermittent HHA (aide).” A review of the POC/physician orders did not contain an order for aide services, nor was there a subsequent physician order for aide services. CR#3 had orders for skilled nursing (SN) visits two (2) times per week, for eight (8) weeks. There was no SN visit documented for 6/12/2025, no documentation of the reason for the missed visit (MV), nor that the physician was notified of the MV. An interview conducted with the administrator and director clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”

“Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This Element is not met as evidenced by: Based on a review of clinical records (CR), home health agency policy, home visit observation, and an interview with the administrator and director clinical services, the HHA failed to prepare and provide to the patient written information regarding the patient’s medication regimen as based on the results of the medication review and physician orders. One (1) of four (4) CR’s reviewed did not meet the requirement: CR#3. Findings include: The HHA’s Policy PC-019.1 Guidelines for Assessment reviewed on July 1, 2025 at 2:00 PM reads in part, “The comprehensive assessment must include, at a minimum, the following components....all medications, including prescription and nonprescription, will be reviewed and compiled into a medication profile for the patient, matching the assessment, POC (plan of care) and written information on the patient.” The HHA’s Policy PC-029.1 Medication Reconciliation reviewed on July 1, 202 at approximately 2:10 PM states in part, “To identify and address discrepancies in a patient’s medication regimen and help improve communication among healthcare team members and with patient regarding their medications...Medication reconciliation is comparing the patient’s medical record to an external list of medications obtained from the patient, hospital or other provider...the medication reconciliation process renders a list, or medication profile, that will be maintained and updated as changes occur. Copies will be retained in the patient’s home and clinical record....The clinician must provide the patient and caregiver with a current, written medication profile outlining medication instructions including but not limited to: medication name, dosage, route, frequency, classification, date prescribed or taken, date discontinued, drug or food allergies, medication that will be administered by the agency and/or personnel acting on behalf of the agency.” A review of CR’s was conducted on June 30, 2025 starting at approximately 10:10 AM through 4:00 PM. The start of care (SOC) and Home Health Certification Period (CP) are indicated below. CR#3 SOC 05/05/2025, CP 05/05/2025 to 07/03/2025. A review of the clinical record did not contain a medication profile. A home visit was conducted on 07/01/2025 at approximately 11:35 AM. A review of the admission packet found that a medication profile had not been prepared for the patient by the HHA. During the home visit, the registered nurse wrote the list of medications on the emergency preparedness/disaster information form that was contained in the admission packet. An interview held with the administrator and director clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”

“Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This Element is not met as evidenced by: Based on a review of quality assessment performance improvement documents and an interview with the administrator, the home health agency (HHA) failed to utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program and failed to collect data to monitor the effectiveness and safety of services and quality of care, identify opportunities for improvement, and ensure that the frequency and detail of the data collection was approved by the HHA’s governing body. Findings include: HHA Policy QAP-001.1 Quality Assessment and Performance Improvement (QAPI) Program reviewed on July 1, 2025 at 1:30 PM states in part, “The Agency’s QAPI program will utilize quality indicators to improve home health services. Indicators will be measurable, objective and quantitative measures of key system elements’ performance (i.e., visit frequency, compliance to physician orders, care coordinator documentation, medication reconciliation, patient satisfaction surveys, or other areas of care).” A review of QAPI materials on July 1, 2025 at approximately 1:30 PM consisted of a review of the QAPI Program Policy only. There was no evidence provided that the HHA used measurable, objective and quantitative quality indicators to improve home health services. The HHA had not selected nor monitored any data for its QAPI program. An interview conducted with the administrator and director of clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”

“A qualified HH aide successfully completed: CFR(s): 484.80(a)(1)(i-iv) A qualified home health aide is a person who has successfully completed: (i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section. This Element is not met as evidenced by: Based on a review of personnel files (PF) and an interview with the administrator, the agency failed to demonstrate the presence of the following: HHA initial competency including 75 hours of classroom training for one (1) of seven (7) files reviewed: PF# 5. Findings includes: A review of policies conducted on July 01, 2025 starting at 2:15 PM revealed following: A policy titled, “New Employee Orientation” Policy: PER-011.1 reads in part, “Procedure 1. New employee, including contract employees, will be required to attend the new-employee orientation…2. A new employee must attend orientation on the first day of employment or the first available date but prior to patient care. A policy titled, “Home Health Aide – PA” Policy: JD-009.1 reads in part, “Qualifications…2. Must be licensed, certified, or registered in accordance with applicable local, state and federal law and regulation. 3. Home Health Aide (HHA) education consisting of in-class hours, training, and hands-on demonstration specific to home health, meeting the 42 C.F.R. 484.36 and Condition of Participation 484.80 requirements for content and duration of HHA classroom and supervised practical training, and as identified in Pennsylvania 601.6. A review of personnel files (PF) was conducted on June 30, 2025 at approximately at 2:00 pm The date of hire (DOH) is indicated below. PF#5 DOH 05/07/2025 did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. File contained a competency exam dated for 5/7/2025 but Administrator could not provide any documentation of that a seventy-five (75) hour training course was provided to PF#5. No evidence on file that PF#5 had previously experience and/or training as a home health aide. An interview conducted with the administrator on July 1, 2025, at approximately 4:15 pm confirmed the above findings.”

“Classroom and supervised practical training CFR(s): 484.80(b)(1) Home health aide training must include classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. Classroom and supervised practical training must total at least 75 hours. This Element is not met as evidenced by: Based on a review of personnel files (PF) and an interview with the administrator, the agency failed to demonstrate the presence of the following: Home health aide training must include classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services for one (1) of seven (7) files reviewed: PF# 5. Findings includes: A review of policies conducted on July 01, 2025 starting at 2:15 PM revealed following: A policy titled, “New Employee Orientation” Policy: PER-011.1 reads in part, “Procedure 1. New employee, including contract employees, will be required to attend the new-employee orientation…2. A new employee must attend orientation on the first day of employment or the first available date but prior to patient care. A policy titled, “Home Health Aide – PA” Policy: JD-009.1 reads in part, “Qualifications…2. Must be licensed, certified, or registered in accordance with applicable local, state and federal law and regulation. 3. Home Health Aide (HHA) education consisting of in-class hours, training, and hands-on demonstration specific to home health, meeting the 42 C.F.R. 484.36 and Condition of Participation 484.80 requirements for content and duration of HHA classroom and supervised practical training, and as identified in Pennsylvania 601.6. A review of personnel files (PF) was conducted on June 30, 2025 at approximately at 2:00 pm The date of hire (DOH) is indicated below. PF#5 DOH 05/07/2025 did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. File contained a competency exam dated for 5/7/2025 but Administrator could not provide any documentation of that a seventy-five (75) hour training course was provided to PF#5. An interview conducted with the administrator on July 1, 2025, at approximately 4:15 pm confirmed the above findings.”

“HHA maintains documentation of training CFR(s): 484.80(b)(4) The HHA must maintain documentation that demonstrates that the requirements of this standard have been met. This Element is not met as evidenced by: Based upon a review of the agencies policy and an interview with the administrator, the agency failed to follow its policy regarding New Employee Orientation and the documentation of required trainings. No evidence of documentation of HHA competency and supervised practical training. for one (1) of seven (7) PF’s reviewed. PF#5. Findings includes: A review of policies conducted on July 01, 2025 starting at 2:15 PM revealed following: A policy titled, “New Employee Orientation” Policy: PER-011.1 reads in part, “Procedure 1. New employee, including contract employees, will be required to attend the new-employee orientation…2. A new employee must attend orientation on the first day of employment or the first available date but prior to patient care. A policy titled, “Home Health Aide – PA” Policy: JD-009.1 reads in part, “Qualifications…2. Must be licensed, certified, or registered in accordance with applicable local, state and federal law and regulation. 3. Home Health Aide (HHA) education consisting of in-class hours, training, and hands-on demonstration specific to home health, meeting the 42 C.F.R. 484.36 and Condition of Participation 484.80 requirements for content and duration of HHA classroom and supervised practical training, and as identified in Pennsylvania 601.6. A review of personnel files (PF) was conducted on June 30, 2025 at approximately at 2:00 pm The date of hire (DOH) is indicated below. PF#5 DOH 05/07/2025 did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. File contained a competency exam dated for 5/7/2025 but Administrator could not provide any documentation of the seventy-five (75) hour training course An interview conducted with the administrator on July 1, 2025, at approximately 4:15 pm confirmed the above findings.”

“Documentation of competency evaluation CFR(s): 484.80(c)(5) The HHA must maintain documentation which demonstrates that the requirements of this standard have been met. This Element is not met as evidenced by: Based on review of personnel files (PF), home health agency (HHA) policy, and an interview with the administrator, the agency failed to maintain documentation that demonstrates home health aide (aide) competency was determined by direct observation and the results of those observations for one (1) of one (1) aide PF reviewed: PF#5. A review of policies conducted on July 01, 2025 starting at 2:15 PM revealed following: A policy titled, “New Employee Orientation” Policy: PER-011.1 reads in part, “Procedure 1. New employee, including contract employees, will be required to attend the new-employee orientation…2. A new employee must attend orientation on the first day of employment or the first available date but prior to patient care. A review of personnel files (PF) was conducted on June 30, 2025 at approximately at 2:00 pm The date of hire (DOH) is indicated below. PF#5 DOH 05/07/2025 did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. File contained a competency exam dated for 5/7/2025 but Administrator could not provide any documentation of the seventy-five (75) hour training course An interview conducted with the administrator on July 1, 2025, at approximately 4:15 pm confirmed the above findings.”

“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 a review of clinical records (CR), agency policy, and an interview with the administrator, the home health agency (HHA) failed to provide evidence that registered nurse (RN) supervisory visits were conducted at least every two (2) weeks for patients receiving home health aide (aide) services for two (2) of four (4) CR’s reviewed: CR#3 and CR#4. Findings include: A review of policies conducted on July 01, 2025 starting at 2:15 PM revealed following: The HHA’s Policy PER-015.1 states in part, ““Procedure:…4. Supervisory visits shall:…c. Occur no less frequently than every fourteen (14) days for HHA services provided to a patient receiving skilled nursing, physical or occupational therapy, or speech-language pathology services. 5. The Registered Nurse or appropriately skilled professional must complete a supervisory assessment of the provided HHA aide services….13. Ensure HHAs (including contract staff) are: A. Following the patient’s plan of care for completion of tasks assigned by the Registered Nurse or other appropriate skilled professional. B. Maintaining an open communication process with the patient, representative (if any), caregiver, and family. C. Demonstrating competency with assigned tasks. 14. Supervisory visits may be made during an HHA visit with the patient when the employee is in the patient’s home so that the supervisor may observe them or when the employee is absent. A review of CR’s was conducted on June 30, 2025 starting at approximately 10:10 AM through 4:00 PM. The start of care (SOC) and Home Health Certification Period (CP) are indicated below. CR#3 SOC 05/05/2025, CP 05/05/2025 to 07/03/2025. A review of the clinical record found that a home health aide (aide) care plan had been prepared by a registered nurse (RN) on 05/05/2025. During the home visit that was conducted on July 1, 2025 at 11:35, the RN stated that the patient is receiving services from an aide. The administrator, in an interview conducted on July 1, 2025 at approximately 12:25 PM, stated that the patient has been receiving aide services since 05/07/2025. A review of skilled nursing (SN) notes for 5/15, 5/20, 5/22, 5/27, 5/29, 6/3, 6/5, 6/10, 6/17, 6/19, 6/24, 6/26 stated “needs met by intermittent HHA (aide).” There were no aide visit notes contained in the clinical record, nor was there any documentation of RN supervisory visits during the CP. CR#4 SOC 3/27/2025, CP 3/27/2025-5/25/2025. A HHA care plan was created on 6/15/2025 but signed on 5/5/2025, however there were no notes on file to indicate that the patient received HHA services or the frequencies of the visits. The administrator indicated that the patient received HHA services but could not locate the notes during the time of the survey. No evidence of RN Supervisory visits were conducted every two (2) weeks during the duration that the patient was supposed to be receiving HHA services. An interview conducted with the administrator and director clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”

“Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This Element is not met as evidenced by: Based on a review of personnel files (PF), home health agency policies, and an interview with the administrator, the HHA failed to assure that criminal background checks, child abuse clearance, FBI clearance, a signed position description, competency assessments, Hepatitis B vaccination/declination, tuberculosis testing, and/or a TB risk assessment was completed upon hire for seven (7) of seven (7) PF’s reviewed: PF#1, PF#2, PF#3, PF#4, PF#5, PF#6, and PF#7. Findings include: The HHA’s Policy Employment PER001.1 reviewed on July 1, 2025 at approximately 10:00 AM states in part, “The applicant will provide a signed and dated job description form....Prior to the date of hire, all employees, including contract staff, who have direct patient care will obtain the following background checks: A Pennsylvania Criminal History Report completed through the Pennsylvania State Police....The agency will maintain health records for employee with direct patient contact separately from their personnel files. The medical record must include...Hepatitis B vaccination acceptance or declination provided to each new employee with patient contact upon hire.” The HHA’s Policy Competency Evaluation PER-014.1 reviewed on July 1, 2025 at approximately 10:10 AM states in part, “The agency will assess competency of any new employee in accordance with the position’s expected requirements before they are allowed to provide independent patient care or services.” The HHA’s Policy Tuberculosis (TB) Infectious Control ICP-005.1 reviewed on July 1, 2025 at approximately 10:20 AM reads in part, “All new agency employees must undergo tuberculosis (TB) screening before starting work. This includes a baseline individual risk assessment (a three-question assessment), a symptoms evaluation, and a TB test upon hire. The two-step testing, the Mantoux skin test (TST) shall be used for baseline or initial testing.” The CDC guidelines state that all Health Care Workers (HCW) should receive baseline tuberculosis screening upon hire using a two-step tuberculin skin test (TST) or a single blood assay for tuberculosis (TB) to test for infection with tuberculosis. After baseline testing for infection with tuberculosis, HCW’s should receive TB screening annually. HCW’s with a baseline positive or newly positive test for tuberculosis infections should receive one chest radiograph result to exclude tuberculosis disease (CDC Guidelines for Preventing Transmission of Mycobacterium Tuberculosis in Health Care Settings, 2005. Morbidity and Mortality World Report 2005, RR-17) (http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf). *Baseline (preplacement) screening and testing, in addition to the IGRA (interferon-gamma release assay) or TST, shall include a symptom screen questionnaire and an individual TB risk assessment. Serial screening and testing not routinely recommended. Annual TB education is recommended. (CDC/MMWR/May 17, 2019/Vol. 68/No. 19). A review of PF’s was conducted on June 30, 2025 starting at 2:55 PM. The date of hire (DOH) is indicated below. PF#1 DOH 05/20/2025 contained a registered nurse job description that was signed by the employee but not dated. There was no Pennsylvania Access to Criminal History (PATCH) report contained in the PF. A TB risk assessment was not completed upon hire. PF#2 DOH 03/26/025 contained a PATCH report that was not obtained until 05/01/2025, thirty-six (36) days after the DOH. The HHA verified that PF#2’s first day of providing service to patients was 03/27/2025. The initial competency assessment was not completed until 05/20/2025, approximately two (2) months after the DOH. A TB risk assessment was not completed upon hire. PF#3 DOH 04/28/2025 contained a PATCH report that was not obtained until 05/01/2025, three (3) days after the DOH. A TB risk assessment was not completed upon hire. PF#4 DOH 05/12/2025 contained a late Pennsylvania Access to Criminal History (PATCH) report dated for 6/9/2025. File did not contain proof that a CPR card was provided to the agency upon hire. New Hire Orientation form on file did not contain dates or signatures. The initial competency assessment was not completed but contained signatures. No evidence that Emergency Preparedness Training and Infection Control Education was provided upon hire, as the form on file did not contain a signature of a date. Employee indicated on the Hepatitis B form that proof would be provided to the agency that a vaccine was received prior to hire but no evidence on file that a vaccine was received. A TB risk assessment was not completed upon hire. PF#5 DOH 05/07/2025 did not contain a PATCH, Child Abuse Report and FBI Clearance on file. File did not proof that the employee had a HHA certification or completed a seventy-five (75) hour training provided by the agency. File contained a competency exam dated for 5/7/2025 but Administrator could not provide any documentation of the seventy-five (75) hour training course. A TB risk assessment was not completed upon hire. PF#6 (contracted) DOH 05/29/2025 did not contain a PATCH report. There was no competency assessment present in the PF. A Hepatitis B antibody (positive) titer result from 09/25/2016 was present in the file, but there was no indication that the individual was offered the Hepatitis B Vaccine upon hire. The results of a QuantiFERON blood assay study dated 01/09/2024 was not obtained within one year of the DOH. A one step TST was administered on 09/23/2024. There was no second step TST contained in the PF nor any other evidence of TB testing. There was no TB symptom screen or TB risk assessment in the PF. PF#7 (contracted) DOH 06/06/2025 did not contain a PATCH report. There was no competency assessment present in the PF. A one step TST was administered on 04/22/2024. There was no second step TST contained in the PF, nor any other evidence of TB testing. A TB risk assessment was not completed upon hire. An interview conducted with the administrator and director clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”

“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 a review of clinical records (CR), home health agency (HHA) policy, home visit observations, and an interview with the administrator and director of clinical services, the HHA failed to assure that clinical notes were present and/or completed in a timely manner. Three (3) of four (4) CR’s reviewed did not meet the requirement: CR#2, CR#3 and CR#4. Findings include: The HHA’s Policy PC-029.1 Medication Reconciliation reviewed on July 1, 2025 at 2:10 PM states in part, “The clinician must provide the patient and caregiver with a current, written medication profile outlining medication instructions including but not limited to: medication name, dosage, route, frequency, classification, date prescribed or taken, date discontinued, drug or food allergies, medications that will be administered by the agency and/or personnel acting on behalf of the agency.” The HHA’s Policy PC-040.1 Documentation reviewed on July 1, 2025 at 2;50 PM reads in part, “Employees will complete documentation of service ordered on the care plan the day service is provided and submit documentation to the agency within seven (7) days.” A review of CR’s was conducted on June 30, 2025 starting at approximately 10:10 AM through 4:00 PM. The start of care (SOC) and Home Health Certification Period (CP) are indicated below. CR#2 SOC 6/6/2025. CP 6/6/2025-8/4/2025. A review of the patient file did not contain any documentation that consents were signed upon admission. File indicated a referral date of 6/2/2025, however the initial assessment was completed late on 6/8/2025. No nursing notes indicating reason why initial assessment was completed late and that the physician was notified. A review of the clinical record found that the patient was referred to PT and MSW. As per the RN, the patient declined the services, however, there were no notes in the patients file indicating the refusal and nothing that indicates that the physician was notified. A review of skilled nursing notes on June 30, 2025 indicated that no notes were available for review for 6/24/2025 and 6/26/2025. The electronic record indicated that the visits were “not yet started.” Both visit notes were completed and co-signed on 6/30/2025 by the director of clinical services and available for review on July 1, 2025. CR#3 SOC 05/05/2025, CP 05/05/2025 to 07/03/2025. A review of the clinical record found that a home health aide (aide) care plan had been prepared by a registered nurse (RN) on 05/05/2025. During the home visit that was conducted on July 1, 2025 at 11:35, the RN stated that the patient is receiving services from an aide. The administrator, in an interview conducted on July 1, 2025 at approximately 12:25 PM, stated that the patient has been receiving aide services since 05/07/2025. A review of skilled nursing (SN) notes for 5/15, 5/20, 5/22, 5/27, 5/29, 6/3, 6/5, 6/10, 6/17, 6/19, 6/24, 6/26 stated “needs met by intermittent HHA (aide).” There were no aide visit notes contained in the clinical record. A review of the electronic clinical record on 06/30/2025 found that CR#3 had orders for skilled nursing (SN) visits two (2) times per week for eight (8) weeks. Upon initial review, SN visit notes were not available for review for the following dates: 05/27, 05/29, 06/03, 06/05, 06/10, 06/12, 06/17, 06/19, 06/24, 06/26. The electronic record noted the above visits as “not yet started.” The visit notes were subsequently “co-signed” by the director of clinical services on 06/30/2025 at which time the visit notes were then available for review. A home visit for CR#3 was conducted on July 1, 2025 at approximately 11:35 AM. The patient is receiving his/her medications through a 3rd party pharmacy packaging company. The pharmacy prepares the medications in strip packaging with the date and time as to when the medication is to be taken by the patient. The pharmacy also provides a monthly medication administration record (MAR) which lists the medications, doses, and times of administration. A review of the pharmacy’s MAR for the time period 06/01/2025 to 06/30/2025 found that the patient is receiving Invega Sust Injection (used to treat schizophrenia) 150 milligrams (mg) per milliliter (ml) via an intramuscular injection every thirty (30) days. The surveyor asked the registered nurse (RN) about the administration of the Invega. The RN stated that the patient probably received it already for this month. A review of the MAR provided by the pharmacy did not contain any documentation of the Invega being administered. The OASIS (Outcome and Assessment Information Set) completed on 05/05/2025 notes that the patient is unable to take injectable medication unless administered by another person. A review of the skilled nursing visit notes encompassing the time frame of 5/05/2025 to 06/26/2025 found that there was no documentation of the Invega being administered by the home health agency, nor was there documentation establishing if the home health agency was responsible for administering the medication, nor documentation to assure that the medication was being administered. CR#4 SOC 3/27/2025, CP 3/27/2025-5/25/2025. A review of the patient file did not contain any documentation that consents were signed upon admission. Plan of Care did not contain frequency of visits for SN, HHA and PT. A HHA care plan was created on 6/15/2025 but signed on 5/5/2025, however there were no notes on file to indicate that the patient received HHA services. The administrator indicated that the patient received HHA services but could not locate the notes during the time of the survey. No Supervisor visits every two (2) weeks were made by the nurse during the duration that the patient was supposed to be receiving HHA services. An interview conducted with the administrator and director clinical services on July 1, 2025 starting at 4:15 PM confirmed the above findings.”