Humble Home Health Care Inc.

“Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms “facility” or “facilities” in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: Based on record review and interview, the Agency failed to develop an emergency preparedness plan that had been reviewed and updated at least every 2 years, resulting in lack of updated direction for Agency personnel in the event of an actual emergency or disaster. This deficient practice could affect the health and safety of all directly employed staff, regularly utilized contracted staff and all patients serviced by this Agency in the event of a facility emergency or disaster (E0004); failed to ensure its Emergency Preparedness policies and procedures were reviewed and updated at least every 2 years, resulting in the potential for poor patient outcomes during a disaster if staff are ill-prepared (E0013); failed to develop and maintain an emergency preparedness communication plan that included contact information for all current staff, patient’s physicians, and volunteers, as appropriate, which had the potential to negatively affect the health and safety of all patients currently serviced by this agency as a result of lack of effective communication in the event of an actual emergency (E0030); failed to develop and maintain an emergency preparedness training and testing program for staff based on the agency’s emergency plan, resulting in agency personnel not being educated in actions to take in the event of an actual disaster (E0036); failed to provide documentation for the required community/facility based full-scale exercises and failed to provide documentation of an actual event that would qualify as a test of the emergency plan, resulting in staff being ill-prepared in the event of an actual emergency. This deficient practice could negatively affect all patients currently serviced by this Agency (E0039). The cumulative effect of these systemic problems could potentially have a negative effect on all patients cared for by the home health agency in the event staff is not properly prepared for an emergency for the Condition of Participation of 42 CFR §484.102, Emergency Preparedness.”

“Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA’s governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA’s performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This Condition is not met as evidenced by: Based on record review and interview, the Agency failed to provide evidence of its efforts to measure, track and analyze its quality indicators in order to assess processes of care and services, (G642); failed to ensure that the collected data was used to monitor the effectiveness and safety of services provided with opportunities for improvement; and failed to ensure the Governing Body approved the program’s frequency and detail of data collection (G644); failed to develop Performance Improvement activities, as part of the Agency’s Quality Assessment Performance Improvement program, in order to track and trend adverse patient events, analyze the cause and implement preventive interventions, (G654); failed to develop a Quality Assessment Performance Improvement (QAPI) program that documented its quality improvement projects, the reasons for conducting these projects with measurable progress achieved for calendar years 2023 and 2024 (G658); and, the Governing Body failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that fulfilled all the regulatory requirements of this section, addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness (G660). The cumulative effect of these systemic problems resulted in the agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation CFR§484.65 Quality Assessment and Performance Improvement (QAPI).”

“Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to maintain a coordinated agency-wide program for the surveillance, identification, and prevention of infections, and failed to ensure the infection control program was an integral part of the agency’s Quality Assessment Performance Improvement (QAPI) program (G684); and, failed to provide documented evidence that infection control education was provided to all staff employed by the agency, including contracted staff (G686). The cumulative effect of these systemic problems resulted in the agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR§484.70 Infection Prevention and Control.”

“Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This Condition is not met as evidenced by: Based on observation, record review and interview, it was determined that the Agency failed to adequately assess and monitor the needs of the patient in 4 (P-3, P-4, P-5, P-7) of 7 sampled patient records reviewed (see G704); failed to ensure services were provided in accordance with the Physician’s orders for 3 (P-1, 6, 7) of 3 patient reviewed, who were ordered to receive Skilled Nursing, Physical therapy, Occupational Therapy and Home Health Aide services, from a total of 7 sampled records reviewed (see G710); and failed to ensure the clinical record was complete and included detailed wound measurements for 1 (P-5) of 7 records reviewed (See 716). The cumulative effect of these systemic failures resulted in a hospitalization for unidentified patient needs; the possibility for decline in physical functioning and unmet care needs; and the physician not having a complete clinical picture of the patient’s health status during the period of care.”

“Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to develop an emergency preparedness plan that had been reviewed and updated at least every 2 years, resulting in lack of updated direction for Agency personnel in the event of an actual emergency or disaster. This deficient practice could affect the health and safety of all directly employed staff, regularly utilized contracted staff and all patients actively serviced by this Agency in the event of a facility emergency or disaster. Findings include: On 2/20/25 at 10:00 am, review of the Agency’s Emergency Preparedness Plan failed to provide any evidence that a review or updates had been documented. This deficient practice was confirmed during an interview with Adm #1 (Administrator) at 11:30 am., on 2/20/25. Adm #1 stated, “We have not updated the Emergency preparedness program since our last survey when we were accredited.” The Agency failed to develop and maintain an emergency preparedness program that included the required elements, that must be reviewed and updated at least every 2 years as required.”

“Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure its Emergency Preparedness policies and procedures were reviewed and updated at least every 2 years, resulting in the potential for poor patient outcomes during a disaster if staff are ill-prepared. Findings include: On 2/20/25 at 10:00 am, review of the Agency’s Emergency Preparedness documents, it was noted that there was no documented evidence that the agency’s Emergency Preparedness policies and procedures had been reviewed and updated at least every 2 years. On 2/20/25 at 11:30 am, Adm #1 (Administrator) was asked if the agency had conducted the required risk assessment and reported, “We have not updated the Emergency preparedness program since our last survey when we were accredited.””

“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, it was determined that the facility failed to develop and maintain an emergency preparedness communication plan that included contact information for all current staff, patient’s physicians, and volunteers, as appropriate, which had the potential to negatively affect the health and safety of all patients currently serviced by this agency as a result of lack of effective communication in the event of an actual emergency. Findings include: During a review of the agency’s emergency preparedness documents on 2/20/25 at 10:00 am, it was noted that there was no updated contact information for all current staff, patient’s physicians, or volunteers as appropriate. On 2/20/25 at 11:30 am, Adm #1 (Administrator) was asked if the agency had conducted the required risk assessment and reported, “We have not updated the Emergency preparedness program since our last survey when we were accredited.””

“EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to develop and maintain an emergency preparedness training and testing program for staff based on the agency’s emergency plan, resulting in agency personnel not being educated in actions to take in the event of an actual disaster. This deficient practice could affect all patients serviced by this Agency. Findings include: During review of the agency’s Emergency Preparedness documents and policies on 2/20/25 at 10:00 am, it was noted that the Agency did not have documented evidence that they had developed a training and testing program for staff that was based on the agency’s emergency plan. The above findings were reviewed with and confirmed by the Adm #1 (Administrator) during an interview on 2/20/25 at 11:30 am, who stated, “Nothing has been updated since the last survey when we were accredited.””

“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 provide documentation for the required community/facility based full-scale exercises and failed to provide documentation of an actual event that would qualify as a test of the emergency plan, resulting in staff being ill-prepared in the event of an actual emergency. This deficient practice could negatively affect all patients currently serviced by this Agency. Findings include: During the review of the agency’s Emergency Preparedness documents on 2/20/25 at 10:00 am, it was noted that there was no evidence the agency had conducted any training or exercises to test the agencies emergency plan. Further, there was no documentation of an actual event that would qualify as an emergency, no community based full-scale exercise, no second full-scale exercise or a table-top exercise that would satisfy this requirement. On 2/20/25at 11:30 am, Adm #1 (Administrator) was asked if the agency had conducted the required risk assessment and reported, “We have not updated the Emergency preparedness program since our last survey when we were accredited.””

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure services were provided in accordance with the Physician ordered visit frequency for 4 (P-2, P-3, P-6, P-7) of 7 sampled records reviewed, resulting in the potential for decline in physical health and unmet care needs. Findings include: P-2: The patient’s start of care was 1/31/25 with diagnoses that included Anemia, Small bowel Obstruction and Stroke. The Plan of Care ordered Physical Therapy (PT) services to be provided at a frequency of 1x/wk. x 1 wk., 2x.wk. x 5 wks., 1x/wk. x 1 wk. During the record review on 2/20/25 at 10:35 a.m., it was noted that PT missed 1 of 2 scheduled visits during the 2nd week of service. A missed visit note documented the patient was not feeling well, however, there was no documented attempt to make up the visit in order to honor the ordered visit frequency. Additionally, PT missed 2 of 2 scheduled visits during the 3rd week of service due to a doctor’s appointment and a request to reschedule. There was no documented evidence to support that the PT attempted to reschedule the missed visits in order to honor the visit frequency, and no Physician’s order to forego the ordered visits. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Chief Executive Officer during an interview on 2/21/25 at 12:38 p.m. P-3: The Start of Care (SOC) was dated 10/10/24. The Plan of Care (POC) identified diagnoses of Transient Ischemic Attack, Hypertension, Paralytic Gail, Muscle Weakness and Shortness of Breath. During record review on 2/18/25, it was noted that the home health aide (HHA) documented a missed visit on 10/18/24 stating, “No answer to phone call. Patient didn’t answer to 3 calls. Will try again tomorrow.” There was no evidence the HHA attempted to contact or complete a visit on 10/19/24. The HHA failed to reschedule the visit to meet the ordered frequency in the plan of care. This finding was reviewed with and acknowledged by the Adm #1 (Administrator) and CM #1 (Clinical Manager) during an interview on 2/21/25 at 10:35 am. **Policy titled “Plan of Care” (revised 2/2021) stated, “30. The patient’s orders for treatments and services are the foundation of the plan of care. If the Agency misses a visit or a treatment or services as required by the plan of care, which results in any potential for clinical impact upon the patient, then the Agency must notify the responsible physician/practitioner of such missed treatment or service. The physician/practitioner decides whether the treatment or service may be skipped or whether additional intervention is required by the Agency due to the clinical impact on the patient.” P-6: This 78-year-old patient was admitted to this home care agency on 12/10/24 with the diagnoses of left shoulder adhesive capsulitis (“frozen shoulder”) and vascular dementia. During record review on 2/19/25, it was noted a missed visit note was written by skilled nursing on 12/27/24 due to “No answer to Phone Call.” The missed visit note indicated the physician was notified, however, there was no indication of the physician’s response or attempts made to reschedule the visit to meet the frequency in the plan of care. P-7: This 75-year-old patient was admitted to this home health agency on 1/22/25 with the diagnoses of a left total knee replacement, hypothyroidism, and type II diabetes. During record review on 2/19/25, it was noted skilled nursing wrote missed visit notes for 1/29/25 and 2/5/25 due to “No answer to Phone Call.” The missed visit note indicated the physician was notified, however, there was no indication of the physician’s response or attempts made to reschedule the visit to meet the frequency in the plan of care. Findings were reviewed with and acknowledged by the Administrator (Adm #1), the Alternate Administrator (Adm #2), and the Clinical Manager (CM #1) during an interview on 2/21/25 at 11:20 AM.”

“Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to provide evidence of its efforts to measure, track and analyze its quality indicators in order to assess processes of care and services, resulting in the inability to determine the scope of services provided and the potential unmet care needs for all patients currently serviced by this agency. Findings include: On 2/20/25 at 12:10 p.m., a review of the agency’s QAPI data was conducted with the Administrator (Adm #1), Clinical Manager (CM #1) and the Chief Executive Officer (CEO #1). During the review, it was noted that there was no data to review for the calendar years 2023 and 2024 that showed the agency’s efforts to measure, track and analyze indicators in order to determine if care and services have been provided safely and appropriately. These findings were reviewed with and acknowledged by Adm #1, CM #1 and CEO #1 at the time of discovery.”

“Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA’s governing body. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure that the collected data was used to monitor the effectiveness and safety of services provided with opportunities for improvement; and failed to ensure the Governing Body approved the program’s frequency and detail of data collection, resulting in the potential for poor patient outcomes for all patients currently serviced by this agency. Findings include: On 2/20/25 at 12:10 p.m., the agency’s QAPI data was requested and reviewed with the Administrator (Adm #1), Clinical Manager (CM #1) and Chief Executive Officer (CEO #1). Upon review of the requested information, it was noted that the agency failed to collect and analyze their QAPI data in order to monitor the quality, effectiveness and safety of services and care provided to their patients, and to identify opportunities for improvement. Additionally, there was no evidence that the Agency’s Governing Body approved the frequency and detail of the QAPI data collected. These findings were reviewed with and acknowledged by Adm #1, CM #1 and CEO #1 at the time of discovery.”

“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 record review and interview, the agency failed to develop Performance Improvement activities, as part of the Agency’s Quality Assessment Performance Improvement program, in order to track and trend adverse patient events, analyze the cause and implement preventive interventions, resulting in the potential for the rendering of substandard care and unmet care needs On 2/20/25 at 12:10 p.m., during a review of the agency’s QAPI documents with the Administrator (Adm #1), Clinical Manager (CM #1) and Chief Executive Officer (CEO #1), it was noted that the agency had no Performance Improvement Projects in place that would serve to track/trend adverse patient events, analyze causative factors and implement preventive interventions. These findings were acknowledged at the time of interview and discovery. These findings were reviewed with and acknowledged by Adm #1, CM #1 and CEO #1 during the above interview.”

“Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA’s services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This Standard is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to develop a Quality Assessment Performance Improvement (QAPI) program that documented its quality improvement projects, the reasons for conducting these projects with measurable progress achieved for calendar years 2023 and 2024, resulting in the Agency’s inability to improve in patient care, health outcomes, patient safety, quality of care and the agency’s performance. Findings include: On 2/20/25 at 12:10 p.m., during a review of the agency’s QAPI documents with the Administrator (Adm #1), Clinical Manager (CM #1) and Chief Executive Officer (CEO #1), it was noted that the agency had no Performance Improvement Projects in place. These findings were acknowledged at the time of interview and discovery.”

“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, it was determined the Governing Body failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that fulfilled all the regulatory requirements of this section, addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to adversely affect the quality of care for all patients currently serviced by this agency. Findings include: On 2/20/25 at 12:10 p.m., the Agency’s QAPI data, including Governing Board meeting minutes for calendar years 2023 and 2024 was reviewed with the Administrator (Adm #1), Clinical Manager (CM #1) and Chief Executive Officer (CEO #1). During the review, it was noted that there was no QAPI data available for review for the requested calendar years. Additionally, the Governing Board meeting minutes made no mention of the agency’s QAPI program. There was no indication that the Governing Board provided oversight of its QAPI program. These findings were reviewed with and acknowledged by Adm #1, CM #1 and CEO #1 at the time of discovery.”

“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 maintain a coordinated agency-wide program for the surveillance, identification, and prevention of infections, and failed to ensure the infection control program was an integral part of the agency’s Quality Assessment Performance Improvement (QAPI) program, resulting in the potential for increased, untreated infections among staff and all patients serviced by this agency. Findings include: On 2/20/25 at 12:00 p.m., during an interview with the Administrator (Adm #1), Clinical Manager (CM #1) and Chief Executive Officer (CEO #1), a request was made to review the agency’s Infection Control data. CEO #1 reported the agency had no infections and therefore, no logs or data to present. When asked to review Infection Control meeting minutes, documented efforts of tracking infections, Employee Infection program and evidence that the Infection Control Program was included as part of the agency’s QAPI program, the administrative staff was unable to provide the requested documentation. The agency failed to maintain an effective Infection Control Program as part of its QAPI program. These findings were reviewed with and acknowledged by Adm #1, CEO #1 and CM #1 during the above interview.”

“Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to provide documented evidence that infection control education was provided to all staff employed by the agency, including contracted staff, resulting in the potential for the development and spread of infection to staff and all patients currently serviced by this agency. Findings include: On 2/18/25 at 1:30 p.m., the Administrator (Adm #1) was asked for permission to review the agency’s Infection Control documentation, specifically evidence of staff infection control education and in-services. Adm #1 presented a binder titled, “New Hire Inservice (Employee/Contract Staff).” Upon review, it was noted that an “Employee In-Service Log Meeting” document listed 5 employees. there was no title or any information regarding the type of in-service provided. Additionally, the date on the form of listed names was 5/24/21, 7/8/21, 7/22/21 and 8/9/21. It could not be determined what staff were educated on and if contracted staff were included in the training. The agency’s “Infection Control Program” policy, undated, documented, “Education of staff in infection control is required at orientation and annually. At a minimum should include the following topics: handwashing, personal hygiene, transmission of infection, standard precautions and blood borne pathogens, disposal of infectious waste and sharps, appropriate cleaning issues...” The agency failed to ensure staff received annual infection control education in the required topics. These findings were reviewed with and acknowledged by Adm #1 during the above review and again during the exit conference.”

“Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This Standard is not met as evidenced by: Based on observation, record review and interview, it was determined that the Agency failed to adequately assess and monitor the needs of the patient in 4 (P-3, P-4, P-5, P-7) of 7 sampled patient records reviewed, resulting in a potentially poor patient outcomes. Findings include: P-7: This 75-year-old patient was admitted to this home health agency on 1/22/25 with the diagnoses of a left total knee replacement, hypothyroidism, and type II diabetes. During record review on 2/19/25, it was noted the plan of care contained “Orders For Discipline and Treatment:…O2 Saturation (10/15 minutes within 6-8 wks.” [sic] Upon further review of the record, it was noted the physical therapist failed to document O2 saturation at the evaluation and at 4 of 4 subsequent follow-up visits. During an interview with the physical therapist (Adm #2) on 2/21/25 at 11:20 AM, Adm #2 stated he did not have a pulse oximeter to measure O2 saturation. The Administrator (Adm #1) and Clinical Manager (CM #1) were also present during the interview and state they would make sure Adm #2 gets one and acknowledged the findings. **Agency Policy: “Skilled Professional Services” (Revised February 2021). The policy states, “Policy: Patients receiving skilled professional services will have appropriate assessments, reassessments, care planning and established outcomes and care per physician/practitioner orders… 3. Skilled professionals must assume responsibility for, but not restricted to the following: Ongoing interdisciplinary assessment of the patient… Providing services that are ordered by the physician/practitioner as indicated in the plan of care. Preparing clinical notes.” **Agency Policy: “Nursing Services” (Revised February 2021). The policy states, “Policy: Patients receiving nursing services will have appropriate assessments, reassessments, care planning and established outcomes performed. Procedure: 2. Professional nursing services will be provided by a registered nurse and include: Initial and ongoing comprehensive assessments of the patient’s needs...Providing those services and/or treatments requiring substantial and specialized nursing skill.” P-3: The Start of Care (SOC) was dated 10/10/24. The Plan of Care (POC) identified diagnoses of Transient Ischemic Attack, Hypertension, Paralytic Gail, Muscle Weakness and Shortness of Breath. During record review on 2/18/25, it was noted that Physical Therapy (PT) completed the comprehensive assessment on 10/10/24 with an ordered frequency of 1w1 (1 time a week for 1 week), 2w6, 1w1. Additionally, the comprehensive assessment noted, “Respiratory Status: When is the patient dyspneic or noticeably short of breath? 2. With moderate exertion (for example, while dressing, using commode or bedpan, walking distances less than 20 feet).” The POC contained “Orders For Discipline and Treatment: …O2 Saturation: less than (On 10/31/24, the PT documented, “Assessment: …Patient get SOB (Short of Breath) with minor execrations, required frequent rest.” (SIC) 14 of 14 completed PT visits failed to document O2 saturation. P-4: The Start of Care (SOC) was dated 2/17/25. The Plan of Care (POC) identified diagnoses of Hypoglycemia, Diabetes Type 2 and Congestive Heart Failure. During a joint in-home observation visit on 2/19/25 with the Registered Nurse (RN), it was observed that the patient had swelling to the left ankle and pedal area and the RN failed to measure edema or complete a pitting test (Gently press your finger on a swollen area of your skin for five to 15 seconds. If a dimple (pit) appears after releasing pressure, it indicates fluid buildup in your tissues). Additionally, the patient had a small amount of bruising near his left ankle. During record review on 2/19/25 and 2/20/20, it was noted that the RN visit completed on 2/19/25 failed to document edema under the cardiovascular section and bruising under the integumentary section. P-5: The Start of Care (SOC) was dated 10/14/24. The Plan of Care (POC) identified diagnoses of Lower Extremity Wounds, Hypertension and Diabetes Type 2. During record review on 2/20/25, it was noted that the Registered Nurse (RN) completed a discharge on 1/15/25 and documented, “Integumentary status: Dry. Wound(s): Blank. Comments: Bilateral Lower extremities elephantitis.” (SIC) The agency received a referral on 1/15/25 stating, “Opening Discipline(s): Skilled Nurse (RN) Additional Discipline(s): Wound Care….I had a face-to-face encounter with this patient on 1/14/2025…Describe the change: Foul odor and purulent drainage from both legs…” The RN failed to accurately assess the wound at discharge which could have the potential for a poor patient outcome. These findings were reviewed with and acknowledged by the Adm #1 (Administrator) and CM #1 (Clinical Manager) during an interview on 2/21/25 at 10:25 am and stated, “I am not sure why that patient was discharged with an odorous wound. They should have been recertified to address the issue.””

“Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the home health aide had clear, written patient care instructions regarding visit frequency in 1 (P-6) of 3 records reviewed with home health aide services from a total of 7 records reviewed, resulting in the potential for unmet care needs. Findings include: P-6: This 78-year-old patient was admitted to this home care agency on 12/10/24 with the diagnoses of left shoulder adhesive capsulitis (“frozen shoulder”) and vascular dementia. During review of the aide care plan dated 12/10/24, it was noted there was no visit frequency indicated. Findings were reviewed with and acknowledged by the Administrator (Adm #1), the Alternate Administrator (Adm #2), and the Clinical Manager (CM #1) during an interview on 2/21/25 at 11:20 AM.”

“Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient’s home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that at least one qualifying service was provided directly by agency employees, resulting in the potential for interruption in continuity of care and unmet care needs for all patients serviced by this agency. Findings include: On 2/18/25 at 10:06 a.m., during the entrance conference, the Administrator (Adm #1) was queried as to what services were provided by the agency and reported, “We provide Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Medical Social Work (MSW), Speech Therapy (ST) and Home Health Aide (HHa) services.” When asked which service(s) were provided directly by the agency, Adm #1 responded, “Skilled Nursing.” A review of the agency’s contracts (AK Staffing & Consulting, LLC, Romeo Staffing Agency and Assist 1 Medical Staffing) was conducted on 2/18/25 at 2:35 p.m. and revealed that all the above services were provided by contracted entities. There was no documented evidence that at least one qualifying skilled service was provided directly by agency employees. These findings were reviewed with and acknowledged by Adm #1 during an interview on 2/19/25 at 2:55 p.m.”

“Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient was allowed the right to participate and be informed about changes in services provided in 3 (P-3, P-4, P-7) of 7 records reviewed, resulting in the potential for unmet care needs and a violation of patient rights. Findings include: P-3: The Start of Care (SOC) was dated 10/10/24. The Plan of Care (POC) identified diagnoses of Transient Ischemic Attack and Hypertension. During record review on 2/18/25, it was noted that a Physical Therapy (PT) completed the comprehensive assessment on 10/10/24. The consent signed by the patient under the section “Initial services and frequency” stated, “SN (Skilled Nursing): Eval, PT 1x1 (1 time a week for 1 week), 2x5, 1x2.” There was no documentation evidence that SN completed an evaluation. The agency failed to provide SN services that the patient consented to. P-4: The Start of Care (SOC) was dated 2/17/25. The Plan of Care (POC) identified diagnoses of Hypoglycemia, Diabetes Type 2 and Congestive Heart Failure. During record review on 2/19/25, it was noted that the referral dated 2/13/25 ordered “Physical Therapy (PT) and Occupational Therapy (OT).” There was no documentation that the patient declined OT services. The agency failed to provide OT services as referred. These findings were reviewed with and acknowledged by the Adm #1 (Administrator) and CM #1 (Clinical Manager) during an interview on 2/21/25 at 10:05 am. **Policy titled “Consent for Treatment and Services” (revised 2/2021) stated, “The patient has the right to be informed in advance regarding the care to be furnished and any subsequent changes in care.” It also stated, “1. The staff member performing the admission visit will explain the Consent/Release of Information form during the initial visit in addition to: Frequency of visits to be provided; Various disciplines to provide services….”. P-7: This 75-year-old patient was admitted to this home health agency on 1/22/25 with the diagnoses of a left total knee replacement, hypothyroidism, and type II diabetes. During record review on 2/19/25, it was noted the consent form signed by the patient (dated 1/22/25) indicated the patient would receive services from skilled nursing, physical therapy, home health aide, and social work. Upon further review of the record, it was determined the patient did not receive any home health aide or social work visits. There was no documentation of any refused, attempted, or missed visits by either discipline. Following a joint home visit with the physical therapist on 2/19/25 at 1:00 PM, P-7 was asked if she had received services from a home health aide or social worker. P-7 stated a home health aide was scheduled to come out 2 weeks after her start of care, however, the visit was cancelled last week due to bad weather and had not been rescheduled. P-7 stated she was never contacted by a social worker to schedule an evaluation. P-7 also stated she wasn’t sure why the nurse had only been there once as she expected a visit once a week. According to the record, the nurse discharged the patient from nursing on 2/12/25 due to difficulty contacting the patient. The agency failed to provide care as consented to and failed to inform the patient of changes in care. Findings were reviewed with and acknowledged by the Administrator (Adm #1), the Alternate Administrator (Adm #2), and the Clinical Manager (CM #1) during an interview on 2/21/25 at 11:20 AM. **Policy titled “Consent for Treatment and Services” (revised 2/2021) stated, “The patient has the right to be informed in advance regarding the care to be furnished and any subsequent changes in care.” It also stated, “1. The staff member performing the admission visit will explain the Consent/Release of Information form during the initial visit in addition to: Frequency of visits to be provided; Various disciplines to provide services….”. P-7: This 75-year-old patient was admitted to this home health agency on 1/22/25 with the diagnoses of a left total knee replacement, hypothyroidism, and type II diabetes. During record review on 2/19/25, it was noted the consent form signed by the patient (dated 1/22/25) indicated the patient would receive services from skilled nursing, physical therapy, home health aide, and social work. Upon further review of the record, it was determined the patient did not receive any home health aide or social work visits. There was no documentation of any refused, attempted, or missed visits by either discipline. Following a joint home visit with the physical therapist on 2/19/25 at 1:00 PM, P-7 was asked if she had received services from a home health aide or social worker. P-7 stated a home health aide was scheduled to come out 2 weeks after her start of care, however, the visit was cancelled last week due to bad weather and had not been rescheduled. P-7 stated she was never contacted by a social worker to schedule an evaluation. P-7 also stated she wasn’t sure why the nurse had only been there once as she expected a visit once a week. According to the record, the nurse discharged the patient from nursing on 2/12/25 due to difficulty contacting the patient. The agency failed to provide care as consented to and failed to inform the patient of changes in care. Findings were reviewed with and acknowledged by the Administrator (Adm #1), the Alternate Administrator (Adm #2), and the Clinical Manager (CM #1) during an interview on 2/21/25 at 11:20 AM. P-3: The Start of Care (SOC) was dated 10/10/24. The Plan of Care (POC) identified diagnoses of Transient Ischemic Attack and Hypertension. During record review on 2/18/25, it was noted that a Physical Therapy (PT) completed the comprehensive assessment on 10/10/24. The consent signed by the patient under the section “Initial services and frequency” stated, “SN (Skilled Nursing): Eval, PT 1x1 (1 time a week for 1 week), 2x5, 1x2.” There was no documentation evidence that SN completed an evaluation. The agency failed to provide SN services that the patient consented to. P-4: The Start of Care (SOC) was dated 2/17/25. The Plan of Care (POC) identified diagnoses of Hypoglycemia, Diabetes Type 2 and Congestive Heart Failure. During record review on 2/19/25, it was noted that the referral dated 2/13/25 ordered “Physical Therapy (PT) and Occupational Therapy (OT).” There was no documentation that the patient declined OT services. The agency failed to provide OT services as referred. These findings were reviewed with and acknowledged by the Adm #1 (Administrator) and CM #1 (Clinical Manager) during an interview on 2/21/25 at 10:05 am.”

“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 the Initial Comprehensive Assessment was conducted within 48 hours of the date of referral, and failed to ensure a registered nurse conducted the initial assessment to determine the patients immediate care needs and home care eligibility in 4 (P-1, P-2, P-6, P-7) of 7 records reviewed, resulting in the potential for unidentified patient care needs. Findings include: P-1: The patient’s start of care (SOC) was 1/4/25 with diagnoses that included Joint Replacement, diabetes Mellitus and Congestive Heart Failure. During the record review on 2/19/25 at 9:30 a.m., it was noted that the referral for home care dated 1/2/25, ordered Skilled Nursing (SN), Physical Therapy (PT) and Occupational Therapy (OT) services to be provided. Though SN services were ordered, PT conducted the initial Comprehensive Assessment. The agency failed to ensure that SN conducted the initial assessment within 48 hours to determine the immediate care needs of the patient and to establish homebound status. These findings were reviewed with and acknowledged by the Administrator (Adm #1) Clinical Manager (CM #1) and Chief Executive Officer (CEO #1) during an interview on 2/21/25 at 12:29 p.m. P-2: The patient’s SOC was 1/31/25 with diagnoses that included Small Bowel Obstruction, Stroke and Anemia. During the clinical record review on 2/20/25 at 10:35 a.m., it was noted that the referral for home care was dated 1/27/25 and ordered Physical Therapy services to be provided. The start of care assessment was conducted 4 days later. There was no documented rationale for the delay in needed care and services. Additionally, there was no documented evidence that the patient requested a later start of care date. The agency failed to ensure the Initial Comprehensive Assessment was conducted within 48 hours of the date of the referral, as per this requirement. These findings were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 2/21/25 at 12:38 p.m. **Policy titled “Initial Assessments/Comprehensive Assessments” (revised 2/2021) stated, “A RN, PT or SLP must conduct the initial assessment visit within 48 hours of referral, within 48 hours of the patient’s return home or on the physician/practitioner-ordered start of care date.” The policy also stated, “A patient who requires short term nursing determined at the start of care in addition to ongoing therapy is not considered a therapy-only case, e.g. a one-time visit by a nurse scheduled to remove sutures. Therefore, the RN must do the initial assessment.” P-6: This 78-year-old patient was admitted to this home care agency on 12/10/24 with the diagnoses of left shoulder adhesive capsulitis (“frozen shoulder”) and vascular dementia. During record review on 2/19/25, it was determined the referral (not dated) ordered services from skilled nursing, physical therapy, occupational therapy, and home health aide. Upon further review of the record, it was determined the physical therapist performed the initial assessment at the start of care on 12/10/24. The nurse performed an evaluation on 12/12/24 – after the initial assessment was completed by the physical therapist. Upon review of the agency policy with the Administrator (Adm #1), the Alternate Administrator (Adm #2), and the Clinical Manager (CM #1) on 2/21/25 at 11:20 AM, Adm #1 agreed the information in the agency policy was conflicting. Additionally, Adm #1 stated he was not aware the physical therapist could no longer do the initial assessment in cases with skilled nursing also ordered. He reported he would update the policy to align with the current regulations. Adm #1 acknowledged the findings at the time of interview. **Policy titled “Initial Assessments/Comprehensive Assessments” (revised 2/2021) stated, “An agency that is unable to complete the initial assessment within 48 hours of the referral or the patient’s return home, will not request a different start of care date from the ordering physician/practitioner to ensure compliance with the regulation or to accommodate the convenience of the agency.” P-7: This 75-year-old patient was admitted to this home health agency on 1/22/25 with the diagnoses of a left total knee replacement, hypothyroidism, and type II diabetes. During record review on 2/19/25, it was determined the referral to start home care was dated 1/15/25 and stated the patient would be discharged home from sub-acute rehabilitation on 1/16/25. Upon further review of the record, it was noted the initial assessment by the registered nurse did not occur until 1/22/25 – 6 days after the patient’s return home. It was also noted an order dated 1/22/25 was sent to the physician regarding “Delayed SOC (start of care) orders.” The order indicated, “Patient requested to be seen on 01/22/2024, hence the delay in SOC.” Following a joint home visit with the physical therapist on 1/19/25 at 1:00 PM, P-7 was asked if she requested a later start date. P-7 stated she was discharged home on 1/16/25 and was ready to start home care right away. She indicated she did not request a later start date, and she was not informed of the reason for the delay in care. During an interview with the Administrator (Adm #1), the Alternate Administrator (Adm #2), and the Clinical Manager (CM #1) on 2/21/25 at 11:20 AM, Adm #1 was informed about the patient’s interview and was asked about the reason for the delay in her care. Adm #1 stated he remembered there were insurance and referral issues with this patient and that was the reason for the delay – not patient request. Adm #1, Adm #2, and CM #1 acknowledged the findings at the time of the interview.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum, the following information: (1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on observation, record review and interview, the agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient’s current health status based on past medical history that included dates of onset, exacerbations, treatments and outcomes, and history of events leading to current home care needs in 2 (P-4, P-6) of 7 records reviewed, resulting in incomplete clinical information to aide in determining the needs of the patient. Findings included: **Agency Policy: “Initial Assessments/Comprehensive Assessments” (Revised February 2021). The policy states, “Procedure: 1. Each patient admitted will receive a comprehensive assessment. The assessment will reflect the patient’s current health status and include information to demonstrate the patient’s progress toward achievement of desired outcomes… 2. The comprehensive assessment will identify the patient’s need for home care and meet the patient’s need for: Medical. Rehabilitative. Nursing… 8. The Initial Comprehensive Assessment also includes: Relevant diagnoses and current health status, including all active health and medical problems. Relevant medical history. Physical assessment/review of systems and pertinent physical findings…” P-4: The Start of Care (SOC) was dated 2/17/25. The Plan of Care (POC) identified diagnoses of Hypoglycemia, Diabetes Type 2 and Congestive Heart Failure. During record review on 2/19/25, it was noted that the comprehensive assessment completed by the Registered Nurse (RN) on 2/17/25 documented, “Height/Weight: Height: Blank. Weight: Blank. Checked box (Information not available. The patient cannot be weighted because of extreme pain, immobility, or risk of pathological fracture. Information is also unavailable if the patient is less than 50 inches tall or more than 80 inches tall and/or weighs less than 65 pounds or more than 440 pounds. Document your reason below. Comments: Blank.” During a joint in-home observation visit on 2/19/25 with the RN, the patient was observed walking to the bathroom and displayed no signs or symptoms of reasons unable to be weighed. Additionally, the RN documented under the Endocrine section, “Diabetes: Blood sugars performed by: Patient. Patient’s blood sugar status unknown (no glucometer, paper logs, visit reports, nor patient ability to report)…Diabetic Care: S/S (Signs and Symptoms) of hypoglycemia: Confusion, Faintness, Shakiness… Comments: Blank.” During a joint in-home observation visit on 2/19/25 with the RN, the patient was observed having a glucometer and log book containing past blood sugar readings. The RN stated that during the recent hospitalization the patient had an HA1C (glycated hemoglobin test) lab value of 8.1. The medical record failed to contain the patient’s weight, frequency to monitor blood sugars, relevant labs regarding HA1C, functioning glucometer, log book and diabetic history. These findings were reviewed with and acknowledged by the Adm #1 (Administrator) and CM #1 (Clinical Manager) during an interview on 2/21/25 at 11:05 am. P-6: This 78-year-old patient was admitted to this home care agency on 12/10/24 with the diagnoses of left shoulder adhesive capsulitis (“frozen shoulder”) and vascular dementia. During record review on 2/19/25, it was noted the Outcome and Assessment Information Set (OASIS) form completed at the start of care identified blood sugar parameters to report to the physician if out of range. Upon further review of the OASIS, it was noted it indicated the patient was not diabetic. Upon review of the referral information from the skilled nursing facility the patient was at prior to home care admission (dated 12/10/24), it was noted the second diagnosis was noted as “Type 2 diabetes mellitus with diabetic chronic kidney disease.” Review of a referral from a previous home care admission (dated 10/5/24) also indicated patient had “Type 2 diabetes mellitus with hyperglycemia, without long-term current use of insulin.” During an interview on 2/21/25 at 11:20 AM, the Alternate Administrator (Adm #2, who was also the physical therapist who completed the OASIS) was asked if this patient is diabetic. Adm #2 stated the patient was not diabetic. When presented with the information in the patient’s referrals, Adm #2 was unable to provide an explanation for the conflicting information and acknowledged it should have been looked into upon admission. Adm #2 acknowledged the findings. The Administrator (Adm #1) and Clinical Manager (CM #1) were present during the interview and also acknowledged the 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 record review and interview, the agency failed to conduct a review of the patient’s medications in 1 (P-6) of 7 records reviewed; and failed to ensure the medication profile contained new/updated medications in 2 (P-6, 7) of 7 records reviewed, resulting in the potential to miss harmful medication reactions. Findings include: **Policy titled “Medication Reconciliation” (revised 2/2021) stated, “2. Medications ordered while the patient is receiving care will be compared to the medication list/ profile. The medication list/profile will be updated with each new or changed medication. The patient’s medication list in the home will also be updated.” P-6: This 78-year-old patient was admitted to this home care agency on 12/10/24 with the diagnoses of left shoulder adhesive capsulitis (“frozen shoulder”) and vascular dementia. During review of the signed medication profiles for this patient, it was noted the last signed medication profile review was dated 10/8/24 – which was the date of the previous home care admission. There was no signed medication profile for the admission starting 12/10/24. Additionally, it was noted the skilled nursing evaluation dated 12/12/24 indicated in the visit narrative that, “….she has new meds midodrine 2 mg 3 x daily.” [sic] A box next to “Medications Reconciled” was also checked. There was no evidence the new medication was added to the medication list and reconciled. P-7: This 75-year-old patient was admitted to this home health agency on 1/22/25 with the diagnoses of a left total knee replacement, hypothyroidism, and type II diabetes. During a joint home visit with the physical therapist on 2/19/25 at 1:00 PM, the patient was asked what she was taking for pain. P-7 stated, “it starts with a ‘P’”, then later indicated it was Percocet, and she only took it at night. Upon review of the medication list on the plan of care, it was noted Percocet was not included. P-7 was then asked when she was prescribed the medication. P-7 stated she got it from the doctor right after being discharged home. She was unsure of the exact date but reported she had been taking it for several weeks. The physical therapist (Adm #2) was asked about the Percocet not being on the medication list following the visit. Adm #2 stated sometimes the patient forgets to tell him of medications they are taking, however, he acknowledged the error and stated he would correct it. Findings were again reviewed with and acknowledged by the Administrator (Adm #1), Adm #2, and the Clinical Manager (CM #1) during an interview on 2/21/25 at 11:20 AM.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care (POC) included allergies for 2 (P-3, P-4) of 7 records reviewed; failed to ensure the plan of care included patient specific parameters to meet the needs of the patient for 3 (P-3, P-4, P-6) of 7 records reviewed; and failed to ensure the plan of care included patient specific and measurable goals in 2 (P-6, 7) of 7 records reviewed, resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes. Findings include: **Agency Policy: “Plan of Care – CMS #485 and Physician Orders” (Revised February 2021). The policy states, “4. The individualized plan of care must include the following: The types of services, supplies and equipment required… Safety measures to protect against injury… Patient-specific interventions and education.” P-3: The Start of Care (SOC) was dated 10/10/24. The Plan of Care (POC) identified diagnoses of Transient Ischemic Attack, Hypertension, Paralytic Gail, Muscle Weakness and Shortness of Breath. During record review on 2/18/25, it was noted that the POC dated 10/10/24 stated, “Allergies: NKA (No Known Allergies).” The referral dated 9/24/24 documented the following allergy: Penicillin’s. The agency failed to document and accurately assess the patient’s allergy. Additionally, the POC documented interventions to monitor “Vital sign parameters for notifying physician: …Fasting Blood sugar: greater than (>) 180 mg/dL less than () 200 mg/dL less than ( P-4: The Start of Care (SOC) was dated 2/17/25. The Plan of Care (POC) identified diagnoses of Hypoglycemia, Diabetes Type 2 and Congestive Heart Failure. During record review on 2/19/25, it was noted that the POC dated 2/17/25 stated, “Allergies: NKA (No Known Allergies).” The referral dated 2/13/25 documented the following allergies: Motrin, Sulfa antibiotics and Tetracyclines. The agency failed to document and accurately assess the patient’s allergy. These findings were reviewed with and acknowledged by the Adm #1 (Administrator) and CM #1 (Clinical Manager) during an interview on 2/21/25 at 10:55 am. P-6: This 78-year-old patient was admitted to this home care agency on 12/10/24 with the diagnoses of left shoulder adhesive capsulitis (“frozen shoulder”) and vascular dementia. During record review on 2/19/25, it was noted the plan of care dated 12/10/24 did not list any goals written by the physical therapist. Under the sections labeled “Goals”, the interventions provided that day were listed instead. Additionally, the plan of care (dated 12/10/24) documented interventions to monitor “Vital sign parameters for notifying the physician: …Fasting Blood sugar: greater than (>) 180 mg/dL less than () 200 mg/dL less than ( Patient/Caregiver will demonstrate competence with self-management of [Disease Process] as evidenced by adherence to medication regimen, ability to identify s/s necessitating contact with medical professionals, diet regimen guidelines, activity compliance and symptom management by 5 weeks -Patient will receive safe and effective personal care during this episode of care. -Patient will attain optimal effectiveness of pain management by 4 weeks These goals lack patient specific, measurable, and quantifiable data to assess the patient’s progress towards meeting them. Additionally, there was no physical therapy goal set to monitor range of motion following surgery for a total knee replacement. Findings were reviewed with and acknowledged by the Administrator (Adm #1), the Alternate Administrator (Adm #2), and the Clinical Manager (CM #1) during an interview on 2/21/25 at 11:20 AM.”

“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 record review and interview, the agency failed to ensure visit were provided only as ordered by the physician for 1 (P-3) of 7 records reviewed, resulting in the potential for the provision of inappropriate care and services. Findings include: P-3: The Start of Care (SOC) was dated 10/10/24. The Plan of Care (POC) identified diagnoses of Transient Ischemic Attack, Hypertension, Paralytic Gail, Muscle Weakness and Shortness of Breath. During record review on 2/18/25, it was noted that Physical Therapy (PT) completed a comprehensive assessment on 10/10/24 and ordered PT at a frequency of 1w1 (1 time a week for 1 week), 2w5 and 1w1, no other services were documented as ordered. A Home Health Aide (HHA) care plan was completed on 10/10/24 that stated, “HHA Frequency: Blank.” The HHA completed 5 visits: 10/23/24, 10/31/24, 11/8/24, 11/13/24 and 11/20/24. The record failed to contain HHA orders. The agency failed to obtain HHA orders. This finding was reviewed with and acknowledged by the Adm #1 (Administrator) and CM #1 (Clinical Manager) during an interview on 2/21/25 at 10:35 am.”

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Physician was promptly notified of 1 (P-2) of 1 patient who experienced a significant change in condition, and failed to promptly notify the Physician concerning a heart rate outside of vital sign parameters for 1 (P-3) patient, from a total of 7 sampled records reviewed, resulting in the potential for worsening of health condition and unmet care needs. Findings include: P-2: The patient’s start of care was 1/31/25 with diagnoses that included Anemia, Small Bowel Obstruction and Stroke. During the clinical record review on 2/20/25 at 10:35 a.m., it was noted that the referral for home care dated 1/27/25, ordered Physical Therapy services to be provided. The hospital paperwork dated 1/23/25 documented “She presented to the ED (Emergency Department) with three days of abdominal pain, nausea and vomiting...” The documentation reported that the patient underwent a laparotomy with reduction of internal hernia and resection of the small bowel to repair a bowel tear. On 2/6/25, a Physical Therapy missed visit note documented, “Pt (patient) canceled, vomiting, not feeling good.” Upon further review of the clinical record, there was no documented evidence that the Physical Therapist promptly notified the Physician regarding the patient’s symptoms. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 2/21/25 at 12:38 p.m. **Agency Policy: “Coordination of Patient Care” (Revised February 2021). The policy states, “Policy: Agency staff members regularly communicate to ensure that their efforts are coordinated effectively and ultimately support the objectives outlined in the plan of care. Procedure: 1. The Agency must: Assure communication with all physicians/practitioners involved in the plan of care...6. Staff provides the physician/practitioner with patient information on an ongoing basis regarding: Current condition and changes in condition…” P-3: The Start of Care (SOC) was dated 10/10/24. The Plan of Care (POC) identified diagnoses of Transient Ischemic Attack, Hypertension, Paralytic Gail, Muscle Weakness and Shortness of Breath. During record review on 2/18/25, it was noted that the POC noted a reportable parameter stating, “Heart Rate: greater than (>) 100 bpm (beats per minute) less than ( This finding was reviewed with and acknowledged by the Adm #1 (Administrator) and CM #1 (Clinical Manager) during an interview on 2/21/25 at 10:05 am.”

“Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure coordination of care between all disciplines in 1 (P-7) of 7 records reviewed, resulting in the potential for unmet care needs. Findings include: **Policy titled “Coordination of Patient Care” (revised 2/2021) stated, “1. The Agency must:…Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines.” P-7: This 75-year-old patient was admitted to this home health agency on 1/22/25 with the diagnoses of a left total knee replacement, hypothyroidism, and type II diabetes. During record review on 2/19/25, it was noted skilled nursing documented missed visits on 1/29/25 and 2/5/25 due to “No answer to Phone Call.” Skilled nursing then documented a discharge note on 2/12/25 that stated, “patient had no further visits since soc. Nurse has not been able to contact patient for further visits. Nurse called multiple times and did drive by x2.” [sic] Upon further review of the record, it was noted that prior to being discharged by nursing, the physical therapist was able to see the patient on 1/27/25, 2/4/25, 2/6/25, and 2/11/25 with no missed visits noted. There was no evidence the nurse attempted to contact the physical therapist to help contact the patient to schedule more nursing visits or to identify any barriers in contacting the patient. During an interview on 2/21/25 at 11:20 AM, the physical therapist (Adm #2) was asked about scheduling this patient. Adm #2 stated this patient often does not get up until after 12:00 PM and does not always answer the phone, however, he was able to regularly contact the patient to make visits. Adm #2 was unable to provide documented evidence of the nurse attempting to coordinate care with the physical therapist to ensure patient was getting the care she needed and as ordered on the plan of care. Adm #2 acknowledged the nurse should have tried to coordinate care and services before discharging the patient. The Administrator (Adm #1) and Clinical Manager (CM #1) were also present during the interview and acknowledged the findings.”

“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 services were provided in accordance with the Physician’s orders for 3 (P-1, 6, 7) of 3 patients reviewed, who were ordered to receive Skilled Nursing, Physical therapy, Occupational Therapy and Home Health Aide services, from a total of 7 sampled records reviewed, resulting in the potential for decline in health status, poor grooming and unmet care needs. Findings include: P-1: The patient’s start of care was 1/4/25 with diagnoses that included Joint Replacement, Diabetes Mellitus and Congestive Heart Failure. During the clinical record review on 2/19/25 at 9:30 a.m., it was noted that the referral for home care dated 1/2/25 ordered Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT) and Home Health Aide (HHa) services to be provided. At the time of this review, no SN, OT or HHa services had been provided as ordered. Additionally, there was no documented evidence that the patient declined the ordered services or that the Physician had been notified that the ordered services had not been provided. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Chief Executive Officer during an interview on 2/21/25 at 12:29 p.m. P-6: This 78-year-old patient was admitted to this home care agency on 12/10/24 with the diagnoses of left shoulder adhesive capsulitis (“frozen shoulder”) and vascular dementia. During record review on 2/19/25, it was noted the plan of care (dated 12/10/24) ordered services from physical therapy 1 time a week for 1 week and 2 times a week for 6 weeks; home health aide 1 time a week for 4 weeks; and occupational therapy to evaluate and treat. Additionally, the referral from the physician (not dated) ordered skilled nursing services. Upon further review of the record, it was noted the patient was seen from 12/10/24 to 12/31/24 (3 weeks) before being transferred to the hospital. During the treatment period, the following was noted: -There were no physical therapy visits after the evaluation the first week and no documentation of missed or refused visits. -There was no evaluation completed by an occupational therapist and no documentation of missed or refused visits. -There were no home health aide visits the 1st week -The plan of care was not updated following the skilled nursing evaluation to include a visit frequency, however, skilled nursing did make 1 additional visit the week after the evaluation. P-7: This 75-year-old patient was admitted to this home health agency on 1/22/25 with the diagnoses of a left total knee replacement, hypothyroidism, and type II diabetes. During record review on 2/19/25, it was noted the plan of care (dated 1/22/25) ordered services from skilled nursing 1 time a week for 5 weeks; physical therapy to evaluate and treat; and home health aide 1 time a week for 5 weeks. Additionally, the referral from the physician (dated 1/13/25) ordered occupational therapy. Upon further review of the record, it was noted the patient started care on 1/22/25 and was still an active patient with this agency. Since the start of care, the following was noted: -There were no visits from skilled nursing in week 2 or 3 before the patient was discharged from skilled nursing services. There was no attempt to reschedule the missed visits to meet the frequency ordered in the plan of care. - There were no visits by a home health aide and no documentation regarding refused or missed visits. -There was no evaluation done by an occupational therapist and no documentation regarding refused or missed visits. Findings were reviewed with and acknowledged by the Administrator (Adm #1), the Alternate Administrator (Adm #2), and the Clinical Manager (CM #1) during an interview on 2/21/25 at 11:20 AM.”

“Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record was complete and included detailed wound measurements for 1 (P-5) of 7 records reviewed, resulting in lack of continuity of care, undocumented health concerns and potential poor outcomes. Findings include: **Agency Policy: “Nursing Services” (Revised February 2021). The policy states, “Policy: Patients receiving nursing services will have appropriate assessments, reassessments, care planning and established outcomes performed. Procedure: 2. Professional nursing services will be provided by a registered nurse and include: Initial and ongoing comprehensive assessments of the patient’s needs...Providing those services and/or treatments requiring substantial and specialized nursing skill…Preparing clinical and progress notes…” P-5: The Start of Care (SOC) was dated 10/14/24. The Plan of Care (POC) identified diagnoses of Lower Extremity Wounds, Hypertension and Diabetes Type 2. During record review on 2/20/25, it was noted that the Registered Nurse (RN) completed a comprehensive assessment on and order RN at a frequency of 1w7 (1 visit a week for 7 weeks). The referral dated 10/10/24 stated, “Opening Discipline(s): Skilled Nurse (RN) Additional Discipline(s): Wound Care…Recurrent Wound Care: Stage 2, Location: LLE, Size: 5cm x 4cm, Depth:1.5cm, Drainage: none…Wound care instructions: Clean and keep dry…” The patient was recertified on 12/9/24 with a frequency of 1w5 and was discharged on 1/15/25. The patient was subsequently admitted again on 1/21/25 for wound care with a frequency of 2w3, 1w6. The record contained no documented wound measurements for both admissions. Furthermore, the RN completed a discharge on 1/15/25 and documented, “Integumentary status: Dry. Wound(s): Blank. Comments: Bilateral Lower extremities elephantitis.” (SIC) The agency received a referral on 1/15/25 stating, “Opening Discipline(s): Skilled Nurse (RN) Additional Discipline(s): Wound Care….I had a face-to-face encounter with this patient on 1/14/2025…Describe the change: Foul odor and purulent drainage from both legs…” The RN failed to accurately document and assess the wounds. These findings were reviewed with and acknowledged by the Adm #1 (Administrator) and CM #1 (Clinical Manager) during an interview on 2/21/25 at 10:25 am and stated, “There should have been wound measurements completed.””

“Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA’s patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This Element is not met as evidenced by: Based on record review and interview, the agency failed to establish a written agreement with the contracted agency or organization from which contracted Home Health Aide services were provided, resulting in the potential for the rendering of unauthorized unsafe care and services, and unmet care needs. Findings include: On 2/18/25 at 10:06 a.m., during the entrance conference, the Administrator (Adm #1) was queried as to what services were provided by the agency and reported, “We provide Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Medical Social Work (MSW), Speech Therapy (ST) and Home Health Aide (HHa) services.” Adm #1 then reported that all the above services were listed in their supported contracts. A review of the agency’s contracts (AK Staffing & Consulting, LLC 1/1/23; Romeo Staffing Agency 1/1/23; and Assist 1 Medical Staffing) was conducted on 2/18/25 at 2:35 p.m. During the review, it was noted that the provision of Home Health Aide services had not been included in any of the listed contracts. On 2/19/25 at 2:55 p.m., Adm #1 was questioned about the absence of Home Health Aide services in any of the above contracts and reported, “I’ll call the contract agency and have them add that service and send me another contract.” The agency failed to establish a written agreement with the contracted agency to which Home Health Aide services would be provided. These findings were reviewed with and acknowledged by Adm #1 during the above interview.”

“Primary HHA is responsible for patient care CFR(s): 484.105(e)(3) The primary HHA is responsible for patient care, and must conduct and provide, either directly or under arrangements, all services rendered to patients. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the written contract for services included language that ensured the home health agency retained overall responsibility for all services provided, and failed to specify how supervision would occur for 3 (Contract #1, Contract #2, Contract #3) of 3 contracts reviewed, that provided hourly or per visit services on behalf of the agency, resulting in the potential to effect the quality of home health care services for all patients that received contracted services. Findings include: A review of the agency’s contracts was reviewed on 2/18/25 at 2:35 p.m. During an interview on 2/19/25 at 2:55 p.m., the Administrator (Adm #1) was asked to provide documented evidence that the home health agency was responsible for providing supervision of the services provided by the contracted staff, and how this supervision would occur. After a review of the contract, Adm #1 stated, “The contracts don’t reflect who retains overall responsibility for all services. I’ll have to call them (contracted agencies) and have them include that language in all our contracts.” The agency failed to provide documentation that they maintain overall supervisory responsibilities of the contracted employees and the responsibility of patient care services. These findings were reviewed with and acknowledged by Adm #1 during the above interview.”

“Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained an accurate representation of all interventions and assessments in 2 (P-6, 7) of 7 records reviewed, resulting in the potential for an unclear picture of the patient’s treatment and an incomplete medical record. Findings include: **Policy titled “Medical Record Content” (revised 2/2021) stated, “The Agency will provide an accurate and current medical record for every patient seen by the Agency.” P-6: This 78-year-old patient was admitted to this home care agency on 12/10/24 with the diagnoses of left shoulder adhesive capsulitis (“frozen shoulder”) and vascular dementia. During record review on 2/19/25, it was noted the physical therapy evaluation documented the following examples of exercises under treatment: “Therapeutic ROM Exercises for both t [sic] U/L EXT. 10x2,” “Balance Training (Static standing Balance) 5x2,” and “Endurance Exercises/Training 10x1.” This documentation does not include information on the specific interventions provided; therefore, the record is an inaccurate and incomplete representation of the patient’s treatment. P-7: This 75-year-old patient was admitted to this home health agency on 1/22/25 with the diagnoses of a left total knee replacement, hypothyroidism, and type II diabetes. During record review on 2/19/25, it was noted the physical therapy notes documented the following examples of exercises under treatment: “Therapeutic ROM (range of motion) Exercises for the both [sic] U/L EXT. 10x2,” “PNF Hold – relax 20x2 for left knee,” “Balance Training (Static and Dynamic Balance) 5x2,” and “Endurance Exercises/Training 10x1.” This documentation does not include information on the specific interventions provided; therefore, the record is an inaccurate and incomplete representation of the patient’s treatment. Findings were reviewed with and acknowledged by the Administrator (Adm #1), the Alternate Administrator (Adm #2), and the Clinical Manager (CM #1) during an interview on 2/21/25 at 11:20 AM. Upon further review of the record for P-7, it was determined the physical therapy notes dated 2/4/25, 2/6/25, and 2/11/25 all had the following statement documented word for word under “Assessment”: “Patient recent discharge form nursing with left total knee surgery and required taxing efforts to leave home due to pain, weakness , Patient get SOB with minor execrations, required frequent rest. Patient dynamic balance is poor with increased risk of Fall. Patient used R/W with CGA for ADLS transfer and due to unsteady gait, [sic]”. During an interview on 2/21/25 at 11:20 AM, Adm #1 was asked about how the assessment section is filled out in the record. Adm #1 stated the assessment from the previous note is auto populated and acknowledged the physical therapist failed to update the assessment after each treatment. Adm #2 and CM # 1 also acknowledged the findings at the time of interview.”