Every finding on record at Sc Home Health Nfp

The Emergency Preparedness requirements were evaluated, in conjunction with the recertification survey, on 08/29/2025. The Agency was in compliance with the Condition, 42 CFR 484.102, Establishment of the Emergency Program for this survey.

A recertification survey was conducted in conjunction with the evaluation of Emergency Preparedness requirements on 8/29/2025. The Agency was not in compliance with 42 CFR 484, Standards for Home Health Agencies, for this survey.

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 staff interview and document review, the facility failed to ensure the administrator was appointed by the governing body. Findings include: 1. A review of the Board of Directors meeting minutes dated June 9, 2025 and March 4, 2025 was completed on 8/27/2025 at approximately 12:00 PM. No documentation was present indicating appointment of E#1 as Administrator of the agency. 2. The Policy titled “Board of Directors”, effective 8/17/2022, states “The Board of Directors is the governing body for Whitestar Home Health Agency (SC Home Health NFP)…The Board of Directors is responsible for…Appointing a qualified Administrator for the Agency.” 3. An interview was conducted on 8/27/2025 at approximately 11:50 AM, with the Director/Administrator, (E#1). During discussion regarding appointment of the administrator, E #1 noted she was promoted to Director/Administrator of the agency in January, 2025. E#1 further noted the Board of Directors had not officially appointed her as Administrator since her promotion to the position.

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on document review and interview, the facility failed to ensure a pre-designated person who assumes the same responsibilities and obligations as the administrator when the administrator is not available, was provided in writing, as authorized by the administrator and governing body. Findings include: 1. A review of the Board of Directors meeting minutes dated June 9, 2025 and March 4, 2025 was completed on 8/27/2025 at approximately 12:00 PM. No documentation was present indicating authorization of a pre-designated person who assumes the same responsibilities and obligations as the administrator when the administrator is not available. 2. The Policy titled “Board of Directors”, effective 8/17/2022, states “The Board of Directors is the governing body for Whitestar Home Health Agency (SC Home Health NFP).” 3. The Policy titled “Organization and Structure”, effective 8/17/2022, states: -The Administrator of Whitestar Home Health Agency (SC Home Health NFP) has overall administrative responsibility for the Agency’s operations. -In the absence of the Administrator, the Director of Patient Care Services assumes responsibility of administrative and operational activities. -In the absence of the Administrator and the Director of Patient Care Services, the Director of Quality Improvement assumes responsibility of administrative and operational activities. -In the absence of the Administrator and the Director of Patient Care Services, a Clinical Supervisor is designated responsibility for the delivery of patient care and services. 4. An interview was conducted on 8/26/2025 at approximately 1:00 PM, with the Director (E #1). During discussion about who is the Director of Patient Services and Director of Quality Improvement, E #1 noted she serves in those roles. During discussion regarding a pre-designated person who assumes the same responsibilities and obligations as the administrator when the administrator is not available, E #1 stated the “back-up person when I’m gone” is E #4, the Vice President of Operations and Quality. E #1 also identified E #4 as the Vice President of the Board of Directors. E #1 further noted a pre-designated person who assumes the same responsibilities and obligations as the administrator when the administrator is not available was not provided in writing, as authorized by E #1 as Administrator, nor the Board of Directors, who serve as the governing body for the agency.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on document review and interview it was determined the Home Health Agency (HHA) failed to obtain an agreement/arrangement for aide training. This has the potential to affect all patients that might need aide services. 1. A request was made for an arrangement/agreement for Aide training on 11/18/2022 at 2:00 PM. 2. An interview was conducted with E#2 on 11/18/2022 at approximately 3:00 PM. E #2 stated, "We don't have a contract with any aide services as I thought we were required to provide Aides. We don't have an agreement for the Aide training as I was not sure what we were supposed to do."

The Emergency Preparedness requirements were evaluated in conjunction with the recertification survey 8/11/22. The Facility was not in compliance with the Condition, 42 CFR 484.22, Establishment of the Emergency Program (EP), as evidenced by:

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, §485.625, §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 document review and interview, the Home Health Agency (HHA) failed to ensure a comprehensive Emergency Preparedness Program was established and maintained, which met regulatory requirements. Therefore, the Condition, 42 CFR 484.102, Establishment of the Emergency Program (EP) was NOT met, as evidenced by: 1. The HHA failed to ensure it's Emergency Preparedness Plan was reviewed and updated at least annually. (See E-0004) 2. The HHA failed to develop and maintain an Emergency Preparedness training and testing program, that is based on the Emergency Plan, which is based on the comprehensive Emergency Preparedness Program findings; and is reviewed/updated at least annually. (See E-0036) 3. The HHA failed to establish an Emergency Preparedness training program based on its comprehensive Emergency Preparedness Program; inclusive of policies and procedure, and initial and annual documented training of new and existing direct staff, contracted staff, and volunteer staff, consistent with their respective roles. (See E-0037) 4. The HHA failed to establish an annual testing plan for its Emergency Preparedness Program, inclusive of participation in an annual full-scale community-based or facility-based exercise or tabletop exercise, with analysis, documentation, and revision of the HHA's emergency plan, as needed. (See E-0039) The cumulative effects of these practices resulted in the Agency's inability to establish and maintain an effective training and testing Emergency Program.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on document review and interview, it was determined that the Agency failed to ensure its Emergency Preparedness Plan was reviewed and updated at least annually. This has the potential to affect all patients, visitors, and staff serviced by the Agency. 1. The Agency's documents titled, "Emergency Preparedness Plan" (revised by the Agency 11/15/19) was reviewed on 8/10/22 at approximately 11:30 AM. The plan was last approved on 11/15/19. 2. During an interview conducted with the Chief Executive Officer (E#1) on 8/10/22 at approximately 2:45 PM, E#1 reviewed the Emergency Plan and stated, "yes we need to update the Emergency Plan and the Policies annually".

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), §485.625(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, 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 document review and interview, it was determined the Home Health Agency (HHA) failed to develop and maintain an Emergency Preparedness training and testing program, that is based on the Emergency Plan which is based on the comprehensive Emergency Preparedness Program findings; and is reviewed/updated at least annually. This has the potential to affect all patients, staff, visitors. 1. The Agency's documents titled, "Emergency Preparedness Plan" (revised by the Agency 11/15/19) was reviewed on 8/10/22 at approximately 11:30 AM. The plan lacked any Emergency Preparedness Plan and/or Emergency Preparedness training and testing program that is to be reviewed and updated at least annually. 2. During an interview conducted with the Chief Executive Officer (E#1) on 8/10/22 at approximately 2:45 PM, E#1 stated, "We need to incorporate more emergency preparedness training for our staff and show that we conduct it annually. The last one is what is in the Emergency Plan book (Tornado Safety dated 11/15/19).

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the Home Health Agency (HHA) failed to establish an Emergency Preparedness training program based on its comprehensive Emergency Preparedness Program; inclusive of policies and procedure, and initial and annual documented training of new and existing direct staff, contracted staff, and volunteer staff, consistent with their respective roles. This has the potential to affect all patients, staff, visitors, and community persons. 1. The Agency's documents titled, "Emergency Preparedness Plan" (revised by the Agency 11/15/19) was reviewed on 8/10/22 at approximately 11:30 AM. The HHA lacked any comprehensive Emergency Preparedness annual training program for Emergency Preparedness policies and procedures for all new and existing staff. 2. The personnel files were reviewed on 8/10/22 and no annual training of staff had been conducted since 2019. 3. During an interview conducted with the Chief Executive Officer (E#1) on 8/10/22 at approximately 2:45 PM, E#1 stated "We have not kept up the training annually as part of our Emergency Preparedness Plan. We will get the training of staff up to date."

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the Home Health Agency (HHA) failed to establish an annual testing plan for its Emergency Preparedness Program, inclusive of participation in an annual full-scale community-based or facility-based exercise or tabletop exercise, with analysis, documentation, and revision of the HHA's emergency plan, as needed. This has the potential to affect all patients, staff, visitors, and community persons. 1. The Agency's documents titled, "Emergency Preparedness Plan" (revised by the Agency 11/15/19) was reviewed on 8/10/22 at approximately 11:30 AM. The HHA lacked an annual full-scale community-based, facility-based exercise, or a tabletop exercise since 11/12/19. 2. During an interview conducted with the Chief Executive Officer (E#1) on 8/10/22 at approximately 2:45 PM, E#1 stated "The last Full Scale drill or Table Top Exercise is the most recent one in the Emergency Preparedness Plan" and verbally agreed one should have been conducted.

A recertification survey was conducted in conjunction with the evaluation of Emergency Preparedness requirements on 8/11/22. The offsite branch location was surveyed on 8/10/22 at 108 North Vermillion Street, IL, 61832. The Agency was not in compliance with the Conditions of Participation for Home Health Agencies 42 CFR 484.65, Quality Assessment/Performance Improvement, 42 CFR 484.70, Infection Prevention and Control, and 42 CFR 484.105, Organization and Administration of Services, 42 CFR 484.22 Emergency Preparedness. Therefore, the Agency is precluded from conducting aide training and/or competency evaluations for 24 months, effective 8/11/22. This applies even if the agency is not currently conducting aide training and/or competency evaluation. Abbreviations: SOC- start of care Pt- patient E- employee POC- plan of care QAPI- Quality Assessment/Performance Improvement PPE- Personal Protective Equipment OT- Occupational Therapist PT- Physical Therapist CEO- Chief Executive Officer RN- Registered Nurse PTA- Physical Therapy Assistant SLP- Speech Language Pathology DOH- Date of Hire ml- milliliter IV- intravenous EP- Emergency Preparedness HHA- Home Health Agency OASIS- Outcome and Assessment Information Set DON- Director of Nursing prep- preparation CPR- cardiopulmonary resuscitation TB- tuberculin (Tuberculosis)

Investigation of complaints CFR(s): 484.50(e)(1) Standard: Investigation of complaints. The HHA must-- This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the Agency failed to ensure complaints were reported and investigated. This has the potential to affect all staff and patients/caregivers that receive care by the Agency with a current census of 42 patients. Findings include: 1. Pt #11 Start of Care (SOC): 10/13/21 Diagnosis: Diabetes Mellitus. A focused record review was conducted on 8/11/22 at approximately 12:30 PM. The record noted on 1/20/22 "... Patient's daughter called and stated (she/he) doesn't want (E#9) back in the house due to (E#9) calling ambulance for patient to be taken to the hospital per patient's request." No documentation or resolution of complaint found. 2. During an interview on 8/9/22 at approximately 8:45 AM, the Complaint and Grievance policy was requested. The Grievance Binder was reviewed on 8/9/22 at approximately 12:30 PM. The binder had a complaint narrative with investigation findings dated 4/26/17 and lacked documentation any other complaints reported since 2017. 3. During an interview on 8/9/22 at approximately 2:30 PM, the Administrator (E#1) stated "We haven't had any complaints since then (2017)." E#1 stated the Agency did not have a complaint and grievance policy. At approximately 4:00 PM, E#1 stated Pt #11's daughter had called to complain that E#9 called the ambulance without consent, although E#9 never returned to work after that incidence, therefore no action was conducted. E#1 verbally agreed complaints had not been reported and investigated and should have been.

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on document review and interview it was determined the Home Health Agency (HHA) failed to provide Aide services to patients needing assistance with medical and/or nursing needs. This has the potential to affect all patients that might need Aide services. 1. The current State of Illinois license for the Home Health Agency with an expiration date of 4/30/23 was reviewed 8/10/22 at 10:00 AM. The license noted "Home Health Aides" as one of the services offered by the Home Health Agency. 2. An interview was conducted with E#2 on 8/10/22 at approximately 3:00 PM. E #2 stated, "We don't have any Home Health Aides employed and we don't have a contract with any aide services."

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 observation, document review, and interview, it was determined for 1 of 3 (Pt #2) patients, where home visits were conducted, the Home Health Agency (HHA) failed to ensure all medications, including over-the-counter medications were included on the patient's drug profile, thereby preventing potential adverse drug reactions, significant side effects, significant drug interaction, and duplicate therapy. This has the potential to affect all patients receiving care from the HHA with a current patient census of 42. Findings include: 1. On 08/09/2022 at approximately 9:00 AM, a home visit was conducted at Pt #2's home. A review of Pt #2's medication bottles revealed the patient was taking Fosamax 70 mg once a week, over the counter medications - Calcium and Vitamin D once a day. An Interview with Pt #2 was conducted during the visit. Pt stated, "I've been of Fosamax for a couple of months and take the Calcium and Vitamin D once a day." 2. On 08/09/2021 at approximately 10:15 AM, the medical record of Pt #2 was reviewed. Pt #2 was admitted on 06/15/2022 with the primary diagnoses of "Osseous and subluxated Stenosis of intervertebral foramin of lumbar region." Pt #2's "Medication Profile" or Plan of Care for certification period 06/05/2022 thru 08/13/2022 did not include Fosamax, Calcium, or Vitamin D. 3. On 08/09/2022 at approximately 12:00 PM, and interview with Director of Nursing (DON) (E#2) was conducted. E#2 confirmed the medication profile and Plan of Care for Pt #2 did not include Fosamax, Calcium, and Vitamin D. E#2 was unable to provide and explanation why. 4. On 08/09/2022 at approximately 1:00 PM, the HHA policy "Medication Management - Patient Information (revised 2015/201)" was reviewed. The policy stated, "... Procedure: During the initial assessment visit, the Registered Nurse/ Therapist generates a list of the patient's current medications, including prescription and over-the-counter (OTC) medications and herbal remedies.... The Registered Nurse/ Therapist performs and assessment of the patients current medications/herbal remedies to determine whether actual or potential interactions exist between the current medications and herbal remedies... The patient's medications are reviewed and assessed during each skilled visit. Any changes to the medications or changes in the patient's response to the medications are conveyed to the ordering physician."

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 document review and interview, it was determined for 1 of 7 (Pt #2) patients, the Agency failed to ensure visits were conducted in accordance with the physician ordered plan of care (PoC). This has the potential to affect all patients who receive care by the Agency with a current census of 42 patients. Findings include: 1. On 08/09/2022 at approximately 10:15 AM, the medical record of Pt #2 was reviewed. Pt #2 was admitted on 06/15/2022 with the primary diagnoses of "Osseous and subluxated stenosis of intervertebral foramin of lumbar region." A physician's order signed 06/23/2022 noted physical therapy visit frequency effective 06/15/2022 twice a week for 9 week and occupational therapy visit once a week for 9 weeks. The record lacked documentation of a 2 physical therapy visits and one occupational therapy visit the week of 06/26/2022 thru 07/02/22. The record lacked any documentation of missed visits or notification of MD of the missed visits. 2. A request was made on 08/10/2022 at approximately 3:00PM for a policy related to missed visits. No policy was provided. 3. On 08/11/2022 at approximately 1:00 PM, an interview was conducted with the Director of Nursing (DON) (E#2). E#2 reviewed Pt #2's record and stated, "There was a group text between providers as (Pt #2) was going to be out of town. An order to hold services should have been placed, but was not. There is no documentation of the missed visits and should have been. (CEO) is putting the order in now."

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 interview it was determine that the agency failed to provide documentation of the development, implementation, evaluation, and maintenance of an effective, ongoing, HHA-wide, data-driven Quality Assessment and Performance Improvement (QAPI) program. Therefore the Condition of Participation, 42 CFR 484.65, Quality Assessment and Performance Improvement was not met, as evidenced by: Findings include: 1. The Agency failed to ensure measurable indicators were developed and were analyzed and tracked to identify trends in patient care. See G-642 2. Agency failed to ensure quality indicators data was utilized to measure effectiveness and identify opportunities for improvement. See G-644 3. The Agency failed to ensure performance improvement focused on high risk safety indicators, identify opportunities for immediate improvement and monitor the success of the interventions implemented. See G-646 4. The Agency failed to ensure performance improvement projects were identified and implemented annually. See G-658 5. The Agency failed to ensure a quality improvement and patient safety program was implemented and maintained. See G-660 The cumulative effect of these practices resulted in the Agency's inability to determine effectiveness of Agency programs.

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 interview, it was determined the Agency failed to ensure measurable indicators were developed, analyzed and tracked to identify trends in patient care. This has the potential to affect all patients who receive care by the Agency with a current census of 42 patients. Findings include: 1. During an interview on 8/11/22 at approximately 1:00 PM, the Director of Nursing (E#2) verbally agreed the Agency failed to ensure measurable indicators had been developed, analyzed and tracked to identify trends in patient care. E#2 verbally agreed the Agency did not have an Agency wide, data driven QAPI program and should have had.

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 document review and interview, it was determined the Agency failed to ensure quality indicators were utilized to measure the effectiveness of the safety of services, the quality of care provided and identified opportunities for improvement. This has the potential to affect all patients who receive care by the Agency with a current census of 42 patients. Findings include: 1. During an interview on 8/9/22 at approximately 8:45 AM, the Quality Assurance Performance Improvement (QAPI) meeting minutes with data were requested. The Agency lacked documentation of QAPI meeting minutes and data as of 8/11/22 at approximately 3:00 PM. 2. During an interview on 8/11/22 at approximately 1:00 PM, the Director of Nursing (E#2) verbally agreed the Agency failed to ensure quality indicators were utilized to measure the effectiveness of the safety of services, the quality of care provided or identified opportunities for improvement and should have been. E#2 verbally agreed the Agency did not have an Agency wide, data driven QAPI program and should have had.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the Agency failed to ensure performance improvement focused on high risk safety indicators, identified opportunities for immediate improvement and monitored the success of the interventions implemented. This has the potential to affect all patients who receive care by the Agency with a current census of 42 patients. Findings include: 1. During an interview on 8/9/22 at approximately 8:45 AM, the Quality Assurance Performance Improvement (QAPI) meeting minutes with data were requested. The Agency lacked documentation of QAPI meeting minutes and data as of 8/11/22 at approximately 3:00 PM. 3. During an interview on 8/11/22 at approximately 1:00 PM, the Director of Nursing (E#2) verbally agreed the Agency failed to ensure performance improvement focused on high risk safety indicators, identified opportunities for immediate improvement and monitored the success of the interventions implemented. E#2 verbally agreed the Agency did not have an Agency wide, data driven QAPI program and should have had.

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 document review and interview, it was determined the Agency failed to ensure performance improvement projects were identified and implemented annually. This has the potential to affect all patients who receive care by the Agency with a current census of 42 patients. Findings include: 1. The "Organizational Quality Improvement Plan" (revised 2015/2016) was reviewed on 8/11/22 at approximately 2:20 PM. The Plan noted on page 9 "... performance measures are identified for monitoring and assessing processes and outcomes of care, including those affecting a large percentage of patients, and/or place patients at serious risk if not performed well, or performed when not indicated, or not performed when indicated; and/or have been or likely to be problem prone." 2. During an interview on 8/9/22 at approximately 8:45 AM, the Quality Assurance Performance Improvement (QAPI) meeting minutes with data were requested. The Agency lacked documentation of QAPI meeting minutes and data as of 8/11/22 at approximately 3:00 PM. 3. During an interview on 8/11/22 at approximately 1:00 PM, the Director of Nursing (E#2) verbally agreed performance improvement projects were not identified and implemented annually and should have been.

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 Board failed to ensure a quality improvement and patient safety program was implemented and maintained. This has the potential to affect all patients who receive care by the Agency with a current census of 42 patients. Findings include: 1. The "Organizational Quality Improvement Plan" (revised 2015/2016) was reviewed on 8/11/22 at approximately 2:20 PM. The Plan's approval page (page 14) noted "The organizational quality improvement plan has been reviewed, approved and adopted by the Board of Directors and by the Agency Administration as attested to by the signatures below..." 1 (Administrator, E#1) of the 5 members noted on the approval page is currently on the Board or in Administration and the form was not signed or dated. 2. During an interview on 8/9/22 at approximately 8:45 AM, the Quality Assurance Performance Improvement (QAPI) meeting minutes with data were requested. The Agency lacked documentation of QAPI meeting minutes and data as of 8/11/22 at approximately 3:00 PM. 3. During an interview on 8/11/22 at approximately 1:00 PM, the Director of Nursing (E#2) reviewed the approval page and stated (E#1) was the only person listed who was still on the board. E#2 verbally agreed the Governing Board failed to ensure a quality improvement and patient safety program was implemented and maintained and should have been.

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 document review and interview, it was determined the Home Health Agency failed to maintain and document an infection control program, which has as its goal the prevention and control of infections and communicable diseases. Therefore, the Condition of Participation, 42 CFR 484.70, Infection Prevention and Control was NOT met. This has the potential to affect all patients serviced by the Agency with a current census of 42. Findings include: 1. The Agency failed to ensure expired biologicals were not available for patient use. See G-682 2. The Agency failed to ensure a program for the surveillance, identification, prevention, control and investigation of infections and communicable diseases which was incorporated into the Agency's Quality Assurance Performance Improvement (QAPI). See G-684 3. The Agency failed to ensure staff were educated on infection control practices upon hire and annually per policy. See G-686 4. The Home Health Agency (HHA) failed to ensure staff were vaccinated or had approved exemptions. See G-687 The cumulative effect of these systemic practices resulted in the Agency's inability to determine the infection Control practices and prevention was maintained by the staff.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: A. Based on document review and interview, it was determined the Agency failed to ensure expired biologicals and medications were disposed of after single patient use or expiration. This has the potential to affect all staff and patients/caregivers that receive care by the Agency with a current census of 42 patients. Findings include: 1. During a tour of the Agency's supply room on 8/10/2022 at approximately 1:00PM, the following items were found to be available for patient use: a) 300 ml (milliliter) Canister Therapy System, 1- expired 2/28/22 and 2 - expired 3/31/22 b) BD Vacutainers blue top, 36 vials expired 5/31/22 c) True Care Biomedex IV (Intravenous) Administration Set with GVS Easydrop Flow Regulator, 16 expired 10/14/21 d) Braun IV Extension Set, 1- expired 12/9/21, 1- expired 4/30/22, 4- expired 5/31/22, and 3- expired 6/20/22 e) the supply room cabinet was observed to have 5 syringes labeled "Heparin 10 units/ml (milliliter) 5 ml Posiflush" in a clear plastic bag labeled with Pt #10's name, address, prescription number (#0530070653) and prep (preparation) date of 4/14/22. 2. Pt #10 Start of Care (SOC): 04/15/202 Diagnosis: Urinary Tract Infection with Sepsis. A focused record review was conducted on 08/11/22 at approximately 12:00 PM. A Physician's Order dated 5/28/22 noted "Patient requested DC (Discharge) due to being independent and goals met." 3. During and interview on 08/11/22 at approximately 1:00 PM, the Director of Nursing (E#2) verbally agreed the items found should have been disposed of after single patient use or expiration.

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 document review and interview, it was determined the Agency failed to ensure a program for the surveillance, identification, prevention, control and investigation of infections and communicable diseases which was incorporated into the Agency's Quality Assurance Performance Improvement (QAPI). This has the potential to affect all staff and patients/caregivers that receive care by the Agency with a current census of 42 patients. Findings include: 1. The policy titled "Infection Control Program" (reviewed by Agency 4/28/2011) was reviewed on 8/10/22. The policy noted "... infection control management functions are delegated to the Infection Control Committee... Agency's Risk Manager is responsible for the implementation of the infection control program... Infection control data are an integral part of the organization's performance improvement program... Review and evaluate of confirmed infections... Periodic site visits to patients' place of residence for direct observation of care, treatment and/or service delivery... Periodic checks of clinicians' automobile trunks... site evaluation to ensure a safe environment for Agency personnel... hazardous waste management and disposal practices... Participation in product evaluation... Minutes from the Infection Control Committee and Quality Improvement Program are forwarded to the Professional Advisory Committee on a quarterly basis..." 2. The Infection Control binder was reviewed on 8/10/22 at approximately 1:00 PM. The binder contained an "Infection Control Monthly Meeting" template to document attendance, the agenda, types of infections, summary of data, employee training and trends/benchmarks/suggestions. The binder contained "Infection Control Sheets" dated 7/1/2021 to 7/31/2022 and each one noted "Showing 0 to 0 of 0 results". The binder lacked documentation of Infection Control Meeting Minutes or infection data or that periodic site visits, periodic check of clinicians' automobile trunk, hazardous waste management and disposal practices and/or participation in product evaluations were conducted for the year starting 7/1/2021 and ending 7/31/2022. 3. The Agency's Organizational Chart was reviewed on 8/10/22 at approximately 1:10 PM. The Organizational chart lacked documentation of a Risk Manager position. Per Agency policy, the risk manager is responsible for the Implementation of the Infection Control Program. 4. The Agency lacked QAPI meeting minutes or data as of 8/11/22 at approximately 3:00 PM. The Agency's 1st and 2nd Quarter Board Meeting (Professional Advisory Committee) minutes dated 7/26/22 lacked documentation Infection Control and/or QAPI data was reviewed. 5. During an interview on 8/10/22 at approximately 3:00 PM, the Director of Nursing (E#2) stated "Infection Control is a shared responsibility among Administration. I don't know that we collect data. You would have to ask (Administrator, E#1)." 6. During an interview on 8/11/22 at approximately 11:10 AM, E#1 stated the staff members make a note in the care communication note that they wore masks, gloves or type of Personal Protective Equipment (PPE). E#1 stated "We don't turn those things into data. No, I don't collect data."

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 document review and interview, it was determined for 11 of 11 licensed staff of Home Health Agency, the Agency failed to ensure staff were educated on infection control practices upon hire and annually per policy. This has the potential to affect all staff and patients/caregivers that receive care by the Agency with a current census of 42 patients. Findings include: 1. The policy titled "Infection Control Program" (reviewed by Agency 4/28/11) was reviewed on 8/10/22. The policy noted "Infection Control inservice education is provided to all... employees... during orientation and at least annually thereafter." 2. The following personnel files were reviewed and lacked documentation infection control education was conducted during orientation and annually: a) E#15, Date of Hire (DOH): 9/4/20 b) E#16, DOH: 11/22/10 c) E#17, DOH: 10/04/17 d) E#18, DOH: 2/12/19 e) E#19, DOH: 5/31/20 f) E#20, DOH: 3/06/17 g) E#21, DOH: 3/20/20 h) E#22, DOH: 11/20/21 i) E#23, DOH: 11/14/13 j) E#24, DOH: 5/25/22 k) E#25, DOH: 1/13/22 3. The Agency was unable to provide documentation of staff infection control education as of 8/11/22 at 3:00 PM 4. During an interview on 8/11/22 at approximately 1:00 PM, the Director of Nursing (E#2) verbally agreed the Agency lacked documentation the staff were educated upon hire and at least annually on infection control practices and they should have been educated.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined for 4 of 12 (E#5, E#6, E#7, E#8) staff members, the Home Health Agency (HHA) failed to ensure staff were vaccinated or had approved exemptions. This has the potential to affect all patients and staff of the HHA. Findings include: 1. A request was made for COVID-19 staff vaccination policies and procedures on 08/09/2022 at 9:45 AM. 2. An interview was conducted with the Administrator (E#1) on 08/09/2022 at 3:30 pm. E#1 stated "We are getting copies of the vaccination cards now. We have 3 staff that have exemptions. One staff member had COVID in November, one has been off, and one has never had COVID." When asked if the Agency had a copy of the exemptions request/approval E#1 stated "We will get those." 3. An interview was conducted with Occupational Therapist (E#5) on 08/10/2022 at approximately 9:45 AM. E#5 stated "I previously had my vaccine from my other employer. I have not reviewed the COVID-19 policies for this facility." 4. On 08/10/2022 at approximately 10:00 AM, a "COVID-19 Binder" was presented. Included in the binder were copies of vaccination cards for 8 staff dated 8/12/22, 2 exemption requests (with no indication of approval) that were signed 08/09/2022, and 2 staff with no vaccination card or exemption. Included in the binder was a policy titled "Covid-19 Policy" (dated August 19, 2022) and a policy titled "COVID-19 Questionnaire Policy" (dated August 9, 2022). 5. An interview was conducted E#1 on 08/11/2022 at 11:00 AM, E#1 stated "The policies were developed the evening of 8/9/2022. The COVID-19 policy is dated the19th awaiting board approval."

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 document review and interview it was determined that the Agency failed to 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. This has the potential to effect all patients being served by the HHA with a current census of 42. Therefore the Condition of Participation, 42 CFR 484.105, Organization and Administration of Services was not met, as evidenced by: Findings include: 1. The Governing Body failed to ensure oversight of its overall program and services. See G-942 A 2. The Agency failed to ensure policies were updated. See G-942 B 3. The Agency failed to ensure employees were oriented, trained, and current on all health immunizations. See G-952 A 4. The Agency failed to ensure the Governing Body prepared an Annual Operating Budget and Capital Expenditure Plan. See G-988 5. The Agency failed to ensure nurses were licensed prior to employment. See G-1072 The cumulative effect of these practices resulted in the Agency's inability to determine effectiveness of Agency programs.

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 document review and interview, it was determined the Governing Body failed to ensure oversight of its overall program and services. This has the potential to affect all patients serviced by the Agency with a current census of 42 patients. Findings include: 1. During an interview on 08/09/2022 at approximately 9:00 AM, the Governing Body Meeting Minutes were requested. The Governing Body Meeting minutes were unable to be produced as of the exit conference on 8/11/22 at approximately 3:30 PM. 2. During an interview on 08/11/2022 at approximately 1:00 PM, the Director of Nursing (E#2) verbally agreed the Annual Operating Budget and Capital Expense Report had not been conducted and should have been. 3. During the Entrance Conference on 08/09/2022 at approximately 9:00 AM, the policy and procedure manual was requested. The policies were last updated in 2016. 4. During an interview on 08/10/2022 at approximately 2:00 PM, the Director of Nursing (E #2) confirmed the policies were last updated in 2016.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on document review and interview it was determined for 11 of 11 (E#15, E#16, E#17, E#18, E#19, E#20, E#21, E#22, E#23 E#24, E#25) Patient Care Staff, the Agency failed to ensure employees were oriented, and trained. This has the potential to affect all patients serviced by the Agency with a current census of 42. Findings include: 1. The policy titled "Performance Evaluations" (revised 2015/2016) was reviewed on 8/11/22. The policy noted "It is the policy of... Agency to periodically and routinely evaluate the job performance and competence of each employee... Three (3) months (90 calendar days) after each new employee begins work... One (1) year from each employee's initial date of employment... Annually thereafter on each employee's anniversary date... documentation of each employee's job performance will be maintained and recorded... document will become a permanent portion of each employee's personnel file." 2. The "Position Description/Performance Evaluation" for Physical Therapists, Occupational Therapists, Speech Therapist and Case Managers (Registered Nurses) were reviewed on 8/10/22 at approximately 3:00 PM. The Position Descriptions note each discipline must demonstrate competence and are required to have a current license. 3. The personnel files were reviewed on 8/11/22 at approximately 3:00 PM. 11 of 11 patient care staff lacked documentation of competency skills 4. During an interview on 8/11/22 at approximately 1:00 PM, the Director of Nursing (E#2) reviewed the personnel files and verbally agreed the Agency failed to ensure personnel were qualified and should have been.

Institutional planning CFR(s): 484.105(h) Standard: Institutional planning. The HHA, under the direction of the governing body, prepares an overall plan and a budget that includes an annual operating budget and capital expenditure plan. (1) Annual operating budget. There is an annual operating budget that includes all anticipated income and expenses related to items that would, under generally accepted accounting principles, be considered income and expense items. However, it is not required that there be prepared, in connection with any budget, an item by item identification of the components of each type of anticipated income or expense. (2) Capital expenditure plan. (i) There is a capital expenditure plan for at least a 3-year period, including the operating budget year. The plan includes and identifies in detail the anticipated sources of financing for, and the objectives of, each anticipated expenditure of more than $600,000 for items that would under generally accepted accounting principles, be considered capital items. In determining if a single capital expenditure exceeds $600,000, the cost of studies, surveys, designs, plans, working drawings, specifications, and other activities essential to the acquisition, improvement, modernization, expansion, or replacement of land, plant, building, and equipment are included. Expenditures directly or indirectly related to capital expenditures, such as grading, paving, broker commissions, taxes assessed during the construction period, and costs involved in demolishing or razing structures on land are also included. Transactions that are separated in time, but are components of an overall plan or patient care objective, are viewed in their entirety without regard to their timing. Other costs related to capital expenditures include title fees, permit and license fees, broker commissions, architect, legal, accounting, and appraisal fees; interest, finance, or carrying charges on bonds, notes and other costs incurred for borrowing funds. (ii) If the anticipated source of financing is, in any part, the anticipated payment from title V (Maternal and Child Health Services Block Grant) or title XVIII (Medicare) or title XIX (Medicaid) of the Social Security Act, the plan specifies the following: (A) Whether the proposed capital expenditure is required to conform, or is likely to be required to conform, to current standards, criteria, or plans developed in accordance with the Public Health Service Act or the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963. (B) Whether a capital expenditure proposal has been submitted to the designated planning agency for approval in accordance with section 1122 of the Act (42 U.S.C. 1320a-1) and implementing regulations. (C) Whether the designated planning agency has approved or disapproved the proposed capital expenditure if it was presented to that agency. (3) Preparation of plan and budget. The overall plan and budget is prepared under the direction of the governing body of the HHA by a committee consisting of representatives of the governing body, the administrative staff, and the medical staff (if any) of the HHA. (4) Annual review of plan and budget. The overall plan and budget is reviewed and updated at least annually by the committee referred to in paragraph (i)(3) of this section under the direction of the governing body of the HHA. This STANDARD is not met as evidenced by: Based on interview, it was determined the Agency failed to ensure the Governing Body prepared an Annual Operating Budget and Capital Expenditure Plan. This has the potential to affect all staff and patients/caregivers that receive care by the Agency with a current census of 42 patients. Findings include: 1. During an interview on 8/11/22 at approximately 1:00 PM, the Director of Nursing (E#2) verbally agreed the Annual Operating Budget and Capital Expense Report had not been conducted since 7/1/2021 and should have been.

Registered Nurse CFR(s): 484.115(k) Standard: Registered nurse. A graduate of an approved school of professional nursing who is licensed in the state where practicing. This STANDARD is not met as evidenced by: Based on document review and interview, 3 of 6 (E#19,E#22, E#24) Registered Nurses personnel files reviewed who where actively providing services, it was determined the Agency failed to ensure nurses were licensed prior to employment. This has the potential to affect all staff and patients/caregivers that receive care by the Agency with a current census of 42 patients. Findings include: 1. The policy titled "Current Licensure/Certification and Registration" (revised 2015/2016) was reviewed on 8/11/22. The policy noted "All newly hired employees, whose job requires licensure by the state or other proof of registry or certification, will provide the original document before the employee may assume duties associated with such license." 2. The following personnel files were reviewed on 8/10/22 at approximately 2:00 PM and lacked documentation of license verification: a) E#19, Date of Hire (DOH): 5/31/20 b) E#22, DOH: 11/10/21 c) E#24, DOH: 5/25/22 3. During an interview on 8/11/22 at approximately 1:00 PM, the Director of Nursing (E#2) verbally agreed the licenses were not verified prior to employment and should have been.