Aveanna Healthcare

“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 home health agency failed to ensure the emergency preparedness plan was reviewed and updated at least every 2 years (see tag E0004); address the patient population, including the type of services the home health agency can provide in an emergency (see tag E0007); ensure the emergency preparedness communication plan was updated at least every 2 years (see tag E0029); ensure the emergency preparedness communication plan included names and contact information for staff and patients’ physicians (see tag E0030); identify a means of providing information about the home health agency’s occupancy, needs, and its ability to assist, to the authority having jurisdiction, the Incident Command Center, or designee (see tag E0034); ensure the training and testing program was reviewed and updated at least every 2 years (see tag E0036); conduct exercises to test the emergency plan every 2 years (see tag E0039). The cumulative effect of these systemic problems resulted in the home health agency’s inability to ensure the provision of quality health care in a safe environment and resulted in the agency being found out of compliance with the condition 42 CFR 484.102 Emergency Preparedness.”

“Condition of Participation: Patient rights. CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient’s rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This Condition is not met as evidenced by: Based on record review, observation and interview, the agency failed to ensure the home health aide (HHA) reported changes in skin condition to the registered nurse (RN), and the RN failed to complete a comprehensive assessment that reflected patient’s current skin condition (G430); Based on record review and interview, the agency failed to ensure all patients were provided with consistent communication regarding staffing of HHA visits (G434); Based on record review and interview, the agency failed to ensure all patients received HHA services as ordered in the plan of care (G436); Based on record review and interview, the agency failed to provide written notification of upcoming discharge (G442). The cumulative effect of these systemic problems resulted in the home health agency’s inability to ensure the provision of quality health care for the Conditions of Participation 42 CFR 484.50 Patient Rights.”

“Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This Condition is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the aide competency evaluation was demonstrated on a patient or pseudo - patient (G768); failed to ensure the aide provided services on the plan of care (G800); failed to ensure the aides reported changes in patient condition (G804); failed to ensure supervisory visits were completed every 60 days for non - skilled patients (G814); and failed to ensure the aides were supervised to ensure the aide reported changes in patient status (G818). The cumulative effect of these systemic problems resulted in the home health agency’s inability to ensure the provision of quality health care in a safe environment and resulted in the agency being found out of compliance with the condition 42 CFR 484.80 Home Health Aide Services. *”

“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 ensure the Emergency Plan was reviewed and updated (if needed) every two years for 1 of 1 agency. Findings include: A review of the agency Emergency Preparedness Plan evidenced a revision date of 3/30/2021, with no review date listed. During an interview on 4/17/2024 at 1:25 PM, the Administrator verified the document titled “Emergency Preparedness Plan” was the agency emergency plan. The Administrator indicated the Emergency Preparedness Plan should be updated when there is a new administrator and quarterly. The Administrator confirmed they did not have the date the plan was last reviewed.”

“EP Program Patient Population CFR(s): 484.102(a)(3) §403.748(a)(3), §416.54(a)(3), §418.113(a)(3), §441.184(a)(3), §460.84(a)(3), §482.15(a)(3), §483.73(a)(3), §483.475(a)(3), §484.102(a)(3), §485.68(a)(3), §485.542(a)(3), §485.625(a)(3), §485.727(a)(3), §485.920(a)(3), §491.12(a)(3), §494.62(a)(3). [(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:] (3) Address [patient/client] population, including, but not limited to, persons at-risk; the type of services the [facility] has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.** *[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 all of the following: (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. *NOTE: [“Persons at risk” does not apply to: ASC, hospice, PACE, HHA, CORF, CMCH, RHC/FQHC, or ESRD facilities.] This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Emergency Plan addressed the patient population and services the agency could provide in an emergency for 1 of 1 agency. Findings include: The agency Emergency Preparedness Plan indicated it should address the patient population and the services the agency could provide in an emergency but failed to address those elements. During an interview on 4/17/2024 at 1:25 PM, the Administrator indicated the Emergency Preparedness Plan did not specifically address those elements.”

“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 ensure the Emergency Preparedness Communication Plan was reviewed and updated every two years for 1 of 1 agency. Findings include: A review of the agency Communication Plan failed to identify the date the Communication Plan was last reviewed. During an interview on 4/17/2024 at 1:25 PM, the Administrator indicated they did not know the last review date.”

“Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Emergency Preparedness Communication Plan included updated employee contact information and failed to identify patient physician names or contact information for 1 of 1 agency. Findings include: A review of the emergency binder included a list of employees with phone numbers. The list failed to list all current employees and included terminated employees. The binder included patient information but failed to evidence physician names and phone numbers. During an interview on 4/17/2024 at 1:25 PM, the Area Supports Manager indicated the employee contact list should have been updated with any staff change. The Area Supports Manager indicated they would look up each patient’s physician information in the electronic medical record. The Administrator indicated that would not be practical in an emergency.”

“Information on Occupancy/Needs CFR(s): 484.102(c)(6) §403.748(c)(7), §416.54(c)(7), §418.113(c)(7) §441.184(c)(7), §482.15(c)(7), §460.84(c)(7), §483.73(c)(7), §483.475(c)(7), §484.102(c)(6), §485.68(c)(5), §485.68(c)(5), §485.727(c)(5), §485.542(c)(7), §485.625(c)(7), §485.920(c)(7), §491.12(c)(5), §494.62(c)(7). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (7) [(5) or (6)] A means of providing information about the [facility’s] occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For ASCs at 416.54(c)]: (7) A means of providing information about the ASC’s needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For Inpatient Hospice at §418.113(c):] (7) A means of providing information about the hospice’s inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Emergency Preparedness Communication Plan included a process for communicating the agency’s capacity, needs, and ability to aid to the identified community officials for 1 of 1 agency. Findings include: A review of the Emergency Preparedness Plan failed to include a process to identify and communicate the capacity, needs, and ability to provide assistance to the designated officials. During an interview on 4/17/2024 at 1:25 PM, the Administrator indicated there was no process in place for this communication.”

“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 maintain an emergency preparedness training and testing program that is based on the emergency plan, risk assessment, policies and procedures, and the communication plan and be reviewed and updated at least every 2 years for 1 of 1 agency. Findings include: During an interview on 4/17/2024 at 1:25 PM, the Administrator indicated they did not know the last time the Emergency Preparedness training was updated.”

“EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to test their emergency plan activation once every two years for 1 of 1 agency. Findings include: A review of the agency event tracking log evidenced “actual events” of a tornado watch and wind advisory. The documentation indicated the emergency plan was activated and they communicated the weather conditions to the families and nurses. A review of the agency Hazard Vulnerability Assessment failed to include a tornado watch or wind advisory as a risk. During an interview on 4/17/2024 at 1:25 PM, the Administrator indicated those events did not test the full emergency plan.”

“Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient’s condition warrants due to a major decline or improvement in the patient’s health status, but not less frequently than- This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was updated according to changes in the patient’s condition for 1 of 1 active record reviewed with wounds (Patient #1). Findings include: 1. A review of an agency policy titled “Comprehensive Assessment” indicated the comprehensive assessment must be updated and revised as frequently as the patient’s condition warrants. 2. A review of the clinical record of Patient #1, included plans of care for certification periods 01/26/24 – 03/25/24 and 03/26/24 – 05/24/24. The POC identified the following diagnosis, but not limited to, quadriplegia (paralysis of upper and lower body). The POC included frequency orders for a skilled nurse to perform visits as needed for any changes in condition including a change in skin condition. A review of home health aide (HHA) visit records for dates 01/01/24 through 02/09/24 and on 03/22/24 indicated Patient #1 had alterations in skin integrity. Documentation failed to evidence the home health aides communicated the skin condition of Patient #1 to the home health office or to a registered nurse (RN). Review of an agency document titled “Patient Assessment Recertification Form” completed by RN 1 on 01/24/24 indicated Patient reported having a sacral wound, unsure of the size, that had top layer of the skin off with some bleeding. Documentation indicated a second wound located to the outer part of the left ankle and end of the fibula, with a length of 1.5 cm and width of 1.5 cm. Documentation failed to evidence RN 1 performed a skin assessment of the sacral wound to identify the patient’s skin condition. A review of an agency document titled “Case Supervision/Interim Assessment” completed by RN 1 on 02/21/24 indicated Patient #1 was sitting in a wheelchair and told RN 1 his/her wound to the tailbone was closed at this time. Documentation failed to evidence RN 1 assessed the skin to the tailbone. 3. During an interview on 04/04/24 at 1:55 PM, when asked what is done if skin issues are observed when providing patient care, HHA 4 indicated he/she would document skin issues in the section for skin or in the narrative section. During an interview on 04/04/24 at 3:00 PM, when asked about the status of wounds of Patient #1, RN 1 indicated patient did not have wounds on his/her last visit and generally referred the patient to a wound clinic. During an interview on 04/04/24 at 4:10 PM, when asked to describe the process a HHA should follow when skin issues are observed, the clinical supervisor indicated the HHA should notify the RN, who would go out to assess skin. During an interview on 04/08/24 at 9:00 AM, when asked what type of wound assessment and care the RN provides, Patient #1 indicated the nurse looks at skin when sitting in chair and has helped with getting dressings for the wound. 410 IAC 17-14-1(a)(1)(B)”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the physician was notified of missed visits for 1 of 2 active records reviewed of patients receiving only skilled nurse services (Patient #2). A review of an agency policy titled “Physician Orders” indicated the physician must be promptly alerted if the Plan of Care (POC) should be altered. A review of the clinical record of Patient #2, included a POC for certification period 02/25/24 – 04/24/24 that indicated a SN visit frequency of 6-8 hours a day for 2-4 days a week. A review of the SN visits made for Patient #2 indicated SN visits were scheduled for the week of 03/31/24-04/06/24. Documentation failed to evidence SN visits were made and failed to evidence the physician was notified about the missing visits. During an interview on 04/15/24 at 10:40 AM, when asked why no SN visits were made the week of 03/31/24-04/06/24, RN 1 indicated either RN 3 or the Patient’s family member was off, and RN 1 indicated she does not do anything with scheduling. During an interview on 04/15/24 at 12:20 PM, when asked why no SN visits were made the week of 03/31/24-04/06/24, registered nurse (RN) 3 indicated the family went on vacation. 410 IAC 17-13-1(a)”

“Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide’s performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure home health aide competencies included all subject areas with the use of a patient or pseudo patient for 3 of 3 home health aide (HHA) personnel record reviews. (HHA #2, 3 and 4) Findings include: A review of the personnel record for HHA 2 evidenced an initial competency assessment dated 11/18/2022. The competency assessment included 10 tasks (hand hygiene, bed bath, sponge, tub, or shower bath; shampoo sink/ tub/ bed; nail care and skin care; oral hygiene; shaving; toileting; safe transfer techniques; and normal range of motion and positioning) which were to be demonstrated on a patient or pseudo – patient (someone trained to respond as a patient would during the task). HHA 2’s competency indicated hand hygiene and sponge, tub, or shower bath were demonstrated. The remaining tasks were verbalized. A review of HHA 3’s competency assessment dated 12/19/2022, indicated hand hygiene was demonstrated; bed bath, shampoo, nail and skin care, and oral hygiene were demonstrated and verbalized. The remaining tasks were verbalized. A review of HHA 4’s competency assessment dated 5/22/2023 indicated toileting was demonstrated and verbalized. During an interview on 4/16/2024 at 2:17 PM registered nurse RN 1 indicated many tasks were demonstrated by simulation (walking through the task) while explaining it. 410 IAC 17-14-1(1)(A)”

“Administrator CFR(s): 484.115(a) Standard: Administrator, home health agency. (1) For individuals that began employment with the HHA prior to January 13, 2018, a person who: (i) Is a licensed physician; (ii) Is a registered nurse; or (iii) Has training and experience in health service administration and at least 1 year of supervisory administrative experience in home health care or a related health care program. (2) For individuals that begin employment with an HHA on or after January 13, 2018, a person who: (i) Is a licensed physician, a registered nurse, or holds an undergraduate degree; and (ii) Has experience in health service administration, with at least 1 year of supervisory or administrative experience in home health care or a related health care program. This Standard is not met as evidenced by: Based on record review and interview, the governing body failed to appoint an administrator with one year administrative experience in home health care or related health care experience for 1 of 1 home health agencies. Findings include: 1. A review of the Administrator’s resume evidenced experience in health care recruiting (3 months) and health coaching (2 years), but failed to evidence any administrative experience. During an interview on 4/16/2024 at 12:05 PM, the Administrator indicated they had supervisory experience in the health care recruiting role but did not include it on the resume. The Administrator indicated they did not have administrative experience in home health or similar health care experience.”

“Be free from abuse CFR(s): 484.50(c)(2) Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property; This Element is not met as evidenced by: Based on record review, observation and interview, the agency failed to ensure the home health aide (HHA) reported changes in skin condition to the registered nurse (RN), and the RN failed to complete a comprehensive assessment that reflected patients current skin condition for 1 active record reviewed that resulted in untreated alteration in skin integrity (Patient #1) and for 1 discharged record reviewed of a patient hospitalized with a Stage IV pressure wound (a wound that penetrates all three layers of skin, exposing muscles, tendons and bones) and septic shock (serious condition that occurs when a body-wide infection leads to dangerously low blood pressure) (Patient #7). Findings include: 1. A review of an agency document titled “Patient Packet” indicated the patient’s right to be free from neglect. 2. A review of an agency policy titled “Wound Care Management” indicated wound care management includes a thorough assessment of the wound, wounds will be assessed every visit and includes documentation regarding the wound assessment, wound care, and treatment. 3. A review of the HHA job description indicated the HHA is to report changes in Patient’s condition to an RN. 4. A review of the clinical record of Patient #7, start of care date 12/19/22, included plans of care (POCs) for certification periods 12/14/23 – 02/11/24 and 02/12/24 – 04/11/24. The plans of care identified the following diagnoses, but not limited to, radiculopathy lumbar region (range of symptoms produced by the pinching of a nerve root in the spinal column), post-laminectomy syndrome (pain that continues after undergoing back surgery), muscle weakness and included a new diagnosis on 12/11/23 of an unstaged pressure ulcer (full-thickness pressure wound in which the wound bed is obscured by slough, tissue formed when dead cells and/or bacteria accumulate in a wound, and/or eschar, a collection of dry, dead tissue in the wound bed) of sacral region (between the lower back and tailbone). The plan of care included frequency orders for a home health aide to visit Patient 2-6 hours a day, for 5-7 days a week: up to 42 hours a week. Review of the “Patient Assessment Resumption of Care (ROC) Form” completed on 12/10/23 by RN 1 indicated a coccyx (tailbone) wound was covered with a dressing, was infected, and unstageable. Documentation failed to evidence the RN performed an assessment of the wound and failed to evidence the RN contacted the physician regarding the wound. Review of the case supervisor/interim assessment dated 1/10/24 by RN 1, indicated the patient went to the ER on 1/9/24 due to a laceration to the left knee. When the patient went to the ER in January, they thought the dressing to the sacrum got changed there because the wound was covered. and they were not supposed to remove it to assess it. Review of orders effective 02/08/24 evidenced Collagenase (enzyme used to clean pressure ulcers) was to be applied to the affected skin once a day at bedtime. Orders effective 02/26/24 included the application of a mepilex dressing (foam dressing that shields the wound and contains silver that helps to kill bacteria) to the sacral wound and to be changed every 3 days. Review of the “Patient Assessment ROC Form” completed on 02/26/24 by RN 2 indicated Other A recommended placement of a mepilex dressing on the sacral area that should be changed every 3 days. Documentation indicated RN 2 did not assess the sacral wound because the agency home health aide would not change Patient’s brief while a maintenance person was in patient’s home. Documentation failed to evidence the RN performed an assessment of the wound and failed to evidence the RN contacted the physician regarding the wound. Review of a Visit Record completed by Home Health Aide 3 on 03/18/24 indicated Patient #7 had a wound infection and left the home by ambulance. Review of a “Care Coordination Note” completed on 03/18/24 by RN 2 indicated Patient #7 was taken to the emergency room by ambulance due to increased sacral wound pain and pus-like drainage from the sacral wound. Review of the “Patient Assessment Form” completed on 03/26/24 by RN 2 indicated the assessment data was taken from the 02/26/24 ROC assessment. Documentation indicated the patient would be transferred to a long-term care facility when discharged from the hospital. Review of a document obtained from Other A indicated Patient #7 had a history of paraplegia (paralysis of the lower body) secondary to spinal cord injury from back surgery and indicated Patient #7 was admitted to the hospital from 03/18/24 – 03/28/24 for a worsening sacral ulcer causing septic shock. Review of the clinical record failed evidence Patient #7 received skilled nursing services since the patient developed the wound on December 10, 2023, and per ordered by the wound clinic and failed to coordinate with the wound clinic and patient to ensure treatments are being done. Review of the Discharge Summary completed on 03/26/24 by RN 2 indicated Patient #7 was discharged from home health services and would be transferred from the hospital to a long-term care facility. During an interview on 04/09/24 at 11:45 AM, when asked who was responsible for the wound management of Patient #7, RN 1 indicated was the wound clinic. When asked for the name of the wound clinic and the frequency of wound clinic visits, RN 1 indicated did not know. When asked why a wound assessment was not completed during the ROC assessment on 12/10/23, RN 1 indicated because they didn’t think the home health agency was to do anything with wounds that are covered with dressing by the wound clinic. During an interview on 4/9/2024 beginning at 11:45 AM, RN 1 indicated she thought that the affected area was the knee. RN 1 indicated the patient was going to the wound clinic on 2/12/24 so no wound assessment was done. RN 1 indicated she was not sure how the patient could apply the Mepilex dressing to the sacral wound and indicated the patient had a friend that might apply and change the dressing. RN 1 indicated she did not know how often the patient goes to the wound clinic. RN 1 indicated she assumed the wound clinic was responsible for the patient’s wounds. 5. A review of the clinical record of Patient #1, start of care date 08/24/20, included POCs for certification periods 01/26/24 – 03/25/24 and 03/26/24 – 05/24/24. The plans of care identified the following diagnosis, but not limited to, quadriplegia (paralysis of upper and lower body). The POC included frequency orders for a home health aide to visit Patient 1-2 hours a day, for 4-7 days a week; up to 14 hours a week, and for the home health aide to report any unusual occurrences to the office. Review of the “Patient Assessment Recertification Form” completed by RN 1 on 01/24/24 indicated patient reported having a sacral wound, unsure of the size, that had the top layer of the skin off with some bleeding. Documentation evidenced RN 1 asked Patient #1 if going to contact the wound clinic and Patient #1 responded would like to wait a week. Documentation indicated a second wound located on the outer part of the left ankle and end of the fibula, with a length of 1.5 cm and width of 1.5 cm. Documentation failed to evidence RN 1 performed a skin assessment of the sacral wound and failed to contact the physician to obtain orders or interventions to manage the wounds. During a home visit with Patient #1 on 04/08/24 between 9:00 AM and 9:45 AM, during a skilled nurse assessment, RN 1 placed the stethoscope on Patient’s back to listen to breath sounds. Patient #1 reported he/she had placed a dressing to lower back area to cover dead skin. RN 1 failed to remove the dressing to observe the skin and failed to transfer Patient from the wheelchair to the bed to perform a skin assessment. During an interview on 04/08/24 at 10:15 AM, when asked why a skin assessment was not performed during the home visit with Patient #1, RN 1 indicated she does not assess the skin of patients when they are dressed and sitting in a chair and does assess the skin if performing home health aide care. During an interview on 04/09/24 at 11:45 AM, when asked who is responsible for the management of Patient #1’s wound, RN 1 indicated the patient likes to take care of himself/herself or go to the wound clinic. When asked if Patient #1 would be able to apply a wound dressing to the sacral area, RN 1 indicated she had never seen Patient apply a dressing. 6. During an interview on 04/04/24 at 4:10 PM, when asked to describe the process a HHA should follow when observes skin issues, the clinical supervisor indicated the HHA should notify the RN, who would go out to assess skin and if the wound needs to be addressed by the physician, the RN would contact the physician and follow physician orders. When asked if the nurse would measure the wound, the clinical supervisor indicated she would expect the RN to observe and not necessarily measure. 410 IAC 17-12-3(b)(2)(B)”

“Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patients were provided with consistent communication regarding staffing of home health aide (HHA) visits for 1 of 1 active record reviewed with a home visit made (Patient #1). Findings include: 1. A review of the clinical record of Patient #1, start of care date 08/24/20, included plans of care for certification periods 01/26/24 – 03/25/24 and 03/26/24 – 05/24/24 that included frequency orders for a home health aide to visit patient 1-2 hours a day, for 4-7 days a week: up to 14 hours a week. A review of the HHA visits made for Patient #1 indicated 1 HHA was visit made the week of 02/04/24-02/19/24, no HHA visits were made the week of 02/11/24-02/17/24, 1 HHA visit was made the week of 02/18/24-02/24/24, no HHA visits made from 02/25/24-03/16/24, and 1 HHA visit was made the week of 03/17/24-3/30/24, which was the last HHA visit made. A review of agency scheduling documentation entered on 02/08/24 by Scheduler 1 indicated Patient #1 asked to be told the truth about his/her HHA schedule and to be notified when he/she would or would not have an HHA visit. Review of agency scheduling documentation entered on 03/25/24 by Scheduler 1 indicated she had notified Patient #1 that HHA 5 would begin making visits on 03/27/24. Review of agency scheduling documentation entered on 04/04/24 by Scheduler 1 indicated Patient #1 had been notified by the administrator of upcoming discharge due to a lack of staffing. 2. During an interview on 04/04/24 at 3:36 PM, when asked how often the agency contacted him/her about HHA visits that couldn’t be made, Patient #1 indicated he/she was not notified and sometimes received a call that an HHA would be making a visit but couldn’t rely on the HHA to show up. During an interview on 04/04/24 at 4:10 PM, when asked to see the documentation of communication with Patient #1 regarding HHA visits, the administrator indicated having spoken with Patient #1 on 03/29/24 regarding upcoming discharge due to staffing and was unable to provide documentation of the conversation. Review of the clinical record failed to evidence the agency provided consistent communication regarding their inability to staff HHA services. During an interview on 04/08/24 at 9:45 AM, when asked about the communication the home health agency provided regarding HHA scheduling, Patient #1 indicated the scheduler told him/her lies about looking for HHA’s to provide care and told Patient #1 she had sent a HHA out and never heard from the HHA. 410 IAC 17-12-3(b)(2)(D)(ii)(AA)”

“Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patients received home health aide (HHA) services as ordered in the plan of care (POC) for 1 of 1 active record reviewed with a home visit made (Patient #1) and for 1 of 2 closed records reviewed (Patient #6). Findings include: 1. A review of an agency document titled “Patient Packet” indicated patients have the right to receive services as outlined in the POC. 2. A review of the clinical record of Patient #1 included plans of care for certification periods 01/26/24 – 03/25/24 and 03/26/24 – 05/24/24 that included frequency orders for a HHA to visit patient 1-2 hours a day, for 4-7 days a week: up to 14 hours a week. A review of the HHA visits made for Patient #1 indicated 1 HHA visit was made the week 02/04/24-02/19/24, no HHA visits were made the week of 02/11/24-02/17/24, 1 HHA visit was made the week of 02/18/24-02/24/24, no HHA visits were made from 02/25/24-03/16/24, and 1 HHA visit was made the week of 03/17/24-3/30/24. The schedule failed to evidence HHA visits were made according to the POC. During an interview on 04/04/24 at 3:00 PM, when asked if Patient #1 had a change in his/her needs for HHA services, registered nurse (RN) 1 indicated she was not aware of any changes. When asked why there were so many missed HHA visits for Patient #1, RN 1 indicated the agency had difficulty staffing HHA’s. 3. A review of the clinical record of Patient #6 included a POC for certification period 01/13/24 – 03/12/24 that included frequency orders for a HHA to visit patient 2-4 hours a day, for 3-5 days a week. A review of the HHA visits for Patient #6 failed evidenced any HHA visits were made from 01/17/24-02/08/24, which was the date of discharge. A review of an agency document titled “Care Coordination Note” entered by RN 1 on 01/17/24 indicated Entity C notified RN 1 that Patient #6 was taken to the emergency room on 01/16/24. A review of an agency document titled “Care Coordination Note” entered by RN 1 on 01/26/24 indicated Entity C notified RN 1 that Patient #6 requested resuming services for Mondays, Wednesdays, and Saturdays. A review of a Physician Order entered on 02/01/24 by RN 1 indicated Patient #6 requested that HHA services be placed on hold effective 02/16/24. During an interview on 04/05/24 at 10:24 AM, when asked why HHA services were put on-hold for Patient #6, RN 1 indicated Patient #6 wanted to place HHA services on-hold. When asked what happened with the request on 01/26/24 from Entity C to resume services for Patient #6, RN 1 indicated did not remember if contacted the scheduler about resuming services During an interview on 04/05/24 at 2:42 pm, when asked why the order dated 02/01/24 for Patient #6 indicated HHA services were on hold 02/16/24, which was after patients discharge on 02/08/24, RN 1 indicated the date for placing on hold should have been 01/16/24. 410 IAC 17-12-3(b)(2)(E)”

“Investigate complaints made by patient CFR(s): 484.50(e)(1)(i) The HHA must— (i) Investigate complaints made by a patient, the patient’s representative (if any), and the patient’s caregivers and family, including, but not limited to, the following topics: (A) Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately; (B) Mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of patient property by anyone furnishing services on behalf of the HHA. This Element is not met as evidenced by: Based on record review and interview, the agency failed to investigate a complaint regarding concerns in the areas of care, professionalism, and property loss/damage, for 1 of 1 complaints of misappropriation of patient property, failure to provide aide services, and unprofessional employee behavior. Findings include: A review of the complaint policy indicated complaints should be documented and include the complaint, action taken, and complaint resolution. The complaint log included a complaint form dated 3/28/2024 which lacked the details, the actions of the complaint, and the resolution of the complaint. During an interview on 4/4/2024 at 4 PM, the Administrator indicated the agency did not complete the details of the complaint since the complaint was under investigation. The agency provided the details of the complaint on 4/5/2024. The complaint included allegations of misappropriation of property, the aide leaving or not showing up for the hours scheduled, and unprofessional behavior by the aide. The details failed to include investigation information or actions.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on record review, observation, and interview, the agency failed to ensure that all patients received a complete and accurate comprehensive assessment which included the patient’s current health status for 1 of 1 active record reviewed with wounds (Patient #1), and for 1 of 1 discharged record reviewed with wounds (Patient #7). Findings include: A review of an agency policy titled “Comprehensive Assessment” indicated each patient will receive a patient specific, comprehensive assessment that will include the patient’s current health status. A review of the clinical record of Patient #1, included a plan of care (POC) for certification period 03/26/24 – 05/24/24 that identified the following diagnosis, but not limited to, quadriplegia (paralysis of upper and lower body). During a home visit on 04/08/24 at 9:00 AM, RN 1 performed an assessment of Patient #1 who was sitting in a wheelchair. Registered nurse (RN) 1 was observed pushing Patient #1 forward in wheelchair to listen to breath sounds and observed a dressing to the lower back of Patient #1 and observed RN 1 feel for pedal pulses on the top of both feet. RN 1 failed to remove the dressing to the lower back and assess the skin and failed to remove the socks on both feet to assess the skin. During an interview on 04/08/24 at 10:15 AM, when asked why the skin was not assessed during the visit with Patient #1, RN 1 indicated does not assess the skin of patients when they are out of bed and dressed. A wound care policy indicated wound care management included the completion of a skilled assessment which would be completed at each visit and include the location, presence of granulation tissue (a sign of wound healing) or necrosis (tissue death), color, odor, drainage, and condition of the surrounding skin; patient’s response to wound care, and the effectiveness of ordered wound care treatment. A review of the clinical record for Patient #7 included a comprehensive assessment dated 12/10/2023 (following a hospitalization 11/30/2023 – 12/9/2023), completed by registered nurse (RN) 1. A new wound was documented, however, the location, measurements and characteristics of the wound bed and edges were not included in the documentation. A review of the hospital documentation obtained from Entity E (not part of the agency clinical record) indicated Patient #7 was admitted for increased sacral (area just above the tailbone) pain to an existing sacral pressure wound. A comprehensive assessment dated 2/26/2024 by RN 2indicated Patient #7 had been hospitalized and had wound care orders for a scraped thigh and a sacral wound. The wound assessment was not completed. The RN failed to include a wound assessment as part of the comprehensive assessments. During an interview on 4/4/2024 at 4 PM, the Clinical Director indicated the nurse should complete a wound assessment on a new wound. When asked, the Clinical Director indicated the wound assessment would include visualizing the wound, but not necessarily measuring it. The Clinical Director indicated the agency does not have wound care nurses. During an interview on 4/9/2024 at 11:45 AM, RN 1 indicated wound assessments were not completed on patients who received wound care from a wound clinic. RN1 indicated Patient #7 would have wound assessments and care completed by a wound clinic.”

“Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient’s updated comprehensive assessment, and contain information concerning the patient’s progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure revised plans of care (POC) were supported by the recertification comprehensive assessment for 1 of 2 active records reviewed with skilled nurse (SN) services only (Patient #2) and for 1 of 2 discharged records reviewed (Patient #7). Findings include: A review of an agency policy titled “Physician Orders” indicated revised POCs must reflect current information from the patient’s updated comprehensive assessment. A review of the clinical record of Patient #2 included a POC for certification period 02/25/24 – 04/24/24 that indicated a SN intervention, effective 08/11/23, for the SN to monitor rectal wound measurements and characteristics. During an interview on 04/15/24 at 10:40 AM, when asked to describe the rectal wound of Patient #2, RN 1 indicated Patient #2 had a reddened area at the time of his/her initial assessment due to a wet diaper but did not have skin breakdown. When asked when the wound healed, RN 1 indicated had forgotten to discontinue the SN intervention. A review of the plan of care (POC) completed by registered nurse (RN) 1 dated 12/12/2023 identified a new pressure ulcer of the sacrum (area just above the tailbone). The date the wound was identified by the agency was 12/11/2023. The POC included new nursing interventions of assessing the site of a new PICC line (a type of intravenous access) at each visit. The POC indicated “PICC line is to be solely managed by [Entity E].” The POC failed to include any interventions related to the care of the wound itself but indicated Patient #7 would see the wound clinic. During an interview on 4/9/2024 at 11:45 AM, RN 1 indicated the wound clinic was responsible for the care of the wound.”

“Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient’s needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure that the patient’s clinical records included information about the services the patient received from other health providers and failed to ensure they coordinated care delivery to meet the patient’s needs for 2 of 2 patients receiving wound care reviewed. (Patients: #1, and 7) Findings Include: 1. The Nursing Supervisor’s job description included the responsibility to coordinate care for assigned patients. 2. A review of the clinical record for Patient #1 included an assessment update dated 2/21/2024 by registered nurse (RN) 1, indicated Patient #1 said the wound on the coccyx (tailbone) was closed but does reopen at times. The patient indicated they had not gone to the wound clinic. A comprehensive assessment dated 1/24/2024, completed by RN 1, indicated Patient #1 reported an unknown-sized sacral (area just above the tailbone) wound but missing the top layer of skin and evidenced some bleeding. The note indicated RN 1 asked Patient #1 if they were going to the wound clinic, and the patient indicated they wanted to wait a week. During an interview on 4/4/2024 at 3 PM, RN 1 indicated they don’t usually provide wound care but refer patients to the wound clinic. RN 1 indicated that Patient #1 saw Entity B and coordinated visits himself. RN 1 indicated they did not know when Patient #1 saw Entity B. 4. During an interview on 4/4/2024 at 3:36 PM, Patient #1 indicated they received wound care from Entity B. The home health agency did not provide wound assessment or care. 5. During an interview on 4/15/2024 at 9:27 AM, Entity B indicated they did not have documentation that Patient #1 received home health care. 6. A review of the clinical record for Patient #7 included a comprehensive assessment dated 12/10/2023, completed by registered nurse (RN) 1, which indicated Patient #7 would see Entity A for wound care. A review of an assessment update dated 1/10/2024, completed by RN 1, indicated Patient #7 had an appointment with Entity A on 1/24/2024. A review of a comprehensive assessment dated 2/26/2024, completed by RN 3, indicated Entity A was caring for Patient #7’s wound. A review of 11 coordination notes dated 1/9/2024 – 3/25/2024 failed to evidence coordination with the wound clinic regarding Patient #7. During an interview on 4/15/2024 at 9:46 AM, Patient # 7 indicated they never went to Entity A for wound care until after they were discharged from the home health agency. Patient #7 indicated they had no transportation to go to Entity A. 7. During an interview on 4/9/2024 at 11:45 AM, RN 1 indicated Entity A was responsible for Patient #7’s wound management. When asked, RN 1 indicated they did not know how often or which wound clinic Patient #7 used. 8. A review of documentation from Entity A (not part of the agency clinical record) indicated Patient #7’s first visit was on 4/1/2024. During an interview on 4/9/2024 at 11:16 AM, Entity A confirmed Patient #7 was first seen on 4/1/2024.”

“Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the licensed practical nurse (LPN) was supervised by a registered nurse (RN) for 1 of 1 patients who received services from an LPN. (RN 2) Findings include: A review of the nursing supervisor job description indicated the registered nurse (RN) was responsible for ongoing supervisory visits to evaluate clinical care. A review of the clinical record for Patient #5 indicated all hands-on care was provided by LPN 1. The record failed to evidence supervisory visits since 1/25/2024. During an interview on 4/15/2024 at 4:34 PM, LPN 1 indicated the RN came out once a month and assessed the patient, but did not do supervisory visits at that time. During an interview on 4/17/2024 at 1:10 PM, RN 2 indicated there were no supervisory visits as the nurse leaves as soon as Patient #5 returns from school and it was difficult to schedule a visit. 410 IAC 17-14-1(a)(1)(J)”

“Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the home health aides (HHA) provided services that were included in the HHA plan of care (POC) for 2 of 3 active records reviewed of patients receiving HHA services only (Patient #1, 4). Findings include: 1. A review of an agency policy titled “Aide Assignments and Duties (Care Plan)” indicated a HHA provides services as ordered in the POC. A review of a HHA job description indicated the HHA provides services as ordered by the physician in the POC. 2. A review of the clinical record of Patient #1 included an agency document titled “Visit Record” completed by HHA 4 on 01/11/24 that indicated HHA 4 applied triple antibiotic ointment to the open area on Patient #1’s tailbone. During an interview on 04/16/24 at 2:25PM, when asked when a HHA could apply triple antibiotic ointment on a patient, RN 1 indicated HHAs cannot apply medicated ointments. 3. A review of the clinical record of Patient #4 included an agency document titled “Care Plan Assessment” completed by registered nurse (RN) 2 on 03/19/24 that indicated the HHA was to assist patient with a shampoo daily. During an interview on 04/08/24 at 8:00 AM, when asked what care the HHA provides, HHA 2 indicated he/she has used Nizoral (used for dandruff) shampoo on Patient #4 for about a month. Documentation failed to evidence a HHA intervention in the HHA POC to use Nizoral shampoo.”

“Aides are members of interdisciplinary team CFR(s): 484.80(g)(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient’s condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA’s policies and procedures. This Element is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the home health aide (HHA) reported changes in the patient’s condition to the registered nurse (RN) for 1 of 1 active record reviewed of patients with wounds (Patient #1) and for 1 of 2 discharged patients with wounds (Patient #7). Findings include: A review of an agency policy titled “Home Health Aide Assignments and Duties” indicated HHAs must report changes in the patient’s condition to an RN. A review of the HHA job description indicated the HHA must observe and report changes in patient’s condition to an RN. A review of the clinical record of Patient #1 included home health aide (HHA) visit records for dates 01/01/24 through 02/09/24 and on 03/22/24 that indicated Patient #1 had alterations in skin integrity. Documentation failed to evidence the home health aides communicated the skin condition of Patient #1 to a registered nurse (RN). During an interview on 04/04/24 at 4:10 PM, when asked to describe the process a HHA should follow when skin issues are observed, the clinical supervisor indicated the HHA should notify the RN, who would go out to assess the patient’s skin. A clinical record review for Patient #7 indicated the patient received home health aide (HHA) services twice daily. A review of the aide note for 3/12/2024, completed by HHA 3, indicated there were no signs of skin breakdown. In the narrative section of the note, HHA 3 reported “I believe [Patient #7] has an infection that needs medical attention, open wound, pus drainage, and an odor. refuses [sic] to contact primary physician. getting [sic] sick/ weaker by the day.” The note failed to indicate HHA 3 notified the registered nurse (RN) of the change in condition. An aide note on 3/18/2024 indicated Patient #7 took an ambulance to Entity E for an infection. The note failed to indicate HHA 3 notified the RN of the change in condition. A review of documentation obtained from Entity E (not part of the agency medical record) indicated Patient #7 was admitted due to a chronic pressure wound. The documentation indicated the patient reported the wound getting more infected over the previous week. During an interview on 4/4/2024 at 4 PM, RN 2 indicated HHA 3 failed to appear to the office for coaching regarding the failure to notify the RN of Patient #7’s change in status on 3/12/2024. RN 2 indicated the agency considered HHA 3 terminated due to the failure to report to the office.”

“Non-skilled direct observation every 60 days CFR(s): 484.80(h)(2) If home health aide services are provided to a patient who is not receiving skilled nursing care, physical or occupational therapy, or speech-language pathology services, the registered nurse must make an on-site visit to the location where the patient is receiving care no less frequently than every 60 days in order to observe and assess each aide while he or she is performing care. This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure a registered nurse (RN) made an on-site visit to supervise the HHAs (Home Health Aide) at least every 60 days for 1 of 3 active records reviewed of patients receiving non-skilled nursing services (Patient # 1) and in 1 of 2 discharged records reviewed of patients receiving non-skilled nursing services (Patient #7). Findings include: A review of the clinical record for Patient #7 evidenced the patient received non- skilled nursing services. The record failed to include documentation of supervisory visits since 10/12/2023. During an interview on 4/17/2024 at 1:10 PM, RN 2 indicated there were no supervisory visits since 10/12/2023. A review of the clinical record of Patient #1, start of care date 08/24/20, included plans of care (POC) for certification periods 01/26/24 – 03/25/24 and 03/26/24 – 05/24/24 that indicated the RN to perform HHA supervisory visits approximately every 30 days. A review of the RN visits made indicated the last HHA supervisory visit was made on 11/22/23. During an interview on 04/15/24 at 3:25 PM, when asked when supervisory visits were completed for Patient #1, RN 1 indicated did not know was supposed to put in supervisory visits until one week ago and indicated the HHA’s were not present during his/her visits with Patient #1 in February and March of 2024 so no supervisory visits were completed.”