RN Home Health Care, PLLC

“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 included a communication plan, training, and testing. These practices could negatively affect the health and safety of all agency patients in the event of a natural, man-made, or facility-based emergency. Findings include: 1. The agency failed to develop an emergency preparedness plan that must be reviewed and updated at least annually. (See E0004) 2. The agency failed to develop an Emergency Preparedness Plan using a facility-based and community-based risk assessment, and utilizing an all-hazards approach. (See E0006). 3. The agency failed to develop Emergency Preparedness policies and procedures that aligned with the emergency plan, risk assessment and communication plan. (See E0013). 4. The agency failed to develop and maintain an Emergency Preparedness communication plan and ensure the communication plan was reviewed and updated at least annually. (See E0029). 5. The agency failed to develop and maintain an Emergency Preparedness training and testing program that is based on the emergency plan, risk assessment, policies, procedures, and the communication plan. The training and testing program must be reviewed and updated at least annually. (See 0036). 6. The home health agency failed to conduct exercises to annually test the emergency plan. (See E0039). The cumulative effect of these systemic problems resulted in the agency’s inability to ensure patient safety during an emergency.”

“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, it was determined the home health agency failed to develop a Quality Assessment and Performance Improvement (QAPI) program that measures, tracks and analyzes it’s quality indicators in order to assess the processes of care and services provided by the agency, resulting in the inability to improve patient care with positive outcomes (See G0642); the agency failed to collect and monitor data for the QAPI program, to ensure the effectiveness and safety of services and quality of care to the patients and to identify opportunities for improvement, and there was no documented evidence the governing body approved the QAPI frequency and data collection process (refer to G0644); failed to initiate any performance improvement activities within their QAPI program (See Q0646); failed to conduct any performance improvement projects within their QAPI program (See G0658); failed to ensure the agency had an active and functioning QAPI program that fulfilled all the regulatory requirements of this section, that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness (See G0660). 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§484.65 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, it was determined the agency failed to document any infection control meeting minutes. (See G0684); failed to provide documented evidence that infection control education was provided to all staff employed by the agency and who were granted clinical privileges. (See G0686). 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 Control.”

“Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to ensure a governing body assumed responsibility for the operation of the agency, the provision of all home health services and its quality assessment and performance improvement program, resulting in a lack of overall leadership in the agency’s provision of home health services (SEE G942); failed to ensure the Administrator was appointed by and reported to the Governing Body (SEE G946). The systemic effects of the above deficiencies had the potential to affect all agency patients, resulting in the provision of substandard care, patients not receiving needed services and the potential for poor patient outcomes.”

“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 must be reviewed and updated at least annually. Resulting in no guidance for agency actions in the event of an actual emergency or disaster. This deficient practice could negatively affect the health and safety of all agency patients in the event of natural, man-made, or facility-based emergency. Findings include: During an interview on 3/25/25, at 11:30 a.m., the administrator (Adm-1) was asked to provide documentation of the agency’s emergency preparedness plan. A binder of the agency’s emergency preparedness program was provided for review. There was no documented evidence in the binder that the agency had developed an emergency preparedness plan. There were a few policies and procedures (The policies and procedures were undated) for adverse events in the binder, but no risk assessment, collaboration, or drills. All agency patients could be impacted by the agency’s failure to develop an emergency preparedness plan. During an interview on 3/25/25, at 1:00 p.m., the Adm-1 acknowledged the above findings.”

“Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: Based on record review and interview, it was determined the agency failed to develop an Emergency Preparedness Plan using a facility-based and community-based risk assessment, and utilizing an all-hazards approach, resulting in the potential to negatively affect all patients seen by the clinic. Findings include: During an interview on 3/25/25, at 11:30 a.m., a request was submitted to review the agency’s Emergency Preparedness Plan, including the facility-based and community-based assessment. When asked about the assessment, the administrator (Adm-1) provided a binder for the emergency preparedness program for review. There was no documented evidence in the binder that the agency had developed an emergency preparedness plan. There were a few policies and procedures (Policies and procedures were undated) for adverse events in the binder, but no risk assessments were documented. All agency patients could be impacted by the agency’s failure to develop an emergency preparedness plan. During an interview on 3/25/25, at 1:00 p.m., Adm-1 acknowledged the above findings.”

“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 develop Emergency Preparedness policies and procedures that aligned with the emergency plan, risk assessment and communication plan. The policies and procedures must be reviewed and updated at least annually. This deficient practice could negatively affect the health and safety of all agency patients in the event of natural, man-made, or facility-based emergency. Findings include: During an interview on 3/25/2025, at 11:30 a.m., the administrator (Adm-1) was asked to provide documentation of the agency’s emergency preparedness program. There was no evidence emergency preparedness policies and procedures were developed based on an all-hazards risk assessment, and there was no evidence the policies and procedures (Policies and procedures were undated) were reviewed and updated at least annually. All agency patients could be impacted by the agency’s failure to develop emergency preparedness policies and procedures based on an all-hazards risk assessment. During an interview on 3/25/25, at 1:00 p.m., Adm-1 acknowledged the above findings.”

“Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an Emergency Preparedness communication plan and ensure the communication plan was reviewed and updated at least annually. This deficient practice could negatively affect the health and safety of all agency patients in the event of a natural, man-made, or facility-based emergency. Findings include: During an interview on 3/25/25, at 11:30 a.m., the administrator was asked to provide documentation of the agency’s emergency preparedness program. There was no documented evidence that the agency had developed an Emergency Preparedness communication plan, and that the communication plan was reviewed and updated at least annually. All agency patients could be impacted by the agency’s failure to develop an emergency preparedness communication plan. During an interview on 3/25/25, at 3:30 p.m., the administrator acknowledged the above findings.”

“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, the agency failed to develop and maintain an Emergency Preparedness training and testing program that is based on the emergency plan, risk assessment, policies, procedures, and the communication plan. The training and testing program must be reviewed and updated at least annually. This deficient practice could negatively affect the health and safety of all agency patients in the event of a natural, man-made, or facility-based emergency. Findings include: During review of the agency’s emergency preparedness program on 3/25/25, it was discovered that there was no documented evidence the agency had developed a training and testing program to guide personnel and agency actions during an emergent situation. All agency patients could be impacted by the agency’s failure to develop and maintain an emergency preparedness training and testing program. During an interview on 3/25/25 at 3:30 p.m., the administrator (Adm-1) acknowledged the above findings.”

“EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: Based on record review and interview, the home health agency failed to conduct exercises to annually test the emergency plan or provide documentation of an actual event that would qualify as a test of the emergency plan; failed to conduct an additional full-scale exercise or a table-top exercise; and failed to analyze the agency’s response to and maintain documentation of all drills, tabletop exercises, emergency events and revise the emergency plan as needed. This deficient practice could negatively affect the health and safety of all agency patients in the event of a facility emergency or disaster. Findings include: On 3/25/25, the agency’s emergency preparedness documentation was reviewed. Record review indicated there was no documentation of a full-scale exercise or a table-top exercise. There was no documentation of the following: an actual event that would qualify as a test of the emergency plan, an additional full-scale exercise or a table-top exercise, and an analysis of the agency’s response to all drills, tabletop exercises, emergency events and revisions to the emergency plan as needed. The findings were confirmed during an interview on 3/25/25, at 1:30 p.m. with the administrator (Adm-1).”

“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, it was determined 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 agency patients. Findings include: During an interview on 3/25/25 at 1:30 p.m., the administrator (Adm-1) was asked to review the agency’s Quality Assessment Performance Improvement (QAPI) program. Upon review of the agency’s QAPI program binder (The program binder was empty), it was noted that there was no data to review 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 during an interview on 3/25/25 at 3:30 p.m.”

“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 collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program, to ensure the effectiveness and safety of services and quality of care to the patients and to identify opportunities for improvement, and there was no documented evidence the governing body approved the QAPI frequency and data collection process. Findings include: During an interview on 3/25/25 at 11:30 a.m., the administrator (Adm-1) was asked to review the agency’s QAPI report and meeting minutes. Adm-1 replied, “We have not had any QAPI or governing body meetings. We do not have any QAPI documentation or policies, and the governing body has not approved anything yet.” During an interview on 3/25/25, at 3:30 p.m., Adm-1 acknowledged the above findings.”

“Program activities CFR(s): 484.65(c) (1) The HHA’s performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This Standard is not met as evidenced by: Based on record review and interview, it was determined the agency failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement (QAPI) program, resulting in the potential for the rendering of substandard care and unmet care needs. Findings include: During review of the agency’s QAPI program on 3/25/25, it was noted that the agency failed to develop and initiate any performance improvement activities as part of their QAPI program. The agency had no QAPI meetings, data, or activities documented. The QAPI binder was empty. During an interview on 3/25/25 at 3:30 p.m., the administrator (Adm-1) acknowledged the above findings.”

“Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA’s services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This Standard is not met as evidenced by: Based on record review and interview, it was determined the agency failed to initiate, develop, or have completed any performance improvement projects within their Quality Assessment Performance Improvement (QAPI) program, resulting in the potential for the rendering of substandard care and unmet care needs. Findings include: During review of the agency’s QAPI program on 3/25/25, it was noted that the agency failed to document any developing, on-going, or completed performance improvement projects (PIP’S) as part of their QAPI program. The agency had no QAPI meetings, data, or activities documented. The QAPI binder was empty. During an interview on 3/25/25 at 3:30 p.m., the administrator (Adm-1) acknowledged the above findings.”

“Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA’s governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This Standard is not met as evidenced by: Based on document 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, that 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 to all patients receiving services. Findings include: During an interview on 3/25/25, 1:30 p.m., when asked to review the agency’s QAPI program, the administrator (Adm-1) replied, “We have not developed an active QAPI program yet.” The agency’s QAPI binder was empty. During an interview on 3/25/25, at 3:30 p.m., Adm-1 acknowledged that they needed to develop an active and functioning QAPI program.”

“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 an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of the agency’s Quality Assessment Performance Improvement program, resulting in the potential spread of infections between patient care staff and agency patients. Findings include: The agency’s Quality Assessment Performance Improvement (QAPI) binder was reviewed on 3/25/25. The binder was empty. There was no documentation of QAPI meetings or the agency’s infection control and prevention activities. There was no documentation of data regarding the tracking/trending of infection control data. There was no documentation of the agency’s efforts to identify infectious and communicable diseases and the resultant actions for improvement and disease prevention. There was no documentation of the agency’s efforts to ensure the infection control program is an integral part of the agency’s QAPI program. During an interview on 3/25/25, at 3:30 p.m., the administrator (Adm-1) acknowledged the above findings.”

“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, it was determined the Agency (HHA) failed to provide documented evidence that infection control education was provided to all staff employed by the agency and who were granted clinical privileges, resulting in the potential for the development and spread of infection. Findings include: On 3/25/25, during review of 3 clinical employee records, it was noted that there was no documented evidence of any initial or on-going infection control education. During an interview on 3/25/25, at 1:00 p.m., Adm-1 acknowledged the above findings.”

“12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This Standard is not met as evidenced by: Based on record review and interview, it was determined the agency failed to have 1 of 1 home health aides complete yearly in-services, resulting in the potential for poor patient outcomes. Findings include: During review of the agency’s employee files on 3/25/25, it was discovered that 1 of 1 home health aides did not have any yearly in-services documented since 2019. During an interview on 3/25/25, at 1:00 p.m., Adm-1 acknowledged the above findings.”

“Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency’s overall management and operation, the provision of all home health services, fiscal operations, review of the agency’s budget and its operational plans, and its quality assessment and performance improvement program. This Standard is not met as evidenced by: Based on record review and interview, it was determined the home health agency failed to have an active Governing Body that met at least annually, and assumed full legal authority and responsibility for the agency’s overall management and operations, all services provided, the fiscal operations, review of the agency’s budget and operations plans and it’s quality assessment and performance improvement program, resulting in the potential to adversely affect the quality of care to all patients receiving services. Findings include: During review of the agency’s documents on 3/25/25, the administrator was asked to present the governing body program for review. Upon receipt of the governing body program binder, it was discovered that the binder was empty (No documents were in the binder). The were no documented governing body activities for the agency. During an interview on 3/25/25 at 1:30 p.m., the administrator (Adm-1) was asked about the governing body program, and she said, “We have not had any governing body meetings yet.” During an interview on 3/25/25, at 3:30 p.m., Adm-1 acknowledged the above findings.”

“Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This Element is not met as evidenced by: Based on record review and interview, it was determined the home health agency failed to advise the patients of the names, addresses and telephone numbers of Federally funded and State funded entities that serve the area where the patient resides, resulting in the potential for patient needs being unmet. Findings include: During review of the agency’s patient information folder on 3/25/25, it was noted that the information for Federally and State funded patient resource entities were not provided to the patients. During an interview on 3/25/25, at 2:30 p.m., after a brief review of the patient information handbook, the administrator (Adm-1) acknowledged the above findings.”

“Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) Standard: Administrator. The administrator must: (i) Be appointed by and report to the governing body; This Element is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to have the administrator be appointed by the governing body. Findings include: During record review on 3/25/25, the administrator (Adm-1) was asked to review the agency’s governing body information. During review of the governing body binder (The binder was empty), it was determined that there was no documented evidence that the governing body appointed the administrator or that the administrator was reporting to the governing body. During an interview on 3/25/25 at 3:30 p.m., Adm-1 acknowledged the above findings.”